Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
syncopized; This is a spontaneous report received from a Physician. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 09Dec2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history was not reported. The patient was 33 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 34 weeks pregnant at the event onset. The patient took concomitant medications. The following information was reported: SYNCOPE (medically significant) with onset 09Dec2025, outcome "recovered" (09Dec2025), described as "syncopized". Patient syncopized 2 hours after receiving the RSV vaccine. It was unknown if therapeutic measures were taken as a result of syncope. Patient examined and otherwise well. The reporter considered "syncopized" not related to rsv vaccine prot.subunit pref 2v.; Sender's Comments: Based on known disease pathophysiology, the event syncope is assessed as not related to RSV VACCINE PROT.SUBUNIT PREF 2V, and more likely a vasovagal reaction.