Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
rash in injection site area; This is a spontaneous report received from a Physician from medical information team. A patient (age and gender not provided) 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash in injection site area". Additional information: The reporter questioned if Abrysvo had shown to cause a rash in injection site area during studies. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.