Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
respiratory failure; neurological distress; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient 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: RESPIRATORY FAILURE (hospitalization, medically significant), 30 days after the suspect product(s) administration, outcome "unknown"; NERVOUS SYSTEM DISORDER (hospitalization), 30 days after the suspect product(s) administration, outcome "unknown", described as "neurological distress". No prior symptoms or diagnosis before the vaccine. Patient has been in the hospital/long term care (LTC) for over 100 days. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.