Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
anaphylactic reaction; This is a spontaneous report received from a Pharmacist from medical information team. An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown". Clinical course: Pharmacist states that her patient previously experienced an anaphylactic reaction to the 2021 COVID vaccine. She states that the patient is recommended to get vaccinated again and she wants to know if there is any overlap with the ingredients of the 2021 formulation and current 2024-2025 Comirnaty PFS formulation. Caller is requesting information on the active and inactive ingredients. Caller did not specify any ingredient as they are unsure which component of the vaccine the patient is allergic to.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile.