Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
The patient had a febrile seizure after getting 3 vaccines at one time.; This is a spontaneous report received from a Physician from a sales representative. An elderly male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: Previous history of stroke. The patient's concomitant medications were not reported. The following information was reported: FEBRILE CONVULSION (hospitalization), outcome "recovered", described as "The patient had a febrile seizure after getting 3 vaccines at one time.". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), rsv vaccine prot.subunit pref 2v, BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 and ABRYSVO in triggering the onset of febrile seizure cannot be fully excluded, considering the plausible temporal relationship. Previous history of stroke and elderly age are major confounders. 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.
Medical History/Concurrent Conditions: Stroke (Previous history of stroke)