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"Notes" "Symptoms" "Symptoms Code" "Vaccine Manufacturer" "Vaccine

Manufacturer Code" "Age" "Age Code" "VAERS ID" "VAERS ID Code" Adverse
Event Description Adverse Events After Prior Vaccinations
"COVID-19" "10084268" "JANSSEN" "592" "40-49 years" "40-49"
"1343571-1" "1343571-1" "Patient received their J&J vaccination on 4/7/2021.
The patient's wife tested positive on 4/12/2021. The patient tested positive on
4/23/2021. The patient presented to the ER with a severe progressive cough
(starting one week prior), worsening shortness of breath, a high fever, chills,
myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with
hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana.
The patient was admitted on the 23rd and continued to decline until their eventual
passing on 4/28/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "40-49 years" "40-49"
"1420257-1" "1420257-1" "hospitalized with respiratory distress and death"
"No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "50-59 years" "50-59"
"1266953-1" "1266953-1" "It was reported that patient had been experiencing
difficulty breathing, walking and delusions as per his fiancT . Fiance notified
Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the
Clinic and they refused to evaluate patient beyond performing a PCR swab test so,
they went back to their apartment. An SMS notification was sent on 1-Apr-21
indicating that patient was COVID-19 positive which was not seen by patient or
fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's
friend and advised him the patient was sick, not able to walk, and having
difficulty." "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "50-59 years" "50-59"
"1350433-1" "1350433-1" "Presented 5/13 to Hospital. Presented to Hospital
on 5/13 with one week of symptoms including cough, dyspnea, diarrhea. COVID-19
testing was positive on 5/8. Treatments prior to arrival included remdesivir and
dexamethasone, started 5/13. She was also placed on pulse dose steroids 1000
mg/day methylprednisolone given her history of ground glass lung opacities in 2018.
Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on
5/17. Paralysis and proning initiated. Transferred to another hospital for
possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid
who has failed treatment with the ventilator despite paralysis and proning. CTS
asked to place patient on VV ECMO. 5/20/21 1135am initiated ECMO Patient is a
50yr old female with past medical history of hypertension, asthma, OSA and obesity
BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of
breath for about a week. Of note, patient also has a history of respiratory
failure presenting with ground glass opacities on CT scan in 2018 with unclear
etiology despite bronchoscopy and serologic studies which resolved with high dose
corticosteroids. Patient recently tested positive for COVID on 5/8 and received
johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with
decadron, remdesivir and tocilizumab. Course complicated by progressive
respiratory failure requiring HFNC followed by Bipap and ultimately intubation on
5/17. Due to elevated d-dimer, lower extremity dopplers were obtained which were
negative, however a heparin gtt was initiated. Course further complicated by cold
left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus
extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore
heparin was switched to argatroban and a HIT panel was sent. On 5/19 patient
continued to decline despite paralytic and pronning. Patient transferred to ICU
for further level of care and VV ECMO evaluation. On arrival patient was started on
veletri; however due to continued respiratory decline a shock call was placed for
VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient
was felt to have an IVC thrombus as clot was seen going into the ECMO circuit
during cannulation. Post cannulation she developed worsening septic shock and DIC.
She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L
albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors
(Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR.
Patient then continue to have worsening hemodynamic instability and went into PEA
and ultimately asystole. She was pronounced deceased at 1815. Family was en route
already due to her instability thus will be notified of her passing once they
arrive. Dr. was notified of patients death." "No prior vaccinations for this
event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1208583-1" "1208583-1" "Chills, Fever,fatigue. Tested positive for COVID on
3/22 and died on 3/29" "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1218602-1" "1218602-1" "colonic necrosis 62 yo woman history of prior L
occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental
status changes. Patient was noted to be in severe metabolic acidosis, renal
failure and shock. Chest x-ray showed interstitial infiltrates and she tested
positive for SARS-CoV2. She required intubation and mechanical ventilation. CT
brain showed encephalomalacia and atrophy, no new changes. She was transferred on
April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she
was only treated with steroids, then antibiotics were added for fever and
persistent hypotension. She started to spike fevers up to 40. Abdominal CXR
ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13
abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV,
portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were
310k, as low as 260 on April 8." "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1266936-1" "1266936-1" "Employee developed a fever and chills on 01-Apr-21
which he managed with Tylenol. Symptoms resolved as per patient who contributed the
symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and
requested a day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the
physician who ordered some labs which were normal. He was then advised to complete
PCR swab and was notified on 12-Apri-21 that his test is positive. As per the
protocol, all COVID-19 positive individuals must report to the Health Center within
24 hours of notification and complete 10 days home isolation. During isolation, on
17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and
notified his supervisor who called 112 for an ambulance. He was transferred to
Hospital. Evaluated and started treatment for pneumonia and was transferred to
Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became
hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD
unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-
21 Dr. from the hospital called and stated that patient expired at 0830." "No
prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1270605-1" "1270605-1" "His brother reporting that he got the vaccine, the
following day he was coughing. The coughing caused him not to be able to sleep and
was weak due to that. He could feel his throat closing and he was having a hard
time breathing and he called his brother who told him to call 9-1-1. He was taken
to Medical Center 4/17/2021, diagnosed with possibly COVID. He was admitted to
the COVID ward and he died on 4/26/2021. The doctor that pronounced him was .
Cause of death diagnosis. Hypoxic respiratory arrest, COVID 19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1302490-1" "1302490-1" ""On 4/26/21 The patient presents to our clinic with
concerns for back pain, fever, shortness of breath, fatigue and coughing. We
performed a covid19 antigen test which resulted positive. Based on this and his
history and examination we recommended he go straight to the hospital for further
evaluation and treatment. He was admitted to medical center where a PCR was
performed and confirmed positive. He was discharged on 4/29. Per his wife, they
felt he was discharged too soon and he went to another hospital. He passed away
5/10/2021. This report is being made in regards to the claim by the CDC that ""no
one that has been infected with covid19 4 weeks after having the janssen vaccine
has been hospitalized."" This patient was not only hospitalized but passed away.""
"No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1331122-1" "1331122-1" "Patient was vaccinated on 3/31/21. Noted to be
positive for Covid on 4/19/21 and passed away on 5/8/21. Per the lab report, this
is the information for the ordering provider: He had an emergency contact but
no number. Phone number for patient is no longer operational." "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "60-64 years" "60-64"
"1437342-1" "1437342-1" "Death 5/21/2021 Causes of death listed on death
certificate 1) COVID-19 2) ARDS Other: Lung Transplant for cystic fibrosis"
"No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1111699-1" "1111699-1" "Patient developed symptomatic COVID infection with
symptoms starting 3/13, was admitted to the hospital for respiratory failure on
3/16 and expired on 3/18/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1167886-1" "1167886-1" "Patient vaccinated against COVID-19; received COVID-
19 Janssen vaccine on 3/10/2021. Patient developed symptoms last week of March.
Called Provider with symptoms and then presented to the hospital (admitted on
4/1/2021). Tested for COVID and found to be positive. 4/1/2021. Patient
declined, admitted to ICU on 4/3/2021. Patient died on 4/4/2021. Chief
Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH
(has had cough for a little over a week) and FEVER (on and off for about a
week)Patient was seen due to feeling ill for over week. Patient states that she
was trying to fight it on her own but symptoms have been progressing. Patient has
felt feverish no known fevers. Has had a persistent now worsening cough. Patient
is feeling very tired and weak due to being sick for over week. Patient does live
alone. Patient is coughing which is productive with sputum. Patient is eating and
drinking well. No N/V/d. No loss of taste or smell. No recent ill exposure.;
Has had covid vaccine. Patient did get the Johnson and Johnson vaccine over a
month ago. Patient is feeling very fatigue; Having feverish/chills. Patient is
taking OTC nightquil which is no longer helping. Patient does see oncologist for
her CLL. DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4.
Anemia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL
COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19
pneumonia with complications of hypoxia. Patient's symptoms of cough and shortness
of breath have been present for approximately 2 weeks. It was noted that 1 month
ago she did receive the Johnson & Johnson vaccine. Upon admission patient was
treated with azithromycin, Rocephin to cover for secondary bacterial infection.
She was not a candidate for remdesivir due to the length of her symptoms. She was
started on Decadron, as well as gentle fluids due to tachycardia for approximately
12 hours. During the night of 4/2-4/3 patient progressively declined requiring
more oxygen she was transferred to the intensive care unit. Patient was a do not
resuscitate continued decline and after exacerbating all treatment options patient
was switched to comfort care earlier this evening. Pronounced dead at 6:45 a.m."
"No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1222868-1" "1222868-1" "According to POC the resident was transferred to the
hospital on 4/8/2021, due to low pressures, high pulse and cough. They certify
death by COVID 19, because it affected the lungs." "No prior vaccinations for
this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1271243-1" "1271243-1" "Symptoms of fever, nausea, and weakness started 3
days following vaccination. Denies any exposure to COVID positive person.
Presented to local emergency department on 3/27/21 with nausea, fever, chills,
dizziness, and confusion. Due to patient's condition, he was transferred to larger
facility for further management. Patient was admitted to hospital and subsequently
transferred to ICU on 4/17/21. He was intubated at that time. Patient went into
multisystem organ failure and died on 4/18/21." "No prior vaccinations for this
event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1273691-1" "1273691-1" "Patient tested positive for COVID 19 on 03/21 after
a symptom onset of 03/19/21. She was admitted to the hospital on 03/24 and passed
away 04/19. Cause of death is listed as multi-organ dysfunction secondary to
hemorrhagic shock, other contributing factors: COVID-19 pneumonia." "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1285561-1" "1285561-1" ""The patient presented with chest pain around 5 pm
on 4/4/21. Patient reported ""pain came out of nowhere."" Patient reported pain
was non-exertional and non-positional. He described it as ""a constant burning
sensation"" located in the center of his chest with radiation upwards toward his
jaw and shoulders, bilaterally. He was transferred to COVID unit, became
hypotensive, hypoxic was seen by house MD. Lung exam crackles bilaterally. IV
fluids stopped, patient was given 40 mg Lasix, Morphine 2 mg and started on a
small dose nitroglycerine drip. POX 70s, low 80s so Bipap ordered. Patient
developed v tach and arrested, resuscitated, defibrillated, received multiple meds,
intubated by anesthesia, transferred in ICU on Levophed and Epinephrine. Arrested
in ICU. Lines were placed by ICU team, arrested again in ICU. Was maxed out on 4
pressors, despite CPR, pulse could not be obtained, patient was pronounced dead
4/6/21 at 3:31am. 1. Triple vessel CAD 2. Moderately severe LV dysfunction with
and EF 30% 3 The recent NSTEMI is secondary to the occlusion of the SVG-OM1.
There is a large thrombus in the SVG which makes PCI of this vessel unlikely to be
successful. 4 The native OM1 is chronically occluded. It may be possible to
attempt to open this with CTO techniques, however, at this time continued medical
treatment. 5. Perclose"" "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1295200-1" "1295200-1" "Pt received Covid-19 vaccine on 3/19 then presented
to ED with fever and shortness of breath on 3/23 admitted to the hospital found to
be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone,
remdesivir and empiric antibiotics. Following admission, O2 requirement
increased, received tocilizumab then required transfer to the ICU on 3/29. On
3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then
on 4/1 patient intubated due to increased need for respiratory support and had
bilateral chest tubes placed, post-intubation course complicated by shock with AKI
requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening
shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum
antibiotics and resumption of stress dose steroids, the family was transitioned to
comfort measures and passed away on 4/29." "No prior vaccinations for this
event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1306869-1" "1306869-1" "Brief HPI and Hospital Course: 67 year old male with
unknown past medical history was brought in by EMS as post-cardiac arrest. Patient
was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS,
approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and
intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on
its own. On arrival to ED, left femoral central line placed. Tox screen was
positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI.
Tested positive for COVID19 on admission. Patient required pressor support on
admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol,
normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death:
Patient remained normothermic with persistent septic shock, multi organ failure,
ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU
team and palliative care team daily without answer. Patient made DNR by two-
physician consent. Patient's BP low despite maximum levophed support." "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1337251-1" "1337251-1" "To ED via ambulance for chest pain and shortness of
breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated
in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted
to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient
had reportedly been sick about a week or 2 earlier, covid positive PCR on admission
to hospital." "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1337780-1" "1337780-1" "Person died on 5/7/2021 with death note stating
acute respiratory failure with hypoxia, thrombocytopenia." "No prior vaccinations
for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1351207-1" "1351207-1" "73 year old male with PMHx of AFib, CAD, and HTN who
presents with c/o dyspnea that started 4/6/21. Patient states it got to the point
where he could not walk in his house without severe dyspnea. States he was
diagnosed with COVID-19 one week prior. Per chart review he was in our ER 4/3/21
and diagnosed with COVID-19. At the time he was 95% on room air. His only other
symptom has been diarrhea. He states he received the Johnson and Johnson vaccine
one month ago. He denies any dizziness, chest pain, abdominal pain, n/v, weakness,
or numbness. In ER patient was hypoxic and improved only with BiPAP. Per chart
review patient had cardiac arrest on 11/2020 for 17 minutes. He has a significant
cardiac history consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib
post ablation 2017, V-tach. He was started on therapy with steroids,
anticoagulation, and Remdesivir. He failed to improve and had increasing oxygen
requirements. He was eventually intubated. Due to failure to improve patient was
made DNR and eventually expired." "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1418084-1" "1418084-1" "Developed s/s of COVID on 4/27/2021, hospitalized,
then transferred to another HCF was inpatient ICU 5/8-6/21 expired 6/21/21" "No
prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1420514-1" "1420514-1" "Symptom onset was 12/26/2020, with nausea, fever,
chills, rigors, fatigue, cough, & myalgia." "No prior vaccinations for this
event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1424154-1" "1424154-1" "death 4/24/2021 causes of death listed on death
certificate: 1) Pneumonia Due to COVID 19 2) Acute Respiratory Failure with
Hypoxia 3) COVID 19 4) Acute Exacerbation of Chronic Obstructive Pulmonary
Disease" "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "65-79 years" "65-79"
"1427858-1" "1427858-1" "COVID-19 symptom onset 4/23, hospital admission date
4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1267883-1"
"1267883-1" "Cardiac Arrest about an hour after being injected." "No prior
vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1296197-1"
"1296197-1" ""Wife reports patient was vaccinated on 3/30/21. She stated
patient only had blurred vision following vaccination which lasted a about 2 days.
On 4/4 family members visited and it was noted that 1 member tested positive for
Covid on 4/5/21 and her spouse was home sick on 4/4/21 and was later positive on
4/5/21. Around 4/5/21 patient began having more frequent episodes of delusion and
confusion. Speech slurred and slouched in chair. Patient would be demanding when
asking for water when water was in his hand. Talking to her but looking at the
ceiling. She stated she thought he was having ""mini strokes."" Increased
weakness with standing. Slid to floor multiple times from chair. She reports loss
of appetite and trembling. Saw MD on 4/12. ""Could hardly breathe."" MD ordered
doxycycline and an inhaler. Patient to Hospital on 4/13/21. Diagnosed with Covid
on 4/13/21 via PCR. Discharged from hospital to Skilled Nursing Facility on
4/16/21. Sent back to Hospital on 4/18/21 and passed away on 5/1/21. Wife states
that death certificate indicates ""Utonic Hypercapnic respiratory failure,
acute/chronic CHF, hypoxemic respiratory failure and HTN, DM, prostate CA and COVID
PNA. No autopsy performed. Medical PCP."" "No prior vaccinations for this
event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1313860-1"
"1313860-1" "patient received Covid 19 vaccine Johnston and Johnston on
03/13/2021, became positive for covid on 04/13/2021, went to hosp, admitted" "No
prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1388920-1"
"1388920-1" "Contracted COVID-19 ~1 month later, tested positive on 5/16/21.
Died 6/9/2021 at 94 years old. Had CLL diagnosed during final hospitalization,
thought to have caused poor vaccine response and susceptibility to COVID." "No
prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1400869-1"
"1400869-1" "Reported to me by patients niece, who developed similar symptoms
around the same time: Patient developed cough aches, fartigue and shortness of
breath about 8 days after receiving COVID vaccine. After another 10 days of illness
was taken to hospital by ambulance as too weak to stand., and died in hospital
about 5 days later, on or about 5/22/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1417204-1"
"1417204-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 5/30/21 after the completion of a full
Janssen vaccine series (Dose 1 on 5/5/21). The patient later died on 6/03/21. Cause
of Death is listed as ?Upper gastrointestinal hemorrhage?.
Comments:=======================nnJune 01, 2021 at 3:07 PM by HD nn6/1 3:06
Supervisor Review completed by HD): ICP needednPT resides at ..nPT admitted to
hospital- as asymptomatic. No dates were provided. shows specimen collected via
hospital on 5/30 and no notes regarding admittance.nClosed as medical
barriers.nnn=======================nnJune 01, 2021 at 2:34 PM by CNA, case is
hospitalized since 5/30. Head of Nursing sent her to hospital for vomiting and is
not currently in the ICU or being treated for any respiratory issues related to
COVID," "No prior vaccinations for this event."
"COVID-19" "10084268" "JANSSEN" "592" "80+ years" "80+" "1426155-1"
"1426155-1" "Death: 5/2/2021 Causes of death listed on death certificate:
Covid 19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "30-39 years" "30-39"
"1313922-1" "1313922-1" "PT NO SHOW FOR APPT 5/11 FOR 2ND DOSE -CHECK OF
agency system SHOWS PT REPORTED DECEASED 5/14- CHECK OF database SHOWS PT FOUND
DECEASED AT HOMEN 5/14/21- AUTOPSY Completed" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "30-39 years" "30-39"
"1347160-1" "1347160-1" "fall on May 19 and admitted to ER May 22 with
subacute R MCA stroke resulting in obtundation and left sided hemiparalysis.
Complicating his presentation is acute COVID 19 infection with pneumonia along with
acute on chronic systolic congestive heart failure." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "30-39 years" "30-39"
"1425926-1" "1425926-1" "Death: 5/7/2021 Causes of death listed on death
certificate: 1) COVID-19 2) Sepsis 3) Sarcoidosis 4) End stage renal disease
Other: Hypertension, Congestive heart failure" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "40-49 years" "40-49"
"1161106-1" "1161106-1" "CONTRACTED COVID, CONFIRMED 3/17/21, PATIENT DIED ON
3/23/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "40-49 years" "40-49"
"1267074-1" "1267074-1" "#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21
patient presented after sudden onset of chest pain early in morning and found to be
covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without
contrast didn't have much in it. He was found to be COVID rapid test+ and IGG
negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and
friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe
viral pericarditis - but wanted echo done after out of isolation. CTA was planned
for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC
was not able to be achieved despite aggressive resuscitation efforts" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "40-49 years" "40-49"
"1347808-1" "1347808-1" ""started with c/o ""feels weird in my chest like a
pulled muscle"", few days later slight short of breath with fatigue, May 2 11:45
cardiac arrest when paramedics placed O2, rounds of CPR and med's, pronounced dead
at hospital after attempts of CPR. Out come on death certificate Bilateral
Pulmonary Thromboemboli. Coroner stated there were multiple PE's in bilateral
lungs. Positive for Covid 19 (Had in Feb, vaccine in April 20)"" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "40-49 years" "40-49"
"1437378-1" "1437378-1" "Died of COVID-19 illness on 05/05/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1049963-1" "1049963-1" "Found lying face down without respiration or pulse,
believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to
get autopsy. Believed to be heart attack secondary to COVID infection, but
unconfirmed. Relative contribution of recent vaccination unknown." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1143895-1" "1143895-1" "13th of January received first Moderna shot. 18-19th
began to have headaches 22nd headaches worsened 25th at the doctor's (tested
negative nose swab) home till 28th (28th tested positive for corona after having
her first shot at Advent) stroke symptoms at school 28th Advent did CT scan MRI
venous thrombosis diagnosis, from front to back, hemorrage in the northern
hemisphere 29th blood thinner administered to attempt to drain clot, seizures 31st
passed away" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1161015-1" "1161015-1" ""Per RN at Group Home where patient worked, on
3/19/21 he called the RN with complaints of a ""low grade"" fever (99-100 degrees)
but otherwise reportedly felt fine. He was advised to stay home, was offered Covid
testing but refused. On 3/22/21 the RN received an email from patient's supervisor
that he still felt unwell and reported vomiting and diarrhea. Was offered a Covid
test but refused. -Per patient's friend (a nurse who informed us of the case)
various friends spoke with patient up until the morning of 3/25 and he reportedly
had no respiratory or cardiac complaints. They were unable to reach him the evening
of 3/25, nor the morning of 3/26 so sent the police for a well check and patient
was found dead. He lived alone. -Per OSME. Patient did not receive an autopsy but
did have an ""inspection"" which includes an external exam, toxicology and other
testing including Covid testing which was positive. The specimen has been sent for
sequencing. -Of note, Patient worked in a group home that had an outbreak of Covid
in Jan/early Feb. His last exposure to a + person was likely 2/8/21 but possibly
2/10/21. He had a Covid test 2/15/21 that was ""inconclusive"". The test was re-run
(same assay) and was also ""inconclusive"""" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1241587-1" "1241587-1" "She was a healthcare worker. It was reported to me
by her immediate supervisor that she tested positive for COVID-19 the day after her
first vaccination. She became symptomatic around January 21, 2021. She was
scheduled to return to work on January 29, 2021 but did not come in. She died on
February 2, 2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1258269-1" "1258269-1" "This pt came in to see me in her normal state of
health and then received moderna #1 here on 4/1. Developed SOB 2 hrs after
vaccination. Presented to ER on 4/2 with hypoxia (80%) and was + for covid. The ER
triage notes states ?C/O SOB, Nausea, vomiting, diarrhea that started yesterday 2
hours after he first COVID Vaccine?. Notes quote her saying ?I got my vaccine
yesterday and I started to feel short of breath.? She died from covid respiratory
failure on 4/23." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1323673-1" "1323673-1" "Subsequently developed respiratory distress and
pneumonia after testing positive for COVID. Pt died due to illness." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1336774-1" "1336774-1" "Patient developed fever, dyspnea and headache on
5/12/2021; tested positive for COVID-19 on 5/12/2021; patient died on 5/20/21"
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1382262-1" "1382262-1" "Patient received first dose of Moderna on 4/15/2021.
Patient tested positive on 4/19/2021 for Covid. Patient admitted to hospital on
4/25/2021. Patient expired 5/14/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "50-59 years" "50-59"
"1417109-1" "1417109-1" "Patient received first dose of Moderna on May 18,
2021. Spouse came to the pharmacy and informed us that the patient passed away in
the hospital on June 15, 2021. She was diagnosed with COVID-19 during her stay at
the hospital." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"0979841-1" "0979841-1" "Pt likely presented to vaccine appt with
asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination
and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where
he eventually died of complications from COVID-19 while in ICU. Date of death was
1/15/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1067358-1" "1067358-1" "1-25-2021- Phone call: pt had cold and cough prior
to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit,
cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt
complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP
128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales
throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19
virus. Sent to ER" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1257832-1" "1257832-1" "Hospitalized +Covid post vaccination with decreased
mental status" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1296384-1" "1296384-1" "Client admitted to the hospital on 4/26/2021 with
Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia.
Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021
with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal.
Client died 5/5/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1296477-1" "1296477-1" "Case had COVID-19 in November 2020 as part of an
outbreak in the SNF she lives in. She recovered then received her first COVID-19
vaccination on 1/4/21. She received her 2nd dose of Moderna on 2/1/21. On 4/11/21
she became ill and was transferred to the hospital where she tested PCR positive
for COVID-19. She continued to decline and was intubated. She died on 4/28/21 while
still in the hospital. The diagnosis on her death summary from the hospital is
COVID-19 pneumonia." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1337701-1" "1337701-1" "64 y.o. female who presented with SOB. She has a
history of CAD, diabetes, CHF, CKD and DVT presents to the ED in respiratory
distress. Patient was brought in by EMS from nursing home. Patient had reported
onset of shortness of breath and respiratory distress over the last 6-7 hours.
Patient has O2 sat of 90% on 6 L. Patient only uses 2 L nasal cannula oxygen all
day long. Patient is coherent and initially was placed on BIPAP but then stated
she wanted to go back, now after ER doc spoke to her she is ok with being admitted
but does not want BIPAP or to be placed in the ICU. She is DNR/DNI. She is working
hard to breathe currently. Patient is unsure if she is making urine at this time.
Workup in the ER revealed AKI on CKD and covid + pneumonia. Patient elected
hospice and expired 5/20/2021. It was reported that patient had received vaccines
at Walmart." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1374761-1" "1374761-1" "COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna);
tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention
pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status,
cardiomyopathy, septic shock, and multiorgan failure; also tested positive for
haemophilus influenza." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1378451-1" "1378451-1" "Unsure, Department followed up on her positive COVID
results in 10/2020 and 11/2020. It came to our attention last week that the reason
stated for her death on 5/28/21 was due to COVID. Due to having 2 positive tests
late last fall and then seeing that she had been vaccinated for COVID in March and
April 2021, I was instructed to complete a VAERS." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "60-64 years" "60-64"
"1454319-1" "1454319-1" "Breakthrough COVID related death" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1020079-1" "1020079-1" "Received Moderna covid vaccination 1/14/2021.
1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital
and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1024539-1" "1024539-1" "patient tested positive for covid on 1/29/21. was
hospitalized on 2/8/21 for shortness of breath, generalized weakness, nausea."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1024627-1" "1024627-1" "covid shot 2/2; feel bad 2/5; covid positive
diagnosis - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er)
- admitted went into DIC per intensivist 2/11 patient died" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1029068-1" "1029068-1" "Patient was given vaccine the following day he
died ," "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1063903-1" "1063903-1" "NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE
PATIENT PASSED AWAY 02/10/2021 DUE TO COVID" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1069026-1" "1069026-1" "Death Narrative: Family was able to be present at
bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes
prior. Patient passed away soon after endotracheal tube removed. Time of death
10:14am." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1080425-1" "1080425-1" "Narrative: Patient with h/o ESRD on HD MWF, HTN
presented to ER on 2/20/21 with worsening dyspnea and GI symptoms; tested positive
for COVID-19. Patient had received first COVID vaccination approx. 9 days prior.
Patient admitted to ICU for treatment of COVID+ PNA. During admission, patient
often could not tolerate removal of fluid during HD d/t tachycardia. He received
dexamethasone, convalescent plasma for COVID. Patient underwent TTE which was
notable for septal wall motion abnormalities and grossly reduced EF. Admission also
c/b acute liver injury, possible cholecystitis, thrombocytopenia, SVT,
encephalopathy. Patient then developed progressive shock and hemodynamic
instability on 3/2 and passed away on 3/2/21." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1088956-1" "1088956-1" "Tested positive and had symptoms for Covid-19 .
Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1094638-1" "1094638-1" "Exposure to Covid 19 either on the date of vaccine
(2/13/21) or shortly thereafter. Symptoms of Covid started on Monday (2/15) early
morning following shot. Dr. ordered Covid test on Weds. (2/17). Taken by ambulance
to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels,
confusion, shaking and cough. Admitted to hospital with threats of ventilator up
until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV
fluids. He went into kidney failure on Thursday (2/25) and put on dialysis. Other
organs began shutting down and was taken off the ventilator on Friday (2/26) and
did not recover. He passed away just before 4:00 p.m. on 2/26/21." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1104815-1" "1104815-1" "Seen in ED for positive COVID symptoms - discharged
with instructions. Death 1/26/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1112585-1" "1112585-1" "patient diagnosed with covid on 2.18.2021 and died
of covid 3.6.2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1127847-1" "1127847-1" "Participant felt flushed, feverish, fatigued with
general aches and dry cough over the weekend after receiving injection, took
acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021
and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and
went into respiratory failure with sepsis due to COVID19. He was treated with
tocilzumab, became paralyzed and DVT in left lower extremity was found. HE
required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was
in multi-organ failure. His level of cognition decreased until he was no longer
responsive and he died on 2/24/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1129951-1" "1129951-1" "72 y/o with hx of HTN, Aortic valve replacement,
venous stasis and venous insufficiency of both lower extremities, CAD, AAA, and s/p
squamous cell carcinoma excision in 2019 Upon reviewing the history, here is what
we found. 1. 2/27 -- Received send-out covid swabbing/testing- Patient did not
disclose this information when screened for his covid vaccination at the clinic.
2. 3/2, 10:00 AM ? Presented to Covid Vaccination Clinic and received 1st dose of
Moderna. Results of pending covid test were not back at this time, nor did he
disclose this information when screened by nurse prior to vaccination. 3. 3/2,
10:30 PM ? Covid result came back to lab as positive SARS Co-V 2019 4. 3/3 ?
patient called and notified of result per ED nurse 5. 3/3 ? Pharmacy recommended
patient for mAB infusion (patient did not receive it) 6. 3/6 ? patient presents
to ED in severe respiratory distress, DX of Covid-19 pneumonia & transferred to ICU
7. 3/21 ? patient dies after 15 day hospitalization in ICU (pt. had received
convalescent plasma x 2 and remdesivir there)" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1130250-1" "1130250-1" "Patient tested positive for Covid on 3/12/21 per
hospital admission notes. Patient was admitted to the hospital on 3/16/2021 with
Covid pneumonia. She passed away on 3/22/21." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1145531-1" "1145531-1" "Pt diagnosed with COVID-19 despite 2 COVID vaccines
(first given 1/15/2021. Pt developed respiratory symptoms, including dyspnea,
which progressed over 3.5 weeks and then systemic symptoms of myalgias, malaise.
He was admitted 3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required
admission to ICU and died of respiratory failure on 3/28/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1147848-1" "1147848-1" "Approximately 3-4 days after her first immunization,
patient became ill. She contacted our triage line 6 days after immunization with
report of chills and weakness. She presented to Medical Center Emergency Room
where she was admitted for hypoxia. She was subsequently diagnosed with COVID by
PCR. She developed respiratory failure, worsening kidney failure necessitating
dialysis, c diff colitis, GI bleed, and acute heart failure. Despite maximal
efforts by the ICU/hospitalist team and specialists her conditioned worsened. She
was made comfort care and died on 2.26.21" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1156579-1" "1156579-1" "Per Hospital medical records patient was admitted to
hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1
week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed
fever, chills, dyspnea, anorexia." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1156595-1" "1156595-1" "Mandatory EUA Reporting - Patient received Moderna
COVID-19 vaccine on 1/4. She was living with someone who was diagnosed with COVID-
19 on 1/11. Patient was tested on 1/11 and was negative for COVID-19. Then about 4-
5 days later developed symptoms and tested positive. She was admitted to hospital
on 1/20/2021 to medical floor, transferred to ICU on 1/27, and died on 2/5/2021."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1161042-1" "1161042-1" "PATIENT CONTRACTED COVID, DATE OF COLLECTION
3/18/2021, DIED ON 3/21/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1179974-1" "1179974-1" "pt was diagnosed with covid on 3-29-21 ,
hospitalized for pneumonia and respiratory failure and expired on 4-6-21 at
Hospital" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1180051-1" "1180051-1" "Was hospitalized (unsure dates on hospitalization);
has no known pre-existing conditions; symptom onset was 3/3/2021 with fever,
chills, rigors, myalgia, rhinorrhea/congestion, sore throat, cough (wet
productive), nausea/vomiting, headache, loss of smell and taste, and fatigue. Was
a household contact to a known COID-19 case." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1183418-1" "1183418-1" "Vaccine breakthrough hospitalization - SOB with O2
sat 50% when EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and
chest pain. BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID
mAb day of admission, but clinical course worsened. Admitted to Medical ICU for
acute respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on
BIPAP and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed
pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain
DNR/DNI, ultimately she elected to transition to comfort measures only given
worsening hypoxia." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1193971-1" "1193971-1" "Respiratory failure; Dizziness; Feeling hot;
Weakness generalized; Muscle pain; COVID-19; This regulatory authority case was
reported by a non-health professional and describes the occurrence of RESPIRATORY
FAILURE (Respiratory failure) and COVID-19 (COVID-19) in a 74-year-old male patient
who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-
19 vaccination. The occurrence of additional non-serious events is detailed below.
Concurrent medical conditions included Spinal disorder (Degeneration of the spine).
On 20-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced
DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized)
and MYALGIA (Muscle pain). On 05-Mar-2021, the patient experienced RESPIRATORY
FAILURE (Respiratory failure) (seriousness criterion death) and COVID-19 (COVID-19)
(seriousness criterion death). The patient died on 05-Mar-2021. The reported cause
of death was Respiratory failure and covid-19, virus identified. It is unknown if
an autopsy was performed. At the time of death, DIZZINESS (Dizziness), FEELING HOT
(Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain) outcome
was unknown. Concomitant product use was not provided. Treatment
information was not provided. The reporter's contact information was not provided.
Reporter did not allow further contact; Reported Cause(s) of Death: Respiratory
failure; COVID-19, virus identified" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1229797-1" "1229797-1" "Paient was vaccinated on 3/29/2021 with dose 1 of
Moderna. Patient developed COVID symptoms on 4/4/2021 and passed away on
4/16/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1242858-1" "1242858-1" "Patient contracted COVID 19 and subsequently expired
from respiratory distress, following completion of the serious of two vaccination
shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have
access to the lot # info- would have to contact vaccination site to obtain" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1246110-1" "1246110-1" "Lethargy, weakness, headache; ultimately pronounced
on 4/3/2021 at 1310 hours" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1247898-1" "1247898-1" "Patient had second covid 19 vaccine on 2/2/21 at
pharmacy. Was admitted on 4/6/21 to hospital with Shortness and Breath, Vomiting,
and COVID-19 (tested positive on 4/6/21). Patient expired on 4/8/21 @ 1954." "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1268137-1" "1268137-1" "Cause of Death A: Acute encephalopathy Cause of
Death B: COVID 19 IMMUNIZATION FOLLOWING COVID 19 VIRUS INFECTION Cause of Death
Other: Chronic Schizophrenia" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1273804-1" "1273804-1" "GI Hemorrhage Covid + Respiratory Failure" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1282517-1" "1282517-1" "Patient visited his doctor/pulmonologist on 3/18/21
and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the
Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a
serious cough/phlegm, he became weak, disoriented, had a hard time
walking/ambulating, lifting his arms and communicating. He was diagnosed with
Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney
disease)" "Patient was hospitalized after a FLU vaccine 5 years ago"
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1303196-1" "1303196-1" ""per medical report from hospital- ""presented to
emergency room at outside facility secondary to worsening shortness of breath. The
patient states that about 1 week ago she started feeling ill directly after
receiving her first covid vaccine. the patient states her medical issues actually
began approximately 2 months ago when she developed sudden onset positional urinary
retention as well as urinary incontinence and constipation. She states that she
thought maybe her known spinal stenosis had worsened causing her bladder
dysfuntion.She states she tries to sit on a commode or a toilet and is unable to
void however when lying flat she has to wear adult briefs as she has no control
over her bladder at all. There is no p"" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1307637-1" "1307637-1" "Patient received dose 1 on 2/12/2021 and dose 2 on
3/15/2021 from community pharmacy. Tested positive on 4/7/2021. Hospitalized for
COVID on 4/19/2021. Discharged on 4/29/2021 to hospice. Passed away on 5/1/2021."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1310651-1" "1310651-1" "Patient received Moderna vaccine 3/2/2021 0.5 ml LD
IM Lot: 029L20A and Moderna vaccine 3/30/2021 0.5 ml LD IM Lot: 019B21A. The
patient was exposed to an infected person with Covid about 1 week after her second
vaccine. She was admitted to the ICU with severe covid on 4/13/21. She was
eventually transitioned to comfort care and died on 5/6/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1311196-1" "1311196-1" "FEVER COUGH FATIGUE HEADACHES" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1313931-1" "1313931-1" "ED Discharged 4/4/2021 (4 hours) Hospital Emergency
Department Last attending ? Treatment team Generalized weakness +4 more Clinical
impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes
Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient
presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history
of COPD for which she wears oxygen at night and as needed, also with a history of
leukemia and obesity who presents to the ED complaining of generalized body aches,
fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days
ago. Patient reports that she received her second COVID-19 vaccine approximately 1
week ago. Tolerated this without any particular symptoms. She has had 2 days of
watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting
earlier today. She is denying any particular abdominal pain. Does believe she
felt her urine burning earlier today but has had no gross hematuria. Denies any
flank pain. No ill contacts although her husband has been at home with a slight
cough. Patient does have a cough presently but it is nonproductive. She is
denying any particular chest pain or subjective shortness of breath. No rash or
unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission
Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment
team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine
Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge
Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present
Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past
medical history of chronic lymphocytic leukemia follow-up that was initially
scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on
2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in
the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough,
fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed
with COVID-19. She had however received a second dose of COVID-19 a week before
and was discharged home due to lack of significant findings on imaging chest x-ray
and lack of requirement for higher oxygen support. She presented to the emergency
via EMS for evaluation of progressive shortness of breath with associated with
fever, chills, headache, persistent shortness of breath, cough productive of thick
clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest
pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently,
she thought she was getting better upon discharge after being kept for about 12
hours in the last ED visit, however she was not feeling well after going to bed
last night and asked the husband to call 911. Upon EMS arrival patient was
saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was
eventually placed on 10 L oxygen support. She was noted to be in significant
respiratory distress during speech. Hospital Course Patient was admitted to
hospital due to shortness of breath, and was found to have severe sepsis on
presentation due to COVID-19 pneumonia. She had evidence of acute on chronic
hypoxic respiratory failure as well. She was started on IV antibiotics, as well as
remdesivir and Decadron at high dose. Unfortunately she continued to have
clinical deterioration, and ultimately required high flow oxygen therapy. She was
then transferred to the ICU, and ultimately required intubation due to severe
profound ongoing hypoxia despite optimal medical treatment. She did not respond to
remdesivir or steroids or antibiotics. Post intubation, she also developed acute
renal failure during the course of her admission. Multiple discussions were had
throughout the hospitalization regarding goals of care, and initially patient and
family wish to be continually aggressive. She received full medical treatment,
including life support, with minimal improvement. Despite being on ventilator for
roughly 5 days, she continued to have severe hypoxia. She was proned, and was
unable to sustain oxygen saturations when supine even for short period. Her renal
function continued to decline as well, and at that point discussion was had with
family regarding goals of care again. They were explained that symptoms continue
to be persistent, and her illness continues to progress despite aggressive medical
therapy. Ultimately decision was made to not pursue dialysis, and to allow the
patient to be kept comfortable and pass away naturally from this infection. She
was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and
acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-
ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen
INDICATION: Nasogastric tube placement, encounter initial Supine portable view of
the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in
the gas-distended stomach. This report was created using Voice Recognition
software. Thank you for allowing us to participate in the care of your patient.
X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No
significant change from the previous examination. END OF IMPRESSION: INDICATION:
Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON:
X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ
central venous catheter are unchanged. Right-sided chest tube is unchanged. There
is a small left pleural effusion. There is diffuse bilateral hazy airspace
opacification. No change from prior. This report was created using Voice
Recognition software. Thank you for allowing us to participate in the care of your
patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW
PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged
patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening
hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray
4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central
venous catheter are unchanged. The right-sided chest tube is unchanged. There is no
pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace
consolidation. There is no significant change. Cardiac silhouette is normal size.
There is calcification of the aorta. This report was created using Voice
Recognition software. Thank you for allowing us to participate in the care of your
patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest
radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal
radiograph of the chest was obtained and compared to the prior study dated
4/13/2021. The heart is at the upper limits of normal. The mediastinum is within
normal limits. Interstitial alveolar opacities are demonstrated bilaterally
consistent with pneumonia. There is an endotracheal tube with the distal end
approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards
the stomach. There is a right jugular central catheter. A right-sided pigtail
catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar
opacities consistent with pneumonia. 2. Lines and tubes in place as described. This
report was created using Voice Recognition software. Thank you for allowing us to
participate in the care of your patient. X-ray Chest 1 View, Portable Result
Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and
time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+
TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR
CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal
tube tip located at the level of the carina. Pigtail drainage catheter tip remains
superimposed over the lateral right mid lung zone. Nasogastric tube enters the
stomach but tip not included on the image. Tip of right internal jugular central
venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally.
Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051
hrs, new consolidation and/or atelectasis in the left lung base. No significant
interval change in scattered patches of ground-glass opacity (GGO) within each
lung. Patient has history of COVID-19. Pleural spaces: Small right apical
pneumothorax (12 mm). New small left pleural fluid collection. No right pleural
fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints:
Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of
the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral
right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to
chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new
consolidation and/or atelectasis in the left lung base. 5. New small left pleural
fluid collection. 6. No significant interval change in scattered patches of
ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS
DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable
Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement
of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect
projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left
thoracostomy tube terminates near the lateral right midlung. No other change.
Extensive
pulmonary infiltrates. Stable life support lines. The previous right pneumothorax
has predominantly resolved, only a thin crescent of air caps the right apex. END OF
IMPRESSION: This report was created using Voice Recognition software. Thank you for
allowing us to participate in the care of your patient. X-ray Chest 1 View,
Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines
as described. There is a small right-sided pneumothorax. Unchanged bilateral
airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and
post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-
ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is
projected over the SVC. There is a small right apical pneumothorax. Endotracheal
tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath
the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally.
Findings do not appear significantly changed from prior. The cardiac silhouette is
normal size. There is calcification of the aorta. This report was created using
Voice Recognition software. Thank you for allowing us to participate in the care of
your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1
VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF
IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening
respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is
acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is
partially excluded. The lungs are adequately expanded. There are large areas of
patchy airspace consolidation bilaterally. Findings have mildly increased in
severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly
enlarged. There is calcification of the aorta. This report was created using Voice
Recognition software. Thank you for allowing us to participate in the care of your
patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT
INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE:
AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021.
FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the
right upper and right lower lobe. No change in the heart, mediastinum, or bony
thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This
report was created using Voice Recognition software. Thank you for allowing us to
participate in the care of your patient. X-ray Chest 1 View - Portable Result
Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute
pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak,
cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON:
6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of
pulmonary arteries. This is stable. There is no focal consolidation or effusion.
This report was created using Voice Recognition software. Thank you for allowing us
to participate in the care of your patient. Transthoracic Echo (tte) Complete
Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021
10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart
Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D,
Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is
normal in size. Ejection Fraction 55% (normal range 50-70%). All wall
segments showed normal motion. Mild concentric LVH.
Trivial aortic regurgitation. No additional significant valvular
abnormality. No prior study for comparison. Presentation and
History: Indication: The patient presents for evaluation of arrhythmia. The
patient has a history of obesity and chronic obstructive pulmonary disease.
Findings: Procedure Information: Contrast agent, definity, is being given per
protocol without apparent complications. Due to technical limitations in the
assessment of the left ventricle, imaging was performed after the administration of
intravenous Definity echocontrast, as per protocol. Left Ventricle: The left
ventricle is normal in size. There is mildly increased left ventricular wall
thickness. The left ventricular systolic function is normal. The visually
estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall
segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly
normal in size and function by subcostal view. Atria: The left atrium is borderline
dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing
aortic valve with no significant aortic stenosis. Trivial aortic regurgitation.
Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler
analysis. There is no mitral valve stenosis by color flow and doppler analysis.
Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or
insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace
tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels:
All visible segments of the aorta are normal in size. Venous: The inferior vena
cava is normal in size and collapses greater than 50% with inspiration.
Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study
Comparison: No prior study for comparison.
Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-
5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6)
LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-
224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT
Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00
LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial:
5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E:
0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33
E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic
Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn
Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00
RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc:
3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final
electronically signed on 4/11/2021 5:10:04 PM with status of Final
Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative:
PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and
time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness
of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid
TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without
contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed
images were created by the technologist. Radiation optimization: All CT scans at
this facility use at least one of these dose optimization techniques: automated
exposure control; mA and/or kV adjustment per patient size (includes targeted exams
where dose is matched to clinical indication); or iterative reconstruction.
COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy
peripheral ground-glass opacities which can be seen with atypical pneumonia.
Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No
cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta.
Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No
acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-
glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN
ELECTRONICALLY SIGNED BY MD" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1337755-1" "1337755-1" "Person died on 5/9/2021, with death note listing
acute and chronic respiratory failure with hypoxia, COVID-19, paroxysmal atrial
fibrillation, chronic heart failure with reduced ejection fraction, follicular
lymphoma, history of CABG, hyperglycemia, and type 2 diabetes." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1355384-1" "1355384-1" "Admitted to the hospital with weakness, fever on
4/14/2021. Transferred to ICU on 4/17/21 requiring bipap. Intubated 4/25/2021.
covid + 4/2/21. Last vaccine dose completed 3/3/2021. Pt died on 5/15/2021" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1357112-1" "1357112-1" "Patient developed COVID after vaccination; She is
now deceased; This spontaneous case was reported by a consumer and describes the
occurrence of DEATH (She is now deceased) in a 73-year-old female patient who
received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19
vaccination. The occurrence of additional non-serious events is detailed below.
Concurrent medical conditions included Cancer (previously had cancer twice).
Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), NIFEDIPINE (PROCARDIA
[NIFEDIPINE]), TICLOPIDINE HYDROCHLORIDE (TICLID), OMEPRAZOLE (PRILOSEC
[OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On
22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19
Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced
COVID-19 (Patient developed COVID after vaccination). The patient died on 23-Apr-
2021. The cause of death was not reported. It is unknown if an autopsy was
performed. At the time of death, COVID-19 (Patient developed COVID after
vaccination) outcome was unknown. It was reported that the patient
previously had cancer twice, and her immune system was not what it should have
been. The patient got really, really sick and had COVID at some point after
receiving the vaccine. No corrective treatment was provided. Action taken with
the drug in response to the events was not applicable. Company comment: Very
limited information regarding this event has been provided at this time. Noting the
subject had received 1st dose of vaccine prior to COVID. However, based on the
mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.;
Sender's Comments: Very limited information regarding this event has been provided
at this time. Noting the subject had received 1st dose of vaccine prior to COVID.
However, based on the mechanism of action of mRNA1273, the event COVID is unlikely
related to vaccine.; Reported Cause(s) of Death: Unknown cause of death" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1366092-1" "1366092-1" "COVID-19 pneumonia; Vaccination failure; COVID-19;
This regulatory authority case was reported by a physician and describes the
occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION FAILURE
(Vaccination failure) and COVID-19 (COVID-19) in a 72-year-old female patient who
received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19
vaccination. The patient's past medical history included COVID-19, COVID-19
pneumonia, Kidney failure chronic and Kidney transplant in June 2015. Concurrent
medical conditions included Insulin therapy, ARDS, Allergy to antibiotic and
Diabetes mellitus. Concomitant products included INSULIN HUMAN (HUMULIN R),
ROSUVASTATIN CALCIUM (XETER), ENALAPRIL MALEATE (EDNYT), ALLOPURINOL (MILURIT),
DOXAZOSIN, ACETYLSALICYLIC ACID, PREDNISOLONE (PREDNISOLON RICHTER), TACROLIMUS
(ADVAGRAF), INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), PANTOPRAZOLE SODIUM
SESQUIHYDRATE (CONTROLOC), FUROSEMIDE, METOPROLOL SUCCINATE (BETALOC ZOK),
POTASSIUM CHLORIDE (KALDYUM) and MYCOPHENOLATE SODIUM (MYFORTIC) for an unknown
indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (COVID
19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Apr-2021, after starting
mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 (COVID-19)
(seriousness criteria death and hospitalization). On an unknown date, the patient
experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death,
hospitalization and medically significant) and VACCINATION FAILURE (Vaccination
failure) (seriousness criteria death and hospitalization). The patient died on 22-
Apr-2021. The reported cause of death was COVID-19 pneumonia, Vaccination failure
and covid-19. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS
(normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-
2 test: positive (Positive) POSITIVE. For mRNA-1273 (COVID 19 Vaccine Moderna)
(Intramuscular), the reporter considered VACCINATION FAILURE (Vaccination failure)
to be possibly related. No further causality assessments were provided for COVID-19
PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19). Treatment medicines were
not provided. Action taken with mRNA-1273 in response to the event was not
applicable. Company comment: Very limited information regarding this events has
been provided at this time.; Sender's Comments: Very limited information regarding
this events has been provided at this time.; Reported Cause(s) of Death: COVID-19
pneumonia; Vaccination failure; COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1368648-1" "1368648-1" "Died on 1/31/2021." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1371859-1" "1371859-1" ""COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021
patient admitted through ED for chief complaint of 5 days shortness of air, tested
positive for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021
admitted to ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021
patient intubated due to respiratory failure/distress/hypoxia; identified in septic
shock. 5/31/2021 went to surgery for left forearm and hand compartment syndrome.
6/3/2021 Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and
Verapamil (intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine
Manufacturer: Moderna Lot #: Clinic Administering Vaccine: ""local church"" - no
specific name was provided, Injection site: Description of event/reaction: Patient
does not have vaccination card and reports not knowing date of first vaccine or
exact clinic location. Date of Hospitalization: 5/24/2021 Reason for clinic visit
or hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if
Yes, date 05/23/2021"" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1377765-1" "1377765-1" "My mother was the patient in question She had a
Moderna Covid Vaccine in Feb/March of 2021. She then had 2 doses of Rituxan on
April 28th of 2021. After her second dose of the medication, she tested positive
for covid 3 days later. She was hospitalized on May 8th and was not able to
recover. She passed away on May 20th. The Drs at the Hospital in told me the
rituxan essentially wiped the vaccine from her body. The reason I'm reporting this
is to warn others in her position about the possible side effects. My mom had a
very false sense of security." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1382638-1" "1382638-1" "Patient received his second dose of the Moderna
vaccine on 5/21/21. On the morning of 5/22/21, patient started having issues with
mobility, heavy sweats, body aches, and headache, although he had no fever and
maintained his sense of smell and taste. Patient was later hospitalized and tested
positive for COVID on Thursday, May 27, 2021. Patient passed away on Friday, May
28, 2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1392262-1" "1392262-1" "COVID-19; Vaccination failure; inappropriate
schedule of vaccination; This regulatory authority case was reported by a physician
(subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-
19) and VACCINATION FAILURE (Vaccination failure) in a 74-year-old female patient
who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The
occurrence of additional non-serious events is detailed below. The patient's
past medical history included Myeloproliferative neoplasm since an unknown date,
Adipositas, Hypertension arterial and Coronary heart disease. On 20-Mar-2021, the
patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular)
1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the
patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate
schedule of vaccination). On 20-Apr-2021, the patient experienced COVID-19 (COVID-
19) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure)
(seriousness criterion death). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT
ADMINISTRATION (inappropriate schedule of vaccination) outcome was unknown. The
patient died on 24-Apr-2021. The reported cause of death was Respiratory failure.
An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided
in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive)
positive and positive (Positive) positive; Ct value = 13 SARS-COV2 lineage B.1.1.7.
For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not
provide any causality assessments. Concomitant medications were not provided.
Treatment information was not provided. Company Comments: This case concerns a 74-
year-old female patient who experienced inappropriate schedule of vaccination and
fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient
had significant underlying co-morbidities to include neoplastic disease in addition
to advancing age. Based in biological implausibility, causal relationship between
the reported events and product use is unlikely.; Sender's Comments: This case
concerns a 74-year-old female patient who experienced inappropriate schedule of
vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273
vaccination. Patient had significant underlying co-morbidities to include
neoplastic disease in addition to advancing age. Based in biological
implausibility, causal relationship between the reported events and product use is
unlikely.; Reported Cause(s) of Death: Respiratory failure""No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1395844-1" "1395844-1" "pt had 2nd Moderna vaccine on 2/10/2021 lot #
013M20A. Pt became Ill on 5/10/2021, test covid-19 positive on 5/17/2021 and
treated with BAM, Intubated on vent 6/1/2021 deceased 6/13/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1410369-1" "1410369-1" "Patient received 2nd dose of the COVID-19 vaccine on
2/10/21 and was considered fully vaccinated two weeks later on 2/24/21. On 6/10/21
patient was hospitalized with a possible upper GI bleed. Overnight the patient
began to have increased oxygen needs and crackles on auscultation. She was
transferred to the ICU, had an abnormal chest x-ray, and tested PCR positive for
COVID-19. The patient had acute kidney failure and respiratory failure with a DNR
and DNI. She expired on 6/11/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1427108-1" "1427108-1" "COVID symptoms began 3/16, positive test 3/19,
hospital admission 3/22, death 4/1" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1431331-1" "1431331-1" "Patient received second COVID vaccine on 2/3/2021.
Was admitted to Medical Center on 6/15/21 for generalized weakness and tested
positive for COVID 19 on 6/15/2021. Patient was also positive for COVID 19 in
November 2020. Patient expired on 6/26/2021 while hospitalized." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1431351-1" "1431351-1" "3/7/2021: dysregulated taste, dyspnea, Myalgia,
pneumonia, hospitalized, treated but died" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1437364-1" "1437364-1" "Death 5/1/2021 Causes of death listed on death
certificate: 1) Cardiac arrest 2) Failure to thrive 3) Parkinson's Disease 4)
COVID-19 infection 4/2021 Other: Coronary artery disease" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "65-79 years" "65-79"
"1441060-1" "1441060-1" "Blood clots in heart with extremely low blood
pressure and shortness of breath. Symptoms suddenly appeared on 04/02/21.
Hospitalization and rehabilitation Until discharge of 05/03/2021. Extremely low
blood pressure, weakness and shortness of breath continued until he was
hospitalized again 06/02/2021 He passed away 06/09/2021. He was labeled as Covid
19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0963235-1"
"0963235-1" "Patient diagnosed with COVID on January 9, 2021 after being
exposed to family member that was under quarantine in the same household. Admitted
to the hospital and was discharged on January 14, 2021 with home hospice. Patient
passed away on January 18, 2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0970930-1"
"0970930-1" "Pt developed COVID-19 infection, symptoms starting 7 days after
first dose was given. Patient was admitted to hospital on 1/21 after falling
(secondary to weakness) and striking head on toilet. Patient expired due to
respiratory complications of COVID on 1/25." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0975689-1"
"0975689-1" "Resident vaccinated on 01/06/21 she acquired COVID 19 on
01/10/2021. Resident had multiple co morbidities and was declining prior to the
vaccine. Resident expired on 01/20/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0975735-1"
"0975735-1" "VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21
RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT
EXPIRED ON 01/25/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0981945-1"
"0981945-1" "weakness and fallsNarrative: 95 yo male w/ a PMH significant
for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout,
BPH, chronic knee infection, and DJD who received his first dose of the Moderna
COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to
receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for
weakness and m PCR test on ultiple recent falls (since receiving his first dose of
the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was
admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The
pt initially required supplemental oxygen via low-flow NC, however his oxygen
requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care.
The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the
patient's hospitalization and eventual death, or whether these events occurred from
COVID-19 itself, however this case is being reported the FDA since this vaccine is
under an emergency use authorization (EUA)." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "0994778-1"
"0994778-1" "Resident received the vaccine on 1-22-21 and she was diagnosed
with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms
except feeling weak and she had a decrease in her appetite. She already had a poor
appetite prior. She died on 2-2-21." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1020195-1"
"1020195-1" "Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening
shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal
tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown
for this episode) then readmitted a third time 1/20/2021 for shortness of breath.
Diagnosed covid + at third hospitalization and continued to get worse. He died
1/23/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1020724-1"
"1020724-1" ""Patient sent to the ED or sudden onset of shortness of breath
on 02/02/2021. Per documentation by the MD, the patient had COVID19 ""several weeks
ago"" and the nursing facility felt like he had recovered. A rapid test done in the
ED was negative. When the patient worsened and seemed to be following the same path
as other COVID patients, a send out PCR test was done, which was positive. The
patient worsened and passed away that same day (02/05/2021) I was not made aware
that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021."" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1032252-1"
"1032252-1" "Resident tested COVID-19 confirmed positive a few days after
covid vaccination." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1041200-1"
"1041200-1" "Patient described feeling nervous, anxious the next morning
(Wednesday) after the vaccine. He later fell in the bathroom after using the
restroom, his legs gave out (his words) and consequently was on the ground for 23
hours before being transported to the hospital. That was Thursday afternoon. He was
diagnosed with COVID-19 on Saturday night and died the following Friday morning."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1042145-1"
"1042145-1" "Patient reported feeling weak, fatigue, fever (102), and loss of
appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for
COVID-19 on 2/7/21 (collection date). See following discharge summary from ED:
82 y.o. female who initially presented to the ED with complaint of generalized
weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving
Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with
02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-
90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate
left lung opacities. She was started on empiric ceftriaxone and azithromycin and
admitted to the hospitalist service for further workup and mgmt. During her stay
in the hospital, pt did test positive for Covid 19. She developed rapidly
progressive respiratory failure, felt to be secondary to ARDS. There was also
question of contributing pulmonary edema, however this was refractory to lasix and
thus ARDS was felt to be the most significant factor. She had requested DNR/DNI
status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and
then to BiPAP support. Unfortunately, she continued to suffer greatly with the
BiPAP in place, and therefore made the decision to transition herself to comfort
measures only after visitation from her family. Her other medical issues were
supported as appropriate during her stay, with dextrose infusion for hypoglycemia
and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to
find any documentation regarding how pt was feeling when she received the vaccine
compared to her baseline state of health. thus am unable to say whether the
severity of her illness represents vaccine� enhanced disease or the much more
common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as
result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death:
ARDS due to Covid 19 pneumonia." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1044247-1"
"1044247-1" "Moderna COVID 19 Vaccine: Patient started with symptoms of covid
5 days after first vaccine. She was hospitalized and passed due to COVID 19 on
2/6/21. Patients family informed us when she was due for the second dose." "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1047634-1"
"1047634-1" "Patient was admitted to hospital on 2-9-21 for urinary tract
infection and tested positive for Covid. Developed pneumonia and expired on 2-12-
21." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1049406-1"
"1049406-1" "Patient rcvd 1st covid 19 vaccine on 1/26/2021. Patient had
house guests on 1/30/21. Those house guests tested positive for covid on 2/1/2021.
Patient started getting symptoms on 02/2/2021. Patient tested postivie on
2/4/2021. Patient was hospitalized 2/7/2021. Patient passed away on 2/21/21."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1055563-1"
"1055563-1" "Pt tested positive for COVID-19 on 2/10/2021 and died from
illness related to COVID-19 on hospice at home on 2/18/2021, per care facility."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1055588-1"
"1055588-1" "Pt tested positive for COVID-19 on 2/10/2021 and was
hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission,
per caregiver." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1055613-1"
"1055613-1" "Pt tested positive for COVID-19 on 2/10/2021 and was deceased on
2/16/2021 per the caregiver." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1055618-1"
"1055618-1" "Pt tested positive for COVID-19 on 2/10/2021, and was deceased
on 2/16/2021 at." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1055629-1"
"1055629-1" "Pt tested positive for COVID-19 on 2/10/2021, and deceased on
2/12/2021, per caregiver at." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1080033-1"
"1080033-1" "COVID symptoms started within 8-9 days of vaccination. No fever,
general not feeling, chills. Turned into very difficult breathing, low oxygen
levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday,
January 27. Died in the hospital Saturday morning, January 30, 2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1080424-1"
"1080424-1" ""Narrative: above in section ""Other relevant history"""""No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1080427-1"
"1080427-1" ""Narrative: above in section ""Other relevant history"""""No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1080932-1"
"1080932-1" "DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION;
HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X
10 DAYS" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1091269-1"
"1091269-1" "A home dialysis patient who received his first COVID-19
(Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic
and reported no signs of symptom of COVID-19. This patient was diagnosed with
COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The
patient's spouse and son (who lives with them) also tested positive for COVID-19.
This patient developed COVID-19 complications while inpatient including stroke and
mechanical ventilation was required. The patient was made a DNR by family and
removed from mechanical ventilation and expired on 2/26/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1094868-1"
"1094868-1" ""Started having confusion at 3#0 a.m. Sunday morning. Unstable
gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks
ago. Had visual hallucinations with seeing ""bugs"" Admitted with positive COVID
and Influenza B diagnosis."" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1102722-1"
"1102722-1" "Patient presented to Hospital ED on 3/14/21 with respiratory
distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in
the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed
by Hospice). The patient passed away on 3/15/2021. Per family patient had recently
received COVID-19 vaccine. Vaccine information verified in portal." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1111389-1"
"1111389-1" "Cough started on 3/5. Hospitalization on 3/7, Expired 3/16.
Doctor's Death Diagnosis: acute on chronic respiratory failure." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1123229-1"
"1123229-1" "Patient received Moderna Dose #1-01/08/2021 and Dose #2-
02/05/2021. He was admitted to Medical Center on 03/08/2021 with confusion and
decreased O2 sats; date of death was 03/12/2021." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1126683-1"
"1126683-1" "Death within 60 days of vaccination. Tested positive for COVID-
19 2/8/2021, admitted outpatient to Hospital 2/8-2/10 readmitted 2/13-2/14 with
transfer to Medical Center in with death on 3/2/2021." "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1130111-1"
"1130111-1" "Patient passed away unrelated to covid vaccine Narrative: The
patient received his first dose of Moderna on 1/14 and he was rushed to the
hospital at 4 am on 1/15. The patient tested positive for COVID and is hospitalized
in the hospital. The patient passed away on 2/8. Cause of death not documented,
possibly due to COVID complication. No indication that death was related to COVID
19 vaccination." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1135603-1"
"1135603-1" "temperatures of 38.4�C; dependent on oxygen,adequate level could
not be reached with 10 L oxygen suppply; Respiratory insufficiency; Covid-19;
severe dyspnoea; productive cough; basilar rales; shivering; fatigue; sepsis; SARS-
CoV-2 exposure; A regulatory report (CH-SM-2021-10854) was received from a
physician concerning a 85-years-old male patient who received Moderna's COVID-19
vaccine (mRNA-1273) and experienced events COVID-19 severe dyspnoea (dyspnoea),
productive cough, rales, decreased oxygen saturation, respiratory insufficiency
(respiratory failure), sepsis, fatigue, shivering (chills), temperature of 38.4
degrees Celsius (pyrexia) and exposure to SARS-CoV-2 . The patient's medical
history was Arterial hypertension, Spondylolisthesis, chronic renal insufficiency,
urolithiasis, colon diverticulitis, polymyalgia rheumatica. Concomitant medications
reported was colchicine, allopurinol, acetylsalicylic acid, hydrochlorothiazide
valsartan, calcium carbonate colecalciferol, gabapentin, prednisolone, torasemide,
tramadol hydrochloride, colecalciferol, and zolpidem tartrate. On 21 Jan 2021,
prior to the onset of the events, the patient received their mRNA-1273 (lot batch:
300042460) intramuscularly for prophylaxis of COVID-19 infection. The patient had
a previous exposure to SARS-CoV-2 on 15Jan2021 which was not made known at the time
of vaccination. On 21 Jan 2021, the patient experienced temperatures of 38.4�C
which resolved by 22Jan2021. The practitioner initially suspected a reaction to the
vaccination, however since the fever returned, recommended testing for SARS-CoV-2.
On 22Jan2021, the patient was evaluated at the emergency department with severe
dyspnoea and tested positive for SARS-CoV-2. The patient was experienced shivering,
productive cough, and fatigue with a slightly deteriorated general condition but
was stable and afebrile. The patient had bilateral basilar rales which were
stronger on the right than left. Laboratory tests included elevated infection
parameters, increased creatinine, and elevated D-Dimer levels. Blood gases showed
acute partial respiratory insufficiency. Legionella and streptococcal urine antigen
test as well as the blood cultures were negative. A chest x-ray was done and showed
bilateral peripheral- and basal-predominant interstitial infiltrates. After being
admitted to the hospital, treatment included antibiotics, pulse steroid therapy,
oxygen therapy and remdesivir. The patient became oxygen dependent. On 25Jan2021,
the patient continued to deteriorate and died in the evening. The cause of death
being covid-19 infection. Autopsy information was not provided. Action taken with
mRNA-1273 in response to the events was not applicable. The outcome of the events
was fatal.; Reporter's Comments: This fatal case concerns an 85 Y/O M with exposure
to SARS-CoV-2 was hospitalized with serious unexpected COVID-19, sepsis,
respiratory failure, oxygen saturation decreased, dyspnea, productive cough, rales,
and expected pyrexia, chills, fatigue. Event onset Day 1 after first dose mRNA-
1273. Cause of death COVID-19. Autopsy unknown. Based on current available
information and temporal association between use of the product and the start date
of the event, a causal relationship cannot be excluded.; Reported Cause(s) of
Death: COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1156392-1"
"1156392-1" ".Mandatory EUA Reporting - Received 2nd Moderna Covid vaccine on
2/26. Admitted to hospital on 3/10 with pneumonia and COVID positive. Patient's son
was living with him and Covid positive. Failed treatment with abx, steroids,
oxygen. Transitioned to comfort care and passed away on day 8 of hospitalization."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1160236-1"
"1160236-1" "covid+ Narrative: Patient with diagnosis of chronic respiratory
failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea
secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM,
Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early
1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency,
Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple
joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility
3/27/21 with new onset Afib/further respiratory decompensation requiring
NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4
gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure
secondary to COPD/COVID with daughter at side." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1160237-1"
"1160237-1" "COVID+ Narrative: Patient administered COVID-19 vaccine
(Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and
was brought by ambulance to tertiary care facility with diagnosis of COVID-19.
Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine
drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021."
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1160722-1"
"1160722-1" "Patient diagnosed with COVID on 2/21/2021 and subsequently
expired" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1182101-1"
"1182101-1" "Completed Moderna series on 02/12/2021. Diagnosed with COVID-19
on 04/06/2021 and expired from COVID-19 pneumonia on 04/06/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1197016-1"
"1197016-1" "patient was hospitalized with COVID-19 on April 6, 2021" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1232988-1"
"1232988-1" "Taken to the Hospital due to COVID-like symptoms (strong cough).
At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin
levels. Dies at the Hospital due to COVID-19." "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1233587-1"
"1233587-1" "Patient received two dose Moderna series of vaccinations for
COVID 19 (1/21/2021 and 2/18/2021). Patient reported to ED feeling weak on
2/20/2021, but was not tested for COVID at that time. Reportedly, patients family
were all tested for COVID and were positive on or about 2/21/2021. The patient was
later admitted to the hospital on 4/13 with COVID. She subsequently expired on
4/14." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1241393-1"
"1241393-1" "Death Narrative: The patient did not have any predisposing
factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient
transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that
day. He was reported to have a reaction to the vaccine including diaphoresis, new
onset afib, and hypotension(vasovagal reaction). He was discharged the next day
with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID
pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure
secondary to COVID-19. Comorbidities include advanced age, obesity, HLD,
atherosclerosis, DM2, HTN." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1241403-1"
"1241403-1" "Death Narrative: Patient tested positive for COVID-19 on
1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from
hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He did not have
any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug
event. The ADR did not occur at the time of administration of the vaccine nor was
there an ADR that occurred between the observation period and the date of death.
Patient had made it through the COVID infection period but suffered complications
including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen.
He required readmission to hospital for the complications in 3/2021 but ultimately
passed away on 3/24/21 likely due to the multi organ failure complication of COVID"
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1267753-1"
"1267753-1" "Case tested positive for COVID-19 on 12/7/2020; vaccinated on
1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021.
Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall. Case
had altered mental status and fever. Case was found to have an acute CVA." "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1275915-1"
"1275915-1" "On 3/25/21, patient presented to the ED with several days
history of nausea, vomiting, and upper abdominal pain, and 1 day history of
shortness of breath and wheeze. Patient recently received her first dose of
Moderna COVID vaccination on March 10. Patient's daughter first developed COVID
symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed
nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was
tested positive for COVID several days prior to admission (either the 22 or 23rd,
patient not sure). On the morning admission, patient had significant worsening of
shortness of breath and wheeze. Patient also became significantly more weak and
fatigued, and was eventually brought to ED. Patient reported chills, but denied
headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21
with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1285947-1"
"1285947-1" "Hospitalized and died of COVID-19 after being fully
vaccinated." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1286213-1"
"1286213-1" "Presented to ED on 4/23/21 with weakness, malaise, poor appetite
and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy
infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia.
Patient referred to hospice." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1286659-1"
"1286659-1" "Shortness of breath, hypoxia, + COVID-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1307516-1"
"1307516-1" "Hospitalized and died due to COVID-19 after being fully
vaccinated. From vital records: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA
DUE TO COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1317367-1"
"1317367-1" "U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1, J96.00 -
Acute respiratory failure due to COVID-19" "No prior vaccinations for this
event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1322807-1"
"1322807-1" "Patient was seen by an outpatient provided and was referred to
emergency department due to hypoxis and respiratory distress on 4/27/21. He was
found to by COVID-19 positive at that time. He was admitted to the hospital for
further management. on 4/28/21, his condition declined. He was intubated and
transferred to the ICU. Patient went into severe acute kidney injury and
eventually into multi-system organ failure. He was placed on comfort measures on
and was pronounced dead on 5/15/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1323550-1"
"1323550-1" "Patient received Moderna COVID vaccine on 2/1/2021 and
2/22/2021. Pt. presented to Medical center within Health system with weakness and
arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for
COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health
system on 5/2/2021 complaining of SOB. Stated that she has had non-productive
cough for months, but felt it had worsened lately. Pt. found to be COVID positive
with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not
intubated but expired from cardiac arrest/COVID on 5/16/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1330750-1"
"1330750-1" "ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours)
Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance
(CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine
Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge
Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021
Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA *
(Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic
stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive
pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes
Coronary artery disease with history of myocardial infarction without history of
CABG Not Applicable Depression Yes History of aortic valve replacement
Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral
vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia
(CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA
(transient ischemic attack) Not Applicable Dementia with behavioral
disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting
Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury)
(CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91]
Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history
of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome
status post pacemaker, aortic stenosis status post valve replacement.Coronary
artery disease status post CABG, CHF, history of peripheral vascular disease,
history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD,
dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia
11/2020 was brought to the emergency room by the family due to worsening confusion
and agitation, as per wife after the patient was discharged back in November in few
weeks patient dementia started to get worse, more confused, more agitated and few
times he was violent to his family members, well for the last few days patient's
wife reported that his confusion was very bad so she decided to bring him to the ED
for further evaluation management. Hospital Course -For the above presentation
patient was admitted to the hospital services, patient was started on oxygen
supplementation, Covid repeat test continue to be positive, started on IV
antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8
patient was found without any spontaneous respiration, patient was pronounced dead
by the RN and CRNP finished the discharge defecate, please refer to RN
documentation for more details." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1353962-1"
"1353962-1" "COVID-19; This regulatory authority case was reported by an
other health care professional and describes the occurrence of COVID-19 (COVID-19)
in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna)
for COVID-19 vaccination. No Medical History information was reported. On
06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced
COVID-19 (COVID-19) (seriousness criterion death). The patient died on 22-Apr-2021.
The reported cause of death was covid-19. An autopsy was not performed. For
mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any
causality assessments. No concomitant products were reported. Action taken with
mRNA-1273 in response to the events was not applicable. ADR description - Covid;
Sender's Comments: Based on biological plausibility, the event is assessed as
unlikely related to mRNA-1273. The event of COVID-19 was consistent with infection
in pandemic set up.; Reported Cause(s) of Death: COVID-19" "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1364724-1"
"1364724-1" "Patient received second COVId 19 vaccine on 4/9/21 @ Health
Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and
Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired
on 5/19/2021 at hospital." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1371177-1"
"1371177-1" "Patient hospitalized and died after testing positive for COVID-
19. Tested positive on 5/3/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1385943-1"
"1385943-1" "04/28/2021: Patient transferred from Hospital with shortness of
breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated
episodes of hypoxemia and hypotension - was intubated on mechanical ventilation,
eventually switched to pressure control inspiratory pressure, extubated, had to be
reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension
pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient
placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00
Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory
failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable
bacterial superinfection, Atrial fibrillation with rapid ventricular response,
Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida
tracheobronchitis, Previous history of prostate cancer status post radiation,
dyslipidemia, hypertension present at admission." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1395420-1"
"1395420-1" "Patient presented to emergency department for increasing trouble
breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on
3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for
management of COVID-19 infection where she also tested positive for COVID-19. She
was admitted for further management of COVID-19 infection. Her symptoms did not
improve and she was placed on comfort measures on 5/4/2021. Patient expired on
5/5/2021 due to complications from COVID-19 infection." "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1403521-1"
"1403521-1" "weak, loss of appetite, pneumonia, ARDS" "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1406851-1"
"1406851-1" "5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female
with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and
HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive
in the ED and was intubated for airway protection. CTA chest with extensive acute
pulmonary embolism with findings of right heart strain. Patient intubated and
sedated, information is obtained from her son, medical staff and medical records.
Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to
slowly be improving until Saturday prior to admission Per son was more tired but
she had worked with physical therapy and HH on Friday. Sunday she was having
difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental
status, unspecified altered mental status type; Pneumonia of left lower lobe due to
infectious organism; Atrial fibrillation with rapid ventricular response (HCC);
Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary
embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory
failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB
(shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial
fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)"
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1410797-1"
"1410797-1" "Initially had fatigue, diarrhea, and loss of appetite. Tested
positive for COVID 19 on 5/28/21 , during surveillance testing related to a
facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness,
high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back
to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia,
treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On
6/12/2021, went to ED for ischemic stroke. Died 6/13/2021.""No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1417223-1"
"1417223-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full
Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died
on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD
and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as:
OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG
DISEASE (ASTHMA/EMPHYSEMA/COPD)" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1417278-1"
"1417278-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 4/22/21 after the completion of a full
Moderna vaccine series (Dose 1 on 2/11 and Dose 2 on 3/11). The patient later died
on 5/13/21 . Cause of Death is listed as ?Intestinal Obstruction?." "No prior
vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1420707-1"
"1420707-1" "Patient presented to ER on 01/18/2021 and stated respiratory
symptoms began on 01/14/2021. Positive Covid test that day. Patient was released
from ER and admitted as inpatient to the hospital on 01/23/2021 and expired of
Covid related symptoms on 02/02/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1424014-1"
"1424014-1" "Death 4/18/2021 Causes of death listed on patient's death
certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis,
Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity"
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1424081-1"
"1424081-1" "Death 4/7/2021 Causes of death listed on death certificate: 1)
Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4)
Atrial fibrillation Other: COVID 19" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1424120-1"
"1424120-1" "Death 04/23/2021 Causes of death listed on death certificate:
1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension"
"No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1425907-1"
"1425907-1" "Death 5/5/2021 Causes of death listed on death certificate: 1)
cardiac arrest 2) unknown cause Other: COVID 19, CAD, AKI needing HD" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1425911-1"
"1425911-1" "Death: 04/20/2021 Causes of death listed on death certificate:
1) Covid" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1425918-1"
"1425918-1" "Death 5/31/2021 Causes of death listed on death certificate: 1)
atherosclerotic heart disease Other: recent Cove at 19, pneumonia, peripheral
vascular disease, hypertension, dementia, extensive squamous cell carcinoma of skin
of scalp, protein calorie malnutrition" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1427795-1"
"1427795-1" "Died 4/24. Immediate cause of death acute hypoxic respiratory
failure, underlying cause COVID-19 associated respiratory distress syndrome and
COVID-19 viral pneumonia" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1431502-1"
"1431502-1" "Patient died of complications due to COIVD-19 illness, which was
4 months after receiving his second dose of vaccine. He was a breakthrough case
that died with full vaccination status for COIVD-19. No one is indicating that the
vaccine had anything to do with this persons' death." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1433471-1"
"1433471-1" "Died of COVID-19 illness on 05/08/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1433788-1"
"1433788-1" "Death 5/29/2021 Causes of death listed on death certificate: 1.
pneumonia 2. COVID 19 3. coronary artery disease, hypertensin, Non insulin
dependant diabetes" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1437443-1"
"1437443-1" "Death 5/31/2021 Causes of death listed on death certificate: 1.
Autoimmune cold-agglutinin hemolytic anemia 2. COVID 19 3. rheumatoid arthritis,
chronic immunosuppression" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1437449-1"
"1437449-1" "Death 5/30/2021 Causes of death listed on death certificate: 1)
Hypertensive Heart disease with Heart Failure Diastolic Other: Covid-19" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1440922-1"
"1440922-1" "ADMITTED TO HOSP AFTER BYSTANDER CPR. COVID TEST AT ADMIT
POSITIVE" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1449945-1"
"1449945-1" ""Vaccination failure; This regulatory authority case was
reported by an other health care professional and describes the occurrence of
COVID-19 and VACCINATION FAILURE (Vaccination failure) in an 85-year-old male
patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EK9788) for
COVID-19 vaccination. No medical history was reported. The patient's past
medical history included Orthostatic hypotension, Abdominal aortic aneurysm and
Cirrhosis of liver. Concomitant products included PERINDOPRIL ERBUMINE (COVERSUM)
for COVID-19 vaccination, AMIODARONE, ATORVASTATIN, DUTASTERIDE, TAMSULOSIN
HYDROCHLORIDE (DUODART), APIXABAN (ELIQUIS), PANTOPRAZOLE SODIUM SESQUIHYDRATE
(PANTOPRAZOLO), ECHINACEA ANGUSTIFOLIA ROOT, SERENOA REPENS FRUIT, TROSPIUM
CHLORIDE (SPASMO URGENIN), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LACTULOSE
(DUPHALAC [LACTULOSE]) and PRIMIDONE (MYSOLIN) for an unknown indication. On 10-
Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna)
(Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273
(COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On
12-May-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient
experienced COVID-19 (seriousness criterion death). On an unknown date, the patient
experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion
death). The patient died on 12-May-2021. The cause of death was not reported. It is
unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine
Moderna) (Intramuscular), the reporter considered COVID-19 to be unlikely related
and VACCINATION FAILURE (Vaccination failure) to have an unknown relationship.
Treatment information was not provided. This is a case of lack of efficacy of the
vaccine with an associated adverse event of Covid-19, therefore causal association
between the event is assessed as not applicable.; Sender's Comments: ""This is a
case of lack of efficacy of the vaccine with an associated adverse event of Covid-
19, therefore causal association between the event is assessed as not applicable"";
Reported Cause(s) of Death: Unknown Cause of Death"" "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1450098-1"
"1450098-1" "Patient experienced onset of COVID symptoms 05/26. Tested
positive for SARS-COV-2 by PCR on 06/09. Presented to ER on 06/12/21 c/o cough,
SOB, and hypoxia. O2 sat was 72%. Patient was hospitalized and passed away on
06/18/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1454305-1"
"1454305-1" "Breakthrough resulted in COVID death" "No prior vaccinations
for this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1454827-1"
"1454827-1" "Patient fell down the stairs on 04/18/2021; EMT services found
no pulse upon their arrival to the scene. Patient was transported to hospital and
found to have several broken bones in neck and ultimately died on 04/18/2021 at the
hospital. Patient tested positive for COVID-19 upon admission to hospital, despite
being fully vaccinated. Patient did not have any known symptoms of COVID-19; the
death is not thought to be related to COVID-19." "No prior vaccinations for
this event."
"COVID-19" "10084268" "MODERNA" "591" "80+ years" "80+" "1454844-1"
"1454844-1" "Patient admitted to hospital on 04/20/2021 for significant
shortness of breath; patent tested positive for COVID-19 despite being fully
vaccinated against it. Patient died on 04/24/2021. Death Certificate Information:
Part I: Cause of Death: A. Repiratory Arrest B. COVID-19 Part II Other Significant
Conditions COPD; Multiple Myeloma" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "Unknown" "U" "1021926-1"
"1021926-1" "Passed away; Positive result; A spontaneous report was received
from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine
(mRNA-1273) and developed COVID-19 and passed away. The patient's medical
history was not provided. Concomitant product use was not reported. On 05 Jan
2021, prior to the onset of the events, the patient received their first of two
planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.
On 08 Jan 2021, the patient had a positive COVID-19 test. On 18 Jan 2021, the
patient passed away. No treatment information was provided. Action taken with
mRNA-1273 in response to the events was not applicable. The patient died on 18 Jan
2021. The cause of death was not reported.; Reporter's Comments: This spontaneous
report concerns a female patient who experienced COVID-19 and passed away. The
event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273
vaccine administered and death occurred 14 days after administration of the mRNA-
1273 vaccine. Based on the information provided and the known etiology of COVID-
19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no
definite information on the clinical details of the death, it is difficult to
adequately assess a causal association with mRNA vaccine. Main field defaults to
�possibly related'; Reported Cause(s) of Death: unknown cause of death" "No
prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "Unknown" "U" "1036480-1"
"1036480-1" "Patient passed away on 2/2/21 after being admitted on 1/31/21
after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the
hospital patient reported having a cough for over 2 weeks (starting approx.
1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed
away on 2/2/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "MODERNA" "591" "Unknown" "U" "1085185-1"
"1085185-1" "testing positive for COVID; Fever for 3 hours after the vaccine/
High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous
report was received from a nurse concerning a 44-year-old female patient who
experienced fever for 3 hours after vaccination, headache, joint pain, and severe
upper back pain. The patient's medical history was not provided. Products known to
have been used by the patient, within two weeks prior to the event, included
dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine,
simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and
vitamin C. On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A)
intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, patient
experienced fever for 3 hours after vaccination. The patient also experienced
headache, joint pain, and severe upper back pain. The patient stated her
temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down.
Treatment information was not provided. Follow-up received on 21 Feb 2021, from
the patient's husband, included that the patient tested positive for Covid-19 on 09
Jan 2021 and was hospitalized on 11 Jan 2021. The patient never recovered from her
symptoms and the patient died on 02 Feb 2021. Action taken with mRNA-1273 in
response to the events was not applicable. The outcome of the events Coronavirus
test positive was fatal and for headache, joint pain, severe upper back pain and
temperature were unknown. The cause of death was reported as Coronavirus test
positive and autopsy details was unknown.; Reporter's Comments: This case concerns
a 44-year-old female who was hospitalized with a serious unexpected event of COVID-
19 with fatal outcome along with NS unexpected back pain and NS expected fever,
headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273.
Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on
current available information and temporal association between use of the product
and the start date of the event, a causal relationship cannot be excluded.;
Reported Cause(s) of Death: Testing positive for COVID" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "6-17 years" "6-17"
"1431289-1" "1431289-1" ""Date of Admission: 6/19/2021 Date of Death:
6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR
ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after
out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field,
found to be in the context of large cerebellar hemorrhage secondary to brain lesion
(AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to
arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine
drips to maintain perfusion and was administered bicarbonate x2. Head CTA was
obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no
contrast enhanced blood flow in the brain. Brain death exams were completed at
09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of
brain death. Official cause of death was brainstem herniation from intracranial
hemorrhage. Mechanical ventilation was continued to allow family time to grieve
and perform last rites. Time of cardiac death after mechanical ventilation
withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central
DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of
ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart
rate. His sodium was 141 upon presentation but reached a maximum of 160 due to
central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to
improve hypernatremia, which was monitored Q1h until normonatremic. He
additionally required vasopressin drip to be started due to central DI, which was
increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was
running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was
increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission,
he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine
and norepinephrine were discontinued. Two doses of adenosine were administered (6
mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4
seconds after the second dose however returned to ~180. EKG arrived which showed
sinus tachycardia so no further medications or cardiac interventions were done.
Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was
administered. Norepinephrine and epinephrine were restarted and escalated due to
low blood pressures in the early afternoon.to allow family time with patient. Both
titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal
pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had
no primary pulmonary disease during this admission. Neuro: #Intraparenchymal
hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and
hypertonic saline 23% x1 were administered to decrease intracranial pressures.
Keppra 2g was administered for seizure prophylaxis. No sedation was needed during
patient's hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology
Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None
No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp
36.5 �C (97.7 �F) | Resp (!) 15 | Ht 1.65 m (5' 4.96"") | Wt 46.5 kg (102 lb 8.2
oz) | SpO2 99% | BMI 17.08 kg/m� Estimated body mass index is 17.08 kg/m� as
calculated from the following: Height as of this encounter: 1.65 m (5' 4.96"").
Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug
Allergies"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "30-39 years" "30-39"
"1212820-1" "1212820-1" "Unexpected death 3 days after vaccination" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "30-39 years" "30-39"
"1332849-1" "1332849-1" "passed away from COVID (positive test on 24Apr2021);
passed away from COVID (positive test on 24Apr2021); This is a spontaneous report
from a contactable physician. A 37-years-old female patient received second dose of
bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an
unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported
as EPT534) as single dose for covid-19 immunisation. Medical history was none. The
patient's concomitant medications were not reported. Patient received first dose of
bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19
immunisation. Patient with no comorbidities passed away from COVID (positive test
on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient's family
members provided vaccination card and she would like to verify if the lot numbers
are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient
developed fatal Covid a month after being fully vaccinated. Additionally, she would
like to verify if it is possible to know where the vaccines were shipped or any
other distribution or facility information she could get from these lots. Stated
that the vaccination card has something written on a box from the right hand side.
Reporter seriousness for Tested Positive for Covid was Hospitalization, Death.
Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy
details not available. Events outcome was fatal. The patient died on 09May2021.;
Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported
events cannot be excluded in a context of LOE. The impact of this report on the
benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as well as
any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. ; Reported
Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "40-49 years" "40-49"
"1156620-1" "1156620-1" "Mandatory EUA Reporting - Patient received COVID-19
vaccine on 1/12/21 and then tested positive for Covid the same day. Was admitted to
hospital from rehab (resides in rehab for chronic respiratory failure). Patient
deteriorated throughout hospitalization, was transitioned to comfort care, and
expired on 2/10/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "40-49 years" "40-49"
"1327755-1" "1327755-1" "Hospitalized for COVID-19 pneumonia on 4/23, ICU on
5/3, passed on 5/17 of 2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1024067-1" "1024067-1" "1/15: Pfizer vaccine dose 1 administered 1/16:
Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and
Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA.
Per her notes, patient said he gets these symptoms annually, requested for an
antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER
suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms
do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID
1/26: Telehealth session w/PA: she informed patient of his positive test, advised
to quarantine and seek medical help at hospital if symptoms worsen. Patient
reported that his sore throat mostly subsided but is still coughing at night. Said
that the pharmacy didn't receive the prescription order for the antibiotic, so this
was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death
certificate issued by state says cause of death: COVID. Autopsy was not performed.
Buried on 2/9/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1031189-1" "1031189-1" "COVID 19 symptoms and a positive test was confirmed
on 1/6, employee noted previous exposure to positive family members Narrative:
Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on
1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was
confirmed COVID positive that day. Positive result was reported to employee health
on 1/8/21. Employee Health continued to track employees progress and was informed
of the need for hospitalization on 1/14/21. Course of hospitalization noted the
need for intubation and significant issue with comorbid condition (rheumatoid
arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to
Vaccine vs. COVID infection, but felt it should be reported." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1047351-1" "1047351-1" "Patient was tested for covid on 2/2/21 with positive
resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed
with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to
ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite.
Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral
lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin,
d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the
patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs
of secondary infection Patient transferred to a different hospital in another
city." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1065573-1" "1065573-1" "Covid-19; This is a spontaneous report from a non-
contactable physician downloaded from the Medicines Agency (MA) regulatory
authority-WEB DE-PEI-PEI2021002654. A 54-year-old male patient received bnt162b2
(COMIRNATY) (lot number unknown), via an unspecified route of administration on
12Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included early
childhood brain damage from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced covid-19 (covid-
19) (death, hospitalization) on 13Jan2021. Patient was vaccination with Comirnaty
on 12Jan2021. After 1 day positive PCR test for SARS-CoV2. Symptoms of a Covid-19
infection after 2 days. Stationary admission on 16Jan2021 due to deterioration.
With intake of massively increased Blood sugar (> 900). Patient died on 21Jan2021.
Preliminary autopsy findings included massive pneumonia with microabscesses, staph.
aureus in the tracheal secretion, PCR positive for SARS-CoV2 in almost all organs,
CT pituitary gland 28. Pathologist expresses suspicion of enhanced disease.
Sequencing pending, Antibody determination pending. The patient died on 21Jan2021.
An autopsy was performed. Comirnaty/ Covid-19/ PEI/ C. Inconsistent causal
association. No follow-up attempts are possible. Information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1096600-1" "1096600-1" "Per the patient's spouse and Hospital: The patient
received a rapid COVID test at clinic prior to vaccination, which read negative.
The patient received vaccination on 2/23/21 and the following day (2/24/21) began
to experience breathing difficulties. The patient was admitted to the emergency
room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t
COVID-19 (oxygen saturation < 50%). Patient was intubated on 3/2/21. Per Hospital
pharmacist, patient expired on 3/12/21 at 6:40pm." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1138370-1" "1138370-1" "he started feeling sick day after vaccine with flu
like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19, About
1 week after that, he was found dead at home on his couch.""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1172767-1" "1172767-1" "Patient presented 4/3 stating received Pfizer COVID-
19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by
Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he
should have production but is not able sputum out. The pain is chest is described
as not being able to fully expand his lungs when he tries to inhale. Patient
presented 4/6-DOA" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1235811-1" "1235811-1" ""COVID pneumonia; Hematological; bleeding; having
hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was
positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches;
This is a spontaneous report from a contactable physician. A 52-year-old female
patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE,
Batch/Lot number was not reported), via an unspecified route of administration at
the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical
history included hemodialysis for many years, adherent to medical care, multiple
DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal
failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family
history included renal failure and had lupus anticoagulant. Concomitant medications
included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol;
ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol.
The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica,
tetracycline. The patient previously was non-responder to hepatitis B vaccine. The
patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19
VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated
with immunomodulating or immunosuppressing medications or received any other
vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former
smoker. There was no any other vaccinations within four weeks prior to the first
administration date of the suspect vaccine. A nephrologist who reported patient in
her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed
with COVID-19. More detail is below on each patient. The patient COVID results were
sent to the local health department for genetic sequencing (pending) and SARS
titers were drawn (pending). Unfortunately, the HD unit does not have B/L
information (although the B/L # was put on the patient's COVID vaccine cards, a
record was not kept in the HD unit). Day she came in for dialysis she was already
short of breath she said she'd had body aches for 5 days, got short of breath on
05Apr2021. The day before, started getting cough, nauseous, chills, abdominal
discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was
admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed.
Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT
scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient
experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to
regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The
patient experienced short of breath on 05Apr2021 and required much more O2 than
normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER.
Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The
patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The
patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration
was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no
heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and
myocarditis. The patient Had chest pain which resolved when O2 was administered.
Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced
nausea but no vomiting or diarrhea and complained of abdominal pain. There was no
Jaundice and acute liver failure. Neurological: There was no altered consciousness,
altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The
patient had headaches a couple days before admitting to ER. Hematological: There
was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to
large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin
increased at 0.37 at admittance, BNP 39. The patient started coughing up blood,
having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic
studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public
health assay. Xray showed vascular congestion with superimposed infiltrate which
could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry:
Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was
90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make
urine. The patient had received Remdesivir, from 06Apr2021,
Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids
from 06Apr2021 for COVID-19. The outcome of event ""GI bleed"" was fatal, the
event ""chest pain"" and ""body aches"" was recovered and other events was unknown.
The patient died on 09Apr2021. An autopsy was not performed. Information on the
lot/batch number has been requested.; Sender's Comments: Based on temporal
association, a contributory role of the suspect drug cannot be excluded for the
events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the
patient's multiple medical comborbidities including renal failure requiring
dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in
light of the current pandemic are the more likely explanations for the development
of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis
and troponin increased are attributed to intercurrent medical conditions, and are
considered unrelated to the suspect drug. The patient is currently on warfarin
which may increase the risk for bleeds. This case will be reassessed upon receipt
of additional information. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed"" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1355174-1" "1355174-1" ""On 5/20/21 the patient was at home with his mother
when he had acute nausea, light-headedness, and abdominal pain. He presented to the
ED by ambulance. Excerpt from ED notes od MD follows: ""Initial ED interventions:
iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives
very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not
seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by
her presence, but she is unable to direct him, and describes his behavior as
irregular, and events acute this evening at her home. Patient rests, and then HR
decrease to 50s on monitior and patient found to be pulseless - I immediately start
chest compressions, and achieve ROSC after PEA arrest with administration of
EPI/compressions. Patient intubated per procedure note without complication. L
femoral central attained per procedure note without complication. CPR performed
over ED course intermittently (always PEA arrest) with ROSC achieved with
administration of EPI, EPI drip started in addition to sedation meds, and iv
fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection
and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I
recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees
with admininstration of alteplase. I disucss risks with mother who consents
verbally. Patient without response to alteplase, and with continued pattern of PEA
arrest following bradycardia. I discuss etiology of presentation with mother,and
that patient is with very poor prognosis of survival, and likely poorer prognosis
of neurological status, and patient is made comfort care, and fentanyl drip
increased, patient is taken off of ventilation and drips. Pronounced deceased at
22:00. MDM: Initial concern for but not limited to appendicitis, AAA,
diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis,
toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis,
intra-abdominal infection), AAA, dissection, PE - as ED course progresses,
differential narrows and consider more likely PEA arrest secondary to ACS, PE,
dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but
do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place,
no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs
reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC,
and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE,
with subsequent cardiac arrest, despite heoric efforts including thrombolysis.
Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition:
deceased."""" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1394137-1" "1394137-1" "Her husband passed away; Sepsis; Shock due to
bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute
disease syndrome due to diffuse alveolar damage; misery and feeling horrible;
Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle
aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a
spontaneous report from a contactable consumer. A 57-year-old male patient received
second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified
route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number:
EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation.
Medical history included high cholesterol from 2017 to an unknown date, seasonal
allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017
to an unknown date. The patient's concomitant medications were not reported. The
patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number:
EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the
patient previously received ZYRTEC (10mg almost daily) for seasonal allergy,
ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient
passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID
Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went
to the hospital emergency room (ER). It was reported that an autopsy was performed
on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and
shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar
damage. The manner of death was natural and the lung presentation is highly
suggestive of diffuse alveolar damage due to COVID-19 although the patient had
several negative tests for COVID. The patient tested negative for influenza AB,
negative for valley fever, negative for Legionnaire's disease and was in the
hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021
and was feeling miserable and asking for blood tests and urine tests, stated at
that time his platelets were low at 122, glucose was high at 105, sodium was low at
134, calcium was low at 8.3, urine was negative and the patient did not get these
labs til Monday when he was on the way to the emergency room and it was all
different when he got to the hospital. The test for strep was negative, the oxygen
was low at 86 percent when he got to the hospital on Monday and they just had to
keep increasing his oxygen, stated a culture, no further details provided about the
culture. A CTA done on the chest on Monday which was bad and stated the patient was
symptomatic and they did not treat him for COVID but had a clinical suspicion for
COVID. Adenovirus was not detected, metapneumonia virus was not detected,
respiratory syncytial virus was not detected, parainfluenza was not detected, his
platelets kept dropping and he had two tests for valley fever which is Cocci IGG
and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of
these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222,
bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at
18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD
was 45.5, and platelets were low at 61. The patient came into the emergency room
those labs were when he was failing completely and on 01Mar2021 was when he arrived
in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at
18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high
at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3,
glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The
patient was negative for strep pneumonia antigen and negative for Legionnaires
Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in
misery and feeling horrible and they sent him home with albuterol and possible
antibiotic to start that Monday and he had severe chills, headache, shortness of
breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore
throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he
tested negative for influenza AB and he never got to the antibiotic because they
said to wait til Monday and by that time this was an emergency. The patient outcome
of sepsis and shock due to bilateral pulmonary acute disease syndrome due to
diffuse alveolar damage was fatal and unknown for the other events. The patient
died on 02Mar2021. An autopsy was performed that revealed the cause of death was
sepsis and complications from sepsis and shock due to bilateral pulmonary acute
disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death:
Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary
acute disease syndrome; Diffuse alveolar damage" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "50-59 years" "50-59"
"1408206-1" "1408206-1" "Patient received both COVID vaccines. On 5/21/21
she presented to the ED with COVID symptoms. She was tested on 5/21/2021 and was
positive for COVID-19. She died on 6/7/2021 in hospital from complications of
COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1069560-1" "1069560-1" "Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at
home when children noticed his lips were blue, ems arrived and found him to be 50%
on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-
year-old male presents with EMS for evaluation of shortness of breath hypoxia.
History is limited due to the patient's current clinical condition and so is
primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5
days ago. He began developing shortness of breath yesterday and his family called
because his lips and fingers were blue today and he appeared short of breath. On
EMS arrival he had a room air saturation of less than 50% so he was placed on
nonrebreather with improvement in his saturation to 70% and he was transported to
the emergency department. Patient does admit to shortness of breath. He denies
any chest pain. He is noted to have a cast on his left ankle and said that he
broke his left ankle on 23 December but has not had surgery. He denies any new
pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB
mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of
1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed
on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to
COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more
pronounced in the bases and left periphery and suspected multifocal pneumonia. At
risk for PE given LLE immobility in the setting of COVID-19 with significantly
elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy.
Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in
60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given
lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s
and PO2 42 so the decision was made to intubate. Oxygenation improved following
intubation, with further improvement following recruitment maneuver and increase in
PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2
as able. ARDS net protocol as much as possible. Consider prone ventilation and/or
epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per
nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and
Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG
levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone
6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets
criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets
and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and
ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia;
EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting
of COVID infection. Urine output and electrolytes acceptable. Closed fracture of
left ankle Suffered fracture following a fall on ice in December. Cast was placed
on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal.
Inhaled epoprostenol started Considered for ECMO but not initiated due to not a
candidate Vasopressors required at times Antihypertensive infusion required at
times severe hypoxia with position changes switched from heparin drip to
enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on
1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and
had worsening respiratory status. He was intubated after arrival, and was on
ventilator for the entire intervening time, until he was extubated on 2/20 at the
time of transition to Comfort measures only. Prior to developing COVID 19, he
had received his first dose of the Pfizer vaccine, as a member of the school
system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in
place at the time of admission. He received Tocilizumab on 1/31, and underwent
several cycles of prone positioning, beginning on 2/2. He completed a course of
Decadron, he received Ceftriaxone and azithromycin beginning on admission, and
completed a course of these. Anticoagulation with enoxaparin was utilized due to
coagulopathy associated with COVID 19. Vasopressor support was required at times,
as well as diuresis for fluid management. He required high levels of sedation to
maintain ventilator synchrony, and high levels of ventilator support with high
oxygen levels throughout his stay. Tracheostomy was being considered, but family
decided that since he was not going to have good recovery, withdrawal of support,
and allowing death was the appropriate choice for the patient and for them. He
was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021.
Children were at bedside." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1091799-1" "1091799-1" "Became COVID-positive, pneumonia, ARDS, hospitalized
for hypoxia 2/21/2021, death 2/25/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1198199-1" "1198199-1" "62-year-old male with number of medical problems
that include history of hepatitis-C, history of cirrhosis, history of alcohol
abuse, cocaine abuse, history of diabetes hypertension who has initially presented
to EMS with increasing shortness of breath. Patient suffered cardiac arrest during
his transportation to the emergency room. A CPR was initiated and was given 3
rounds of epinephrine. Most of the history is taken from the ER physician chart
review. ACUTE RESPIRATORY FAILURE SECONDARY TO HYPOXEMIA, COVID-19 , cardiac
arrest, possible anoxic brain damage : Patient is 62-year-old male with
complicated history with history of hepatitis-C, cirrhosis, alcohol use, cocaine
abuse diabetes who presented after having cardiac arrest and possible anoxic brain
damage. Patient was intubated after the arrest. Patient stayed in the hospital
for number of days. Patient was found to have COVID-19 positive. Patient was
found to have diffuse bilateral infiltrate. Patient was started on broad-spectrum
antibiotics including cefepime Flagyl and Decadron. Due to patient's cardiac
arrest patient was started on hypothermia protocol. Patient was rewarming after
that. There was no purposeful movement or neurological recovery. After long
discussion with the family, patient has been made comfort care. Patient was
extubated. Patient expired promptly after that. Family is notified." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1230246-1" "1230246-1" "My husband developed severe COVID symptoms, despite
testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23. He
was hospitalized on 3/28 due to low blood oxygen levels. Was diagnosed with COVID
and pneumonia. Treated with remdesivir and a steroid, then monoclonal antibodies.
Despite making progress to the extent doctors were cautiously optimistic on 4/9/21
he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21,
placed on a ventilator on 4/11/21 and died on 4/15/21." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1233795-1" "1233795-1" "Information obtained from the Hospital. Began to not
feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on
4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1236493-1" "1236493-1" "A.R.D.S.; COVID-19; COVID-19; Dyspnoea; Shivering;
Coughing; Fever; peripheral circulatory failure; exhaustion; Groggy; This is a
spontaneous report from a non-contactable physician downloaded from the regulatory
authority-WEB, regulatory authority number DE-PEI-202100032679. A 61-year-old male
patient received bnt162b2 (COMIRNATY), via an unspecified route of administration
on 06Jan2021 (Batch/Lot Number: EJ6797) as 0.3 mL, single for COVID -19
immunization. Medical history included ongoing Arterial hypertension. The patient's
concomitant medications were not reported. The patient experienced shivering,
fever, exhaustion, groggy, coughing, peripheral circulatory failure on 07Jan2021,
Dyspnoea and COVID-19 on 11Jan2021 (both hospitalization), experienced ARDS on
02Feb2021 (hospitalization). The patient died on 02Feb2021 caused by ARDS. An
autopsy was not performed. The event outcome was not recovered for shivering,
fever, exhaustion, groggy, coughing, peripheral circulatory failure, dyspnoea,
COVID-19, fatal for ARDS. No follow-up attempts possible. No further information
expected. Information on lot# already obtained.; Reported Cause(s) of Death: ARDS"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1238478-1" "1238478-1" "He was healthy before vaccine. After vaccine a
small amount of chills for a couple days. He was sicker and was exposed to COVID
19, so went to hospital 4/14/2021 tested neg for influenza and + Coronavirus. Died
on 4/15/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1275910-1" "1275910-1" "Patient presented to ED on 3/28/21 with the
following information: patient reports home daughter was diagnosed with COVID-19
infection a few days ago. For about a week now the patient herself has had severe
fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She
denies fevers. She has however had a persistent cough and over the last few days
has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside
facility. Last night patient had multiple episodes of diarrhea making her fatigue
significantly worse today. Has been drinking a lot of free water. Additionally
noted increased cough and shortness of breath. Patient was admitted to the hospital
with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1282520-1" "1282520-1" "62F with stage 2 mycoises fungoides, peripheral
neuropathy, HTN, HLD, admitted from hepatology clinic on 3/25/21 for worsening
liver injury and URI symptoms, found to be COVID positive. Liver biopsy with
evidence of severe hepatitis with bridging necrosis. Course complicated by increase
encephalopathy 3/31/21 concerning for acute liver failure, requiring stay in COVID
ICU, transferred to hepatology service on 4/2/21. DDx remains viral hepatitis,
autoimmune hepatitis, and drug-induced liver injury now on steroid therapy as of
3/31/21 and NAC. Pt. had worsening ALF and encephalopathy, transitioned to comfort
care. Pt died early morning of 4/4/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1289390-1" "1289390-1" "Patient hospitalized and died of pneumonia caused by
COVID-19 after being fully vaccinated." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1319463-1" "1319463-1" "COVID-19 pneumonia; Oxygen saturation of 30%;
Unconscious at arrival to Hospital; airway compromised by gastric content; Apneic;
central pulse not palpable; COVID-19; Dysopnea/Respiratory distress; Fever of 38
degrees Celsius; Diarrhea; Rhinorrhea; Cough; Dysopnea/Respiratory distress;
Myalgia; Arthralgia; This is a Spontaneous report from a non-contactable Other
Health Professional. This is a report received from Agency Regulatory Authority via
email. Regulatory authority report number is 12907-5 A 62-years-old male patient
received bnt162b2 (BNT162B2), via intramuscular, administered in Arm Left on
12Mar2021 (Batch/Lot Number: ER1742; Expiration Date: 30Jun2021) as 1st dose single
for covid-19 immunisation.Age at vaccination 62 years. The patient medical history
was not reported. The patient's concomitant medications were not reported. The
patient experienced fever of 38 degrees celsius on 22Mar2021 , diarrhea on
22Mar2021 , rhinorrhea on 22Mar2021 , cough on 22Mar2021 , dysopnea/respiratory
distress on 22Mar2021 , myalgia on 22Mar2021 , arthralgia on 22Mar2021 , covid-19
on 30Mar2021 , covid-19 pneumonia on 04Apr2021 , oxygen saturation of 30% on
04Apr2021 , unconscious at arrival to hospital on 04Apr2021 , airway compromised by
gastric content on 04Apr2021 , apneic on 04Apr2021 , central pulse not palpable (on
04Apr2021. The patient underwent lab tests and procedures which included blood
immunoglobulin g: 19.88 on 31Mar2021 , blood immunoglobulin m: 12.78 on
31Mar2021 , computerised tomogram: covid-19 on 30Mar2021 , oxygen saturation:
30 % on 04Apr2021. The patient died for the events n 04Apr2021. Clinical picture:
62-year-old male, unknown personal background, with a background of covid-19
vaccination in PRIVACY on 12Mar2021, begins with symptoms on 22Mar2021 of type of
flu mentioned by the patient's wife, letting go a week without presenting an
improvement, they go to a doctor on 30Mar2021 where they diagnosed covid-19 by
tomography and on 31Mar2021 they go to take quantitative antibodies at laboratory,
resulting in IgM 12.78 and IgG 19.88. Continues treatment at home with supplemental
oxygen without presenting an improvement, it is brought to this unit on 03Apr2021
in a private vehicle from their home, in treatment with supplemental oxygen for
pneumonia by sarscov2, relatives refer important desaturation as low as 30% prior
to his transfer to this unit. Unconscious patient is received on admission, airway
compromised by gastric content, apneic, non-palpable central pulse. Family members
refer at least 10 minutes of cessation of breathing until the arrival at this unit.
Declaring date of death 03Apr2021. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: unconscious at arrival to hospital; airway
compromised by gastric content; fever of 38 degrees celsius; diarrhea; rhinorrhea;
cough; dysopnea/respiratory distress; dysopnea/respiratory distress; myalgia;
arthralgia; Covid-19; covid-19 pneumonia; oxyg" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1350521-1" "1350521-1" "Patient was hospitalized 5/7/2021 after testing
positive for COVID-19 on 4/30/2021. Patient was fully vaccinated. He died
5/18/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1368008-1" "1368008-1" "4/28/21 Pt presented to the ED with complaints of a
cough that started 2 weeks ago and was getting worse and weakness with several
falls. She also admitted to intermittent diarrhea. She was found to be febrile with
a temp to 101.1, tachypneic w/RR of 20. Sats were in the low 90's. NP was was
positive for SARS-CoV-2. CXR showed bilateral opacities and she was admitted for
PNA and sepsi. She was given Rocephin and Z-max in ED and both were discontinued
upon admission. She was started on Decadron in ED 4/30 she had increasing
hypoxemia and was placed on a non rebreather. She was transferred to critical care
and given tocilizumab. Her respiratory status continued to worsen and she was
intubated. She subsequently developed a pneumothorax that persisted despite 2 chest
tubes. She developed a large air leak and she was not a surgical candidate. Family
ultimately decided to w/draw care on 5/15/21" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1410464-1" "1410464-1" "Patient was diagnosed with COVID-19 on 6/13/2021 and
subsequently died on 6/17/2021. Patient was considered to be fully vaccinated as of
3/24/2021 having received both doses of Pfizer." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "60-64 years" "60-64"
"1417119-1" "1417119-1" "lightheadedness, weakness, Pain Narrative: A 63yo
male with history of tobacco use, Cocaine dependence in remission, PTSD,
Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal
Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he
received Covid-19 vaccine on January 11, 2021, per protocol, without complications
and was advised to stay on site for 15 minutes. Instructions about side effects and
ADR reporting were also provided. He called hospital advice line on January 12,
2021 to report ADR symptoms of having LT arm pain that radiates to his back and
chest which started on his way home after he received the vaccine. Also reported he
felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the
call documenting nurse, to go the hospital ED, for evaluation. Per telephone note -
Physician A/P documentation included that symptoms were discussed with the patient
on January 12, 2021 @13:01 PM, patient was assured what he experienced was an
expected reaction from the vaccine and it'd be safe to get his second scheduled
shot On January 14 the patient called back to report feeling a little light headed,
having muscle/ body ache and feeling weaker after the Covid-19 vaccine.
Recommendation was made to go to the ER by the call taker Patient called on January
15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17,
2021 the patient presented to the ED with chief complaint of Chest pain, was
hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation
improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and
admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained
in MICU and passed away on February 4, 2021" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1016981-1" "1016981-1" "Virologic failure; SARS-CoV-2 infection; SARS-CoV-2
infection; Taking regular medicines for rheumatoid arthritis, received BNT162B2;
Taking regular medicines for rheumatoid arthritis, received BNT162B2; This is a
spontaneous report from a contactable physician. This is a report received from the
Regulatory authority report number GB-MHRA-WEBCOVID-202102021534304120, Safety
Report Unique Identifier GB-MHRA-ADR 24686672 A 76-year-old male patient received
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 09Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical
history included rheumatoid arthritis (Taking regular medicines for rheumatoid
arthritis (or other types of arthritis except osteoarthr..). Patient was not
enrolled in clinical trial. The patient's concomitant medications were not
reported. The patient experienced SARS-CoV-2 infection on 24Jan2021 (also reported
as suspected COVID-19 from 24Jan2021 to 01Feb2021),Virologic failure, serious
criteria reported as death. Not a vaccine reaction as such but unexpected COVID
related death in patient who was vaccinated 2 weeks prior to positive test dies a
week later after positive test. The patient underwent lab tests and procedures
which included COVID-19 virus test: yes - positive covid-19 test on 24Jan2021. The
patient died on 01Feb2021. The outcome of rest events was unknown. It was unknown
if an autopsy was performed. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2
infection; Virologic failure; SARS-CoV-2 infection" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1019911-1" "1019911-1" "Client was administered the vaccine while
symptomatic (01/25/21) although client did not know he was symptomatic for COVID-
19. He had been exposed to a family member who had tested positive and should have
been in quarantine but wasn't either because it was not felt he was considered a
close contact by his family opinion or his family member never notified public
health of this close contact...?. Clinet had presented to the ED following day
after vaccination for shortness of breath and fatigue and an antigen test showed he
was positive for COVID-19. He was sent home that same day 01/26/21. He was back in
ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on
ventilator. He passed away on 02/09/2021 (date of death was per his wife)." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1032880-1" "1032880-1" "Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB,
cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN,
former smoker. patient in hospice and died 2/10/2021." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1048253-1" "1048253-1" "vaccinated with two doses of Comirnaty/ COVID-19
virus test positive; Diagnosis was confirmed by COVID-19 virus test (result:
positiv/positive, unit: NA); This is a spontaneous report from non-contactable
physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002548.
A 69-year-old male patient received two doses of bnt162b2 (COMIRNATY), via an
unspecified route of administration on 31Dec2020 (lot number: EJ6796, first dose)
and on 26Jan2021 (second dose, lot number: EK9788) at single dose for covid-19
immunisation. The patient medical history and concomitant medications were not
reported. After vaccination the patient experienced COVID-19 virus test positive on
05Feb2021 and developed Death on 10Feb2021, lasting for unknown. The patient was
dead and was hospitalized. Diagnosis was confirmed by COVID-19 virus test (result:
positiv/positive, unit: NA) on 05Feb2021. It was not reported if an autopsy was
performed. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: Lethal outcome/Death; Diagnosis was confirmed by COVID-
19 virus test (result: positiv/positive, unit: NA); vaccinated with two doses of
Comirnaty/ COVID-19 virus test positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1055298-1" "1055298-1" "Emergency Room HPI: The patient is a 71 y.o. female
with a PMH notable for COPD, hypertension and anxiety and depression who presented
on 2/6/2021 for evaluation of shortness of breath. Patient presented to our
emergency room yesterday morning from local nursing facility rehab nursing staff
reported that she had had a increased shortness of breath for the last 3 days she
has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both
COVID-19 vaccines. Patient presented to the emergency room with labored
respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to
our emergency room patient's temperature 101.6�, pulse 169, respirations 40 to
blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient
received a chest x-ray that showed chronic emphysema and fibrotic changes in the
lung no acute processes identified. Patient's white count 12.8, glucose 197,
creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient
has urine culture pending. Patient has received about 3 L normal saline boluses
patient was having hypotension 86/52. Patient also received IV acetaminophen a
1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient
was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19
and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71
year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted
coronavirus (COVID-19) at the nursing home. Her respiratory status started to
decompensate and so she was brought into the hospital. Initial workup showed
significant bilateral pleural effusions and ground-glass opacity of both lungs.
She had a significant supplemental oxygen requirement. She was admitted for
further evaluation and treatment. Hospital course: The patient was admitted and
started on IV Remdesivir. She was given IV Decadron. She was given immune support
vitamins. Despite this, her sepsis worsened. When it became apparent that the
patient was not going to recover, her daughter did make her comfort care only and
hospice was consulted. The patient was found to be appropriate for general
inpatient hospice and was made comfort care. Her requirement for morphine and
Ativan did slowly rise. Eventually, the patient did succumb to her respiratory
failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge
Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to
acute respiratory failure secondary to coronavirus (COVID-19) pneumonia
Disposition: Deceased" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1058464-1" "1058464-1" "Pt tested Covid positive 2/8/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1059344-1" "1059344-1" "death 2/25/21" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1059621-1" "1059621-1" "1/14/21 - Resident complained of SOB. SPO2 66% on
RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID
results. Resident transferred to COVID wing. Family (HCP) updated and declined
transfer to hospital Resident continued with fever, hypoxia and lethargy. Family
elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1072763-1" "1072763-1" "The same day that the person was vaccinated he
started feeling dizzy and had difficulty breathing. He was hospitalized from
February 5 to February 23. Patient died in the hospital on February 23, 2021"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1073452-1" "1073452-1" "death; Since the vaccination, the patient has been
tested for COVID-19/ nasal swab: positive; This is a spontaneous report from a
contactable Consumer received via COVAES portal IL-COVAES-8443f81e-417d-4bfb-8ab8-
e8884c15af83. A 68-year-old male patient received first dose of bnt162b2
(Batch/lot number: Unknown), via an unspecified route of administration, at arm
left, on 03Feb2021 at single dose for covid-19 immunisation. Medical history
included parkinson's disease from an unknown date and was on Parkinson medications.
The patient's concomitant medications included Parkinson medications received
within 2 weeks of vaccination. The patient did not receive any other vaccines
within 4 weeks prior to the COVID vaccine. The patient experienced death on
03Feb2021. The patient was hospitalized for death for 2 days. Prior to vaccination,
the patient was not diagnosed with COVID-19. Since the vaccination, the patient has
been tested for COVID-19. The patient underwent lab tests and procedures which
included nasal swab: positive on unknown date. The outcome of nasal swab positive
was unknown.The patient died on an unspecified date. An autopsy was not performed.;
Sender's Comments: Information provided is limited and does not allow a thorough
medical assessment of this fatal case. Causality cannot be completely excluded for
the ongoing treatment with suspect drug according to Company internal procedure
for cases reporting death cause unknown. The impact of this report on the
benefit/risk profile of the Pfizer drugs is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as well as
any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. ; Reported
Cause(s) of Death: Pfizer vaccine" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1104666-1" "1104666-1" "Patient presented with dyspnea and found to have
COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated
and died" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1117213-1" "1117213-1" "Case tested positive for COVID-19 on 3/1/2021 by
rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on
3/3/2021 for shortness of breath and occult infection. Case was previously
admitted and discharged from hospital on 2/22/2021 after a lumbar compression
fracture. Case had monoclonal antibody infusions; was afebrile and denied chills,
but had a dry cough. Case was a previous smoker, quit 2 years prior. Case
developed pneumonia. Case required supplemental oxygen." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1126834-1" "1126834-1" ""vaccinated 1/13. presented for COVID screening on
1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness,
congestion, poor appetite, coughing. Previous headache and sweating had resolved
by the time she presented. Discharged with isolation instructions. Returned to ED
late on 1/22 with "" right-sided chest pain described as sharp constant 6/10
nonradiating pain localized to the right side of upper chest, shortness of breath
with exertion since this afternoon. She does endorse subjective fevers, with
associated increased coughing which is productive in nature, shortness of breath.""
Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21."" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1135124-1" "1135124-1" "No event description for this event." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1156224-1" "1156224-1" "Patient has a renal transplant; developed fever and
seen in Emergency Ctr.; tested positive for COVID." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1200438-1" "1200438-1" ""cardiac arrest; COVID-19 infection; fever (39
degrees Celsius); This is a spontaneous report from a contactable physician
downloaded from a regulatory authority-WEB, regulatory authority number GR-GREOF-
20211826. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 1
intramuscularly on 09Mar2021 (Batch/Lot Number: EP2166) at 75-years-old as 0.3 mL,
single for COVID-19 immunization. Medical history included chronic dyslipidaemia
from an unknown date and unknown if ongoing, unregulated arterial hypertension from
an unknown date and unknown if ongoing, very high Body Mass Index (BMI) increased
from an unknown date and unknown if ongoing, mild symptoms of infection of the
upper respiratory tract from 05Mar2021 to an unknown date. Concomitant medications
included rosuvastatin (MANUFACTURER UNKNOWN) taken for dyslipidaemia, start and
stop date were not reported. On 09Mar2021, the patient experienced: fever (39
degrees Celsius) (non-serious), cardiac arrest (death, medically significant),
COVID-19 infection (death, medically significant), death (as reported) (death,
medically significant). The clinical course was reported as follows: According to
the reporter, the patient on the day of the vaccination did not report any acute
symptoms while he was providing his medical history, neither any allergies. The
patient just reported the chronic dyslipidaemia treatment. It was the first dose of
the vaccine COMIRNATY and the patient remained in the vaccination center for 15
minutes according to the guidelines; without presenting any symptoms. On 16Mar2021,
the patient's son, called the reporter to declare the death of his father. The
patient's son stated that the patient had a fever the same day of the vaccination
and passed away approximately six hours later. A close relative was found positive
with SARS-CoV-2 on 13Mar2021; and on the day of the report was still hospitalized.
The patient was ""buried after the death certificate from a private physician."" On
18Mar2021, the patient's son was contacted, who was also a physician. According to
the patient's son, his father had unregulated arterial hypertension, dyslipidaemia
and very high Body Mass Index (BMI) (weighed 110 kilograms for over 40 years with
170 cm height). The patient, four days before his vaccination, had mild symptoms of
infection of the upper respiratory tract (mild cough, sniffle and sore throat). On
09Mar2021, the patient was vaccinated and three hours later presented high fever
(39 degrees Celsius). The patient three hours later died. The patient's son stated
that the physician who examined his father told him that he found representative
data of cardiac arrest and the cause of death was cardiac arrest. Three days later,
the patient's wife was found positive with COVID-19 infection and was hospitalized.
According to the patient's son's opinion, his father died from COVID-19 infection,
even though the patient had not tested positive. The patient underwent lab tests
and procedures which included body temperature: 39 Centigrade on 09Mar2021. The
clinical outcome of the events: cardiac arrest, COVID-19 infection, death, was
fatal. The clinical outcome of the event fever (39 degrees Celsius), was unknown.
The patient died on 09Mar2021 due to cardiac arrest, death, COVID-19 infection
(according to the patient's son). It was unknown if an autopsy was performed.
The causality assessment from the a regulatory authority for vaccines was unlikely;
Method of assessment: a regulatory authority causality criteria. No follow-up
attempts are possible. No further information is expected. ; Reported Cause(s) of
Death: COVID-19 infection; Cardiac arrest"" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1202899-1" "1202899-1" "Oxygen saturation decreased; COVID-19 antigen test
positive/positive COVID-19 test with symptoms; COVID-19 antigen test
positive/positive COVID-19 test with symptoms; High fever; This is a spontaneous
report from a contactable consumer downloaded from a regulatory authority-WEB,
Regulatory Authority report number is PL-URPL-DML-MLP.4401.2.156.2021. A 71-year-
old male patient of an unspecified age received the first dose of bnt162b2
(COMIRNATY), (Batch/Lot Number: EP9598) intramuscular on 19Feb2021 (at the age of
70 years-old) as single dose for covid-19 immunisation. The second dose was
scheduled for 12Mar2021. Medical history included ongoing diabetes treated with
oral hypoglycaemic drugs, ongoing hypertension. The patient's concomitant
medications were not reported. On 05Mar2021, SARS-COVID 2 test by ABBOTT was
performed with a positive result. The patient also had a high fever for several
days, the primary care physician did not start any treatment. On 05Mar2021,
patient's cardiovascular and respiratory were efficient, in full contact, sat.
Without oxygen 93%. Patient was prescribed with Levoxa 500 mg, Pyralgina, Berodual
N, Pabi-Dexamethason, Neoparin. Patient was then referred home. On 07Mar2021, in
the morning, the patient's condition worsened, and he was taken by ambulance to the
hospital at the Emergency Room, and then placed in the Department of Infectious
Disease. Oxygen was administered. On 09Mar2021, the patient's condition worsened,
and was connected to a ventilator. On 13Mar2021, at 18:20, patient was pronounced
dead. Oxygen saturation decreased, COVID-19 antigen test positive and High fever
all from 05Mar2021 were reported as the cause of death of the patient on 13Mar2021.
An autopsy was not performed. Sender's comment: Pyrexia is an expected adverse
reaction as described in the SmPC following the administration of Comirnaty.
Reduced saturation and a positive COVID-19 test result are unexpected symptoms. As
of 19Mar2021, 197 cases of SARS-Cov-2 test positive and 231 cases of oxygen
saturation decreased were reported in the database. The patient suffered from
hypertension and diabetes. Due to the lack of medical information on the cause of
death (no autopsy was also performed), the influence of other factors on the
patient's death cannot be ruled out. There is a time relationship between
vaccination and the occurrence of adverse reactions. A regulatory authority due to
the health result: death assessed the application as serious. No follow-up
attempts are possible. No further information is expected; Reported Cause(s) of
Death: high fever; COVID-19 antigen test positive/positive COVID-19 test with
symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms;
Oxygen saturation decreased" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1203542-1" "1203542-1" "Unknown if pt had s/s at time of vaccination on
1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp
insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm
edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later,
readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette,
sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin,
rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT
w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA
r/t either a fib hx or hypercoagulability r/t covid. Pt died." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1203575-1" "1203575-1" "Patient contracted COVID-19 after receiving 2 COVID-
19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is
still an inpatient currently. Patient admitted with hypoxic respiratory failure on
3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p
remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient
with persistent respiratory failure/ARDS requiring intubation. Course further
complicated by CMV viremia as well as shock with rising procalcitonin concerning
for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter.
Goals of care conversations occurring with ICU team and family." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1213032-1" "1213032-1" "D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19
D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia
U07.1, J12.82 - Pneumonia due to COVID-19 virus" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1213047-1" "1213047-1" "This is the patient's spouse reporting. The day
following the vaccination, wife began to suffer mild, common vaccination symptoms
such as fatigue, hills, and joint pain. In the days following, in addition to
those symptoms, she began to cough and had a sore throat. By March 8th, she had
lost her sense of taste and sense of smell. We realized we needed to have her
tested for COVID-19. We went to a testing area. She was seen and tested. She tested
positive for COVID-19 (as did I). The belief was that our illness was
uncomplicated and we were sent home with instructions to monitor our symptoms. On
03/14/2021, I took her to the hospital because her condition was worsening." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1238623-1" "1238623-1" "Patient was asymptomatic and was vaccinated on
1/22/2021. A facility caregiver tested positive for COVID, so patient was tested
and received results on 1/27/2021 indicating positive for COVID-19. Patient
expired early morning of 2/1/2021, still completely asymptomatic. Patient's
physical condition had been fairly stable for the previous few years." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1240346-1" "1240346-1" "COVID-19 virus test positive; Weakness; Body
temperature increased/ 38 centigrade; This is a spontaneous report received from a
contactable consumer (patient's son) downloaded from the Regulatory Authority (RA).
The regulatory authority report number is PL-URPL-DML-MLP.4401.2.190.2021. A 73-
years-old female patient received BNT162B2 (COMIRNATY), intramuscular on 03Mar2021
(Batch/Lot Number: ER2659) as single dose for covid-19 immunisation. Medical
history included diabetes from 30 years ago. The patient's concomitant medications
were not reported. Patient was not pregnant during the period of taking the drug.
From 06Mar2021 there was a weakening, increased body temperature 38 centigrade. On
08Mar2021, a medical rescue team performed the COVID-19 virus test (positive), did
not take the patient to the hospital. On 12Mar2021 21:00 (9 days from the
administration) patient died. An autopsy was not performed. The reporting person
did not classified seriousness of the adverse reactions. The event outcome for
events was fatal. Sender comment: On 26Mar2021, additional information was
obtained during a telephone conversation (it was added to the notification) and the
statistical number of the death was sent by e-mail. Until 29Mar2021 no response was
received. Pyrexia is an expected adverse reaction listed in section 4.8 of
COMIRNATY Summary of Product Characteristics. Asthenia is an unexpected side effect
not included in the Summary of the Suspected Drug. There is a time relationship
between drug administration and the occurrence of side effects. Due to the lack of
detailed information (autopsy results, health history, medications taken, etc.), it
cannot be ruled out that a factor other than the administered vaccine may have
contributed to the death. The reporting person did not classify the seriousness of
the adverse reactions. Company classified the notification as serious (death). No
follow-up attempts possible. No further information expected.; Reported Cause(s) of
Death: Weakness; Body temperature increased; COVID-19 virus test positive" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1269848-1" "1269848-1" "Death Narrative: Patient was admitted to facility
from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and
poor oral intake. Admission was uneventful and follow-up notes post discharge from
both Cardiology APRN and Primary Care Physician that the Patient was recovering
well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and
second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15
minutes after administration of each dose. No reaction was noted during the post
vaccination observation period of either dose. Notice of death was received 5 days
after second dose of Covid Vaccine from funeral home. There were no reports of an
ADR occurring between observation period and death. There were no progress notes in
patients chart between second Covid 19 Vaccine note 4/22/201 and death notice
4/27/2021. Cause of death is unknown at this time." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1271190-1" "1271190-1" "Contracted COVID-19 on 4/4/2021, Pt. demise
4/15/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1275922-1" "1275922-1" "On 3/8/21, patient presented to the ED with cough,
fever > 103, chills, SOB, all starting 9 days ago (2/27/21) about 3 days after 2nd
dose of Pfizer vaccine. Patient was admitted to the hospital with main diagnosis
COVID-19 pneumonia and patient expired on 4/8/21." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1283204-1" "1283204-1" "Per the nursing home facility patient received her
second dose of vaccine on 01/14/2021 but it was not listed on KYIR. Patient tested
positive on 04/14/2021 and died on 04/16/2021." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1285303-1" "1285303-1" "Patient admitted to Hospital on 4/16/2021 with 2
weeks of generalized weakness, chills, poor oral intake and nonproductive cough.
Chest x-ray shows consolidation. Patient tested for covid-19 which returned
positive on 4/18/21. Patient remained hospitalized and started on steroids and
vitamin c/e after covid testing returned positive. Patient respiratory status
worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not
want to be intubated and decided to go to comfort care. Patient passed away on
5/3/21 in the hospital." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1296067-1" "1296067-1" "Patient completed 2-dose Pfizer series on 1/31/21
and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness,
diffuse abdominal pain and diarrhea that started that day. Pt tested positive for
COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd
dose: 1/31/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1311276-1" "1311276-1" "Pneumonia due to COVID-19 virus ED to Hosp-
Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment
team Maxillary fracture Principal problem Final Summary for Deceased Patient
Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal
Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-
19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension
Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic
shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory
failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition
(CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History
of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure
with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1]
COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old
female with past medical history of hypertension, hyperlipidemia, recent
hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented
to the emergency room after a fall in her house on 4/14. She had significant face
pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She
was then found to be Covid positive. Initially admitted to the medical floor
however required increasing amounts of oxygen and was ultimately transferred to the
ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21
when she was intubated and increasing vasopressor requirements. Given her
worsening condition, her husband elected to palliatively extubate and pursue
comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the
body: morgue" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1323372-1" "1323372-1" "Patient received both doses of Pfizer vaccine (#1 on
2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on
5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by
PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent
plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with
Hypoxia, Pneumonia due to COVID-19." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1324706-1" "1324706-1" "comatose state / a state of hyper osmolarity linked
to a decompensation of her diabetes/hyperosmolar coma; decompensation of her
diabetes; respiratory decompensation; hypoxia/oxygen saturation 85%; Vaccination
failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021,
Injection 2; COVID-19 confirmed by positive COVID-19 test; Vaccination date:
19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; Vaccination
date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; This is
as spontaneous report received from a contactable pharmacist downloaded from the
regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-
TO20213292, Safety report unique identifier FR-AFSSAPS-2021049377. A 69-year-old
female patient received BNT162B2 (COMIRNATY), intramuscularly on 25Mar2021 as 2nd
dose, single (Batch/Lot Number: ER9470), intramuscularly on 19Jan2021 as 1st dose,
single (Batch/Lot Number: ES6788) for covid-19 immunisation. Medical history
included ketosis-prone diabetes mellitus, insulin-dependent diabetes, arterial
hypertension, complete arrhythmia due to atrial fibrillation (AFib), kidney
failure, sequelae cognitive disorders, stroke, sleep apnea, hypothyroidism,
obesity, hyperuricaemia, deglutition disorder, hyponatraemia, hyperkalemia,
swallowing disorders with currently rehydration by exclusive gastric tube.
Concomitant medications included phenobarbital (GARDENALE); oxazepam (SERESTA 10 mg
tablet); mirtazapine 15 mg tablet; levothyroxine sodium (L THYROX); erythromycin;
racecadotril (TIORFAN); hyoscine (SCOPODERM patch); oxycodone hydrochloride
(OXYNORMORO 5mg); insulin lispro (HUMALOG). On 25Mar2021, vaccination against COVID
19 Dose 2. On 02Apr2021, covid-19 tested positive, British variant. On 06Apr2021,
tested positive for COVID 19 with on 06Apr2021 respiratory decompensation, dextro
5.8g/l, oxygen saturation 85%, heart beat 65, blood pressure 100/60. Patient was
hospitalized on an unspecified date. Hospital care put under oxygen (O2) 6L/min.
the patient presented on arrival a comatose state with concomitant hypoxia linked
to COVID and especially a state of hyper osmolarity linked to a decompensation of
her diabetes. Treatment was performed with rehydration for hyperosmolar coma
insulin therapy antibiotic therapy. Palliative comfort management given the
patient's condition and the seriousness of the situation with the appearance of
signs of respiratory discomfort justifying the prescription of a low dose of
MIDAZOLAM. The patient eventually died on 08Apr2021 despite the treatment. An
autopsy was not performed. The reported cause of death was drug ineffective, COVID-
19, hyperosmolar (non-ketotic) coma and decompensation of diabetes. Outcome of drug
ineffective, COVID-19, hyperosmolar (non-ketotic) coma and decompensation of
diabetes was fatal, outcome of other events was unknown. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
Vaccination failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination:
25Mar2021, Injection 2; COVID-19 confirmed by positive COVID-19 test;
decompensation of her diabetes; Hyperosmolar (non-ketotic) coma" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1327666-1" "1327666-1" "Patient received second Pfizer vaccine on 2/8/2021.
Became symptomatic with COVID like S/S on 4/30/2021. Was admitted to Hospital on
5/4/2021 and tested positive for COVID 19 upon admission. Patient was intubated on
5/12/21 and expired while still admitted to the hospital on 5/17/21." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1327946-1" "1327946-1" "Respiratory distress; Vaccination failure; COVID-19
positivity; This is a spontaneous report from a consumer or other non HCP
downloaded from the regulatory authority. Regulatory Authority Report Number: FR-
AFSSAPS-DJ20211054. Safety Report Unique Identifier: FR-AFSSAPS-2021048085.
Declaration from an EHPAD director via the reporting portal of the Agency and
registered under the number 2021.0503124559648. This consumer reported similar
events for two patients. This is the first of two reports. A 69-year-old female
patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 11Feb2021 (Lot
Number: EJ6789) as single dose, dose 2 via intramuscular on 04Mar2021 (Lot Number:
EP2166) as single dose for COVID-19 immunisation. Patient age at vaccination was
reported as 69 years old. The patient medical history included ongoing diabetes,
ongoing hypertension arterial, ongoing obesity, ongoing insufficiency renal,
coronary arteritis. The patient had no history of COVID-19 disease. The patient's
concomitant medication included potassium chloride (DIFFU K), etifoxine
hydrochloride (STRESAM), furosemide, insulin aspart (NOVORAPID), insulin glargine
(LANTUS), clopidogrel bisulfate (PLAVIX), allopurinol (ZYLORIC), esomeprazole,
nicorandil (IKOREL), bisoprolol. The patient experienced vaccine failure with a
fatal outcome. The registrant reported on 26Apr2021, or 53 days after the injection
of the second dose of vaccine, the occurrence of COVID-19 positivity. Before
26Apr2021 no variant has been identified. On 02May2021 the patient presented with
respiratory distress requiring hospitalization. The patient died on 06May2021. The
cause of death was reported as COVID infection following vaccination failure.
Autopsy was not done. Hospitalization report pending. Several cases in the same
AFDEP (Accommodation facility for dependent elderly people), in particular another
death (DJ20211042). No follow-up attempts possible. No further information
expected.; Sender's Comments: Linked Report(s) : FR-PFIZER INC-2021546915 Different
patient/ same AE and suspect product.; Reported Cause(s) of Death: COVID infection
following vaccination failure; respiratory distress; COVID infection following
vaccination failure" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1330021-1" "1330021-1" "Patient was vaccinated on 1/22/2021 and 2/12/2021
and had out of hospital cardiac arrest on 5/5/2021 where he was tested for COVID-19
and was positive. He had previously tested negative on 4/19/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1333218-1" "1333218-1" "No event description for this event." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1347843-1" "1347843-1" "4/21/21 Pt was reportedly admitted to the Hospital
for generalized weakness. Her nephrologist noted worsening renal function and had
her admitted for hemodialysis. Of note, she had not been able to keep her
appointment for mAB due to weakness. At the outlying hospital she had a palliative
consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour
after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a
complete LBBB. She was transferred to a different Hospital for further evaluation.
Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival,
she became unresponsive. Heart rate was very irregular in what appeared to be a
fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and
started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt
became apneic. She was transitioned to comfort care and death was pronounced at
04:13 on 4/25/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1350978-1" "1350978-1" "78y.o. male with a past medical history of COPD, DM
II, and HTN who presented to the hospital's emergency department from an extended
care facility. Patient was recently hospitalized and treated with IV antibiotics
for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for
ischemic signs but patient had an elevated troponin. CXR showed right pleural
effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory
failure. Patient's oxygenation continued to deteriorate despite Remdesivir,
decadron and lovenox. Patient went into respiratory failure and expired from
progressive respiratory failure." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1354193-1" "1354193-1" "Patient received second COVID 19 vaccine on 4/13/21
at Site. Patient tested positive for COVID on 5/16/2021. Patient had worsened short
of breath on 5/25/2021 and was admitted to Medical and placed on a vent. Patient
expired on 5/26/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1381212-1" "1381212-1" "Hypoxic respiratory failure; pneumonia; Stomach
cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is
a spontaneous report from a contactable consumer (patient's husband). A 65-year-old
female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an
unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot
Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation.
Medical history included back disorder from an unknown date and unknown if ongoing.
The patient's concomitant medications were not reported. Previously the patient
received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot
number: ENG201, injection in arm, possibly in left arm: patient had no problems
with the first shot. The patient experienced covid-19 (death, medically
significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on
08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-
serious) on an unspecified date with outcome of unknown, could not breathe well
(non-serious) on an unspecified date with outcome of unknown, she had back problems
(non-serious) on an unspecified date with outcome of unknown. Patient went to
Emergency Room (ER) 8 hours later administration of the second dose and on
08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she
died. Patient was positive for covid 19 on unknown date. She was diagnosed with
covid when she went to ER. Patient was on a ventilator. The patient underwent lab
tests and procedures which included endoscopy: gerd or abdomen problem on
unspecified date, COVID test: positive on unknown date. Therapeutic measures were
taken as a result of hypoxic respiratory failure and pneumonia (on ventilator).
The patient died on 16Apr2021. An autopsy was not performed. It was stated that
cause of death on death certificate listed as Covid 19, pneumonia, hypoxic
respiratory failure. Follow attempts are needed. Further information is expected;
Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory
failure" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1385401-1" "1385401-1" "Patient received Pfizer COVID-19 vaccine on 1/24/21
(first dose) and 2/5/21 (second dose). Patient tested positive for COVID on
5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and
passed away on 5/29/21: Preliminary cause of death: Respiratory failure with
hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19
vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on
methotrexate Anemia Hypertension Obesity" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1388057-1" "1388057-1" "Admitted 5/26 from outside facility for GI bleed,
cardiac arrest and severe sepsis. COVID+. Treated with tocilizumab, vit C, vit D,
alinia, zinc. Family opted for comfort care and W/D life support. Expired 6/5."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1395873-1" "1395873-1" "Pt went to the hospital with covid 05/30. She was on
bipap at 100%. Pt ended up passing away 06/11 at 5:32 pm.""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1403441-1" "1403441-1" "dyspnea, pneumonia, difficulty breathing. positive
for COVID-19 3/25/2021, hospitalized and later died of COVID-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1407048-1" "1407048-1" "Pt. did not die from COVID vaccine. He was
diagnosed with COVID19 on 06/04/2021. He had an extensive past medical history
with several preexisting conditions which COVID exacerbated." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1407151-1" "1407151-1" "DIARRHEA, COUGH , PNEUMONIA STARTING 4/27/2021"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1408205-1" "1408205-1" "2/22/2021 - Tested positive for Covid 3/9/2021 -
found down at her SNF, taken to ER. complains of lower back pain, left hip pain,
bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC),
*Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff
negative. 3/22: placed on palliative care after speaking with family 3/23:
Expired" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1408894-1" "1408894-1" "bradycardia; cardiorespiratory failure; heart
attack; COVID-19 pneumonia; COVID-19 confirmed by positive COVID-19 test; This is a
spontaneous report from a contactable physician. This is a report received from the
Regulatory Authority HU-OGYI-394221. This spontaneous, serious, medically confirmed
case was reported on 27May2021 by a physician and concerns the occurrence of Covid-
19 infection and pneumonia resulting in death after COMIRNATY injection for active
immunization to prevent COVID-19. A 67-years-old male patient received bnt162b2
(COMIRNATY, concentrate for dispersion for injection tozinameran [COVID-19 mRNA
Vaccine embedded in lipid nanoparticles]), dose 1 intramuscular on 12Apr2021 (at
the age of 67-year-old) (Batch/Lot number and expiry date was reported as unknown)
as 1st dose, 0.3ml single dose for covid-19 immunisation. Medical history of the
patient included COVID-19, COVID-pneumonia, chronic bronchitis, COPD, diabetes
mellitus, gastric ulcer, hypertension, obesity, prostatitis, BPH and ischemic heart
disease. Concomitant drugs were acetylsalicylic acid (ASACTAL 100 mg), niflumic
acid (DONALGIN 250 mg), diclofenac (FLECTOR), furosemide (FURON 40 mg), potassium
chloride (KALIUM-R), fentanyl (MATRIFEN 25 microgram), metformin hydrochloride
(METFOGAMMA 1000 mg), beclometasone; formoterol; glycopyrronium bromide (TRIMBOW)
and salbutamol (VENTOLIN EVOHALER l) all taken for an unspecified indication, start
and stop date were not reported. On 20Apr2021, patient started experiencing COVID
symptoms. On 25Apr2021, patient underwent a lab test of COVID-19 antigen and
resulted positive for COVID-19, and his wife also died because of COVID-19 on
25Apr2021. On 28Apr2021, the patient was hospitalized because of dyspnea which was
ongoing for 3 days. On 28Apr2021, patient had a chest X-ray and was diagnosed with
COVID-19 pneumonia. Patient received therapy, but on 29Apr2021 suddenly bradycardia
and cardiorespiratory failure occurred. After an unsuccessful reanimation, the
patient passed away at 05:25. Cause of death was reported as COVID-19. According to
the autopsy report, the direct cause of death was a heart attack. Health
authority comment: The patient got infected with Covid-19 after the first dose,
therefore immunity may not have developed yet. Based on the above, the causal
relationship is unlikely between the suspected drug and the adverse events. The
case is considered serious because the outcome was fatal. Further information is
not expected. Case Comment: Based on the current available information and the
plausible drug-event temporal association, a possible contributory role of the
suspect product BNT162B2 to the development of serious events COVID-19, COVID19-
Pneumonia,Myocardial infarction,cardiopulmonary failure and bradycardia cannot be
totally excluded. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate. No follow-up attempts possible. No further
information expected. Information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: COVID-19; Autopsy-determined Cause(s) of Death: heart
attack" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1410894-1" "1410894-1" "Patient was hospitalized due to COVID-19 from May
19, 2021 to May 22, 2021. Patient was then placed on hospice on 6/5/2021 and
expired on 6/7/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1413141-1" "1413141-1" "Patient had bad headache within the hour, difficulty
breathing soon after, became delirious, couldn't make sense, couldn't walk and had
to call EMS." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1414207-1" "1414207-1" "Pt w/hx significant for COPD (on 1L O2 a baseline)
p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test
positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted
for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. During
admission received dexamethasone, convalescent plasma, remdesivir. Culture
indicated pseudomonas PNA, but likely colonization given hx, however, due to
illness and underlying bronchiectasis, was given cefepime. Hospital stay
complicated by significant resistant hypercarbia and respiratory failure, pt placed
on comfort measures given that death is imminent. Unfortunately, pt passed on
6/13/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1414492-1" "1414492-1" "Nursing Home Visit 6/2/2021 Geriatric Medicine
COVID-19 virus infection +4 more Dx Progress Notes SUBJECTIVE: Patient with history
of multiple myeloma, osteonecrosis of jaw on IV antibiotic, CAD with history of
stent, seizure disorder and hypertension was seen today. She has been complaining
of sinus congestion for past 3 to 4 days. Apparently there has been other resident
who tested positive for COVID-19 so rapid antigen test was performed on her.
Unfortunately she also tested positive for COVID-19. She has received full dose of
COVID-19 vaccine earlier in February. She denies any fever or chills. She denies
any shortness of breath. She does complain of cough and sinus congestion going on
for a week or so. Chief complaint: Acute hypoxic respiratory failure due to
COVID-19 SUBJECTIVE: Patient with history of multiple myeloma, osteonecrosis of
jaw on IV antibiotic, hypertension, CAD and seizure disorder was tested positive
for COVID-19 yesterday. She has been complaining of sinus congestion for the past
for 5 days. However this has been at her baseline. She has multiple allergies and
taking antihistamine chronically. There has been Covid outbreak in the facility
and multiple other residents are positive for COVID-19. She also tested positive
for COVID-19 yesterday. Unfortunately this morning she declined and needed oxygen
support. Her oxygen saturation dropped to mid 70s to upper 80s on 5 L O2. She was
not using any accessory muscle. She did complain of mild cough but denied any
chest pain. Her appetite is poor. She does not look toxic. Date: 6/3/2021
Admission Date: 6/3/2021 Assessments Patient is a 74 y.o. female on hospital
day number 0 Medical Problems Hospital Problems POA * (Principal)
Pneumonia due to COVID-19 virus Yes Plan Chief Complaint
Patient presents with ? Shortness of Breath #. COVID-19 pneumonia with
hypoxia. -Patient was offered plasma and she wants to get plasma therapy. Patient
has signed a consent form for blood product transfusion. -Patient states she cannot
take steroids due to her medical history. She is refusing steroid therapy. -IV
remdesivir ordered for the patient. -Patient is consulted with the ID due to her
complicated history. -Patient is on oxygen support via nasal cannula. #.
Mandible osteomyelitis diagnosed recently. -Patient has been seen by infectious
disease during the prior admission and has PICC line for long-term IV antibiotic.
-Patient is reordered IV antibiotic in the form of imipenem and oral doxycycline as
well as azithromycin. #. Essential hypertension -Patient continues on various
antihypertensive medication. #. Diabetes mellitus type 2 -Patient is on insulin
therapy while in the hospital. Patient is on polypharmacy and was advised to
discuss with her family doctor to cut down on her unnecessary or unimportant
medications if possible. History of Present Illness Patient is an 74 y.o.
female. Patient is 74-year-old Caucasian female, who presented from a facility
chief complaint of acute hypoxic respiratory failure due to COVID-19 pneumonia.
Patient has been at this facility since 5/12/2021 after being diagnosed with
bisphosphonate related out for necrosis of the jaw with cellulitis and possible
osteomyelitis. Patient had been transferred from a Hospital on 5/12/2021. Patient
had been getting IV antibiotics for the osteomyelitis of the mandible and was
apparently doing well until today when she was noted to be hypoxic. Patient has
been complaining of sinus congestion over the past 5 to 7 days. According to the
medical director, there has been Covid outbreak in the facility and multiple other
residents are noted to be positive for COVID-19. Patient had a Covid test done
yesterday and she was COVID-19 positive. Patient respiratory status declined.
Patient required oxygen support. Her oxygen saturation had dropped into the mid
70s to upper 80s and patient was on 5 L/min of oxygen via nasal cannula. Patient
had not been using accessory muscles. Patient also reports occasional cough and
has yellowish phlegm production. Patient was referred to Hospital emergency
department for further evaluation and treatment. ED to Hosp-Admission Discharged
6/3/2021 - 6/14/2021 (11 days) Last attending ? Treatment team Sepsis due to
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Principal problem
DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for
Admission Hypoxia COVID-19 virus infection Pneumonia due to COVID-19 virus Acute
respiratory failure Hospital Course Patient is a 74 y.o. female with a history
of multiple myeloma on fifth line treatment. Patient with recent diagnosis of
osteomyelitis and on antibiotics per ID. She was admitted to the hospital 6/3 with
acute shortness of breath and following 2 days on the general medical floor she
required increasing oxygen supplementation and was transferred to the ICU. In the
ICU patient had a seizure and required acute intubation for protection of her
airway. Patient had further decline of her respiratory status. She did pass SBT's
and was extubated. Shortly after she experienced likely an episode of aspiration.
She continued to have increased work of breathing following this event. Patient
transitioned to comfort care per family request. She received morphine and Ativan
as needed and experienced asystole at 0834 this morning." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1417184-1" "1417184-1" "The patient died of COVID-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1417294-1" "1417294-1" "I am the epidemiologist for reporting on behalf of
patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of
a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later
died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic
encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing
conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE,
IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing
chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14
was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she
could be admitted to hospital for cardiac catheterization. Case reports having a
mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX
was mild case of COVID with elevated enzymes that indicated a cardiac event. Case
is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has
history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-
3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to
follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines.
Case lives alone but has 2 adult sons who live nearby that will provide food drop-
offs at door. Emailing vaccination breakthrough info to Epidemiologist &
supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1417329-1" "1417329-1" "I am the epidemiologist reporting on behalf of
patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of
a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The
patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal
cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR
DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the
case adult daughter. She informed that the case resides at a rehabilitation center.
The case's daughter stated that her mother is not having any symptoms and was fully
vaccinated. The daughter did not have all the information on dates of vaccine.
called center spoke to the administrator who provided the information. The case was
at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-)
test four days after returning. The case test (+) on her 4th day 4/5.nnn" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1421500-1" "1421500-1" "Covid 19, Blood Clot in Lung, Myocardia" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1423882-1" "1423882-1" "Death 4/1/2021 Causes of death listed on patient's
death certificate: 1) Acute on chronic respiratory failure 2) Metastatic spindle
cell malignancy Other: COVID-19, pneumonia" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1424098-1" "1424098-1" "Death 4/27/2021 Causes of death listed on death
certificate: 1) ADULT RESPIRATORY DISTRESS SYNDROME WITH HYPOXIA 2) RAPID ATRIAL
FIBRILLATION WITH DIASTOLIC HEART FAILURE 3) COVID-19 Other: COVID-10
ENCEPHALOPATHY, COVID-19 PNEUMONITIS, MULTIPLE MYELOMA, STAGE 3 CHRONIC KIDNEY
DISEASE, TYPE 2 DIABETES MELLITUS" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1427664-1" "1427664-1" "Died 3/6/2021" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1427697-1" "1427697-1" "Tested positive for COVID-19 on 3/7, likely an
incidental finding. Died of liver cancer 3/17." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1427848-1" "1427848-1" "Symptom onset 4/12, hospital admission date 4/19,
died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to
COVID-19, hepatic encephalopathy, liver cirrhosis" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1431522-1" "1431522-1" "Pt's cause of death was due to COIVD -19 illness. No
one believes that the vaccine was part of the death. The patient was fully
vaccinated with 2 doses of Pfizer vaccine." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1433128-1" "1433128-1" "Patient developed dyspnea, diarrhea, chills and
cough. Presented at the ED on 06/11 and was found to be COVID-19 positive.
Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB,
flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple
pressors, and full vent support, the patient continued to decline and remained with
increasing pressor requirements. He suffered severe pneumomediastinum and bilateral
pneumothoraces requiring bilateral chest tubes" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1433374-1" "1433374-1" "Died of COVID-19 illness on 05/17/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1433430-1" "1433430-1" "Died of COVID-19 illness on 05/03/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1433452-1" "1433452-1" "Died of COVID-19 illness on 05/08/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1433809-1" "1433809-1" "Death 5/19/2021 Causes of death listed on death
certificate: 1) COVID 19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1437439-1" "1437439-1" "Death 5/25/2021 Causes of death listed on death
certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19
pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal
failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1437946-1" "1437946-1" "COVID-19 infection resulting in severe ARDS
requiring intubation and ultimately death from COVID-19 infection." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1440148-1" "1440148-1" "Body pain; Dyspnea; COVID PCR swab positive; COVID
PCR swab positive; Death; This is a spontaneous report from a contactable Other HCP
(Other Health Professional). A 74-year-old male patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA5715; Expiration
Date: 31May2021) at single dose on 27May2021 09:37 at age of 73-year-old for covid-
19 immunization. Medical history included hypertensive. Concomitant medications
included simvastatin, doxycycline, enoxaparin sodium (CLEXANE), oseltamivir
phosphate (TAMIFLU), chlorphenamine maleate (ALLERGEX), betamethasone
acetate/betamethasone sodium phosphate (CELESTONE). On 10Jun2021, the patient was
reported to have experienced body pain and dyspnea and patient was hospitalized
from 11Jun2021. Patient had COVID PCR swab positive on 13Jun2021. The patient died
on 13Jun2021. An autopsy was not performed. Lab results included ABG: metabolic
acidosis noted; chest presented bilateral crepitation's; oxygen saturation: 52-63
%, 88-92 %; COVID Ag test negative. The outcome of event death was fatal. The
outcome of rest events was unknown. The information on the lot/batch number has
been requested.; Sender's Comments: Based on information currently available a
causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE) cannot be completely excluded. The case will be reevaluated should
additional information including the cause of death become available. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part
of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.;
Reported Cause(s) of Death: Death" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1454552-1" "1454552-1" "Patient vaccinated with pfizer COVID vaccines
02/26/21 and 03/18/21 Patient presented to ER due to nonhealing lesion of right
heel as well as erythema and was admitted on 06/15/21 Patient tested negative for
COVID-19 on 06/15/21 Patient deteriorated and tested again for COVID-19 and
positive on 06/28/21 Patient expired on 07/01/21" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1454790-1" "1454790-1" "Patient tested positive for COVID-19 on 03/29/2021
via both antigen and PCR despite being fully vaccinated. She was subsequently
hospitalized and then died on 03/30/2021. Symptom onset for COVID-19 was
03/23/2021, with symptoms of fever (101.8) and respiratory distress which required
an increase in oxygen. Per the death certificate, causes of death are as follows:
Part 1: Cause of Death: A. Multi organ failure B. COVID-19 infection Part 2: Other
Significant Conditions: Congestive Heart Failure, Diastolic Heart Failure with
Preserved Ejection, history of cerebrovascular accident, diabetes mellitus type 2,
and morbid obesity" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1454878-1" "1454878-1" "65-year-old with history of TBI and end-stage renal
disease subsequently initially admitted to the floor secondary to fever and chills.
Found to have COVID-19 pneumonia. On June 13 a rapid response was called for
worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP
at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates.
Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage
renal disease. Additionally on cefepime and Rocephin for 10 days subsequently
restarted on meropenem. Fortunately patient continued to have hypoxemia
unresponsive to noninvasive ventilation. He was intubated on June 19. At the time
of intubation he expresses desire not to be intubated for an extended period of
time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2
with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on
prednisone taper off of dexamethasone. In addition to above patient had
complications A. fib with RVR further complicated by hypotension. Was on 3
pressors. Suspect multifactorial to sedation and patient with severe Covid who also
has end-stage renal disease. SLED initiated while in-house. On the afternoon of
June 23 palliative team did meet with patient's siblings. That time determined to
transition to comfort care. Compassionate extubation performed. Patient passed away
shortly after extubation. Patient died of COVID-19 despite being fully vaccinated
against it. Death Certificate Information: Part I: Cause of Death A. Respiratory
Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions:
Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "65-79 years" "65-79"
"1454969-1" "1454969-1" "COVID-19; This is a spontaneous report from a non-
contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB,
regulatory authority number DE-PEI-CADR2021107017. A 74-years-old female patient
received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection,
lot number: ET3045 expiry date Unknown) via unspecified route of administration, on
14Apr2021 (age at vaccination: 74-years-old ) at 0.3 mL as single dose for COVID-19
immunization. Medical history and concomitant medications were not reported. The
patient became ill with Covid-19, 2 days after the first vaccination and there was
development of first symptoms on 16Apr2021. From 25Apr2021 she had to be
ventilated, and from 17May2021 Palliative care was given. The affected person died.
The outcome of event was fatal. Senders comments: The affected person became ill
with Covid-19 2 days after the first vaccination, development of first symptoms on
16Apr2021. From 25Apr2021 she had to be ventilated, from 17May2021 Palliative care.
The affected person died. Result of Assessment: Comirnaty/event(s): COVID-
19/Regulatory Authority: D. Unclassifiable No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: COVID-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0962784-1"
"0962784-1" "patient expired 1/15/2021; had been treated as outpatient for
pneumonia, likely COVID-19 but no positive test result in December 2020. PMH
diabetes" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0976486-1"
"0976486-1" "SARS-CoV-2 infection; SARS-CoV-2 infection; Headache; Nausea;
Unwell; Death; This is a spontaneous report received by Pfizer from the Medicines
and Healthcare products Regulatory Agency (MHRA). The regulatory authority report
number is GB-MHRA-WEBCOVID-202101181401032020 and Safety Report Unique Identifier
GB-MHRA-ADR 24609241. A contactable physician reported that an 83-year-old male
patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1688),
via an unspecified route of administration on 06Jan2021 at a single dose for COVID-
19 immunisation. Medical history included frontotemporal dementia with some motor
neurone disease (MND) features, chronic obstructive pulmonary disease, diarrhea,
reflux gastritis. Concomitant medications included beclometasone dipropionate,
formoterol fumarate (FOSTAIR) from 20Oct2020 for chronic obstructive pulmonary
disease, loperamide from 29Dec2014 for diarrhoea, omeprazole from 01Feb1996 for
reflux gastritis, and salbutamol from 19Jun1998 for chronic obstructive pulmonary
disease. Patient previously received SEQIRUS VACCINES INFLUENZA on 27Oct2020 for
influenza immunization. Patient has not had symptoms associated with COVID-19, not
had a COVID-19 test. Patient is not enrolled in clinical trial. Patient had been
feeling well. He attended for his COVID-19 vaccination on 6th January 2021 and when
he returned home began to feel unwell, with nausea and headache. That evening his
carers were concerned so they called an ambulance. The patient tested positive for
COVID-19 (SARS-CoV-2 infection) on 7th January 2021 and unfortunately died on 11th
January 2021 in the hospital. It was unclear if vaccine could have been
contributing factor. Reporter was unsure if the vaccine and death could be
connected. The cause of death was unknown. It was unknown if an autopsy was
performed. The outcome of SARS-CoV-2 infection was not recovered, while for the
other events was unknown.; Reported Cause(s) of Death: Death" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0978341-1"
"0978341-1" "The patient passed away on 20Jan2021. Cause of death was not
reported.; Corona positive; Corona positive; This is a spontaneous report from a
contactable physician and a consumer received via Regional Authority and Biontech.
An 80-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via
an unspecified route of administration on 05Jan2021 at single dose for COVID-19
immunisation. The patient's medical history and concomitant medications were not
reported. The patient experienced infection of respiratory tract and Corona (COVID-
19 test) positive from 07Jan2021, infection with worsening of general condition and
fever > 38.0 centigrade. The patient passed away on 20Jan2021. Cause of death was
not reported (pending for clarification). No vaccination complications after
previous vaccinations and vaccine had not been re-administered. Outpatient
treatment was necessary. It was not reported if an autopsy was performed. Outcome
of the event Corona positive was unknown. Causal relation to Covid vaccination
questionable. Information on the lot/batch number has been requested.; Sender's
Comments: A causal association between BNT162B2 and the reported events Drug
ineffective and COVID-19 cannot be excluded based on a compatible temporal
relation. However, full immunity is only expected 2 weeks after the second dose.
The information currently provided is too limited to make a meaningful medical
assessment. However, per company causality assessment guidance, the event of death
with unknown cause is assessed as related until the cause of death is clarified and
assessed as unrelated. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and
analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any as any appropriate action in response, will be
promptly notified to Regulatory Authorities, Ethics Committees, and Investigators,
as appropriate.; Reported Cause(s) of Death: The patient passed away on 20Jan2021.
Cause of death was not reported." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0978343-1"
"0978343-1" "Corona Infection; Respiratory infection with cough; reduced
general condition; condition worsened; Corona Infection; This is a spontaneous
report from a non-contactable physician received via Regional Authority and
Biontech. An 87-year old female patient received first dose of BNT162B2 (COMIRNATY,
Solution for injection; lot number and expiry date not reported) via an unspecified
route of administration on 05Jan2021, single dose for COVID-19 immunization.
Relevant medical history and concomitant medications were not reported. The patient
had no vaccination complications after previous vaccinations. On 07Jan2021, the
patients diagnoses/ suspected diagnosis was Corona infection. On the same day of
07Jan2021, the patient experienced respiratory infection with cough and reduced
general condition, rapid general health deterioration, and condition worsened. The
patient died 19Jan2021. Course and therapy of the vaccination reaction: outpatient
treatment was necessary, inpatient treatment at the hospital was necessary but was
refused. The vaccination reaction was life- threatening. Outcome of events was
fatal. The patient died on 19Jan2021. The reported causes of death were corona
infection, respiratory infection with cough and reduced general condition, rapid
general health deterioration. It was unknown if an autopsy was performed. Causal
relation to Covid vaccination was reported as questionable. Information on the
lot/batch number has been requested.; Reported Cause(s) of Death: Corona infection;
Corona infection; respiratory infection with cough; reduced general condition;
condition worsened" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0983192-1"
"0983192-1" "Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine
clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She
demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was
initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal
cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and
without vital signs. Orders were for DNR and CPR was not initiated." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0985367-1"
"0985367-1" "TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO HOSPITAL ON
1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND
EXPIRED ON 1-25-2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0985527-1"
"0985527-1" "COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON 1-23-2021 DUE
TO HYPONATREMIA" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0994635-1"
"0994635-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms; General physical health deterioration; This is a spontaneous report
from a non-contactable physician downloaded from the Regulatory Authority. A 80-
years-old female patient received the first dose of bnt162b2 (COMIRNATY) vaccine ,
via an unspecified route of administration on 05Jan2021 at single dose for covid-19
immunisation . The patient medical history and concomitant medications were not
reported. The patient experienced positive covid-19 test with symptoms on
07Jan2021. Symptoms included: Upper respiratory tract infection General physical
health deterioration and Fever, lasting for 15 days. The patient died on 20Jan2021.
It was not reported if an autopsy was performed. Death cause was reported as
General physical health deterioration. No follow-up attempts are possible,
information on batch number cannot be obtained.; Reported Cause(s) of Death: COVID
19; General physical health deterioration" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0994858-1"
"0994858-1" "Coronavirus infection; Coronavirus infection; General physical
health deterioration; This is a spontaneous report from a non-contactable physician
via Regulatory Authority, downloaded from the Regulatory Authority-WEB (DE-PEI-
PEI2021001369). An 87-year-old female patient received the first dose of BNT162B2
(COMIRNATY) via an unspecified route of administration on 05Jan2021 at single dose
for COVID-19 immunisation. Relevant medical history and concomitant medications
were not reported. On 07Jan2021, the patient experienced coronavirus infection and
general physical health deterioration and died due to coronavirus infection on
19Jan2021. Death cause was reported as coronavirus infection. It was not reported
if an autopsy was performed. The information on the batch number has been
requested.; Reported Cause(s) of Death: Coronavirus infection" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "0998175-1"
"0998175-1" "Resident vaccinated-1/7/21 Resident covid positive 1/11/21
Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1000379-1"
"1000379-1" "Chest infection; positive COVID-19 virus test/suspected COVID-
19; positive COVID-19 virus test/suspected COVID-19; This is a spontaneous report
received from a contactable other healthcare professional by Pfizer from the
products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-
202101280002382610, Safety Report Unique Identifier GB-MHRA-ADR 24657514. A 100
years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine,
Lot Number and Expiration Date unknown) via an unspecified route of administration
on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical
history heart failure. Patient is not enrolled in clinical trial. The concomitant
medications was not reported. Patient had suspected COVID-19 from 15Jan2021. Onset
of chest infection on 15Jan2021, revived the course of antibiotics. But the course
not completed as became too poorly moved to the stage of end of life. Patient died
on 27Jan2021. Lab test included positive COVID-19 virus test on 06Jan2021. The
outcome of events was fatal. Unknown if autopsy was done. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
chest infection; positive COVID-19 virus test/suspected COVID-19; positive COVID-19
virus test/suspected COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1011130-1"
"1011130-1" "Temp of 100.1 and unproductive cough on 1/17; temp of 100.4
1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on 1/18/2021
Patient passed away on 1/29/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1011492-1"
"1011492-1" "1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic,
unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her
baseline ranging at high 90's. 1/27/2021 Patient passed." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1011677-1"
"1011677-1" "Lethargic, refusing medications and meals. 1/11/2021- Covid+,
poor appetite." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1011905-1"
"1011905-1" "Ongoing decline overall. Remained on Hospice with increased
lethargy documented on 1/20/21 and progressively worsening thereafter." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1012021-1"
"1012021-1" "Resident on Hospice. 1/18 Hand Shaky. 1/19- Covid +19. 1/20
Desat 85% on RA, provided 2L O2 supplement= 97% 1/20 congestive cough, 1/28- RR-
28;1/29- Hypoglycemia 1/30-NPO. 1/30-resident passed away." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1012703-1"
"1012703-1" "1/14/2021-0545, blood noted left and right ear. 0715, vomited x
1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing.
Increased confusion." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1016804-1"
"1016804-1" "lack of efficacy; corona infection; This is a spontaneous report
from a non-contactable Physician downloaded from the Medicines Agency (MA)
Regulatory Authority-WEB DE-PEI-PEI2021002000. This is a report received from the
Regulatory Authority. An 87-year-old female patient received the first dose of
BNT162B2 (COMIRNATY, batch/lot number: EM0477), via an unspecified route of
administration on 12Jan2021 at single dose for covid-19 immunisation. Medical
history included coronary insufficiency, renal insufficiency, diabetes mellitus,
dementia, gastroenteritis, bloody stool. The patient's concomitant medications
were not reported. Unknown date in Jan2021 after vaccination the patient developed
COVID-19, lasting for unknown. The patient underwent lab tests and procedures which
included COVID-19 PCR test: positiv/positive on 19Jan2021, diagnosis was confirmed
by COVID-19 PCR test. The patient died on 19Jan2021. Death cause was reported as
COVID-19. It was not reported if an autopsy was performed.; Reported Cause(s) of
Death: COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1024157-1"
"1024157-1" "7 days after receiving the vaccine, patient suffered excessive
diarrhea and slight coughing. 9 days after vaccine, patient was tested for Covid
19, and received positive results. Patient was transported to hospital via
ambulance but hospital returned her to the nursing home since chest was clear, no
respiratory issues, and no fever. 10 days after receiving the vaccine, patient was
turned over to hospice care but still in the nursing home. Hospice was called in
to provide better physician advice and access 24/7. 14 days after receiving
vaccine, patient began experiencing excruciating body aches, coughing, low oxygen
levels, and no appetite. 18 days after vaccine, patient died." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1025980-1"
"1025980-1" "death 9 days after vaccination, asymptomatic until vaccination
date, positive test 3 days following vaccination; death 9 days after vaccination,
asymptomatic until vaccination date, positive test 3 days following vaccination;
This is a spontaneous report from a contactable physician (patient's son). An 84-
year-old male patient received the first dose of the bnt162b2 (COMIRNATY),
intramuscularly in the left arm on 21Jan2021 at 84-years-old at 0.3 mL, single for
COVID-19 immunization; administered at a nursing home/senior living facility. Prior
to the vaccination, the patient was not diagnosed with COVID-19. Medical history
included hypertension from an unknown date and unknown if ongoing, allergy to
iodine from an unknown date and unknown if ongoing. Concomitant medications
included calcium carbonate, colecalciferol (CALCIMED D3), sertraline (MANUFACTURER
UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER
UNKNOWN); all taken for an unspecified indication from an unspecified date to an
unspecified date. The patient did not receive any other vaccines within 4 weeks
prior to the COVID vaccine. On 24Jan2021, the patient experienced death 9 days
after vaccination, asymptomatic until vaccination date, positive test 3 days
following vaccination (Drug Ineffective, Covid-19); which required hospitalization,
and resulted in death. No treatment was received for the adverse events. The
patient was hospitalized for the events for 4 days. The patient underwent lab
tests and procedures which included COVID-19 PCR test nasal swab: positive on
25Jan2021. The clinical outcome of the events: drug ineffective and COVID-19, was
fatal. The patient died on 30Jan2021 due to COVID-19 disease. An autopsy was not
performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and
will be requested during follow up.; Sender's Comments: Based on the information
currently available, lack of efficacy of the suspected vaccine BNT162B2 (COMIRNATY)
cannot be completely excluded. However, individuals may not be protected until at
least 7 days after their second dose of the vaccine. It is unlikely that the
patient would have fully developed immunity due to the very short time lag (3 days
in this case) between the first vaccine dose and the event onset. Instead, the
positive COVID likely represents the pre-existing infection prior to vaccine use.
Further information is needed for full medical assessment; Reported Cause(s) of
Death: COVID-19 disease" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1026141-1"
"1026141-1" "death 2/12/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1029937-1"
"1029937-1" "Pneumonia; SARS-CoV-2 infection; SARS-CoV-2 infection; Dementia;
Shaking; Encephalitis; This is a spontaneous report from a contactable consumer.
This is a report received from the regulatory authority. Regulatory authority
report number GB-MHRA-WEBCOVID-202102041702516100, Safety Report Unique Identifier
GB-MHRA-ADR 24701055. An 83-years-old male patient received bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE, LOT# EJ1688), via an unspecified route of administration
on 07Jan2021 at single dose for COVID-19 immunization. Medical history included
prostate cancer, dementia, myocardial infarction. Concomitant medication included
atorvastatin, bisoprolol, lansoprazol, ranolazine, temazepam, warfarin for
myocardial infarction. Patient has not had symptoms associated with COVID-19.
Patient is not enrolled in clinical trial. The patient experienced pneumonia
(death) on an unspecified date, sars-cov-2 infection (medically significant) on
15Jan2021 with outcome of not recovered, dementia (medically significant) on
07Jan2021 with outcome of not recovered, shaking (medically significant) on
07Jan2021 with outcome of not recovered, encephalitis (medically significant) on
07Jan2021 with outcome of not recovered. Event description: Massive and immediate
increase in dementia symptoms, hospitalized with suspected stroke but tests ruled
out this. Violent whole body convulsions developed and became uncontrollable.
Treated for potential encephalitis / bacterial meningitis but again ruled out
following test. Treated with antibiotics for undetermined infection but ongoing
deterioration in condition. Developed pneumonia and contracted corona virus whilst
still in hospital and ultimately died 2 week after admission to hospital with COD
listed as pneumonia. No coronavirus symptoms shown despite positive test. The
patient underwent lab tests and procedures which included sars-cov-2 test: yes -
positive covid-19 test on 15Jan2021. The patient died on 22Jan2021, cause of death
was pneumonia. It was not reported if an autopsy was performed. No follow-up
activities are possible. No further information is expected.; Reported Cause(s) of
Death: Pneumonia" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1033102-1"
"1033102-1" "Patient received first dose of vaccine on 1/7/21 at a community
Public Health clinic. On 1/29/21 he received a second dose at the community Public
Health clinic. On 2/5/21, the patient presented to the ED with complaints of
shortness of breath worsening over the last 2 weeks. Patient reported that he had
decreased exercise capacity and increased coughing with sputum production
intermittently. Patient reported that he had been feeling chilled, but no fevers.
Patient was admitted and treated with Decadron and Remdesivir. Patient experienced
increased oxygen requirement. Patient was a DNI and did not want to be on life
support. After discussion with the patient and family, patient was moved to
comfort care. passed away on 2/11/21." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1035046-1"
"1035046-1" "Exitus letalis/ Sudden death unexplained; sars-cov-2 test:
positive on 14Jan2021; sars-cov-2 test: positive on 14Jan2021; This is a
spontaneous report from a non-contactable physician downloaded from the regulatory
authority, number DE-PEI-PEI2021002162. This report was forwarded via RA, however
no RA number was provided. A 89-years old female patient received the first dose of
bnt162b2 (COMIRNATY), lot number unknown, via an unspecified route of
administration on 13Jan2021 (at the age of 89-years old) as a single dose for
COVID-19 vaccination. The patient's medical history and concomitant medications
were not reported. The patient experienced exitus letalis on 31Jan2021. Death
cause was reported as Sudden death unexplained. The patient underwent lab tests and
procedures which included sars-cov-2 test: positive on 14Jan2021, sars-cov-2 test:
negative on 27Jan2021. An autopsy was performed and results were not provided.
Outcome of the sars-cov-2 test: positive on 14Jan2021 was unknown. Reporter
comment: Patient in stable general condition. Sender comment: According to the
nursing staff in the home, this is the 12th death in temporal connection with the
Corona vaccination. No follow-up attempts possible. No further information
expected. Information on lot and batch numbers cannot be obtained.; Reported
Cause(s) of Death: Exitus letalis/ Sudden death unexplained" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1037375-1"
"1037375-1" "COVID-19; COVID-19; This is a spontaneous report from a
contactable physician from the Medicines Agency (MA) -WEB FR-AFSSAPS-MA20210291
. A 93 year-old female patient received the first dose of bnt162b2 (COMIRNATY;
Lot # EJ6788) vaccine , intramuscular on 19Jan2021 at single dose for covid-19
immunisation . Medical history included cerebrovascular accident from ,
osteoporosis , hypertension, gastrooesophageal reflux disease , embolism ,
asthma , stent placement , myocardial infarction and undernutrizion (+++) The
patient's concomitant medications were not reported. The patient was tested
positive to Covid-19 Nasal PCR test on 02Feb2021. The patient died on 03Feb2021
from Covid-19 It was not reported if an autopsy was performed. No follow-up
attempts possible. No further information expected; Reported Cause(s) of Death:
Covid-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1037865-1"
"1037865-1" "respiratory failure from COVID19; presented to the ER with COVID
symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19;
presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from
respiratory failure from COVID19; This is a spontaneous report from a contactable
physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021
at 12:00 at a single dose for COVID-19 immunization. The patient's medical history
and concomitant medications were not reported. The patient had no COVID prior to
vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The
patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021.
Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It
was unknown if autopsy was done. The patient was tested for COVID post vaccination
via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in
emergency room/department or urgent care, hospitalization, and patient died. No
follow-up attempts are possible, information about batch number cannot be obtained.
No further information is expected.; Sender's Comments: The Company cannot
completely exclude the possible causality between the reported COVID post
vaccination and respiratory failure with fatal outcome, and the administration of
COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More
information on the underlying medical condition in this 89-year-old male patient is
required for the Company to make a more meaningful causality assessment. The
impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death:
presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient
subsequently died on 09Feb from respiratory failure from COVID19; presented to the
ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on
09Feb from" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1042049-1"
"1042049-1" "Respiratory failure; Pneumonia; covid-19; This is a spontaneous
report from a non-contactable physician downloaded from the Medicines Agency (MA)
Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-
PEI2021001974. An 86-year-old female patient received BNT162B2 (COMIRNATY,
PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 16Jan2021 at single dose for
covid-19 immunization. Medical history included dementia, stroke, and atrial
fibrillation from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced covid-19 on
19Jan2021; the patient also experienced respiratory failure and pneumonia on an
unspecified date, which were serious as they were life threatening, and lead to
death. Details were as follows: covid-19 on 19Jan2021 was noted. Also reported
unknown after vaccination, the patient developed respiratory failure and pneumonia,
reported as lasting until 29Jan2021. The patient was dead and condition was
reported as life threatening. Death cause was reported as respiratory failure and
pneumonia. The patient died on 29Jan2021. It was not reported if an autopsy was
performed. The patient under lab test include covid-19 virus test: covid-19 on
19Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and
will be requested during follow-up. Follow-up (15Feb2021): This follow-up is being
submitted to notify that the batch number is not available, follow-up activities
not applicable, information about lot/batch number cannot be obtained. Further
follow-up information will be provided automatically upon availability via MA.;
Reported Cause(s) of Death: pneumonia; respiratory failure""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1048236-1"
"1048236-1" "COVID-19/CT angiogram confirming a picture compatible with SARS-
CoV-2 disease; Diarrhea; Asthenia; Respiratory distress; This is a spontaneous
report received from a contactable pharmacist via agency, the regulatory authority.
Regulatory authority report number CH-SM-2021-11420. An 89-year-old female patient
received first dose of bnt162b2 (COMIRNATY), intramuscular on 17Jan2021 at single
dose for COVID-19 immunisation. Medical history included arterial hypertension,
dyslipidemia and type 2 diabetes mellitus. The patient's concomitant medications
were not reported. The patient experienced covid-19 on 19Jan2021, diarrhea on
18Jan2021, asthenia on 18Jan2021, respiratory distress on 18Jan2021. The patient
was hospitalized for the event from 19Jan2021 to an unknown date. The events were
also fatal. Clinical course: On 17Jan2021 she received the administration of the
first dose of Comirnaty. The next day (18Jan2021) she began to manifest diarrhea,
asthenia and respiratory distress because of which, on 19Jan2021, she presented at
the emergency room. Laboratory tests showed an inflammatory syndrome with C
Reactive Protein at 92 mg/L (normal range less than 5 mg/L) and lymphocyte count at
0.6x10E9/L (on 19Jan2021) (normal range 1.50-4.00x10 9/l). On the same day, a SARS-
CoV-2 swab is performed, which is positive, a chest X-ray showing parenchymal
thickening in the left mid-basal and right supradiaphragmatic areas, and a CT
angiogram confirming a picture compatible with SARS-CoV-2 disease. The woman was
hospitalized on 19Jan2021 and treated pharmacologically with dexamethasone (6mg for
7-10 days). On 20Jan2021, respiratory distress worsens so high-flow oxygen therapy
is required. The subsequent course was unfavorable with progressive deterioration
of general conditions and worsening of the respiratory picture. The woman died of
COVID-19 on 22Jan2021. An autopsy was not done. A causal relationship between
Comirnaty and all events was assessed as being unlikely. Agency assessed this case
as serious, results in death. Sender's comment: COVID-19 infection (confirmed by
swab on 19Jan2021), with diarrhea, asthenia and respiratory distress in a
polymorbid elderly woman (89 years old) on 18Jan2021, the day after vaccination
with the first dose of Comirnaty (17Jan2021). At the hospital, laboratory and
imaging investigations show a picture compatible with SARS-CoV-2 disease. The woman
dies from the viral infection due to progressive worsening of her general
condition. In the Swiss monograph of Comirnaty it is reported that the duration of
protection offered by the vaccine is not known, since it is still being determined
in ongoing clinical trials, and, as with any vaccine, vaccination with Comirnaty
may not protect all recipients. In particular, it is reported that subjects may not
be fully protected until 7 days after the second dose of the vaccine. Although the
woman did not present with any symptoms at the time of the first vaccination, the
fact that she was not swabbed for COVID-19 before vaccination does not allow us to
exclude that the infection was already ongoing before vaccination. In addition, the
timing of the onset of the symptomatology described here, one day after the first
vaccination, speaks against a causal role of Comirnaty, in agreement with what has
been reported in the monograph, namely the possibility that vaccinated subjects are
not fully protected until 7 days after the second dose (which the woman did not
receive) and are therefore susceptible to COVID-19 infection in the period between
the first and second dose of vaccine. On the basis of these considerations, in the
current state of knowledge, the Comirnaty-COVID-19 causal link is judged unlikely.
Note the rapidity of the lethal event for COVID-19 from the time of onset of
symptoms (only 5 days).; Reported Cause(s) of Death: Diarrhea; Asthenia;
Respiratory distress; COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1048323-1"
"1048323-1" ""sudden death / Death unexplained; acute respiratory distress;
80% desaturation; agitation without disturbance of consciousness; Polypnea,
thoraco-abdominal rocking, pursed lip; slight edema of the lower limbs; a sinus
tachycardia with a shift in particular in V5-V6; a sinus tachycardia with a shift
in particular in V5-V6; cardio-respiratory failure; Blood pressure still low at
9/5; Positive COVID test; Positive COVID test (screening as part of a cluster in
the service; disoriented in time and space; Tachycardia around 100 bpm; slight
pallor; This is a spontaneous report from a contactable physician downloaded from
the Agency Regulatory Authority-WEB FR-AFSSAPS-RS20210171. An 83-year-old female
patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6788),
intramuscularly on 01Feb2021 at single dose for COVID-19 immunization. Medical
history included hypertension arterial (HTA treated and balanced), cognitive
disturbance (moderate), diabetes mellitus insulin-dependent, hospitalized due to
deterioration of general condition and vomiting revealing cardiac decompensation,
anemic syndrome associated with melena treated by a transfusion of 2 red blood
cells bags and E. coli infection, all from an unknown date and unknown if ongoing.
Concomitant medication included amoxicillin from 12Jan2021 to 18Jan2021 for E. coli
infection. Clinical course: On 12Jan2021, the patient was hospitalized due to
deterioration of general condition and vomiting revealing cardiac decompensation.
The selected decompensation factors are an infection with a cytobacterioligical
urine exam positive to E. coli sensitive to Amoxicillin, treated with amoxicillin 1
g x 3 for 7 days as well as an anemic syndrome associated with melena, treated by a
transfusion of 2 red blood cells bags. Progressive resolution of the cardiological
symptoms and progressive regression of the inflammatory syndrome during
hospitalization. After vaccination, medical observation of 01Feb2021: rather
coherent remarks, but patient disoriented in time and space. No somatic complaint.
Tachycardia around 100 bpm, slight pallor. Clear and symmetrical pulmonary
auscultation. No right or left cardiac insufficiency sign. Physical examination:
Soft, painless calves. Hydroaeric noises ok, abdomen soft, no guarding, no
tenderness. No urinary symptoms. No externalized bleeding observed. 02Feb2021:
Patient partially oriented in time. Blood pressure still low at 9/5, tachycardia at
115 bpm. Stable clinical condition. Cardio-pulmonary auscultation: aortic stenosis,
abdomen soft, no guarding, no tenderness. Positive COVID test (screening as part of
a cluster in the service). Asymptomatic patient. 03Feb2021: good constants, patient
""as usual"". 04Feb2021: without an established cause according to the declarant.
Call for acute respiratory distress with 80% desaturation and with agitation
without disturbance of consciousness. BP 140/80, 145bpm. Polypnea, thoraco-
abdominal rocking, pursed lip. No cyanosis observed. Patient placed under O2 in a
high concentration mask between 10 and 15L allowing correct saturation> 90%.
Crackling in the 2 fields, frothy sputum in a second step, slight edema of the
lower limbs. ECG made finding a sinus tachycardia with a shift in particular in V5-
V6 already present on the previous ECG. Rapid degradation, no improvement after
40mg of furosemide (LASILIX) IV. Then cardio-respiratory failure, start of an
external heart massage, no flow <1min. Initial notice to the resuscitator on call,
resuscitation continued. Non-shockable rhythm, administration of 2x1mg of
adrenaline. Decision not to continue resuscitation after review of the file, after
20min of CPR. Sudden death occurred; death noted at 3:05 am. Coded as ""unexplained
death"" (because death without an established cause according to the declarant)
pending the final hospitalization report for update of the file. The patient died
at 3:05 am on 04Feb2021. It was not reported if an autopsy was performed. The
outcome of events was not recovered. No follow up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: sudden death / Death
unexplained"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1054698-1"
"1054698-1" "THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND
POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED
SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1057082-1"
"1057082-1" "Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and
cough. His wife was diagnosed with COVID-19 at approximately the same time when the
patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the
vaccine and had some changes in taste or smell. He became acutely worse 2-3 days
p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral
infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone
back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of
care and decided on comfort measure approach. Pt expired on 2/19/21." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1065920-1"
"1065920-1" ""never woke up after arrival; Suffered with vascular dementia;
Death cause: Covid/Tested positive to Covid 31Jan, tested due to increased
lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old
male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an
unspecified route of administration on 22Jan2021 at single dose for COVID-19
immunization. The patient received the vaccine at nursing home/senior living
facility. Medical history included dementia, hypertension, past strokes. The
patient was exposed to asymptotic staff member on or prior to 25Jan2021. The
patient had no known allergy. No COVID prior vaccination. Concomitant medication
included lisinopril. No other vaccine was received in four weeks. The patient was
tested positive to COVID on 31Jan2021, tested due to increased lethargy started
from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up
to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to
quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the
patient expired 12Feb2021. Cause of death was COVID. The patient did not receive
treatment for events. The autopsy was not performed. The outcome of events ""never
woke up, vascular dementia"" was unknown. Information on Lot /Batch Number has
been requested.; Reported Cause(s) of Death: Death cause: Covid"" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1066178-1"
"1066178-1" "Caller is nephew of patient. Patient was admitted to Hospital on
2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid
2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed
away in hospital 2/22/21 0612." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1068549-1"
"1068549-1" "2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted
to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on
2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient
died 2/26/21.." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1075097-1"
"1075097-1" "Pt received initial dose on 1/5/21, diagnosed with COVID-19 on
1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF
exacerbation, anasarca, and renal failure during acute illness. Pt also treated for
pneumonia during this time. Pt was considered terminal status on 1/25/21. She
received second COVID-19 vaccine on 2/15/21. Pt then experienced increased
difficulty eating and taking medications this same day, in addition to
hallucinations she was experiencing. Patient subsequently died on 2/16/21." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1075486-1"
"1075486-1" "Exitus letalis/dead; COVID-19 rapid POC test
positiv/positive,COVID-19 PCR test positiv/positive; This is a spontaneous report
from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-
PEI-PEI2021002943. This is a report received from the Regulatory Authority. A
85-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number:
EJ6789), intramuscular on 13Feb2021 at single dose for Covid-19 immunisation.
Medical history included coronary heart disease, cardiac insufficiency, heart valve
insufficiency, atrial fibrillation, osteoporosis and herpes zoster all from an
unknown date and unknown if ongoing. The patient's concomitant medications were not
reported. On 23Feb2021 after vaccination the patient developed exitus
letalis/death, lasting for unknown. The patient was dead. The patient underwent lab
tests and procedures which included COVID-19 rapid POC test (result:
positive/positive, unit: NA), COVID-19 PCR test (result: positive/positive, unit:
NA) both on 22Feb2021. An autopsy was not performed. Relatedness of drug to
reaction/event assessed as D. Unclassifiable. No follow-up attempts are possible.
No further information is expected.; Reported Cause(s) of Death: Exitus
letalis/dead" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1075636-1"
"1075636-1" "1/21/2021 During Covid 19 outbreak on the unit, resident
contracted the virus. 1/21 MD updated on increased weakness, twitching, fatigue
noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with
diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza
swab results received. PCR-Influenza negative, covid-19 positive. Palliative care
updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry
cough. 1/22 Palliative MD and APRN visited. Family preference for no
hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on
1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began
refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for
Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition
declining and comfort maintained. Meds slowly discontinued. Expired at facility on
2/18/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1080404-1"
"1080404-1" "Severe fatigue, lethargy observed by family members on date of
discharge from sub-acute nursing care to home 02/03/2021 and subsequently on
02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of
breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite,
chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath
and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for
shortness of breath. Rapid Covid screen at ER was positive and staff reported
beginning treatment with dexamethasone and remdesivir. Hospital staff reported to
family that patient had pneumonia, congestive heart failure, confusion on
02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics.
Patient was transported for care by pulmonary specialist at Hospital on
02/13/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1082172-1"
"1082172-1" "THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON 2/3 (COUGH
AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS POSITIVE. SHE
RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE, ALBUTEROL MDI,
MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON 2/15/21." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1082400-1"
"1082400-1" "Patient developed COVID after vaccines. There was an outbreak
at her facility . She ended up with pneumonia and expired on 03/07/2021" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1086566-1"
"1086566-1" "Covid-19; Covid-19; This is a spontaneous report from a non-
contactable physician from the regulatory authority-WEB DE-PEI-PEI2021003038 . A
80-year-old female patient received two doses bnt162b2 (COMIRNATY) , via an
unspecified route of administration on 04Jan2021 and 25Jan2021 both at single doses
for covid-19 immunisation. Medical history included myositis. Concomitant
medication included immunotherapy with mycophenolate mofetil (CELLCEPT) for
myositis. On 12Feb2021 after vaccination the patient developed COVID-19 and death
on 12Feb2021. Diagnosis was confirmed by COVID-19 PCR test (result: positive) in
Feb2021. Death cause was reported as COVID-19. The patient died on 12Feb2021. An
autopsy was not performed. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-
19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1088320-1"
"1088320-1" "Pt tested positive for COVID on 2/6/2021. Deceased on 2/15/21.
Not marked COVID death on death certificate." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1088365-1"
"1088365-1" "Pt tested positive for COVID on 02/29/2021. Passed away on
02/25/2021. COVID listed on death certificate." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1088401-1"
"1088401-1" "Pt tested positive for COVID on 2/15/21. She passed away on
02/23/21. Not listed as COVID death on death certificate." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1101991-1"
"1101991-1" "In ED on 2/25/21 Chief complaint: Patient's daughter present at
bedside stating patient was not vocalizing this morning when she woke up.
Patient's daughter was talking to her and she would orient to her but not answer
any of her questions. EMS called and by the time they arrived patient was acting
her normal self. Daughter states she has had a very difficult time managing
patient's behaviors over the last several weeks and it has been getting more
difficult. Daughter states that over the last several weeks her behaviors have
been worsening and been more difficult to deal with. These include her getting up
at night and sundowning as well as yelling and screaming during the day. Daughter
states that she gets in the shouting matches with the patient during the day.
Daughter breaks down and starts to cry when discussing that she thinks her mother
will need long-term placement as she is having a difficult time dealing with her
behaviors. Of note patient did receive second dose of Covid vaccine yesterday.
-Patient has not been complaining of any symptoms over the last several days and
daughter has not noticed cough or congestion or other signs of URI/illness -No
focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid
positive, incidental finding ? tested so she could go to nursing facility -Patient
asymptomatic -Vital signs stable, afebrile -She does not need treatment at this
time -She will need a repeat Covid test 14 days after the original Covid test prior
to going to SNF -Plan- discharge to skilled nursing facility Discharge summary
Principal Problem: Comfort measures only status Active Problems: Chronic atrial
fibrillation Essential hypertension Dementia with behavioral disturbance
Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis
Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old
female with a past medical history of dementia, likely combined
vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on
2/25/2021 due to behavioral disturbance as well as need for long-term care
placement due to progressive dementia. She did have an incidental positive Covid
test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She
did not require medication or oxygen treatment for COIVD-19. She developed
tachycardia/tachypnea and cough later productive for blood after suctioning
attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's
overall function declined after, and she was refusing/unable to eat or drink. She
was transitioned to comfort care status on 03/03/2021. She eventually slipped
into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was
provided. She had decreased urinary utput and respiratory function indicating
expected progression. She was noted to not have a heart rate on 03/08/2021.
Auscultation did not reveal any breath sounds or heart sounds; unable to palpate
pulse; no pupillary response to light was seen; and patient did not respond to
painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1107556-1"
"1107556-1" "Vaccination failure; Covid-19; respiratory problems/distress
respiratory; Oxygen saturation drop 90%; This is a spontaneous report from a non-
contactable physician downloaded from the regulatory authority-WEB [DE-PEI-
PEI2021003122]. An 81-year-old male patient received bnt162b2 (COMIRNATY, Lot #
EM0477) at single dose 1st dose on 05Jan2021 and 2nd dose on 26Jan2021 for COVID-19
immunisation. The patient medical history and concomitant medications were not
reported. The patient experienced vaccination failure, COVID-19, respiratory
problems/distress respiratory and, oxygen saturation drop 90% lasting for 9 day on
05Feb2021 (32 days after the first vaccination, as reported). The patient underwent
lab tests and procedures which included oxygen saturation: 90% on 05Feb2021. The
patient died on 13Feb2021. It was not reported if an autopsy was performed. Cause
of death was reported as COVID-19. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1110746-1"
"1110746-1" ""4 am seething breathing, 7 am died; COVID-19 confirmed by
positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; Acute
deterioration of general condition, no fever; This is a spontaneous report
downloaded from The Regulatory Authority-WEB (DE-DCGMA-21187734). A non-
contactable physician reported that an 88-years-old female patient received the
first dose of BNT162B2 (COMIRNATY, Lot. EM0477) on 02Jan2021, at single dose, for
COVID-19 immunisation. Relevant medical history included cerebral infarction from
on an unspecified date in 2007, acute myocardial infarction on an unspecified date
and unknown if ongoing, diabetes mellitus from an unspecified date and unknown if
ongoing and hypertension from an unspecified date and unknown if ongoing.
Concomitant medication included furosemide (FUROSEMID), amlodipine (AMLODIPIN),
RAMIPRIL AL10 mg, insulin human injection, isophane (BERLINSULIN H BASAL),
bisoprolol fumarate (BISOPROLOL 1A PHARMA), potassium chloride (KALINOR) 1,56 g,
acetylsalicylic acid (ASS-RATIOPHARM) and thiamazole (METHIZOL). On 18Jan2021, the
patient experienced acute deterioration of general condition, no fever. On
19Jan2021, the patient developed breathing difficult described as ""at 4 AM
seething breathing, at 7 AM the patient died"". It was unknown if autopsy was done.
COVID-19 rapid POC test performed on 07Jan2021, on 09Jan2021, on 11Jan2021, and on
12Jan2021, all with negative results. COVID-19 PCR test performed on 13Jan2021 with
negative result. COVID-19 rapid POC test performed on 18Jan2021 with positive
result. Oxygen saturation was at 96 % on 18Jan2021. Clinical outcome of the adverse
event ""COVID-19 confirmed by positive COVID-19 test"" was unknown at time of the
patient's death. Relatedness of drug to reactions/events by Regulatory Authority:
A. Consistent causal association to Follow-up attempts completed. No further
information expected.; Reported Cause(s) of Death: General physical condition
decreased; Breathing difficult"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1110878-1"
"1110878-1" "Only received 1st round dosage of COVID vaccination, he seemed
to handle vaccination okay. On January 17, 2021, he tested COVID positive on a
resident screening test done in response to an employee positive case in days
previous to the residents testing. Fifteen days after his first innoculation,his
AM nurse found him non-responsive on early vital checks. Vitals at that time were
normal range. The facility physician was contacted and advised that he should be
taken to Emergency Room at local hospital for further evaluation. Blood work was
taken and ER DR diagnosed Heart enzymes elevated indicating a heart attack.
Advised additional testing should be done, and that monoclonal antibody treatment
wasn't an option due to time lapse since diagnosis of COVID, The option of
comfort care was chosen as the treatment plan." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1131557-1"
"1131557-1" "COVID-19 disease, symptoms started 3/5/21, deceased of COVID-19
on 3/14/21" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1144356-1"
"1144356-1" "Pfizer COVID -19 Vaccine EUA Patient's wife reported to
facility, upon contacting for 2nd dose appointment, that the patient passed away
from COVID-19. This patient did not pass away at facility, as there are no records
of this patient in our EHR. Per patient?s wife, patient was vaccinated on 2/3/21
at the clinic with the initial Pfizer COVID-19 vaccine. The patient passed away on
2/22/21 from COVID-19 (3 weeks after the initial dose, but prior to the booster
dose). Pfizer/BioNtech NDC# 59267-1000-2 Pfizer/BioNtech Lot # EL9269 Lot Exp:
05/30/2021 Site: left Deltoid Time of vaccination: 2/3/2021 6:15:53 PM" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1145508-1"
"1145508-1" "Patient presented to the ED 2/6/2021 with increasing SOB and
found to have abnormal labs as an outpatient. Patient was found to be COVID
positive on 2/6/2021 as well. Patient was discharged on 2/9/2021 for acute
decompensations diastolic HF. At 2/19/2021 visit with Nephrology, patient found to
have hypervolemic hyponatremia, not responding to oral diuretics and decision was
made to manage as an inpatient. Patient found to have cardiomegaly, mild pulmonary
vascular congestions with small bilateral pleural effusions, EF 59%, severely
elevated pulmonary artery systolic pressure, and had a AKI. Patient did not
improve with diuretic therapy. Hospice and comfort care measures were pursued and
patient expired on 3/1/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1146467-1"
"1146467-1" "NA- patient refused second dose of vaccine - Patient condition
at time of death Chronic Conditions Renal failure Advanced age 100 y/o
Cardiopulmonary arrest secondary to Covid 19" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1146678-1"
"1146678-1" "Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and
second dose on 2/26/21. She had no adverse reaction to either dose. Around
3/2/2021, she saw her physician complaining of pain in her arm, which was
attributed to gout. At the time, she also had a nonproductive cough, generalized
weakness and one episode of loose stool. She presented to the emergency room on
3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid
test and PCR. A quantitative test for COVID antibodies was sent out to a reference
lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP,
High Flow Oxygen and ultimately intubation. Was not oxygen dependent before
hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held
due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent
plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for
variants of interest in joint effort between pathology and infectious disease.
Report not yet available." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1146787-1"
"1146787-1" "death Narrative: Pt has been declining prior to starting COVID
vaccine doses; then he got COVID after first dose (VAER reported); and then was
admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary
incontinence with foley catheter in place, bedbound, dysphagia." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1151636-1"
"1151636-1" "My father received his first Pfizer vaccine on 02/03/21. On
2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of
breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted
several hours. They tested him for Covid and did a chest x-ray. Tested positive for
Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5
days and was then released to nursing home for physical and occupational therapy.
He was very weak and on days experienced what they called Covid fog. After 2 weeks
of therapy, he was released on 03/06/21 to go back home to his apartment, with
extended visiting nurse therapy. On 3/10/21, was the first visiting nurse
appointment. At 12:00 an RN came to his apartment from Home Health Care. She
checked his vitals. She said his blood pressure was good, lungs sounded good and
oxygen level was 98. She said he was doing good and that she would not need to
continue to come out and check on him weekly. She left. At 2:30 the same day, a
Physical Therapist from Home Health Care came. She asked him lots of questions and
adjusted my fathers' walker for him. He showed her how he was doing using the
walker. Walked approximately 15-20 feet in his apartment. She checked his vitals
before she left. His oxygen level was now at 91. She had him take a few deep
breathes until his oxygen level was up to 93. She left and said she would be back
on Friday the 12th to begin the actual physical therapy then. Within 10 minutes
after she left my father started shaking uncontrollably and was having difficulties
breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the
way down to 74. They took him to the ER. When getting him out of ambulance he began
vomiting. Vomiting lasted for hours just like when he went to the hospital back in
February. They tried 3 different drugs to control the nausea. They did EKG, chest
and abdomen scans. Was found that he had multiple blood clots and inflammation in
his lungs and a bacterial infection in his blood. After testing, bacteria was found
to be E Coli. Treated him with heparin for clots and antibiotics for infection and
had him on oxygen in nose. Every day thereafter, he felt worse. They switched him
to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early
morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked
him up to a BiPap oxygen machine because his oxygen levels were dropping too low.
We were then told by the lung doctor, that the damage to his lungs was extreme and
that the next step would be to put him on a ventilator and feeding tube. My father
did not want this per his will and his discussion with Dr earlier in the week. Dr
indicated that he would not get better just being on the BiPap machine and we then
chose to have them take him off of the machine because he did not want to go on
life support. My father passed away on Sunday, March 14th around 6:30pm." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1152686-1"
"1152686-1" "Respiratory distress, Atrial fibrillation, Acute Kidney Injury,
COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1154151-1"
"1154151-1" "FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA,
HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital
with multiple complaints. He was reporting falls, chest pain, his wife was
diagnosed with Covid. While he was there, he was found to have hemorrhagic
contusion in the right frontoparietal region with minimal surrounding edema, Covid,
pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and
arrives with no complaints. 2/26/2021 Patient died after code blue was called Death
Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per
initial CT - serial CT head showing stability Acute hypoxic respiratory failure
secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain,
improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan
with intermittent probability PE Acute kidney injury on CKD, improving unlikely
that vaccine contributed to patient's death." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1161302-1"
"1161302-1" "Covid-19 Pneumonia; Covid-19 Infection; This is a spontaneous
report from a non-contactable physician downloaded from the Agency Regulatory
Authority-WEB with regulatory authority number DE-PEI-PEI2021003484. An 87-year-old
male patient received his first dose of bnt162b2 (COMIRNATY; unknown lot number and
expiration date) at vaccination age of 87-year-old intramuscular on 15Feb2021 as a
single dose for covid-19 immunisation. The patient's medical history and
concomitant medications were not reported. It was reported that 13 days (27Feb2021)
after vaccination the patient developed COVID-19 and COVID-19 pneumonia, lasting
for 3 days. The patient is dead. The events was reported as serious with criterion
of death. The patient underwent lab tests and procedures which included COVID-19
PCR test was positive on an unspecified date. It was reported that the cause of
death was COVID-19 pneumonia. The outcome of the events was fatal. The patient died
on 01Mar2021. It was unknown if an autopsy was performed. No follow-up attempts
possible, batch/lot number cannot be obtained. No further information expected.;
Reported Cause(s) of Death: COVID-19 pneumonia" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1200600-1"
"1200600-1" "drug ineffective/ positive COVID-19 PCR test; drug ineffective/
positive COVID-19 PCR test; asthenia and diarrhea; asthenia and diarrhea; This is a
spontaneous report received from a contactable physician downloaded from the Agency
Regulatory Authority-WEB, regulatory authority report number is IT-MINISAL02-
709108. An 84-year-old male patient received BNT162B2 (COMIRNATY), on 23Mar2021 at
08:50 (lot number: ET3620; second dose) at 0.3 mL, single in the left arm and on
02Mar2021 (lot number: EP2166; first dose), single dose (as reported); both
intramuscularly, for COVID-19 immunization. The patient medical history included
hypertension, ischemic cardiomyopathy, diabetes mellitus, prostatic hypertrophy
(benign), and hyperuricemia. Concomitant medications included amlodipine besilate
(NORVASC, strength: 5 mg) taken for hypertension; hydrochlorothiazide (strength: 80
mg), telmisartan (strength: 12.5 mg) (PRITORPLUS) taken for hypertension;
metoprolol tartrate (LOPRESOR [METOPROLOL TARTRATE], strength: 100 mg) taken for
ischemic cardiomyopathy; gliclazide (DIAMICRON, strength: 30 mg) taken for diabetes
mellitus; tamsulosin hydrochloride (OMNIC, strength: 0.4 mg) taken for prostatic
hypertrophy (benign); and allopurinol (ZYLORIC, strength: 300 mg) taken for
hyperuricemia. On 23Mar2021, the patient experienced asthenia and diarrhea. On
26Mar2021, the patient experienced drug ineffective/ positive COVID-19 PCR test.
The patient died on 28Mar2021 due to the events. It was not reported if an autopsy
was performed. Reporter comments: first dose vaccine lot EP2166 administered on
02Mar2021: no adverse reactions. Symptoms appeared a few hours after second
vaccination therefore I prescribed the COVID-19 PCR test with a positive outcome on
26Mar2021. From my point of view it is not clinical vaccination failure due to lack
of adequate distance from the administration of the second dose or the result. No
follow-up attempts are possible. No further information is expected.; Reporter's
Comments: first dose vaccine lot EP2166 administered on 02Mar2021: no adverse
reactions. Symptoms appeared a few hours after second vaccination therefore I
prescribed the COVID-19 PCR test with a positive outcome on 26Mar2021. From my
point of view it is not clinical vaccination failure due to lack of adequate
distance from the administration of the second dose or the result.; Reported
Cause(s) of Death: asthenia and diarrhea; asthenia and diarrhea; drug ineffective/
positive COVID-19 PCR test; drug ineffective/ positive COVID-19 PCR test" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1204069-1"
"1204069-1" "Death Acute kidney injury COVID-19 virus infection COVID-19"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1227511-1"
"1227511-1" "Unknown cause of death; COVID-19 virus test: yes-positive; This
is a spontaneous report from a non-contactable physician downloaded from the
regulatory authority. The regulatory authority number is DE-PEI-202100032177. A 90-
year-old female patient received BNT162B2 (COMIRNATY, lot number and expiration
date were unknown) at the age of 90-years-old, via an unspecified route of
administration on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation. The
patient's medical history was not reported. There were no concomitant medications.
The patient died on 15Mar2021 due to an unknown cause. The patient underwent lab
test and procedure which included COVID-19 virus test: yes-positive on 02Feb2021.
The outcome of the event COVID-19 was unknown. The patient died on 15Mar2021. The
cause of death was unknown. An autopsy was not performed. Relatedness of the drug
to unknown cause of death was reported as unclassifiable. No follow-up attempts
are possible; information on batch/lot number cannot be obtained.; Reported
Cause(s) of Death: Unknown cause of death" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1230054-1"
"1230054-1" "Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on
1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with
complaints of acute mental status change. He was recently diagnosed with
enterocoal/pseudomonas UTI four days prior to presenting to ED and was being
treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with
the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on
2/7/2021 x3, developed three pressor shock, and required maximum ventilator
settings. Patient subsequently expired." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1234378-1"
"1234378-1" "drug ineffective; COVID-19 aggravated; unmeasurable fever;
cardiovascular decompensation; This is as spontaneous report received from a
contactable physician downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority report number is FR-AFSSAPS-MA20211228, Safety report unique
identifier FR-AFSSAPS-2021035332. A 93-year-old female patient received bnt162b2
(COMIRNATY), dose 1 intramuscular on 19Jan2021 (Lot Number: EM0477) as SINGLE DOSE
for covid-19 immunisation. Medical history included cognitive
disorder/neurocognitive disorders, renal failure, breast cancer, atrial
fibrillation, starvation, thyroid nodule. The patient's concomitant medications
were not reported. The patient experienced drug ineffective (death) on 02Feb2021,
covid-19 aggravated (death) on 02Feb2021, unmeasurable fever (death) on 02Feb2021,
cardiovascular decompensation(death) on 02Feb2021. On 02Feb2021, a unmeasurable
fever, a cardiovascular decompensation. PCR Covid 19 test performed and result was
positive on 02Feb2021. The patient died on 02Feb2021. It was not reported if an
autopsy was performed. Time Interval between Beginning of Drug Administration and
Start of Reaction / Event was 15 days. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: drug ineffective;
COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1234964-1"
"1234964-1" "Respiratory tract infection; REDUCED RESPIRATION RATE, O2;
REDUCED RESPIRATION RATE, O2; WEAK; PHYSICAL DETERIORATION; COVID-19; This is a
spontaneous report from a contactable other healthcare professional downloaded from
the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-
066080. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an
unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as Single
Dose for COVID-19 immunisation. Medical history included lower respiratory tract
infection secondary to aspirations, rectal cancer from 2013, oral cancer stage
unspecified from 2010. The patient's concomitant medications were not reported. The
reporter outlined that no adverse reactions were noted post vaccination. On
28Jan2021, the patient tested positive for COVID-19 via PCR nasal/pharyngeal swab.
It was reported that the patient's condition deteriorated in the days prior to his
death (onset date: Feb2021). On 03Feb2021, the patient was last seen by his General
Practitioner (GP). The patient's condition was comfortable but weak and the patent
experienced a reduced respiration rate and O2. The patient's GP was contacted.
Therapeutic measures were taken as a result of reduced respiration rate and O2. The
patient was treated for a respiratory tract infection (RTI) (onset date not
reported) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. The
patient also experienced physical deterioration on Feb2021. On 04Feb2021, at 11:40
am, the patient died. It was reported that the patient did not have any COVID-19
symptoms prior to vaccination, however, his death occurred as a result of COVID-19
seven days later. Other causes of death reported included weak, reduced respiration
rate and O2, and physical deterioration. It was unknown if an autopsy was
performed. Follow-up attempts are completed. No further information is expected.;
Sender's Comments: Linked Report(s) : IE-HPRA-2021-066081 HPRA; Reported Cause(s)
of Death: REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; PHYSICAL
DETERIORATION; WEAK; COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1234966-1"
"1234966-1" "DEVELOPED COVID 19; This is a spontaneous report from a
contactable consumer or other non healthcare profesional downloaded from the Agency
Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070505. A 88-
years-old female patient received BNT162B2 (COMIRNATY, BioNTech Covid-19 mRNA
vaccine), via an unspecified route of administration on 14Jan2021 (Batch/Lot
Number: Unknown) as single dose for COVID-19 immunisation. Medical history included
living in residential institution, renal disorder receiving treatment in clinic;
and hip arthroplasty from 2019 (18 months previously). Patient was recovering in
nursing home after treatment in Clinic for kidney issues. The patient was not
taking any concomitant medication. On 15Jan2021, the patient developed COVID-19. It
was reported that the patient had been doing well in residential care but then
crashed very quickly and it was decided not to send her to hospital as it was felt
the patient would not have wanted that. The patient received palliative care for
three days before she died. The patient died on 23Jan2021. It was unknown if an
autopsy was performed. No follow-up attempts are possible; information about
batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1237672-1"
"1237672-1" "Presents with dyspnea for a few days. Pt was tested positive for
COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied
f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat
at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day
course), completed 5 day course of remdesivir and received tocilizumab due to
increased oxygen requirements. Pt also has mildly elevated troponin and cardiology
was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute
coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel
disease but due to difficulty revascularizing LAD in setting of worsening K+,
Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be
hypotensive and bradycardic. PEA arrest. Family contacted during code and in
agreement to transition to comfort measures." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1241494-1"
"1241494-1" ""COVID-19 aggravated/ positive COVID-19 test with symptoms; This
is a spontaneous report from a contactable physician downloaded from the Agency
Regulatory Authority-WEB FR-AFSSAPS-2021035128. A 97-year-old male patient
received first dose of bnt162b2 (COMIRNATY, Lot ER9470) intramuscular on 23Mar2021
at single dose for COVID-19 immunisation (vaccination against covid-19). Medical
history included prostate neoplasia, arterial hypertension, vascular device user
from 2007 (stent in 2007), dyslipidaemia, cardiovascular disease and diabetes.
Concomitant medications were not provided. On 19Mar2021, the patient was in contact
with a non-symptomatic person carrying the variant who found out after, the patient
was vaccinated. On 24Mar2021 (also reported as two days after the beginning of drug
administration), the patient developed COVID-19 aggravated which led to death on
29Mar2021 (the event was reported that lasted for 7 days). On 24Mar2021, onset of
fever with dyspnea (cough) and fatigue. On 26Mar2021, patient hospitalized with an
OAP (Acute pulmonary edema). On admission, patient placed on high flow Optiflow
with 94% saturation under 100% FiO2, corticosteroid therapy, antibiotic therapy,
furosemide (ES) and hydration. No indication for heavy resuscitation. CT scan,
typical image of COVID-19 with severe involvement, dilated cardiomyopathy and
""small"" pleurisy. PCR Covid positive. Event was reported as life threatening.
Unfavorable evolution leading to the death of the patient on 29Mar2021. Conclusion:
Covid-19 associated with PDO in patient 2 days after a first vaccination. Patient
died on 29Mar2021. An autopsy was performed and the reported cause of death was
covid-19, autopsy result was covid-19 and acute pulmonary edema. No follow-up
attempts possible. No further information expected.; Reported Cause(s) of Death:
COVID-19; Autopsy-determined Cause(s) of Death: covid-19 and Acute pulmonary edema;
covid-19 and Acute pulmonary edema"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1243574-1"
"1243574-1" "Cause of death is believed to be a fatal arrhythmia resulting
from advanced old age and aggravated by sepsis due to COVID-19 infection along with
gastroenteritis. The death was natural and not unexpected. Tobacco is not believed
to have contributed to t" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1247832-1"
"1247832-1" "patient was vaccinated with second covid vaccine on 2/12/21.
Patient was admitted to the hospital on 03/04/2021 with fatigue and diagnosed with
COVID 19 (positive lab test on 2/26/21 and 3/4/21). Case expired on 3/8/21." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1255836-1"
"1255836-1" "Presented to ED on 1/12/21 slowly worsening constant myalgias,
generalized weakness where she couldn't walk, dry cough. Per daughter not acting
herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is
s/p her first dose of vaccine and this precludes plasma. Supportive care steroids
and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am.
1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success
pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless
and expired at 0451." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1257542-1"
"1257542-1" "Pneumonia; COVID-19 confirmed by positive COVID-19 test; COVID-
19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-
contactable consumer or other non hcp downloaded from a regulatory authority-WEB
[regulatory authority number: DE-PEI-CADR2021047458]. An 85-year-old male patient
received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on
20Jan2021, dose 2 via an unspecified route of administration on 10Feb2021
(Batch/Lot Number: EK9877); both at vaccination age of 85 years old as single dose
for covid-19 immunisation. The patient medical history and concomitant medications
were not reported. On 10Mar2021 the patient experienced pneumonia, COVID-19,
vaccination failure. The patient underwent lab tests and procedures which included
PCR-Covid-Test: positive on 10Mar2021 and positive on 19Mar2021. The patient's
outcome was fatal for Pneumonia, fatal for COVID-19. The patient died on
31Mar2021. It was not reported if an autopsy was performed. Sender's comment: The
affected person received both vaccine doses from Comirnaty (20Jan21 and 10Feb21).
One month after the second vaccination (10Mar21) the person got sick with Covid-19.
The first symptoms were cough, runny nose and general symptoms of illness. On
19Mar2021 a PCR test was positive for Covid-19. On 25Mar2021, the affected person
developed pneumonia. The affected person was treated on an outpatient basis and
hospitalization was required. The person concerned died on 31Mar2021. Relatedness
of drug to reaction/events: It was D. Unclassifiable for all events per a
regulatory authority. No follow up attempts are possible, no further
information is expected. ; Reported Cause(s) of Death: Pneumonia; COVID-19
confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1267468-1"
"1267468-1" "patient received her covid vaccine per her record: 1/3 and
1/24/21. Patient presented to Facility 4/20/21 diagnosed with COVID, patient died
4/23/21 due to hypoxic respiratory failure/ bilateral pneumonia due to covid."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1269851-1"
"1269851-1" "Death Narrative: Patient was previously tested COVID-19
positive on 3/2/2021, but did not have any other predisposing factors(PMH,
allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at
the time of the administration of the vaccine nor was there an ADR that occurred
between the observation period and the date of death. Patient was admitted with
afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled
during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more
times over the next two months for cardiac symptoms with last hospitalization
occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure.
Patient never recovered and transitioned to hospice before passing on 4/16/21.
Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2
2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic
foley" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1282523-1"
"1282523-1" "Pt received first COVID Pfizer vaccine on 3/2/21 and second
vaccine dose of Pfizer on 3/23/21 and tested positive for COVID 3/24/21 was
admitted through the ED on 3/24/21 with decreased oxygen levels (50%) and SOB.
Admitted to the floor on 3/25/21, Patient was never intubated but was put on
continuous BiPap. Patient treated with acetaminophine, albuterol, solumedrol, and
remdesivir. Patient expired on 4/15/21. Cause of death was secondary COVID
pneumonia and acute respiratory failure." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1289414-1"
"1289414-1" "Patient tested positive on 04/20/2021 via PCR. Upon arriving to
hospice care, patient tested positive via rapid on 04/29/2021. She died in hospice
care on 05/01/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1289450-1"
"1289450-1" "Hospitalized and died due to COVID-19 after being fully
vaccinated." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1292940-1"
"1292940-1" "tested positive for covid" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1295712-1"
"1295712-1" "cough, body aches, fever--COVID +, afib, tachycardia, acute
coronary syndrome" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1295875-1"
"1295875-1" "Presented to urgent care on 5/1/21 with dry cough which started
about 4 days prior. Symptoms worsened and presented to emergency department on
5/5/21. Was found to be COVID-19 positive and was admitted for further management.
Patient had been exposed to COVID-19 positive person prior to presentation. Patient
is currently admitted at time of writing." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1298642-1"
"1298642-1" "Respiratory failure; Pneumonia; Oxygen saturation low; Dyspnoea;
Psychomotor retardation; SARS-CoV-2 infection; This is a spontaneous report from a
contactable physician. This is a report received from the Regulatory Authority.
An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at the age of 86-
year-old, intramuscular, administered in left arm on 15Mar2021 12:00 (Lot Number:
ET3674; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The
patient's medical history and concomitant medications were not reported. The
patient experienced respiratory failure, pneumonia, oxygen saturation low,
dyspnoea, and psychomotor retardation on 27Mar2021 at 10:00; and SARS-CoV-2
infection on 27Mar2021. The patient died on 04Apr2021. It was unknown if an autopsy
was performed. The events were reported as medically significant. The outcome of
the events was fatal. No follow-up attempts are possible. No further information
is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; pneumonia;
dyspnoea; psychomotor retardation; respiratory failure; low oxygen saturation"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1299650-1"
"1299650-1" "COVID-19 infection with pneumonia: Present on admission.
Patient was treated with remdesivir and convalescent plasma." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1302209-1"
"1302209-1" "death from covid 3 months after completing series" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1302294-1"
"1302294-1" "fever and generalized weakness bilateral pneumonia secondary to
COVID-19 infection Failure to Thrive, Severe Sepsis antibiotics: Levaquin,
ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1306940-1"
"1306940-1" "Hospitalized and died due to COVID-19 after being fully
vaccinated." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1310308-1"
"1310308-1" "Patient hospitalized on 4/15/2021 after being fully vaccinated.
Tested positive on 4/19/2021. Patient died on 4/27/2021." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1314801-1"
"1314801-1" "Death: CHRONIC COMBINED SYSTOLIC -CONGESTIVE- AND DIASTOLIC
-CONGESTIVE- HEART FAILURE, COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1316428-1"
"1316428-1" "COVID-19 pneumonia; Tachycardia; COVID-19; Fever;
Inanition/gaunt; Diarrhea caused by Clostridium difficile; Klebsiella pneumoniae
infection; induced coma; Headache, elevated temperature, fatigue; Ear pain; ear
inflammation; Rhinorrhea; Dacryorrhea; Pain in the left upper limb; This is a
spontaneous report from a contactable consumer downloaded from the regulatory
authority-WEB CZ-CZSUKL-21004773. An 81-year-old female patient received first
dose of bnt162b2 (COMIRNATY), intramuscular in left arm on 25Feb2021 (Lot Number:
Unknown, at age of 81 years old) as single dose for COVID-19 immunisation. The
patient's medical history and concomitant medications were not reported. In the
evening after the vaccination on 25Feb2021, the patient appeared pain of the
vaccinated arm (left). The next day on 26Feb2021, the patient had a headache, ear
pain, rhinorrhea, and dacryorrhea, Flu-like symptoms (Headache, elevated
temperature, fatigue). The headache escalated and fatigue appeared during the next
two days. On the fourth day after the vaccination on 01Mar2021, elevated body
temperature and dry cough appeared. On the fifth day on 02Mar2021, the cough
escalated and her physician prescribed Isoprinosine to her. On the seventh and
eighth day (04Mar2021 and 05Mar2021), a fever of 39�C appeared (also reported as
less or equal to 39) and she had prescribed Augmentin for ear inflammation. On the
tenth day (07Mar2021), an ambulance was called for the patient and she was admitted
to the hospital. On the eleventh day on 08Mar2021, a COVID-19 test was done with a
positive result, the level of her c-reactive protein was 100 mg/L and she still
complained about ear pain (ORL examination found no pathology). After 4 days, the
patient was put on an oxygen mask. She was then transferred to the Anesthesiology
department because of CRP elevation, where she was set to an induced coma and she
breathed using mechanical ventilation. She was administered Meropenem. After waking
up from the artificial sleep, a Klebsiella pneumoniae was isolated from the
patient's sputum and she was administered Vancomycin and Solumedrol in Mar2021.
After two more days in Mar2021, her O2 saturation decreased and she had diarrhea. A
Clostridium difficile was confirmed microbiologically, which resulted in a change
of antibiotics to Biseptol. Finding on chest CT was unspecified, the patient still
had a cough, was gaunt (Inanition) and her CRP kept elevating. She was administered
oxygen and after a week she was transferred to the pulmonary department (standard),
where she was put on an oxygen mask. On 10Apr2021, the patient developed
tachycardia and was therefore transferred to the Intensive care unit. According to
the reporter, the patient's lung was destroyed (about a 1/3 was working). Events
COVID-19 & COVID-19 pneumonia were reported with event stop dates DATA 14APR2021.
The outcome of events COVID-19 and COVID-19 pneumonia was fatal. The outcome of
event persistent dry cough was not recovered. The outcome of rest events was
unknown. On 14Apr2021, the patient died of pneumonia. The patient died on
14Apr2021. It was not reported if an autopsy was performed. No follow-up attempts
possible; batch/lot number cannot be obtained. No further information is expected.;
Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1316645-1"
"1316645-1" "Patient received dose 1 of the pfizer covid vaccine on 1/22/21
and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic
after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she
presented to our emergency department with persistence of the above symptoms and
hypoxia to the 70s on room air and again tested positive for COVID. Initially
required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7
days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but
refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%.
However on 5/13 she acutely desaturated and was found pulseless. Patient was
DNR/DNI so was pronounced dead." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1322956-1"
"1322956-1" "Patient got second dose of the vaccine on 2/4/2021. He was
diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was
hypoxic, developed changed in mental status. Died on 5/16/2021" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1324154-1"
"1324154-1" "5/2/2021 - productive persistent cough and poor appetite.
Received physician order to transfer to Hospital for evaluation." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1328793-1"
"1328793-1" "covid-19 infection; covid-19 infection; Congestive Heart
Failure; Atrial Fibrillation; Arrhythmia; Acute kidney injury; Altered
consciousness; Thrombocytopenia; Increased lethargy; This is a spontaneous report
from a contactable physician. A 96-years-old female patient received BNT162B2
(COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Arm Left
on 11Feb2021 (Lot Number: EL8723) as 2nd dose, single; dose 1 intramuscular,
administered in Arm Left on 21Jan2021 (Lot Number: EM0477) as 1st dose, single for
covid-19 immunisation. Medical history included hypertension, atrial fibrillation,
chronic kidney disease since 2016, right eye cataract, spinal osteoarthritis. Non-
smoker. Concomitant medications included atenolol at 100 mg daily; bumetanide
(BURINEX) at 1 mg daily; amitriptyline hydrochloride (AMIROL) at 10 mg nocte;
omeprazole at 20 mg twice daily; paracetamol at 1 g, as needed (tds) and Diarolyte
sachet as needed (twice daily). The patient experienced covid-19 infection
03Apr2021. The patient was hospitalized for covid-19 infection on 03Apr2021. The
patient experienced Dyspnea (Hypoxia), Tachypnea (RR more than 25bpm), Respiratory
failure (Type 1 Respiratory Failure), Arrhythmia (atrial fibrillation known case),
Hypoxemia (SPO2 73% RA rising to 95% on 15L/min NRM), Acute kidney injury (CKD -
GFR about 38), Altered consciousness, Increased lethargy, Thrombocytopenia
(Platelets - 77). On 05Apr2021 she was administered treatment with Remdesivir
200mg iv stat, then 100mg iv daily, Dexamethasone 6mg iv daily and Augmentin 1.2g
8hrly IV. The patient underwent lab tests and procedures which included: Nasal swab
(RT-PCR) - positive on 05Apr2021 (new infection, Detected: CT=36 Abnormal). On
admission (03Apr2021: Rectal Temp 36.4; RR=28; Pulse=54; Heart 54 - Slow AF; SpO2
on room air - 73%. Oxygen saturations rose to 96% on 15L/min Oxygen. ABGs on
15L/min NRM: pH 7.498; pCO2 28.1; pO2 79.4; SO2 97.2; HCO3 22. Imaging for COVID-
Pneumonia (04Apr2021) No significant abnormality. On 04Apr2021 WBC, Neutrophils -
normal, Lymphocytes 0.82 (1.3-3.6 X 109 g/L) LOW, Hb - 10.5 (12-15.5g/dL) LOW,
Platelets - 77 (132-349 X109/L) LOW, PT 11.7 (9.96-11.24s) RAISED, INR 1.13 (0.94-
1.06 ratio) RAISED, Imaging for COVID-Pneumonia: No significant abnormality, Urine
microscopy E.coli ESBL positive cultivated. On 07Apr2021 D-DIMER 563 (0-500ng/ml)
ABNORMALLY HIGH, Creatinine 118 (45-84micromol/L) RAISED, Bilirubin 29.6 (0-
21micromol/L) RAISED, Alk phosphatase 143 (40-104 units/L) RAISED, GFR 39
ml/min/1.73m2, CRP 50.3 (0-5mg/L) RAISED, Procalcitonin 0.137 (0.02-0.046 ng/mL)
RAISED. The patient died on 09Apr2021. It was unknown if an autopsy was performed.
Cause of death: Hypoxia due to COVID-19 infection. Significant contributory causes:
Congestive Heart Failure; Atrial Fibrillation. Outcome of the events covid-19
infection, Congestive Heart Failure, Atrial Fibrillation was fatal; of the other
events was unknown. Follow-up attempts completed. No more information are
expected.; Sender's Comments: This patient experienced Fatal vaccination failure
since a COVID-19 Infection developed 1 month 23 days days after the administration
of the 2nd dose. The doses were properly spaced (42 days between the 1st and second
dose).The vaccine preventable illness, COVID-19 infection, showed unfavorable
course with Respiratory failure, Hypoxemia and Congestive Heart Failure, Atrial
Fibrillation as significant contributory factors to the fatal outcome. Other
serious events, like Arrhythmia, Acute kidney injury, Altered state of
consciousness, Thrombocytopenia further worsened the clinical course of current
infection. The impact of this report on the benefit/risk profile of the Pfizer
product is evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety concern
identified as part of this review, as well as any appropriate action in response,
will be promptly notified to Regulatory Authorities, Ethics Committees, and
Investigators, as appropriate; Reported Cause(s) of Death: Hypoxia due to COVID-19
infection; Congestive Heart Failure; Atrial Fibrillation; Hypoxia due to COVID-19
infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1346723-1"
"1346723-1" "Patient contracted covid 2 months after receiving the full
vaccine series. He was admitted the hospital and subsequently passed away. Variant
testing was conducted (results are pending) and antibody testing was done. Antibody
testing showed no antibodies were produced in response to the vaccine." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1351466-1"
"1351466-1" "88-year-old male with lymphoma that received a transfusion of 2
units of packed red blood cells prior to admission. The patient has a history of
pleural effusions and he states after the blood transfusion, he became increasingly
more short of breath and could not catch his air. He was dyspneic at rest and
exertion. There is no cough. No fevers. He also has a history of cardiomyopathy
and chest x-ray is suggestive of increasing sizes of his pleural effusions. Tested
positive for COVID on 4/20/2021. Moved to hospice and expired on 4/22/2021." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1354959-1"
"1354959-1" "Muscle ache, loss of smell and taste The PUI started feeling ill
on 4/29/21 with minor symptoms. The patient is having body aches and a loss of
appetite due to his loss of taste/smell. The patient is currently undergoing chemo
therapy and is most likely the reason why he still got sick with COVID-19 even
though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE,
COVID 19 PNEUMONIA" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1357990-1"
"1357990-1" "Patient hospitalized. Patient died after testing positive for
COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested positive on
4/1/2021. Died 4/29/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1366669-1"
"1366669-1" "Pneumonia; Anaemia; COVID-19 PCR test positive; Parkinson's
syndrome; Gastritis; Fever 40-40.4 degree Celsius up to 24 hours; Vaccination
failure; COVID-19; This is a spontaneous report from a contactable physician
downloaded from a regulatory authority-WEB PL-URPL-3-633-2021t An 88-year-old
male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in
Arm Left on 18Feb2021 15:18 (Batch/Lot Number: EP9598; Expiration Date: 30Jun2021)
as 0.3ml single at the age of 88-year-old for COVID-19 immunisation. The patient
medical history and concomitant medications were not reported. The patient received
bnt162b2 (COMIRNATY), dose 1 on an unknown date for COVID-19 immunisation. On
03Mar2021 the patient experienced pneumonia, anaemia, COVID-19 PCR test positive,
Parkinson's syndrome, gastritis, fever 40-40.4 degree celsius up to 24 hours,
vaccination failure, COVID-19. The patient underwent lab tests and procedures which
included: body temperature increased: 40-40.4 centigrade on 03Mar2021, Sars-cov-2
antibody test: negative on 03Mar2021, Sars-cov-2 test: positive on 03Mar2021. The
patient died on 04Mar2021. It was not reported if an autopsy was performed. The
course of events was as follows: Description of the reaction: on 03Mar2021 a
patient was admitted to Hospital in a serious condition with diagnosed pneumonia.
On admission, an antigen test for COVID-19 (-) and a PCR test for Covid-19 (+) were
performed. On 04Mar2021, at approximately 14 hour, the patient died. Additional
information: Emergency department diagnosis: COVID 19 virus identified, pneumonia,
anemia, gastritis, parkinsonian syndrome, cause of death has not been clearly
defined. Sender Comments: Pyrexia is an expected adverse drug reaction as
described in a publication, after Comirnaty administration. Pneumonia and a
positive covid-19 PCR test result are unexpected symptoms, but reported in a
database (pneumonia, SARS-Cov-19 test positive). There is a time relationship
between the second dose of the vaccine and the occurrence of side effects.
Parkinson's syndrome (so-called parkinsonism) is an unexpected adverse drug
reaction for Comirnaty vaccine. Parkinsonism is most often caused by other virals
or it occurs in inflammatory and neurodegenerative diseases. Anemia is most likely
a symptom of inflammation in the lining of the stomach. A regulatory authority
considers that these adverse drug reactions (parkinsonian syndrome, anemia,
gastritis) coincided with vaccination. The reporting person qualified NOP as heavy.
A regulatory authority assessed the NOP as heavy. The notification concerns the
medicinal product Comirnaty, with regard to the lack of protective efficacy of the
vaccine and the severe course of COVID-19 after vaccination (VAED - vaccine
associated enhanced disease), therefore the reporting person was provided with a
form on 13May2021 in order to obtain additional data, in accordance with Corminaty
RMP. No follow-up attempts possible. No further information expected.; Reported
Cause(s) of Death: unknown cause of death" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1368670-1"
"1368670-1" "Admitted to hospital on 5/2/2021 due to hypoxia and ultimately
intubated. Family moved to comfort care and he died on 5/2/2021 at 10am." "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1371438-1"
"1371438-1" "Clinet was vaccinated on 2/16/21 and on 3/9/21" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1375972-1"
"1375972-1" "Symptom onset began on 4/29/2021. Tested (+) on 4/29/2021.
Symptoms included fatigue, congestion, cough. Case was interviewed by public health
department on 5/3/2021 and family reported he was in hospital and was admitted on
4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically ventilated."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1382347-1"
"1382347-1" "COVID Infection post immunization" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1382468-1"
"1382468-1" "Per discharge summary, patient presented to BHL with his wife
with increased shortness of breath, diarrhea and hematuria. Found to be COVID +.
Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations.
Patient was admitted and started on treatment for Covid with remdesivir and
steroids. He was continued on his home dialysis schedule. He continued to have
intermittent confusion and then for the last 3 to 5 days was very confused and more
unresponsive. Reviewed goals of care with wife at length and palliative care was
consulted. Decision was made not to pursue feeding tube due to patient having
clearly outlined his wishes and his advanced directive. Upon further discussion
with family hospice was consulted and patient was transitioned to inpatient
hospice" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1387001-1"
"1387001-1" "Positive RT-PCR for SARSCoV2 on 22Mar2021 in a subject
vaccinated with two doses of COMIRNATY (18Jan2021 and 11Feb2021). Deceased on
01Apr2021. Positive genotyping for variant; Positive RT-PCR for SARSCoV2 on
22Mar2021 in a subject vaccinated with two doses of COMIRNATY (18Jan2021 and
11Feb2021). Deceased on 01Apr2021. Positive genotyping for variant; This is a
spontaneous report received from a contactable physician downloaded from a
regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-
736211. A 94-year-old male patient received BNT162b2 (COMIRNATY, Solution for
injection) of 2nd dose, single dose (Lot number- EJ6790-14-006, Expiration date:
31May2021) via intramuscularly in right arm on 11Feb2021 at 09:00 and 1st dose,
single dose (Lot number: unknown) via unspecified route of administration on
18Jan2021 for COVID-19 immunization. Medical history included diabetes mellitus,
COPD, IHD, chronic renal failure. Concomitant medication (before hospitalization)
included acarbose (GLUCOBAY), insulin, furosemide, nadroparin calcium (SELEPARINA),
bisoprolol, thiamazole (TAPAZOLE), paroxetine, paracetamol, omeprazole, lorazepam
(LORAZEPAM), macrogol. It was reported that covid 19 comirnaty vaccine (pfizer)
195FL 0.45ML. On 22Mar2021, Positive RT-PCR and subsequent detection of the
specific country variant of SARSCoV2 at the genotyping performed and resulted
positive at the Local Healthcare Area. It was reported that addition of antibiotic
therapy, enoxaparin 6000UI qd (daily) and Oxygen Therapy Reservoir - Actions taken
(Hospitalization, Repeated Testing of Healthcare Workers and other guests of the
Nursing Home, genotyping, cohortization of guests). On 01Apr2021, patient was died
due to COVID-19 respiratory infection. It was not reported if an autopsy was
performed. The outcome of the events was fatal. Reporter's comments: Outbreak of
COVID19 in the Nursing Home involving health workers and residents vaccinated with
two doses of Comirnaty Sender's comments: 28May2021: adverse reaction updated;
Reporter's Comments: Outbreak of COVID19 in the Nursing Home involving health
workers and residents vaccinated with two doses of Comirnaty; Sender's Comments:
Linked Report(s) : IT-PFIZER INC-2021650363 Original Case : 2021638906; Reported
Cause(s) of Death: COVID-19 respiratory infection" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1388763-1"
"1388763-1" "Pulmonary congestion, ARDS, cardiac decompensation; Pulmonary
congestion, ARDS, cardiac decompensation; Pulmonary congestion, ARDS, cardiac
decompensation; COVID-19; COVID-19 pneumonia; Vaccination failure; This is a
spontaneous report from a non-contactable consumer downloaded from the Regulatory
Authority-WEB, regulatory authority number DE-PEI-CADR2021079508, Sender's (Case)
Safety Report Unique Identifier DE-PEI-202100072522. An 84-year-old female patient
received bnt162b2 (COMIRNATY, 0.3 ml), dose 2 via an unspecified route of
administration on 19Feb2021 (Batch/Lot Number: EP9598) as single dose, dose 1 via
an unspecified route of administration on 28Jan2021 (Batch/Lot number was not
reported) as single dose for covid-19 immunisation. Medical history included type
II diabetes mellitus, CHD (coronary artery disease). Concomitant medications
included furosemide; meropenem trihydrate (MERONEM); enoxaparin sodium (CLEXANE);
insulin glulisine (APIDRA). On 27Feb2021 the patient experienced pulmonary
congestion (fatal, hospitalization), ARDS (acute respiratory distress syndrome)
(death, hospitalization), Vaccination failure, COVID-19, COVID-19 pneumonia,
Decompensated heart failure. The patient underwent lab tests and procedures which
included sars-cov-2 test: positive on 27Feb2021, x-ray: covid-19 pneumonia on
27Feb2021. The affected person was hospitalized and died. She received both
vaccinations with Comirnaty. One week after the second vaccination, a Covid-19
infection was detected by means of PCR (27Feb2021). Sequencing was not performed.
Symptoms (from 27Feb2021): Covid pneumonia (confirmed by X-rays), pulmonary
congestion, Acute Respiratory Distress Syndrome, cardiac decompensation. The person
concerned died on 11Mar2021. An autopsy was not performed. The patient's outcome
reported as fatal for Acute Respiratory Distress Syndrome, fatal for Decompensated
heart failure, not recovered for other events. This report is serious - death.
Sender Comment: Information on risk factors or previous illnesses. Comirnaty/ all
events/ Regulatory Authority/ Unclassifiable. No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: Vaccination failure;
Decompensated heart failure; Pulmonary congestion; COVID-19; COVID-19 pneumonia;
ARDS" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1389385-1"
"1389385-1" "Fever, Covid pneumonia, congestive bronchitis and ARDS; COVID-
19; Fever, Covid pneumonia, congestive bronchitis and ARDS; Fever, Covid pneumonia,
congestive bronchitis and ARDS; Fever, Covid pneumonia, congestive bronchitis and
ARDS; Vaccination failure; This is a spontaneous report from a non-contactable
consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB DE-
PEI-CADR2021078045, Safety Report Unique Identifier DE-PEI-202100071274. An 85-
year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2,
via an unspecified route of administration on 19Feb2021 at single dose(Lot number:
EP9598), dose 1, via an unspecified route of administration on 28Jan2021 at single
dose(Lot number unknown), all at the age of 85 years old for covid-19 immunisation.
The patient's medical history included chronic renal insufficiency, COPD, atrial
fibrillation, chronic kidney failure, all ongoing. Concomitant medications were not
reported. The patient experienced fever, Covid pneumonia, congestive bronchitis,
ARDS, COVID-19 on 17Mar2021. The patient was hospitalized due to Covid pneumonia,
COVID-19, congestive bronchitis and ARDS. The patient died on 23Mar2021 at the
sanatorium. The cause of death was Covid pneumonia. It was not reported if an
autopsy was performed. The patient underwent lab test included Covid-19 PCR test:
positive on 17Mar2021(Sequencing showed the mutant B.1.1.7.). The outcome of the
event Covid pneumonia was fatal, of the other events was not recovered. Senders
comment: Information on risk factors or previous illnesses: COPD, chronic kidney
failure, atrial fibrillation / *Privacy. The affected person received both
vaccinations with Comirnaty, about one month after the second vaccination, a Covid-
19 infection was detected by means of PCR on 17Mar2021. Sequencing showed the
mutant B.1.1.7. Symptoms were fever, Covid pneumonia, congestive bronchitis and
acute respiratory distress syndrome. The person concerned died on 23Mar2021 at the
sanatorium.Relatedness of drug to events for all events was unclassifiable. No
follow-up attempts are possible; information about lot/batch number cannot be
obtained.; Reported Cause(s) of Death: Covid pneumonia" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1389479-1"
"1389479-1" "ischemic stroke; Vaccination failure; COVID-19; This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority-WEB, regulatory authority number FR-AFSSAPS-2021059716. A 94-year-old
male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular in the
right arm on 21Jan2021 (Batch/Lot Number: unknown) at 0.3 mL, single and the second
dose via intramuscular in the right arm on 11Feb2021 (Batch/Lot Number: EJ6789) at
0.3 mL single for covid-19 immunisation. Medical history included ongoing
hypercholesterolaemia, ongoing arterial hypertension, ongoing type 2 diabetes
mellitus, ongoing vascular dementia (Iso-Resource Groups score (dependence level):
2), pacemaker user (Unspecified indication) from unspecified date. Concomitant
medications included tamsulosin hydrochloride (unspecified trade name) and ramipril
(unspecified trade name). On 06May2021, positive SARS COV 2 test (N50Y1 mutation)
detected in the context of a cluster at the establishment for dependent elderly
people. The patient developed a form of covid-19 that was not very symptomatic
(onset of symptoms estimated on 28Apr2021). On 19May2021, occurrence of an ischemic
stroke with hemiplegia and swallowing disorders, according to the referring
physician, related to the ongoing covid19 infection. Outcome: Death of the patient
on 22May2021 following the stroke. in Total, confirmed vaccine failure associated
with the onset of a stroke (attributed to low-symptomatic SARS-CoV-2 infection)
leading to death in a 94-year-old patient. The patient died on 22May2021. Reported
cause of death was ischemic stroke. An autopsy was not performed. The outcome of
the event ischemic stroke was fatal, while the other events were unknown. No
Follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: Ischaemic stroke" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1407166-1"
"1407166-1" "84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the
colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week.
He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever.
Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started
on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements,
prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2
requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated
5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8.
Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS.
Decision to dc to hospice" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1407184-1"
"1407184-1" "DYSPNEA 3/7/2021, CONFIRMED BREAKTHROUGH WITHA POSITIVE COVID-
19 RESULTING IN DEATH" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1411020-1"
"1411020-1" "Shaking, almost spasm type shaking. Weakness in her legs.
progressing to abd. pain, cough, headache, nausea" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1411815-1"
"1411815-1" "Respiratory failure in subject with positive antigenic swab;
COVID-type interstitial pneumonia with >75% involvement; pulmonary embolic
thrombosis in CPAP (Continuous Positive Airway Pressure); pulmonary embolic
thrombosis; respiratory failure; vaccination failure; sars-cov-2 test: positive on
21May2021; This is a spontaneous report received from a contactable pharmacist
downloaded from the Agency Regulatory Authority-WEB, regulatory authority number
IT-MINISAL02-739120. An 85-year-old female patient received first dose of
BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EW2246-
37-030, expiration date: 31Jul2021) via an unspecified route of administration on
10Apr2021 as single dose for COVID-19 immunisation. The patient received second
dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number:
EX0893-01-117, expiration date: 31Jul2021) via an intramuscular route of
administration on 01May2021 at a dose of 0.3 ml as single dose for COVID-19
immunisation. The patient's medical history included ongoing chronic kidney
disease, ongoing hypertension and atrial fibrillation. Concomitant medications
included amlodipine besilate, olmesartan medoxomil (GIANT) taken for hypertension,
bisoprolol fumarate taken for hypertension, torasemide sodium (DIURESIX [TORASEMIDE
SODIUM]) taken for chronic kidney disease and olmesartan medoxomil taken for
hypertension. On 21May2021, the patient experienced respiratory failure in subject
with positive antigenic swab, COVID-type interstitial pneumonia with >75%
involvement, pulmonary embolic thrombosis in CPAP (continuous positive airway
pressure) and vaccination failure. The patient underwent lab tests and procedures
which included SARS-COV-2 antibody test: positive on 24May2021, SARS-COV-2 antibody
test: positive on 24May2021, SARS-COV-2 test: positive on 21May2021. Therapeutic
measures were taken as a result of adverse event. The patient died on 03Jun2021.
The death was due to respiratory failure in subject with positive antigenic swab;
COVID-type interstitial pneumonia with >75% involvement; pulmonary embolic
thrombosis in CPAP (Continuous Positive Airway Pressure), pulmonary embolic
thrombosis, respiratory failure, vaccination failure and SARS-COV-2 test: positive
on 21May2021. It was not reported if an autopsy was performed. The outcome of
events was fatal.; Sender's Comments: Linked Report(s) : IT-PFIZER INC-2021668395
patient spouse case; Reported Cause(s) of Death: Respiratory failure in subject
with positive antigenic swab; COVID-type interstitial pneumonia with >75%
involvement; pulmonary embolic thrombosis in CPAP (Continuous Positive Airway
Pressure); Pulmonary embolic thrombosis; Respiratory failure; Covid" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1413354-1"
"1413354-1" "Active COVID infection diagnosed 06/14/21" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1417182-1"
"1417182-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 5/15/21 after the completion of a full
Pfizer vaccine series (Dose 1 on 2/8 and Dose 2 on 3/1). The patient later died on
5/28/21. Cause of Death is listed as ?Acute hypoxemic respiratory failure Pneumonia
COVID-19?. Pre-existing conditions listed as: CARDIOVASCULAR DISEASE, DIABETES
MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1417262-1"
"1417262-1" "Died of COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1417263-1"
"1417263-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full
Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died
on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES,
IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the
hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal
failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic
respiratory failure requiring intubation. Despite maximum therapies, the patient's
respiratory status did not improve. He remained mechanically ventilated from 4/29
through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient
died at 10:45." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1417680-1"
"1417680-1" "presented with a cough, difficulty breathing, sinus congestions
and headache on 2/7. tested positive for COVID-19. admitted to the hosp. completed
5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1420492-1"
"1420492-1" "Patient hospitalized after testing positive for COVID-19.
Patient died. Patient was fully vaccinated." "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1421893-1"
"1421893-1" "Vaccination failure; acute respiratory distress syndrome with
comatose state; 20May2021, positive Covid-19 PCR test, presence of a variant.; This
is a spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB regulatory authority number FR-AFSSAPS-NY20211436, Safety Report
Unique Identifier FR-AFSSAPS-2021064802. A 95-year-old female patient received
second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot
number: EJ6789) via intramuscular route of administration on 16Feb2021 as single
dose for COVID-19 immunisation. The patient received first dose of BNT162B2
(COMIRNATY, formulation: solution for injection, batch/lot number: EJ6788) via
intramuscular route of administration on 26Jan2021 as single for COVID-19
immunisation. The patient's medical history included ongoing hypertension,
atrioventricular block (with pace-maker), ongoing hypertrophic heart disease, fall
with a fracture on a prosthesis, and on 22FEb2021 fracture surgery (favorable
operative consequences). Concomitant medication included candesartan cilexetil
(CANDESARTAN CILEXETIL) taken for an unspecified indication, start and stop date
were not reported, tramadol hydrochloride (TRAMADOL HYDROCHLORIDE) taken for pain
from 20May2021 to an unspecified stop date, mianserin hydrochloride (MIANSERIN
HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not
reported, pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start
and stop date were not reported; potassium chloride (DIFFU K) taken for an
unspecified indication, start and stop date were not reported; acetylsalicylate
lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not
reported; heparin calcium (HEPARIN CALCIUM) taken for an unspecified indication
from 20May2021 to an unspecified stop date, paracetamol (DOLIPRANE) taken for an
unspecified indication, start and stop date were not reported, risperidone
(RISPERDAL) taken for an unspecified indication, start and stop date were not
reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and
stop date were not reported. It was reported as, vaccination failure with acute
respiratory distress syndrome in a 95 years old patient, 3 months after vaccination
with 2 doses of COMIRNATY (26Jan2021 lot EJ6788, 16Feb2021 lot EJ6789) during
hospitalization after a fall with a fracture on a prosthesis (which had a
favourable outcome) leading to the patient's death. The patient's clinical
condition was satisfactory for her age (still walking). On 20May2021, the patient
presented with hoarseness of the voice. 1 hour later, she fell. Transported to the
emergency room, diagnosis of fracture on prosthesis and evidence of a COVID-19
infection, asymptomatic. 20May2021, positive COVID-19 PCR test, presence of the
British variant. On 25May2021, in the afternoon, sudden onset of a severe 70%
desaturation requiring the establishment of oxygen therapy. Diagnosis of acute
respiratory distress syndrome with comatose state leading to death around midnight.
The patient underwent lab tests and procedures which included oxygen saturation: 70
% on 25May2021 requiring the establishment of oxygen therapy, SARS-COV-2 test:
positive on 20May2021 with presence of a variant. Treatment added during
hospitalization: heparin calcium, tramadol 50 mg (1.0.1). Reduction of the dosage
of furosemide to 40 mg/day. The patient died on 25May2021. The death was due to
acute respiratory distress syndrome with comatose state. It was not reported if an
autopsy was performed. Event vaccination failure was reported with outcome event
stop date as 25May2021. No follow-up attempts are needed. No further information
was expected.; Reported Cause(s) of Death: acute respiratory distress syndrome with
comatose state" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1421895-1"
"1421895-1" "Vaccination failure; COVID-19 respiratory infection; Acute
respiratory decompensation; Fever; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority. A 87-years-old female patient
received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number:
EP2166) via intramuscular route of administration on 03Mar2021 as single dose and
second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EW2239) via
intramuscular route of administration on 09Apr2021 as 0.3 ML single dose both for
covid-19 immunization (both at the age of 87 years). The patient medical history
and concomitant medications were not reported. On 24Apr2021, the patient had
respiratory decompensation accompanied by fever. In this context, patient was
transferred to the hospital. An anti SARS-COV2 PCR test was carried out and came
back positive. In total, vaccination failure demonstrated by a respiratory
infection with COVID-19 characterized by respiratory decompensation, which occurred
on Day + 16 of a second vaccination with COMIRNATY and evolution to death. The
clinical outcome of all the events was fatal and the patient died on 07May2021. All
the events were considered as the cause of death. It was not reported if an autopsy
was performed. Reporter's Comments: Reaction(s) Events Assessed All AEs Comitnaty.
Time Interval between Beginning of Drug Administration and Start of Reaction Event
16 Days. Time Interval between Last Dose of Drug and Start of Reaction Event
16Days. Did reaction recur on re-administration YES - UNK rechallenge was done,
outcome unknown. No follow-up attempts are possible. No further information
expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 respiratory
infection; Acute respiratory decompensation; Fever" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1423092-1"
"1423092-1" "ischemic stroke; infection; progressive weakness; poor appetite;
hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count;
mild elevated liver enzymes and WBC count; SOB; possible lung infection; some
lesions on her liver; a small mass in her lung,which they said were suspicious for
cancer; a small mass in her lung,which they said were suspicious for cancer; This
is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female
patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular
on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation.
Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II
diabetes mellitus (DM2). Concomitant medications included regular prescribed
medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four
weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post
vaccination in May2021 was negative. The patient had no acute issues prior to her
1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and
poor appetite to the point of hardly being able to walk. The patient saw her
primary doctor who ran some blood work and noticed she was dehydrated with mild
elevated liver enzymes and WBC count. The patient was admitted to the hospital (for
21 days) for IV fluids and was on oral antibiotics. The patient started having some
SOB and scans done indicated possible lung infection. The patient was switched to
IV meropenem which did not help. The doctors also noted some lesions on her liver
and a small mass in her lung (no biopsy was done cause she declined) which they
said were suspicious for cancer. The patient then suffered a large ischemic stroke
and she passed about a week later. The patient was feeling well before her vaccine
and everything started to go downhill after her vaccine. AEs result in Doctor or
other healthcare professional office/clinic visit and Emergency room/department or
urgent care. The patient underwent covid test: negative in May2021. The outcome of
events weakness, decreased appetite, unable to walk, dehydration, elevated liver
enzymes, white blood cell count increased, short of breath, lung infection, hepatic
lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due
to ischemic stroke and infection. An autopsy was not performed. No follow-up
attempts are possible; information about lot/batch number cannot be obtained.;
Sender's Comments: Based on the available information and known product profile,
the causal relationship between the reported suspicion on malignancy and BNT162B2
use is unrelated while the causal relationship between the remaining events and
the use of BNT162B2 cannot be fully excluded. There is limited information
available which precludes a more meaningful assessment. However, the underlying
conditions and the age of the patient maybe risk factors. The impact of this
report on the benefit/risk profile of the Pfizer drug is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate;
Reported Cause(s) of Death: ischemic stroke; infection" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1423438-1"
"1423438-1" ""PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids,
hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to
ED after her caregiver found her in bed in AM w/a ""dark substance in her bed"" and
minimally responsive. On admission vomiting x1, no cough, no SOB, abnormal CXR,
covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid
decline.Pt w/ shallow breathing, guarded prognosis.In the morning on May 1, 2021
around 830 in the morning patient found to be without any pulse or breathing. DNR
DNI with pupils fixed and dilated without any spontaneous breathing. No pulse
palpated.pronounced dead at 8:30 a.m."" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1423845-1"
"1423845-1" "Death 3/25/2021 Causes of death listed on patient's death
certificate: 1) COVID-19 Infection, 2) Acute Hypoxic Respiratory Failure, 3) Acute
on Chronic Deconditioning" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1424049-1"
"1424049-1" "Death 3/30/2021 Causes of death listed on death certificate: 1)
Respiratory distress 2) ITP 3) COVID 19 4) Dementia Other: acute
cardiopulmonary failure" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1425840-1"
"1425840-1" "Died 5/11/2021 Causes of death listed on death certificate: 1)
covid 2) chronic lymphocytic leukemia" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1426483-1"
"1426483-1" "Death 5/26/2021 Causes of death listed on death certificate: 1.
COVID 19 pneumonia 2. acute respiratory distress syndrome due to COVID 19 3.
Acute heart failure with reduced ejection fraction 4. aspergillus pneumonia 5.
history of prostate cancer, history hypertension" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1427004-1"
"1427004-1" "Died of COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1427073-1"
"1427073-1" "Death on 3/12/2021. Primary cause of death was COPD, with COVID-
19 listed as an underlying cause." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1428052-1"
"1428052-1" "cough, difficulty breathing, productive cough, 02 requirement,
weakness resulting in hospitalization and death. received treatment : Azithromycin
and Decadron 02/09/2021-02/19/2020" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1431548-1"
"1431548-1" "Patient died due to COVID-19 illness after being fully
vaccinated. no one believes the death to be related to the vaccine." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1431730-1"
"1431730-1" "Patient died due to COVID-19 illness after being fully
vaccinated. no one believes the death to be related to the vaccine." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433164-1"
"1433164-1" "Patient diagnosed with COVID on 6/6/21. Patient was fully
vaccinated. Patient admitted to our hospital with respiratory failure and COVID-19
pneumonia on 6/9/21. Patient was treated with oxygen, remdesivir, dexamethasone,
and antibiotics. His pneumonia progressed, oxygen requirements increased, and
chest xray showed worsening airspace opacities and decreased aeration. Patient's
code status was updated to DNR/DNI per family request. Patient's condition
continued to deteriorate and patient expired on 6/13/21." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433312-1"
"1433312-1" "Died of COVID-19 illness 05/14/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433345-1"
"1433345-1" "Died of COVID-19 Illness on 05/13/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433471-1"
"1433471-1" "Died of COVID-19 illness on 05/08/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433753-1"
"1433753-1" "dry cough, difficulty breathing, SOB, fatigue, pneumonia" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433813-1"
"1433813-1" "Death 5/12/2021 Causes of death listed on death certificate: 1)
Acute Myocardial Infarction 2) Acute Coronary Artery Thrombosis 3) COVID-19
Other: Acute Respiratory Failure" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1433899-1"
"1433899-1" "Died of COVID-19 illness on 02/26/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1434034-1"
"1434034-1" "Died of COVID-19 illness on 05/27/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1434041-1"
"1434041-1" "Died of COVID-19 illness on 05/25/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1434056-1"
"1434056-1" "Died of COVID-19 illness on 05/23/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1434271-1"
"1434271-1" "Died of COVID-19 illness on 06/02/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1437373-1"
"1437373-1" "Death 05/24/2021 Causes of death listed on death certificate:
1) COVID 2) ATRIAL FIB 3) CKD 3 4) Hypertension" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1437419-1"
"1437419-1" "Died of COVID-19 illness on 03/16/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1440303-1"
"1440303-1" "Severe ARDS to SARS-CoV-2 post vaccination; Severe ARDS to SARS-
CoV-2 post vaccination; Severe ARDS to SARS-CoV-2 post vaccination; This is a
spontaneous report received via medic, the regulatory authority. Regulatory
authority report number CH-SM-2021-15474. A contactable physician reported that an
84-years-old male patient received his second dose of BNT162B2 (COMIRNATY,
formulation: Solution for injection, Batch/Lot Number: EL8723), via an
intramuscular on 19Feb2021 (at the age of 84-years-old), as 1DF, single, dose 1,
via an intramuscular route of administration on 22Jan2021 (Lot Number: E0477) as
single for covid-19 immunisation. Medical history included Arterial hypertension,
ongoing urinary incontinence, Ex-smoker (5 per day and stopped 50 years ago). The
patient had no known allergies, not alcohol consumer, not hepatopathic. The patient
had no renal disease, no kidney disease, and no liver disease. Concomitant
medications included Olmesartan medoxomil (VOTUM [OLMESARTAN MEDOXOMIL]) taken for
Arterial hypertension, start and stop date were not reported; mirabegron (BETMIGA)
taken for overactive bladder, start and stop date were not reported; zolpidem
tartrate (ZOLDORM) taken for an unspecified indication, start and stop date were
not reported. On 16Apr2021, the patient experienced severe ARDS (Acute respiratory
distress syndrome) to sars-cov-2 post vaccination. On 23Apr2021, the patient was
NSIP (Nonspecific interstitial pneumonia) admitted because of hypoxemic respiratory
failure on COVID-19 whose symptomatology begins on 16Apr2021. The patient was
hospitalized for severe ARDS (Acute respiratory distress syndrome) to sars-cov-2
post vaccination on 23Apr2021. The patient underwent lab tests and procedures which
included, blood culture: negative on 23Apr2021. X-ray thorax (26Apr2021): Compared
to the X-ray of 23Apr2021, the poorly delineated, binasal infiltrates in the right
upper lobe are progressing, suggesting a progression of the pulmonary infectious
process with possible bacterial superinfection. Blunting of the left costo-
diaphragmatic sinus in relation to a possible pleural effusion. The rest is
superimposable with respect to the comparative. computerized tomogram thorax on
23Apr2021, showed absence of pulmonary embolism visualized up to segmental. Ground
glass infiltrates, subpleural reticulations and discrete bronchiectasis speaking
primarily for fibrotic involvement of NSIP pattern. However, the radiological
pattern may correspond to an infectious viral lung disease of the SARS-Cov-2 type.
Thoracic angio-CT 23Apr2021, X-ray of Acute respiratory distress syndrome, DVT of
the muscular Bedside echocardiography on 30Apr2021, did not show indirect signs of
pulmonary hypertension suggestive of pulmonary embolism with cardiac repercussion.
The antilogical assessment on 30Apr2021 of the lower limbs shows a DVT (Deep vein
thrombosis) of muscular veins of the right and left calves, indicating
anticoagulation for 3 months. Legionella infection was negative on 26Apr2021.
Pneumonia pneumococcal was negative. Echocardiogram on 30Apr2021 LVEF 55 percent,
no dilatation of the right chambers, no LV dysfunction, no indirect signs of PH
(PAPs estimated at 35mmHg), IVC collapsed on inspiration and fibrin d dimer: 26793
ng/ml. A treatment with Ceftriaxone from 26Apr2021 (dosage regimen unknown) and
Dexamethasone from 25Apr2021, (dosage regimen unknown) is instituted. Due to an
increase in oxygen requirements, the patient was transferred to the Intensive Care
Unit at the hospital in the context of ARDS (Acute respiratory distress syndrome)
on COVID-19 for further management on 29Apr2021. On admission, the patient was in
respiratory distress and required high flow oxygen therapy and intermittent non-
invasive ventilation. Antibiotic therapy was replaced by piperacillin - tazobactam
from 30Apr2021 (dosage regimen unknown). Therapeutic anticoagulation (type of drug,
posology, dosage unknown) was empirically introduced in view of very increased D-
dimer 26793 ng/ml, making suspect a venous thromboembolic disease. A positivity for
SARS-CoV-2 IgG antibodies with positivity threshold of greater than 33.8 BAU/ml was
identified at the laboratory: 100.4 BAU/ml (30Apr2021) and 345.8 BAU/ml
(04May2021). Virus variants were not researched by the infectiologists. The patient
died on 05May2021 following the rapid deterioration of respiratory failure. It was
not reported if an autopsy was performed. The outcome of all the events was fatal.
A causal relationship between Comirnaty and COVID-19 respiratory infection and Deep
vein thrombosis was assessed as being unlikely. A causal relationship between
Comirnaty and Vaccination failure was assessed as being certain. Medic assessed
this case as serious with fatal outcome. Sender comment (Medic): Pulmonary
infection with Covid-19 ARDS (Acute respiratory distress syndrome) with admission
to intensive care and subsequent death, deep vein thrombosis, in an 84-year-old
patient in good general health except for an arterial hypertension and urinary
incontinence who had received both doses of Comirnaty (22Jan201, 19Feb2021). In
the Comirnaty monograph, it is reported that the duration of protection offered by
the vaccine was unknown, as it was still being determined in ongoing clinical
trials, and, as with any vaccine, vaccination with Comirnaty may not protect all
recipients. In particular, it is reported that subjects may not be fully protected
until 7 days after the second dose of the vaccine. In the case of this patient who
finished his vaccination cycle on 19Feb2021 and develops the first symptoms of
Covid-19 disease confirmed at the laboratory on 16Apr2021 we judge the
ineffectiveness of the vaccine as certain. In order to increase the knowledge of
the case it would have been interesting to determine the variant of the virus but
the infectivologists involved did not consider necessary this additional analysis.
Pulmonary infection with Covid-19 ARDS (Acute respiratory distress syndrome) that
led to the death of the patient, this is not a side effect noted for Comirnaty. We
therefore enter the causal role of the vaccine in Covid-19 infection as unlikely.
Finally, with regard to the deep vein thrombosis manifested by the patient, they
are not currently counted among the possible adverse events to Comirnaty either in
the monograph or in the international literature. The literature reports a first
case report of deep vein thrombosis diagnosed a few days after the second dose of
Comirnaty in a 66-year-old woman. The authors hypothesize: the intense
immunological response evoked by the second dose of vaccine could be a trigger for
the thrombotic event described, a mechanism recognized in many clinical conditions
(1). However, given the long temporal latency between vaccination and DVT, the
other possible concomitant causes most likely Covid-19 disease, immobilization for
hospitalization, we consider the causal role of the vaccine in the DVT presented by
the patient as unlikely. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Severe ARDS to SARS-CoV-2
post vaccination; rapid deterioration of respiratory failure; Severe ARDS to SARS-
CoV-2 post vaccination" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1440746-1"
"1440746-1" "Pneumonia, SOB, and Fatigue" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1446875-1"
"1446875-1" "Patient is an 83 year old male admitted with COVID respiratory
failure who has end stage COPD. His condition declined throughout hospitalization
and expired 7/2/2021." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454063-1"
"1454063-1" "I am the epidemiologist reporting on behalf of patient. Patient
received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to
hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and
tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21.
Cause of death is listed as sepsis. Death cert # 20210042573." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454278-1"
"1454278-1" "Breakthrough death resulted from COVID." "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454364-1"
"1454364-1" "~5 months following vaccination, COVID-19 infection: Abnormal
CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient
died as result of illness 4 days after admittance to hospital from nursing home."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454753-1"
"1454753-1" "Pt had long complicated course spanning almost a month. He was
initially admitted for right intertrochanteric hip fracture (following a fall at
home) for which he required surgery. Also had bacterial pneumonia and received
Zosyn. He was close to discharge at 1 point but then had Covid testing done which
came back positive. He gradually worsened from there with acute hypoxic
respiratory failure and very poor oral intake. He had multiple episode of
hypoglycemia and required D5. He was made care only but improved on his own and was
back on medical Mx. It did not last long and he again became very tachypnic in 60s
and hypoglycemic. He was made care again. Pt passed away peacefully with his
daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1. Cardiopulmonary
arrest due to reason #2 2. Failure to thrive due to reason #3 3. Old age and COVID-
19 No autopsy performed." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454812-1"
"1454812-1" "Patient admitted to the hospital with shortness of breath and
cough after being diagnosed with pneumonia in the clinic. He was found to have
Covid pneumonia and was treated with maximal support but unfortunately became
profoundly delirious and developed worsening hypoxia associated with Covid
pneumonia. Family was called to the bedside due to progression in his illness
and concerns for cardiac dysrhythmias occurring in the setting of worsening
hypoxia on maximal support. Decision was made to transition to comfort care and
aggressive life-prolonging interventions were discontinued for primary focus on
comfort. Patient subsequently expired at 1810 on 04/18/2021. Patient
was vaccinated against COVID 19. Death Certificate Information: Part 1: Cause of
Death: A. COVID B. SARS COVID 19 Part 2: Other Significant Conditions: Diabetes
Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1454861-1"
"1454861-1" "Patient admitted to hospital on 03/24/2021 for high fever and
shortness of breath; these symptoms began in 3/17. Patient tested positive for
COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully vaccinated
against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the death
certificate. Death Certificate Information: Part I Cause of Death: A. Acute
Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II: Significant
Other Conditions: COVID 19 subacutely" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1457207-1"
"1457207-1" "Patient was fully vaccinated. Doses on 1/14/21 and 2/4/21.
Diagnosed with COVID-19 on 6/21/2021 and passed away on 7/3/2021." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459398-1"
"1459398-1" "Died of COVID-19 illness on 05/05/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459403-1"
"1459403-1" "Died of COVID-19 illness on 04/11/2021" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459409-1"
"1459409-1" "Died of COVID-19 on 05/26/2021 Symptoms: Dyspnea (shortness of
breath), Fatigue" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459444-1"
"1459444-1" "Died of COVID-19 illness on 06/02/2021 Symptoms: low oxygen
levels" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459461-1"
"1459461-1" "From EMR: Immediate cause of death: acute hypoxemic respiratory
failure (2 days from onset to death) Secondary conditions leading to death:
pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present
at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism
Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19
PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of COVID-19
illness on 06/13/2021" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "80+ years" "80+" "1459478-1"
"1459478-1" "Died of COVID-19 illness on 06/14/2021 Immediate Cause of
Death: Acute respiratory distress syndrome with respiratory failure Due To or as a
Consequence Of: COVID-19 infection Interval between Onset & Death: 4 days COD
listed as ACUTE RESPIRATORY DISTRESS SYNDROME WITH RESPIRATORY FAILURE INTERVAL
BETWEEN ONSET & DEATH and COVID-19 INFECTION INTERVAL BETWEEN ONSET & DEATH" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0934966-1"
"0934966-1" "COVID-19; COVID-19; Pneumonia; respiratory failure; This is a
spontaneous report from a contactable consumer. An 80-year-old female patient
received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an
unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical
history included Alzheimer's and others. No known allergies. Concomitant
medications included unspecified medications. The reporter's mother in law was
tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On
02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she
developed a high fever, needed oxygen and was positive for COVID-19. Date of death
was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure
and COVID-19. No autopsy performed. No treatment received. No one knew if the
vaccination contributed to her death. It was hard to know if her death was due to
the administration of the vaccine or it exacerbated the COVID19 symptoms which led
to her death. Since this was unknown, it could have been a possibility. The
reporter wanted to give us this information because we might want to consider
having high risk population, patients with underlying conditions, older population
tested for COVID-19 prior to the vaccination, as this is not currently a
recommendation or a requirement. All is very new and they are all learning so the
reporter wanted to share this information with us. The patient did not receive any
other vaccines within 4 weeks prior to the COVID vaccine. There are medications the
patient received within 2 weeks of vaccination. Prior to vaccination, the patient
was not diagnosed with COVID-19. Since the vaccination, the patient has been tested
for COVID-19. The outcome of the events was fatal. Information about Lot/Batch
has been requested.; Sender's Comments: The association between the fatal event
lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not
be fully excluded. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia,
respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19;
Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and
COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0961901-1"
"0961901-1" "sick with Covid 19 and died after the vaccination. Covid
positive after the first vaccination; sick with Covid 19 and died after the
vaccination. Covid positive after the first vaccination; This is a spontaneous
report from a contactable physician, based on information received by Pfizer from
Biontech (manufacturer control number: not provided), license party for BNT162B2.
The physician reported similar events for 2 patients. This is the case for the
first of 2 patients. An elderly patient of an unspecified gender received the first
dose of BNT162b2 (COMIRNATY,Lot/Batch Number and Expiration Date unknown), via an
unspecified route of administration on 06Jan2021 at 1 dose form (DF) single dose
for covid-19 prophylaxis. The patient's medical history and concomitant medications
were not reported. It was reported that the physician was a vaccinator of a
vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3
elderly residents in a nursing home with the vaccine Corminaty. It turned out that
2 of the elderly residents were sick with Covid 19 and died after the vaccination
in Jan2021. Covid tested positive after the first vaccination in Jan2021. This
patient was vaccinated on 06Jan2021. It was not reported if an autopsy was
performed. Information on the lot/batch number has been requested.; Sender's
Comments: Based on the information available, a possible contributory role of the
suspect products cannot be excluded for the reported event of positive for corona
virus infection for the lack of efficacy of the vaccine. However, based on the
mechanism of action of the vaccine, it is unlikely the patient would have fully
developed immunity for the vaccine to be effective, due to the number of days
passed since the vaccine is given. Case will be reevaluated based on follow-up
information,Linked Report(s) : DE-PFIZER INC-2021043240 same Reporter, same events,
different patient; Reported Cause(s) of Death: Covid-19; Covid-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0990314-1"
"0990314-1" "Death; positive Covid-19 virus test after vaccination; positive
Covid-19 virus test after vaccination; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority (SE-MPA-2021-000325
& SE-MPA-1610531706795). An 84-year-old female patient received bnt162b2
(COMIRNATY; Lot number: EL 1484), intramuscularly in Jan2021 at a single dose for
COVID-19 immunization. Medical history included atrial fibrillation, Celiac
disease, ejection fraction low (35%), type II diabetes mellitus, hypothyroidism,
heart failure, COVID-19. Concomitant medication included atorvastatin
(MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021, cefuroxime (FURIX), taken
from 01Jan2017 to Jan2021, oxazepam (SOBRIL), taken from 01Jan2017 to Jan2021,
metoprolol (MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021, levothyroxine
sodium (LEVAXIN), taken from 01Jan2013 to Jan2021, warfarin sodium (WARAN), taken
from 01Jan2011 to Jan2021 and ramipril (MANUFACTURER UNKNOWN) taken from 01Jan2013
to Jan2021. The patient had a positive Covid-19 virus test after vaccination and
experienced death in Jan2021. The patient had no infection symptoms but tiredness
days before vaccination. The patient was found dead, the day after vaccination with
a suspected cerebro/cardiovascular event. The patient underwent lab tests and
procedures which included COVID-19 virus test: positive in Jan2021. The outcome of
positive Covid-19 virus test after vaccination was unknown. The patient died in
Jan2021. It was not reported if an autopsy was performed. According to
rapporteur, patient is not autopsied. Cerebro/cardiovascular event is only a
suspicion based on patients medical history. No follow-up attempts are possible.
No further information is expected.; Reported Cause(s) of Death: Unknown cause of
death" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0993422-1"
"0993422-1" "SARS-CoV-2 infection; SARS-CoV-2 infection; Immune imbalance;
Shortness of breath; This is a spontaneous report received from a contactable
physician by Pfizer from the Medicines and Healthcare products Regulatory Agency
(MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-
202101241753594380, Safety Report Unique Identifier GB-MHRA-ADR 24639286. A 65-
years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot
EJ688), via an unspecified route of administration on 05Jan2021 at single dose for
covid-19 immunisation. Medical history included ongoing endometrial cancer (Figo
stage 3c1), uterine cancer (not ongoing), renal cancer (not ongoing) treated 2006,
ongoing type 2 diabetes mellitus (longstanding), obesity (unknown if ongoing),
chronic kidney (unknown if ongoing), cataract (unknown if ongoing), nephrolithiasis
(recurrent, unknown if ongoing) and ankylosing spondylitis (unknown if ongoing).
Patient was not enrolled in clinical trial. Concomitant medications were not
reported. The patient previously received influenza vaccine (split virion,
inactivated) on 01Oct2020 and pneumococcal vaccine polysacch on 03Dec2020 bot for
immunization. The patient experienced sars-cov-2 infection, immune imbalance and
shortness of breath on 06Jan2021. The patient was admitted to hospital on 06Jan2021
and died on 07Jan2021 due to SARS-CoV-2 infection. It was unsure if patient has had
symptoms associated with COVID-19. The patient underwent lab tests and procedures
which included blood test, culture and chest x-ray on unknown date with unknown
results. The patient ad and inconclusive COVID-19 virus test on 06Jan2021. It was
not reported if an autopsy was performed. All the events were considered serious as
important medical events and hospitalization. Only sars-cov-2 infection had a fatal
outcome. No follow up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: SARS-CoV-2 infection" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0994885-1"
"0994885-1" "Yes- Positive COVID-19 test; Yes- Positive COVID-19 test; Death;
sore arm; This is a spontaneous report from a contactable physician. This is a
report received from the Regulatory Authority. The Regulatory authority report
number is GB-MHRA-WEBCOVID-202101222143440710, Safety Report Unique Identifier GB-
MHRA-ADR 24635342. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-
19 VACCINE, solution for injection, lot number:EK4243, expiry date unspecified),
via an unspecified route of administration on 19Jan2021 at a single dose for COVID-
19 immunisation. Medical history included suspected covid-19 (unsure when symptoms
started, unsure when symptoms stopped), cardiac LBBB (left bundle branch block),
dilated left ventricle, dilated atrium, dyskinesia septum, 2nd degree heart block,
and left ventricular hypertrophy. Patient was not enrolled in clinical trial.
Concomitant medication included ramipril on unspecified date for left ventricular
hypertrophy. In the evening of 19Jan2021, the patient volunteered and received the
vaccine. Sore arm reported only afterwards on unspecified date in Jan2021. On
20Jan2021, the patient was found dead in bed (death). The patient underwent lab
test which included COVID-19 virus test: Yes- positive COVID-19 test on unspecified
date. Cause of death was unknown. It was unknown if an autopsy was performed. No
follow-up activities are possible. No further information is expected.; Reported
Cause(s) of Death: death" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0994886-1"
"0994886-1" "Unconscious; positive COVID-19 virus test; SARS-CoV-2 infection;
This is a spontaneous report received from a contactable healthcare professional
from the regulatory authority. The regulatory authority report number is GB-MHRA-
WEBCOVID-202101241937221860 and GB-MHRA-ADR 24639419. A 90-year-old male patient
received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route
of administration, on 06Jan2021 at a single dose for COVID-19 vaccination. Medical
history included dementia Alzheimer's type and cardiac failure congestive (CCF).
The patient did not have symptoms associated with COVID-19. The patient was not
enrolled in a clinical trial. The patient's concomitant medications were not
reported. The patient experienced SARS-CoV-2 infection on 06Jan2021, which was
reported as fatal. The patient experienced positive COVID-19 virus test on
06Jan2021 and unconscious on 07Jan2021. The patient underwent lab tests and
procedures which included COVID-19 virus test: yes - positive COVID-19 test on
06Jan2021. The clinical outcome of positive COVID-19 virus test and SARS-CoV-2
infection was fatal and of unconscious was not recovered. The patient died on
09Jan2021. The cause of death was reported as SARS-CoV-2 infection. It was not
reported if an autopsy was performed. No follow up attempts are possible;
information about batch number cannot be obtained.; Reported Cause(s) of Death:
SARS-CoV-2 infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "0996674-1"
"0996674-1" "SARS-CoV-2 infection; SARS-CoV-2 infection; High temperature;
Dysstasia; Skin discolouration; Tremor; Feeling abnormal; This is a spontaneous
report received from a contactable consumer. This is a report received from the
Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-
202101241732075000, Safety Report Unique Identifier GB-MHRA-ADR 24639306. An 86-
year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-
19 VACCINE), Lot EJ05536450, via an unspecified route of administration on
07Jan2021 at single dose for covid-19 immunisation. The patient previously
received the firs dose of BNT162B2 on unspecified date with no adverse events.
Medical history included non-tobacco user (Never smoked), dementia with Lewy
bodies. The patient's concomitant medications were not reported. No physical
illnesses. Unsure if patient has had symptoms associated with COVID-19. Patient was
not enrolled in clinical trial. On 08Jan2021 the patient experienced high
temperature, dysstasia, skin discolouration, tremor, feeling abnormal: the patient
could not stand up from his bed, he was grey in skin colour, shaking and he said he
felt terrible. The patient did not go to hospital and was stabilized with oxygen
mask. The events were non serious with outcome of not recovered. On 08Jan2021 the
patient experienced SARS-CoV-2 infection. The patient underwent lab tests and
procedures which included COVID-19 virus test: yes - positive covid-19 test on
20Jan2021. The event SARS-CoV-2 infection was fatal, and the patient died for SARS-
CoV-2 infection on 20Jan2021 at 7.05am. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: SARS-CoV-2 infection" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1000275-1"
"1000275-1" ""Death unexplained/massive pulmonary embolism in the context of
neoplastic COVID +; Massive stroke related to intracardiac thrombus; massive
pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed:
positive/CT scan compatible with covid 19 infection; massive pulmonary embolism in
the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan
compatible with covid 19 infection; This is a spontaneous report from a contactable
physician downloaded from the Medicines Agency (MA) -WEB, FR-AFSSAPS-DJ20210104. A
75-year-old female patient received bnt162b2 (COMIRNATY, lot number: EM0477), via
intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history
included stage IIIB colon adenocarcinoma- (pT3N1aM0) from Aug2020 and unknown if it
was ongoing with rectosigmoid resection on 27Aug2020 and ileostomy closure on
09Oct2020. HTA (arterial hypertension), ACFA (complete arrhythmia by atrial
fibrillation), Non-insulin-dependant diabetes, Dyslipidemia, Obstructive
pyelonephritis in renal colic, Hypothyroidism, right acoustic neuroma (operated on
in 2014 with sequelae facial palsy), and all unknown if they were ongoing and
notion of allergy to iodine. The patient followed in particular for an
adenocarcinoma of the colon treated with simplified LV5FU2 (cisplatin, 5-
fluorouracil, leucovorin) as an adjuvant with a 4th treatment carried out in a day
hospital on 14Dec2020. The patient is non-DPD deficient. The patient lives at home
with her husband, a household helper, a nurse who comes several times a week.
Autonomous for toilet and meals. The report of the day hospitalization of 14Dec2020
mentioned: INTERCURE: G1 asthenia throughout the intercure, improvement in BP,
better general condition. CLINICAL REVIEW: WHO 1-2, BP 117/70 mmHg, HR 102 bpm,
afebrile, 97% AA saturation. Weight 62 kg stable. Normal clinical examination. She
received her cure of LV5FU2. She was hospitalized on 17Dec2020 for a stroke in the
territory of the right posterior cerebral artery, with thrombus in P1, not
revascularized (fall from her bed at 6 a.m., her husband noting a left
hemicorporeal deficit and dysarthria). An MRI is immediately performed which
reveals an ischemic stroke of the posterior arm of the right internal capsule and
of the diffusing right internal and occipital temporal cortex. On the TOF, we find
an occlusion of the posterior cerebral artery from the beginning and an occlusion
of the right internal carotid artery with slow cerebral artery and permeable middle
cerebral artery. EDTSA carried out on 18Dec2020: ""The echo-Doppler anomalies
presented can be compatible either: with an obliteration of the right internal
carotid artery downstream of the portion visualized by echo-Doppler (which is
difficult to assert because on indirect arguments), if this is the case, it looks
old since ''with good replacement of the cerebral arteries via the anterior
communicating artery or with a stenosis of the right siphon without occlusion of
the internal carotid artery explaining the velocities preserved in right MCA"".
Cerebral MRI of 21Dec2020: Ischemic stroke made up of the right posterior
superficial Sylvian territory and the superficial and deep territories of the right
posterior cerebral artery. Recanalization of the right internal carotid artery and
the right posterior cerebral artery of fetal origin. During the stay, she improved
neurologically, with partial regression of motor impairment, total regression of
visual impairment and dysarthria. Upon discharge, she presented a NIHSS score of 2,
with a slight drop in her left upper limb before 10 seconds, and sensitive
extinction. There persist ataxia of the lower limbs and facial paralysis which were
sequelae respectively of an old cerebellar lesion and a neuroma. The patient is
anticoagulated by LMWH tinzaparin sodium (INNOHEP), due to the occurrence of a
stroke under ELIQUIS, her known AF, and the neoplastic context. INNOHEP will be
continued in the long term. She was leaving for her home on 24Dec2020. Patient
finally admitted to Follow-up and Rehabilitation Care on 30Dec2020. Decision with
the patient not to resume adjuvant chemotherapy given the loss of autonomy and an
unfavorable benefit-risk balance. Similarly contraindication to any colonoscopy.
Exploration of an adrenal adenoma accidentally discovered on the control hepatic
MRI. Hypercalcemia on 31Dec2020 prompting the administration of Pamidronate. On
12Jan2021: Positive orthostatic hypotension test. Concomitant medications included
oxazepam (SERESTA) from Dec2020, atorvastatin calcium (ATORVASTATINE ARROW),
tinzaparin sodium (INNOHEP) from 22Dec2020 for Atrial fibrillation, enalapril
maleate (ENALAPRIL EG), calcium phosphate monobasic, magnesium glycerophosphate,
phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS) from 19Jan2021,
bisoprolol fumarate (BISOPROLOL SANDOZ), pantoprazole sodium sesquihydrate
(PANTOPRAZOLE MYLAN) from Dec2020, dexamethasone from 19Jan2021, sitagliptin
(JANUVIA), amoxicillin, clavulanate potassium (AUGMENTIN) from 19Jan2021,
cinacalcet hydrochloride (MIMPARA) from 12Jan2021, apixaban (ELIQUIS), enalapril
maleate, lercanidipine hydrochloride (LERCAPRESS), esomeprazole, macrogol 3350,
potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), alprazolam.
Notification from a hospital specialist concerning this patient who died as a
result of vaccination with COMIRNATY. Vaccination by COMIRNATY on 14Jan2021 with
good immediate tolerance. The same day realization of a transthoracic ultrasound
which was programmed: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP
11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m� and right atrium
21 cm�. No increase in left ventricle filling pressures. Central minimal mitral
insuffisiency. Tricuspid aortic valve, mean gradient 2 mmHg. Moderately impaired RV
function, no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free
pericardium. Transesophageal echocardiography: Left auricle not free with impaired
emptying rate, no thrombus directly visualized but significant spontaneous
contrast. Bubble test: No patent foramen ovale found. On 15Jan2021: Well
clinically. No headache, no cough, no transit disorder following the Covid
vaccination. Good constants, afebrile. On 16Jan2021: Appearance of a cough. She was
reviewed in hospitalization oncology day on 18Jan2021 for reassessment. CLINICAL
EXAMINATION: WHO 3 with above all significant loss of autonomy. Consciousness
normal, higher functions a little slowed down and tendency to drowsiness. BP 106/67
mmHg, HR 89 bpm, afebrile, 97% AA saturation. Weight 60 kg (-2 kg). Staggering walk
with loss of balance, must hold on to furniture. On 18Jan2021: No fever, no
diarrhea, no other symptom found apart from the cough. Covid19 PCR performed:
positive. On 19Jan2021: blood pressure 140/70 mmHg, pulse 60 / min, respiratory
level: FR at 15 / min, Rhinorrhea, expectorating cough, no dyspnea, no chest pain,
no anosmia or ageusia, asthenia, no headache auscultation with clear reduction of
MV on the left base, elimination of vibrations and dullness therefore: possible
pleural effusion. At the cardio level: no palpitation, no sign of HF, or sign of
DVT, regular auscultation without noticeable breath. At the digestive level: no
diarrhea, no nausea or vomiting, no abdominal pain, palpation within the standards.
Note that the patient does not want to go to intensive care in the event of
deterioration, she does not want intubation. At the end of the morning, episode of
loss of contact with return to full consciousness for several minutes, it is
possible that she was suffering from epilepsy after his stroke with lowering of the
epileptogenic threshold on COVID / fever. No brain imaging. On the other hand, in
view of the saturation: initiation of dexamethasone and AUGMENTIN + realization of
an emergency chest scanner today (on 19Jan2021). CT scan compatible with covid 19
infection (minimal degree of involvement <10%). On 20Jan2021 at 11:30 am the
consultation word mentions: better today, FR at 22 / min, no anosmia or ageusia, no
diarrhea, no dyspnea, no chest pain, no sign of cardiac insufficiency no sign of
DVT or VTE. Auscultation with the same anomalies as yesterday (clear drop in MV in
left base) therefore monitoring. The same day on 20Jan2021, call from a licensed
nurse around 2:35 p.m. for a patient found on the ground, not reactive. Arrival of
the doctor in the room: patient in a state of clinical death, facial cyanosis, no
pulse, no breathing, no heart rate. Total asystole. Time of death recorded 14:45.
Most likely in no flow for 15 minutes. Patient who had refused resuscitation care
yesterday in the event of degradation (refusal of CPR and intubation) so in this
context no resuscitation procedure started. Opinion of the doctor in charge of the
patient since entry into Follow-up and Rehabilitation Care: presence of an
intracardiac thrombus with great certainty according to cardiologists. Possible
cause of death: massive pulmonary embolism in the context of neoplastic COVID +,
Massive stroke related to intracardiac thrombus. Exclusive role of COVID (see
respiratory distress) very unlikely because no major respiratory damage in this
patient, correct respiratory rate and saturation. AF was fairly stable (no recent
ECG either). Unexplained death notified because the participatory role of the
vaccine cannot be completely excluded. The patient died on 20Jan2021. An autopsy
was not performed. No follow-up attempts are possible, no information is
expected.; Reported Cause(s) of Death: massive pulmonary embolism in the context of
neoplastic COVID +; Massive stroke related to intracardiac thrombus; Massive stroke
related to intracardiac thrombus; massive pulmonary embolism in
the context of neoplastic COVID +; massive pulmonary embo"" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1000375-1"
"1000375-1" "COVID-19 pneumonia/sars-cov-2 infection/dyspnoea, cough and
pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough; Dyspnoea; This
is a spontaneous report received from a contactable physician by Pfizer from the
products Regulatory Agency. The regulatory authority report number is GB-MHRA-
WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR 24651485.
A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,
lot# EK1768), via an unspecified route of administration on 15Jan2021 at single
dose for COVID-19 immunization. Medical history included cardiac pacemaker
insertion, hypertension, chronic lymphocytic leukaemia, atrial fibrillation, type 2
diabetes mellitus, angina pectoris, prostate cancer, deep vein thrombosis, cardiac
failure. Concomitant medication included allopurinol, atorvastatin, hydralazine,
lansoprazol, isosorbide mononitrate (MONOMIL XL), rivaroxaban for atrial
fibrillation. On 17Jan2021, patient was admitted with shortness of breath/
dyspnoea, cough and pyrexia, he was suspected covid-19 then confirmed having sars-
cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included
COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the
virus at the time of vaccination. He said he didn't have any temperature at the
time of the vaccination. Outcome of event covid-19 pneumonia was fatal, sars-cov-2
infection was not recovered, and the events pyrexia, cough, dyspnoea was unknown.
The patient died on 21Jan2021. It was not reported if an autopsy was performed. The
cause of death was covid-19 pneumonia/drug ineffective. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: COVID-19
pneumonia; COVID-19 pneumonia" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1010240-1"
"1010240-1" "COVID-19 pneumonitis; fever 39 Celsius degree; Atrioventricular
block third degree; Oxygen saturation decreased; drug ineffective; Radiographic
Image of Covid Pneumonitis + Positive PCR Test; This is a spontaneous report from a
contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory
Authority-WEB BE-FAMHP-DHH-N2021-75795. An 84-year-old male patient received
bnt162b2 (COMIRNATY), via unknown route of administration on 11Jan2021 at single
dose for covid-19 immunisation. Medical history was not reported. Concomitant
medications were not reported. The patient experienced drug ineffective and covid-
19 on an unspecified date with outcome of unknown, oxygen saturation decreased on
13Jan2021, covid-19 pneumonitis on 13Jan2021, fever on 13Jan2021, atrioventricular
block third degree on 13Jan2021. On 13Jan2021 symptom onset. On 15Jan2021 admission
with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV
block. The patient died on 19Jan2021. The outcome of the other events was
fatal.Treatment was unknown. The patient underwent lab tests and procedures which
included blood lactate dehydrogenase: unknown results, c-reactive protein: unknown
results, serum ferritin: unknown results on unknown date and Radiographic Image of
Covid Pneumonitis + Positive PCR Test. It was not reported if an autopsy was
performed. Reporter's comment: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1
admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd
degree AV block. Treatment -Unknown. Evolution of the ADR - Died. Examinations -
Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid
Pneumonitis + Positive PCR Test. Event assessment: FAMHP/to all events/unlikely.
No follow-up attempts are possible; information about lot/batch number cannot be
obtained.; Reporter's Comments: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1
admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd
degree AV block Treatment - Unknown Evolution of the ADR - Died Examinations -
Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid
Pneumonitis + Positive PCR Test; Reported Cause(s) of Death: COVID-19 pneumonitis;
Oxygen saturation decreased; Atrioventricular block third degree; fever 39 Celsius
degree" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1010483-1"
"1010483-1" "Death in COVID 19, VIRUS positive; Death in COVID 19, VIRUS
positive; This is a spontaneous report from a contactable physician downloaded from
the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-001581 and SE-MPA-
1611603955343). An 86-year-old male patient received the first dose of BNT162B2
(COMIRNATY; Lot number: EJ6795), intramuscularly, on 05Jan2021 at a single dose for
COVID-19 immunisation. Medical history included chronic obstructive lung disease
and dementia Alzheimer's type (late onset). Concomitant medications included
oxazepam (OXASCAND) from 2012, memantine (MANUFACTURER UNKNOWN) from 2016,
acetylsalicylic acid (MANUFACTURER UNKNOWN) from 2009, simvastatin (MANUFACTURER
UNKNOWN) from 2009, cyanocobalamin (BETOLVEX) from 2009, folic acid (FOLVIDON) from
2009, mirtazapine (MANUFACTURER UNKNOWN) from 2012, and levothyroxine sodium
(LEVAXIN) from 2009. The patient had no previous drug reactions. The patient
experienced death in COVID 19, virus positive on 07Jan2021, which was reported as
fatal. The clinical course was reported as follows: Two days after the vaccination,
the patient suddenly desaturated and was sent to a hospital, where a COVID-19 virus
test was taken, which came back positive on 07Jan2021. The man was treated with
high levels of oxygen and parenteral fluid and nutrition, but his consciousness
decreased, and he died after a week in the hospital, reported as 9 days after the
vaccination. The physician reported that the patient was probably already infected,
both health care providers and residents had verified ongoing COVID-19 during that
time and the man tested positive 2 days after the first dose of vaccination. The
patient died on 14Jan2021. The cause of death was reported as COVID-19. It was not
reported if an autopsy was performed. The physician reported that the vaccination
in itself is not suspected to have caused the death and does not suspect aggravated
COVID-19 infection due to vaccination.; Reported Cause(s) of Death: COVID-19"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1015572-1"
"1015572-1" "SARS-CoV-2 infection/COVID-19 disease/reduced general condition;
SARS-CoV-2 infection/COVID-19 disease/reduced general condition; This is a
spontaneous report from contactable physician downloaded from the Medicines Agency
(MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umm9d, Safety Report Unique
Identifier NO-NOMAADVRE-E2B_00014345. An 87-years-old male patient received the
first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on
05Jan2021 at single dose in right arm for COVID-19 immunisation. Medical history
included living in residential institution, recurrent pneumonias, dementia.
Concomitant medication included paracetamol (PARACET) (N02BE01 (unspecified number)
reported for paracetamol) for fever. It reported that the patient experienced SARS-
CoV-2 infection on 06Jan2021. The patient had vaccinated on 05Jan2021. He had
reduced general condition on 06Jan2021. COVID-19 outbreak detected on 07Jan2021 due
to positive test in fellow resident. Patient tested (COVID-19 test) positive on
08Jan2021, alongside several staff members. He developed COVID-19 disease and died
due to COVID-19 on 19Jan2021. The outbreak is traced back to a staff member, and
time of transmission is judged to be prior to vaccination. Reporting physician
assumes no link between vaccination and COVID-19 disease with fatal outcome.
Assessment of relatedness reported as no relationship by reporter. The patient died
on 19Jan2021. It was not reported if an autopsy was performed. Sender's Comment:
It is stated in the report that the patient was infected with COVID-19 before the
time of vaccination. The vaccine used is not live. It can therefore not cause
diseases that are vaccinated against or any other infections. The incident is
therefore considered to have no connection with the vaccine. Information on the
lot/batch number has been requested.; Sender's Comments: Based on the information
provided by the reporter, it appears unlikely that subject vaccine contributed to
the event of COVID-19 infection with fatal outcome. The reported event likely
represent intercurrent medical condition in this elderly 87 year old patient.
There is limited information provided in this report. This case will be reassessed
upon receipt of follow-up information. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.; Reported
Cause(s) of Death: SARS-CoV-2 infection/COVID-19" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1016989-1"
"1016989-1" "Pneumonitis; Drug ineffective; Covid-19; This is a spontaneous
report from a contactable healthcare professional, received from the Regulatory
authority report number GB-MHRA-WEBCOVID-202102031728405430, Safety Report Unique
Identifier GB-MHRA-ADR 24694509. A 80-year-old female patient received BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE), on 15Jan2021 at single dose for COVID-19
immunization, via an unspecified route of administration. Medical history included
suspected covid-19 on 17Jan2021. Concomitant medication included calcium carbonate,
colecalciferol (ADCAL D3), amlodipine, atorvastatin, edoxaban, lansoprazole,
losartan, paracetamol, salbutamol, trimipramine. The patient experienced
pneumonitis on 21Jan2021 and the sars-cov-2 test was positive on 21Jan2021. The
patient died on 23Jan2021. It was not reported if an autopsy was performed. Patient
was not enrolled in clinical trial. No follow-up attempts are possible;
information about lot/batch number cannot be obtained.; Reported Cause(s) of Death:
Pneumonitis" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1029877-1"
"1029877-1" "bothsided pneumonia in the presence of COVID-19
infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of
COVID-19 infection/positive PCR test on COVID-19; This is a spontaneous report from
a contactable physician by Pfizer from BIONTECH. An 82-year-old female patient
received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of
administration on 05Jan2021 at single dose for covid-19 immunisation. The patient
medical history was not reported. The patient's concomitant medications were not
reported. The patient was vaccinated with 1 first dose on 05Jan2021. The vaccines
have not been administered before. The patient had positive PCR test on COVID-19 on
07Jan2021. On 19Jan2021, the patient had progressive worsening of general
condition, bedridden, very weak, nutrition (food and drink) has to be supported and
served, no cough, no fever. On 25Jan2021, hospitalization with further worsening of
general condition and in soporous state. Positive PCR Test on COVID-19 on
25Jan2019. Treatment in hospital from 25Jan2021 to 27Jan2021, Diagnosis: bothsided
pneumonia, epicrisis available. On 28Jan2021, the patient had further worsening of
general condition, very week, sopor, as per relatives' wish palliative care
initiation. The patient experienced bothsided pneumonia in the presence of COVID-19
infection, firstly diagnosed on 25Jan2021. The diagnoses are confirmed as per
hospital epicrisis. The vaccine has not been administered again. The patient died
on 01Feb2021. It was not reported if an autopsy was performed. Without any
relation to COMINARTY has lead to a prophylactic hospitalization and treatment. A
causal relation between course of disease and vaccination is not given.
Information about lot/batch number has been requested.; Sender's Comments: Based on
the information available, a possible contributory role of the suspect BNT162B2
cannot be excluded for the reported positive PCR test on COVID-19 based on the
known safety profile. However the short duration of 2 days since the vaccine first
dose is given it is unlikely patient would have fully developed immunity.; Reported
Cause(s) of Death: bothsided pneumonia in the presence of COVID-19
infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of
COVID-19 infection/positive PCR test on COVID-19" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1029878-1"
"1029878-1" ""oxygen saturation 81%; cold; livid discoloration of acra;
respiratory infection with respiratory insufficiency; respiratory infection with
respiratory insufficiency; slightly confused; very weak; COVID-19 PCR test
positive; COVID-19 PCR test positive; This is a spontaneous report from a
contactable physician via local license partner. A 85-year-old male patient
received first dose of BNT162B2 (COMIRNATY) on 05Jan2021 at single dose for COVID-
19 immunization. Medical history and concomitant medications were not reported. The
patient had respiratory infection with respiratory insufficiency on 20Jan2021. On
20Jan2021 patient was in reduced general condition, slightly confused, very weak,
no cough, no fever. On 25Jan2021 positive PCR test (throat swab). On 26Jan2021 very
bad general condition, confused, cold and livid discoloration of acra, oxygen
saturation 81%. Palliative therapy with alleviation of symptoms after consultation
of his daughter. On 27Jan2021 further deterioration of general condition,
temperature 38 degrees Celsius, ""Exitus letalis"" at 5:10 p.m. All events except
COVID-19 PCR test positive required outpatient treatment, hospitalization and was
life-threatening. The patient died on 27Jan2021 at 5:10 p.m due to all events
except COVID-19 PCR test positive. The outcome of COVID-19 PCR test positive was
unknown. Information on the lot/batch number has been requested.; Sender's
Comments: Based on available information, a possible contributory role of the
subject product, BNT162B2 vaccine, cannot be excluded for the reported events of
COVID-19 and suspected LOE. However, based on the mechanism of action of the
vaccine, it is unlikely the patient would have fully developed immunity for the
vaccine to be effective, due to the number of days passed since the vaccine is
given and due to only the first dose was administered. Based on available
information, a possible contributory role of BNT162B2 vaccine cannot be excluded
for the other reported events due to temporal relationship Additional information
is needed to better assess the case, including complete medical history,
diagnostics including chest x-ray and autopsy results, counteractive treatment
measures and concomitant medications. This case will be reassessed once additional
information is available. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to Regulatory Authorities, Ethics Committees
and Investigators, as appropriate. ; Reported Cause(s) of Death: respiratory
infection with respiratory insufficiency; respiratory infection with respiratory
insufficiency; slightly confused; very weak; oxygen saturation 81%; cold; livid
discoloration of acra"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1035119-1"
"1035119-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms; This is a spontaneous report from a contactable other health
professional downloaded from the regulatory authority FR-AFSSAPS-SE20210154. This
reporter reported similar events for two patients. This is the second of two
reports. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot
no. EJ6796), intramuscularly in left arm on 14Jan2021 at single dose for covid-19
immunization. Medical history included cataract (probable cataract of the right
eye), Anterior cruciate ligament tear (Ligamentoplasty of the right anterior
cruciate ligament), ulcerative gastritis, peripheral arterial occlusive disease,
Transmetatarsal amputation (trans metatarsal amputation of the right foot),
pancreatitis chronic, hyperthyroidism, Hypertension arterial, diabetes mellitus,
appendicectomy, Humerus fracture, Blindness, one eye, Tetraparesis all from an
unknown date and unknown if ongoing; Chronic alcoholism from an unknown date not
ongoing. Background included: diabetes complicated by transmetatarsal amputation of
the right foot under insulin; AOMI; HTA (hypertension); probable cataract of the
right eye with blindness of the right eye; Right humeral fracture with braces;
Ligamentoplasty of the right anterior cruciate ligament, appendectomy; Calcifying
pancreatitis; Biological hyperthyroidism; Ulcerated gastritis; Insane syndrome: CT
scan of 27Aug18 which found diffuse encephalic atrophy with old left frontal
ischemic sequelae + per-ventricular leucoaraiosis. Appearance of a motor deficit in
the 2 upper limbs making it difficult to take meals alone from the summer of 2018.
The neurological examination had highlighted a tetraparesis around 4/5 greater with
a more marked deficit in the upper right limb, probably related to humeral surgery
in 2013, associated with advanced peripheral neuropathy, related to diabetes and
cognitive impairment with notable dysexecutive syndrome. Patient institutionalized
around the age of 60 in a context of chronic alcoholism, currently weaned.
Treatment in 2019 included: insulin glargine (ABASAGLAR) 100: 10-0-0; alprazolam
0.5: 0.5-0.5-1; amlodipine 5: 1-0-0; rosuvastatin 5: 0-0-1; boric acid; sodium
borate (DACRYOSERUM) 1-0-1; betamethasone dipropionate; calcipotriol (DAIVOBET) 50:
1-0-1; econazole 1-0-1; latanoprost (MONOPROST) 0-0-1; clopidogrel 0-1-0;
retinol;tocopherol (VITAMIN A) 0-0-1. The patient's concomitant medications were
not reported. The patient experienced covid-19 (death) on 26Jan2021, Symptoms:
dyspnea, fever, asthenia => put on O2. The patient underwent lab tests and
procedures which included computerised tomogram: found diffuse encephalic atrophy
with old left frontal ischemic sequelae + per-ventricular leucoaraiosis on
27Aug2018, motor dysfunction: Appearance of a motor deficit in the 2 upper limbs
making it difficult to take meals alone from the summer of 2018 on 27Aug2018,
neurological examination: had highlighted a tetraparesis around 4/5 greater with a
more marked deficit in the upper right limb, probably related to humeral surgery in
2013, associated with advanced peripheral neuropathy, related to diabetes and
cognitive impairment with notable dysexecutive syndrome on 27Aug2018, Constant
monitoring before injection on 14Jan2021: pulse: 60; TA (Atrial fibrillation):
128/73; Saturation: 95; Temperature: 36.7. Constant monitoring 15 minutes after
injection on 14Jan2021: pulse: 78; TA: 12/7; Saturation: 97; Temperature: 36.1. PCR
(polymerase chain reaction): COVID positive on 14Jan2021. The patient died on
28Jan2021. It was not reported if an autopsy was performed.; Sender's Comments:
Linked Report(s) : FR-PFIZER INC-2021134697 different patient, same cluster of
reports; Reported Cause(s) of Death: positive COVID-19 test with symptoms; positive
COVID-19 test with symptoms" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1035120-1"
"1035120-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms; This is a spontaneous report from a contactable other HCP from the
Medicines Agency (MA) Regulatory authority WEB FR-AFSSAPS-SE20210161. This other
HCP reported similar events for 2 patients. This is the first of two reports. A 78-
year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot#EJ6796),
intramuscularly on 14Jan2021 at single dose, left arm for covid-19 immunisation.
Medical history included cataract surgery, senile macular degeneration, Internal
carotid endarterectomy from 1988, Alzheimer's disease from 2015, hypothyroidism,
Anxiodepressive syndrome, Catarct surgery. The patient's concomitant medications
were not reported. Treatment in Dec2020 included acetylsalicylate lysine (KARDEGIC)
75mg 1 sachet at noon; paroxetine 20 mg 1 + 0.5 in the morning; mianserine 10mg 2
tablets if needed; diazepam 10 drops at bedtime; olanzapine 5mg 0.5 -0 -0.5;
zopiclone 7.5mg 0-0-1; levothyroxine sodium (LEVOTHYROX) 100�g 1-0-0; calcium D3:
500mg 1 sachet in the morning. The patient experienced covid-19 (PCR COVID +) on
18Jan2021. The event was serious as death. Symptoms reported as dyspnea, fever,
fatigue. The patient was put on O2. The patient underwent lab tests and procedures
which included blood pressure (Constant monitoring before injection): 115/10, blood
pressure (Constant monitoring 15 minutes after injection): 11/8, body
temperature(Constant monitoring before injection): 36.5, body temperature (Constant
monitoring 15 minutes after injection): 36.2, pulse rate(Constant monitoring before
injection): 80, pulse rate(Constant monitoring 15 minutes after injection): 84,
oxygen saturation(Constant monitoring before injection): 91, oxygen
saturation(Constant monitoring 15 minutes after injection): 93, PCR covid + on
18Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was
performed. ; Sender's Comments: Linked Report(s) : FR-PFIZER INC-2021134701
different patient, same cluster of reports; Reported Cause(s) of Death: COVID-19
infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1035310-1"
"1035310-1" "Seizure; SARS-CoV-2 infection; SARS-CoV-2 infection; Chest
infection; This is a spontaneous report from a contactable other healthcare
professional. This is a report received from the RA. Regulatory authority report
number: GB-MHRA-WEBCOVID-202102062019418600, Safety Report Unique Identifier GB-
MHRA-ADR 24714675. An 85-year-old male patient received his first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on
06Jan2021 at single dose for COVID-19 immunization. Medical history included lower
respiratory tract infection, hypertension, cerebrovascular accident and atrial
fibrillation unknown if ongoing. Patient had not had symptoms associated with
COVID-19. Patient was not enrolled in clinical trial. Concomitant medication
included prednisolone. The patient experienced SARS-CoV-2 infection on 20Jan2021,
chest infection on 10Jan2021, seizure on 02Feb2021. SARS-CoV-2 infection, chest
infection and seizure. Length of being unwell after the vaccination, not to put
finger on. Then chest infection treated with antibiotics and prednisolone. Had
seizure like episode before completing those medications. Passed away the day after
the episode. The patient underwent lab tests and procedures which included COVID-19
virus test: yes - positive covid-19 test on 20Jan2021. The patient died on
03Feb2021 with SARS-CoV-2 infection as cause of death. The outcome of rest events
was unknown. It was unknown if an autopsy was performed. No follow-up attempts
possible; information regarding batch/lot cannot be obtained; No further
information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2
infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1037617-1"
"1037617-1" "Contracted Covid-19 with breathing difficulties; Contracted
Covid-19 with breathing difficulties; This is a spontaneous report from contactable
consumer (patient) and daughter via a company representative. Patient's daughter
was a Health Care Professional. A 95-year-old male patient received BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021, at single dose, for COVID-19
immunization. Medical history included underlying heath issues with his heart
(something to do with the valves) and was allergic to mustard. The patient's
concomitant medications were not reported. The patient contracted COVID-19 on an
unspecified date, in Jan2021 and was in hospital on Friday 15Jan2021 with breathing
difficulties. It was reported that he contracted COVID after the vaccine had be
given. However, the patient had been self-isolating and only going to his allotment
in the mornings. He did however have Christmas dinner with his family Christmas
day, with his daughter and son in law who are both active paramedic. They both now
also have Covid and yesterday his daughter moved in with him to take care of him
and she only has mild symptoms. It could be he contracted it at Christmas but the
symptoms didn't show until this week. According to the patient's daughter, the
patient went before to have the Pfizer vaccine and was asked if he had any
allergies, he said he did, he was allergic to mustard. It was reported that the
patient was one of the first people to be asked to get the vaccine he even cycled
to the place and when he got there, they didn't allow him because of his allergy to
mustard. Accordingly, due to that the patient was not given the vaccine at that
time was told that he would be contacted when the AstaZenca one was available. He
had to wait for the Astrazeneca vaccine but ended up having the Pfizer one and
contracted COVID. Reporter stated that if he had it 3 weeks earlier when he was
supposed to would still be alive now. The patient died on an unspecified date, in
Feb2021 due to COVID-19. It was unknown if autopsy was done. Information on batch
number has been request. Follow-up (25Jan2021): New information reported from a
consumer (daughter) via a company representative includes: medical history
(allergic to mustard and additional reporter (daughter). No follow-up attempts are
possible, information about batch number cannot be obtained. Follow up
(11Feb2021): New information received includes: details regarding patient's death
and event's updated.; Reported Cause(s) of Death: COVID-19; Breathing difficult"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1045017-1"
"1045017-1" "COVID-19 aggravated/Fever/ PCR test which turns out to be
positive/ suspicion of bronchitis/ deterioration of the patient's condition; This
is a spontaneous report from a contactable other HCP from the Medicines Agency (MA)
regulatory authority-WEB FR-AFSSAPS-LY20210485. An 88-year-old male patient
received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on
19Jan2021 at single dose, for covid-19 immunisation. Medical history included
chronic bronchitis, autonomy: GIR 1, and living in nursing home from an unknown
date and unknown if ongoing. The patient's concomitant medications were not
reported. Usual treatment not known. On 19Jan2021, in the morning, 1st injection of
bnt162b2, after pre-vaccination consultation. At this time, no symptoms. Stable
state of health throughout the day. On 20Jan2021, faced with the presence of a
fever at the end of the day, he benefits from a PCR test which turns out to be
positive (but the result will not be discovered by the nursing home until
23Jan2021). On 21Jan2021, prescription of antibiotics on suspicion of bronchitis.
In the following days, deterioration of the patient's condition, with several trips
to / from the hospital with return to nursing home as soon as the patient's
condition stabilizes. On 28Jan2021, hospitalization. On 30Jan2021, death. COVID-19
cluster in the facility. The patient underwent lab tests and procedures which
included sars-cov-2 test: positive on 20Jan2021. The outcome of the event was
fatal. The patient died on 30Jan2021. It was not reported if an autopsy was
performed. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19 aggravated/Fever/ PCR test which turns out to
be positive/ suspicion of bronchitis/ deterioration of the patient's condition"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048282-1"
"1048282-1" "COVID-19; COVID-19; This is a spontaneous report downloaded from
the Medicines Agency (MA) Regulatory Authority-Web [Regulatory Authority number ES-
AEMPS-746451] from a contactable consumer. A 99-year-old female patient received
the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in
the arm, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history
included ongoing chronic kidney disease, ongoing dementia Alzheimer's type and
atrial fibrillation. Concomitant medications were not reported. The patient
experienced COVID-19 on 19Jan2021. The patient presented symptoms and was
hospitalized due to the event from 01Feb2021. The patient underwent lab tests and
procedures which included COVID-19 virus test: positive on 19Jan2021. The patient
died on 09Feb2021 due to the event. An autopsy was not performed. No follow-up
attempts are possible; information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: COVID-19; COVID-19" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048324-1"
"1048324-1" "COVID-19 infection; COVID-19 infection; This is a spontaneous
report from a contactable physician downloaded from the Medicines Agency (MA)
Regulatory Authority -WEB regulatory authority FR-AFSSAPS-RS20210172. A 73-year-old
female patient received the first dose bnt162b2 (COMIRNATY, lot number: EJ6788),
intramuscular on 21Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical
history included Cardiac arrhythmia, Dementia with Lewy bodies, Atrial
fibrillation, COPD, Ulcer, Chronic cor pulmonale, Thyroidectomy, Arteriopathic
disease, Hernia hiatal, all from unknown date and unknown of ongoing, Bilateral
pulmonary thromboendarterectomy in 2000, severe dementia from Oct2020, hyperthermia
and sudden desaturation from 31Dec2020. Concomitant medication included warfarin
sodium (COUMADINE). The patient previously received clozapine (LEPONEX) for
dementia, ceftriaxone sodium (ROCEPHINE), amoxicillin clavulanic acid (AUGMENTIN),
and ofloxacin. The patient experienced COVID-19 infection on 03Feb2021 with outcome
of fatal. Clinical course: In Oct2020, the patient presented psychotic symptoms of
severe dementia. Introduction of clozapine. 31Dec2020: episode of hyperthermia and
sudden desaturation. PCR COVID negative. Treatment with ceftriaxone sodium in
probabilistic mode. Switch ceftriaxone sodium to amoxicillin clavulanic acid +
ofloxacin for cutaneous + urinary tract. 14Jan2021: seat lesion on the way to
healing but widening of the orifice of the lesion which is flush with the anus.
21Jan2021: vaccination with bnt162b2. Apyretic patient at 36.5 deg C before
injection. No reaction 15 minutes after injection. Patient under warfarin sodium
(COUMADINE) (not administered on 20Jan2021 in the evening). Long compression at the
injection site, no hematoma. Medical observations following vaccination: 23Jan2021:
INR 2.9 check. 26Jan2021: biologically: Hb 16, 4 g / dL; Leuco 8.7 G / L; platelets
277 G / L. New rise in INR despite reduction in dose of warfarin sodium, new
warfarin sodium treatment regimen. Hemoconcentration, it is recommended that the
patient drink well. 29Jan2021 and 02Feb2021: INR 1.7. 03Feb2021: occurrence of
acute asphyxial febrile respiratory distress on massive PAO, call from the IDE for
acute dyspnea with desaturation below 70 percent. Fever at 38.7 deg C. Stage IV
dyspnea. Rales diffuse in the 2 pulmonary fields. No edema of the MIG. Rapid pulse
+++ BP retained. 03Feb2021: SARS-Cov2 RT-PCR positive. COVID 19 infection GD. Poor
short-term prognosis. Part of cardiac decompensation on AC / AF rapid. The patient
died on 03Feb2021 at 5:15 p.m. It was not reported if an autopsy was performed.;
Reported Cause(s) of Death: COVID-19 infection; COVID-19 infection" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048327-1"
"1048327-1" "2019 novel coronavirus infection; Covid PCR test: positive;
Pneumopathy; Dyspnoea; Hypoxia; worsening of the respiratory state, respiratory
distress; hemodynamic instability; appearance of signs of cardiac decompensation;
appearance of signs of cardiac decompensation; left basal pneumonia treated with
antibiotics; This is a spontaneous report from a contactable pharmacist downloaded
from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-ST20210155. A
90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch
number and expiry date unknown), intramuscular on 05Jan2021 at unknown age at 0.3
mL single dose for covid-19 immunization. Medical history included atrial
fibrillation, Cognitive disturbance, insulin-requiring type 2 diabetes mellitus,
hyperthyroidism, anxiety, Chronic renal failure, Decompensation cardiac,
depression, and cardiomyopathy, all from an unknown date and unknown if ongoing.
The patient's concomitant medications were not reported. The patient experienced
pneumopathy on 15Jan2021. On 11Jan2021, the patient had evidence of dyspnea with
moderate hypoxia. On 15Jan2021, the patient had evidence of left basal pneumonia
treated with antibiotics. On 17Jan2021, the patient performed an antigenic covid
test with negative result. On 20Jan2021, the patient had worsening of the
respiratory state with appearance of signs of cardiac decompensation. On 21Jan2021,
the patient carried out of a new antigenic Covid test with negative result and
Covid PCR test with positive test. On 22Jan2021, the patient was worsening of the
respiratory state, respiratory distress and hemodynamic instability. The patient
had comfort care in the service. The patient died on 23Jan2021. Seriousness
criteria provided for hypoxia, pneumopathy, dyspnea, 2019 novel coronavirus
infection and Covid PCR test with positive test was hospitalization and death. The
reporter considered the picture of concomitant COVID-19 infection to be worsened by
vaccination. The patient died for hypoxia, pneumopathy, dyspnea, 2019 novel
coronavirus infection and Covid PCR test with positive test on 23Jan2021. An
autopsy was not performed. Outcome of other events were unknown. No follow-up
attempts are possible. No further information expected. Information on batch/lot
number can not be obtained.; Reported Cause(s) of Death: dyspnea; hypoxia;
Pneumopathy; 2019 novel coronavirus infection; covid pcr test: positive" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048390-1"
"1048390-1" "confusion; hallucinations; increased tone in arms; tremor;
myoclonic jerks; Acute kidney injury; Seizures; Drug ineffective; SARS-CoV-2
infection; Encephalopathy acute; This is a spontaneous report from a contactable
physician, received from the regulatory authority. Regulatory authority report
number GB-MHRA-WEBCOVID-202102151314380170 , Safety Report Unique Identifier GB-
MHRA-ADR 24765082. A 85-year-old female patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an
unspecified route of administration on 14Jan2021 at single dose for covid-19
immunisation. Medical history included deafness neurosensory, pulmonary embolism,
ischaemic stroke, gingival hypertrophy, hypertension, chronic kidney disease, stage
2 pulmonary sarcoid and liver steatosis, all unknown if ongoing. Concomitant
medications included amlodipine, atorvastatin, bisoprolol, colecalciferol,
edoxaban, famotidine. The patient experienced encephalopathy acute on 24Jan2021 and
was admitted to hospital on 27Jan2021 with few days history of confusion and
hallucinations, tremor, increased tone in arms. Also had Acute kidney injury
(resolved in days with treatment). Developed myoclonic jerks and then seizures on
01Feb2021. Tested positive for covid around a week into admission on 31Jan2021.
Lab data included a suspected covid-19 infection on 06Feb2021. Neurology opinion
sought - unable to perform LP due to agitations and seizures, too unwell by the
time CEPOD available. MRI unable to do due to covid and then deterioration. EEG
showed general slowing, nil specific. Treated with intravenous acyclovir and
ceftriaxone empirically (possible infective cause). Loaded on levetiracetam.
Deteriorating level of consciousness throughout admission. Started on steroids,
however, went to palliative care on 12Feb2021. It was not reported if an autopsy
was performed. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: drug ineffective;
confusion; hallucination; hypertonia; tremor; myoclonus; seizure; covid-19;
encephalopathy" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048391-1"
"1048391-1" "unwell; Death NOS; sars-cov-2 infection; sars-cov-2 infection;
This is a spontaneous report from a contactable healthcare professional received
from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory
authority report number GB-MHRA-WEBCOVID-202102151354130980, Safety Report Unique
Identifier GB-MHRA-ADR 24765674. A 53-years-old female patient received the first
dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot EJ1688), via an
unspecified route of administration on 09Jan2021 at single dose for covid-19
immunisation. Medical history included learning disorder from an unknown date and
unknown if ongoing reported as severe learning difficulties with self-harm, low
mood and behavioural disorder. Patient was not enrolled in clinical trial.
Concomitant medication included citalopram (unknown manufacturer), olanzapine
(unknown manufacturer), pregabalin (unknown manufacturer), carbamazepine (TEGRETOL
RETARD). The patient experienced death nos on 13Feb2021. The patient experienced
also unwell on an unspecified date with outcome of recovered and sars-cov-2
infection on 23Jan2021 with outcome of unknown. The events were life-threatening.
The patient underwent lab tests and procedures which included positive covid-19
test on 23Jan2021. The patient died on 13Feb2021. An autopsy was not performed. The
events were reported as mild non specific malaise. Contact with carrier positive so
screened and found positive. Not acutely unwell when went to bed, found dead in
morning of 13Feb2021. No follow-up attempts are possible. No further information
expected.; Reported Cause(s) of Death: Death NOS" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1048626-1"
"1048626-1" "Cardio-respiratory arrest; conclusion that she caught Covid and
the vaccine did not protect her/ extreme tiredness/ a slight cough/ a fever; This
is as spontaneous report received from a contactable consumer downloaded from the
Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report
number is PT-INFARMED-T202102-951. A contactable consumer reported that a 92-
years-old female patient received 1st dose of bnt162b2 (COMIRNATY), intramuscular
on 19Jan2021 at 0.3 mL single for covid-19 immunisation. There was reference to
clinical history in the past of melanoma, stroke, gastric ulcer, pneumonia and
unknown if ongoing. There was a history of allergy to penicillin. Concomitant
medication included esomeprazole, furosemide, clopidogrel. The adverse reaction,
appeared about 6 days after the administration of the first dose of the suspected
drug (25Jan2021), and was initially characterized by extreme tiredness that led her
to eat in the bedroom and a slight cough. After 9 days of inoculation, a fever
developed. The patient died on the 10th day (29Jan2021). The conclusion was that
the patient caught COVID and the vaccine did not protect her associated with the
use of bnt162b2 against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml,
concentrate for dispersion for injection, in 1st dose, for active immunization to
prevent COVID-19 caused by the SARS-CoV virus-2, with the dosage of 2 intramuscular
doses (0.3 ml each) with an interval of at least 21 days between each dose. The
patient was not previously infected with the SARS-CoV-2 virus, according to the
notifier, the patient was institutionalized and everyone tested Covid, they were
confined to their rooms, the test result was negative. The patient died of
cardiorespiratory arrest. No autopsy was performed. There was no concrete diagnosis
of Covid infection, the notifier said in funeral homes say they would be treated as
a suspect for Covid and, according to information from the institution, they were
also hit hard by this plague. Evolution of adverse reaction was death. There was no
reduction in dosage. The suspected drug was suspended once the vaccination schedule
was incomplete, and the second dose was not administered. There was no suspicion of
interaction between drugs. There is no information on the specific treatment of the
reaction. The events outcome was fatal. No follow-up attempts are possible,
information about batch number cannot be obtained.; Reported Cause(s) of Death:
conclusion that she caught Covid and the vaccine did not protect her/ extreme
tiredness/ a slight cough/ a fever; Cardio-respiratory arrest" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1055837-1"
"1055837-1" "COVID-19; COVID-19; General physical health deterioration; This
is a spontaneous report from a contactable consumer downloaded from the Agency
Regulatory Authority-WEB. Regulatory Authority Report Number: CZ-CZSUKL-21001043.
An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot
number and expiry date unknown) intramuscular on 21Jan2021 at single dose for
COVID-19 immunization. Medical history included ongoing Parkinson's disease treated
for a long time (about 4 years) with partial senile dementia. For better care, she
was placed in a nursing home and the family was satisfied with the care. According
to the attending physician, the patient was in a satisfactory physical condition,
but the mental state was not optimal. Before vaccination, the patient was tested
and COVID-19 PCR test was negative in Jan2021. The patient's concomitant
medications were not reported. On 21Jan2021, the patient was vaccinated with
BNT162B2 vaccine. After a few days in Jan2021, she was placed in isolation because
of Covid-19 positivity. On 11Feb2021 the husband was invited because the patient
got much worse. She was in a desperate state, just wheezing and not perceiving her
surroundings at all. She did not respond to the stroking of her hands and face and
there was no eye contact. She did not recognize her husband or nephew with his
wife. The nurses gave antibiotics in drink, the patient had an inserted cannula and
artificial nutrition. For general worsening of the condition, the patient was taken
by ambulance to the hospital, where she was placed in the infection department. On
14Feb2021, the patient died due to COVID-19 and general worsening of the condition.
The outcome of the events was fatal. It was unknown if an autopsy was done. Events
were considered as serious with death, medically significant, hospitalized and
life-threatening from regulatory authority. No follow-up attempts are possible;
information about batch/lot number cannot be obtained.; Reported Cause(s) of Death:
COVID-19; General physical health deterioration" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1056153-1"
"1056153-1" ""septic shock; multi-organ failure; SARS-CoV 2 infection; acute
respiratory failure caused by untyped bacterial pneumonia; acute respiratory
failure caused by untyped bacterial pneumonia; vaccination failure; This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority manufacturer report number IT-MINISAL02-678359. A 63-year-old female
patient received the second dose of BNT162B2 (Comirnaty, Lot No. EJ6797)
intramuscularly on 27Jan2021, the first dose (Lot No. EL1484) was received on
05Jan2021, both at single dose for COVID-19 immunisation. Relevant history induced
Type 2 diabetes mellitus, arterial hypertension, Chronic renal failure under
dialysis treatment, closed fracture of multiple cervical vertebrae since 01Sep2020
(C1-C2 fracture (September 2020) with diver - atlanto-axial flux and compression at
the bulb-medullary passage and on the cervical cord, without neurosurgical
indication due to the high risk-benefit ratio. The patient had Long-term
hospitalization. Relevant concomitant drug included levothyroxine sodium (EUTIROX)
50mcg tablet and epoetin zeta (RETACRIT) 4000 IU / 0.4 ML solution for injection
for Chronic renal failure. Therapy administered in a nursing home included: Eutirox
50mcg, Humalog 6 UI for Diabetes mellitus, Lobivon 5 mg for Hypertension arterial,
catapresan CRTT for Hypertension arterial, Nitrodem 10 mg, Calcium 1cpr, retacrit
4,000 for Chronic renal failure, Rocaltrol 0.25mcg, Omeprazen 20mg, Adalat crono 30
mg for Hypertension arterial, Lantus 12U.I for Diabetes mellitus. 15 days after the
Covid-19 vaccination (II dose), the patient was found to have positive SARS-CoV 2
infection, and arrived in emergency room and then in Intensive T. on 10Feb2021 for
acute respiratory failure caused by untyped bacterial pneumonia, died within 24
hours of septic shock and multi-organ failure (chest x-ray not suggestive of Covid
pneumonia), with onset of respiratory symptoms on 05Feb2021 (reported by doctor).
Treatment therapy included: Resuscitation treatment of the picture Respiratory,
Hemodynamic and Renal (Invasive ventilation, amine-vasoactive, broad spectrum
antibiotic therapy, CVVHDF dialysis treatment). Examinations performed on
admission: Chest x-ray (on 10Feb2021): ""complete opacification of the left
hemithorax is documented as per lung atelectasis. Other more circumscribed
parenchymal thickenings are noticeable on the right. ECHO-lung: diffuse pattern of
B lines bilaterally (left hemithorax greater than right hemithorax), presence of
bilateral pleural sliding without macroscopic signs of pleural effusion. Rapid swab
positive for SARS CoV-2 performed by 118 crew (on 10Feb2021). Upper respiratory
panel filmarray (nasopharyngeal swab) (on 10Feb2021): positive for SARS-COV 2. SARS
CoV 2 PCR rt Positive (nasopharyngeal swab) (on 11Feb2021). FILMARRAY blood culture
panel on 10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on
10Feb2021, culture tests are in progress). FILMARRAY blood culture panel on
10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on 10Feb2021,
culture tests are in progress); complete opacification of the left hemithorax is
documented as from pulmonary atelectasis. Other more circumscribed parenchymal
thickenings are noticeable on the right; SUCCESSFUL; upper respiratory panel
filmarray (nasopharyngeal swab) (10Feb2021): positive for SARS-COV 2; diffuse
pattern of B lines bilaterally (left hemithorax greater than right hemithorax),
presence of bilateral pleural sliding without macroscopic signs of pleural
effusion.; Reported Cause(s) of Death: untyped bacterial pneumonia; acute
respiratory failure; SARS-CoV 2 infection; vaccination failure; septic shock;
multiorgan failure"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1056237-1"
"1056237-1" "COVID-19 virus test was positive; COVID-19 virus test was
positive; Patient died on 04Feb2021 with pneumonia; This is a spontaneous report
downloaded from the Regulatory Authority -WEB DK-DKMA-WBS-0032249. The case was
received from a contactable physician via The Regulatory Authority. An 81-year-old
male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection;
lot number; EJ679) via Intramuscular route on 03Jan2021 and second dose (lot
number; EJ6136, expiry date; 30Apr2021) via intramuscular route, on 24Jan2021, and
both were at single dose for COVID-19 immunisation. Medical history included
ongoing dementia. Concomitant medications were not reported. The patient underwent
COVID-19 virus test on 26Jan2021 and resulted as positive. On an unknown date in
2021, patient had pneumonia. On 04Feb2021 the patient died due to pneumonia. There
are no other ADRs to COMIRNATY. An autopsy has not been performed. The test was
positive when the patient died. No treatment or medical procedure due to the ADRs
was reported. Seriousness of the event pneumonia was fatal. Outcome of the event
pneumonia was fatal and for other events it was unknown. Causality: The hospital
believes that the patient has died from Pneumonia. The reporting physician does not
believe that there is a causal relationship between pneumonia and COMIRNATY, but he
sticks to reporting the case due to the temporal correlation. No follow-up
attempts are possible, batch number already obtained.; Sender's Comments: The
association between the event fatal pneumonia and lack of effect (COVID-19 virus
test positive) with COMIRNATY use can not be fully excluded.; Reported Cause(s) of
Death: Patient died on 04Feb2021 with pneumonia" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1061821-1"
"1061821-1" "COVID-19; general deterioration in her health status; Drug
ineffective; This is a spontaneous report from contactable consumers and nurse via
other company. A 53-year-old female patient received bnt162b2 (Formulation:
Solution for injection), via an unspecified route of administration on an unknown
date in Jan2021 at single dose for COVID-19 immunisation. Medical history included
endotracheal intubation and ongoing mechanical ventilation. Concomitant medication
included macitentan (OPSUMIT) at 10mg once a day for pulmonary arterial
hypertension, selexipag (UPTRAVI, Strength: 800 ug) at 800 ug, twice a day for
pulmonary arterial hypertension. It was reported that patient was vaccinated with
the first dose of COVID-19 vaccine and one week after that began general
deterioration in her health status on an unknown date in Jan2021. The patient was
hospitalised and diagnosed with COVID-19 on 29Jan2021 and shortly after that had
severe dyspnea on an unknown date in Jan2021. The patient was intubated and sedated
on MV(mechanical ventilation). It was reported that patient was hospitalized since
29Jan2021 until death. The patient died on 04Feb2021. It was not reported if an
autopsy was performed. The outcome of the events was fatal. No follow-up attempts
are possible, information on batch number cannot be obtained.; Sender's Comments:
Based on the temporal relationship, the association between the event lack of
effect (fatal COVID19) with BNT162b2 can not be fully excluded. The impact of this
report on the benefit/risk profile of the Pfizer product is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.;
Reported Cause(s) of Death: general deterioration in her health status; COVID-19;
severe dyspnea" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1061852-1"
"1061852-1" "Diagnised by pathologist with COVID-19 but negative test;
Respiratory dysfunction; This is a spontaneous report downloaded from the
Regulatory Authority-WEB [Lareb (LRB) number NL-LRB-00445009] from a contactable
consumer (patient's daughter or son). An elderly male patient received bnt162b2
(COMIRNATY), via an unspecified route of administration, on 28Jan2021, at single
dose, for COVID-19 immunisation. The patient's medical history and concomitant
medications were not reported. The patient was diagnosed by a pathologist with
COVID-19 in Jan2021 but test was negative on 31Jan2021, and experienced respiratory
dysfunction in Jan2021. After events onset the patient underwent lab tests and
procedures which included COVID-19 virus test: negative on 31Jan2021. The patient
died on 02Feb2021. An autopsy was performed and results were not available. Case
summary and Reporter comment: My father was vaccinated on 28Jan2021. Sadly died on
02Feb2021 from the effects of the vaccine, he was chronically short of oxygen and
his lungs stopped functioning. I have come into conflict with the pathologist who
diagnosed COVID-19. What the pathologist didn't know was that my father had been
tested for COVID-19 after the symptoms started. COVID-19 negative test result was
on 31Jan2021. The pathologist, after initial doubts, stayed with his diagnosis of
COVID-19 and said it was not contagious (unbelievable), I myself warned the
nursing home to take measures, but that was according to not need the pathologist.
The pathologist himself reported to the nursing home that the investigation was
still ongoing (various signals, miscommunication). No follow-up attempts are
possible; information about lot/batch number cannot be obtained.; Reporter's
Comments: My father was vaccinated on 28Jan2021. Sadly died on 02Feb2021 from the
effects of the vaccine, he was chronically short of oxygen and his lungs stopped
functioning. I have come into conflict with the pathologist who diagnosed COVID-19.
What the pathologist didn't know was that my father had been tested for COVID-19
after the symptoms started.; Reported Cause(s) of Death: Respiratory dysfunction;
Diagnised by pathologist with COVID-19 but negative test" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1064480-1"
"1064480-1" "Bilateral pneumonia; COVID-19; This is a spontaneous report from
a contactable consumer downloaded from the Regulatory Authority-WEB. This is a
report received from the regulatory authority report number is CZ-CZSUKL-21001001.
An 88-year-old male patient received the first dose of the bnt162b2 (COMIRNATY),
via an unspecified route of administration on 18Jan2021 at a single dose for COVID-
19 immunization. The patient's medical history included below knee amputation on
07Feb2020. Concomitant medications were not reported. On 26Jan2021, the patient
experienced COVID-19 (death, hospitalization, medically significant, life
threatening). On an unspecified date, the patient experienced bilateral pneumonia
(death, hospitalization, medically significant). The patient underwent lab tests
and procedures which included SARS-CoV-2 test: positive on 26Jan2021. The clinical
outcome of the events: bilateral pneumonia and COVID-19, was fatal. The patient
died on 04Feb2021 due to bilateral pneumonia and COVID-19. An autopsy was not
performed. No follow-up attempts are possible; information about batch/lot number
cannot be obtained. ; Reported Cause(s) of Death: Bilateral pneumonia; COVID-19"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1065049-1"
"1065049-1" "COVID-19; This is a spontaneous report received from a
contactable physician, downloaded from the Regulatory Authority NL-LRB-00444454. A
90-year-old female patient received bnt162b2 (COMIRNATY) (Lot # EJ6134), via an
unspecified route of administration at single dose on 29Jan2021 for covid-19
immunisation. Medical history included ongoing chronic obstructive pulmonary
disease, ongoing emphysema. Concomitant medication included midazolam, morfine.
The patient experienced Covid-19 on 06Feb2021 with fatal outcome. The patient died
on 12Feb2021. The patient underwent lab tests and procedures which included sars-
cov-2 test: positive on 06Feb2021. It was not reported if an autopsy was performed.
The patient died at home using palliative sedation as a result of complications
from Covid-19. Unknown if there was a relationship with vaccination with Comirnaty.
Clinical course as follows: 5 days after vaccination, the patient experienced
symptoms of a Covid-19 infection, 8 days after vaccinations the patient had a
positive SARS COV 2 test and 14 days after vaccination the patient deceased with
palliative sedation. The patient died of complications of a Covid-19 infection. No
follow-up attempts possible. No further information expected.; Reported Cause(s) of
Death: complications of COVID19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1065211-1"
"1065211-1" "COVID-19; This is a spontaneous report from a contactable
pharmacist downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-
AFSSAPS-LY20210735. A 90-years-old male patient received the first dose of
bnt162b2 (COMIRNATY; Lot # EJ6795 ) vaccine , intramuscular in the left arm
19Jan2021 at SINGLE DOSE for covid-19 immunisation . Medical history included
mixed anxiety and depressive disorder, cognitive disorder , Parkinson's disease,
starvation , carcinoid tumour (vertex carcinoid, untreated) , Sars-cov-2 test
negative on 18Jan2021, bedridden . The patient's concomitant medications were not
reported. On 25Jan2021 during a systematic COVID-19 screening, the patient had a
COVID PCR test positive: no symptoms presented to date. On 02Feb2021: the patient
presented symptoms such as rapid breathing, fever. he was put under O2. His
condition deteriorated rapidly, he presented with dehydration and a back pressure
ulcer. On 05Feb2021 comfort care were implemented. On 11Feb2021 the patient died
at 8 a.m. The cause of death was Covid-19. Follow up information cannot be
obtained. The patient experienced covid-19 (covid-19) (death) on 25Jan2021.
The patient underwent lab tests and procedures which included sars-cov-2 test:
negative on 18Jan2021 , sars-cov-2 test: positive on 25Jan2021 . The action
taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic
measures were taken as a result of covid-19 (covid-19). The patient died on
11Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of
Death: Covid-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1065267-1"
"1065267-1" ""positive COVID-19 test; This is a spontaneous report from a
contactable consumer received from the regulatory authority. Regulatory authority
report number GB-MHRA-WEBCOVID-202102221318192820, Safety Report Unique Identifier
GB-MHRA-ADR 24814558. An 84-year-old male patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration at single dose on 19Jan2021 for covid-19 immunisation . Medical
history included amnesia, dementia Alzheimer's type. Concomitant medications were
not reported. The patient experienced positive Covid-19 test on 25Jan2021. The
patient died on 05Feb2021. It was not reported if an autopsy was performed. The
patient had not had symptoms associated with COVID-19. The patient was not enrolled
in a clinical trial. The reporter stated that: ""My father was ok leading up to
the vaccine he was quiet and tired due to boredom of being locked away in a care
home unable to see relatives frequently or go outside and live a normal life"". No
follow-up attempts possible; information regarding batch/lot cannot be obtained; No
further information expected.; Reported Cause(s) of Death: COVID-19"" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1065567-1"
"1065567-1" "COVID-19/positive antigen Covid-19 test; became ill; Sleep
excessive/still asleep/she was sleepy; tired; Communication disorder/stopped
communicating by phone; suspected of having another stroke/Suspicion of
cerebrovascular accident; This is a spontaneous report received from a contactable
consumer, downloaded from the Medicines Agency (MA) regulatory authority CZ-CZSUKL-
21001005. A 72-year-old female patient received the first dose of BNT162B2
(COMIRNATY, lot number EL1491) via Intramuscular on 13Jan2021 at single dose for
COVID-19 immunisation. Medical history included: ischemic heart disease,
dysrhythmic form, recurrent stroke with mild residual left-sided finding, last
stroke May2014, endarterectomy bilaterally 1999, ongoing vascular and hypoxic
encephalopathy, ongoing arterial hypertension, type 2 diabetes mellitus since 2006,
now without therapy, ongoing diabetic nephropathy, ongoing diabetic polyneuropathy,
ongoing diabetic retinopathy bilateral and age-related macular degeneration
(practical blindness on right), ongoing dyslipidemia on statin therapy,
thyroidopathy, goitre, effector, dysfunction thyroid, ulcerative colitis, relapse
in May2016, small bowel resection for volvulus with peritonitis in 2005,
cholecystolithiasis, ongoing hepatic steatosis, psoriasis vulgaris, ongoing
psoriatic arthropathy, ongoing vertebrogenic algic polytopic syndrome, ongoing
cerebello-vestibular syndrome, instability with repeated falls, ongoing
polyarthrosis, ongoing postmenopausal osteoporosis, recurrent urinary tract
infections, intestinal resection for volvulus in 2009, trochanter abscess l.dx.
sepses etiologically MRSA, appendectomy, hysterectomy + adnexectomy/
hysterosalpingo-oophorectomy for myomatosis, cataract surgery bilaterally, ongoing
glaucoma, allergies to penicillin (swelling of the face), smoker (3-5 cigarettes
/day). Family history was insignificant. Before the vaccination, the patient was a
lying patient, but she raised her hands and communicated. Concomitant medications
were not reported. Previous vaccination included: against tetanus in Jan2017. It
was reported the next day she stopped communicating by phone/ communication
disorder. The patient was in a nursing home, from where the reporter had
information that the patient was sleep excessive/still asleep. She didn't even say
hello to the phone and stopped moving. Before the vaccination, the patient was a
lying patient, but she raised her hands and communicated. The reporter was
suspected of having another stroke/suspicion of cerebrovascular accident. According
to the reporter, Covid-19 disease was also added. The patient died on 24Jan2021. On
15Feb2021, the attending physician was called: added medical history of the
patient. 48 hours after vaccination, the patient was monitored and no deterioration
was observed. On 17Jan2021 the patient became ill and was very sleepy. An ambulance
was called and the patient was hospitalized. On 16Feb2021, charge nurse was called:
patient was alright at the time of vaccination. No marks of stroke or infection.
She was cooperating, consciousness. On 15Jan2021 she was sleepy and tired. On
17Jan2021 she had positive antigen Covid-19 test. Many patients had similar
symptoms and many of them had antigen Covid-19 positive test. Rales, normal
saturation, normal physiological function. She was transferred to neurological
department after nurse urging. A hospitalisation report was requested. On 24Jan2021
patient died. Outcome of event COVID-19/positive antigen Covid-19 test was fatal,
for other events were not recovered. Autopsy was not indicated. And the reported
cause of death was COVID-19/positive antigen Covid-19 test.; Reported Cause(s) of
Death: COVID-19/positive antigen Covid-19 test" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1065568-1"
"1065568-1" "Pulmonary embolism; PCR Covid-19 positive; PCR Covid-19
positive; Vomiting; aggravated food intake; Eating disorder; Condition aggravated;
This is a spontaneous report from a contactable consumer (patient) downloaded from
the Regulatory Authority-CZSUKL-21001137. An 85-year-old female patient received
bnt162b2 (COMIRNATY), 1st dose on 11Jan2021 and 2nd dose on 01Feb2021, both via
intramuscular at single dose for COVID-19 immunisation. Medical history included
ongoing thyroid disorder and patient was on therapy (psychotropic medicinal
products and food supplements) and varicose vein operation. The patient's
concomitant medications were not reported. After 7 days after the 2nd dose, there
were some adverse reaction: aggravated condition, vomiting, aggravated food intake,
eating disorder, all on 08Feb2021. She was transferred to the hospital, where she
was diagnosed with massive pulmonary embolism with saturation 50% on 08Feb2021. PCR
Covid-19 was positive on 09Feb2021. PCR Covid-19 positive 09Feb2021. Patient died
on 09Feb2021. The cause of death was reported as embolism lung. Autopsy was done.
Autopsy results was not available and will be informed about autopsy results. No
follow-up attempts possible. Batch/Lot numbers cannot be obtained.; Reported
Cause(s) of Death: Embolism lung" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1067874-1"
"1067874-1" "death; COVID-19 positive; low oxygen saturation levels (79%);
throat pain; This is a spontaneous report from a contactable physician downloaded
from the Regulatory Authority-WEB NL-LRB-00446680 via Regulatory Authority. A 74-
years-old female patient received first dose of BNT162B2 (COMIRNATY), via unknown
route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The
patient medical history was not reported. The patient's concomitant medications
were not reported. The patient experienced death on 12Feb2021. It was also
reported that COVID-19 positive caused patient death. Three days after vaccination
on 07Feb2021, the patient had throat pain. 08Feb2021, COVID-19 PCR test performed
and patient tested positive. On 10Feb2021, COVID-19 PCR test was positive. The
patient was treated with 5L oxygen, but low oxygen saturation levels (79%) remained
on 11Feb2021. Start morphine with restrained policy. On 12Feb2021, the patient
deceased. Outcome of the event other event was unknown. It was unknown if an
autopsy was done or not. No follow-up attempts are possible; information on
batch/lot number cannot be obtained.; Reporter's Comments: BioNTech / Pfizer
vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no
Death Additional information ADR: 04Feb vaccination. 07Feb arise sore throat. 08Feb
Covid-19 PCR test performed. 10Feb result: positive. 11Feb low saturation (79%)
despite 5 liters of oxygen. Start morphine with restrained policy. 12Feb death BSN
available: yes COVID19 Previous COVID-19 infection: disease symptoms:
hospitalization; Reported Cause(s) of Death: Covid 19 positive; death" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1069329-1"
"1069329-1" ""COVID-19 post Infection/COVID-19 respiratory infection/COVID-19
PCR test on 28Jan2021; COVID-19 post Infection/COVID-19 respiratory
infection/COVID-19 PCR test on 28Jan2021; This is a spontaneous report from a
contactable physician downloaded from the Regulatory Authority-WEB via Regulatory
Authority with Regulatory Authority number: AT-BASGAGES-2021-07099. An 88-year-old
male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection,
batch/lot number: EL1491), via an unspecified route of administration on 15Jan2021
(at unspecified age) at single dose for covid-19 immunisation. Medical history
included ongoing Renal insufficiency (NINS), ongoing Polyneuropathy, ongoing COVID-
19, ongoing Coronary heart disease, ongoing Dementia. The patient's weight was not
reported, and height was not reported. No concomitant medication reported. ""A
possible connection between deaths and COVID vaccinations carried out shortly
before is suspected. The people were all vaccinated against COVID-19 on 15Jan2021
(1st vaccination with Comirnaty, batch EL1491), tested positive 4 to 13 days later
(one patient 32nd Days later) and died 10 to 20 days after the vaccination (said
patient 37 days later). A comparable number of deaths has not occurred in the
nursing home in recent years."" COVID infection has been circulating in the home
since January. All 12/14 deceased have been tested positive for Sars-CoV2 by PCR.
The patient in this NW report also tested positive for Sars-CoV2 by PCR
(28Jan2021), then died of his COVID infection at the home on 16Feb2021. On Jan2021
the patient experienced COVID-19 death. The patient's outcome was fatal for COVID-
19. The patient died on 16Feb2021 from COVID-19 respiratory infection. The patient
underwent lab tests and procedures which included COVID-19 PCR test: Positive on
28Jan2021. The patient died on 16Feb2021. An autopsy was not performed. No follow-
up attempts possible. No further information expected.; Reported Cause(s) of Death:
COVID-19 respiratory infection/COVID-19 post Infection"" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1072559-1"
"1072559-1" "COVID-19 PCR test Positive; COVID-19 respiratory infection;
COVID-19 PCR test Positive/COVID-19 respiratory infection; This is a spontaneous
report from a contactable physician downloaded from the Regulatory Authority-WEB
and received via Regulatory Authority AT-BASGAGES-2021-04882. A 93-year-old female
patient received first dose of BNT162B2 (COMIRNATY, lot number EL1491), via an
unspecified route of administration on 15Jan2021 at single dose for COVID-19
immunization. Medical history included ongoing COVID-19 Infection. Concomitant
medications were not reported. In Jan2021 the patient experienced COVID-19
respiratory infection. The patient's COVID-19 PCR test was Positive on 25Jan2021.
The patient died on 02Feb2021 from COVID-19 respiratory infection. No autopsy was
done. The outcome of the events was fatal. Relatedness of Comirnaty to AE assessed
by BASGAGES as Unlikely. No follow-up attempts are possible. No further
information is expected. Lot/batch number was provided.; Reported Cause(s) of
Death: COVID-19 respiratory infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1075434-1"
"1075434-1" "Death/ Sars-CoV-2 infection positive; This is a spontaneous
report from a contactable physician downloaded from the Regulatory Authority-WEB
[AT-BASGAGES-2021-04879]. A 89-years-old female patient received bnt162b2
(COMIRNATY, batch/lot number: EL1491), via an unspecified route of administration
on 15Jan2021 at single dose for covid-19 immunisation. Medical history included
status after Cervix-Ca (not ongoing Cervix carcinoma). The patient's concomitant
medications were not reported. The patient experienced SARS-COV-2 test positive on
22Jan2021. The patient died on 27Jan2021 from COVID-19 respiratory infection (also
reported the patient experienced death on 22Jan2021). The cause of death was SARS-
COV-2 infection according to death certificate. It was not reported if an autopsy
was performed. The patient's outcome was fatal. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: COVID-19
respiratory infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1075435-1"
"1075435-1" "COVID-19 respiratory infection; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority -WEB AT-
BASGAGES-2021-04881. A 91 years old male patient received first dose of bnt162b2
(COMIRNATY, Lot Number EL1491 and Expiration Date unknown) via an unspecified route
of administration on 15Jan2021 at single dose for COVID-19 immunisation. The
patient's medical history COVID-19 from unknown date (continuing). The concomitant
medications were not reported. In Jan2021 the patient experienced COVID-19 and died
on 30Jan2021 from COVID-19 respiratory infection. Lab test included positive COVID-
19 PCR test on 25Jan2021. There is no autopsy was done. The outcome of event was
fatal. No follow-up attempts are possible. No further information is expected. ;
Reported Cause(s) of Death: COVID-19 respiratory infection""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1075436-1"
"1075436-1" "COVID-19 pos infection/COVID-19 respiratory infection; COVID-19
pos infection/COVID-19 respiratory infection; This is a spontaneous report from a
contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-
2021-04885. An 85-years-old female patient received first dose of bnt162b2
(COMIRNATY, lot EL1491), via an unspecified route of administration on 15Jan2021 at
SINGLE DOSE for covid-19 immunisation. Medical history included exposure to COVID-
19 (ongoing COVID infection in patient's retirement home since Jan2021). The
patient's concomitant medications were not reported. The patient experienced covid-
19 pos infection on 28Jan2021. The patient died on 05Feb2021 from COVID-19
respiratory infection. The patient underwent lab tests and procedures which
included COVID-19 PCR test: positive on 28Jan2021. The patient died on 05Feb2021.
An autopsy was not performed. BASGAGES comment: no further info available.;
Reported Cause(s) of Death: COVID-19 respiratory infection""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1075437-1"
"1075437-1" "Cardio-respiratory arrest; Cardiac insufficiency; COVID post
Infection; This is a spontaneous report from a contactable physician downloaded
from the Regulatory Authority -WEB AT-BASGAGES-2021-04887. A 91-year-old female
patient received 1st vaccination of bnt162b2 (COMIRNATY, lot number: EL1491) via an
unspecified route of administration on 15Jan2021 at single dose for covid-19
immunisation. Ongoing underlying diseases include polyneuropathy, chronic pain
syndrome, chronic renal insufficiency, cardiac insufficiency. Patient had COVID-19
(COVID post Infection) in Jan2021. The patient's concomitant medications were not
reported. A possible connection between deaths and COVID vaccinations carried out
shortly before is suspected. The people were all vaccinated against COVID-19 on
15Jan2021 (1st vaccination with Comirnaty, batch EL1491), tested positive 4 to 13
days later (one patient 32nd Days later) and died 10 to 20 days after the
vaccination (said patient 37 days later). A comparable number of deaths has not
occurred in the retirement home in recent years. Since 01Jan COVID infection is
circulating in the home. All 12/14 deceased were tested positive for Sars-CoV2 by
means of PCR. The patient of this report is also positive, tested for Sars-CoV2 by
means of PCR (20Jan2021), then on 06Feb2021 patient died in the home. Patient died
on 06Feb2021 from COVID-19 respiratory infection, Cardio-respiratory arrest,
Cardiac insufficiency. Causes of death according to death certificate from
07Feb2021: Cardiovascular arrest, known cardiac insufficiency, status post COVID
positive infection. No autopsy performed. No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: Cardiac insufficiency;
Cardio-respiratory arrest; COVID post Infection" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1076452-1"
"1076452-1" "SARS-CoV-2 infection; unwell; This is a spontaneous report from
a contactable Physician. This is a report received from the MHRA. Regulatory
authority report number GB-MHRA-WEBCOVID-202102282003076740, Safety Report Unique
Identifier GB-MHRA-ADR 24852738. A 68 year old male patient received first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:EL0739) via an
unspecified route of administration, on 29Jan2021 at single dose for COVID-19
immunisation. The patient medical history included: reporter was unsure if patient
has had symptoms associated with COVID-19. Patient was not enrolled in clinical
trial. The patient's concomitant medications were not reported. On 04Feb2021 the
patient experienced SARS-CoV-2 infection (death, hospitalization and medically
significant) and unwell (hospitalization and medically significant). The patient
underwent lab tests and procedures which included oxygen saturation (04Feb2021): 60
% and COVID-19 virus test (04Feb2021): yes - positive COVID-19 test. The patient
died on 13Feb2021. The patient had not recovered from the event unwell at the time
of death. It was not reported if an autopsy was performed. The reported cause of
death was SARS-CoV-2 infection. The clinical course was reported as follows:
Patient became unwell on the evening of the day of his covid jab. Gradually
deteriorated and was tested positive for covid on the 04Feb2021. The reporter saw
him at the covid hub on the 4th where his saturations were 60%. He was sent to
hospital where he passed away on the 13Feb2021. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: SARS-
CoV-2 infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1076464-1"
"1076464-1" "tested positive on 16th February/ died directly as a result of
COVID; tested positive on 16th February/ died directly as a result of COVID; This
is a spontaneous report from a contactable consumer reporting on behalf of her
father (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an
unspecified route of administration on Jan2021 at a single dose for COVID-19
immunization. Medical history included chronic lymphocytic leukaemia (CLL). The
patient's concomitant medications were not reported. The patient received his first
Pfizer COVID vaccine in early January. The reporter returned and both she and her
father (patient who received the vaccine) displayed symptoms of COVID last week
(Feb2021). They tested positive on 16Feb2021. The patient tested positive following
receipt of the Pfizer vaccine. He was a retired general practitioner and currently
shielding. The patient has died directly as a result of COVID, the elderly
gentleman was 77 with underlying, treated CLL and received immunoglobulins on a 3
monthly basis. He was admitted to hospital on Saturday 27Feb2021 as his SATS were
incredibly low and then placed on CPAP on Sunday 28Feb2021. He passed away on the
evening of Monday 1Mar2021. He had received his first dose of the Pfizer vaccine
some weeks ago but not received the 2nd dose. It was not reported if an autopsy was
performed. Information on the lot/batch number has been requested.; Reported
Cause(s) of Death: died directly as a result of COVID; died directly as a result of
COVID" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1081820-1"
"1081820-1" "COVID-19 aggravated; COVID-19 PCR test positive; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority, regulatory authority [FR-AFSSAPS-MP20210273]. A 96-year-old male patient
received the first dose of bnt162b2 (COMIRNATY, Lot no.: EJ6788), intramuscular in
the right arm on 21Jan2021 at single dose for covid-19 immunization. Medical
history included ischaemic heart disease, cancer of prostate, and CVA
(cerebrovascular accident). The patient's concomitant medications were not
reported. The patient experienced covid-19 aggravated on 02Feb2021. The patient was
vaccinated as part of the COVID-19 vaccination campaign. The patient considered to
be at risk of developing a severe form of COVID-19 disease. It was not specified if
the patient had a history of COVID-19. On 26Jan2021: performance of a positive PCR
test (no variant search) and on 02Feb2021: Onset of symptoms of COVID-19. The
patient was treated in the nursing home. The patient died on 05Feb2021. The cause
of death was COVID-19 aggravated and COVID-19 PCR test positive. The outcome of the
events was fatal. It was unknown if an autopsy was performed. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID-19 aggravated; COVID-19 PCR test positive" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1081821-1"
"1081821-1" "COVID-19 AGGRAVATED; COVID-19 PCR test positive; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB FR-AFSSAPS-MP20210274. An 82-year-old female patient received the
first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ9788), via
intramuscular on 21Jan2021 at single dose in right arm for COVID-19 immunisation.
Medical history included dwarfism from an unknown date and unknown if ongoing,
ongoing renal insufficiency, dementia from an unknown date and unknown if ongoing.
The patient's concomitant medications were not reported. Patient was considered to
be at risk of developing a severe form of COVID-19 disease (age). Patient
vaccinated as part of the COVID-19 vaccination campaign. It was reported on
26Jan2021: performance of a positive COVID-19 PCR test (no variant search). On
02Feb2021, onset of symptoms of COVID-19, COVID-19 aggravated. Patient treated in
the nursing home. Duration was reported as 5 days. Evolution: On 06Feb2021, death
of the patient. It was unknown if an autopsy was performed. The outcome of the
events was fatal. No follow-up attempts are possible, no information is
expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19
AGGRAVATED" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1081822-1"
"1081822-1" "COVID-19 aggravated; COVID-19 PCR test positive; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority FR-AFSSAPS-MP20210275. A 90-year-old male patient received first dose of
bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 21Jan2021 at single dose
in right arm for covid-19 immunisation. Medical history included ongoing
arteritis. The patient's concomitant medications were not reported. On 28Jan2021,
the patient Symptoms of COVID-19 appear Covid-19 aggravated was reported,
performance of a positive PCR test (no variant search). Patient treated in the
nursing home. EVOLUTION: On 03Feb2021: Death of the patient. It was not reported if
an autopsy was performed. No follow-up attempts are possible, no information is
expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19 PCR test
positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1081823-1"
"1081823-1" "COVID-19 PCR test positive; COVID-19 aggravated; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB FR-AFSSAPS-MP20210277. A 78-year-old male patient received he first
dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on the left arm, on
21Jan2021 at a single dose for covid-19 immunisation. Ongoing medical history
included Afib, heart failure, and CVA (cerebrovascular accident). The patient's
concomitant medications were not reported. On 23Jan202, symptoms of COVID-19
appear/ COVID-19 aggravated. On 25Jan2021: performed a positive PCR test (no
variant search)/ COVID-19 PCR test positive. The patient died on 28Jan2021. It was
not reported if an autopsy was performed. No follow-up attempts are possible, no
information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive;
COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1084861-1"
"1084861-1" "COVID-19 respiratory infection; This is a spontaneous report a
contactable physician downloaded from the Regulatory Authority [regulatory
authority AT-BASGAGES-2021-04880]. The reporter reported similar events for 2
patients, this is the 1st of 2 reports. A 90-year-old female patient received the
first dose of bnt162b2 (COMIRNATY, lot number EL1491) via an unspecified route of
administration on 15Jan2021 at a single dose for covid-19 immunisation. The
patient's medical history included Heart failure (continuing), Viral hepatitis B,
COVID-19 (continuing). The patient's concomitant medications were not reported. The
patient was positive tested for Sars-CoV2 by means of PCR (25Jan), on 30Jan2021
21:05 and died in the home from COVID-19 respiratory infection. The patient was
already palliative before COVID-19 and considered as a terminal patient. No autopsy
was done. Causality between the event and vaccine was assessed as unlikely by the
HA. No follow-up attempts are possible. No further information is expected.;
Sender's Comments: Linked Report(s) : AT-PFIZER INC-2021242520 same reporter, same
vaccine, similar events in different patient; Reported Cause(s) of Death: COVID-19
respiratory infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1084862-1"
"1084862-1" ""SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/
COVID-19; SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19;
This is a spontaneous report from a contactable physician downloaded from the
Regulatory Authority-WEB regulatory authority AT-BASGAGES-2021-04886. A 94-year-old
female patient received bnt162b2 (COMIRNATY, lot/batch number: EL1491) , via an
unspecified route of administration on 15Jan2021 at single dose for COVID-19
immunisation . Medical history included ongoing breast carcinoma (Mammary gland
right) and Infarct cerebral (ischemic infarction) from an unspecified date and not
ongoing. The patient's concomitant medications were not reported. The patient
experienced sars-cov2-positive infection/ covid-19 respiratory infection/ covid-19
(drug ineffective) (death) on Feb2021. The patient underwent lab tests and
procedures which included COVID-19 PCR test: positive on 05Feb2021. Narrative case
summary and further information was reported as ""possible association between
deaths and COVID vaccinations given promptly before is suspected. The individuals
were all vaccinated against COVID-19 on Jan152021 (1st partial vaccination with
Comirnaty, batch EL1491), tested positive 4 to 13 days later (One patient 32 days
later), and died 10 to 20 days after vaccination (said patient 37 days later). A
similar cluster of deaths did not occur at the nursing home in recent years. COVID
infection has been circulating in the home since 01Jan2021. All 12/14 decedents
have tested positive for Sars-CoV2 by PCR. The patient in this NW report also
tested pos. for Sars-CoV2 by PCR (05Feb2021), then died at the home on 11Feb2021.
"" The patient died on 11Feb2021 from COVID-19. An autopsy was not performed. No
follow-up attempts are possible. No further information is expected. ; Reported
Cause(s) of Death: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/
COVID-19"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1084863-1"
"1084863-1" "drug ineffective; COVID-19; This is a spontaneous report a
contactable physician reporting on different patients, this is the second case.
The first case report was downloaded from the Regulatory Authority [regulatory
authority AT-BASGAGES-2021-04880]. A elderly patient of an unspecified gender
received the first dose bnt162b2 (COMIRNATY; Lot # EL1491) vaccine , via an
unspecified route of administration 15Jan2021 at single dose for covid-19
immunisation. The patient medical history and concomitant medications were not
reported. The patient was tested positive to SARS-COV-2 on 16Feb2021 and died from
it on 21Feb2021. It is unknown if an autopsy was carried out. No follow-up
attempts are possible. No further information is expected.; Sender's Comments:
Linked Report(s) : AT-PFIZER INC-2021221786 same reporter, same vaccine, similar
events in different patient.; Reported Cause(s) of Death: Covid-19" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1084890-1"
"1084890-1" "symptoms of COVID-19 appeared; symptoms of COVID-19 appeared and
performance of a positive PCR test (no variant search); This is a spontaneous
report from a contactable physician downloaded from the regulatory authority. The
regulatory Authority Report Number is FR-AFSSAPS-MP20210276. A 93-year-old female
patient received the first dose of bnt162b2 (COMIRNATY; lot number EJ6788),
intramuscular in the left arm on 21Jan2021 at a single dose for covid-19
immunisation. Medical history included ongoing diabetes, ongoing dementia, and
ongoing Afib. The patient's concomitant medications were not reported. Declaration
made through the national portal, made by a health professional. Patient considered
to be at risk of developing a severe form of COVID-19 disease was yes (age).
History of COVID-19 was not specified. Patient was vaccinated on 21Jan2021 as part
of the COVID-19 vaccination campaign. On 26Jan2021, symptoms of COVID-19 appeared
and performance of a positive PCR test (no variant search). Patient was treated in
the nursing home. On 27Jan2021, the patient died. Accountability made without
prejudice to the elements of investigations which could be carried out within the
framework of legal or amicable compensation procedures. It was not reported if an
autopsy was performed. The events are serious, fatal. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: symptoms
of COVID-19; positive PCR test" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1084891-1"
"1084891-1" "COVID-19 PCR test positive/ COVID-19 aggravated; This is a
spontaneous report from a contactable physician downloaded from Regulatory
Authority, regulatory authority FR-AFSSAPS-MP20210278. A 77-year-old male patient
received first dose of BNT162B2 (COMIRNATY; lot number: EJ6788) on left arm,
intramuscular on 21Jan2021 at single dose for COVID-19 immunisation. Medical
history included ongoing epilepsy, cerebrovascular accident (CVA) from 2011 to
2013, and dementia. The patient's concomitant medications were not reported. The
patient experienced COVID-19 PCR test positive and COVID-19 aggravated on
25Jan2021. The patient was considered to be at risk of developing a severe form of
COVID-19 disease. The patient was vaccinated as part of the COVID-19 vaccination
campaign. It was also reported that on 25Jan2021, symptoms of COVID-19 appeared.
Additionally on 25Jan2021, performance of a positive PCR test (no variant search).
Patient was treated in the nursing home. On 28Jan2021, death of the patient. The
patient died on 28Jan2021. It was not reported if an autopsy was performed. No
follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: COVID-19 PCR test positive" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1086537-1"
"1086537-1" "acute shortness of breath, immediately transferred to the
hospital; Death NOS; COVID-19 respiratory infection; This is a spontaneous report
downloaded from the regulatory authority-WEB [Regulatory Authority number AT-
BASGAGES-2021-04883] from a contactable physician. An 87-year-old female patient
received the 1st dose of bnt162b2 (COMIRNATY) (lot# EL1491), via an unspecified
route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation.
The patient's medical history and concomitant medications were not reported. The
patient experienced death NOS (death) on 29Jan2021, acute shortness of breath,
immediately transferred to the hospital (death, caused hospitalization on
27Jan2021) on 27Jan2021, COVID-19 respiratory infection (death) on 26Jan2021. The
patient underwent lab tests and procedures which included COVID-19 PCR test:
positive on 26Jan2021. It was not reported if an autopsy was performed. No follow-
up attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID-19 respiratory infection; Acute dyspnea; Death NOS" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1086668-1"
"1086668-1" "COVID-19 aggravated; fever between 38 and 39 C; desaturation
(91%); loss of appetite; isolated cough; This is a spontaneous report from a
contactable physician from the Medicines Agency (MA)WEB. The Regulatory Authority
report number is FR-AFSSAPS-RS20210256. A 71-year-old male patient received the
first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration date not
reported), intramuscular in the left arm on 27Jan2021 at a single dose for COVID-19
immunisation. Medical history included Hypertension arterial, Iron deficiency
anemia, arrhythmia, Diabetes, Delusional psychosis, and hypothyroidism. The
patient's concomitant medications were not reported. The patient is considered to
be at risk of developing a severe form of COVID19 disease (diabetes, heart
disease). The patient experienced COVID-19 aggravated on 05Feb2021. It was further
reported that on 05Feb2021, onset of fever between 38 and 39 C, desaturation (91%),
loss of appetite and isolated cough. The patient was hospitalized on an unspecified
date in Feb2021 due to the events. On 13Feb2021, death of the patient due to
complicated COVID following according to the declaring doctor. It was not reported
if an autopsy was performed. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: isolated cough; COVID-19
aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1089835-1"
"1089835-1" "sudden death/death after vaccination; This is a spontaneous
report from a contactable consumer downloaded from the regulatory authority-WEB CZ-
CZSUKL-21001643. A 78-year-old male patient received his first dose of BNT162B2
(COMIRNATY), via an unspecified route of administration on 11Jan2021 at single dose
for covid-19 immunisation. Medical history included abdominal pain from 23Dec2020
and patient was admitted to hospital. On 30Dec2020, the patient was diagnosed with
pancreatic tumour. It was decided to not operate. Stent was applied instead. Three
patients from the same room was tested as Covid-19 positive, the patient was
negative on 30Dec2020. He might have been Covid-19 positive in Oct2020 (two days
fever, loss of smell), but was not tested that day. On 08Jan2021 the patient had
fever, unknown reason. Concomitant drugs were not reported. The patient experienced
sudden death/death after vaccination on 12Jan2021. The event was serious for death,
hospitalization, medical significant, and life-threatening. The cause of death was
unknown. According to a physician, patient was not at terminal stage, preparation
for home care with perspective of 3 months. It was not reported if an autopsy was
performed. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: unknown cause of death" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1094268-1"
"1094268-1" "Confusion; shortness of breath; seizure; SARS-CoV-2 infection;
SARS-CoV-2 infection; Seizures; Heart rate drop; This is a spontaneous report from
a contactable consumer received from the Regulatory Agency. The Regulatory
Authority report number is GB-MHRA-WEBCOVID-202103061608463700. Safety Report
Unique Identifier GB-MHRA-ADR 24889457. An 85-year-old male patient received the
1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Ek4243), via an
unspecified route of administration, on 21Jan2021, at single dose, for COVID-19
immunisation. The patient's medical history and concomitant medications were not
reported. Patient had not had symptoms associated with COVID-19, did not have a
COVID-19, was not enrolled in clinical trial. The patient experienced seizure in
Jan2021 with outcome of unknown , sars-cov-2 infection (death) on 04Mar2021 with
fatal outcome on 04Mar2021, confusion (non-serious) on 23Jan2021 with outcome of
unknown, seizures (non-serious) on 23Jan2021 with outcome of unknown. It was
reported that the patient had a seizure overnight in Jan2021, ended up confused (on
23Jan2021) and short of breathe. He was admitted to hospital and treated with
antibiotics. Patient had 2nd seizure and was treated for further infection. 3rd
seizure just over a week later with continued confusion. Heart rate dropped.
Patient tested positive and passed away. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1094669-1"
"1094669-1" "a positive SARS COVID 19 PCR test; COVID-19 aggravated; COVID-19
pneumonitis; This is a spontaneous report from a contactable physician downloaded
from the Regulatory Agency-WEB (FR-AFSSAPS-AM20210427). A 96-year-old female
received BNT162B2 (COMIRNATY), intramuscularly, first dose on 19Jan2021 (Lot
number: EJ6788) and second dose on 09Feb2021 (Lot number: EK9788) in the left
deltoid, both at a single dose for COVID-19 immunisation. Medical history included
osteoarthritis knee, coxarthrosis, cataract, venous peripheral insufficiency,
erysipelas, atrial fibrillation (AFib), hand osteoarthritis, and recurrent fall.
The patient was not previously diagnosed with COVID-19. Concomitant medications
included pantoprazole (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), zopiclone
(IMOVANE), potassium chloride (DIFFU K), pregabalin (MANUFACTURER UNKNOWN) ,
furosemide (MANUFACTURER UNKNOWN), trimebutine (MANUFACTURER UNKNOWN), salbutamol
sulfate (VENTOLINE), oxazepam (SERESTA), ramipril (MANUFACTURER UNKNOWN), and
bisoprolol hemifumarate (MANUFACTURER UNKNOWN). The patient experienced a positive
SARS COVID 19 PCR test and COVID-19 aggravated on 13Feb2021, which caused
hospitalization on 13Feb2021 and were reported as fatal. The patient also
experienced COVID-19 pneumonitis in Feb2021, which was reported with
hospitalization and fatal. The clinical course was reported as follows: On
11Feb2021, the patient had an onset of fever and was hospitalized on 13Feb2021
before a positive SARS COVID-19 PCR test. There was clinical degradation
thereafter, initiation of oxygen therapy and unspecified corticosteroid therapy on
14Feb2021. It was also reported that the patient experienced behavioral disorder
and hallucinations from the first dose of the vaccine. The patient underwent lab
tests and procedures which included SARS-CoV-2 PCR test: positive on 13Feb2021. The
patient died on 22Feb2021. The cause of death was reported as COVID-19 pneumonitis.
It was not reported if an autopsy was performed. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: COVID-19
pneumonitis" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1099516-1"
"1099516-1" "Reduced general condition; COVID-19 respiratory infection; This
is a spontaneous report from a contactable physician. This is a report received
from the Regulatory Authority-WEB. Regulatory authority number AT-BASGAGES-2021-
04874. An 88 years old female patient received the first dose of BNT162B2
(COMIRNATY, Lot. EL1491) at single dose, on 15Jan2021, for COVID-19 immunisation.
Relevant medical history and concomitant medications were unknown. Post the
vaccination, the patient has been tested for COVID-19 and resulted positive on
19Jan2021. On 22Jan2021, the patient experienced reduced general condition and died
on 30Jan2021. Clinical outcome of reduced general condition and death was fatal.
Cause of death was reported as COVID-19 respiratory infection. It was unknown if
autopsy was done. Relatedness of drug to reaction(s)/event(s) for Comirnaty to
all events, reported as Unassessable/Unclassifiable by BASGAGES. No follow-up
attempts possible. No further information expected.; Reported Cause(s) of Death:
COVID-19 respiratory infection; Reduced general condition" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1099517-1"
"1099517-1" "COVID-19 PCR test positive; Death; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB AT-
BASGAGES-2021-04884. A 76-year-old female patient received the first dose of
bnt162b2 (COMIRNATY) (Lot # EL1491), via an unspecified route of administration at
single dose on 15Jan2021 for COVID-19 immunisation. Medical history included
ongoing chemotherapy NOS. Concomitant medications were not reported. The patient
experienced death NOS on 01Feb2021, COVID-19 PCR test positive on 26Jan2021. The
patient underwent lab tests and procedures which included SARS-CoV-2 test: positive
on 26Jan2021. The patient died on 01Feb2021 from COVID-19 respiratory infection. It
was not reported if an autopsy was performed. Missing info on cause of death and
possible underlying diseases. Clinical course was reportrd as follows: Since
01Jan2021 a COVID infection was circulated in the retirement home. All 12/14
deceased were tested positive for Sars-CoV2 by means of PCR. The patient of this AE
report was also positive. Tested for Sars-CoV2 by means of PCR (26Jan2021), on
29Jan2021 in the hospital due to deterioration, died there on 01Feb2021. No
follow-up attempts possible. No further information expected.; Reported Cause(s) of
Death: COVID-19 respiratory infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1099628-1"
"1099628-1" "COVID-19 aggravated; This is a spontaneous report from a
contactable physician downloaded from the Regulatory Authority-WEB. The Regulatory
Authority report number is FR-AFSSAPS-BR20210398. A 93-year-old male patient
received the first dose of BNT162B2 (COMIRNATY, batch number: EK9788, expiration
date not reported), intramuscular on 11Feb2021 at a single dose for COVID-19
immunisation. Medical history included Type 2 diabetes mellitus, cerebrovascular
accident (CVA), and dementia. The patient's concomitant medications were not
reported. The declaration was made by a domestic hospitalisation physician for a
resident of a facility for dependent elderly people. Note the absence of a
coordinating physician in this facility. On 01Feb2021, this patient left a
Pneumology department which was the center of a large cluster on that date. PCR
negative at the exit. He was admitted to facility for dependent elderly people. On
03Feb2021, his state of health began to deteriorate and this was initially
attributed to frustration at leaving his home. On 11Feb2021, first injection of the
COMIRNATY was administered with continued deterioration of the general condition.
On 16Feb2021, the patient experienced bronchial congestion, stopping hydration and
PCR COVID positive. On 17Feb2021, the patient experienced COVID-19 aggravated. On
18Feb2021, intervention by the domestic hospitalisation physician for respiratory
deterioration (distress) with agitation and pain which appeared the day before
which included introduction of hyoscine butylbromide (SCOBUREN) and midazolam. On
19Feb2021, death of the patient. In total, the patient probably infected with COVID
before his first vaccine injection, which deteriorated in the days that followed.
The domestic hospitalisation physician cannot rule out a severe form of COVID
following vaccination. It was not reported if an autopsy was performed. No
follow-up attempts are possible, no information is expected.; Reported Cause(s) of
Death: COVID-19 aggravated" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1099645-1"
"1099645-1" "COVID-19 PCR test positive; COVID-19 aggravated/fever, rapidly
worsening; This is a spontaneous report from a contactable physician downloaded
from the regulatory authority-WEB regulatory authority FR-AFSSAPS-MP20210279. A
101-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution
for injection, lot: EJ6788), intramuscular on left arm on 21Jan2021 at single dose
for covid-19 immunisation. Medical history included cerebrovascular accident (CVA)
from 2013 to 2013 (not ongoing). The patient's concomitant medications were not
reported. On 22Jan2021, the patient experienced fever, rapidly worsening and COVID-
19 aggravated. On 25Jan2021 with PCR test for COVID-19: positive, no variant
testing. The patient died on 27Jan2021 due to COVID-19 and COVID-19 PCR test
positive (reported as severe COVID leading to death). It was unknown if an autopsy
was performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: COVID-19 aggravated/fever, rapidly
worsening; COVID-19 PCR test positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1101613-1"
"1101613-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms with fatal outcome/died on 10Feb2021; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Agency-WEB AT-BASGAGES-
2021-04888. A 90-year-old female patient received first dose of BNT162B2
(COMIRNATY, lot number: EL1491), via an unspecified route of administration on
15Jan2021 at single dose for COVID-19 immunisation. Medical history included
ongoing palliative care palliative and COVID-19 from 07Feb2020 and ongoing. The
patient's concomitant medications were not reported. On 07Feb2021, the patient
experienced positive COVID-19 test with symptoms with fatal outcome. The patient
underwent lab tests and procedures which included COVID-19 PCR test: positive on
07Feb2021 and COVID-19 virus test negative on 04Feb2021. The patient died on
10Feb2021. It was not reported if an autopsy was performed. No follow-up attempts
are possible, batch number already obtained. Amendment: This follow-up report is
being submitted to allow appropriate reporting to health authorities.; Reported
Cause(s) of Death: COVID-19 respiratory infection" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1104932-1"
"1104932-1" "shortness of breath; PCR test was then made and turned out
positive; Death; This is a spontaneous report downloaded from the Regulatory
Authority-WEB regulatory authority number DE-PEI-CADR2021017328. A non-contactable
consumer reported that a 95-year-old female patient received BNT162b2 (COMIRNATY,
solution for injection, batch/lot: unknown), via an intramuscular route of
administration on 09Jan2021 at single dose for COVID-19 immunization. Medical
history included ongoing cardiac failure chronic. Concomitant medications was not
reported. Heart failure / the person complained 10 days after vaccination about
shortness of breath and thus directed to the city hospital. The person was from the
beginning of December in quarantine since there was a positive case in the home.
All PCR tests were negative. In the hospital a PCR test was then made and turned
out positive. On 02Feb2021 the person died. The cause of death was unknown. Outcome
of death was fatal and outcome of both events was not recovered. Causality from
regulatory authority: Inconsistent causal association to immunization No
follow-up attempts are needed, follow-up automatically provided by regulatory
authority.; Reported Cause(s) of Death: Unknown cause of death" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1104992-1"
"1104992-1" "Hypoxia; Vaccination Failure; COVID-19; This is a spontaneous
report from a contactable physician downloaded from the regulatory authority-WEB.
The regulatory authority report number is FR-AFSSAPS-CF20210232. A 91-year-old
female patient received BNT162B2 (COMIRNATY), intramuscular with the first dose on
08Jan2021 (Lot number unknown) and the second dose in the left arm on 29Jan2021
(Lot number EJ6788) and second dose (Lot number EJ6788) for covid-19 immunization.
Medical history included hypertension arterial, dementia, pulmonary embolism,
chronic bronchitis, each from an unknown date and unknown if ongoing. The
patient's concomitant medications were not reported. The patient experienced
covid-19 and vaccination failure on 08Feb2021; the patient also experienced hypoxia
on 14Feb2021. The events were serious as they lead to death. The patient underwent
lab tests and procedures which included polymerase chain reaction (PCR), which was
negative on 02Feb2021; SARS-CoV-2 test which was positive on 08Feb2021. The
clinical course was as follows: the first injection was given on 08Jan2021. The
patient tested positive for COVID-19 on 08Feb2021 (about 10 days after the second
injection), but tested negative for PCR on 02Feb2021. As of 08Feb2021, this
patient presented fatigue without clinical signs (absence of oedema, urticaria,
respiratory and cardiocirculatory failure). On 14Feb2021, the patient's condition
deteriorated. A rapidly settling hypoxia was observed requiring the intervention of
the doctor on duty in emergency. Death occurred within 15-20 minutes after the
hypoxia was detected. Death of the patient occurred before she could be
hospitalised. No search for a viral variant was performed. Hypoxia stop date was
reported as 14Feb2021, with fatal outcome. The patient died on 14Feb2021. An
autopsy was not performed. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Unknown cause of death"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1112855-1"
"1112855-1" "SARS COVID 19; died within a week; Haematemesis; This is a
spontaneous report from a contactable physician downloaded from the Agency
Regulatory Authority-WEB [regulatory authority number AT-BASGAGES-2021-09458]. A
76-year-old male patient received his first dose of BNT162b2 (COMIRNATY, lot number
EP2163), intramuscular on 14Jan2021, at single dose for COVID-19 immunisation. The
patient medical and concomitant medications were not reported. The patient
experienced haematemesis and SARS COVID 19 on 17Jan2021. On 17Jan2021 the patient
was hospitalized. On the same day, in hospital, the patient was found positive
COVID-19 PCR test. The patient was vaccinated on Thursday and was positive on
Sunday, so was probably vaccinated in the incubation period. Previously, he was
never tested positive and tests were carried out very frequently in the affected
nursing home. Patient was hospitalized on 17Jan2021 and died within a week due to
SARS COVID 19 (on unspecified date in Jan2021). The outcome of event haematemesis
was unknown. It was not reported if an autopsy was performed. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: SARS COVID 19; died within a week" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1112896-1"
"1112896-1" ""Acute respiratory failure; COVID-19; Fever; Comirnaty was
administered via subcutaneous route; This is a spontaneous report from a non-
contactable consumer downloaded from Regulatory Authority-WEB DE-PEI-
CADR2021015865. An 84-year-old female patient received the first dose of
bnt162b2 (COMIRNATY) (Batch/Lot Number: Unknown) subcutaneous on 09Jan2021 at
single dose for COVID-19 immunisation. The patient medical history and concomitant
medications were not reported. On 21Jan2021 the patient experienced fever, acute
respiratory failure, COVID-19. The outcome for fever and COVID-19 was unknown, the
outcome for acute respiratory failure was fatal. The patient underwent lab tests
and procedures which included SARS-CoV2 test: positive on 21Jan2021. The patient
died on 24Jan2021. An autopsy was not performed. Sender Comment: The current
admission took place in COVID intensive care unit, accompanied by the emergency
doctor. The emergency doctor reports that the patient developed a fever about a
week ago with a known SARS-CoV2 infection. The patient had previously been
vaccinated for the first time on 09Jan2021. A home resident had previously tested
positive for SARS CoV2. When the emergency doctor arrived, the patient was already
respiratory unstable with an SO2 of 50%. After NIV ventilation the saturation was
90%. Upon arrival at our hospital, we saw a cardiorespiratory unstable patient. The
BGA showed global respiratory insufficiency with a pH value of 6.8. Within 5
minutes of her arrival, the patient was gasped and required resuscitation. The
resuscitation remained frustrated. The patient died on 24Jan2021 at 7:19 a.m."".
Causality from Regulatory Authority: Inconsistent causal association to
immunization for all events. No follow-up attempts needed, follow-up
automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Acute
respiratory failure"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1112923-1"
"1112923-1" "Severe acute respiratory syndrome; Respiratory insufficiency;
COVID-19/severe acute respiratory syndrome/ respiratory insufficiency; COVID-19;
This is a spontaneous report downloaded from the Regulatory Authority-WEB (ES-
AEMPS-775868). A contactable physician reported that a 86-year-old female patient
received bnt162b2 (COMIRNATY), via an unspecified route of administration on
05Jan2021 (first dose, lot EJ6796) at single dose, and via an unspecified route of
administration on 12Feb2021 (second dose, lot unknown) at single dose for covid-19
immunization. Medical history included being institutionalized, exposure to COVID-
19 from Feb2021 (close contact of confirmed cases). The patient's concomitant
medications were not reported. The patient experienced covid-19 on 27Jan2021, and
severe acute respiratory syndrome/ respiratory insufficiency on 16Feb2021.
Ambulance was notified of severe acute respiratory syndrome associated with
coronavirus. The patient underwent lab tests included COVID-19 PCR test: negative
on 22Jan2021, COVID-19 PCR test: positive on 09Feb2021 with antibodies not
performed, COVID-19 antigen test: positive on 27Jan2021. Outcome of events was
fatal. The patient died on 18Feb2021. It was not reported if an autopsy was
performed. The cause of death included drug ineffective, COVID-19, severe acute
respiratory syndrome, respiratory insufficiency. This notification also informed
that of the possibility of a post-vaccination reaction event to the second dose
that was administered on 12Feb2021. The evaluation after reviewing and expanding
the available information, considered that the verification of a previous positive
Active Infection Diagnostic Test, a positive PCR prior to the events reported and
the clinical judgment of severe acute respiratory disease associated with
coronavirus, allowed establishing a relationship between the reported event with
covid infection in a patient with incomplete immunization. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
Respiratory insufficiency; covid-19; Severe acute respiratory syndrome; COVID-
19/severe acute respiratory syndrome/ respiratory insufficiency" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1113080-1"
"1113080-1" "COVID-19 aggravated; This is a spontaneous report from a
contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-
MP20210365. An 89-year-old male patient received first dose of bnt162b2
(COMIRNATY, Batch/Lot Number: EJ6788), intramuscular, in Arm Left on 21Jan2021 at
single dose (reported as 1 DF) for covid-19 immunisation. Medical history
included Hip prosthesis user and COVID-19. The patient's concomitant medications
were not reported. The patient experienced covid-19 aggravated on 26Jan2021,
serious due to resulted in death. Therapeutic measures were taken as a result of
covid-19 aggravated (covid-19). The patient died on 18Feb2021. An autopsy was not
performed. The clinical course was reported as follows: Reporting via national
website from a healthcare professional. Patient considered to be at risk of
developing severe COVID-19. The patient had history of COVID-19. Testing was done
on 26Jan2021. Course of the events: The patient was vaccinated in the framework of
anti-COVID-19 vaccination plan. The first injection was performed with COVID-19
mRNA Vaccine (nucleoside modified) (COMIRNATY), lot #EJ6788 by intramuscular route
in the left arm on 21Jan2021. On 26Jan2021, the patient was diagnosed with
aggravated COVID-19 with fever and oxygen desaturation. On 03Feb2021, oxygen
(unspecified trade name) therapy and IV fluids were given. From 09Feb2021, the
patient presented with appetite loss, refusal of feeding and urinary retention. On
18Feb2021, the patient died. The conclusion was aggravated COVID-19 leading to
death 28 days following vaccination. No other information was available. No FU
attempts possible. No further information expected.; Reported Cause(s) of Death:
COVID-19 aggravated" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1114005-1"
"1114005-1" ""Tested positive for COVID-19; Exsiccosis; Oliguria; Gut pain;
Pyrexia; Nausea; Appetite lost; Diarrhoea; Hypotension; Unknown cause of death;
BNT162b2 (COMIRNATY), intravenous; This is a spontaneous report from a non-
contactable consumer, downloaded from the Regulatory Authority (regulatory
authority number DE-PEI-CADR2021014173). A 75-year-old female patient received a
single dose of BNT162b2 (COMIRNATY), intravenous, on 09Jan2021, for COVID-19
immunisation. The patient's medical history included ongoing polyarthralgia,
ongoing adipositas, ongoing cardiac valve replacement, ongoing apoplexy, ongoing
atrial fibrillation, Hashimoto-Thyreoiditis, and ongoing hypertension. The
patient's concomitant medications included unspecified anti-hypertensive drug(s).
The patient previously took Phenprocoumon (MARCUMAR) as anticoagulant therapy. On
10Jan2021 the patient experienced gut (abdominal) pain, fever, nausea, loss of
appetite, and diarrhea (described as liquid stool). On 12Jan2021 the patient
experienced deterioration with diarrhea, exsiccosis, and oliguria. On 15Jan2021,
the patient was treated with infusions, and her hypertensive medication was reduced
due to hypotension; the patient was hospitalized. On 16Jan2021, the patient tested
positive for COVID-19. On 16Jan2021 the patient died, however the cause of death
was not provided. No autopsy was performed. The patient had not recovered from
diarrhea, exsiccosis, oliguria, while the outcome of the other events was unknown.
Sender Comment: Arterial hypertension, adipositas, atrial fibrillation,
anticoagulation with Marcumar, condition after cardiac valve replacement,
polyarthrosis, Hashimoto-Thyreoiditis, condition after apoplexy. On 09Jan2021
vaccination COVID-19, on 10Jan2021 abdominal pain, fever, nausea, loss of appetite,
liquid stool, 12Jan2021 deterioration with diarrhea, exsiccosis, oliguria; Therapy
with infusions, reduction of hypertensive medication due to hypotension, on
15Jan2021 Hospitalization, positve test for Covid-19, on 16Jan2021 Exsitus letalis
Causality has been assessed as ""D. Unclassifiable "" for all events by the
Facility. No follow-up attempts needed, follow-up automatically provided by
Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death"" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1114009-1"
"1114009-1" "27Jan2021 positive rapid test; Respiratory distress; This is a
spontaneous report from a non-contactable consumer downloaded from the Regulatory
Authority-WEB regulatory authority number DE-PEI-CADR2021015257. A 90-year-old
female patient received bnt162b2 (COMIRNATY, lot number unknown), via intramuscular
on 23Jan2021 at single dose for COVID-19 immunisation. The relevant medical history
included asymptomatic COVID-19 from 27Dec2020. Concomitant medications were not
reported. On 26Jan2021 the patient experienced breathing difficulties and
respiratory distress. The patient had rapid test positive on 27Jan2021. The patient
died on 31Jan2021. No autopsy was done. The patient underwent lab test included
rapid test which showed positive on 27Jan2021; PCR smear with unknown results (PCR
result is not yet available) on 29Jan2021. The outcome of the event respiratory
distress was fatal, while other events were unknown. Sender Comment: Presumably
the time of infection was 1-2 days before vaccination, 23Jan2021 first vaccination,
26Jan2021 first symptoms, 27Jan2021 positive rapid test, 29Jan2021 PCR smear,
31Jan2021 died, PCR result is not yet available. Information about lot/batch
number cannot be obtained. No further information expected.; Reported Cause(s) of
Death: Respiratory distress" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1114050-1"
"1114050-1" "COVID-19 aggravated; This is a spontaneous report from a
contactable physician via Agency downloaded from the Regulatory Authority FR-
AFSSAPS-MP20210366 A 97-years-old male patient received the first dose of bnt162b2
(COMIRNATY Batch/Lot Number: EJ6788), intramuscular, administered in Arm Right on
21Jan2021 as single dose for covid-19 immunisation. Medical history included
starvation, dementia and anaemia macrocytic all unknown if ongoing. The patient had
medical history of COVID-19 and was considered at risk of developing a severe form
of COVID-19. The patient's concomitant medications were not reported. The patient
experienced covid-19 aggravated on 30Jan2021 with fatal outcome. The patient died
on 19Feb2021. An autopsy was not performed. The clinical course of the events was
reported as follows. On 30Jan2021, the patient presented dyspnea, fever and oxygen
desaturation which required oxygen therapy was tested for COVID-19 on 30Jan2021 and
was diagnosed with COVID-19 aggravation. The patient then presented worsening of
confusion and agitation, increased crackles heard over lower lung fields and
increase of N-terminal prohormone brain natriuretic peptide, asthenia and anorexia.
Outcome: On 19Feb2021, 29 days after vaccination, the patient died due to COVID-19
aggravation. Complete file, no further information available.; Reported Cause(s) of
Death: COVID-19 aggravated" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1114057-1"
"1114057-1" ""COVID-19 respiratory infection; This is a spontaneous report
from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB.
This is a report received from the Agency, Regulatory authority report number FR-
AFSSAPS-RE20210613. An 81-year-old male patient received his first dose of
bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 05Feb2021 (Lot
Number: EJ6788) as single dose for covid-19 immunisation. Medical history included
acute on chronic renal failure from Nov2020 to an unknown date, Diabetes mellitus
insulin-dependent from an unknown date and unknown if ongoing, Cold type auto-
immune hemolytic anemia from an unknown date and unknown if ongoing, obesity from
an unknown date and unknown if ongoing, bilateral deep vein thrombosis from Jan2021
to an unknown date. Long-standing treatment included anticoagulant (unspecified).
The patient experienced covid-19 respiratory infection with fatal outcome on
12Feb2021. Course of the event: On 21Jan2021, a test was performed and turned out
to be negative. On 05Feb2021, the patient received a first injection of bnt162b2.
On 12Feb2021, it was reported ""Highly positive PCR"". The patient experienced an
Apathetic confusional state, ""respiratory distress could not be corrected"". This
was due to SARS-CoV-2 infection progression in context of multiple underlying
pathologies, it was not an adverse event but a lack of efficacy a week after the
injection of the vaccine. The patient was considered at risk of developing a severe
form of the disease ""because of his medical history"". The patient died on
12Feb2021. It was not reported if an autopsy was performed. No FU attempts
possible. No further information expected.; Reported Cause(s) of Death: COVID-19
respiratory infection"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1114593-1"
"1114593-1" "Rapid deterioration of general condition; resp. Insufficiency;
Unknown cause of death; COVID-19 confirmed by positive COVID-19 test; COVID-19
confirmed by positive COVID-19 test; This is a spontaneous report from a non-
contactable consumer downloaded from the Agency Regulatory Authority-WEB with
regulatory authority number DE-PEI-CADR2021016372. A 69-year-old male patient
received the first dose of BNT162B2 (COMIRNATY), via unknown route of
administration on 31Dec2020 at single dose, and received the second dose of
BNT162B2, intramuscularly in Jan2021 (Lot Number: EK9788) at single dose, both for
COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing
arterial hypertension, ongoing dementia, ongoing multiple vessel coronary artery
disease, and adipositas. The patient's concomitant medications were not reported.
It was reported '10 days after second vaccination positive test to Covid 19. Rapid
deterioration of general condition and resp. Insufficiency in Feb2021,
Hospitalization, ventilation there, died on 10Feb2021'. The patient experienced
unknown cause of death on 10Feb2021 and Positive test to Covid 19 on 05Feb2021. The
patient underwent lab tests and procedures which included SARS-COV-2 test: positive
on 05Feb2021 (also reported as 10 days after second Vaccination). Therapeutic
measures were taken as a result of respiratory insufficiency included treatment
with ventilation. The outcome of events 'COVID-19 confirmed by positive COVID-19
test' was not resolved, of events 'Rapid deterioration of general condition' and
'resp. Insufficiency' was unknown. The patient died on 10Feb2021. It was not
reported if an autopsy was performed. No follow-up attempts needed, follow-up
automatically provided by Regulatory Authority.; Reported Cause(s) of Death:
Unknown cause of death" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1121390-1"
"1121390-1" "general and respiratory condition deterioration; SARS-CoV-2 (RT-
PCR) was positive/COVID-19 aggravated; discreet edema of lower limbs; chills; light
dry cough; fever; pneumonia to SARS-Cov-2; bacterial pyelonephritis; infection to
Klebsiella Pneumoniae extended-spectrum beta-lactamases; important septic state;
important asthenia; This is a spontaneous report from a contactable pharmacist
downloaded from the WEB FR-AFSSAPS-LY20211184. A 73-year-old female patient
received first dose of bnt162b2 (COMIRNATY), intramuscular on 29Jan2021 (Batch/Lot
Number: EJ6788) at single dose for COVID-19 vaccination. Medical history included
heart block atrioventricular, anemia, arterial hypertension, type 2 diabetes
mellitus, hyperparathyroidism secondary, ongoing chronic renal failure associated
with diabetic nephropathy, obesity, bipolar disorder, sleep apnea syndrome,
hyperuricemia, nephroangiosclerosis, cardio-renal syndrome, with hemodialysis
initiated on 10Apr2019, heart disease with conserved fraction of ejection with
multiple episodes of congestive heart failure, atrioventricular block with
pacemaker. SARS-Cov-2 history was unknown. Concomitant medications included
bisoprolol, atorvastatin, valproate semisodium (DEPAKOTE), risperidone, furosemide,
candesartan cilexetil, sevelamer carbonate (RENVELA), pregabalin (LYRIC),
lactulose, paraffin, liquid (MELAXOSE), cinacalcet hydrochloride (MIMPARA),
caffeine, papaver somniferum latex, paracetamol (LAMALINE), insulin aspart
(NOVORAPID), insulin glargine (ABASAGLAR), acetylsalicylate lysine (KARDEGIC),
pantoprazole, calcium carbonate (CALCIDOSE), zopiclone (IMOVANE), sodium
polystyrene sulfonate (KAYEXALATE). On 29Jan2021 patient received a first injection
of COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY) for vaccination against
SARS-COV-2. On 03Feb2021 patient felt after dialysis. On 05Feb2021 patient
experienced chills, but no fever, with light dry cough not noticed before.
Hemodynamic state was stable. No clinical evidence of infection was observed, no
dysuria, no bowel disorder. No unusual sign on cardiac examination, but discreet
edema of lower limbs. No clinical evidence of pneumonia. No bowel disorder. The
patient presented with important asthenia, but Glasgow score was 15. Antibiotics by
ceftriaxone sodium (unspecified trade name) and gentamicin (unspecified trade name)
were started. On 06Feb2021 SARS-CoV-2 reverse transcriptase-polymerase chain
reaction (RT-PCR) was positive. Later, pulmonary condition decreased with wheezing
and crackles in bases, requiring oxygen therapy. Direct microscopy and culture of
urine disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-
lactamases, requiring a treatment by imipenem (unspecified trade name) 500mg twice
daily. In Feb2021, the patient presented with important septic state with unwell
tolerated fever, and covid-19 aggravated. On 16Feb2021 due to general and
respiratory condition deterioration it was decided to stop active treatments and to
continue comfort care. Patient died on 17Feb2021. In total: complications of
pneumonia to SARS-Cov-2 with (bacterial) pyelonephritis to Klebsielle Pneumoniae
extended-spectrum beta-lactamases. Laboratory work-up: On 05Feb2021: white blood
cells 6 x10^9/L, heamoglobin 100 g/L, platelets 152 x10^9/L, sodium 139 mmol/L,
potassium 3.2 mmol/L, bicarbonates 28 mmol/L, creatinine 194 umol/L (usual range
not known), liver function was normal, C-reactive-protein 27 mg/L. On 11Feb2021:
white blood cells 5.2 x10^9/L, hemoglobin 87 g/L, platelets 132 x10^9/L, creatinine
544 umol/L (usual range not known), increased transaminases (Aspartate
aminotransferase 250 and alanine aminotransferase 195 normal ranges not available).
Additional examination: In Feb2021 thoracic computed tomography disclosed
compatible aspect with SARS-cov-2 pneumonia, with multiple focus of superinfection
of pneumonic appearance. The patient died on 17Feb2021. Cause of death was
bacterial pyelonephritis and COVID-19 pneumonitis, covid-19, infection to
Klebsiella Pneumoniae extended-spectrum beta-lactamases and general and respiratory
condition deterioration. It was not reported if an autopsy was performed. No
follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: infection to Klebsiella Pneumoniae extended-spectrum beta-
lactamases; general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR)
was positive/COVID-19 aggravated; Bacterial pyelonephritis; COVID-19 pneumonitis"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1121397-1"
"1121397-1" "COVID-19 with symptoms; COVID-19 PCR test positive; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB FR-AFSSAPS-PO20211154. A 93-years-old female patient received
bnt162b2 (COMIRNATY) vaccine, dose 2 intramuscular, administered in Arm Right on
10Feb2021 (Batch/Lot Number: EJ6789) as 0.3 mL, single, dose 1 intramuscular on
20Jan2021 (Batch/Lot number was not reported) as single dose for covid-19
immunisation . Medical history included hypertension , cardiac failure. The
patient's concomitant medications were not reported. The patient experienced
covid-19 PCR test positive on 18Feb2021 , covid-19 with symptoms on 21Feb2021:
appearance of fever at 39 �C, cough, bronchial congestion and desaturation. Treated
with 5 L O2 and antibiotic therapy. The patient underwent lab tests and procedures
which included pyrexia: 39�C on 21Feb2021 , sars-cov-2 test positive on
18Feb2021. The patient died on 23Feb2021. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is expected.
Batch/lot number of the first dose cannot be obtained.; Reported Cause(s) of Death:
Covid-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1122448-1"
"1122448-1" "neutropenic sepsis; Neutropenia; cough; SARS-CoV-2 infection;
This is a spontaneous report from a contactable consumer. This is a report received
from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-
WEBCOVID-202103150909596000, Safety Report Unique Identifier GB-MHRA-ADR 24942833.
A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH
COVID-19 VACCINE), via an unspecified route of administration on 31Jan2021
(Batch/Lot Number EN1185) as single dose for covid-19 immunization. Medical history
included neutropenic sepsis from an unknown date and unknown if ongoing, neoplasm
from an unknown date and unknown if ongoing (Recently had treatment for cancer,
leukemia or lymphoma; radiotherapy or chemotherapy), acute myeloid leukemia from
Jan2016 to an unknown date, acute lymphocytic leukemia from Jan2016 to an unknown
date, stem cell transplant from May2016 to an unknown date, leukemia from Jan2018
to an unknown date (replaced leukemia), stem cell transplant from May2018 to an
unknown date (second stem cell transplant). Patient has not had symptoms
associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant
medications included acyclovir taken for an unspecified indication, start and stop
date were not reported; amlodipine taken for an unspecified indication, start and
stop date were not reported, calcium carbonate (CALCICHEW) taken for an unspecified
indication, start and stop date were not reported; ciprofloxacin taken for an
unspecified indication, start and stop date were not reported, co-trimoxazole taken
for an unspecified indication, start and stop date were not reported; fluconazole
taken for an unspecified indication, start and stop date were not reported;
hyaluronate sodium (HYLO-FORTE) taken for an unspecified indication, start and stop
date were not reported; metoclopramide taken for an unspecified indication, start
and stop date were not reported; ondansetron taken for an unspecified indication,
start and stop date were not reported. Patient had relapsed AML receiving
chemotherapy at home as part of palliative care package. Patient was shielded for
12 months with her husband. Intravenous nurses wearing full PPE were the only other
contacts within the past 2 weeks, prior to that hematology appointment on
27Jan2021, again full PPE worn at all times. Patient was on day 5 of chemo when
nurse measured temperature and recorded as 38.5C therefore sent to emergency on
neutropenic pathway. Neutrophil count 0.0 at clinic and also on admission
05Feb2021. Swabbed positive in Emergency for COVID-19 same day. Admitted to
hospital and treated for neutropenic sepsis. Developed a cough and increased Oxygen
requirement, resulting in continuous positive airway pressure treatment 10Feb2021.
The patient experienced sars-cov-2 infection (covid-19) (death) on 05Feb2021,
neutropenic sepsis (neutropenic sepsis) (hospitalization, medically significant) on
an unspecified date with outcome of unknown, neutropenia (neutropenia)
(hospitalization, medically significant) on an unspecified date with outcome of
unknown, cough (cough) (non-serious) on an unspecified date with outcome of
unknown. The patient underwent lab tests and procedures which included sars-cov-2
test: no, negative covid-19 test on 27Jan2021 and positive on 05Feb2021, neutrophil
count: 0.0 on an unspecified date. Therapeutic measures were taken as a result of
neutropenic sepsis (neutropenic sepsis), cough (cough). The patient died on
15Feb2021. It was not reported if an autopsy was performed. Sadly died 15Feb2021
due to Covid-19. Patient had Covid PCR test and ongoing palliative treatment under
joint care of MRI. Patient was fully shielded from Feb2020. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
SARS-CoV-2 infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1126490-1"
"1126490-1" "COVID PCR coming back positive/Sars-Cov2 infection;
Cholecystitis; This is a spontaneous report from a contactable physician from the
regulatory authority FR-AFSSAPS-RS20210385. An 87-year-old male patient received
first dose of bnt162b2 (COMIRNATY), intramuscular in arm left on 01Feb2021 (Lot
Number: EJ6788) as single dose for COVID-19 immunization. Medical history included
cholangitis from 2020, myocardial infarction from 2011, Dyslipidaemia, Hypertension
arterial, femoral fracture (Patient hospitalized in follow-up and rehabilitation
care since 08Dec following surgery on a femoral fracture), stroke from 2006.
Concomitant medications included glucose, potassium chloride, sodium chloride
(POLYIONIQUE G5, 5% 1L/24h); macrogol 3350, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL PLAIN, reported as Movicol 1 sachet / day); atorvastatin;
enoxaparin sodium (LOVENOX); acetylsalicylate lysine (KARDEGIC); furosemide. The
patient experienced COVID PCR coming back positive/Sars-Cov2 infection complicated
by cholecystitis on 04Feb2021. 01Feb2021: Vaccination with bnt162b2 in the left arm
(first dose). 04Feb2021: in front of a fever and oxygen refereeing, realization of
a COVID PCR coming back positive. This Sars-cov2 infection is complicated by
cholecystitis (presence of a Murphy sign). The thoracic scanner found in the low
sections a possible vesicular wall thickening with lithiasis at the neck and
infiltration to be confronted at the clinic. The opinion with the radiologist finds
a peri-vesicular effusion. Cholecystitis is treated with Ceftriaxone and
metronidazole (FLAGYL) from 04Feb2021 in the evening. 05Feb2021: evidence of
cytolysis (ASAT 201 IU / L, ALAT 221 IU/ L) as well as anicteric cholestasis
( phosphatases alcalines (PAL) 316 IU / L, G-GT at 734 IU / L). Biological
inflammatory syndrome decreasing with the last CRP of 08Feb2021 at 57.1 mg / L. In
terms of Covid, the patient is on 2L of O2 without the need for dexamethasone for
the moment. Transfer on 08Feb2021 for close monitoring Upon entering the service:
Physical examination: Aware and Oriented, Glasgow 15, BP 158/86 mmHg, heart rate 78
bpm, Fever at 38.1 degrees C, 92% saturation under 2L of O2 with a respiratory rate
of 28 / min, no draft, no cyanosis. His pulmonary auscultation found a bilateral
and symmetrical vesicular murmur without added noise. His cardiac auscultation
found regular heart sounds without a perceived breath. His abdominal examination
found a supple, depressible and painless abdomen without pain at the epigastric
level or in the right hypochondrium. He shows no resistance, no contracture, no
Murphy sign. Evolution: Respiratory worsening with the need for the introduction of
8L of O2 associated with increased polypnea; introduction of corticosteroid therapy
with dexamethasone from 09Feb2021 to 17Feb2021. 09Feb2021: Thoraco-abdomino-pelvic
CT scan (to look for pulmonary embolism and abdominal cuts to look for an abdominal
infectious focus in this context of suspected cholecystitis). Sub-optimal quality
injection that does not allow formal pulmonary embolism to be eliminated. No
embolus detected up to the lobe level. Aggravation of bilateral frosted glass
areas, compatible with Covid, involving 30 to 50% of the pulmonary parenchyma. It
was found that the appearance of cholecystitis, with an overall irregular and
laminated wall, with probable rupture of the vesicular fundus seeming to
communicate with a small collection coming into contact with the right colic angle
just under the abdominal wall. Interest of a surgical opinion. An opinion from
digestive surgeons was taken proposing the following management: continuation of
inpatient monitoring; continuation of antibiotic therapy with ceftriaxone and
Flagyl and performance of radiological cholecystostomy. An 8.5F drain was therefore
placed in the gallbladder. 12Feb2021: respiratory worsening; oxygen therapy at 15L
with a high concentration mask and increase in the dose of furosemide to 250 mg /
day. 15Feb2021: The biliary sample during drainage by radiological cholecystostomy
returned positive for Citrobacter Freundii, the antibiotic treatment is switched by
cefepime 2g morning and evening for 5 days. Biologically, the patient presents
hypokalaemia at 3 mmol / L without any sign of ECG, requiring supplementation with
Diffu-K. During hospitalization serum potassium gradually normalized. 17Feb2021:
Introduction of Midazolam 0.1 mg / h h intravenous via infusion pump + Morphine 0.5
mg / h intravenous via infusion pump in front of the discomfort and the non-
regression of the severity of the COVID infection. Increase on 21Feb2021 of
Midazolam to 0.2 mg / h and Morphine to 1 mg / h. 22Feb2021: death of the patient
noted. In total: PCR Sars cov2 positive 3 days after the first dose of COMIRNATY.
Patient died of severe Sars-Cov2 infection, complicated by cholecystitis. It was
not reported if an autopsy was performed. No follow-up attempts are possible. No
further information is expected. ; Reported Cause(s) of Death: COVID PCR coming
back positive/Sars-Cov2 infection; Cholecystitis" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1132474-1"
"1132474-1" ""fever; problem with breathing; Sars COV-2 test positive; the
patient died; Sars COV-2 test positive; This is a spontaneous report from a
contactable pharmacist. A male patient of an unspecified age received bnt162b2
(COMIRNATY), dose 1 via an unspecified route of administration on 19Feb2021 (Lot
Number: EP9598) as SINGLE DOSE for COVID-19 immunisation. The second dose was
scheduled for 12Mar2021 Medical history included arterial hypertension, diabetes
treated with DL HG, respiratory efficiency, full contact, oxygen saturation 93%;
all from an unknown date and unknown if ongoing. The patient's concomitant
medications were not reported. On 04Mar2021, the patient reported to the general
physician due to high fever that has been going on for several days (the reporter
doesn't know when the fever started). General physician did not initiate any
treatment, he referred the patient to the internal ward of the hospital. On
05Mar2021, the patient reported to the hospital where SARS COV-2 test for COVID 19
was performed - the result: positive, the test was performed at 20:59. The reporter
gave the data from the discharge from this hospital: ""patient with quarantine,
headed by the general physician as a fever, claims he had not had a PRC swab
before. A high fever for several days, the primary health care physician did not
start any treatment. The patient was prescribed the following drugs: levoxa,
pyralgina, berodual, neoparin, monitoring with the general physician and he was
sent home. On 07Mar2021 in the morning, the patient had a problem with breathing,
the patient was hit to the hospital in the infectious diseases ward. First, the
patient was connected to oxygen. On 09Mar2021 patient was put on a respirator due
to health deterioration. On 13Mar2021 the patient died. It was not reported if an
autopsy was performed. The outcome of Sars COV-2 test positive, fever and problem
with breathing was unknown.; Sender's Comments: The causal relationship between
BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive, pyrexia,
dyspnoea and patient death cannot be excluded as the information available in this
report is limited and does not allow a medically meaningful assessment. This case
will be reassessed once additional information becomes available. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part
of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.;
Reported Cause(s) of Death: the patient died"" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1133428-1"
"1133428-1" "Positive molecular swab; COVID-19/dyspnea; This is a spontaneous
report from contactable physician downloaded from the Regulatory authority-WEB
regulatory authority IT-MINISAL02-697591. A 98-years-old female patient received
the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration
on 19Jan2021 at single dose, and the second dose (Batch/Lot Number: EL0725;
Expiration Date: 31Mar2021), via intramuscular administered in left arm on
09Feb2021 09:52 at 0.3 mL, single for COVID-19 vaccination. The patient medical
history and concomitant medications were not reported. The patient experienced
positive molecular swab on 17Feb2021, dyspnea from 20Feb2021, died hospitalized in
hospital on 20Feb2021. The patient underwent lab tests and procedures which
included COVID-19 PCR test: positive on 17Feb2021. The patient died on 20Feb2021.
It was not reported if an autopsy was performed. Reporter comment: 1st DOSE TAKEN
ON 19Jan2021. Positive molecular swab on 17Feb2021 Died hospitalized in hospital on
20Feb. Sender comment: 12Feb2021: contacted the reporter to request a clinical
report of death.; Reported Cause(s) of Death: Positive molecular swab; COVID-
19/dyspnea" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1133429-1"
"1133429-1" "drug ineffective; positive molecular swab/fever 37.5 � c; This
is a spontaneous report from contactable physician downloaded from the Regulatory
authority-WEB regulatory authority IT-MINISAL02-697594. A 92-years-old female
patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route
of administration on 19Jan2021 at single dose, and the second dose (Batch/Lot
Number: EL0725; Expiration Date: 31Mar2021), via intramuscular administered in left
arm on 09Feb2021 09:48 at 0.3 mL, single for COVID-19 vaccination. The patient
medical history and concomitant medications were not reported. The patient
experienced drug ineffective on 13Feb2021, positive molecular swab on 13Feb2021,
fever 37.5 � c on 13Feb2021, admitted and died at the hospital on 21Feb2021. The
patient underwent lab tests and procedures which included COVID-19 PCR test:
Positive on 13Feb2021. The patient died on 21Feb2021. It was not reported if an
autopsy was performed. Reporter comment: 1st dose taken on 19Jan2021. Positive
molecular swab dated 13Feb2021. Admitted and died at the hospital on 21Feb Sender
comment: 12Feb2021: the reporter contacted and the death clinical report requested.
Stop date for events (21Feb2021) No follow-up attempts possible. No further
information expected. Lot/Batch number already obtained.; Reported Cause(s) of
Death: drug ineffective; positive molecular swab/fever 37.5 � c" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1135088-1"
"1135088-1" "SARS-CoV-2 infection/ COVID +ve; SARS-CoV-2 infection/ COVID
+ve; This is a spontaneous report from a contactable physician. This is a report
received from the Regulatory authority Regulatory authority report number: GB-MHRA-
WEBCOVID-202103161715400580, Safety Report Unique Identifier: GB-MHRA-ADR 24958447.
An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA
VACCINE; lot number: EL0739, Expiration Date: not reported) dose 1, via an
unspecified route of administration on 17Jan2021 as single dose for COVID-19
immunisation. The patient's medical history and concomitant medications were not
reported. The patient had not had symptoms associated with COVID-19, not had a
COVID-19 test and was not enrolled in clinical trial. The patient experienced sars-
cov-2 infection on 31Jan2021. The patient was hospitalized for sars-cov-2 infection
from 31Jan2021. Admitted to hospital via ambulance on 31Jan2021 and confirmed COVID
+ve. The case was reported as death, hospitalization, medically significant. The
patient underwent lab tests and procedures which included COVID +ve on 31Jan2021.
The outcome was fatal. The patient died on 04Feb2021. It was not reported if an
autopsy was performed and the reported cause of death was SARS-CoV-2 infection.
No follow-up attempts are possible. No further information is expected. ; Reported
Cause(s) of Death: SARS-CoV-2 infection/ COVID +ve; SARS-CoV-2 infection" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1140573-1"
"1140573-1" "Dyspnoea; Fever; Ischemic stroke; Saturation at 82%; Atypical
bilateral pneumonitis; probable superinfection of bronchial origin within the left
upper lobe; COVID-19; 10.42 G/L of PNN (neutrophils); did not eat all day;
hyperleukocytosis 11.29 G/L; thrombocytopenia 90 G/L; This is a spontaneous report
received from a contactable physician downloaded from the Regulatory Authority
(RA). The regulatory authority report number is FR-AFSSAPS-RS20210427. An 86-year-
old female patient received the first dose of bnt162b2 (COMIRNATY; Lot Number:
EP9605) intramuscular, administered in Arm Right, on 10Mar2021, as SINGLE DOSE for
covid-19 immunisation. Medical history included cerebrovascular accident from 2020
to an unknown date, coronary artery bypass from an unknown date and unknown if
ongoing, Penicillin allergy from an unknown date and unknown if ongoing,
hyperlipidaemia from an unknown date and unknown if ongoing, caesarean section,
Appendectomy, Carcinoma of tongue from an unknown date and unknown if ongoing, and
ongoing significant speech problems. Concomitant medications included paracetamol,
nebivolol, amlodipine besilate, clopidogrel, levothyroxine sodium (LEVOTHYROX),
pravastatin, calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D), lorazepam,
and paroxetine. On 11Mar2021, emergency services was alerted by neighbours who
have not seen the patient during the day. Patient found lying in bed, dyspneic,
febrile, did not eat all day. On arrival of the emergency services, the patient was
congested, saturated 95% AA (Amino Acids), febrile 39.5 C, FR (fractional
shortening) 56/min. She was hospitalised. Questioning was not very helpful,
significant speech problems since an operation for tongue cancer. According to her
daughter-in-law, patient is usually comprehensible. Emergency examination:
pulmonary auscultation: some crackles in the right base, decrease in vesicular
murmur on the left. Supra-clavicular pull, thoraco-abdominal swing. Polypneic
40/min. Cardiovascular: regular heart sounds, no murmur; no IMO, no jugular turgor;
soft, painless calves. Abdomen soft, depressible, tender in the epigastric region.
Biology: hyperleukocytosis 11.29 G/L including 10.42 G/L of PNN (neutrophils);
thrombocytopenia 90 G/L. Normal blood ionogram, normal renal function. CRP (C-
reactive protein) (< 342.0mg/l) = 2.5, ABG (arterial blood gases): pH 7.44; PO2
(partial pressure of oxygen) 66 mmHg, PCO2 (partial pressure of carbon dioxide) 32
mmHg, bicarbonates 21.7 mmol/l; COVID PCR (Polymerase chain reaction) negative.
Chest CT: no detectable acute proximal pulmonary embolism within the limits of the
examination. Atypical bilateral pneumonitis, potentially suggestive of COVID
involvement (moderate relaxation), with probable superinfection of bronchial origin
within the left upper lobe. Introduction of levofloxacin. On 12Mar2021: clinical
examination: patient is reactive Glasgow 3 with pupils in a reactive mydriasis, eye
rolling; generalized mottling; grazing. Saturation at 82% AA (Amino Acids)
increased to 95% on 15l oxygen. Lung auscultation: bilateral crackles. Emergency
brain scan: systematized left frontal hypodensity suggesting an acute constituted
ischemic focus. In view of the patient's neurological condition and the severe
cardiovascular terrain, it was decided to start palliative care. Dyspnoea, fever
and ischaemic stroke the day after a D1 of COMIRNATY in a frail patient with a long
cardiovascular history; COVID PCR (Polymerase chain reaction) negative but atypical
lung lesions suggestive of moderate COVID involvement with probable bronchial
superinfection. Outcome of dyspnoea, fever and ischaemic stroke was fatal while it
was unknown for the other events. The patient died on 12Mar2021 at 14:30. Causes of
death were reported as dyspnoea, fever and ischaemic stroke. It was unknown if an
autopsy was performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Dyspnoea; fever; ischaemic stroke" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1146552-1"
"1146552-1" "COVID-19 RESPIRATORY INFECTION; ABNORMAL OXYGEN SATURATION;
POLYPNOEA; MENTAL CONFUSION; FALL; ASTHENIA; This is a spontaneous report from
contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory
authority report number is FR-AFSSAPS-LL20211120. An 86-year-old female patient
received BNT162B2 (COMIRNATY, lot number and expiry date were unknown, unknown if
1st or 2nd dose), via intramuscular route on 25Feb2021 as a single dose for COVID-
19 immunisation. Medical history included heartburn, GIST with partial gastrectomy,
essential thrombocythemia, diabetes, breast cancer, osteoporosis with vertebral
collapse. Concomitant medications included glimepiride 1 mg, indapamide/perindopril
2/0.625 mg, acetylsalicylate lysine (KARDEGIC 75 mg), nebivolol 2.5 mg/ day; folic
acid 5 mg, anastrozole 1 mg/day. On 04Mar2021 7:00 p.m., the patient referred to
the emergency department by her attending physician for polypnea, 89% desaturation
in ambient air and confusion. According to the patient, asthenia and falls for
about 3 days and diarrhea for 2 days (therefore date of onset of symptoms on
01Mar2021). COVID + Antigen test in the emergency room. On 05Mar2021, the patient
was hospitalized in a COVID unit for COVID +. Medical treatment included O2 8L /
min, lovenox 0.4 x 2 / day, Dexamethasone 6mg IV per day, antibiotic therapy for
extensive pulmonary involvement: Cefotaxime and Rovamycin. On 06Mar2021, rapid
deterioration of the patient's state of health was reported. At 3h O2 15L / min, at
4 p.m. O2 30L / min. At 7 p.m., the patient's vital prognosis was engaged, she
received comfort care. On 07Mar2021 at 2 a.m., death of the patient was reported.
Events were fatal. The cause of death was COVID19. NB: imputability without
prejudice to the elements of investigation which could be carried out within the
framework of legal or amicable compensation procedures. No follow-up attempts are
possible, information on batch/ lot number cannot be obtained.; Reported Cause(s)
of Death: COVID19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1149589-1"
"1149589-1" "COVID-19 aggravated; COVID-19 aggravated; Anemia; Lymphopenia;
Stage 3 renal failure; This is a spontaneous report from a contactable physician
downloaded from the Regulatory Authority-WEB, regulatory authority number FR-
AFSSAPS-AM20210581. A 100-year-old male patient living in a retirement home
received first dose of bnt162b2 (COMIRNATY) intramuscular, administered in Deltoid
Left on 21Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation.
Medical history included double inguinal hernia, fracture, closed, colles'
(fracture beam glues left), nasal polyps, venous peripheral insufficiency (lower
limbs), haemorrhoids, oesophagitis ulcerative (stage IV), chronic obstructive
airways disease, hypercholesterolaemia, pyelonephritis, dupuytren's contracture,
shoulder dislocation and pleuritis. Concomitant medications included candesartan
cilexetil (CANDESARTAN CILEXETIL), pravastatin sodium (PRAVASTATIN SODIUM),
pantoprazole (PANTOPRAZOLE), macrogol 4000, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL), paracetamol (DOLIPRANE), hydrochlorothiazide
(HYDROCHLOROTHIAZIDE), prednisone (PREDNISONE). On 21Jan2021, the patient received
his first injection of COMIRNATY. Four weeks after his vaccination, on 09Feb2021,
in front of a pulmonary symptomatology, realization of a PCR SarS-CoV-2 which
returned positive. Support was as follows: amoxicillin, clavulanic acid (AUGMENTIN)
and levofloxacin (LOVENOX). On 16Feb2021, faced with the development of a severe
form of COVID-19, he was hospitalized. The management was as follows: bi antibiotic
therapy with ceftriaxone sodium (ROCEPHIN) and erythromycin, high flow oxygen
therapy (12L/ min). No intensive care. On unknown date, on the laboratory
assessment, anemia at 11.6g/ dL, lymphopenia at 0.93G/ L, stage 3 renal failure
with a clearance of 44.2mL/ min. From 17Feb2021 to 22Feb2021 degradation of the
patient requiring sedation. Patient died on 22Feb2021 due to COVID-19. An autopsy
was not performed. Outcome of the events renal failure, lymphopenia and anemia was
unknown. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: Drug ineffective; Drug ineffective; COVID-19" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1149874-1"
"1149874-1" "After the 1st dose, the patient became ill with COVID-19.; After
the 1st dose, the patient became ill with COVID-19.; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB IT-
MINISAL02-703039. A 92-year-old male patient received the first dose of BNT162B2
(COMIRNATY; Lot Number: EJ6790; Expiration Date: 31Mar2021), intramuscular,
administered on the right arm on 24Feb2021 as 0.3 mL, single for covid-19
immunisation. The patient's medical history and concomitant medications were not
reported. On 14Mar2021, following serious asthenia, the other healthcare
professional was contacted and performed a rapid positive antigenic swab and
transported to the emergency room where positivity was confirmed with a molecular
test. In ER, bilateral interstitial pneumonia was diagnosed and death occurs on
16Mar2021. Therapeutic measures were taken as a result of the event. The patient
died on 16Mar2021. It was not reported if an autopsy was performed. Reporter's
comment: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks
after 1st vaccination.; Reporter's Comments: Onset of Covid 19 with bilateral
interstitial pneumonitis about 2 weeks after 1st vaccination.; Reported Cause(s) of
Death: bilateral interstitial pneumonia; Covid-19" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1153708-1"
"1153708-1" "SARS-CoV-2 infection/ Vaccine breakthrough infection; This is a
spontaneous report from a contactable healthcare professional. This is a report
received from the regulatory authority. Regulatory authority report number GB-MHRA-
WEBCOVID-202103231343284950, Safety Report Unique Identifier GB-MHRA-ADR 25005895.
An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a
single dose for COVID-19 immunisation. Medical history included ongoing dementia
(advanced). Unsure if patient has had symptoms associated with COVID-19. She was
not enrolled in clinical trial. The patient's concomitant medications were not
reported. The patient experienced SARS-CoV-2 infection and vaccine breakthrough
infection on 01Feb2021. The events were assessed as serious by HA (fatal and
medically significant). Case narrative: The patient received COVID vaccination
19Jan2021, confirmed COVID positive 01Feb2021. Treated with antibiotics. Chest x-
ray unremarkable. Died 13Feb2021. Cause of death 1) advanced dementia and 2) COVID-
19. An autopsy was not performed. The patient underwent lab tests and procedures
which included COVID-19 virus test: yes - positive COVID-19 test on 01Feb2021. No
follow-up attempts are possible. Information about lot/batch number cannot be
obtained. No further information is expected.; Reported Cause(s) of Death:
Dementia; SARS-CoV-2 infection/ Vaccine breakthrough infection" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1161353-1"
"1161353-1" "Vaccination failure; Vaccination failure; Urinary tract
infection; This is a spontaneous report from a contactable pharmacist downloaded
from the Agency Regulatory Authority-WEB (regulatory authority number: FR-AFSSAPS-
CN20210903). An 89-year-old male patient received the first single dose of
BNT162b2 (COMIRNATY), via an unspecified route of administration, on 11Jan2021 (Lot
Number: EM0477), and the second dose, intramuscular, on 01Feb2021 (Lot Number:
EK9788), for COVID-19 immunisation. The patient was vaccinated with a 25G 25 mm
needle. The patient's medical history included cancer of lower rectum discovered at
the end of 2018, initially treated with concomitant radiochemotherapy, then
discharge colostomy was performed in Dec2019, and finally palliative care from
Jul2020, due to which the patient was in a nursing home. Additional medical history
included complete arrhythmia due to atrial fibrillation, herniated disc,
osteoarthritis, purulent pleurisy, benign prostatic hyperplasis, thoracic aortic
aneurysm operated by custom thoracic endoprosthesis, and popliteal aneurysm. The
patient had no previous history of COVID-19. On 04Mar2021 the patient was
hospitalized following fever and pharyngeal pain. The patient was put in isolation
and a PCR Covid test returned positive for the variant (presence of the N501Y and
A570D mutations of the S gene). There was a progressive worsening with associated
urinary tract infection (ECBU positive for Citrobacter freundii), patient objecting
to treatment. The patient eventually died on 12Mar2021 at 7:05 p.m. It was unknown
if an autopsy was performed. The reported event was 'vaccination failure' with
fatal outcome. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19; Vaccination failure" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1161379-1"
"1161379-1" "sars-cov-2 test: contracted (positive); sars-cov-2 test:
contracted (positive); Death NOS; deterioration of the general condition as well as
a progressive loss of autonomy; (Urine culture) positive; chills; hyperthermia at
38 degree C; This is a spontaneous report from a contactable physician reporting
for a patient downloaded from the Regulatory Authority, regulatory authority number
FR-AFSSAPS-TO20211826. An 88-year-old female patient received bnt162b2 (COMIRNATY),
first dose, intramuscular, administered in Arm Right on 11Feb2021 (Batch/Lot
Number: EJ6788) as SINGLE DOSE for covid-19 immunisation. Medical history included
dementia alzheimer's type (severe Alzheimer's type dementia) and starvation
(undernutrition) from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced death nos on
16Mar2021. Clinical course was reported as follows: The patient received the first
injection of the COMIRNATY vaccine on 11Feb2021 and presented the following day,
i.e. 12Feb2021, with hyperthermia at 38 degree C and chills. She was put on
antibiotics, CRP at 15 and ECBU (Urine culture) positive. A deterioration of the
general condition as well as a progressive loss of autonomy were reported leading
to his death on 16Mar2021, i.e. 33 days after vaccination. The patient underwent
lab tests and procedures which included body temperature: 38 centigrade on
12Feb2021, c-reactive protein: 15 on 12Feb2021, sars-cov-2 test: contracted
(positive) on an unspecified date, and ECBU test (urine culture): positive on
12Feb2021. The patient died on 16Mar2021 (Death NOS). Outcome of the other events
was unknown. It was not reported if an autopsy was performed. No follow-up
attempts possible. No further information expected. Lot number has been obtained.;
Reported Cause(s) of Death: death NOS" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1161667-1"
"1161667-1" "SARS-CoV-2 infection; This is a spontaneous report from a
contactable other hcp received from the Regulatory Authority. The regulatory
authority report number is GB-MHRA-WEBCOVID-202103230953268490, Safety Report GB-
MHRA-ADR 25004289. A 93-year-old male patient received bnt162b2 (BNT162B2), dose
1 via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not
reported) at a single dose for covid-19 immunisation. Medical history included
clinical trial participant from an unknown date and unknown if ongoing (RECOVERY,
REGN monoclonal antibodies), It was unsure if patient has had symptoms associated
with COVID-19. The patient's concomitant medications were not reported. The
patient experienced sars-cov-2 infection on 26Jan2021. The patient underwent lab
tests included Covid-19 virus test: positive on 26Jan2021 (Yes - Positive COVID-19
test), polymerase chain reaction (PCR) and chest x-ray (CXR): unknown results.
Therapeutic measures were taken as a result of sars-cov-2 infection. The patient
died on 31Jan2021. It was not reported if an autopsy was performed. Additional
information: Patient received covid vaccine 14Jan2021, admitted to hospital and
tested positive for COVID 26Jan2021. Patient treated with REGN monoclonal
antibodies covid vacs as part of RECOVERY trial. Also treated with dexamethasone
and antibiotics as part of usual treatment. No follow-up attempts are possible;
information about lot/batch number cannot be obtained.; Reported Cause(s) of Death:
COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1161668-1"
"1161668-1" "SARS-CoV-2 infection/Vaccine breakthrough infection; SARS-CoV-2
infection/Vaccine breakthrough infection; This is a spontaneous report from a
contactable healthcare professional received from the Regulatory Authority. The
regulatory authority report number is GB-MHRA-WEBCOVID-202103231247133620, Safety
Report Unique Identifier is GB-MHRA-ADR 25005489. An 86-year-old female patient
received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for
injection, lot number and expiry date were not reported), via an unspecified route
of administration on 07Jan2021 at a single dose for COVID-19 immunization. The
patient's medical history and concomitant medications were not reported. It was
unsure if patient has had symptoms associated with COVID-19. Patient was not
enrolled in clinical trial. On 31Jan2021, the patient experienced SARS-CoV-2
infection/vaccine breakthrough infection. It was reported that the patient received
COVID vaccine on 07Jan2021. Tested positive for COVID on 31Jan2021 and was admitted
to hospital. Treated with antibiotics and dexamethasone. The reporter assessed the
events as serious (hospitalization and death). The patient underwent lab tests and
procedures which included chest x-ray: unknown results on an unspecified date and
COVID-19 virus test: positive (yes/positive COVID-19 test) on 31Jan2021. The
outcome of the events was fatal. The patient died on 08Feb2021 due to SARS-CoV-2
infection/vaccine breakthrough infection. It was not reported if an autopsy was
performed. No follow-up attempts are possible; information about batch/lot number
cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/Vaccine
breakthrough infection; SARS-CoV-2 infection/Vaccine breakthrough infection" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1165295-1"
"1165295-1" ""COVID-19 aggravated; This is a spontaneous report from a
contactable consumer downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority report number is FR-AFSSAPS-NC20211060. An 80-year-old female
patient received her first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown),
via intramuscular route in the arm on 25Feb2021 as a single dose for COVID-19
immunisation. Medical history included cardiac decompensation, and hypertension in
July 2019, obesity, calcified aortic valve, and DTE carotid atheroma (55%).
Concomitant medications included hydrochlorothiazide (ESIDREX), ginkgo biloba
(TANAKAN), losartan potassium (COZAAR), atenolol, and furosemide. Since 27Feb2021,
the patient has presented chills, cough, dyspnea-orthopnea, two episodes of
vomiting, loss of appetite, two coughing up blood (one red and one black).
Cardiology consultation recently does not mention his calcified aortic stenosis in
the report of 26Nov. The patient tested positive for COVID-19 (variant) on
01Mar2021 while going to the emergency room and then returned home. The patient
consulted again on 02Mar2021 because his condition deteriorated during the day.
Acidosis and hypercapnia were corrected by non-invasive ventilation. The next day,
patient had respiratory deterioration. On 03Mar2021, the patient was referred by
his doctor in emergency. On 03 Mar2021, PH was 7.17 and PCO2 was 87. Patient was
put under non-invasive ventilation. Initial clinical examination showed ""Sym and
bilateral vesicular murmur, bilateral crackles, irregular heart noise, calcified
aortic stenosis murmur, edema of the lower limbs, soft and painless abdo, confused
glasgow scale GSC 14."" CARDIO ADVICE: decompensation which seems to be more due to
COVID than to acute lung edema. CAR BNP (Btype natriuretic peptide) very high.
Summary of management and evolution: Respiratory decompensation on COVID and acute
lung edema (for cardio). Effectiveness of the non-invasive ventilation following a
session of one more hour, control gas PH 7.344, PCO2 52. Patient was still confused
after refusal of care. Serious opinion was made, comfort care. During the first
week of hospitalization, patient was relatively stationary. However, there was
clear deterioration of the disease in the second week of hospitalization.
Unfavorable changes with the death on 15Mar2021. It was not reported if an autopsy
was performed. Conclusion: Covid-19 possibly aggravated by vaccination. Indeed, all
her family circle has tested positive for COVID19 (variant): woman (57 years old,
co-morbidities with cancer right cardiac decompensation, COPD(Chronic obstructive
pulmonary disease), neurodegenerative disease) and the young girl (24 years old).
They did not benefit from the vaccination and remained asymptomatic, except for the
patient. This obviously remains a hypothesis. The pharmacovigilant notes:
Accountability score(s) established without prejudice to the elements of
investigation which could be carried out within the framework of legal or amicable
compensation procedures. No follow-up attempts are possible, information on batch
number cannot be obtained.; Reported Cause(s) of Death: Covid-19 aggravated""
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1165315-1"
"1165315-1" "Drug ineffective; confirmed COVID-19 positive result; Sepsis;
This is a spontaneous report from a contactable pharmacist received from a
regulatory authority. The regulatory authority report number is GB-MHRA-MIDB-
ece38980-a6e9-4449-af5e-f32722a8a8ea, Safety Report Unique Identifier GB-MHRA-ADR
25042533. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19
MRNA VACCINE) intramuscularly on 22Jan2021 (Batch/Lot number was not reported) at
single dose for covid-19 immunisation. Medical history included Type 2 Diabetes
Mellitus, Angina (Ischeamic Heart Disease), perforated duodenal ulcer requiring
surgery and osteoporosis. Concomitant medications included gabapentin,
lansoprazole, simvastatin, sitagliptin, metformin, carbidopa, and co-careldopa.
The patient experienced drug ineffective, confirmed covid-19 positive result, and
sepsis, all from 18Feb2021, which were reported as fatal outcome and causing
hospitalization. The patient was hospitalized for drug ineffective, confirmed
covid-19 positive result, and sepsis from 18Feb2021. Therapeutic measures were
taken as a result of drug ineffective/confirmed covid-19 positive result included
treatment Palliated on 26Feb2021 post admission. The patient died on 26Feb2021.
No follow-up attempts are possible; information about lot/batch number cannot be
obtained.; Reported Cause(s) of Death: drug ineffective; confirmed covid-19
positive result; sepsis" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1165558-1"
"1165558-1" ""Pneumonia associated with SARS-CoV-2 infection/SARS-CoV-2
infection positive; Pneumonia associated with SARS-CoV-2 infection/SARS-CoV-2
infection positive; This is a spontaneous report from a contactable Physician
downloaded from the regulatory authority RO-NMA-2021-SPCOV1021 A 74-year-old male
patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of
administration on 23Jan2021 (Batch/Lot number was not reported), second dose
intramuscular on 13Feb2021 (Batch/Lot Number: Unknown) both as single dose for
COVID-19 immunisation. Medical history included the patient is known with: operated
clear cell renal cell carcinoma (right nephrectomy), ongoing chronic renal failure
stage 3, ongoing chronic obstructive pulmonary disease (COPD), ongoing
hypertension, ongoing hypertensive nephropathy and fixed nitrogen retention,
ongoing obesity, ongoing type 2 diabetes, ongoing systemic atheromatosis (aortic
and other large vessels), ongoing ischemic heart disease, ongoing stable angina
pectoris, ongoing prostate adenoma, ongoing hepatic steatosis and ongoing lithiasic
cholecystitis. The patient's concomitant medications were not reported. On
13Feb2021, the patient received the 2nd intramuscular dose of Comirnaty for active
immunisation. On 20Feb2021, the patient developed pneumonia associated with SARS-
CoV-2 infection. As a corrective therapy the patient received Anakinra (400 mg/day
subcutaneous, SC) starting with 25Feb2021 up to 01Mar2021, Anakinra (200 mg/day SC)
starting with 02Mar2021up to 07Mar2021, Clexane 0.8 ml (2/day SC) starting with
25Feb2021 up to 08Mar2021, dexamethasone 8 mg intravenous (IV) (2 x 8 mg/day)
starting with 25Feb2021 up to 08Mar2021, Controloc 40 mg IV (2 x 40 mg/day)
starting with 25Feb2021 up to 02Mar2021, Quamatel 20 mg IV (2 x 20 mg/day) starting
with 03Mar2021 up to 08Mar2021, levofloxacine 500 IV (1 vial/day) starting with
28Feb2021 up to 08Mar2021, furosemide IV (40 mg/day) starting with 02Mar2021 up to
08Mar2021, hyperimmune plasma 200 ml IV starting with 28Feb2021 up to 02Mar2021,
amikacin IV ( 1000 mg/day) 02Mar2021 up to 08Mar2021, piperacilline/tazobactam 4.5
g every 8 hours IV starting with 02Mar2021 up to 08Mar2021, tocilizumab and
parenteral hydro-electrolytic rebalancing. At a date not specified in Mar2021 by
the rapporteur the patient died. The patient has been tested for SARS-CoV-2
infection (RT-PCR test) on 25Feb2021 and the result was positive. On 01Mar2021,
SARS-CoV-2 neutralizing IgG antibodies (anti-spike) were dosed and result was 554
AU/mL. On 23Jan2021, the patient received his 1st dose of Comirnaty, without
further specification. The patient died on an unspecified date in Mar2021. It was
unknown if an autopsy was performed. The adverse reaction was assessed as ""results
in death"" by the primary reporter. In the reporter's opinion pneumonia associated
with SARS-CoV-2 infection were related to Comirnaty. Sender Comment: The medical
assessor of the Authority requested the investigation of the case at agency to no
result yet. No follow-up attempts are possible. The information about lot number
and expiration date cannot be obtained. Amendment: This follow-up report is being
submitted to amend previously reported information: Updating the listedness of the
events.; Reported Cause(s) of Death: Pneumonia associated with SARS-CoV-2
infection/SARS-CoV-2 infection positive"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1173177-1"
"1173177-1" "confused; cough; diarrhoea; short of breath; Hypoxia; SARS-CoV-2
infection/ COVID positive; Vaccine breakthrough infection; General physical health
deterioration/ gradual deterioration/ off legs; This is a spontaneous report from a
contactable pharmacist received from the Regulatory Agency (RA). The regulatory
authority report number is GB-MHRA-WEBCOVID-202103281032444760. Safety Report
Unique Identifier GB-MHRA-ADR 25039712. A 91-years-old male patient received 1st
dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 20Jan2021 (Lot Number: EK4243) as single dose for covid-19
immunisation. The patient medical history was not reported. Patient had not had
symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient was
enrolled in clinical trial. Concomitant medication included influenza vaccine
reported as a/guangdong-maonan/swl1536/2019 (h1n1)pdm09-like strain
(a/victoria/2454/2019 ivr-207), a/hong kong/2671/2019 (h3n2)-like strain (a/hong
kong/2671/2019 ivr-208), b/washington/02/2019-like strain (b/victoria/705/2018 bvr-
11), influenza virus strains inactivated, virus influenza a/california/7/2009
(h1n1) derived strain used nymc x-181, virus influenza a/perth/16/2009 (h3n2)-like
strain used nymc x-187 derived from a/victoria/210/2009, virus influenza
b/brisbane/60/2008 like strain (SEQIRUS VACCINES INFLUENZA) taken for influenza
immunisation on 08Oct2020. The patient experienced sars-cov-2 infection, confused,
cough, diarrhoea, short of breath on an unspecified date; vaccine breakthrough
infection, general physical health deterioration on 01Feb2021; hypoxia on an
unspecified date. The case was reported as serious with seriousness criteria death,
medically significant and hospitalization. It also reported as the patient
experienced COVID positive on 01Feb2021. Since then, had had gradual deterioration.
2 called ambulances prior to admission, not brought into hospital due to saturating
okay. General practitioner (GP) gave oral antibiotics. On date of admission -
confused, off legs and hypoxic. Cough and feeling short of breath were the main
issues, and diarrhoea. Received azithromycin, ceftriaxone and dexamethasone as per
hospital policy. Palliative management started 08Feb2021 and patient passed away
09Feb2021. The patient died on 09Feb2021 with COVID-19 listed as cause of death.
The outcome of event COVID-19 was fatal, of the other events was not recovered. It
was not reported if an autopsy was performed. Follow-up attempts are completed. No
further information is expected.; Reported Cause(s) of Death: COVID-19" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1173211-1"
"1173211-1" "COVID-19 test positive; COVID-19 test positive; This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority-WEB [HU-OGYI-176021] received via Regulatory Authority. A 78-years-old
male patient received bnt162b2 (COMIRNATY, concentrate for dispersion injection;
active substance: tozinameran), dose 1 intramuscular on 04Mar2021 (batch number:
ET1831) as 0.3 mL (30 micrograms), single for covid-19 immunisation. Medical
history included chemotherapy unknown if ongoing. The patient's concomitant
medications were not reported. On 18Mar2021, the patient's COVID-19 test was
positive. He had a severe COVID requiring hospital treatment. The patient was died
on 20Mar2021. It was not reported if an autopsy was performed. Sender Comment:
COVID-19 was detected 14 days after first dose of COMIRNATY. Immunity may have not
developed within two weeks after the first dose of vaccine was given.; Reported
Cause(s) of Death: COVID-19 test positive; COVID-19 test positive" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1173442-1"
"1173442-1" "Sputum; Malaise; Fatigue; covid-19; This is a spontaneous report
from a contactable consumer downloaded from the Medicines Agency (MA) NL-LRB-
00485125 and received via Regulatory Authority (RB). An 86-year-old male patient
received bnt162b2 (vaccine), via an unspecified route of administration on
25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19
immunisation. Medical history included ongoing COPD. The patient's concomitant
medications were not reported. The patient experienced covid-19, sputum, malaise,
fatigue all on 01Mar2021 with fatal outcome. The patient underwent lab tests and
procedures which included corona test: positive on 01Mar2021. The patient died on
an unspecified date in Mar2021. It was not reported if an autopsy was performed.
Reporter's comment: No past drug therapy BioNTech/Pfizer vaccine). BSN available:
yes. Confounding factors was COPD. No previous COVID-19 infection: disease
symptoms. No follow-up attempts possible. No further information expected.
Lot/Batch number cannot be obtained.; Reporter's Comments: No past drug therapy
BioNTech/Pfizer vaccine. BSN available: yes. Confounding factors was COPD. No
previous COVID-19 infection: disease symptoms.; Reported Cause(s) of Death: covid-
19; Fatigue; Malaise; Sputum" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1174572-1"
"1174572-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms; This is a spontaneous report from a contactable physician downloaded
from the Agency Regulatory Authority-WEB manufacturer report number FR-AFSSAPS-
RS20210587. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 1
intramuscular on Jan2021 (Lot number was not reported) as single dose, dose 2
intramuscular, administered in arm left on 11Feb2021 (Lot Number: EJ6789) as single
dose, for covid-19 immunisation. Medical history included dementia, cerebrovascular
accident, myocardial infarction, coronary arterial stent insertion. The patient's
concomitant medications were not reported. 23 days after the second dose (on
06Mar), patient had respiratory decompensation with dyspnoea and desaturation.
Positive PCR test during hospitalisation. Patient died on 20Mar2021, 37 days after
the second dose. It was not reported if an autopsy was performed. No follow-up
attempts possible. No further information expected; Reported Cause(s) of Death:
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1174740-1"
"1174740-1" "diarrhoea; Urinary incontinence; SARS-CoV-2 infection; SARS-CoV-
2 infection; Vaccine breakthrough infection; antitussive therapy (cough); shortness
of breath; This is a spontaneous report from a contactable pharmacist received from
the regulatory authority. The regulatory authority report number is GB-MHRA-
WEBCOVID-202103301347126960, Safety Report Unique Identifier GB-MHRA-ADR 25051069.
An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE), lot number: EL0141, via an unspecified route of administration
on 11Jan2021 at single dose for COVID-19 immunisation. The patient's medical
history was not reported. Patient has not had symptoms associated with COVID-19 and
has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant
medication included influenza vaccine inact sag 3v (FLUAD) for influenza
immunisation on 15Oct2020. The patient experienced SARS-CoV-2 infection on
07Feb2021, diarrhoea on an unspecified date, vaccine breakthrough infection on
07Feb2021, antitussive therapy (cough) on 05Feb2021, shortness of breath on
05Feb2021, and urinary incontinence on an unspecified date. Case is reported with
the seriousness criteria of death. The clinical course was reported as follows:
Patient has had PPM inserted on 02Feb2021. Patient has 2-day history of 'inability
to cough' (as reported) and SOB (shortness of breath) from 05Feb2021. He also
developed loose brown diarrhoea and urinary 'leaking.' He was treated with
azithromycin, dexamethasone and ceftriaxone as per hospital policy. Diarrhoea
settled on 11Feb2021. Deterioration despite O2 via CPAP. Patient was started on
palliative medications on 16Feb2021. Patient passed away on 17Feb2021. It was not
reported if an autopsy was performed. Follow-up attempts are completed. No further
information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-
CoV-2 infection; diarrhoea; Vaccine breakthrough infection; antitussive therapy;
shortness of breath; urinary incontinence" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1174773-1"
"1174773-1" "melena; Vaccination failure; Vaccination failure; Subfebrile;
This is a spontaneous report from a contactable physician downloaded from the
regulatory authority-WEB regulatory authority HR-HALMED-300045644. An 83-years-old
female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1
intramuscular on 20Jan2021 (Lot Number: EJ 6134, lot number not reported) as 30 ug,
single; and dose 2 intramuscular on 17Feb2021 (Lot Number: EJ 6790, lot number not
reported) as 30 ug, single; for covid-19 immunisation. Medical history included
patient was a hemodialysis (also reported as dialysis) patient with kidney failure
chronic (also reported as chronic renal failure) from an unknown date to an unknown
date; and patient was in contact with a positive person (ongoing at the time of the
events reported). The patient's concomitant medications were not reported. It was
reported that patient had vaccination failure on 13Mar2021. This dialyzed patient
was admitted to the hospital about 14 days ago for melena (Mar2021), and was in
contact with a positive person in the same room, had died on 13Mar2021, and was
subfebrile 2-3 days ago (Mar2021). It was reported that COVID PCR test results on
an unknown date were not available. The events vaccination failure and subfebrile
were reported as medically significant. The outcome of the event melena was
unknown. The patient died on 13Mar2021. The causes of death were vaccination
failure and subfebrile. It was unknown if an autopsy was performed. Sender
Comment: Information on Covid 19 PCR test is not available. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
subfebrile; vaccination failure; vaccination failure" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1180959-1"
"1180959-1" ""COVID-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority-WEB, regulatory authority number
FR-AFSSAPS-AN20211060. A 96-year-old female patient received first dose of
bnt162b2 (COMIRNATY; Batch/Lot Number: EJ6789), intramuscular on 16Feb2021 on the
left arm as single dose for COVID-19 immunization. Medical history included
varicose veins, cognitive disorder, hypertension arterial, venous insufficiency,
and arterial insufficiency coronary; from an unknown date and unknown if ongoing.
In Jan2021, the patient was admitted to the hospital for general health
deterioration. Following discharge, the patient returned weak to the nursing home.
No previous Coronavirus disease 2019 (COVID-19) infection (prior to the episode
described below). The patient was at risk of developing a severe form of COVID-19
and she did not know if she had allergies/ hypersensitivity. The patient's
concomitant medications included acetylsalicylate lysine (KARDEGIC 75 mg), folic
acid (SPECIAFOLDINE), ferrous sulfate (TARDYFERON),lactulose (unspecified trade
name), metoprolol tartrate (LOPRESSOR), perindopril (unspecified trade name),
paracetamol ( unspecified trade name). On 22Feb2021, severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test was
performed in the context of a cluster in the nursing room. The PCR returned
positive on the same day. On 26Feb2021 the patient presented with COVID symptoms
with saturation of peripheral oxygen (oxygen saturation) at 60% (22Feb2021) in
ambient air. The patient was not hospitalized due to the pre-existing general
health condition deterioration. On 28Feb2021, at 6:00 a.m., the patient ate as
usual. Death was noticed at the beginning of the afternoon. Severe COVID-19 was
diagnosed in a patient 6 days following vaccination with the first dose of COVID-
19 mRNA Vaccine (nucleoside modified), in the context of a cluster in the nursing
room. The patient became symptomatic ""10 days following vaccination"" and died 12
days after vaccination. The patient experienced covid-19 (death) on 22Feb2021. The
patient died on 28Feb2021. It was not reported if an autopsy was performed. No
follow-up attempts are possible. No further information expected.; Reported
Cause(s) of Death: COVID-19"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1180960-1"
"1180960-1" "Acute respiratory distress syndrome; cough; vomiting; asthenia;
vaccination failure; PCR positive, variant covid-19 infection; fever; respiratory
discomfort; This is a spontaneous report received from a contactable physician
downloaded from the Agency Regulatory Authority-WEB. The regulatory authority
number: FR-AFSSAPS-BS20210413. This physician reported similar event for two
patients. This is the first of two reports. An 88-year-old female patient received
BNT162B2 (COMIRNATY) first dose (Lot Number: EM0477) on 14Jan2021 and second dose
(Lot Number EJ6788) on 04Feb2021; both given intramuscular at single dose for
COVID-19 immunisation. Medical history included arteriopathic disease, morbid
obesity, carotid artery stenosis , osteoarthritis , failure respiratory, type 2
diabetes mellitus, and heart failure; all ongoing. Concomitant medications included
acetylsalicylate lysine (KARDEGIC); febuxostat (ADENURIC); furosemide, nebivolol
and cetirizine hydrochloride (CETRIZINE). On 01Mar2021 the patient experienced
fever and respiratory discomfort. On 09Mar2021 the SARS-CoV-2 PCR was positive for
COVID-19, variant, sequencing in progress. On 10Mar2021the patient experienced
fever, cough, vomiting and asthenia. On 15Mar2021 she was hospitalized for acute
respiratory distress syndrome (ARDS), prognosis live threatening on 18Mar2021. In
total, variant covid-19 infection on 01Mar2021 after a complete well-conducted
vaccination schedule. No conservation condition problem. The patient died on
21Mar2021. Cause of death was COVID-19 pneumonia, vaccination failure, fever,
cough, vomiting, and Acute respiratory distress syndrome. Autopsy was not
performed. No follow-up attempts possible. No further information expected.
Follow-up (02Apr2021): New information downloaded from the Agency Regulatory
Authority-WEB FR-AFSSAPS-BS20210413 includes updated outcome of events (fatal). No
follow-up attempts possible. No further information expected.; Sender's Comments:
Linked Report(s) : FR-PFIZER INC-2021333550 same reporter, different
patient;AFSSAPS-BS20210414; Reported Cause(s) of Death: vaccination failure; fever;
cough; vomiting; Acute respiratory distress syndrome; COVID-19 pneumonia" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1185642-1"
"1185642-1" "Vomiting blood; Bloody stool; Generelized discomfort since
vaccination; Melena; Haemodynamic instability; Coffee ground colored vomiting;
positive COVID-19; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority. Regulatory authority number DK-DKMA-WBS-
0055221. A 82-years-old female patient received the first dose of bnt162b2
(COMIRNATY), intramuscular on 02Mar2021 (Lot Number: ER2659; Expiration Date:
30Jun2021) as single dose for covid-19 immunisation. Medical history included
apoplexy cerebral on 2010, ongoing hypercholesterolaemia, apoplexy cerebral on
2009, ongoing hypertension, ongoing atrial fibrillation, ongoing urinary tract
infection, ongoing renal failure, apoplexy cerebral on 2008, back surgery, ongoing
diabetes mellitus, ongoing dementia, ongoing wheelchair user. There is no
information regarding past medication. Concomitant medications included rivaroxaban
(XARELTO) taken for atrial fibrillation from 2018. The patient experienced vomiting
blood on 02Mar2021, bloody stool on 02Mar2021, generelized discomfort since
vaccination on 02Mar2021, melena on 02Mar2021, haemodynamic instability on
02Mar2021, coffee ground colored vomiting on 02Mar2021. The ADRs were reported by
the physician as causing acute hospitalisation on 11Mar2021, as being fatal (all
besides from general discomfort) on 11Mar2021 and being life threatening. No
treatment or medical procedure due to the ADRs were reported. General discomfort
was not recovered. Bloody stool, coffee ground vomiting, haemodynamic instability,
melena and vomiting blood were all fatal. Patient died on 11Mar2021. It was not
reported if an autopsy was performed. The patient underwent lab tests and
procedures which included sars-cov-2 test: positive on 11Mar2021 (outcome unknown).
No follow-up attempts are needed. No further information is expected.; Reported
Cause(s) of Death: Melena; Bloody stool; Coffee ground vomiting; Vomiting blood;
Haemodynamic instability" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1185680-1"
"1185680-1" "Vaccination failure; PCR-SARS Cov 2:positive; This is a
spontaneous report downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority number FR-AFSSAPS-NT20210851. A contactable pharmacist
reported that a 97-years-old male patient received first dose of BNT162B2
(COMIRNATY, Formula-tion: Solution for injection, lot number: EJ6795 and Expiry
date not reported), via intramuscular route of administration on 21Jan2021, as
single dose and second dose of BNT162B2 (CO-MIRNATY, Formulation: Solution for
injection, lot number: EJ6789 and Expiry date not reported), via intramuscular
route of administration on 11Feb2021, as single dose both for COVID-19
immunization. Medical history included Recurrence of inoperable squamous cell
carcinoma of the left cheek with ipsilateral orbital extension initially diagnosed
in 2015, Current functional signs: Complete eyelid occlusion, Extension assessment:
MRI on 14Aug2018: existence of a suspicious left eye-lid tissue infiltration
extending into the temporal and preseptal region, 64mm long in axis, associated
with suspicious left intraparotid lymphadenopathy (11x19mm), Treatments received:
Excision performed in June 2017: incomplete, Peripheral artery disease, trans
metatarsal amputation of the left foot in 2015, Hypertension, AF with cardiac
decompensation, Rhizomelic pseudopolyarthritis, Typhoid fever, Malformation of the
pelvis, Right foot toe amputation, Inguinal hernia, left patella surgery.
Concomitant medication(s) included: potassium chloride (DIFFU K); hydrocortisone
(HY-DROCORTISONE); furosemide (LASIX [FUROSEMIDE]); lorazepam (LORAZEPAM);
nebivolol (NEBIV-OLOL); mirtazapine (NORSET); omeprazole (OMEPRAZOLE); paracetamol
(PARACETAMOL); macrogol (MACROGOL); apixaban (ELIQUIS); budesonide, formoterol
fumarate (SYMBICORT TURBO-HALER) all taken for an unspecified indication, start and
stop date were not reported.It was re-ported that very fragile patient having
presented numerous decompensations of COPD with secondary infections. Greasy cough
with increasing dyspnea since 16Mar2021, with crackling right base: put under
AUGMENTIN with hydrocortisone increase. 2 episode of hematuria described on
16Mar2021. In emergencies: Clinical picture of multi-visceral failure predominant
on the respiratory side in a 97-year-old GIR 3 patient in nursing home with a
history of rhythmic heart disease and locally infiltrating squamous cell carcinoma.
Major respiratory distress without argument for a quickly curable cause in
particular no argument for a pulmonary edema. Background of anti-gene test COVID-
positive the day before In view of the age of the history of autonomy and the
severity of the current clinical picture, after discussion with the family and the
medical and paramedical team, decision of comfort care alone. The patient underwent
lab tests and procedures which included blood creatinine: 278 umol/l on, blood
gases: under mhc: ph 7.31, hypocapnia, normoxia on under MHC: pH 7.31, hypocapnia,
normoxia , blood potassium: 3.7 mmol/l on, blood pressure measurement: 97/44 mmhg
on, blood sodium: 170 mmol/l on, body temperature: 37.4 centigrade on, glomerular
filtration rate: 16 ml / min / 1.73 m2 on, haemoglobin: 14.5 g/dl on macrocytic ,
heart rate: 75/ min on, magnetic res-onance imaging: no values on 14Aug2018
existence of a suspicious left eyelid tissue infiltration ex-tending into the
temporal and preseptal region, 64mm long in axis, associated with suspicious left
intraparotid lymphadenopathy (11x19mm) , oxygen saturation: 93 % on nasal cannula ,
platelet count: 216 10*6/l on, respiratory rate: 40/min on, sars-cov-2 test:
positive on, sars-cov-2 test: positive on. Physical examinations: Glasgow 3,
hypotension, with mottling of the knees, cold ex-tremities Sign of respiratory
distress, polypnea, unencumbered Implementation of comfort care. The outcome of the
events was fatal. The patient died on 27Mar2021. It was not reported if an autopsy
was performed. No follow-up attempts possible. No further information expected."
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1189371-1"
"1189371-1" ""Developed lung embolisms and respiratory failure, and died of
the complications.; Lung embolisms; COVID-19; multimorbidity; This is a spontaneous
report from a contactable Physician downloaded from the Regulatory Authority-WEB
DK-DKMA-WBS-0059241. This is a spontaneous case, received on 23Mar2021 from a
physician (Internal ID: XMO-A09DA4056C6C4C3A8199155E969CD535) and a requested
follow-up received on 26Mar2021 from the same physician, which describes the
occurrence of Embolism lung (Lung embolisms) and Respiratory failure (Developed
lung embolisms and respiratory failure, and died of the complications) in a 57
years old female patient vaccinated with COMIRNATY (tozinameran). A 57-year-old
female patient received BNT162b2 (COMIRNATY, Lot #EMO477) via an unspecified route
of administration on 07Jan2021 at single dose for COVID-19 immunisation. Relevant
medical history included severe multimorbidity/co-morbidity and living in nursing
home, both ongoing. Patient concurrent conditions included: depression, skin
infection (exit site), vitamin B12 deficiency, cardiac disorder, edema caused by
kidney failure, sleeplessness, constipation, pain, bipolar disorder and type 2
diabetes mellitus. Concomitant medications included oral bisacodyl (TOILAX) taken
for constipation from 23Jul2020 at 10mg 1x/day; oral zopiclone (IMOVANE) taken for
insomnia from 26Jun2020 at 7.5mg 1x/day; oral cefuroxime (FURIX) taken for oedema
from 05Jan2021 at 250mg 1x/day; oral kaliumklorid taken for potassium
supplementation from 05Jan2021 at 2 tablets morning and 1 tablet evening; oral
ascorbic acid taken for vitamin supplementation from 01Sep2020 at 80 mg, 1x/day;
oral quetiapine fumarate (QUETIAPIN ACCORD) taken for bipolar disorder from
25Jun2020 400 mg, 1x/day; oral lactulose (LACTULOSE ORIFARM) taken for constipation
from 14Jun2018 15 mL, 1x/day; oral cyanocobalamin zinc tannate (BETOLVEX) taken for
vitamin B12 deficiency at 1 mg, 1x/day; oral calcium pantothenate, nicotinamide,
pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (APOVIT B COMBIN)
taken for vitamin supplementation from 01Sep2020 at 1 DF, 1x/day; oral
amitriptyline hydrochloride (AMITRIPTYLIN ""DAK"") taken for depression from
02Aug2018 at 100 mg, 1x/day; oral oxycodone hydrochloride (OXYNORM) taken for pain
from 30Dec2020 to 13Jan2021 at 10 mg, 1x/day; oral macrogol 3350, potassium
chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from
07Oct2020; oral simvastatin (SIMVASTATIN KRKA) taken for cardiovascular disorder
from 06Jun2019 at 10 mg, 1x/day; oral mirtazapine (MIRTAZAPIN ""ACTAVIS"") taken
for depression from 26Jun2020 at 30 mg, 1x/day; oral tramadol hydrochloride
(TRADOLAN) taken for pain from 26Jun2018 at 50 mg, as needed; oral calcium
carbonate, vitamin D NOS (CALCIUM + VIT D) taken for calcium supplementation from
07Dec2020 at 2 DF, 1x/day; subcutaneous insulin glargine (TOUJEO) taken for
diabetes mellitus from 28Aug2018 at 20 DF, 1x/day; oral folic acid (FOLIMET) taken
for vitamin supplementation from 02Sep2020 at 15 mg, weekly; cutaneous mupirocin
calcium (BACTROBAN) taken for skin infection from 11Nov2020 at 2 DF, 1x/day; oral
carvedilol (CARVEDILOL HEXAL) taken for cardiac disorder from 26Mar2013 at 25 mg,
1x/day; oral paracetamol (PANODIL) taken for pain from 07Dec2020 at 4000 mg,
1x/day; oral linagliptin (TRAJENTA) taken for type 2 diabetes mellitus from
07Jun2015 at 5 mg, 1x/day. The patient was routinely tested for COVID-19 a few days
before vaccination and one day after vaccination, on 08Jan2021, test result was
positive. On 11Jan2021 the patient developed embolism lung (onset first dose day
4). On 28Jan2021 the patient developed respiratory failure (onset first dose day
21). The ADRs were reported as being life threatening, resulting in
hospitalisation, and being fatal (28Jan2021). No treatment or medical procedure due
to the ADRs were reported. No autopsy was performed. Reported cause of death was
respiratory failure, lung embolism, COVID-19, multimorbidity (severe co-morbidity).
Only normal confirmation of death was performed post-mortem, findings unknown. Test
results included SARS-CoV-2 test, 08Jan2021, positive; laboratory test, Jan2021,
unspecified, unknown results; diagnostic procedure, Jan2021, unspecified diagnostic
imaging, unknown results. It was unknown if the death was reported to the police
since the reporting physician has not conducted the confirmation of death. The
physician does not wish to report the death to the police. Causality: The
physician comments that she originally hadn't reported the ADRs on her own
initiative and believed the COVID-19 infection compared with severe co-morbidity is
cause of the patient's death. The reason for the late report is that the patient's
daughter has contacted her after the cases regarding thrombosis and AstraZeneca
(ChAdOx1 nCoV-19) was announced in the media, and requested of having the case
reported - despite the patient was vaccinated with Comirnaty. The physician
comments furthermore that she despite of her not believing the vaccine is the cause
of death, she cannot rule it out due to the timeframe from given vaccination to the
lung embolisms and the death occurs. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19; Respiratory failure;
Lung embolism; Multimorbidity"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1199927-1"
"1199927-1" "COVID-19/Covid infection, 1 month after the 2nd dose (complete
vaccination schedule); Vaccination failure/Covid infection, 1 month after the 2nd
dose (complete vaccination schedule); COVID-19 pneumonitis; Multiple organ
dysfunction syndrome; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority FR-AFSSAPS-BX20212622. A 70-year-old male
patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EM0477),
administered in arm left on 13Jan2021 as a single dose, then the second dose
(Batch/Lot Number: EJ6789), administered in arm right on 13Feb2021; both
intramuscular as a single dose for COVID-19 immunisation. Medical history included
morbid obesity (BMI 35), oedema of lower extremities, encephalopathy, anal
carcinoma (squamous cell carcinoma of the anal canal), weaned alcoholism, apathy,
venous insufficiency (with lymphedema of the lower limbs) and dysuria (with chronic
urinary retention) from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced Covid infection,
1 month after the 2nd dose (complete vaccination schedule)/vaccination failure,
with diagnosis confirmed by PCR (English variant) and images of Covid pneumonia on
chest scanner, rapidly progressing with respiratory deterioration 3 days after the
first signs and death from multiple organ failure 2 weeks after diagnosis.
Description of the effect: 1 month after dose 2, 13Mar: high fever, 14Mar: PCR
positive, 16Mar: desaturation leading to hospitalization in medical service then
transfer to continuing care. Evolution: 29Mar: death of the patient. Update V1:
18Mar: referred to emergency for deterioration of general condition, mottling and
dyspnea. Normal constants arterial pressure at 110, heart frequency at 89,
afebrile, 93% saturation under 2L of O2, Glasgow 15, no deficit sign, no headache,
no focusing sign. Lungs free. Heart noise regular, no congestive signs, no signs of
heart failure. Mild edema of the lower limbs (known lymphedema). Diagnosis of
COVID-19 type pneumonia, English variant. Patient stabilized under 3L of O2 with
glasses. Thoracic CT: COVID-type pneumonia with frosted glass areas with an
impairment estimated at 25%, condensation in bilateral subpleural bands, no image
in favor of pulmonary superinfection. Ectatic aspect of the ascending aorta at 6
cm. Biology: CRP at 29 mg/L, fibrinogen at 7 g/L, D-dimer at 750 ng/mL and
lymphopenia at 0.32 G/L. Mild renal failure with creatinine at 113 umol/L. No ionic
problem. Undernutrition with albumin at 26 g/L and pre-albumin at 0.165 g/L. Normal
liver test. Blood gases: hypoxia at 60 mm Hg, normal capnia and pH. Put on
dexamethasone 6 mg / day and enoxaparin. Hospitalization in medical service. 21Mar:
initiation of treatment with amoxicillin/clavulanic acid. 24Mar morning:
respiratory degradation with 84% saturation under 6L,> 93% under 15L. Marked
asthenia. On auscultation, diffuse crackling, indrawing, polypnea. Arterial
pressure at 122/72 and heart rate at 115. Apyretic. Transfer to continuing care
service. Very hypoxic patient, polypneic at 45/min, setting up FiO2 at 90% under
Optiflow 60 L/min. Glasgow 15. Correct hemodynamics. 28Mar: marked worsening with
multiple organ failure. Patient less and less reactive and communicating. On the
respiratory level, congestion, polypnea, episodes of desaturation, clear tendency
to hypercapnia with respiratory acidosis. OptiFlow shutdown and permanently
switched on non-invasive ventilation. Also, hemodynamic degradation with
hypotension, mottling. Renal function degradation. Hypernatremia and increased
lactates. 29Mar: death at 10:40 a.m. of a COVID + patient with multiple organ
failure. Change in cause of death (multiple organ failure and Covid-19 pneumonia).
The patient was hospitalized for vaccination failure, covid-19, COVID-19
pneumonitis and multiple organ dysfunction syndrome from 16Mar2021 to an unknown
date. The causes of death were reported as COVID-19 pneumonitis and multiple organ
dysfunction syndrome. Therapeutic measures were taken as a result of all events.
The outcome of the events was fatal. The patient died on 29Mar2021. An autopsy was
not performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: COVID-19 pneumonitis; Multiple organ
dysfunction syndrome" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1199966-1"
"1199966-1" "Vaccination failure; COVID-19; This is a spontaneous report from
a contactable physician downloaded from the regulatory authority, regulatory
authority number FR-AFSSAPS-NY20210628. An 88-year-old female patient received
first dose of bnt162b2 (COMIRNATY; lot number not reported) on 15Jan2021 and second
dose of bnt162b2 (COMIRNATY; Lot Number: EK9788) on 04Feb2021 both given
intramuscular as single dose for covid-19 immunisation. Medical history included
ongoing chronic obstructive pulmonary disease, ongoing insulin-requiring type 2
diabetes mellitus, ongoing hypertension, ongoing cardiac failure, and living in
residential institution. Concomitant medications included ipratropium; insulin
aspart (NOVORAPID); paracetamol (DOLIPRANE); terbutaline sulfate (TERBUTALINE
ARROW); amlodipine besilate (AMLOR); zopiclone (IMOVANE); budesonide (BUDESONIDE
ARROW); valsartan (VALSARTAN ARROW). On 28Feb2021, the patient was diagnosed with
COVID infection (variant) in the context of cluster COVID cases in nursing homes.
The patient was hospitalized in 2021 in response to the event. The patient died on
03Mar2021. Cause of death was reported as COVID-19 infection. It was unknown if an
autopsy was performed. Imputability (according to the method): I1 dubious. NB:
Accountability without prejudice to the elements of investigations which could be
carried out within the framework of legal or amicable compensation procedures.
Therapy 1985; 40: 111-8. No follow-up attempts possible. No further information
expected. ; Reported Cause(s) of Death: COVID-19; COVID-19""No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1200655-1"
"1200655-1" "23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact
tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization
The Patient resides in a country; hyperbilirubinaemia aggravated; creatinine:
increased; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact tracking;
20Mar insuff. acute respiratory tract with the need for hospitalization The Patient
resides in a country; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact
tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization
The Patient resides in a country; This is a spontaneous report from a contactable
physician downloaded from a regulatory authority-WEB [IT-MINISAL02-710342]. A 99-
year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number:
EP9598; Expiration Date: 30Jun2021), intramuscular, administered in left deltoid
(reported as left shoulder) on 23Feb2021 13:12 as single dose for COVID-19
immunization. The patient's medical history and concomitant medications were not
reported. On 23Feb2021 the patient had the first vaccine dose of bnt162b2. On
11Mar2021, TNF SARS-COV 2 for positive contact tracing. On 20Mar2021, the patient
had insuff. acute respiratory tract (Failure respiratory) with the need for
hospitalization as the patient resides in certain area. Actions taken for the
events insuff. acute respiratory tract and TNF SARS-COV 2 for positive included
oxygen therapy, hydration, steroids. The patient underwent lab tests and procedures
which included TNF SARS-CoV 2: positive on 11Mar2021, creatinine: increased on
20Mar2021, and hyperbilirubinaemia aggravated on 25Mar2021. The patient died on
26Mar2021. Cause of death was insuff. acute respiratory tract and TNF SARS-COV 2
for positive. It was unknown if an autopsy was performed. The outcome of the events
insuff. acute respiratory tract and TNF SARS-COV 2 for positive was fatal. The
outcome of the remaining events was unknown.; Reported Cause(s) of Death: insuff.
acute respiratory tract; TNF SARS-COV 2 for positive; TNF SARS-COV 2 for positive"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1202850-1"
"1202850-1" "multiple organ failure with acute respiratory distress syndrome
(ARDS) severe; multiple organ failure with acute respiratory distress syndrome
(ARDS) severe; myocardial astonishment and renal failure on dialysis; myocardial
astonishment with global hypokinesia/myocardial astonishment and renal failure on
dialysis; myocardial astonishment with global hypokinesia; AFib; arterial
hypotension (blood pressure 80/40 mmHg); mottling/Diffuse mottling of the lower
limbs and trunk.; sepsis with fever at 38.9C; PCR COVID19 positive; PCR COVID19
positive; This is a spontaneous report from a contactable consumer downloaded from
the regulatory authority FR-AFSSAPS-LY20211640. This is a report received from the
Regulatory Authority. A 77-year-old male patient received bnt162b2 (COMIRNATY),
dose 1 intramuscular on 18Jan2021 as single dose (lot EM0477); and dose 2
intramuscular on 15Feb2021 as single dose (lot EK9788), for COVID-19 vaccination.
Medical history included metastatic renal carcinoma in the lung, mediastinum and
bone treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence,
new recurrence of renal carcinoma in 2017 with pleural involvement initially
treated with pazobanib then nivolumab since Jun2018, pneumocystosis in 2019 treated
with bactrim, now on pentamidine for prophylaxis, chronic renal failure (basic
creatinine was 130umol / L), melanoma (operated on in 2016), ischemic heart disease
with myocardial infarction (MI) in 2018, hypertension arterial, complete arrhythmia
by atrial fibrillation, Hyperthyroidism (thyroid overload), and long-term
corticosteroid therapy in a context of colitis under immunotherapy -
corticosteroids a priori suddenly stopped suddenly recently. History of COVID19 was
not specified. Concomitant medications included bisoprolol fumarate (BISOCE),
prednisone (CORTANCYL), desloratadine (DESLORATADINE), apixaban (ELIQUIS),
acetylsalicylate lysine (KARDEGIC), furosemide (LASILIX), metoclopramide,
nivolumab, perindopril and pantoprazole. On 19Feb2021, the patient experienced
fever, body aches, chills, headache, digestive disorders. On 21Feb2021, the patient
had a PCR COVID-19 positive. On 22Feb2021, the patient presented to the emergency
room with the persistence of fever and the appearance of rapidly progressive
dyspnea. In the emergency room, a picture of sepsis with fever at 38.9C, mottling,
arterial hypotension (blood pressure 80/40 mmHg) which rises after vascular
filling. Oxygen request was at 3 L / min with no sign of respiratory distress.
Thoraco-abdominal CT scan showed COVID19 infection extended to 25% of the lung
parenchyma. Start ceftriaxone and rovamycin + an injection of amikacin.
Hydrocortisone EPS in the face of suspected acute adrenal insufficiency (sudden
stop of chronic corticosteroid therapy). On 22Feb2021: heart rate was 83 bpm, and
76 bpm. On 24Feb2021, heart rate was at 83 bpm. On 25Feb2021, sudden respiratory
degradation and was resuscitation. Respiratory: polypneic at 45 / min, 87%
saturation under non-invasive ventilation (NIV). Hemodynamically: stable except
amine. Patient had diffuse mottling of the lower limbs and trunk and cold ends.
Cardiovascular: tachycardia at 150 bpm and ECG: atrial fibrillation with appearance
of right bundle branch block. Neurologically: Glasgow 15 On the digestive level:
supple and painless abdomen. On the renal level: no urinary functional signs.
Creatinine 137umol / L. Before the sudden onset of distress and the surge of
complete arrhythmia by atrial fibrillation, a cardiac origin to the respiratory
distress was suspected. Treatment of challenge with furosemide, maintenance of NIV,
slowing of complete arrhythmia by atrial fibrillation with amiodarone and
magnesium. There was no improvement after one hour, patient was intubated +
noradrenaline. Reduced atrial fibrillation on 27Feb2021 with amiodarone ESP.
Curative anticoagulation by Calciparin. Probable acute coronary syndrome (ACS) type
2. On 25Feb2021, heart rate was at 104bpm. On 01Mar2021, echocardiography showed
myocardial astonishment with global hypokinesia without recovery on the iterative
ultrasounds performed. On 02Mar2021, there was multiple organ failure with acute
respiratory distress syndrome (ARDS) severe, myocardial astonishment and renal
failure on dialysis which led to discontinuation of active therapies. Outcome of
event AFib was not recovered; and outcome of the rest of the events was unknown.
The patient died on 02Mar2021 due to PCR COVID19 positive. It was unknown if
autopsy was performed.; Reported Cause(s) of Death: PCR COVID19 positive; PCR
COVID19 positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1208840-1"
"1208840-1" "contracts covid; contracts covid; This is a spontaneous report
from a contactable consumer (Pfizer colleague). A 104-year-old female patient
received first dose of bnt162b2 (COMIRNATY; Lot number was not reported) in Jan2021
and second dose (Lot number was not reported) in the beginning of Feb2021 both
given via an unspecified route of administration, as single dose for covid-19
immunisation. The patient medical history and concomitant medications were not
reported. The patient contracted covid in the mid of Mar2021 with fatal outcome.
The patient died on 26Mar2021 in the hospital. Cause of death was COVDI-19. It was
unknown if an autopsy was performed. Information on the lot/batch number has been
requested.; Reported Cause(s) of Death: covid; covid" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1211717-1"
"1211717-1" "fell again twice in a row; Fibrin D dimer is above 12000 ng/ml;
Fibrin D dimer on 26Feb2021 was 12011 ng/ml.; collapsed (had syncope); melaena
diarrhea; gastrointestinal bleeding was suspected; developed anemia; impaired renal
function; erosive gastritis; pneumonia; COVID-19 was detected; COVID-19 was
detected; hypotonic, anuric; pulmonary circulation decompensation; low GFR
(glomerular filtration rate); dyspnoea; catarrhal cough; incipient bronchitis;
tension; he became confused; respiratory deterioration; cardiomegaly; Suspicion of
urinary incontinence; his condition started to gradually worsen/patient's condition
showed a gradual and unstoppable progression; melaena diarrhea; This is a
spontaneous report downloaded from the Regulatory authority-WEB. Regulatory
Authority report number is HU-OGYI-158121. A contactable physician reported that
an 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via
intramuscular route, administered in the left arm on 20Feb2021 (Batch/Lot Number:
EL0725) at 0.3 mL, as single dose for covid-19 immunization. Medical history
included hypertension, ischemic heart disease, atrial fibrillation and COPD.
Concomitant medications included tamsulosin, rivaroxaban (XARELTO), bisoprolol,
furosemide (FURON), allopurinol (MILURIT) potassium chloride (KALDYUM),
theophylline sodium aminoacetate (THEOSPIREX), salbutamol (VENTOLINE), budesonide,
formoterol fumarate (BUFOMIX EASYHALER) and amiloride hydrochloride,
hydrochlorothiazide (AMILOZID); all taken from unspecified dates (unknown if
ongoing) for unspecified indications. On 21Feb2021, the patient felt unwell while
standing in line before vaccination which resolved when he sat down. After the
observation period, the patient collapsed (had a syncope) after 10 m long walking.
The patient was taken home, where he fell again twice in a row, and had melaena
diarrhea twice. Ambulance was called because gastrointestinal bleeding was
suspected. In the emergency department, laboratory tests confirmed impaired renal
function and low GFR (glomerular filtration rate) which presumably caused the
development of erosive gastritis as a source of gastrointestinal bleeding. Due to
the developed anemia, a total of 6 units of blood were transfused without
complications, the patient's blood count improved. Anticoagulant therapy was
suspended and switched to low-dose LMWH corresponding to low (glomerular filtration
rate). During further observations, on day 5 of treatment, dyspnoea, catarrhal
cough occurred, and physical examination revealed pulmonary circulation
decompensation and incipient bronchitis. The patient became hypotonic, anuric, so
he received a pressor agent, his tension settled, and his diuresis started.
Parenteral broad-spectrum antibiotics were initiated with further careful infusion,
diureticization, and Berodual (ipratropium bromide; fenoterol)-ambroxol inhalation,
supplemented with oxygen therapy. However, his condition started to gradually
worsen, he became confused, so low-dose sedatives, steroids and intravenous
bronchodilator was also initiated. Due to significant respiratory deterioration,
the patient received mechanical ventilation for a short period of time. A chest X-
ray was taken, which showed significant cardiomegaly, a congestive pattern, and no
lesions suggestive to pneumonia. Suspicion of urinary incontinence also arose
during a urine test, based on the results of inoculation, antibiotic therapy was
switched to targeted treatment. Despite the treatment applied, the patient's
condition showed a gradual and unstoppable progression, the patient died on
06Mar2021 at 08:30 am. Autopsy was not done, COVID-19 was detected. The patient
underwent lab tests and procedures on 20Feb2021 which included ECG: HR: 90-130/min.
Tachyarrhythmia, left axis, right bundle branch block, disturbed repolarization and
gastroscopy showed gastric erosions. COVID-19 antigen test on 21Feb2021 was
negative. COVID-19 PCR test on 26Feb2021 was negative. Fibrin D dimer on 26Feb2021
was 12011 ng/ml. Senders Comment: The 83 year-old patient had syncope after
Comirnaty vaccination. TTO was around 30 minutes. The patient also felt unwell
right before vaccination. The patient had gastric erosions, anaemia, and impaired
renal function. Fibrin D dimer was 12011 ng/ml 6 days after vaccination. The
patients condition worsened, and died in hospital 14 after vaccination. Autopsy was
not done, COVID-19 was detected. The causal relationship between the events and
Comirnaty is considered unlikely. The case is serious due to hospitalization and
fatal outcome. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: collapsed (had syncope); Fibrin D dimer is
above 12000 ng/ml; Fibrin D dimer on 26Feb2021 was 12011 ng/ml." "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1227708-1"
"1227708-1" "COVID-19/ COVID INFECTION; CONDITION DETERIORATED; RTI; This is
a spontaneous report from a contactable physician downloaded from the regulatory
authority, IE-HPRA-2021-066081. This is a report received from the regulatory
authority. A 90 -year- old male patient received first dose of bnt162b2
(COMIRNATY, Lot Number: EJ6134), via an unspecified route of administration on
21Jan2021 at single dose for covid-19 immunisation . Medical history included type
2 diabetes mellitus, atrial fibrillation and chronic obstructive pulmonary disease.
There were no concomitant medications. The patient did not have any COVID-19
symptoms prior to vaccination. On 21Jan2021, the patient was vaccinated and It was
reported that no adverse reactions were noted post vaccination. On 28Jan2021, the
patient tested positive for COVID-19 following a PCR nasal/pharyngeal swab. It was
reported that the patient's condition deteriorated in the days prior to death. The
patient was seen by a General Practitioner (GP). The patient was treated for a
respiratory tract infection (RTI) with antibiotics, intramuscular Rocephin and
oxygen (O2) therapy. However, there were no significant improvements. A palliative
care pathway was commenced. On 10Feb2021, at 12.10pm, the patient died. The
reported fatal events were Covid-19/COVID infection, condition deteriorated and
respiratory tract infection (RTI). On 11Feb2021 a Coroner reported that the patient
's death occurred as a result of COVID-19 following vaccination with COVID-19
vaccine. Follow-up information was received by the regulatory authority from a
healthcare professional on 16Mar2021: It was reported that the patient's death
certificate had been completed as ''COVID, vaccine related''. Follow-up attempts
are completed. No further information is expected; Sender's Comments: Linked
Report(s) : IE-HPRA-2021-066080 regulatory authority; Reported Cause(s) of Death:
COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1231929-1"
"1231929-1" "COVID-19 PCR test positive; 06Mar21 died of virus flu with
proven Covid-19 infection; Influenza A virus infection from Mar2021; This is a
spontaneous report from a non-contactable consumer downloaded from the regulatory
authority, regulatory authority number is DE-PEI-CADR2021044761. Safety report
unique identifier DE-PEI-202100032456. A 71-year-old male patient received the
first dose of bnt162b2 (COMIRNATY), intramuscular on 24Feb2021 (Lot Number: EP9598)
as 0.3 mL, single for COVID-19 immunisation. Medical history included
schizophrenia; type 2 diabetes mellitus and all unknown if ongoing. The patient's
weight was 70 kg, and height was 167 cm. Concomitant medications were not reported.
The patient died of virus flu with proven covid-19 infection (unknown cause of
death) on 06Mar2021. He had Influenza A virus infection from Mar2021. And he had
cough on 04Mar2021 (2 days before death). Pulmonological clinically normal. The
patient underwent lab tests and procedures which included COVID-19 PCR test with
result of positive. The patient died on 06Mar2021. An autopsy was not performed.
No follow-up attempts possible. No further information expected.; Reported Cause(s)
of Death: Influenza A virus infection; Unknown cause of death; COVID-19 PCR test
positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1231930-1"
"1231930-1" ""Despite Covid-19 vaccination on 24Feb2021, the patient died
according to the death certificate on 21Mar2021 of viral pneumonia with proven
COVID-19 infection.; proven COVID-19 infection; vaccination on 24Feb2021, Covid-19
on 09Mar2021; This is a spontaneous report from a non-contactable consumer
downloaded from the Regulatory Agency-WEB DE-PEI-CADR2021044771, Safety Report
Unique Identifier DE-PEI-202100032478. An 88-year-old female patient received
bnt162b2 (COMIRNATY), dose 1 intramuscularly on 24Feb2021 (Lot Number: EP9598) as
0.3 mL, single for covid-19 immunisation. Medical history included ongoing arterial
hypertension, ongoing depression, ongoing osteoporosis, ongoing apoplexy, ongoing
dementia, ongoing hemiparesis. The patient's concomitant medications were not
reported. On 09Mar2021 the patient experienced pneumonia viral NOS, COVID-19.
Despite Covid-19 vaccination on 24Feb2021, the patient died according to the death
certificate on 21Mar2021 of viral pneumonia with proven COVID-19 infection. The
patient's outcome was fatal for Pneumonia viral NOS, not recovered for COVID-19.
The patient died on 21Mar2021. An autopsy was not performed. Sender's comments:
""Are you or the person concerned known of any allergies? If yes, which? No.
Information on risk factors or previous illnesses: known dementia, depression,
condition after apoplexy with hemiparesis, arterial hypertension, osteoporosis /
09Mar21 cough, pulmonary increased vesicular breathing, weakness"". The PEI
assessed Pneumonia viral NOS and COVID-19 were D. Unclassifiable. No follow-up
attempts are possible. No further information is expected. ; Reported Cause(s) of
Death: Pneumonia viral NOS"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1231931-1"
"1231931-1" "cardiovascular failure/Sudden cardiac death; cardiovascular
failure/Sudden cardiac death; COVID-19; COVID-19; Viral infection of the
respiratory tract; This is a spontaneous report from a non-contactable consumer
downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DE-
PEI-CADR2021044779, Safety Report Unique Identifier DE-PEI-202100032482. A 74-
year-old female patient received bnt162b2 (Pfizer vaccine, Solution for injection),
intramuscular on 24Feb2021 (Lot Number: EP9598) as single dose for covid-19
immunisation. Medical history included ongoing Chronic renal insufficiency, ongoing
Coronary heart disease, ongoing Arterial hypertension, ongoing Type 2 diabetes
mellitus. The patient's concomitant medications were not reported. The patient's
weight was 72 kg, and height was 156 cm. On 08Mar2021, the patient experienced
Viral infection of the respiratory tract, COVID-19. On 09Mar2021, the patient
experienced cardiovascular failure/Sudden cardiac death. The patient died on
09Mar2021. No autopsy was performed. It was reported that Information on risk
factors or previous illnesses arterial hypertension, coronary heart disease,
Diabetes mellitus type 2, chronic renal insufficiency / one day before death in
general. physical weakness, Pulmo exacerbated vesicular breathing. No concerned
have any allergies. Relatedness of drug to reactions was assessed as D.
Unclassifiable by PEI. The outcome of the events cardiovascular failure/Sudden
cardiac death was fatal, of the other events was not recovered. No follow-up
attempts are possible. No further information is expected. ; Reported Cause(s) of
Death: cardiovascular failure; Sudden cardiac death" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1231936-1"
"1231936-1" ""patient died approximately 1 week after first vaccination;
Covid-19 test positive; This is a spontaneous report based on information received
by Pfizer from a company [manufacturer control number: 38084], license party for
Comirnaty. A non-contactable physician reported that a female patient of an
unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified
route of administration on an unspecified date in Apr2021 at SINGLE DOSE for COVID-
19 immunisation. The patient was not pregnant at the time of vaccination. The
patient's medical history and concomitant medications were not reported. The
patient has been vaccinated with bnt162b2 during Easter holidays. A few days later
the COVID-19 test was positive in Apr2021. The patient died approximately 1 week
after first vaccination according to the daughter in Apr2021. It was not reported
if an autopsy was performed. The outcome of the event COVID-19 test was positive
was unknown. No follow-up attempts are possible, information about lot/batch
number cannot be obtained.; Sender's Comments: The limited information provided in
this report does not allow a full assessment of the case. The event ""death"" with
unknown cause is assessed as related to the suspect drug per company guidance. This
case will be reassessed when additional information, particularly the clinical
course before death, complete medical history and concomitant medication and
autopsy report, becomes available. COVID-19 is most likely related to an
intercurrent or underlying condition which is not related to the suspected drug.
Individuals may not be protected until at least 7 days after their second dose of
the vaccine. The case will be reassessed if additional information becomes
available. The impact of this report on the benefit/risk profile of the Pfizer
product is evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety concern
identified as part of this review, as well as any appropriate action in response,
will be promptly notified to Regulatory Authorities, Ethics Committees and
Investigators, as appropriate.; Reported Cause(s) of Death: patient died
approximately 1 week after first vaccination"" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1231946-1"
"1231946-1" "Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR test was
positive; Vaccination failure/ SARS-CoV-2 PCR test was positive; This is as
spontaneous report received from a contactable Physician downloaded from the
regulatory authority. The Regulatory Authority report number is EE-SAM-29862103261.
A 72-year-old male patient received BNT126B2 (COMIRNATY), first dose intramuscular
on 15Jan2021 (Batch/Lot number was not reported) as 0.3 mL, single and second dose
intramuscular on 05Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single
for COVID-19 immunisation. Medical history included Aneurysm aortic, Cardiac
insufficiency, Hypertension not adequately controlled, Permanent atrial
fibrillation, Terminal renal insufficiency (has been receiving hemodialysis for
many years), chronic obstructive pulmonary disease (COPD). The patient's
concomitant medications were not reported. The patient was vaccinated with the two
doses of Comirnaty vaccine (on January 15th and February 5th). SARS-CoV-2 PCR test
was positive on 21Mar2021. The patient is in the hospital since 21Mar2021, with
severe respiratory failure. Exitus letalis 25 March 2021. Serious side effects, as
a result of the ineffectiveness of the vaccine, the patient became ill with COVID-
19. The patient died on 25Mar2021. It was not reported if an autopsy was
performed. The causal link is considered possible. The outcome of the events was
fatal. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: Death; Respiratory failure; COVID-
19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was
positive" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1234402-1"
"1234402-1" "positive COVID-19 test with symptoms; positive COVID-19 test
with symptoms; This is a spontaneous report received from a contactable pharmacist
downloaded from the Agency Regulatory Authority-WEB. The regulatory authority
report number is FR-AFSSAPS-RS20210728, Safety report unique identifier FR-AFSSAPS-
2021036243. A 98-year-old female patient received the first dose of BNT162B2
(COMIRNATY), intramuscularly administered in Arm on 13Jan2021 (Batch/Lot Number:
unknown) and the second dose of BNT162B2 intramuscularly administered in Arm on
03Feb2021 (Batch/Lot Number: Unknown), both as single dose for COVID-19
immunisation. Medical history included cardiac failure from Dec2016 and ongoing,
bronchial infection from Dec2016 to an unknown date, decompensation cardiac from
Jan2018 to May2019 (Left ventricular decompensation in Jan2018, then Feb2018, then
May2019), Stroke in 2017 without sequelae, depression, Hypothyroidism due to
Hashimoto's thyroiditis, Extra pyramidal syndrome without proper Parkinson's
disease, Left eye blindness due to tumor enucleation, left eye prosthesis.
Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR);
paroxetine hydrochloride (DEROXAT); levothyroxine sodium (LEVOTHYROX);
acetylsalicylate lysine (KARDEGIC); ramipril; oxazepam (SERESTA); furosemide; and
tamsulosin. The patient has no history of COVID-19. On 19Feb2021, 16 days after the
second dose of BNT162B2 injection, symptoms appeared. The patient complained of
body aches. Pulmonary auscultation in which crackles were found mid-field of ICG.
Hyperthermia at 38.6 T. Oxygen requirement (saturation 97/3L). SARS-CoV2 PCR
positive the same day (PCR V1 profile- initial strain). On 22Feb2021, patient
apyretic, reports feeling tired. On 24Feb2021, hyperthermia at 39.1T, headache. On
25Feb2021, hyperthermia at 39 T and increased crackles. On 26Feb2021, intercostal
indrawing, cyanosis of the hands. On 27Feb2021, patient apyretic, severe crackles,
very mild Oedema of the Lower Extremities.On 03Mar2021, reduction of crackles.
Saturation 95/5L. On 05Mar2021, good clinical course with persistence of apyrexia,
no polypnea or cyanosis. Subsequently, on 20Mar2021, it was noted that the patient
was very anxious. On 22Mar2021, the patient was very thirsty and a wrong route was
observed during her hydration. On 23Mar2021, at 5.30 p.m., the patient was still
very anxious and dehydrated. Cyanosis, saturation 84/2L, polypnea, wet cough and
wrong routes, dry bi-basal, symmetrical crackles. Oxygen saturation increased to
93% under 10L. The patient's physician declares aspiration brings back milk-white
mucous fluid. On 23Mar2021, at 11 p.m., hemodynamic and respiratory failure with
desaturation to 79% under 15L. Patient in tachycardia. The patient's physician
declared Doubtful about pulmonary oedema in spite of dehydration and due to rapid
installation, auscultation and history. On 24Mar2021, hypotension at 70/60,
tachycardia with saturation at 89%, slight polypnea. The patient's physician
suggests cardiorespiratory failure due to hypovolemia. On 24Mar2021, collegial
decision to stop the treatment, death of the patient on 26Mar2021 Overall, vaccine
failure with a positive PCR 16 days after the second injection of the Comirnaty
vaccine, improvement in symptoms of COVID infection on 05Mar2021. Subsequently,
deterioration of the general condition with the onset of hemodynamic and
respiratory failure on 23Mar2021 in a context of dehydration and possible
aspiration. Death of the patient. Therapeutic measures were taken as a result of
positive COVID-19 test with symptoms. The patient died on 26Mar2021. An autopsy
was not performed. No follow-up attempts possible. No further information
expected. Information on lot and batch numbers cannot be obtained.; Reported
Cause(s) of Death: positive COVID-19 test with symptoms; Vaccination failure"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1234958-1"
"1234958-1" "drug ineffective; COVID-19 induced respiratory insufficiency;
respiratory insufficiency; thrombophlebitis; erysipelas; phlegmon; This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority HU-OGYI-196821. Case narrative: This spontaneous, serious report
received on 27Mar2021 from a physician describes the occurrence of adverse events
after vaccination with COMIRNATY (tozinameran). On 13Feb2021 at 8:20 a.m., the 77
years old male patient received COMIRNATY (concentrate for dispersion injection;
active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19
mRNA vaccine; batch number: PAA156571, expiry date: Mar2021, MAH: BioNTech
Manufacturing GmbH) applied intramuscularly to the left upper arm for COVID-19
immunisation. Following vaccination, in Mar2021, the patient reported to have
erysipelas, thrombophlebitis and phlegmon. The patient was hospitalised, the
symptoms were resolving, but in the hospital, the patient had acquired COVID-19 and
developed respiratory insufficiency, and died. Discharge summary is not available.
The patient general condition, medical history and concomitant medicines were not
reported. Sender comment: Erysipelas, thrombophlebitis and phlegmon are not
expected adverse events of COMIRNATY. Alternatively, they might have been in
relation with the patient underlying diseases, but there is no detailed information
about them. Time to onset might have been several weeks, it is not correctly known
either. Causality between the adverse events and COMIRNATY is unlikely. The patient
acquired COVID-19 infection in hospital several weeks after the presumably first
dose of vaccine. Immunity might have not developed within this time frame. The case
is serious because the patient died. Further information is expected.; Reported
Cause(s) of Death: COVID-19 respiratory insufficiency; COVID-19 respiratory
insufficiency; drug ineffective" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1235283-1"
"1235283-1" "cough/choking cough; fever; very tiring; felt unwell/ill;
pneumonia caused by a virus; severe respiratory failure; Covid-19; This is a
spontaneous report from a contactable consumer. A 69-year-old male patient received
bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on
12Feb2021 (Lot Number: EL8723) as a single dose for covid-19 immunisation. Medical
history included heart attack from 16Nov2020 to an unknown date. The patient's
concomitant medications were not reported. The reporter mentioned that her husband
was vaccinated with the Pfizer Comirnaty vaccine and after the vaccination, he felt
unwell sometime later, tests were done (unspecified results) on Feb2021, it turned
out that the patient was ill, he has Covid. On 20Mar2021 (also reported as
16Mar2021), he was taken to hospital but unfortunately the patient died. The
reporter confirmed that her husband had received the 1st dose of 12Feb21, lot
number EL8723. From the third day (15Feb2021) after vaccination, a fever developed,
and the patient was taking Teraflu. The temperature was maintained until 20Feb2021.
Meanwhile a cough appeared. 25Feb2021, the cough worsened and the patient was
referred for a COVID-19 test. The test came out positive on Feb2021. On 26Feb2021,
the patient was in an ambulance but did not take him to the hospital. On 29Feb2021,
the cough got worse and was very tiring. 01Mar2021 the patient was taken to
hospital because of a choking cough. On 03Mar2021, the patient was connected to a
respirator and on 16Mar2021, the patient died. The patient was not autopsied.
Doctors cited COVID-19 as the cause of death, viral pneumonia and severe
respiratory failure. The reporter mentioned that the patient on 16Nov2020 had a
heart attack. He has been taking heart medications since then, but she has not
stated what. The patient did not suffer from chronic diseases. The patient
underwent lab tests and procedures which included COVID-19 test was positive on
Feb2021, tests was done (unspecified results) on Feb2021 temperature was maintained
until 20Feb2021 (Feb2021). The outcome of the events malaise and fatigue were
unknown while the outcome of the other events was fatal. The patient died on
16Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: pneumonia
caused by a virus; severe respiratory failure; COVID-19" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1241418-1"
"1241418-1" "Acute pulmonary embolism resulting in death; COVID positivity;
This is a spontaneous report received from a contactable physician downloaded from
the regulatory authority. The regulatory authority report number is BE-FAMHP-DHH-
N2021-87195. An 81-years-old male patient received first dose of bnt162b2
(COMIRNATY), via an unspecified route of administration on 01Apr2021 (Lot Number:
ER9480) as single dose for COVID-19 vaccination. Medical history included COPD,
hypertension and obesity. Concomitant medication(s) included metoprolol; amlodipine
besilate, perindopril arginine (COVERAM); fluticasone propionate, salmeterol
xinafoate (SERETIDE); tiotropium bromide (SPIRIVA HANDIHALER); lormetazepam. The
patient experienced acute pulmonary embolism resulting in death on 02Apr2021. There
was no treatment. After death COVID positivity determined (Apr2021). The patient
died on 02Apr2021. An autopsy was performed and results were not provided. The
outcome of COVID positivity was unknown. Reporter's comments: Treatment - No
Evolution of the ADR - Deceased Examinations - autopsy performed After death
COVID positivity determined No follow-up attempts possible. No further information
expected. Reported Cause(s) of Death: acute pulmonary embolism" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1241511-1"
"1241511-1" "Vaccination failure; COVID-19 confirmed by positive COVID-19
test; This is a spontaneous report received from a contactable consumer downloaded
from the Agency Regulatory Authority-WEB. The regulatory authority report number is
FR-AFSSAPS-MP20211103, Safety report unique identifier FR-AFSSAPS-2021036865. An
84-year-old female patient received bnt162b2 (COMIRNATY) intramuscular, first dose
on 11Feb2021 at single dose, second dose on 04Mar2021 at single dose as COVID-19
vaccination. Medical history was not provided. Concomitant medications were not
provided. The vaccination was desaturation supported by attending physician.
Patient was considered to be at risk of developing a severe form of COVID-19
disease, COVID-19 confirmed by positive COVID-19 test. Search for the viral variant
not specified. The patient underwent lab tests and procedures, which included on
01Apr2021, PCR COVID 19 by RT PCR positive. It was confirmed vaccination failure.
Patient was hospitalized in a COVID unit on 04Apr2021. Patient died on 07Apr2021.
An autopsy was not performed, the reported cause of death was COVID-19 aggravated
and vaccination failure. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination
failure; COVID-19 aggravated" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1241517-1"
"1241517-1" "COVID-19 aggravated; bacterial right lower lobe superinfection;
This is a spontaneous report from a contactable physician downloaded from the
Agency Regulatory Authority-WEB manufacturer report number FR-AFSSAPS-NY20210690 .
Sender's (Case) Safety Report Unique Identifier FR-AFSSAPS-2021035236 An 85-years-
old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular,
administered in Arm Right on 15Mar2021 (Lot Number: EP9605) as single dose for
COVID-19 immunisation. Medical history included ongoing Type 2 diabetes mellitus
(NIDDM), Ischemic cardiomyopathy, ongoing Arterial hypertension, ongoing
hypercholesterolemia, ischemic heart disease, right trans-tibial amputation
(following an accident at work). Concomitant medications included molsidomine ;
atorvastatin calcium (TAHOR); acetylsalicylate lysine (KARDEGIC); atenolol
(BETATOP); metformin hydrochloride, sitagliptin phosphate (VELMETIA); amlodipine
besilate (AMLOR); captopril, hydrochlorothiazide (ECAZIDE); gliclazide (DIAMICRON);
metformin (GLUCOPHAGE). The patient experienced covid-19 aggravated on 23Mar2021.
The event was assessed serious as death, hospitalization. On 23Mar2021, 9 Day after
the last drug administration, the patient developed COVID-19 infection which
required hospitalization or prolongation of hospitalization. The patient died on
31Mar2021. It was not reported if an autopsy was performed. Imputability : I1
(dubious) for COMIRNATY Reporters comment: File from the 20210330154320877 85-
year-old patient. History: DNID, hypertension, hypercholesterolemia, ischemic heart
disease, right trans-tibial amputation (following an accident at work). 15Mar2021,
first injection of the COMIRNATY vaccine (batch EP9605) in the right arm. On
23MAr2021, occurrence of COVID-19 pneumonia. Patient hospitalized for treatment. No
indication for heavy resuscitation. 29Mar2021, patient transferred for further care
and implementation of palliative care in the event of clinical deterioration. On
the respiratory level, presence of dyspnea with indrawing. No cough. Limit ambient
air saturation under 15L of O2. On auscultation, bi-basal crackles without other
anomaly. Cardiovascularly, no chest pain. Regular heart sounds, without audible
murmur. No sign of right or left cardiac decompensation. No edema. Neurologically,
Glasgow 15/15. No disturbance of higher functions. No respiratory
encephalopathy.Note since the COVID-19 infection marked asthenia with reduced
autonomy. To biology, GB 7.3 G / L, Hb 13.7 g / dL, platelets 209 G / L. Urea
13.19, mmol / L, creatinine 92.3 �mol / L. CRP 167 mg / L. Normal troponin and BNP.
Gas without under 12L of O2: pH 7.42, pCO2 32 mmHg, pO2 53 mmHg for 85% saturation.
ECG: regular sinus rhythm, without other abnormality. Lung CT scan (not injected):
no pulmonary embolism. COVID-19 pneumonia occupying 40% of the lung volume
bilaterally associated with a focus of superadded bacterial right lower lobe
superinfection. Management with increased oxygen therapy, IV hydration, antibiotic
therapy with AUGMENTIN, corticosteroid therapy with dexamethasone. Unbalanced
diabetes treated with NOVORAPID. Evolution marked by a stability of the patient's
condition for 24 hours. Despite the absence of any sign of worsening of his
clinical condition, the patient died in his sleep on 31Mar2021. Conclusion: COVID-
19 lung disease in an 85-year-old patient, 8 days after a first injection of the
COMIRNATY vaccine (batch EP9605). Hospitalized patient. Unfavorable evolution
leading to the death of the patient. No follow-up attempts possible. No further
information expected.; Reporter's Comments: Conclusion: COVID-19 lung disease in an
85-year-old patient, 8 days after a first injection of the COMIRNATY vaccine (batch
EP9605). Hospitalized patient. Unfavorable evolution leading to the death of the
patient.; Sender's Comments: There is not a reasonable possibility that events
COVID-19 aggravated and pneumonia bacterial are related to BNT162B2. The events
are more likely intercurrent medial conditions. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.; Reported
Cause(s) of Death: COVID-19 aggravated" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1241519-1"
"1241519-1" ""severe form of COVID; vaccination failure; This is a
spontaneous report from a contactable physician downloaded from the Agency
Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20210461. Safety
Report Unique Identifier FR-AFSSAPS-2021036800. A 93-years-old male patient
(Husband of a resident) received bnt162b2 (COMIRNATY), dose 2 intramuscular on
05Mar2021 (Batch/Lot Number: EP2166) as 0.3 ml, single, dose 1 via an unspecified
route of administration on 09Feb2021 (Batch/Lot Number: EJ6795) as single dose for
covid-19 immunisation. Medical history included Chronic obstructive pulmonary
disease, Cardiac insufficiency, Hypertension arterial. No previous history of
covid. Concomitant medication included fluindione (PREVISCAN [FLUINDIONE]);
rosuvastatin calcium (CRESTOR); atenolol (ATENOLOL), Izaar. The patient had good
tolerance for the first dose. The patient experienced severe form of covid and
vaccination failure on 23Mar2021, which required hospitalization in Mar2021 and
death on 26Mar2021. Clinical detail was reported as: the patient had respiratory
symptoms about 7/8 days after the second dose of vaccine which the patient
neglected. Then he presented with asthenia, fever and respiratory discomfort around
15 March 2021. He was hospitalised following his visit to the emergency room and
died on 26 March 2021 of a severe form of COVID (65% invasion on the thoracic
scan). The PCR done on 23Mar2021 showed an variant. IN TOTAL, severe SARS COV2
infection variant B117 resulting in the death of an elderly man with a risk factor
for developing a severe form of the disease. The patient underwent lab tests and
procedures which included thoracic scan: severe form of COVID (65% invasion on the
thoracic scan) on Mar2021, Covid-19 PCR test: positive on 23Mar2021 variant. The
patient died on 26Mar2021. An autopsy was not performed. NB: Imputation made
""without prejudice to the elements of investigation which could be carried out
within the framework of legal or amicable compensation procedures"". Reported
Cause(s) of Death: SEVERE FORM OF COVID"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1244820-1"
"1244820-1" "Positive corona test 1 day after completion of vaccination and
death on 09Apr2021 as a result of Covid; Positive corona test 1 day after
completion of vaccination and death on 09Apr2021 as a result of Covid; This is a
spontaneous report from a contactable physician downloaded from a regulatory
authority-WEB, received from Regulatory Authority. The regulatory authority report
number is NL-LRB-00505868. A 96-year-old female patient received second dose of
bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 (Lot
Number: ER7812) as single dose, first dose was administered via an unspecified
route of administration on 20Feb2021 (Lot number was not reported) as 0.3 mL,
single dose for covid-19 immunisation. Medical history and concomitant medications
were not reported. On 28Mar2021 patient experienced covid 19 following
administration of covid-19 vaccine pfizer Injectable solution. Patient was admitted
on unknown date in response to the event. Patient had positive corona test one day
after completion of vaccination (on 28Mar2021) and death on 09Apr2021 as a result
of Covid-19. The patient underwent laboratory tests and procedures which included
sars-cov-2 test: positive on 28Mar2021. The patient died on 09Apr2021 due to Covid-
19. It was not reported if an autopsy was performed. Reporter's Comments:
BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine
(Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after
completion of vaccination and death on 09Apr21 as a result of Covid.
Hospitalization information: Covid Additional information ADR: not applicable.
Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up
attempts possible. No further information expected.; Reporter's Comments:
BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine
(Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after
completion of vaccination and death on 09Apr21 as a result of Covid.
Hospitalization information: Covid Additional information ADR: not applicable.
Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up
attempts possible. No further information expected.; Reported Cause(s) of Death:
covid; Drug ineffective" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1245691-1"
"1245691-1" "inaugural seizure; Seizures (generalized); General physical
health deterioration; covid smear positive 26Jan; This is a spontaneous report from
a contactable pharmacist downloaded from the regulatory authority BE-FAMHP-DHH-
N2021-78170. A 79-years-old female patient received bnt162b2 (COMIRNATY), dose 1
via an unspecified route of administration on 22Jan2021 (Batch/Lot Number: EM04777)
as single dose for covid-19 immunisation. The patient medical history and
concomitant medications were not reported. The patient experienced inaugural
seizure, convulsions 2 hours after vaccine and emergency room admission with
outcome of fatal, general physical health deterioration with outcome of fatal,
sars-cov-2 test: positive with outcome of unknown. The patient was hospitalized for
inaugural seizure (epilepsy) from 22Jan2021 to an unknown date. The patient
underwent lab tests and procedures which included sars-cov-2 test: negative on
22Jan2021, sars-cov-2 test: positive on 26Jan2021. The patient died on 10Feb2021.
It was not reported if an autopsy was performed. Reporter's comment: 2 hours
after vaccine seizure epilepsy admission emergency room covid smear negative 22Jan
-> transfer to neurology department, initiation of depakine with stabilization of
the state of consciousness but clear general deterioration, planned return to
nursing home -> covid smear positive 26Jan-> transfer to hospital covid unit -
performance deteriorated significantly on 03Feb - call from the rest home on 04Feb
for DEG -> readmission to hospital -> status epilepticus, 2nd then 3rd line of
unsuccessful treatment Passage to palliative care -> death on 10Feb. No follow-up
attempts possible. No further information expected.; Reporter's Comments: Summary
of Reporter Comment: 2 hours after vaccine, seizure epilepsy admission emergency
room covid smear negative 22Jan -> initiation of depakine with stabilization of the
state of consciousness but clear general deterioration, covid smear positive 26Jan,
transfer to hospital covid unit - performance deteriorated significantly on 03Feb -
call from the rest home on 04Feb for DEG, readmission to hospital, status
epilepticus, 2nd then 3rd line of unsuccessful treatment, death on 10Feb; Reported
Cause(s) of Death: inaugural seizure; Seizures (generalized); General physical
health deterioration" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1250291-1"
"1250291-1" "suspected aspiration pneumonia; Vaccination failure/COVID-19
confirmed by positive COVID-19 test with symptoms; COVID-19 confirmed by positive
COVID-19 test with symptoms; This is a spontaneous report from a contactable
pharmacist downloaded from a regulatory authority-WEB with regulatory authority
number FR-AFSSAPS-DJ20210885 and Safety Report Unique Identifier is FR-AFSSAPS-
2021037781. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 2
intramuscular on 05Feb2021 (Lot Number: EJ6788) as a single dose; and dose 1
intramuscular on 15Jan2021 (Lot Number: EM0477) as a single dose for covid-19
immunisation. Medical history included tobacco user, anxio-depressive syndrome,
hypertension arterial, chronic alcoholism (hepatic cirrhosis), alcoholic cirrhosis,
chronic obstructive pulmonary disease (COPD) under oxygen 2L / min day and night
and ischemic stroke from 2003 to an unknown date. Concomitant medications included
fluindione (PREVISCAN); budesonide; salbutamol; acetylsalicylate lysine (KARDEGIC);
ipratropium; tiotropium bromide (SPIRIVA); and tramadol hydrochloride (TOPALGIC),
indication, start and stop date were not reported. It was reported that on
01Apr2021, the experienced covid-19 pcr test positive and vaccination failure. It
was further reported that the patient received the first dose of COMIRNATY on
15Jan2021 and the second dose on 05Feb2021. On 01Apr2021, the patient is vomiting
and was more tired. He didn't have fever. On 02Apr2021, the RT-PCR is positive with
the presence of mutations suggestive of the variant. Also on 02Apr2021, the death
of the patient was observed at 6 a.m. in his bed before the results of the PCR. The
reported cause of death was suspected aspiration pneumonia. The patient underwent
lab tests and procedures which included COVID-19 PCR test was positive on 02Apr2021
which showed positive with the presence of mutations suggestive of the variant. The
outcome of the events was fatal. The patient died on 02Apr2021. An autopsy was not
performed. No follow-up attempts are possible, no information is expected.;
Sender's Comments: Linked Report(s) : FR-AFSSAPS-DJ20210888 AFSSAPS;FR-AFSSAPS-
DJ20210896 AFSSAPS;FR-AFSSAPS-DJ20210890 AFSSAPS;FR-AFSSAPS-DJ20210892 AFSSAPS;FR-
AFSSAPS-DJ20210893 AFSSAPS;FR-AFSSAPS-DJ20210886 AFSSAPS; Reported Cause(s) of
Death: suspected aspiration pneumonia" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1250307-1"
"1250307-1" "Patient's COVID-19 PCR test was positive on 08Apr2021; Patient's
COVID-19 PCR test was positive on 08Apr2021; patient's first dose given on
11Feb2021 and second dose on 25Mar2021; patient's first dose given on 11Feb2021 and
second dose on 25Mar2021; This is a spontaneous report from a contactable physician
downloaded from the Agency Regulatory Authority-WEB, regulatory authority number
FR-AFSSAPS-MP20211192. A 99-year-old female patient received bnt162b2 (COMIRNATY),
dose 2 intramuscular, administered in arm on 25Mar2021 (Batch/Lot number was not
reported) as single dose for COVID-19 immunization; bnt162b2 (COMIRNATY), dose 1
via unspecified route of administration on 11Feb2021 (Batch/Lot number was not
reported) as single dose for COVID-19 immunization. Medical history included
ongoing heart failure, dyspnea, and pleural effusion. The patient's concomitant
medications were not reported. The patient's COVID-19 PCR test was positive on
08Apr2021. The patient underwent lab tests and procedures which included Covid-19
PCR test: negative on 01Apr2021 and Covid-19 PCR test: positive on 08Apr2021. The
patient died on 10Apr2021 due to COVID-19. An autopsy was not performed. No
follow-up attempts are possible; information on lot/batch number cannot be
obtained.; Reported Cause(s) of Death: Covid" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1250308-1"
"1250308-1" "Vaccination failure/ On 23Mar2021, patient tested PCR + for
SARSCov2; Vaccination failure/ On 23Mar2021, patient tested PCR + for SARSCov2;
hypokalaemia 3.07 mmol/L; increased SRIS; tachycardia; Clinically fatty cough
without expectoration; neutrophil count 10 g/L; lymphopenia 0.5 g/L; Thoracic CT:
pneumopathy in the lower right lobe; This is a spontaneous report from a
contactable healthcare professional downloaded from the Regulatory Authority-WEB.
The regulatory authority number is FR-AFSSAPS-NC20211589 and the other case
identifier is FR-AFSSAPS-2021038008. An 88-year-old male patient received BNT162B2
(COMIRNATY) on 28Jan2021 (lot number: EJ6788) as first dose and on 16Feb2021 (lot
number: EJ6788) as second dose, both intramuscular at single dose for COVID-19
vaccination. Medical history included transient ischemic attack, anemia, beta
thalassemia minor, acute cholecystitis, mixed vascular dementia (cortical and
subcortical), partial epilepsy, hiatal hernia, arterial hypertension, pericarditis,
pneumonia with pleural effusion from Feb2020, alcoholic polyneuritis, and pyloric
stenosis. The patient is a GIR2 patient (as reported) residing in a nursing home.
Concomitant medications included tamsulosin, acetylsalicylate lysine (KARDEGIC),
lansoprazole, and folic acid. On 23Mar2021, the patient experienced vaccination
failure as he tested PCR positive (+) for SARS-Cov-2; the patient became
symptomatic: asthenia, hitchhiking and desaturation from 02Apr2021 prompting
hospitalization on 03Apr2021. Clinical examination on 03Apr2021: oxygen-retaining
at 6 L/min, bilateral crackles, polypneic without sign of struggle, no sign of
cardiac decompensation. Biology: D-dimer at 882, moderate anemia, CRP at 189.6
mg/L, BNP at 465 and troponins at 203. GDS: pH: 7.476, pCO2: 36.0, pO2: 71.1.
Thoracic CT: pneumopathy in the lower right lobe, presence of the VARIANT. Gradual
degradation. On 10Apr2021, afebrile, stable HD, hypertension and tachycardia, 92%
SAO2 under 7 L/ min with glasses. Clinically fatty cough without expectoration:
risk of major aspiration. No acute respiratory distress. Respiratory rate 22 cpm,
CRP 200 vs 100, and WBC 11 g/L including neutrophil count 10 g/L and persistence of
lymphopenia 0.5 g/L, hypokalaemia 3.07 mmol/L. D3 of tazocillin: extended
antibiotic therapy on increased SRIS, initiation of Dexamethasone on increase in O2
requirements above 6 L/ min, supplementation K + 1 g/24H in reaction + bio control
H48, introduction of SAP midazolam 0.2 mg/H for anxiolysis because it removes O2.
Summary of management: Hospitalized patient. Degradation in hospital with fatal
outcome on 12Apr2021 in the morning. Conclusion: Vaccine ineffectiveness with fatal
outcome. The pharmacovigilant notes: Accountability score (s) established without
prejudice to the elements of investigation which could be carried out within the
framework of legal or amicable compensation procedures.Official Bulletin of the
Minister in charge of Health no.84/50, January 24, 1985. Published in Therapy 1985;
40: 111-8. The patient died on 12Apr2021. The causes of death were vaccination
failure and COVID-19. It was unknown if autopsy was performed. The outcome of all
other events was unknown. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Vaccination failure/ On
23Mar2021, patient tested PCR + for SARSCov2; Vaccination failure/ On 23Mar2021,
patient tested PCR + for SARSCov2" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1250695-1"
"1250695-1" ""He died on 22Feb; Apparently pneumonia; Oxygen dropped;
couldn't eat anymore; He had silent delirium and was absent; couldn't drink
anymore; Tested positive for corona on 17Feb2021; Drug ineffective; This is a
spontaneous report from a contactable consumer or other non hcp downloaded from the
Medicines Agency (MA) -WEB NL-LRB-00507869. A 72-years-old male patient received
BNT162B2 (Pfizer-vaccine), dose 1 via an unspecified route of administration on
29Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation.
Medical history included ongoing dementia, covid-19 from Mar2020 to an unknown date
(disease symptoms: hospitalization). The patient's concomitant medications were not
reported. The patient died on 22Feb2021; patient experienced oxygen dropped
(oxygen saturation decreased) (death) on 17Feb2021, couldn't eat anymore (feeding
disorder) (death) on 17Feb2021 , he had silent delirium and was absent (delirium)
(death) on 17Feb2021, couldn't drink anymore (fluid intake reduced) (death) on
17Feb2021, tested positive for corona on 17feb2021 (covid-19) (death) on 17Feb2021,
drug ineffective (drug ineffective) (death) on 17Feb2021. The patient underwent
lab tests and procedures which included sars-cov-2 test positive on 17Feb2021,
urine analysis unknown results on an unspecified date, ventilation/perfusion scan
unknown results on an unspecified date, pulmonary function test unknown results on
an unspecified date, oxygen saturation dropped on 17Feb2021. Therapeutic measures
were taken as a result of oxygen dropped (oxygen saturation decreased), couldn't
eat anymore (feeding disorder), he had silent delirium and was absent (delirium),
couldn't drink anymore (fluid intake reduced) , tested positive for corona on
17feb2021 (covid-19). The patient died on 22Feb2021, cause of death was also
reported as apparently pneumonia. It was not reported if an autopsy was performed.
The clinical course was reported as follows: ""This serious spontaneous report from
a consumer or other non-health professional concerns a male aged 72 years, with
death nos (death), Covid 19 (death), hypoactive delirium (death), unable to eat
(death), oxygen saturation decreased (death), fluid intake reduced (death)
following administration of covid-19 vaccine pfizer (Injection fluid) (action
taken: not applicable) for Covid 19 immunisation. Treatment: on 18Feb2021 Covid 19
is treated with mechanical ventilation, on 18Feb2021 fluid intake reduced is
treated with mechanical ventilation, on 18Feb2021 hypoactive delirium is treated
with mechanical ventilation, on 18Feb2021 oxygen saturation decreased is treated
with mechanical ventilation and on 18Feb2021 unable to eat is treated with
mechanical ventilation. The outcome of Covid 19 is fatal, the outcome of death nos
is fatal, the outcome of fluid intake reduced is fatal, the outcome of hypoactive
delirium is fatal, the outcome of oxygen saturation decreased is fatal and the
outcome of unable to eat is fatal. Drugs and latency: 1. Covid-19 vaccine pfizer
(Injection fluid), death nos: 22 days after start, Covid 19: 19 days after start,
hypoactive delirium: 19 days after start, unable to eat: 19 days after start,
oxygen saturation decreased: 19 days after start, fluid intake reduced: 19 days
after start. Concomitant medication: non specified drug. Medical history Covid 19,
dementia. Additional information ADR: After vaccination on 29Jan2021 he was feeling
well. He got fitter than before. Suddenly on 17Feb2021, he collapsed on. On
18Feb2021 - artificial respiration. He had silent delirium and was absent - could
no longer eat and drink. Oxygen dropped. He had already had Corona in March and was
quarantined for it. He never had a cold and had no complaints when he had corona
last year. BSN available: yes. Confounding factors: dementia. Previous COVID-19
infection: disease symptoms: hospitalization. Other: diagnostic procedures: They
examined lungs and a urine and did lung scan. Pfizer vaccine LOT number: UNKNOWN.
Reporter Comment: Past drug therapy BioNTech/Pfizer vaccin : no. 22Feb died.
Additional information ADR: After vaccination on 29Jan2021 he was feeling well. He
got fitter than before. Suddenly on 17Feb2021, he collapsed on. On 18Feb2021 -
artifical respiration. He had silent delirium and was absent - could no longer eat
and drink. Oxygen dropped. He had already had Corona in March and was quarantined
for it. He never had a cold and had no complaints when he had corona last year. BSN
available: yes. Confounding factors: dementia. Previous COVID-19 infection:
disease symptoms: hospitalization. Other: diagnostic procedures: They examined
lungs and a urine and did lung scan. No follow-up attempts are
possible; information about lot/batch number cannot be obtained.; Reported Cause(s)
of Death: Apparently pneumonia; Hypoactive delirium; Fluid intake reduced; COVID-
19; Drug ineffective; Death NOS; Oxygen saturation decreased; Unable to eat""
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1257606-1"
"1257606-1" "COVID-19; Drug ineffective; This is a spontaneous report from
Medical Agency, regulatory authority number FR-AFSSAPS-TO20212594. A contactable
physician reported that a 99 year old female patient received the second dose of
BNT162B2 (Pfizer vaccine, Lot number unknown) intramuscularly at single dose for
COVID-19 immunisation on 04Feb2021, the patient receive the first dose of Pfizer
vaccine intramuscularly at single dose for COVID-19 immunisation on 12Jan2021.
Relevant history included FA (arterial fibrillation) and HTA (arterial
hypertension). Relevant concomitant drugs included folic ac, apixaban (ELIQUIS),
mirtazapine (NORSET), colecalciferol (UVEDOSE), oxazepam (SERESTA), all were long-
term used. The clinical course was reported as: 10Feb2021, the patient was
asthenic and listless since. 13Feb2021: resident found reactive in bedroom;
clinical signs: significant decrease in appetite, asthenia ++, desaturation,
diarrhea; call of 15: put under O2: 2l / min and no hospitalization. 16Feb2021:
Positive PCR test, English variant B.1.1.7. 17Feb2021: no longer takes anything
orally, asthenia ++, fever at 38.6 deg C , desaturation at 94% under 3l / min, goes
back to 92% after respiratory physiotherapy, not painful. Gradually deterioration
of the general condition: introduction of 5% Glucose, comfort care; clinically:
dyspnea on congestion: physiotherapist spends 2f / day to do respiratory
physiotherapy; not painful, asthenia ++, black tongue. Respiratory physiotherapy
continued on February 19, 20 and 21. Death was noted on 22Feb2021 at 6 am by the
nursing team; SOS doctor came to notice the death in the morning. No follow-up
attempts are possible. No further information is expected. Information on batch/lot
number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; COVID-19"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1260554-1"
"1260554-1" "THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12,
she was admitted for septic shock and multi-organ failure (MOF) that resulted in
the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12,
she was admitted for septic shock and multi-organ failure (MOF) that resulted in
the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12,
she was admitted for septic shock and multi-organ failure (MOF) that resulted in
the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12,
she was admitted for septic shock and multi-organ failure (MOF) that resulted in
the death of the patient; This is a spontaneous report from a contactable physician
downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-
MINISAL02-716828. An 86-years-old female patient received 2nd dose of BNT162B2
(Pfizer vaccine, Formulation: Solution for injection) intramuscular on 24Mar2021
(Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. Medical
history included pulmonary embolism, depressive symptom, intestinal, atrial
fibrillation, hyperthyroidism, osteoarthritis, type 2 diabetes mellitus from an
unknown date and unknown if ongoing. The patient's concomitant medications were not
reported. On 08Apr2021, the patient experienced the vaccination failure,
coronavirus infection, septic shock and multiple organ dysfunction syndrome and was
positive to nasopharyngeal tampon. On 12 Apr 2021, she was admitted for septic
shock and multi-organ failure (mof) that resulted in the death of the patient.
Reporter comment: The death was related to multi-organ failure in the course of
septic shock in covid-19 positive post-vaccination (16 days interval between second
vaccination and positive swab and symptomatology). The action taken in response to
the events for bnt162b2 was not applicable. Actions taken (Non-invasive ventilation
with CPAP modality, empiric IV antibiotic therapy with ceftriaxone, meropenem and
vancomycin, high-flow oxygen therapy, administration of vasoactive amines, EBPM at
anticoagulant dosage, hydration and bicarbonate supplementation. Performance of
hemocultures with positive finding for Staphylococcus Capitis). The patient died on
12Apr2021. It was not reported weather an autopsy was performed or not.; Reporter's
Comments: The death was related to multi-organ failure in the course of septic
shock in covid-19 positive post-vaccination (16 days interval between second
vaccination and positive swab and symptomatology).; Reported Cause(s) of Death: THE
PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE
WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic
shock and multi-organ failure (MOF) that resulted in the death of the patient; THE
PA" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1265029-1"
"1265029-1" "Vaccination failure/Patient PCR + (positive) COVID on 16Mar2021,
39 days after the second dose; Patient PCR + (positive) COVID on 16Mar2021, 39 days
after the second dose; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority-WEB, regulatory authority number FR-
AFSSAPS-BX20213213. An 84-year-old female patient received bnt162b2 (COMIRNATY),
dose 2 intramuscular, administered in left arm on 05Feb2021 (lot number: EJ6788) as
single dose, and dose 1 intramuscular, administered in right arm on 16Jan2021 (lot
number: EJ6795) as single dose for COVID-19 immunisation. Medical history included
dementia, meningioma surgery, arterial hypertension; all from an unknown date and
unknown if ongoing, and ongoing residing in nursing homes. The patient's
concomitant medications were not reported. The patient experienced vaccination
failure/patient PCR + (positive) COVID on 16Mar2021, 39 days after the second dose.
Lung deterioration 3 days later, implementation of comfort care in agreement with
the family, death on 02Apr2021. No information on the variant. The patient
underwent COVID-19 PCR test: positive on 16Mar2021. The patient died on 02Apr2021
due to COVID-19 infection. An autopsy was not performed. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
Infection COVID" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1265037-1"
"1265037-1" ""Vaccination failure/tested PCR + for SARSCov2/Covid-19 type
pneumonia with severe involvement (50/70%); Vaccination failure/tested PCR + for
SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination
failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement
(50/70%); COVID-19 complicated by superinfection; severe dehydration; disoriented;
Na: 153 mmol/l; This is a spontaneous report from a contactable healthcare
professional downloaded from the regulatory authority-WEB, regulatory authority
number FR-AFSSAPS-NC20211590. This healthcare professional reported similar events
for two patients. This is the first of two reports. An 85-year-old male patient
received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Batch/Lot Number:
EJ6788/EJ6788) as single dose; and dose 2 via an unspecified route of
administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for
covid-19 immunisation. Medical history included prostate adenoma, macular
degeneration, renal failure, biliary lithiasis, follicular B lymphoma in remission
and post-chemotherapy pulmonary disease from 2014. The patient's concomitant
medications were not reported. The GIR2 patient residing in nursing house was
vaccinated with COMIRNATY carried out on 28Jan2021 (D1) and 16Feb2021 (D2). On
15Mar2021, the patient tested PCR + for SARSCov2; the patient also presented
abnormal ""facies"". Stability at first then degradation with desaturation which
motivated his hospitalization on 29Mar2021. On admission (29Mar2021), PAS/PAD:
152/75 mmHg, FC (heart rate): 65 bpm , SAT/O2: 92% /6 l/min, T: 36.2 degrees C, GC:
1.06 g/l, ScGw: 15 = Y4/V5/M6, BU: Leuco/Nitrites/Blood: -/-/traces, details: pro
+. Clinically, patient was conscious but disoriented, under O2 mask 6 l/min, cough,
crackling of the 2 fields, supple calves, no other sign of HF. Biology showed D
dimer 1300, BNP 34 pg/ml, CKD 40ml, gb 15000 without lymphopenia, tropo 73,
hyperleukocytosis at 15 G/l at PNN (83.7 G/l), platelet 191 G/l, CRP 237 mg/l, Na:
153 mmol/l, urea: 14.7 mmol/l, serum creatinine 137 umol/l and osmolality 338
mosm/l. Imaging showed Covid-19 type pneumonia with severe involvement (50/70%).
Diagnosis of COVID-19 complicated by superinfection and context of severe
dehydration. No variant analysis performed at the time of his hospitalization.
However, for all positive patients who were tested for a variant, the variant was
found. Patient was placed on corticosteroids, Lovenox and augmentin before
hospitalization. Other treatments inlcuded tamsulosin and Seresta. Rapid
deterioration in hospital with fatal outcome on 04Apr2021 in the evening.
Conclusion: Vaccine ineffectiveness with fatal outcome. The outcome of the events
was unknown. The patient died on 04Apr2021 due to vaccination failure, COVID-19 and
COVID-19 pneumonia. It was unknown if an autopsy was performed. The
pharmacovigilant notes: Accountability score (s) established without prejudice to
the elements of investigation which could be carried out within the framework of
legal or amicable compensation procedures "" No follow-up attempts possible. No
further information expected.; Sender's Comments: Linked Report(s) : FR-PFIZER INC-
2021431443 same reporter/drug, similar events, diferent patients; Reported Cause(s)
of Death: Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia
with severe involvement (50/70%); Vaccination failure/tested PCR + for
SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination
failure/tested PCR + for SARSC"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1265519-1"
"1265519-1" "Cardiorespiratory insufficiency due to COVID-19;
Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency
due to COVID-19; This is a spontaneous report downloaded from the Regulatory
Authority-WEB (Regulatory Authority report number: HU-OGYI-201721). A contactable
healthcare professional (contactable through Regulatory Authority only) reported
that an 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY,
Lot Number: EL0725; Expiration date was not reported), intramuscularly on the right
arm on 17Feb2021 as a single dose for COVID-19 immunization. Medical history
included hypertension, cholecystectomy, carotid artery stenosis, diabetic
nephropathy, vertebrobasilar insufficiency, ischemic heart disease, hypertensive
encephalopathy and diabetes; all were not ongoing. Concomitant medications included
alprazolam (FRONTIN), allopurinol (MILURIT), urapidil (EBRANTIL), fenofibrate
(FENOSWISS), amlodipine besilate (NORMODIPINE), rosuvastatin, amlodipine besilate,
indapamide, perindopril arginine (COVERCARD PLUS), acetylsalicylic acid and
piracetam (NOOTROPIL). On 07Mar2021, the patient had tested positive to COVID-19
antigen test (symptoms described as dizzy, weak, and had headache and cough). The
patient's chest X-ray showed bilateral multifocal infiltration, congestion and
cardiomegaly and C-reactive protein was 94.8 mg/l; both on 10Mar2021. On 22Mar2021,
the patient had cardiorespiratory insufficiency. The patient had died on 22Mar2021,
and the cause of death was cardiorespiratory insufficiency due to COVID-19. It was
unknown if an autopsy was performed. The causal relationship between the reported
death and Comirnaty was considered unlikely. Follow-up activities have been
closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of
Death: cardiorespiratory insufficiency due to COVID-19; cardiorespiratory
insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1274892-1"
"1274892-1" "Vaccination failure; PCR carried out on 24Mar2021 is positive
for SarsCov-2; This is a spontaneous report from a contactable pharmacist
downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-
AN20211330. Safety Report Unique Identifier is FR-AFSSAPS-2021039336. A 86-years-
old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2
via an unspecified route of administration on 12Feb2021 (Lot Number: EJ6789), dose
1 via intramuscular route, in Arm Left on 19Jan2021 (Lot Number: EJ6795), both as
single dose for covid-19 immunization. Medical history included arterial
hypertension, permanent atrial fibrillation, mixed anxiety and depressive disorder
(chronic anxiety-depressive syndrome), hypercholesterolemia, hypertensive and
rhythmic heart disease, thyroid insufficiency and cardiac pacemaker insertion. The
patient had no history of anaphylactic shock. Concomitant medications included:
bisoprolol (2.5 mg) tablet, 1 DF in the morning, paracetamol (DOLIPRANE) 1 gram
morning, noon and evening, econazole (ECONAZOLE) 1% powder, 1 application morning
and evening, apixaban (ELIQUIS) (2.5 mg) 1 morning and evening, furosemide (40 mg)
1 in the morning, furosemide (500 g) 1/2 in the morning and at noon, levothyroxine
sodium (LEVOTHYROX) 125 �g in the morning, levothyroxine sodium (LEVOTHYROX) (25
�g) 1/2 in the morning, oxazepam (SERESTA) 10 mg as needed, macrogol 3350,
potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous
(TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM
CHLORIDE;SODIUM SULFATE ANHYDROUS]) as needed and salbutamol (VENTOLIN
[SALBUTAMOL]) (100 �g / dose) 2 doses morning, noon and evening. The patient
considered to be at risk of developing a serious form of COVID based on her age.
Previously the patient was not infected with Covid-19. On 23Mar2021, the patient
worsened clinically with the onset of a fatty cough, clear sputum, oxygen
regression (90% Sat under oxygen), crackles in the left base, afebrile. The patient
had already felt very asthenic the previous days and was lying more and more in her
bed. From 23Mar2021, she is initially put on Augmentin 1gram / 125 mg three times a
day for 7 days, and oxygen therapy. The hypotheses put forward are a new cardiac
decompensation, a lung infection or a COVID infection. The PCR carried out on
24Mar2021 is positive for SarsCov-2, an English variant found and had vaccination
failure. She was then transferred to a hospital unit for further care. She had
received the second dose of the vaccine by Comirnaty 6 weeks before. On 24Mar2021,
the patient's hypokalaemia at 3.3 mmol / l was demonstrated on the blood test but
there was no inflammatory syndrome. Augmentin is stopped and Diffu K is introduced.
On 25Mar2021, the patient was increasingly asthenic, became confused, saturation
was 90% under 3L of O2, had some nausea during meals, fever at 38 C. The PCR came
back positive that day and she was transferred for further treatment. The patient
was conscious, not oriented, respiratory distress with slight pulling and invasion
of the 2 lungs with crackles with spasticity. On 26Mar2021, pulmonary auscultation
improved, the patient remained very asthenic, was febrile, presented serious risk
factors (with lymphopenia at 644 / mm3, thrombocytopenia at 121 G / L). She
probably has an associated cardio-renal syndrome. On 26Mar2021, the patient
underwent lab tests and procedures which included: ALAT: 19 iu/l, AST: 65 iu/l,
serum albumin: 32 g/l, LDH: 705 iu/l, potassium: 3.6 mmol/l, sodium: 143 mmol/l,
TSH: 0.69 uiu/ml, CRP: 20.6 mg/l, GGT: 69 iu/l, haemoglobin: 14.6 g/dl, lymphocyte
count: 644 /mm3 and oxygen saturation: 90 %. On 29Mar2021, there was a
deterioration in his respiratory state with desaturation requiring a high
concentration mask. The cracklings are present in a diffuse way. She is very
asthenic, and every word spoken is extremely short of breath, she is dehydrated and
there is a sudden increase in ferritin at 1700, witnessing the inflammatory passage
of COVID. The IV hydration, corticosteroid therapy and PES furosemide are set up.
On 01Apr2021, she was still feverish at 39.4 C sweating with 82% saturation under
9L of O2, there was cyanosis of the extremities. On 05Apr2021, she deteriorates
more and more at the respiratory level, then enters a state of coma, is reactive.
She died during the day at 12:45 p.m. An autopsy was not performed. The outcome of
events was fatal. No follow-up attempts possible. No further information expected.
Amendment: This follow-up report is being submitted to amend previously reported
Information: Amended Listedness of vaccination failure from listed to unlisted and
added new event Covid-19.; Reported Cause(s) of Death: Respiratory distress
following vaccine failure" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1274939-1"
"1274939-1" "death of the patient; Vaccination failure/ positive COVID PCR
test (screening: variant); Vaccination failure/ positive COVID PCR test (screening:
variant); This is a spontaneous report from contactable pharmacist downloaded from
a regulatory authority-WEB, regulatory authority report number: FR-AFSSAPS-
NT20211117, Safety Report Unique Identifier: FR-AFSSAPS-2021039449. An 88-year-old
female patient received bnt162b2 (COMIRNATY), second dose on 11Feb2021 (lot number:
EJ6789) and first dose on 21Jan2021 (lot number: EJ6795), both via intramuscular as
single dose for COVID-19 immunisation. Medical history included dementia
alzheimer's type, starvation, myocardial infarction, falling down, bradycardia,
hypothyroidism, fracture of the 2 lower limbs, road accident, Arterial
hypertension, and COVID-19. Concomitant medications included bisoprolol fumarate
(CARDENSIEL); acetylsalicylate lysine (KARDEGIC); levothyroxine sodium
(LEVOTHYROX); oxazepam (SERESTA); colecalciferol (ZYMAD); paracetamol (DAFALGAN);
chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine
hydrochloride (DEXERYL); macrogol 3350, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL); and dietary supplement. The patient experienced death of
the patient on 12Apr2021, and vaccination failure/ positive covid pcr test
(screening: variant) on 01Apr2021 with outcome of unknown. The event 'vaccination
failure/ positive covid pcr test' was assessed as medically significant. The
clinical course was reported as follows: Resident of nursing home GIR1 - ambulation
- Person prone to swallowing disorder. On 21Jan2021: 1st dose of COMIRNATY and on
11Feb2021: 2nd dose of COMIRNATY. On 01Apr2021, patient was positive COVID PCR test
(screening: English variant). The patient did not develop a severe form of the
disease: no cough, no fever, no desaturation, no polypnea, but severe fatigue. On
11Apr2021: fatigue, eats very little. Body temperature at 36.6 C and minimum 96% O2
saturation. On 12Apr2021: resident crowded at breakfast, eats little. At lunch,
also eat very little. The patient left for a walk after lunch, fell suddenly and
died quickly. She was found with phlegm in her mouth. Doctor was called then
patient was put into immediate burial (no autopsy). NB: mouth treatments had been
carried out to see if there was any foreign body but nothing had been found. On
12Apr2021: death of the patient. NB: Accountability without prejudice to the
elements of investigation which could be carried out within the framework of legal
procedures. The patient died on 12Apr2021. An autopsy was not performed. No
follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: death of the patient" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1274975-1"
"1274975-1" "Reduced general condition; incoherent remarks; hallucinations;
anorexia; 2 falls; malaise; ARDS; Vaccination failure; Vaccination failure/ ARDS
linked to covid-19 infection; degradation of his chronic renal failure (Cl at 25
mL/min); dehydrated; malnourished; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority-WEB. The regulatory authority
number is FR-AFSSAPS-PA20210562. An 83-year-old male patient received BNT162B2
(COMIRNATY, lot number and expiration date were unknown), intramuscular on
19Feb2021 as first dose and on 19Mar2021 as second dose at 0.3 mL, single for
COVID-19 immunisation. Medical history included adult T-cell leukemia-lymphoma
which was not ongoing (in remission with CT), radiotherapy (RT) and gastrectomy in
1996, ongoing cardiac arrhythmia (NOS), ongoing hypertension arterial, ongoing
chronic renal insufficiency, and concept of benign liver tumor but normal liver
markers. Concomitant medications included bisoprolol fumarate (CARDENSIEL);
furosemide (LASILIX); perindopril arginine (COVERSY); acetylsalicylate lysine
(KARDEGIC); and alfuzosin hydrochloride (XATRAL), calcium and PPI. The patient
experienced reduced general condition on 19Mar2021 and vaccination failure on
14Apr2021. The course of events was as follows: Notion of incoherent
remarks/hallucinations reported by the family in the aftermath of this second dose
associated with an alteration of the general condition (anorexia, 2 falls on
malaise) on an unspecified date in 2021 leading to hospitalization in geriatrics
from 05Apr2021 to 15Apr2021. The patient was dehydrated and malnourished on an
unspecified date in 2021 with degradation of his chronic renal failure (Cl at 25
mL/min) on arrival (05Apr2021). 3 PCR tests were carried out during
hospitalization: negative on 06Apr2021, undetermined on 13Apr2021 and positive
(weakly) on 14Apr2021 (search for mutation not done because too little virus). On
14Apr2021, appearance of respiratory distress requiring high flow oxygen (OPTIFLOW)
but not sufficient. On 15Apr2021, the patient died from ARDS linked to COVID-19
infection. Note that the service hosts a COVID-19 unit. In total, death of an 83-
year-old man, hypertensive and chronic renal failure, as a result of a severe form
of COVID-19 in a context of SAE since second dose and confirmed vaccine failure.
The patient underwent lab tests and procedures which included SARS-COV-2 PCR test:
negative on 06Apr2021, undetermined on 13Apr2021, and positive (weakly) on
14Apr2021; creatinine clearance: 25 mL/min on 05Apr2021; and liver markers: normal
on an unspecified date. The patient died on 15Apr2021. The causes of death were
ARDS linked to COVID-19 infection and vaccination failure. An autopsy was not
performed. The outcome of the event reduced general condition was not recovered and
unknown for all other events. No follow-up attempts are possible; information on
lot/batch number cannot be obtained. No further information is expected.; Reported
Cause(s) of Death: ARDS; Vaccination failure; Vaccination failure/ ARDS linked to
covid-19 infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1275079-1"
"1275079-1" "COVID antigen test positive/sars-cov-2 test PCR: positive stain;
COVID antigen test positive/sars-cov-2 test PCR: positive stain; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-RN20211105. An 82-
year-old female patient received BNT162B2 (COMIRNATY) dose 1 via unspecified route
of administration (Batch/Lot Number: Unknown) in Jan2021; and dose 2 intramuscular
(Batch/Lot Number: EJ6788) in Feb2021 for COVID-19 immunization. Medical history
included in situ follicular lymphoma, shoulder arthroplasty, hypothyroidism and
COVID-19. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM
FORTE); valaciclovir hydrochloride (ZELITREX); calcium folinate (LEDERFOLINE);
paracetamol; esomeprazole; mianserin (MIANSERIN); phloroglucinol (SPASFON);
bilastine; zopiclone; levothyroxine sodium (LEVOTHYROX); all taken for an
unspecified indication, start and stop date were not reported; and 3 courses of the
association zanubrutinib (BRUKINSA) and obinutuzumab (GAZYVARO) taken for lymphoma
from an unspecified start date to Mar2021. The patient experienced degradation of
general health status in the middle of Mar2021: antigen test positive on 23Mar2021.
On 25Mar2021, patient hospitalized for general health status degradation with fever
at 38.5 degrees, saturation at 87% in ambient air requiring oxygen supplementation,
sars-cov-2 test PCR: positive stain. Dexamethasone was introduced. On 01Apr2021, no
improvement, patient was still hospitalized and treated with dexamethasone,
increase of oxygen supplementation as saturation was 85%, strong asthenia,
respiratory frequency at 30, sweating, dry cough, diffuse crackling. The patient
died on 01Apr2021. It was not reported if an autopsy was performed. The events were
reported as serious-fatal. Reporter's comment: degradation of general health
status in the middle of Mar2021 : antigen test positive on 23Mar2021. On 25Mar2021,
patient hospitalized for general health status degradation with fever at 38.5
degrees, saturation at 87% in ambient air requiring oxygen supplementation.
Dexamethasone introduced. On 01Apr2021, no improvement, patient still hospitalized
and treated with dexamethasone, increase of oxygen supplementation as saturation
was 85%, strong asthenia, respiratory frequency at 30, sweating, dry cough, diffuse
crackling. death of patient on 01Apr2021; Reported Cause(s) of Death: antigen test
positive/sars-cov-2 test PCR: positive stain; antigen test positive/sars-cov-2 test
PCR: positive stain" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1275092-1"
"1275092-1" "hospitalized following a fall; increase in the weight loss;
Vaccination failure; COVID-19; wound on the bridge of the nose; open nose fracture;
o the emergency room and there was a fracture of the left humerus; persistence of
pain; This is a spontaneous report from a contactable physician downloaded from the
Regulatory Authority (RA)-WEB FR-AFSSAPS-ST20211495, Safety Report Unique
Identifier FR-AFSSAPS-2021038673 A 93-year-old male patient received bnt162b2
(COMIRNATY), then second dose intramuscular on 15Mar2021 (Batch/Lot Number: ET3620)
as (reported as 0.3 mL, single) and first dose intramuscular on 23Feb2021
(Batch/Lot Number: EK9788) as Single Dose (reported as 0.3 mL, single); both for
covid-19 immunisation. It was added that there was no adverse event between the
doses on 15Mar2021 and 31Mar2021. Medical history included extrapyramidal syndrome,
vascular dementia, prostate adenoma, Choked on food, gastritis, Deglutition
disorder, Collapsed vertebra, osteoporosis, Chronic renal insufficiency (reported
as chronic renal failure), Starvation, anemia, Falling down (reported as history of
fall), Vascular atheroma, undernutrition and Bedridden patient; all from an unknown
date and unknown if ongoing. Concomitant medication included macrogol 4000 (FORLAX)
taken for an unspecified indication, start and stop date were not reported. It was
reported that on 31Mar2021, the patient was hospitalized following a fall. On
01Apr2021, faced with the persistence of pain, the patient was referred to the
emergency room and there was a fracture of the left humerus: Zimmer splint and
lesion of the nose treated with Steristrip. On 02Apr2021, new fall, wound on the
bridge of the nose with open nose fracture. A Covid-19 PCR is performed and is
negative. 04Apr2021, deterioration of the general condition. Positive Covid-19
antigen test. On 05Apr2021, the general condition continued to deteriorate in this
patient with an increase in the weight loss due to the fractures. On 07Apr2021, a
PCR test is positive. No variant. Beginning of O2 desaturation. 90-92% saturation
under 2 L of O2; does not exceed 84% even by increasing the flow of O2. On
08Apr2021, gradual desaturation under 6L of O2. 09Apr2021: Death. It was concluded
that: confirmed vaccine failure. Time Interval between Beginning of Drug
Administration was 41 days (as reported) and Time Interval between Last Dose of
Drug: 21 days (as reported). The patient died on 09Apr2021. An autopsy was not
performed. The outcome of other events was unknown. Based on the information
currently available, the company assessed the relationship of COMIRNATY,
concentrate for injection. COVID-19 mRNA vaccine(modified nucleoside) to the
events, vaccination failure. Reporters' comments: COVID-19 HISTORY: NO, Bedridden
patient. (goes from bed to chair). No more information expected/was available.;
Reported Cause(s) of Death: Covid-19; vaccine failure" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1275103-1"
"1275103-1" ""positive COVID-19 test with symptoms; Death unexplained/Sudden
death; cyanotic appearance of the upper body (seen a few hours before); asthenia;
fall; respiratory alkalosis; CRP at 29; D Dimers at 2680; Troponin at 37; This is a
spontaneous report from a contactable physician downloaded from the regulatory
Agency-WEB. The regulatory authority number is FR-AFSSAPS-TS20211312. A 92-year-
old male patient received the first dose of BNT162B2 (COMIRNATY, lot number:
EK9788), intramuscular, on 19Feb2021, as single dose, for COVID-19 immunisation.
The patient medical history included constipation. Concomitant medication included
an unspecified laxative for constipation. The patient received the first dose on
19Feb2021. On 20Feb2021, next day, the patient experienced asthenia and had a fall.
A cluster of COVID cases in his residence was reported. On 22Feb2021, day 4, the
patient was coughing and tested positive for SARS-CoV2 with respiratory
symptomatology with desaturation (value not reported) justifying his
hospitalization from 23Feb2021 to 25Feb2021. In Feb2021, the patient underwent
examination which showed soft calves and no bleeding; D Dimers at 2680; CRP at 29;
Troponin at 37; proBNP at 311; and normal lung scan. In Feb2021, respiratory
improvement was noted after an episode of respiratory alkalosis. On 25Feb2021, day
7, the patient got better and was able to return on home with hospitalization at
home request. On 26Feb2021, day 8, the patient was found deceased in his bed (death
unexplained/sudden death), his phone in his hand with cyanotic appearance of the
upper body (seen a few hours before). It was reported that ""Overall, unexplained
death on D8 of the 1st dose of COMIRNATY in an elderly patient but independent and
without medical history, with recent symptomatic COVID, but stabilized the day
before death."" The outcome of the events positive COVID-19 test with symptoms and
respiratory alkalosis was recovering, and the remaining events was unknown. The
patient died on 26Feb2021. Autopsy was not performed. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: Death
unexplained/Sudden death"" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283618-1"
"1283618-1" "Vaccination failure/COVID-19 PCR test was positive for variant
V1/of respiratory problems; Vaccination failure/COVID-19 PCR test was positive for
variant V1/of respiratory problems; This is a spontaneous report from a contactable
consumer, downloaded from the regulatory authority. Regulatory Authority Report
Number: FR-AFSSAPS-LL20212111, Safety Report Unique Identifier FR-AFSSAPS-
2021041026. A 92-years-old male patient received bnt162b2 (COMIRNATY), (dose 2)
intramuscular on 19Feb2021 (Batch/Lot Number: Unknown) as a single dose, and (dose
1) intramuscular on 29Jan2021 (Batch/Lot Number: Unknown) as a single dose for
COVID-19 immunization. The patient's medical history and concomitant medications
were not reported. It was reported that the patient experienced vaccination
failure; a PCR test was done on 22Mar2021, and the COVID-19 PCR test was positive
for variant V1. On 26Mar2021, appearance of respiratory problems occurred. The
patient was hospitalized and died on 02Apr2021. It was not reported if autopsy was
performed. No follow-up attempts are possible; information about batch/lot number
cannot be obtained.; Reporter's Comments: COVID Vaccine declaration 92 year old
patient vaccinated with COMIRNATY IM Lot not specified 1st injection on 29Jan2021
2nd injection on 19Feb2021 On 26Mar2021 appearance of respiratory problems PCR test
done on 22Mar2021 PCR test positive for variant V1 The patient is hospitalised and
dies on 02Apr2021 NB: Imputability without prejudice to the elements of
investigation which could be carried out in the context of legal or amicable
compensation procedures.; Reported Cause(s) of Death: Vaccination failure/COVID-19
PCR test was positive for variant V1; Vaccination failure/COVID-19 PCR test was
positive for variant V1" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283835-1"
"1283835-1" "COVID-19/COVID-19 test was positive; patient died, cause of
death was not reported; febrile; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority, regulatory authority number HU-
OGYI-219821. An 86-year-old male patient received first dose bnt162b2
(COMIRNATY; Lot Number: EL0725) intramuscularly administered into left arm on
12Feb2021 14:20 as 0.3 mL, single for COVID-19 immunisation. The patient's medical
history and concomitant medications were not reported. The patient started to have
symptoms of COVID-19 two days after vaccination, patient became febrile on
14Feb2021. The patient was diagnosed to have COVID-19 4 days after vaccination on
16Feb2021 and was admitted to the hospital on an unspecified date. The patient died
on 20Feb2021, cause of death was not reported. The patient underwent lab tests and
procedures which included SARS-CoV-2 test: positive on 16Feb2021. It was not
reported if an autopsy was performed. Outcome of events COVID-19 and pyrexia was
unknown. Sender Comment: The patient started to have symptoms of COVID-19 two days
after vaccination and diagnosed to have COVID-19 4 days after vaccination. Immunity
may have not developed within 4 days after the first dose of vaccine. The case is
serious because the patient died. No further information is expected. Follow-up
attempts are completed. No further information is expected.; Reported Cause(s) of
Death: patient died, cause of death was not reported" "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283836-1"
"1283836-1" "died; COVID-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority, regulatory authority number HU-
OGYI-220021. An 85-year-old female patient received first dose of bnt162b2
(COMIRNATY, solution for injection, lot: EL0725), intramuscular in left arm on
12Feb2021 as 0.3 mL, single for covid-19 immunisation. Medical history included
ongoing diabetes, ongoing angina pectoris and ongoing myocardial infarction. Before
vaccination the patient's chronic diseases were in balance. The patient's
concomitant medications were not reported. The patient experienced occurrence of
covid-19 after vaccination with bnt162b2 (non-serious) in Feb2021. The outcome of
covid-19 was unknown. The patient died of an unknown cause on 22Feb2021. An autopsy
was not performed. The physician considered the report as serious. In the opinion
of the patient's physician, the death was not related to the vaccination. Sender
Comment: The patient died ten days after vaccination. Death is not expected adverse
event of COMIRNATY. It might be related to the patient's chronic cardiovascular
diseases. Based on the above, and in lack of detailed medical information,
relationship between death and COMIRNATY is not assessable. The case is serious
because the patient died. No further information is expected. Follow-up attempts
are completed. No further information is expected.; Sender's Comments: The
information provided is very limited and does not allow for a complete medical
assessment. Based on current convention, the case of death is assessed as related
to bnt162b2 until sufficient information is available to confirm an unrelated cause
of death. The patient's angina pectoris, myocardial infarction and diabetes may
have contributed to the patient's death. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.; Reported
Cause(s) of Death: died" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283838-1"
"1283838-1" "COVID-19; Drug Ineffective; This is a spontaneous report from a
contactable physician downloaded from a regulatory authority-WEB, regulatory
authority number: HU-OGYI-243821. An 83-year-old female patient received first dose
of bnt162b2 (COMIRNATY), intramuscular, administered on left arm on 04Mar2021 (lot
number: EP2163) at 0.3 mL, single for COVID-19 immunisation. Medical history
included COVID-19 from an unknown date and unknown if ongoing. Concomitant
medications were not reported. On 30Mar2021, the patient experienced COVID-19 and
drug ineffective with fatal outcome. It was reported as occurrence of COVID-19
infection resulting in death after COMIRNATY injection for active immunization to
prevent COVID-19. The patient was hospitalized on an unknown date because of COVID-
19, and on 30Mar2021 at 21:15, the patient passed away. It was not reported if an
autopsy was performed. Sender's Comment: According to the SmPC of Comirnaty,
immunity usually develops 14 days after the second dose of the vaccine. The patient
received the first dose of Comirnaty on 04Mar2021 and passed away on 30Mar2021
after getting infected with the virus, therefore immunity may have not developed
yet. Based on the above, the causal relationship is unlikely between the suspected
drug and the adverse event. The case is considered serious because the outcome was
fatal. Further information is not expected. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: COVID-19; drug
ineffective" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283839-1"
"1283839-1" "COVID-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority-WEB, regulatory authority number
HU-OGYI-244621. An 83-year-old male patient received bnt162b2 (COMIRNATY),
intramuscular in the left arm on 03Mar2021 (Lot Number: EP2163) as 0.3 mL, single,
1st dose for COVID-19 immunisation. Medical history included COVID-19 from an
unknown date and unknown if ongoing. The patient's concomitant medications were not
reported. The patient experienced COVID-19 on 11Mar2021. Outcome of event COVID-19
was fatal. The patient died on 11Mar2021. It was unknown if an autopsy was
performed. It was also reported as follows: occurrence of Covid-19 infection
resulting in death after COMIRNATY injection for active immunization to prevent
COVID-19. The patient was hospitalized on an unknown date because of Covid-19, and
on 11Mar2021 at 06:15 the patient passed away. Senders comment: According to the
HA of Comirnaty, immunity usually develops 14 days after the second dose of the
vaccine. The patient received the first dose of Comirnaty on 03Mar2021 and passed
away on 11Mar2021 after getting infected with the virus, therefore immunity may
have not developed yet. Based on the above, the causal relationship is unlikely
between the suspected drug and the adverse event. The case is considered serious
because the outcome was fatal. Further information is not expected. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID 19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283910-1"
"1283910-1" "O2 saturation at 93%; COVID-19/positive SARS-CoV-2 PCR test;
COVID-19/positive SARS-CoV-2 PCR test; Respiratory distress due to severe hypoxemic
SARS-Cov-2 infectious lung disease; onset of symptoms suggestive of bronchitis
(pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms
suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-
38.5C); onset of symptoms suggestive of bronchitis (pharyngitis, congestion,
coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of bronchitis
(pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms
suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-
38.5C); This is a spontaneous report from a contactable pharmacist downloaded from
a regulatory authority-WEB FR-AFSSAPS-PS20210841. Safety Report Unique Identifier
FR-AFSSAPS-2021042007. An 80-year-old female patient received second dose of
bnt162b2 (COMIRNATY) intramuscularly on 15Feb2021 and first dose intramuscular on
19Jan2021; both as single dose for COVID-19 immunisation. Medical history included
follicular lymphoma, deep vein thrombosis right leg from 2017, extrinsic allergic
alveolitis, diverticulosis of the sigmoid and a 4 mm left colon polyp resected with
forceps in 2013, hypertension and functional colopathy. Concomitant medications
included diltiazem hydrochloride (DILTIAZEM LP), hydrochlorothiazide (ESIDREX),
losartan (LOSARTAN), sertraline (SERTRALINE), valaciclovir (VALACICLOVIR). On
28Feb2021 patient experienced onset of symptoms suggestive of bronchitis
(pharyngitis, congestion, coughing up sputum, fever 38-38.5C). The patient was
treated with antibiotic therapy with amoxicillin. On 12Mar2021, patient had COVID-
19 confirmed by a positive SARS-CoV-2 PCR test. On 18Mar2021 patient's O2
saturation was at 93% leading to a visit to the emergency room and was then
hospitalized. The patient underwent lab tests and procedures which included CT scan
(18Mar2021): unknown results, thoracic angioscan (24Mar2021): No pulmonary embolism
on angioscan or signs of PAH. Increased parenchymal abnormalities of Covid-19
compared to the CT scan of 18Mar2021. Extensive involvement estimated to date at
50%, thoracic angioscan (02Apr2021): No sign of pulmonary embolism or PAH.
Appearance of diffuse mediastinal and cervical emphysema (tracheal rupture?).
Increase in ground-glass areas and thoracic angioscan (09Apr2021): Subtotal
resorption of the subcutaneous emphysema. Clear regression of pneumomediastinum
which persists in the pericardium and anterior mediastinum. Complete resorption of
the right pneumothorax. Persistence of a thin blade of left apical pneumothorax.
Increased parenchymal involvement at Covid-19 from 50% to 70%. Absence of
adenopathy with a pejorative appearance. No pleuropericardial effusion. Respiratory
distress due to severe hypoxemic SARS-CoV-2 infectious lung disease leading to
transfer to a continuing care unit. The patient was treated with Oxygen therapy,
Optiflow under 100% FiO2, G 5 500 ml + PV 1 ampoule B1-B6 500 mg,
piperacillin/tazobactam (TAZOCILLIN) 4 g IV (intravenous) every 8 hours,
tocilizumab 600 mg IV, lansoprazole 15 mg/day, trimethoprim/sulfamethoxazole
(BACTRIM) 800/160 mg, valaciclovir 500 mg, Novorapid subcutaneous protocol,
tinzaparin (INNOHEP) 10,000 IU subcutaneous at night. The patient died on 11Apr2021
due to respiratory distress due to severe hypoxemic SARS-Cov-2 infectious lung
disease. It was not reported if an autopsy was performed. Outcome of all other
events was unknown. No follow up attempts are possible; information about
lot/batch number cannot be obtained. No further information is expected.; Reported
Cause(s) of Death: Respiratory distress due to severe hypoxemic SARS-Cov-2
infectious lung disease; COVID-19/positive SARS-CoV-2 PCR test; COVID-19/positive
SARS-CoV-2 PCR test" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283962-1"
"1283962-1" "Cardiorespiratory insufficiency; COVID-19; COVID-19; This is a
spontaneous report downloaded from the regulatory authority (Regulatory Authority
report number: HU-OGYI-219921). A contactable physician (contactable through
Regulatory Authority only) reported that an 84-year-old male patient received the
first dose of BNT162B2 (COMIRNATY) on 12Feb2021 (Lot Number: EL0725; Expiration
date was not reported) and the second dose on 05Mar2021 (14:20) (Lot Number:
EJ6790; Expiration date was not reported); both intramuscular as a single dose, for
COVID-19 immunization. Medical history included ongoing colonic neoplasm (received
chemotherapy); ongoing cardiac decompensation; and general condition was wrong. The
patient's concomitant medications were not reported. On an unspecified date in
2021, after the first and second doses of vaccination, the patient had COVID-19. On
15Mar2021, the patient had cardiorespiratory insufficiency. The outcome of the
event, COVID-19, was unknown. The patient had died on 15Mar2021, and the reported
cause of death was cardiorespiratory insufficiency. An autopsy was not performed.
As reported, death was not an expected adverse event of BNT162B2. It might be
related to the patient's chronic diseases and bad general condition. Based on the
above, and in the lack of detailed medical information, the relationship between
death and COMIRNATY was not assessable. Follow-up attempts are completed. No
further information is expected.; Reported Cause(s) of Death: Cardiorespiratory
insufficiency" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1283963-1"
"1283963-1" "Cardio-respiratory arrest; Drug Ineffective; COVID-19 pcr test
positive; This is a spontaneous report from a contactable physician downloaded from
the regulatory authority-WEB, regulatory authority number HU-OGYI-241121. An
88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular,
administered in Arm Left on 02Mar2021 (Batch/Lot Number: EP2163) as 0.3 ml, single,
left arm for covid-19 immunisation. Medical history included ongoing cerebral
infarction, ongoing arteriosclerosis, ongoing cardiac failure, ongoing
Vertebrobasilar artery syndrome, ongoing dementia , ongoing covid-19, ongoing
cerebral arteriosclerosis , ongoing hypertension , ongoing hypertensive
cardiomyopathy , ongoing anaemia, ongoing epilepsy, ongoing osteoporosis.
Concomitant medications included folic acid (FOLIC ACID) taken for anaemia;
potassium chloride (KALDYUM) taken for cardiac failure; ferrous sulfate (SORBIFER
DURULES [FERROUS SULFATE]) taken for anaemia; furosemide (FUROGAMMA) taken for
cardiac failure; alprazolam (FRONTIN) taken for dementia; carbamazepine (TEGRETOL)
taken for epilepsy; start and stop dates were not reported. On 21Mar2021,
occurrence of cardio-respiratory arrest after the use of Comirnaty was reported.
The patient experienced cardio-respiratory arrest and died. The patient was
hospitalized from an unknown date and received the vaccine in the hospital. On
19Mar2021, a COVID-19 PCR test was positive. Drug ineffective was reported. The
patient underwent lab tests and procedures which included sars-cov-2 test: positive
on 19Mar2021. The patient died on 21Mar2021. An autopsy was not performed.
Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for
injection, cardio-respiratory arrest is not listed and not expected. TTO is 19
days. Dechallenge and rechallenge were not applicable. The causal relationship
between the suspected drug and the event is considered not relatable. According to
the reporting physician, he does not consider a causal relationship between the
death of the patient and the vaccine. The case is considered serious due to fatal
outcome. Follow-up activities closed. No routine follow-up is possible for EV-WEB
ICSRs.; Sender's Comments: Reported cardio-respiratory arrest is considered
intercurrent and unrelated to suspect BNT162B2. Consider patient underlying
conditions and comorbidities as causative. ; Reported Cause(s) of Death: cardio-
respiratory arrest" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1287149-1"
"1287149-1" "consciousness disorder; hypernatremia due to dehydration;
hypernatremia due to dehydration; general state alteration; Vaccination failure;
Covid-19 test returned positive; respiratory failure due to Covid-19 infection; the
first signs of pneumonia; This is a spontaneous report from a contactable consumer
or other non hcp downloaded from the Medicines Agency (MA) -WEB, regulatory
authority number FR-AFSSAPS-GR20211364. A 98-year-old male patient received first
bnt162b2 (Pfizer vaccine, solution for injection) (Batch/Lot Number: EJ6789) on
05Feb2021 via intramuscular route of administration as 30 ug, at single dose and on
04Mar2021, second dose (Batch/Lot Number: EP2166) as 30 ug, at single dose for
covid-19 immunization. A 98-year-old male patient with a medical history of optic
nerve degeneration, benign prostatic hyperplasia treated with surgery, right leg
carcinoma, transient ischemic attack in Apr2014, carotid artery atheroma, chronic
glaucoma. Also prostatic adenoma from an unknown date and unknown if ongoing , TIA
from Apr2014 to an unknown date , carcinoma skin from an unknown date and unknown
if ongoing , optic nerve disorder from an unknown date and unknown if ongoing ,
glaucoma from an unknown date and unknown if ongoing , carotid artery atheroma from
an unknown date and unknown if ongoing. The patient's concomitant medications were
not reported. The patient experienced vaccination failure (death) on 29Mar2021. The
patient died on 01Apr2021. An autopsy was not performed. Course of the events : On
05Feb2021, first dose of COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY)
was administered (lot number EJ 6789), followed by the second dose on 04Mar2021
(lot number EP 2166). On 09Mar2021, the patient was hospitalized for general state
alteration, and discharged on 23Mar2021 with negative PCR Covid-19 test. On
26Mar2021, the patient presented the first signs of pneumonia. On 29Mar2021, the
patient was hospitalized for dyspnea with bronchial congestion and breathing
pauses. On the same day, nasopharyngeal real-time polymerase chain reaction (RT-
PCR) Covid-19 test returned positive, target 1 (protein envelope) at 13.2 and
target 2 (nucleocapsid protein ) at 14.2. SARS-CoV2 variant screening showed the UK
variant VOC202012/01. Blood work up in an emergency unit showed no anemia with
hemoglobin at 147 g/L and platelets at 243 x 10^9/L, laboratory signs of
inflammation with leucocytes at 11.4 x 10^9/L and CRP at 134 mg/L probably related
to pulmonary superinfection in the context of Covid-19 infection. Stable renal
failure with creatinine at 119 uM (glomerular filtration rate (GFR) at 44ml/min),
urea 13.9 mM. Blood electrolytes analysis showed hypernatremia at 154 mM, and
normal potassium level at 4.4 mM..Blood glucose was at 7.01 mM, calcium at 2.33 and
corrected calcium at 2.43 mM. proBNP was at 15255 and troponins at 112. Overall,
the patient was hospitalized for acute respiratory failure due to Covid-19
infection in the context of a general and especially cardiac vulnerability. The
patient presented hypernatremia due to dehydration, which contributed to a
consciousness disorder. Long-standing treatment included ramipril (unspecified
tradename), 5 mg in the morning, DL-lysine acetylsalicylate (KARDEGIC 75 mg, powder
for oral solution in sachet dose) 1 sachet at noon. Patient's family requested only
palliative care. On 01Apr2021, the patient presented alternation of long breathing
pauses followed by polypnea with agitation. Patient passed away. The outcome of the
event general state alteration was recovered on 23Mar2021 and other events was
fatal. No FU attempts possible. No further information expected.; Reported
Cause(s) of Death: COVID-19 infection" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1287787-1"
"1287787-1" "Dizziness; Fatigability; Appetite lost; Breathing difficult;
diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021;
This is a spontaneous report from a contactable consumer who is also the patient's
daughter downloaded from the regulatory authority-WEB, regulatory authority number
RO-NMA-2021-SPCOV6833-FU1. A 63-year-old female patient received bnt162b2
(COMIRNATY), dose 1 intramuscular on 07Mar2021 (Batch/Lot Number: EP2166) as SINGLE
DOSE (1 DF) for covid-19 immunisation. Medical history included Cancer of head of
pancreas (The patient had surgery for a pancreatic head cancer in December 2016).
The patient's concomitant medications were not reported. On 12Mar2021 the patient
experienced fatigue/ Fatigability, dizziness, lack of appetite/ Appetite lost,
difficult breathing/ Breathing difficult. The events were assessed as serious
(hospitalization, fatal). The patient needed hospitalization where she was
diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021.
The patient underwent lab tests and procedures which included sars-cov-2 test:
diagnosed with sars-cov-2 virus infection on 16Mar2021 (diagnosed with SARS-CoV-2
virus infection confirmed by a test on March 16, 2021). The patient died on
20Mar2021. It was not reported if an autopsy was performed. Sender Comment:
Follow up information added on 26-Apr-2021: following investigation of the case, on
22-Apr-2021 it was concluded: it is denied that the death was caused by the post-
vaccination reaction; the person was confirmed with COVID-19 infection on 16-Mar-
2021 and died on 20-Mar-2021 at the Hospital. Routine follow-up is not conducted
for HA-web reports. No follow-up attempts are needed. No further information is
expected. The information about lot number was provided within the initial report.
The case was closed for follow-up activities.; Reported Cause(s) of Death:
Dizziness; Fatigability; Appetite lost; Breathing difficult" "No prior
vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1296831-1"
"1296831-1" ""COVID-19; suspected vaccination failure; This is a spontaneous
report from a contactable other hcp downloaded from a regulatory authority-WEB,
regulatory authority number AT-BASGAGES-2021-24417. A 79-years-old female patient
received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on
13Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an
unspecified route of administration on 04Feb2021 (Batch/Lot number was not
reported) as single dose for COVID-19 immunization. The patient's weight and height
were not reported. No relevant medical history reported. The patient's concomitant
medications were not reported. On 25Mar2021 the patient experienced COVID-19 death,
Vaccination failure. It was reported that 1st dose was on 04Feb2021, 2nd dose was
on 13Mar2021, date of illness on 25Mar2021, diagnosis date was 29Mar2021. The
patient had respiratory symptoms (e.g. cough with or without fever), no hospital,
Variant: (unlisted). Patient hospitalization was reported as no but it was also
reported that ""Stat. [PRIVACY, hospital] from 01Apr to 06Apr2021. Deceased on
06Apr2021 in the [PRIVACY, hospital]"". The patient's outcome was fatal for COVID-
19, unknown for Vaccination failure. It was not reported if an autopsy was
performed.; Reported Cause(s) of Death: patient experienced COVID-19 death,
Vaccination failure; patient experienced COVID-19 death, Vaccination failure""
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1296917-1"
"1296917-1" "received both doses of bnt162b2 and on 15Mar2021, the patient 's
PCR test for COVID-19 was positive reported as vaccination failure; received both
doses of bnt162b2 and on 15Mar2021, the patient 's PCR test for COVID-19 was
positive reported as vaccination failure; This is a spontaneous report from a
contactable pharmacist downloaded from the Regulatory Authority (RA)-WEB,
regulatory authority number FR-AFSSAPS-BS20210631. An 86-year-old male patient
received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20Jan2021 (lot number:
EJ6788) as SINGLE DOSE and dose 2 intramuscular on 10Feb2021 (lot number: EJ6788)
as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing
auricular fibrillation. Concomitant medication included fluindione (PREVISCAN
[FLUINDIONE]). The patient received both doses of bnt162b2 and on 15Mar2021, the
patient 's PCR test for COVID-19 was positive reported as vaccination failure. The
patient was hospitalized for the events from 15Mar2021 to an unknown date. The
patient died on 30Mar2021 due to the events. An autopsy was not performed. No
follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: received both doses of bnt162b2 and on 15Mar2021, the patient 's
PCR test for COVID-19 was positive reported as vaccination failure; received both
doses of bnt162b2 and on 15Mar2021, the patient 's PCR test for COVID-19 was
positive reported as vacci" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1297083-1"
"1297083-1" "Acute respiratory decompensation; bronchitis without fever;
Vaccination failure/antigentic test positive/PCR test positive; antigentic test
positive/PCR test positive; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority-WEB, regulatory authority number
FR-AFSSAPS-PO20211949. A 90-year-old male patient received bnt162b2
(COMIRNATY), second dose on 16Feb2021 (Lot Number: EK9788) at 0.3 mL, single dose
in the left arm and first dose on 26Jan2021 (Lot Number: EJ6795) as single dose,
both intramuscular for COVID-19 immunization. Medical history included chronic
bronchitis, depression, rheumatoid arthritis (treated by tocilizumab (ROACTEMRA)
and methotrexate(NOVATREX)), lung nodule (2 pulmonary tissue nodules of 10mm),
heart failure, and arterial hypertension all from an unknown date. Inflammation
(Inflammatory syndrome) from Jul2019. The patient's concomitant medications were
not reported. On 25Mar2021, the patient tested positive for COVID-19 antigenic test
and on 26Mar2021, tested positive for COVID-19 PCR test (variant not communicated).
On 27Mar2021 had a negative antibody test result. On 02Apr2021, bronchitis without
fever was reported and start of treatment with amoxicillin. On 05Apr2021, the
patient had acute respiratory decompensation. Oxygen desaturation at 78%. Put under
9L of O2 in high concentration. Saturation raised to 85% in 1 hour. Death of the
patient occurred on 05Apr2021 around 6 pm and the cause was considered to be acute
respiratory decompensation and vaccination failure due to COVID-19. The outcome of
the event bronchitis without fever was unknown while for the acute respiratory
decompensation and vaccination failure due to COVID-19 was fatal. The patient died
on 05Apr2021. An autopsy was not performed. No follow up attempts possible. No
further information expected.; Reported Cause(s) of Death: Acute respiratory
decompensation; Vaccination failure/antigentic test positive/PCR test positive;
antigentic test positive/PCR test positive" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1297230-1"
"1297230-1" "Vaccination failure; cardiorespiratory decompensation; oxygen
desaturation; Covid-19 virus test positive; This is a spontaneous report from a
contactable other healthcare professional (HCP) downloaded from the regulatory
authority FR-AFSSAPS-LL20212270, Safety Report Unique Identifier FR-AFSSAPS-
2021043050. A 96-year-old male patient received bnt162b2 (COMIRNATY), via
intramuscular, first dose on 18Feb2021 and second dose on 12Mar2021, at single dose
for COVID-19 immunisation. The relevant medical history and concomitant medications
were not reported. The patient experienced vaccination failure on an unspecified
date, Covid-19 virus test positive on 11Apr2021, cardiorespiratory decompensation
on an unspecified date, oxygen desaturation on an unspecified date. The patient
presented with cardiorespiratory decompensation with 89% desaturation under 3L of
O2, PCR test carried out on 11Apr2021 Sending of the test positive on 11Apr,
variant not specified. The patient died on 11Apr2021. It was unknown if autopsy was
performed. The patient underwent lab test included O2 saturation showed 89% (under
3L of O2) on an unspecified date; Covid-19 PCR test showed positive (variant not
specified) on 11Apr2021. The outcome of the events was fatal. No follow-up
attempts are possible. Information on batch/lot number cannot be obtained.;
Reported Cause(s) of Death: Vaccination failure; Covid-19 virus test positive;
oxygen desaturation; cardiorespiratory decompensation" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1304016-1"
"1304016-1" "cough; fevers of 39.5; apathy; heart failure; urosepsis; COVID-
19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19
test; bilateral pneumonia; This is a spontaneous report from a contactable consumer
and a physician downloaded from the Regulatory Authority-WEB, regulatory authority
number CZ-CZSUKL-21004736. A 73-year-old male patient received bnt162b2
(COMIRNATY), dose 1 intramuscular on 31Mar2021 (Batch/Lot Number: Unknown) as 1ST
DOSE, SINGLE for Covid-19 immunization. Medical history included hip surgery from
14Mar2021 to an unknown date, decubitus ulcer (heel) from Mar2021 to an unknown
date, ongoing non-smoker, ongoing hypertension arterial, and ongoing diabetes.
Concomitant medication included anti-diabetic (not specified). The patient was
recovering in a private medical center after hip surgery (14Mar2021), where he was
vaccinated on 31Mar2021. One day before the vaccination, the patient already had
elevated levels of CRP-120mg/l. It was reported that the patient died 8 days after
the first dose of Comirnaty vaccine, which was administrated on 31Mar2021. On
02Apr2021, the patient was apathetic, he was thirsty, felt cold, was moaning while
urinating, and had decubitus on his heel. Since 04Apr2021, the patient had fevers.
On 06Apr2021, he had a cough. At night on 06Apr2021, the patient was transported to
another hospital. In the hospital, he was diagnosed with severe urosepsis and on
07Apr2021 he had a positive PCR test for Covid-19, chest imaging shown bilateral
infiltrates on his lungs also reported as bilateral pneumonia; his condition was
getting worse then. The patient died on 08Apr2021 because of heart failure due to
severe urosepsis. On 28Apr2021, his physician was contacted and reported that the
patient already had elevated levels of CRP-120mg/l one day before the vaccination,
since 04Apr2021, the patient had fevers of 39.5, on the day of his admission to the
hospital (06Apr2021) urea 16mmol/l, creatinine 166umol/l, the patient died because
of heart failure due to severe urosepsis. The patient died on 08Apr2021. It was not
reported if an autopsy was performed. The outcome of other events was unknown.
Bilateral pneumonia assessed by Healthcare professional: Result of Assessment: not
related; Fever assessed by Healthcare professional: Result of Assessment: not
related; Urosepsis assessed by Healthcare professional: Result of Assessment: not
related; Apathy assessed by Healthcare professional: Result of Assessment: not
related; Cough assessed by Healthcare professional: Result of Assessment: not
related. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: The patient died on 08Apr2021
because of heart failure due to severe urosepsis." "No prior vaccinations for
this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1304083-1"
"1304083-1" "Status epilepticus; SARS-COV2 PCR: Positive; This is a
spontaneous report received from a contactable physician downloaded from the
regulatory authority. The regulatory authority report number is ES-AEMPS-846623. A
79-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot:
EW2246), intramuscularly on 10Apr2021 at 0.3 mL single for COVID-19 immunisation.
Medical history included arterial hypertension, pain loin, ventricular bigeminy,
facial droop (right hemiparesis from childhood due to infantile paralysis), and
mild cognitive impairment. She was admitted from 01Apr2021 to 09Apr2021 due to
dysarthria and disorientation, with a diagnosis of isovolemic hypotonic
hyponatremia, SIAD (syndrome of inappropriate antidiuretic hormone secretion)
(uncertain etiology), and UTI (urinary tract infection) due to multisensitive E.
Coli. Concomitant medications included omeprazole, calcium carbonate/colecalciferol
(CALCIUM CARBONATE AND VITAMIN D), acetylsalicylic acid 100 mg, amlodipine, sodium
valproate, denosumab (PROLIA), and trazodone. On 16Apr2021 she went to the
Emergency Service of a hospital due to paraphasia and disorientation, starting
treatment with valproic and was discharged. On 20Apr2021, she was admitted due to a
non-convulsive status, with progressive onset in recent weeks despite treatment
with valproic acid ((poor compliance). No evidence of epilepsy until Apr2021, but
there were episodes of similar characteristics on admission in 2020 Therefore, it
does not seem like status epilepticus in the context of any acute trigger, but
rather a serious epileptic decompensation within an infectious occurrence such as
covid19. Previous etiological study without significant alterations, although the
patient suffered from infantile cerebral palsy and had mild-moderate cognitive
impairment. Diagnostics: Complex focal epileptic status, in a patient with residual
brain injury that might be the etiology of the seizure, the injury was old and had
decompensated 10 days after vaccination. Severe bilateral pneumonia from COVID19.
Lab data on 20Apr2021 included: CT (computed tomography): No signs of acute
intracranial pathology. Residual areas of left frontoparietal encephalomalacia;
SARS-COV2 PCR: Positive; EEG (electroencephalogram) on admission: Focal status
epilepticus; The main novelty was a respiratory worsening, with work of breathing
and SatO2(Oxygen saturation) 87% with GN at 6lp. At the respiratory level:
Bilateral pneumonia due to severe covid19, requiring oxygen therapy with GN at 5
bpm. COURSE: No improvement despite pharmacological adjustment after 24h. The
patient died on 23Apr2021. No autopsy was done. Assessment of causality (SEFV): The
patient had severe bilateral Covid-19 pneumonia. Status epilepsy had been described
in positive CoVID-19 patients, so there was an alternative causal explanation to
the vaccine that could explain the condition. Outcome of event SARS-COV2 PCR:
Positive was unknown. No follow-up attempts are possible. No further information
expected.; Reported Cause(s) of Death: Status epilepticus" "No prior vaccinations
for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1304542-1"
"1304542-1" "Drug Ineffective; COVID-19; This is a spontaneous report from a
contactable physician downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority number is HU-OGYI-243321. A 60-year-old male patient
received BNT162B2 (COMIRNATY; Lot Number: ET3620), intramuscular on 21Mar2021 as
0.3 mL, single, first dose for covid-19 immunisation. Medical history included
covid-19 from an unknown date and unknown if ongoing. The patient's concomitant
medications were not reported. The patient experienced covid-19 on 15Apr2021, at
09:40, which was serious as it lead to death. The patient died on 15Apr2021. It
was not reported if an autopsy was performed. Sender Comment: According to the
SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the
vaccine. The patient received the first dose of Comirnaty on 21Mar2021 and passed
away on 15Apr2021 after getting infected with the virus, therefore immunity may
have not developed yet. Based on the above, the causal relationship is unlikely
between the suspected drug and the adverse event. The case is considered serious
because the outcome was fatal. Further information is not expected. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1304623-1"
"1304623-1" "ischemic and valvular heart disease; ischemic and valvular heart
disease; Positive molecular swab in subject vaccinated on 16Jan and 06Feb. Dead.;
vaccination failure; This is as spontaneous report received from a contactable
Healthcare Professional (HCP) downloaded from the Agency-WEB. The regulatory
authority report number is IT-MINISAL02-722826. A 99-year-old female patient
received BNT162B2 (COMIRNATY) via intramuscular administered in Arm Left (shoulder)
on 06Feb2021 as 2nd dose, 0.3 ml single (Batch/Lot Number: EL0725; Expiration Date:
31Mar2021), via intramuscular administered in Arm Left (shoulder) on 16Jan2021 as
1st dose, 0.3 ml single (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) for
covid-19 immunisation. Medical history included left bundle branch block (LBBB),
femur fracture from 04Nov2020, hypokinesia, ischemic heart disease (IHD), permanent
atrial fibrillation, choledocholithiasis from 30Dec2020, hypokalaemia, pneumonitis
from 30Dec2020, interstitial lung disease from 01Jan2015, decompensation cardiac.
The patient's concomitant medications were not reported. The patient experienced
positive molecular swab on 19Apr2021 in subject vaccinated on 16Jan2021 and
06Feb2021 and died. Reported evident signs of decompensation on the day of death.
Most relevant cause of death reported as ischemic and valvular heart disease. The
patient underwent SARS-CoV-2 molecular test and revealed negative on 29Mar2021 and
on 12Apr2021; revealed positive on 19Apr2021. The patient died on 24Apr2021. It
was not reported if an autopsy was performed. The reported cause of death was
ischemic and valvular heart disease, positive molecular swab. Outcome of the
events was fatal. Reporter comment: Death certificate attached. Most relevant
cause of death: ischemic and valvular heart disease.; Reported Cause(s) of Death:
Positive molecular swab; Positive molecular swab; ischemic and valvular heart
disease; ischemic and valvular heart disease" "No prior vaccinations for this
event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1304892-1"
"1304892-1" "NAUSEA; died/Cause of death was unknown; covid19
detected/vaccination failure; covid19 detected/lack of drug effect; covid19
detected/asymptomatic covid-19; exposure to covid-19/Infection exposed; TIA; This
is a spontaneous report from a contactable physician downloaded from the Regulatory
Authority (RA)-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uqwd1x.
Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00026428]. An 88-year-old male
patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular
on 26Jan2021 14:15 (Lot Number: EJ6134) as single dose, dose 1 intramuscular on
05Jan2021 16:15 (Lot Number: EJ6795) as single dose, for covid-19 immunisation.
Medical history included Living in nursing home; Chronic ischemic heart disease,
unspecified; Hyperplasia of prostate; Uncomplicated hypertension. Concomitant
medications included oxazepam (SOBRIL); tamsulosin hydrochloride (OMNIC);
lercanidipine hydrochloride (ZANIDIP); metoprolol succinate (SELO-ZOK);
rivastigmine (EXELON [RIVASTIGMINE]); apixaban (ELIQUIS). The patient experienced
TIA (Transient ischaemic attack) on 15Mar2021, asymptomatic covid-19 on 05Apr2021;
exposure to covid-19 from 27Mar2021 - 28Mar2021) (B.1.351 lineage); Infection
exposed 27Mar2021-28Mar2021 - possibly also 01Apr2021-02Apr2021. On 05Apr2021, the
patient developed vaccination failure, lack of drug effect, COVID-19. Relevant
laboratory findings and investigations included in the report: SARS-COV-2 RT-PCR
TEST on 05Apr2021, Result: Positive. B.1.351 lineage. Low Ct value). COVID-19
detected as part of infection tracing 05Apr2021 - asymptomatic at the time. Little
affected in subsequent days. On 11Apr2021 at 14: 30, the patient developed a little
nausea but otherwise in good shape. Relevant laboratory findings and investigations
included in the report: C-reactive protein on 11Apr2021 14: 30: 6 mg/l; oxygen
saturation on 11Apr2021 14: 30: 96%; body temperature on 11Apr2021 14: 30: Normal
(value not specified). On the basis of findings stated above and after conversation
with the hospital, the patient started treatment with prednisolone 40 mg. The
patient was found dead in bed on 11Apr2021 just before midnight. An autopsy was not
performed. The reporter suspected that the patient died with and not because of
COVID-19. Cause of death was unknown to the reporter. The patient's outcome was
fatal. The case was considered to be Serious. The outcome of the event died/Cause
of death was unknown was fatal, of exposure to covid-19/Infection exposed was
recovered on 02Apr2021, of the other events was unknown. Health Authority Comment:
Since the vaccine is new, it will be subject to special monitoring to identify any
new safety information as soon as possible. It is especially important that serious
and/or unusual side effects be reported. Your message is therefore important to
expand knowledge about adverse reactions that were not discovered in the studies,
and it is an important contribution to international cooperation to maintain safe
vaccination worldwide. Causality assessment (Relatedness of drug to
reaction(s)/event(s)): Vaccination failure: Source of assessment: Center. Result
of Assessment: Possible; Drug ineffective: Source of assessment: Center. Result of
Assessment: Possible; COVID-19: Source of assessment: Center. Result of Assessment:
No relationship; Nausea: Source of assessment: Center. Result of Assessment:
Possible.; Reported Cause(s) of Death: died/Cause of death was unknown" "No
prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1311647-1"
"1311647-1" "Vaccination failure; Symptomatic Covid sets in with
desaturation.; This is a spontaneous report from a contactable physician downloaded
from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20213133,
Safety Report Unique Identifier FR-AFSSAPS-2021047051. A 96-year-old female
patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Lot
Number: EK9788) as single dose, dose 1 intramuscular on 14Jan2021 (Lot Number:
EM0477) as single dose for COVID-19 immunisation. Medical history included disease
coronary artery, diabetes mellitus insulin-dependent, cardiac valvulopathy, cardiac
failure, peripheral obliterative arteriopathy, chronic renal failure, glaucoma,
atrial fibrillation paroxysmal, hypertension arterial, hernia hiatal, and carotid
artery stenosis; all from an unknown date and unknown if ongoing. Concomitant
medications included darbepoetin alfa (ARANESP); insulin aspart, insulin aspart
protamine (crystalline) (NOVOMIX); lansoprazole; clopidogrel; lercanidipine;
amiodarone; furosemide; and colecalciferol (ZYMAD); all taken for an unspecified
indication, start and stop date were not reported. The patient experienced
vaccination failure and symptomatic covid sets in with desaturation on 08Apr2021.
Support: monitoring and putting on oxygen. The patient underwent lab tests and
procedures which included PCR: positive (variant) and oxygen saturation:
desaturation on 08Apr2021. The patient died due to events on 22Apr2021. An autopsy
was not performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Vaccination failure; Symptomatic Covid sets
in with desaturation." "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1312091-1"
"1312091-1" "Dyspnea; Coughing; Cardiac failure left; Drug ineffective;
COVID-19/COVID-19 PCR test positive; This is a spontaneous report from a
contactable physician downloaded from the Agency Regulatory Authority-WEB,
regulatory authority number HU-OGYI-254821 reported on 19Apr2021. An 81-year-old
male patient received bnt162b2 (COMIRNATY, tozinameran, concentrate for dispersion
for injection, COVID-19 mRNA Vaccine embedded in lipid nanoparticles), dose 1
intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EP2166) as
first dose, 0.3 mL single, for COVID-19 immunization/for active immunization to
prevent COVID-19. Relevant medical history includes myocardial infarction acute,
ischemic heart disease, COVID-19 and hypertension from unspecified dates and
unknown if ongoing. The patient's concomitant medications were not reported. On
08Apr2021, the patient's COVID PCR test was positive. On 15Apr2021 the patient was
admitted in the hospital because of coughing and dyspnea which started the day
before (14Apr2021). The patient received oxygen therapy as his oxygen saturation
was 85% and had severe dyspnea. On 17Apr2021 at 17:45 the patient died. The cause
of death were COVID-19 infection and cardiac failure left. The patient underwent
lab tests and procedures which included COVID-19 PCR test: positive on 08Apr2021,
and oxygen saturation: 85 % on an unspecified date. The patient died on 17Apr2021.
It was not reported if an autopsy was performed. Case was reported as serious,
medically confirmed. Sender Comment: According to the SmPC of Comirnaty, immunity
usually develops 14 days after the second dose of the vaccine. The patient received
the first dose of Comirnaty on 19Mar2021 and got infected with the virus 20 days
after, therefore immunity may not have developed yet without the second dose. Based
on the above, the causal relationship is unlikely between the suspected drug and
the adverse events. The case is considered serious because the outcome was fatal.
Further information is not expected.; Reported Cause(s) of Death: Drug ineffective;
Dyspnea; Coughing; COVID-19/COVID-19 PCR test positive; Cardiac failure left"
"No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1316495-1"
"1316495-1" "Vaccination failure; Covid-19; This is a spontaneous report from
a contactable physician downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority report number FR-AFSSAPS-DJ20211039 Safety Report Unique
Identifier FR-AFSSAPS-2021047437 A 96-year-old female patient received bnt162b2
(COMIRNATY), intramuscular on 28Jan2021 (Batch/Lot Number: EK9788) as 1st dose,
single and intramuscular on 18Feb2021 (Batch/Lot Number: EK9788) as 2nd dose,
single for covid-19 immunization. The patient's medical history included ongoing
cardiac failure and ongoing dementia. The patient's concomitant medications were
not reported. The patient experienced vaccination failure on 21Apr2021 as the
patient had covid-19. First signs on 21Apr2021 includes hoarse cough, wheezing. The
patient's PCR return positive (variant identified) on 22Apr2021. Quickly appeared a
desaturation (80%) and congestion.The patient contracted COVID probably following a
personal visit (no other patient in the sick nursing home at this time nor any
member of the staff). Patient was placed on antibiotics, corticosteroids and O2.
The outcome of the event vaccination failure and Covid-19 was fatal. The patient
died on 29Apr2021. An autopsy was not performed. No follow-up attempts are
possible; information about batch number already obtained.; Reported Cause(s) of
Death: vaccination failure; COVID-19" "No prior vaccinations for this event."
"COVID-19" "10084268" "PFIZER\BIONTECH" "590" "Unknown" "U" "1316585-1"
"1316585-1" "Desaturation and right focus; Vaccination failure/COVID-
19/Carrying out a PCR which turns out to be positive (so-called variant).; COVID-
19/Carrying out a PCR which turns out to be positive (so-called variant).; fever;
auscultatory bronchitis; This is a spontaneous report from a contactable pharmacist
downloaded from a regulatory authority-WEB regulatory authority [FR-AFSSAPS-
NT20211359], Sender's Safety Report Unique Identifier [FR-AFSSAPS-2021047756].
An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 on 12Feb2021 (Lot
Number: EJ6789) and dose 1 on 22Jan2021 (Lot Number: EJ6788); both via
intramuscular at single dose for SARS-CoV-2 vaccination. Medical history included
stable COPD living in a nursing home. No respiratory pathology since 2015. The
patient's concomitant medications were not reported. On 13Apr2021, the patient
experienced early auscultatory bronchitis. No cough (sore throat isolated symptom).
On 18Apr2021, he had fever. On 19Apr2021, carrying out a PCR which turns out to be
positive (so-called variant), Covid 19. On 21Apr2021: Desaturation and right focus.
Progressive worsening despite increased antibiotics, dexamethasone and oxygen
therapy and right pleural puncture. Therapeutic measures were taken as a result of
the events. The patient died on 25Apr2021 around 5 a.m. Cause of death was
Vaccination failure and Covid 19. It was unknown if an autopsy was performed. The
outcome of the events auscultatory bronchitis, fever and desaturation was unknown.
The outcome of the remaining events was fata