Clinical Trials – Vaccine Safety
Page last updated 08 December 2022
Key Points
Key Points are meant to be a scientific, factual summary of the available information that relates solely to the Pfizer-BioNTech COVID-19 Vaccine, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.
Pfizer-BioNTech Vaccine-related Safety | Key Points | References | ||||||||||||
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Most Common Adverse Drug Reactions (ADRs) |
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(1) Walter; (2) Frenck; (3) Polack; (4) Thomas NEJM 2021; (5) Moreira; (6) Thomas Vaccine 2022 | ||||||||||||
ADRs identified during Post-marketing surveillance7-12 |
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(7) EUA Fact Sheet For Vaccination Providers (≥12 Years), BIVALENT (Original and Omicron BA .4/BA .5 ),DO NOT DILUTE, Gray Cap (8) EUA Fact Sheet For Vaccination Providers (5-11 years), BIVALENT (Original and Omicron BA .4/BA .5) , DILUTE BEFORE USE, Orange Cap (9) Full prescribing information (≥12 years) , DO NOT DILUTE BEFORE USE, Gray Cap (10) EUA Fact Sheet for Vaccination providers (≥12 years), DO NOT DILUTE, Gray Cap. (11) EUA Fact Sheet For Vaccination Providers (5-11 years), DILUTE BEFORE USE, Orange Cap (12) EUA Fact Sheet for Vaccination Providers (6 months- 4 years), DILUTE BEFORE USE, Maroon Cap | ||||||||||||
General considerations |
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(1) Walter; (2) Frenck; (3) Polack; (4) Thomas NEJM 2021; (5) Moreira; (6) Thomas Vaccine 2022 |
*Please refer to the Vaccine-related Myo/pericarditis Key Point Summary