Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | LA |
Severe vomiting; diarrhoea; Nausea; Chills; Body ache; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jun2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Body ache"; CHILLS (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); NAUSEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); VOMITING (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Severe vomiting"; DIARRHOEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025). The patient was hospitalized for vomiting, diarrhoea, nausea, chills, pain (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of vomiting, diarrhoea, nausea, chills, pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No