Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | OT |
4mm bump which has not gone down, is red; This is a spontaneous report received from a Consumer or other non HCP. A 39-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for maternal immunisation. The patient's relevant medical history was not reported. The patient was 3 trimester pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 3 trimester pregnant at the event onset. There were no concomitant medications. The following information was reported: RASH PAPULAR (non-serious) with onset Oct2025, outcome "not recovered", described as "4mm bump which has not gone down, is red". Additional information: the patient was given Abrysvo 5 days ago (Oct2025) and thinks has a 4mm bump which has not gone down, is red, not itching. Start date: reporter said has been there for 5 days. Patient is 34.5 weeks gestation. Patient is on nothing else and has never had a reaction to a vaccine before. The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received.