Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | DD72H | — |
Nausea; she presented cold toes; body jerking; presented dehydration; This non-serious case was reported by a physician via call center representative and described the occurrence of nausea in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. Co-suspect products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for prophylaxis. On 05-MAR-2025, the patient received Bexsero and MENQUADFI. In MAR-2025, less than 2 weeks after receiving Bexsero, the patient experienced nausea (Verbatim: Nausea), cold feet (Verbatim: she presented cold toes), jerkiness (Verbatim: body jerking) and dehydration (Verbatim: presented dehydration). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the nausea, cold feet, jerkiness and dehydration were unknown. It was unknown if the reporter considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the nausea, cold feet, jerkiness and dehydration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The Vaccine Administration Facility is the same as Primary Reporter A sales representative communicated on behalf of the health care provider in charge of the case to report an adverse event with Bexsero vaccine. The doctor did not fully believed what patient was presenting, but the patient went to the Emergency Room and the situation was really dramatic The patient presented cold toes, body jerking, nausea and although she was with body jerking, she was able to talk and being normally. The father of the patient pulled over on the side of the road because the patient started presenting these symptoms and took her to the Emergency Room where, she received 2 doses of Benadryl and presented dehydration. The father of the patient was blaming the doctor for giving Bexsero and Menquadfi at the same time. The sales representative only wanted to the report the case and agent asked for a phone number to contact the health care provider and also asking if she was ok to being contacted, to which sales representative replied that would be great, providing her office phone number. Then, the agent called the health care provider and confirmed the information provided by the sales representative and gather the essential information to create the adverse event report. The health care provider did not share any more symptoms. It was unknown if the reporter considered the adverse events to be related to Menquadfi.