Pfizer COMIRNATY® (COVID‑19 Vaccine, mRNA) lab rat information

A. 

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals, USA National Library of Medicine, version of December 2021. (Found on December 15, 2021)

B.1

The Main COMIRNATY Clinical Trial Was One of the Largest Vaccine Trials Conducted by Pfizer.

The multicenter, randomized, placebo-controlled trial evaluated the efficacy and safety of COMIRNATY in a diverse population of ~46,000 people 12 years of age and older.
The age, gender, race, and ethnicity of people in the placebo and vaccine groups of the efficacy analyses were similar, as were the characteristics between people in the safety populations.
Source: 
COMIRNATY side effects, October 2024
COMIRNATY clinical trial, October 2024

6.2 Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of COMIRNATY, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 

Cardiac Disorders: myocarditis, pericarditis

Gastrointestinal Disorders: diarrhea, vomiting

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

Nervous System Disorders: syncope, dizziness
Source: https://labeling.pfizer.com/ShowLabeling.aspx?id=16351&format=pdf, October 2024

B.2 

"These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied."

Source: FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA) WHICH HAS EMERGENCY USE AUTHORIZATION (EUA) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE, 22 August 2024

B.3

"Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to FDA Philippines via online reporting through the FDA Philippines website at https://www.fda.gov.ph/pharmacovigilance/ and include batch/lot number if available. By reporting side effects, you can help provide more information on the safety of this medicine."

Source: Pfizer-BioNTech/Comirnaty 30 micrograms/dose package leaflet, Philippines EUA Product information, 16 March 2023

B.4

No columns of side effects.

COMIRNATY® (Tozinameran), COVID-19 mRNA vaccine (nucleoside modified) – Pfizer-BioNTech COVID-19 vaccine, June 03, 2022

It is one of those ongoing social experiments. 

Be alert. Be healthy. 

Take real protective actions. 

We are blessed. 

Strengthen me.