Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
got an anaphylactic reaction to this initial MRNA vaccine; This is a spontaneous report received from a Physician. Other Case identifier(s): NOV25-00837 (NOVAVAX). An adult patient received BNT162b2 (BNT162B2), as dose 1, 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", described as "got an anaphylactic reaction to this initial MRNA vaccine". Clinical course: It was reported that when the Pfizer vaccine first came out for Covid-19 and it received emergency authorization, the patient received two doses. The patient got an anaphylactic reaction to this initial MRNA vaccine. After the first dose, the reaction was somewhat mild. With the second dose, the reaction was quite stronger. The patient was told by Pfizer and the CDC that patient should not have another MRNA based vaccination. The patient had never had a reaction to any other vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile. ,Linked Report(s) : US-PFIZER INC-202500192354 same reporter/patient/AE, different doses;