Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
Delivered a stillborn baby at 37 weeks; This is a spontaneous report received from a Nurse. A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing). The patient was 37 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: STILLBIRTH (medically significant) with onset Mar2025, outcome "unknown", described as "Delivered a stillborn baby at 37 weeks". The pregnancy resulted in still birth. This was the patient's second pregnancy. The reporter stated that a friend of hers received the RSV vaccine and delivered a stillborn baby about a month ago. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event stillbirth and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V 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.,Linked Report(s) : US-PFIZER INC-202500078577 mother/ baby case;
Medical History/Concurrent Conditions: Pregnancy