Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
Guillian Barre; This is a spontaneous report received from a Physician from a sales representative. An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "Guillian Barre". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 2 day(s)). The event "guillian barre" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: Patient received Abrysvo and experience Guillian-Barre. She went to ER two days after injection and was admitted to hospital for 2 days, was given IVIg infusion. She is recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile, and plausible temporal association the event Guillain-Barre syndrome is assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V. 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.