Report #2845218

Overview

Sex

Unknown

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

serious adverse effects; sick afterwards, like a fever and body aches; sick afterwards, like a fever and body aches; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant), outcome "unknown", described as "serious adverse effects"; PYREXIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sick afterwards, like a fever and body aches". The patient reported she would usually take them on the weekend because she knew she was going to be sick afterwards, like a fever and body aches, etc. Company Comment: The causality of the event Immunisation reaction, Pain and Pyrexia was assessed conservatively as related, due to the unknown temporal association and limited information provided. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event immunization reaction based on the known safety profile and temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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.