Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | N4TY2 | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | AZ240050 | — |
Diarrhea; Fever; Vomiting; Inappropriate age at vaccine administration; Nose bleeds; This non-serious case was reported by a consumer via call center representative and described the occurrence of epistaxis in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number N4TY2, expiry date 31-JAN-2027) for prophylaxis. Co-suspect products included RSV vaccine (batch number AZ240050) for prophylaxis. On 30-OCT-2025, the patient received Menveo .5 ml and RSV vaccine. On 30-OCT-2025, less than a day after receiving Menveo and RSV vaccine, the patient experienced epistaxis (Verbatim: Nose bleeds) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea), fever (Verbatim: Fever) and vomiting (Verbatim: Vomiting). The outcome of the epistaxis, diarrhea, fever and vomiting were not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the epistaxis, diarrhea, fever and vomiting to be related to Menveo and RSV vaccine. It was unknown if the company considered the epistaxis, diarrhea, fever and vomiting to be related to Menveo and RSV vaccine. Additional Information: GSK Receipt Date: 14-NOV-2025 The reporter was the father of the patient. The patient was five months old and had received menveo one-vial dose presentation on 30-Oct-2025. The PI stated that one vial contained Menveo (pink cap), which did not require reconstitution before use and was intended for individuals aged 10 through 55 years. The reporter stated that a few days after receiving the vaccine, the patient had vomiting, fever, diarrhea, and nosebleeds. All symptoms persisted. The infant was in the emergency department during the call for evaluation. The reporter also stated that at the time of menveo administration, the infant had also received an RSV vaccine manufactured by Sanofi Pasteur Inc.