Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
sustained hypertension; This is a spontaneous report received from a Pharmacist. A 29-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Sep2025 as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. 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: HYPERTENSION (non-serious) with onset Sep2025, 18 hrs after the suspect product(s) administration, outcome "recovered" (Sep2025), described as "sustained hypertension". The event "sustained hypertension" required physician office visit. Therapeutic measures were taken as a result of hypertension. Additional information:Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: Unknown,Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: Unknown,Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Unknown,Reported Event: Patient reported side effect occurring approximately 18-24 hours after receiving the Abrysvo vaccination (Maternal indication). Side effect included sustained hypertension, resulting in a clinic visit and physician consultation. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.