Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
had still born baby, same day as vaccination; The patient was 36 weeks and few days pregnant; The patient was 36 weeks and few days pregnant; This is a spontaneous report received from an Other HCP. A 21-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2024 as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2024, outcome "unknown" and all described as "The patient was 36 weeks and few days pregnant"; STILLBIRTH (medically significant) with onset 2024, outcome "unknown", described as "had still born baby, same day as vaccination". The pregnancy resulted in still birth. Clinical course: The only patient information provided was that, patient was years old and this happened last year. The patient was 36 weeks and few days pregnant, when she got vaccinated and same day, had stillborn baby.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of the reported event STILLBIRTH cannot be excluded. 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