Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
Arm swelled up quite a bit; Arm was red; arm was painful; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 36 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 36 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "Arm swelled up quite a bit"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovering", described as "Arm was red"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "arm was painful". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain. Additional information: Patient in 36th week of pregnancy received 1 shot Abrysvo. Arm swelled up quite a bit, was red and painful for over a week. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.