Please donot epot the se side-effect) to both systems as all reports wil be share between Pier snd MHRA (in an anonymized fom) and dl epvtng wil race unecessary dopicts, By reporting side effects, you ean hep provide more information onthe safety ofthis vaceine, S. How tostore COVID-I9 mRNA Vaceine BNTI6202 Dorot we this medicine after the expiry date which i stated on the box and labo after EXP. ‘The expiry date refers to the last day of that mouth, Store in freezer at 80°C 0 60°C. ‘Store in the original package inorder o protect from lg ‘After thawing, the vaccine shouldbe diluted and administered by a healthcare profesional and used within 6 hours, However, in-use stability dat have demonstrated that once removed from freezer, the undiluted vaccine can he stored for upto I month (31 days) at 2°C to8°C. ‘Any unused vaccine should be discarded, 6 Contents ofthe pack and other information What COVID-I9 mRNA Vacsine BNT16202 contains ‘+ Theaetive substances BNT16262 RNA. After dition the viel contains 6 doses, of 0:3 ml with 30 micrograms miRNA exch, ‘his vaccine conn plyetylene lycoUinacrogl (PEG) as pa of ALC-0L59 +The other ingretons are = ALCORS = (ydroxybtyaznediDbis(hexane6,1-ibis(-hexyeanon), eteadecyacstaie, = ALC-0159=24(plyethylene gly) 200) + 12Distesoylsnepyeoro}-phosphocholne, © choleteo, = potassium chord, = potassium eitydogen phosphate, = Siam slo, = sca hydrogen phosphate dinate, + wate fo injections What COVED-19 mRNA Vaccine BNTI62?2 loks like and contents of the pack ‘The vaccine i white o off-white elton provided in a multidose vial of 6 doses in a2 mL. cea vi (pe li), with rubber topper anda lipo plastic cap wit aluminium seal Pack siz: 195 vials Manufacturers) DBioW Tech Manicuring Grblt ‘Kupfrbergterasse 17-19 {5116 Make, enany ‘This eat was las revise fn 62021 BIONTECH Pfizer ‘aclage leaflet: Information for the recipient ‘mRNA Vaccine BNTIO202 concentrate fr soution for nection “This medicinal prodvct has bee given authorisation Tor temporary supply by the UR Departnent of Health and Social Care andthe Medicines de Healthcare products Regulatory “Agency. It does net have a marketing authorisation, but dis temporary authorisation grants permission for the medicine to e used for ative immunisation to prevent COVID-19 disease ‘used by SARS-CoV-2 virus in individuals aged 12 years of age and over. Read allo this leat crefully before you recsve tis vaccine because contains importa information for 30 ‘+ Rep this elt. You may need tread it gin, ‘Ifyou haveany father qvostions, sk yout deter, pharmacist ce mse + Ttyou got any side effets talk to your doco, pharmacist or nurse. This inches any posible ‘doefleets no ited inthis leat Se setion 4, ‘What fn this teat ‘What COVID-19 mRNA Vaceine BNT16242 is an what itis sed for ‘What you nedto know before youresive COVID-19 mRNA Vai How COVID-19 mRNA Vaccine BNT16202 5 given, Possible side effec How to store COVID-I9 mRNA Vaccine BNTG262 Cones ofthe pack and other information BNTIEIZ 1. What COVID.19 mRNA Vaccine BNTI62b2 is and what itis used for (COVID-19 miRNA Vaccine BNT16262 ie vain woud for ative immsnstion to prevent COVID- 19 disease cansed by SARS-CoV2 vis, (COVID-19 mRNA Vaccine BNT162H? i given to adults and adolescents om 12 yeas. ‘The vaccine gars the body tral production of etbodis and stimulates immune calls -roec against COVID-19 isase. 2 What you need fo know before you receive COVED-19 mRNA Vaccine BNTIG262 ‘COVED-19 mRNA Vaccine BNTI6242 should not be given ‘+ iyou ae alla to the active substance or any ofthe oer ingredients ofthis meine (listed insection 6) Sins ofa allergic eaeton may include icy skin rash, shortness of breath and sweling ofthe face or tongue, Contact your doctor or healthcare professional immediatly or go tothe nates hospital emergency room right away if you have a allergic ection Ivean be -reteing‘Warnings nd precautions Talk to your doto, aac or muse before you te given the vaccine if you have 1+ ever several action or beshing problems afr an other vaccine inieton or ‘teryou wer given COVID-19 MA Vadoe BNT 1620 eps ‘+ ascvereillnes wth igh fever However, ami fever or upper scway infection ik aco, re ot easons to delay + atveakened insane tem ih ax dt LV infection or aon medicine hat atts Your imme system ‘+ Ablsding problen, bras easily or use a medicine to inhibit ood cloting ‘As with ny vactne, COVID-19 mRNA Vaccine BNTI6202 may not filly protect ll thse wis ‘ceive it. No data ae curently avallable in invidals with a weakened immune sytem or wh ae ‘aking chron testeen tat uppresss or prevents immune responses, Chtaven CCOVID-19 mRNA Vacine BNT162b2 isnot recommended for children under 12 years Other medicines and COVED-19 mRNA Vaccine BNTIG22 ‘Tell your doetor or pharmacist ifyou are using, have recently used or might we ay ote dines ‘oc have recenly received any other vacsne, Pregnancy and breast-feeding ‘you are pregnant or breast-feeding, think you maybe pregnant or are planing to hive a baby, ask _yur doctor or pharmacist for advice before you recive this vce. Driving and using machines ‘COVID-19 mRNA Vaccine BNT16262 has no or negligible influence a the ability to dive and se ‘machines. However, same ofthe effets mentioned unde section 4 Possible sid effets may temporary fee the ably co eve or use machines. Do ot hive or operate machinery tl you are sue that you a not affected. COVED-19 mRNA Vaccine BNTI62b2 contalns sodium and pots ‘his vacine contin potassium, Less than I mmol (39 mg) per dose. essentially “potassium ee “This vaccine contains estan Immo soa (23mg) pe ose, that ist say essentially ead fie. How COVID-19 mRNA Vaccine BNT6242 i given COVID-19 miRNA Vaccine BNTI6202 i given er dion as an injection of 0 mito x muscle of your upper ann You will receive injections, given teat 2 days apart. youreceive one dose of COVID-19 mRNA Vaccine BNT16242, you sould receive a second dose ofthe sme vaccine a es 21 days Inter to cmplete te vaccination series Profeton ognst, ‘COVID-I9 disease may not be maximally elective ui at east days ater he second ose {you ave any further questions onthe use of COVID-19 miRNA Vacine BNT16202, ask your doctor, pact prmse. 4. Possible side effects Like ll vaccines, COVID-19 mRNA Vaceine BNTI62b2can case side eet, although not everybody ge hem, ‘Most sid effets ae mild o maderate and go away within a fe days of appearing, I side fete suchas pain an fever ae woul, they con be tated by mci for pn ad Fever eck pret Side effets may occur with following frequencies: Very common: ny tft more tan lin 10 people + ajc sit: pis, sweling + firedess + headache isle pin + ctl joint pain siaboos fever Common: ray afet wp 01 in 10 people + relnesatinjotion site + vomiting ‘Uncommon: may tect upto 1a 10 people + calaged ph nodes + feling uel + arnpain + injoction st tehing + allergic eacton sch sash o itching Rareslde eects may acct pt 1 in 1,000 people 4+ temporty one sided facial drooping ‘allergic eactions such as hives or swelling ofthe ice [Not known (cannot bo estimated rom the svi dt) + severllergi rection ‘Same people hive reece sudden felng of old with shiveringthaking sccompasid by arise in ‘expertise possibly wih sweating, headache including migrane-lke hendaches), nase, muscle aches and fling unwell, tacing widhin dy of having the Yasin and ually ating fr day or Ifyou fevers igh and lasts lange than thee days, or you have aor pritent symptoms might not be de to side effects ofthe vacine and you shoud sesk appropriate medial advice accoutig 0 your symptoms, Reporting of side effects Ifyou get any side effet, alto your deter, pharmacist or mie, This includes any possible side fet nt ised in this leaflet, you ste cooemed about a side-effect it ean be repre diet via the Coronavirus Yellow Card reporting st tps:/coronvis Md or seach for MHRA Yellow Cain the ‘Google Ply a Apple App Stor. When completing repo pens include the vaccine brand and ‘bate/Lot number eval ‘Altenatively, sie-ffecs of cancer in sociation with Pier BioNTech COVID-19 mRNA vacsine [BNT16052 canbe reported to Pfizer Medical nfation on 01308 616161 or vin won pizeafesreporting