COMIRNATY® - Pfizer-BioNTech vaccine

What adverse reactions are associated with Pfizer/BioNTech’s Comirnaty vaccine?

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17/4/2021

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Pfizer/BioNTech’s Comirnaty vaccine safety assessment was performed during a phase 3 study with more than 44,000 participants (16 years of age or older), of which more than 21,700 received a vaccine (the others received a placebo) and more than 19,000 were followed up during 2 months after receiving the 2nd dose.

The most frequent adverse reactions were: pain at the site of injection (>80%), fatigue or a feeling of tiredness (>60%), headache (>50%), myalgias and cold cramps (>30%), arthralgias (>20%), fever, and inflammation at the site of injection (>10%); being mostly of mild or moderate intensity and disappearing in a few days after vaccination.

These reactions were more frequent after the second dose and this decreased with age.

Symptomatic treatment can be used, with analgesics and/or antipyretics (such as paracetamol) to treat these effects, although prophylactic use before vaccination is not currently recommended.

Most common adverse reactions

  • Are mild or moderate
  • Disappear within a few days
  • Are more frequent after second dose

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