Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
may have developed GBS; This is a spontaneous report received from a Pharmacist from a sales representative. An adult (18-64 years) 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 and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "may have developed GBS". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome. It was reported by a pharmacist that she knew someone who was pregnant that received Abrysvo and may have developed GBS. 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 Guillain-Barre syndrome 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.