Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
patient has a severe allergy to an excipient in the Pfizer vaccine.; This is a spontaneous report received from a Pharmacist. Other Case identifier(s): MOD-2025-790297 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC REACTION TO EXCIPIENT (hospitalization), outcome "recovered", described as "patient has a severe allergy to an excipient in the Pfizer vaccine.". Clinical course: HCP seeks vaccine location for a patient. She also stated that the patient has a severe allergy to an excipient in the Pfizer vaccine. Unknown if the patient experienced any additional symptoms/events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event allergic reaction to excipient and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. 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.