The document contains reports of adverse events following immunization with COVID-19 vaccines. It describes cases such as a woman complaining of headache and abdominal pain day after her second Pfizer dose and being found unresponsive. It also includes a report of a man feeling sick after his Moderna shot, calling his mother saying he was vomiting blood and being found dead. A third report describes a patient developing symptoms like stomach pain and coughing blood after vaccination.
The document contains reports of adverse events following immunization with COVID-19 vaccines. It describes cases such as a woman complaining of headache and abdominal pain day after her second Pfizer dose and being found unresponsive. It also includes a report of a man feeling sick after his Moderna shot, calling his mother saying he was vomiting blood and being found dead. A third report describes a patient developing symptoms like stomach pain and coughing blood after vaccination.
The document contains reports of adverse events following immunization with COVID-19 vaccines. It describes cases such as a woman complaining of headache and abdominal pain day after her second Pfizer dose and being found unresponsive. It also includes a report of a man feeling sick after his Moderna shot, calling his mother saying he was vomiting blood and being found dead. A third report describes a patient developing symptoms like stomach pain and coughing blood after vaccination.
"VAERS ID Code" "Month Reported" "Month Reported Code" "Month Died"
"Month Died Code" Adverse Event Description "ABDOMINAL PAIN" "10000081" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1104175-1" "1104175-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "ABDOMINAL PAIN UPPER" "10000087" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "ABDOMINAL PAIN UPPER" "10000087" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1297262-1" "1297262-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "ABNORMAL BEHAVIOUR" "10061422" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED" "10000636" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "ACUTE CARDIAC EVENT" "10081099" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "ACUTE KIDNEY INJURY" "10069339" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "ACUTE MYOCARDIAL INFARCTION" "10000891" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "ACUTE RESPIRATORY FAILURE" "10001053" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "ACUTE RESPIRATORY FAILURE" "10001053" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "AGONAL RHYTHM" "10054015" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ALANINE AMINOTRANSFERASE INCREASED" "10001551" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ALANINE AMINOTRANSFERASE INCREASED" "10001551" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "ANAEMIA" "10002034" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "ANALGESIC DRUG LEVEL THERAPEUTIC" "10060943" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ANEURYSM" "10002329" "COVID19 (COVID19 (MODERNA))" "1201" "1306986-1" "1306986-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient expired of probable aneurysm at Hospital on 5/10/2021" "ANEURYSM RUPTURED" "10048380" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1391006-1" "1391006-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM. The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing. The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm" "ANGIOGRAM CEREBRAL ABNORMAL" "10052906" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "ANGIOGRAM PULMONARY ABNORMAL" "10002441" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "ANION GAP" "10002522" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "ANTINUCLEAR ANTIBODY NEGATIVE" "10002809" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "APNOEA" "10002974" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "APPETITE DISORDER" "10060961" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1026362-1" "1026362-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th." "ARRHYTHMIA" "10003119" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "ARTHRALGIA" "10003239" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "ASPARTATE AMINOTRANSFERASE INCREASED" "10003481" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ASTHENIA" "10003549" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1264618-1" "1264618-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "103 fever 2 days after the vaccine. Then became afebrile. Then found deceased on 4-26- 2021" "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1312456-1" "1312456-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021" "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "AUTOPSY" "10050117" "COVID19 (COVID19 (MODERNA))" "1201" "1372112-1" "1372112-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination." "AUTOPSY" "10050117" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1026362-1" "1026362-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th." "AUTOPSY" "10050117" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "AUTOPSY" "10050117" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1322310-1" "1322310-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report." "AUTOPSY" "10050117" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "AUTOPSY" "10050117" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1381705-1" "1381705-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "First shot Lot# ER 8732 administered 04/03/2021 Death" "BACK PAIN" "10003988" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "BIOPSY" "10004720" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "BLINDNESS" "10005169" "COVID19 (COVID19 (JANSSEN))" "1203" "1247816-1" "1247816-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "BLOOD ALBUMIN DECREASED" "10005287" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD ALKALINE PHOSPHATASE INCREASED" "10059570" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD BILIRUBIN INCREASED" "10005364" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD CREATININE INCREASED" "10005483" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "BLOOD CREATININE INCREASED" "10005483" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD CULTURE NEGATIVE" "10005486" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "BLOOD CULTURE POSITIVE" "10005488" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD FIBRINOGEN DECREASED" "10005520" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD GLUCOSE" "10005553" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "BLOOD GLUCOSE DECREASED" "10005555" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "BLOOD GLUCOSE INCREASED" "10005557" "COVID19 (COVID19 (MODERNA))" "1201" "1293909-1" "1293909-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose." "BLOOD GLUCOSE INCREASED" "10005557" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "BLOOD GLUCOSE NORMAL" "10005558" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "BLOOD GLUCOSE NORMAL" "10005558" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "BLOOD LACTIC ACID" "10005632" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD LACTIC ACID" "10005632" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "BLOOD LACTIC ACID INCREASED" "10005635" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "BLOOD MAGNESIUM INCREASED" "10005655" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "BLOOD MAGNESIUM INCREASED" "10005655" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD POTASSIUM DECREASED" "10005724" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "BLOOD POTASSIUM INCREASED" "10005725" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "BLOOD TEST" "10061726" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "BLOOD UREA INCREASED" "10005851" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "BLOOD URINE PRESENT" "10018870" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "BODY TEMPERATURE INCREASED" "10005911" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "BRAIN DEATH" "10049054" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "BRAIN DEATH" "10049054" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1391006-1" "1391006-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM. The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing. The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm" "BRAIN NATRIURETIC PEPTIDE INCREASED" "10053405" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "BRAIN NATRIURETIC PEPTIDE INCREASED" "10053405" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "BRAIN STEM HAEMORRHAGE" "10006145" "COVID19 (COVID19 (MODERNA))" "1201" "1372112-1" "1372112-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination." "BRONCHOALVEOLAR LAVAGE" "10049413" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "C-REACTIVE PROTEIN INCREASED" "10006825" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "C-REACTIVE PROTEIN NORMAL" "10006826" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "CAESAREAN SECTION" "10006924" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "CARBON DIOXIDE DECREASED" "10007223" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (JANSSEN))" "1203" "1098028-1" "1098028-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Cardiac arrest, death approx 12 hours later" "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (JANSSEN))" "1203" "1216091-1" "1216091-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (JANSSEN))" "1203" "1247816-1" "1247816-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1198967-1" "1198967-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Cardiac arrest, death" "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1270366-1" "1270366-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "cardiac arrest 5 days post vaccination." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1289723-1" "1289723-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (MODERNA))" "1201" "1372112-1" "1372112-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Pt died of massive pontine hemorrhage and then cardiac arrest two weeks after vaccination." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1124794-1" "1124794-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1293657-1" "1293657-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout." "CARDIAC ARREST" "10007515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "CARDIAC DISORDER" "10061024" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "CARDIAC DISORDER" "10061024" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "CARDIAC FAILURE ACUTE" "10007556" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CARDIAC FAILURE CONGESTIVE" "10007559" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CARDIO-RESPIRATORY ARREST" "10007617" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "CARDIO-RESPIRATORY ARREST" "10007617" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "CARDIO-RESPIRATORY ARREST" "10007617" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "CARDIO-RESPIRATORY ARREST" "10007617" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "CARDIOGENIC SHOCK" "10007625" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "CARDIOMEGALY" "10007632" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "CARDIOMEGALY" "10007632" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "CARDIOVERSION" "10007661" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "CATHETERISATION CARDIAC ABNORMAL" "10007816" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "CENTRAL NERVOUS SYSTEM INJURY" "10081266" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "CENTRAL NERVOUS SYSTEM LESION" "10051290" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "CEREBRAL HAEMORRHAGE" "10008111" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CEREBRAL HAEMORRHAGE" "10008111" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "CEREBRAL INFARCTION" "10008118" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "CEREBRAL MASS EFFECT" "10067086" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CEREBRAL MASS EFFECT" "10067086" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "CEREBRAL THROMBOSIS" "10008132" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CEREBROVASCULAR ACCIDENT" "10008190" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CEREBROVASCULAR ACCIDENT" "10008190" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "CHEST PAIN" "10008479" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "CHEST PAIN" "10008479" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "CHEST PAIN" "10008479" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1124794-1" "1124794-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "CHEST PAIN" "10008479" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "CHEST X-RAY ABNORMAL" "10008499" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CHEST X-RAY ABNORMAL" "10008499" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "CHILLS" "10008531" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "CHILLS" "10008531" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "CHILLS" "10008531" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "CHILLS" "10008531" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1293657-1" "1293657-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout." "CHLAMYDIA TEST NEGATIVE" "10070273" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "CHLAMYDIAL INFECTION" "10061041" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "COMPUTERISED TOMOGRAM ABNORMAL" "10010235" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "CONDITION AGGRAVATED" "10010264" "COVID19 (COVID19 (JANSSEN))" "1203" "1104671-1" "1104671-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "CONDITION AGGRAVATED" "10010264" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "COUGH" "10011224" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "COUGH" "10011224" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre- existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "COUGH" "10011224" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "COUGH" "10011224" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "COUGH" "10011224" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "COVID-19" "10084268" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "COVID-19" "10084268" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "COVID-19" "10084268" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1212820-1" "1212820-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death 3 days after vaccination" "COVID-19" "10084268" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1332849-1" "1332849-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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)" "COVID-19 PNEUMONIA" "10084380" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "CRANIOTOMY" "10011322" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "CULTURE" "10061447" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "CULTURE URINE POSITIVE" "10011640" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "CYANOSIS" "10011703" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1098028-1" "1098028-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Cardiac arrest, death approx 12 hours later" "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1104671-1" "1104671-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1154639-1" "1154639-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient began having seizures about four hours post vaccine while at a friends house and passed away" "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1223714-1" "1223714-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed." "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1223941-1" "1223941-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death 4/17/21" "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1247816-1" "1247816-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "DEATH" "10011906" "COVID19 (COVID19 (JANSSEN))" "1203" "1366333-1" "1366333-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "Death" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre- existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1198967-1" "1198967-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Cardiac arrest, death" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1232541-1" "1232541-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient found unresponsive at approximately 12:00 am 10/11. EMS called and patient was pronounced dead at scene." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1243650-1" "1243650-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1247401-1" "1247401-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic. Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1264618-1" "1264618-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "103 fever 2 days after the vaccine. Then became afebrile. Then found deceased on 4-26- 2021" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1267278-1" "1267278-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1289723-1" "1289723-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1306986-1" "1306986-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient expired of probable aneurysm at Hospital on 5/10/2021" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1312456-1" "1312456-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1317203-1" "1317203-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "DEATH" "10011906" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "0948418-1" "0948418-1" "Jan., 2021" "2021/01" "Jan., 2021" "2021/01" "Expired on 1/12/2021; unknown cause of death" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "0986901-1" "0986901-1" "Jan., 2021" "2021/01" "Jan., 2021" "2021/01" "Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1026362-1" "1026362-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1095327-1" "1095327-1" "Mar., 2021" "2021/03" "Feb., 2021" "2021/02" "I was alerted on 3.11.21 by the patient's wife that patient had passed away the night after having received the vaccine. The wife informed me that she did not wake up the next morning." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1104175-1" "1104175-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1124794-1" "1124794-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1177548-1" "1177548-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1212820-1" "1212820-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death 3 days after vaccination" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1242117-1" "1242117-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Healthy male, no substance use, no symptoms reported made plans to go hiking with a friend the following Sunday (4/18/21) on 4/16/2021 in afternoon. This was last known contact, patient stopped responding to phone after text and was found deceased in home on 4/22/2021, appearing to have passed away in sleep, likely 4/16/2021 in evening." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1310174-1" "1310174-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death on 2 May 2021" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1314342-1" "1314342-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "He died. He got the shot then several hours later he was found DEAD in his sleep. We are still awaiting coroners reports." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1322310-1" "1322310-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337723-1" "1337723-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "PATIENT WAS IMMUNIZED 5/13. PATIENT WAS FOUND DECEASED IN THEIR APARTMENT ON 5/18. FAMILY LAST SAW HIM ON 5/16 WHEN THEY DROPPED HIM OFF AT HIS APARTMENT. MEDICAL EXAMINER HAS NOT YET DETERMINED CAUSE OF DEATH OR EXACT DATE OF DEATH." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1378118-1" "1378118-1" "Jun., 2021" "2021/06" "Jun., 2021" "2021/06" "Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli." "DEATH" "10011906" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1381705-1" "1381705-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "First shot Lot# ER 8732 administered 04/03/2021 Death" "DECREASED APPETITE" "10061428" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "DECREASED APPETITE" "10061428" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1104175-1" "1104175-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "DEEP VEIN THROMBOSIS" "10051055" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "DEPRESSED LEVEL OF CONSCIOUSNESS" "10012373" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "DIABETIC HYPEROSMOLAR COMA" "10012669" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "DIABETIC KETOACIDOSIS" "10012671" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "DIARRHOEA" "10012735" "COVID19 (COVID19 (MODERNA))" "1201" "1293909-1" "1293909-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose." "DIZZINESS" "10013573" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "DIZZINESS" "10013573" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "DOUBLE STRANDED DNA ANTIBODY" "10050418" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "DRUG SCREEN" "10050837" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "DRUG SCREEN POSITIVE" "10049177" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "DYSPNOEA" "10013968" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "DYSPNOEA" "10013968" "COVID19 (COVID19 (MODERNA))" "1201" "1267278-1" "1267278-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away." "DYSPNOEA" "10013968" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "DYSPNOEA" "10013968" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "DYSPNOEA" "10013968" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1177548-1" "1177548-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired." "DYSPNOEA" "10013968" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "DYSPNOEA" "10013968" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "DYSPNOEA" "10013968" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1297262-1" "1297262-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "ECHOCARDIOGRAM ABNORMAL" "10061593" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "ECHOCARDIOGRAM NORMAL" "10014115" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "ELECTROCARDIOGRAM NORMAL" "10014373" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "ENCEPHALITIS" "10014581" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "ENCEPHALOPATHY" "10014625" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "ENDOTRACHEAL INTUBATION" "10067450" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ENDOTRACHEAL INTUBATION" "10067450" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "ENDOTRACHEAL INTUBATION" "10067450" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "ENDOTRACHEAL INTUBATION" "10067450" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "ERYTHEMA" "10015150" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "ESCHERICHIA TEST POSITIVE" "10070090" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "EXPOSURE DURING PREGNANCY" "10073513" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "EYE MOVEMENT DISORDER" "10061129" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "EYE MOVEMENT DISORDER" "10061129" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "FALL" "10016173" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "FALL" "10016173" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "FATIGUE" "10016256" "COVID19 (COVID19 (MODERNA))" "1201" "1293909-1" "1293909-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose." "FATIGUE" "10016256" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1297262-1" "1297262-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "FEELING ABNORMAL" "10016322" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "FEELING ABNORMAL" "10016322" "COVID19 (COVID19 (MODERNA))" "1201" "1317203-1" "1317203-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021." "FEELING ABNORMAL" "10016322" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "FULL BLOOD COUNT" "10017411" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "GAIT DISTURBANCE" "10017577" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "HAEMATEMESIS" "10018830" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "HAEMATOCHEZIA" "10018836" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "HAEMATOCRIT DECREASED" "10018838" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "HAEMOGLOBIN DECREASED" "10018884" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "HAEMOGLOBIN DECREASED" "10018884" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "HAEMOPTYSIS" "10018964" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1297262-1" "1297262-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "HAEMOPTYSIS" "10018964" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "HEAD INJURY" "10019196" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "HEAD INJURY" "10019196" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "HEADACHE" "10019211" "COVID19 (COVID19 (JANSSEN))" "1203" "1243648-1" "1243648-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "headache on 4/8/21, sudden death 4/11/2021" "HEADACHE" "10019211" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "HEADACHE" "10019211" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "HEADACHE" "10019211" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "HEADACHE" "10019211" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1104175-1" "1104175-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "HEADACHE" "10019211" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1124794-1" "1124794-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "HEADACHE" "10019211" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "HEMIPLEGIA" "10019468" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "HEMIPLEGIA" "10019468" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "HIGH RISK SEXUAL BEHAVIOUR" "10020082" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "HIV TEST NEGATIVE" "10020187" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "HYPERHIDROSIS" "10020642" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "HYPOTENSION" "10021097" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "HYPOTENSION" "10021097" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "HYPOXIA" "10021143" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "HYPOXIA" "10021143" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre- existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "IMMUNE THROMBOCYTOPENIA" "10083842" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "IMMUNOGLOBULIN THERAPY" "10069534" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "INCOHERENT" "10021630" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "INFLUENZA A VIRUS TEST NEGATIVE" "10070417" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "INFLUENZA B VIRUS TEST" "10071544" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "INJECTION SITE ERYTHEMA" "10022061" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "INJECTION SITE PAIN" "10022086" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "INJECTION SITE PAIN" "10022086" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "INJECTION SITE PAIN" "10022086" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "INJECTION SITE PAIN" "10022086" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "INJECTION SITE PRURITUS" "10022093" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "INJECTION SITE REACTION" "10022095" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "INJECTION SITE SWELLING" "10053425" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "INTENSIVE CARE" "10022519" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "INTERNAL HAEMORRHAGE" "10075192" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "INTERNAL HAEMORRHAGE" "10075192" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "INTERNATIONAL NORMALISED RATIO INCREASED" "10022595" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "INTRACRANIAL PRESSURE INCREASED" "10022773" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "LABILE BLOOD PRESSURE" "10023533" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "LABORATORY TEST" "10059938" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "LEFT VENTRICULAR FAILURE" "10024119" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "LEUKOCYTOSIS" "10024378" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "LIFE SUPPORT" "10024447" "COVID19 (COVID19 (JANSSEN))" "1203" "1216091-1" "1216091-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "LIFE SUPPORT" "10024447" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "LIFE SUPPORT" "10024447" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "LIVER FUNCTION TEST ABNORMAL" "10024690" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (MODERNA))" "1201" "1312456-1" "1312456-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021" "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "LOSS OF CONSCIOUSNESS" "10024855" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "LUMBAR PUNCTURE" "10024999" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "LUNG INFILTRATION" "10025102" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "LUNG INFILTRATION" "10025102" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "MAGNETIC RESONANCE IMAGING" "10078223" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "MAGNETIC RESONANCE IMAGING HEAD ABNORMAL" "10085256" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "MALAISE" "10025482" "COVID19 (COVID19 (JANSSEN))" "1203" "1104671-1" "1104671-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "MALAISE" "10025482" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "MALAISE" "10025482" "COVID19 (COVID19 (JANSSEN))" "1203" "1223714-1" "1223714-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed." "MALAISE" "10025482" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "MALAISE" "10025482" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "MATERNAL DEATH DURING CHILDBIRTH" "10066376" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "MEDICAL INDUCTION OF COMA" "10070677" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "MEMORY IMPAIRMENT" "10027175" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "MENTAL STATUS CHANGES" "10048294" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "MENTAL STATUS CHANGES" "10048294" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "METABOLIC FUNCTION TEST" "10062191" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "MIGRAINE" "10027599" "COVID19 (COVID19 (JANSSEN))" "1203" "1223714-1" "1223714-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed." "MIGRAINE" "10027599" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "MIGRAINE" "10027599" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1026362-1" "1026362-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th." "MOUTH ULCERATION" "10028034" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "MUSCULOSKELETAL DISCOMFORT" "10053156" "COVID19 (COVID19 (MODERNA))" "1201" "1317203-1" "1317203-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021." "MYOCARDIAL INFARCTION" "10028596" "COVID19 (COVID19 (MODERNA))" "1201" "1244990-1" "1244990-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21" "MYOCARDIAL INFARCTION" "10028596" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "NASOPHARYNGITIS" "10028810" "COVID19 (COVID19 (MODERNA))" "1201" "1317203-1" "1317203-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021." "NAUSEA" "10028813" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "NAUSEA" "10028813" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "NAUSEA" "10028813" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "NAUSEA" "10028813" "COVID19 (COVID19 (MODERNA))" "1201" "1293909-1" "1293909-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose." "NAUSEA" "10028813" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "NAUSEA" "10028813" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "NERVOUSNESS" "10029216" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "NEUROLOGICAL SYMPTOM" "10060860" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "OVERDOSE" "10033295" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "OXYGEN SATURATION DECREASED" "10033318" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "PAIN" "10033371" "COVID19 (COVID19 (JANSSEN))" "1203" "1247816-1" "1247816-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "PAIN" "10033371" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "PAIN" "10033371" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "PAIN" "10033371" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "PAIN IN EXTREMITY" "10033425" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "PAIN IN EXTREMITY" "10033425" "COVID19 (COVID19 (MODERNA))" "1201" "1176010-1" "1176010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding." "PAIN IN EXTREMITY" "10033425" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "PAIN IN EXTREMITY" "10033425" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "PAIN IN EXTREMITY" "10033425" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1293657-1" "1293657-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout." "PANCYTOPENIA" "10033661" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "PARASYSTOLE" "10033929" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "PATHOLOGY TEST" "10068056" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1372096-1" "1372096-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Patient died abruptly 2-3 hours after receiving shot." "PERIPHERAL COLDNESS" "10034568" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "PERIPHERAL EMBOLISM" "10061340" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "PERIPHERAL SWELLING" "10048959" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "PETECHIAE" "10034754" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "PLATELET COUNT DECREASED" "10035528" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "PLEURAL EFFUSION" "10035598" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "PNEUMONIA" "10035664" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre- existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "PNEUMONIA" "10035664" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "PNEUMONIA BACTERIAL" "10060946" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "POSTICTAL STATE" "10048727" "COVID19 (COVID19 (JANSSEN))" "1203" "1216091-1" "1216091-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "PROTHROMBIN TIME PROLONGED" "10037063" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (JANSSEN))" "1203" "1237092-1" "1237092-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Massive pulmonary thromboemboli" "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1357369-1" "1357369-1" "May, 2021" "2021/05" "Mar., 2021" "2021/03" "Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson- white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn't caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death. He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient's death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that's what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don't have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism" "PULMONARY EMBOLISM" "10037377" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1378118-1" "1378118-1" "Jun., 2021" "2021/06" "Jun., 2021" "2021/06" "Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli." "PULMONARY IMAGING PROCEDURE ABNORMAL" "10082582" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1378118-1" "1378118-1" "Jun., 2021" "2021/06" "Jun., 2021" "2021/06" "Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli." "PULSE ABSENT" "10037469" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "PULSE ABSENT" "10037469" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "PULSE ABSENT" "10037469" "COVID19 (COVID19 (MODERNA))" "1201" "1289723-1" "1289723-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally." "PULSELESS ELECTRICAL ACTIVITY" "10058151" "COVID19 (COVID19 (MODERNA))" "1201" "1242520-1" "1242520-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour." "PUPIL FIXED" "10037515" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre- existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1264618-1" "1264618-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "103 fever 2 days after the vaccine. Then became afebrile. Then found deceased on 4-26- 2021" "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "PYREXIA" "10037660" "COVID19 (COVID19 (MODERNA))" "1201" "1365485-1" "1365485-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" "On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms." "PYREXIA" "10037660" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1124794-1" "1124794-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Extreme head ache, chest pain, fever 101 F. Gave 1000 mg Tylenol, albuterol via nebulizer Q4hr. Died 3/20/2021 approx 11:00 am from Cardiac Arrest." "RASH" "10037844" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1297262-1" "1297262-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21." "RECTAL HAEMORRHAGE" "10038063" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "RED BLOOD CELL COUNT DECREASED" "10038153" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "RENAL DISORDER" "10038428" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "RENAL IMPAIRMENT" "10062237" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "RENAL INFARCT" "10038470" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "RESPIRATION ABNORMAL" "10038647" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "RESPIRATORY ARREST" "10038669" "COVID19 (COVID19 (JANSSEN))" "1203" "1104671-1" "1104671-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "RESPIRATORY ARREST" "10038669" "COVID19 (COVID19 (MODERNA))" "1201" "1247401-1" "1247401-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic. Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm." "RESPIRATORY ARREST" "10038669" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "RESPIRATORY ARREST" "10038669" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "RESPIRATORY DISORDER" "10038683" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "RESPIRATORY FAILURE" "10038695" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "RESTLESSNESS" "10038743" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "RESUSCITATION" "10038749" "COVID19 (COVID19 (JANSSEN))" "1203" "1216091-1" "1216091-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1201114-1" "1201114-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1243650-1" "1243650-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts" "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1289723-1" "1289723-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally." "RESUSCITATION" "10038749" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "RESUSCITATION" "10038749" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "RESUSCITATION" "10038749" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1177548-1" "1177548-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired." "RESUSCITATION" "10038749" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1223650-1" "1223650-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "In the evening on March 15th, she began having shortness of breath and chest pain. She asked her boyfriend for her blood pressure cuff so she could take her blood pressure. As he was getting it she told him to call 911 and then her eyes rolled back in her head and she stopped breathing. Paramedics attempted to revive her but were unsuccessful. She was taken to the hospital and pronounced dead. Cause of death listed as heart disease." "RESUSCITATION" "10038749" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "RESUSCITATION" "10038749" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "SARS-COV-2 TEST" "10084354" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1332849-1" "1332849-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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)" "SARS-COV-2 TEST NEGATIVE" "10084273" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "SARS-COV-2 TEST NEGATIVE" "10084273" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "SARS-COV-2 TEST NEGATIVE" "10084273" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "SARS-COV-2 TEST NEGATIVE" "10084273" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "SARS-COV-2 TEST NEGATIVE" "10084273" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "SARS-COV-2 TEST POSITIVE" "10084271" "COVID19 (COVID19 (MODERNA))" "1201" "1313922-1" "1313922-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "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" "SARS-COV-2 TEST POSITIVE" "10084271" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "SARS-COV-2 TEST POSITIVE" "10084271" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1212820-1" "1212820-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death 3 days after vaccination" "SCAN BRAIN" "10061500" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1296030-1" "1296030-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021." "SEIZURE" "10039906" "COVID19 (COVID19 (JANSSEN))" "1203" "1104671-1" "1104671-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital." "SEIZURE" "10039906" "COVID19 (COVID19 (JANSSEN))" "1203" "1154639-1" "1154639-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Patient began having seizures about four hours post vaccine while at a friends house and passed away" "SEIZURE" "10039906" "COVID19 (COVID19 (JANSSEN))" "1203" "1216091-1" "1216091-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room." "SEIZURE" "10039906" "COVID19 (COVID19 (MODERNA))" "1201" "1054160-1" "1054160-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021." "SEIZURE" "10039906" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "SEIZURE LIKE PHENOMENA" "10071048" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "SEPSIS" "10040047" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "SEPTIC SHOCK" "10040070" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "SHOCK" "10040560" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "SHOCK" "10040560" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "SICKLE CELL ANAEMIA WITH CRISIS" "10040642" "COVID19 (COVID19 (JANSSEN))" "1203" "1247816-1" "1247816-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died." "SKIN REACTION" "10040914" "COVID19 (COVID19 (MODERNA))" "1201" "1322484-1" "1322484-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere." "SPLENIC INFARCTION" "10041648" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "SPLENOMEGALY" "10041660" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "SUBSTANCE USE DISORDER" "10079384" "COVID19 (COVID19 (MODERNA))" "1201" "1228010-1" "1228010-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Death Narrative: Patient was not previously Covid positive and 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 died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol." "SUDDEN DEATH" "10042434" "COVID19 (COVID19 (JANSSEN))" "1203" "1243648-1" "1243648-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "headache on 4/8/21, sudden death 4/11/2021" "SUDDEN DEATH" "10042434" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085783-1" "1085783-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "Sudden Unexpected Death - No signs or symptoms" "SUDDEN DEATH" "10042434" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1228351-1" "1228351-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "He died unexpectedly early in the morning. He woke up suddenly, said he needed help, and then was gone." "SUDDEN DEATH" "10042434" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1372096-1" "1372096-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "Patient died abruptly 2-3 hours after receiving shot." "SYNCOPE" "10042772" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1085413-1" "1085413-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead." "SYNCOPE" "10042772" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1290128-1" "1290128-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation." "SYNCOPE" "10042772" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1322310-1" "1322310-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report." "SYNCOPE" "10042772" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1364631-1" "1364631-1" "Jun., 2021" "2021/06" "May, 2021" "2021/05" ""This is reported by his mother. Around 10:00 AM he got his vaccine. Mother met him at 12:30 and went to lunch, said he felt OK. She stayed with him a couple of hours, went home and apparently he went to sleep. The next day he texted his mother and said that he felt yucky. She told him to give it a couple of days, and he went to work all week, but said that after he ate he felt ""funny"". Then on Sunday, Mother's day on 5/9/21 and they face timed and was supposed to meet him at 5:30. At 12:45 he had finished eating, ate some enchilladas and said that he felt weird. He said that he was going to be ok to meet him at 5:30. At 4:37 PM she texted him to say that she was on her way to meet him. She got at the meeting place at 5:30 and he was usually there before her, this is a normal weekend ritual to exchange his dog. She waited 9 minutes and she tried to facetime him thinking he was in traffic, and he didn't answer. She thought he was just not answering. She then waited 9 more minutes and then called his phone and local Hospital answered the phone and asked who she was, and she answered the questions, and she told her to get to the hospital. She went to the hospital and the doctor came in and told her that he had the car running and he went to the gas pump to get gas and he stepped out of the car and collapsed. The person who saw him told the attended that he had collapsed and they called 9-1-1 and he was pronounced dead. He worked in a warehouse and was doing well and about to be certified to be a forklift driving. They said that they worked on him and that they could not get his heart started again. They had to do an autopsy which is against her religion and she will not find out those results for 3-6 months. She said that he was healthy and looking forward to get tested at work. They told her that he had an enlarged heart and an enlarged spleen, and had never had any heart issues in the past. He walked 20,000 steps a day in the warehouse. He was living in a sober man's facility, he has been clean for 18 months. He had an addiction to pain pills and Xanax. She feels that there was something in the vaccine that had something to do with it as he was perfectly healthy before the vaccine."" "THROMBOPHLEBITIS SUPERFICIAL" "10043595" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "TOXICOLOGIC TEST" "10061384" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1322310-1" "1322310-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Death. Coroner said collapsed of unknown cause. Autopsy performed. Awaiting final report and toxicology report." "TRANSFUSION" "10066152" "COVID19 (COVID19 (MODERNA))" "1201" "1257204-1" "1257204-1" "Apr., 2021" "2021/04" "Mar., 2021" "2021/03" "Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021." "TROPONIN INCREASED" "10058267" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "TROPONIN INCREASED" "10058267" "COVID19 (COVID19 (MODERNA))" "1201" "1186348-1" "1186348-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21" "TROPONIN INCREASED" "10058267" "COVID19 (COVID19 (MODERNA))" "1201" "1347160-1" "1347160-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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." "ULTRASOUND SCAN ABNORMAL" "10061606" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (JANSSEN))" "1203" "1220723-1" "1220723-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (MODERNA))" "1201" "1232541-1" "1232541-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient found unresponsive at approximately 12:00 am 10/11. EMS called and patient was pronounced dead at scene." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (MODERNA))" "1201" "1243650-1" "1243650-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts" "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1104175-1" "1104175-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1177548-1" "1177548-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1293657-1" "1293657-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "34 y/o male with no PMHx presenting in cardiac arrest from home. Per pt's wife, he received 2nd dose of the Pfizer vaccine roughly 24 hours prior. He complained of arm soreness yesterday afternoon and some chills this morning, took Tylenol for these symptoms. She found him unresponsive in bed after speaking to him roughly 2 hours earlier. Per EMS, patient was in asystole upon their arrival. He received ~ 30 minutes of prehospital ACLS and an additional 20 minutes in the ED and remained in asystole throughout." "UNRESPONSIVE TO STIMULI" "10045555" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1337198-1" "1337198-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day." "URINARY RETENTION" "10046555" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "URINARY TRACT INFECTION" "10046571" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "URINE ANALYSIS" "10046614" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1101884-1" "1101884-1" "Mar., 2021" "2021/03" "Mar., 2021" "2021/03" "History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care." "URINE ANALYSIS NORMAL" "10061578" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "VACCINATION FAILURE" "10046862" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1332849-1" "1332849-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "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)" "VENOUS OCCLUSION" "10058990" "COVID19 (COVID19 (JANSSEN))" "1203" "1201543-1" "1201543-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Death" "VENTRICULAR TACHYCARDIA" "10047302" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1246604-1" "1246604-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" ""Patient presented to ED on 04/18/2021 with cardiopulmonary arrest, per ED ""He was receiving CPR with EMS for arrival to the emergency. Two rounds epi. Asystole and then went into V-tach. Got shocked once. Then after that has been strip PA asystole."" ED called time of death on patient 04/18/2021 at 05:14AM."" "VENTRICULO-PERITONEAL SHUNT" "10047304" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "VIRAL TEST NEGATIVE" "10062362" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "VISION BLURRED" "10047513" "COVID19 (COVID19 (MODERNA))" "1201" "1281531-1" "1281531-1" "May, 2021" "2021/05" "Apr., 2021" "2021/04" "Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism" "VISUAL IMPAIRMENT" "10047571" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "VOMITING" "10047700" "COVID19 (COVID19 (MODERNA))" "1201" "1037207-1" "1037207-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl." "VOMITING" "10047700" "COVID19 (COVID19 (MODERNA))" "1201" "1246534-1" "1246534-1" "Apr., 2021" "2021/04" "Apr., 2021" "2021/04" "Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am." "VOMITING" "10047700" "COVID19 (COVID19 (MODERNA))" "1201" "1338625-1" "1338625-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her." "VOMITING" "10047700" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "VOMITING" "10047700" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200" "1337439-1" "1337439-1" "May, 2021" "2021/05" "May, 2021" "2021/05" "ACCORDING TO DAD, HE GOT THE VACCINE ON 4/28/21. ON MAY 11 HE WAS COMPLAINING OF N/V, LATER HEADACHE AND ALTERED VISION, ENCEPHALOPATHY, CARDIAC ARREST AND DEATH.... AFTER MULTIPLE LOCAL ER VISITS. HE NEVER HAD FEVER. I WAS CALLED ON HIS CASE DUE TO CONCERN FOR CNS INFECTION. HE WAS ADMITTED ON 5/18 AND DIED ON 5/20 THIS MAY OR MAY NOT BE RELATED TO THE COVID VACCINE, BUT IT IS IMPORTANT IT IS REPORTED JUST INCASE IT IS AND MAY HELP SOMEONE." "WHITE BLOOD CELL COUNT DECREASED" "10047942" "COVID19 (COVID19 (PFIZER- BIONTECH))" "1200" "1046447-1" "1046447-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM" "WHITE BLOOD CELL COUNT INCREASED" "10047943" "COVID19 (COVID19 (MODERNA))" "1201" "1040170-1" "1040170-1" "Feb., 2021" "2021/02" "Feb., 2021" "2021/02" "Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation." "WHITE BLOOD CELL COUNT INCREASED" "10047943" "COVID19 (COVID19 (MODERNA))" "1201" "1198211-1" "1198211-1" "Apr., 2021" "2021/04" "Feb., 2021" "2021/02" "The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination." "WITHDRAWAL OF LIFE SUPPORT" "10067595" "COVID19 (COVID19 (MODERNA))" "1201" "1368271-1" "1368271-1" "Jun., 2021" "2021/06" "Apr., 2021" "2021/04" "On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months." "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Age: 30-39 years" "Date of Onset: 2021" "Date Report Completed: 2021" "Date Report Received: 2021" "Date Vaccinated: 2021" "Event Category: Death" "Recovered: No" "Serious: Yes" "State / Territory: The United States/Territories/Unknown" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: Symptoms; Vaccine; VAERS ID; Month Reported; Month Died" "Show Totals: False" "Show Zero Values: Disabled" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Jun 19, 2021 11:49:27 AM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Jun 19, 2021 11:49:27 AM" "---" Messages: "1. The full results are too long to be displayed, only non-zero rows are available." "2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "3. These results are for 77 total events." "4. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "5. Click on a VAERS ID to see a report containing detailed information for the event." "---" Footnotes: "1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse" "event (possible side effect)." "---" Caveats: "1. <p> VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine" "manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports" "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain" "information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they" "are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports" "should always be interpreted with these limitations in mind. </p> <p> The strengths of VAERS are that it is national in scope" "and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to" "post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events," "also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as" "the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have" "the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine." "</p> <p> Key considerations and limitations of VAERS data: <ul><li> Vaccine providers are encouraged to report any clinically" "significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause. </li><li>" "Reports may include incomplete, inaccurate, coincidental and unverified information. </li><li> The number of reports alone" "cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated" "with vaccines. </li><li> VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date" "for which data are available. </li><li> VAERS data do not represent all known safety information for a vaccine and should be" "interpreted in the context of other scientific information. </li></ul> </p>" "2." "3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "4. Data contains VAERS reports processed as of 06/11/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or" "reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting." "5. Under Title 21, Code of Federal Regulations Section 600.80: http://wonder.cdc.gov/wonder/help/vaers/21CFR600-80.htm., a" "serious event is defined with any of the following outcomes: Death, a life- threatening adverse experience, inpatient" "hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital" "anomaly/birth defect." "6. Values of Event Category field vary in their availability over time due to changes in the reporting form. The ""Emergency" "Room/Office Visit"" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The" """Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit"" values are available only for events reported" "using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for" "these categories." "7. For more information on how many persons have been vaccinated in the US for COVID19 to date, see" "https://covid.cdc.gov/covid-data-tracker/#vaccinations/"