Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 2 | — | LA |
passed out; Light headed/Dizzy; headache; fatigue; nausea; This is a spontaneous report received from a Consumer or other non HCP. A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 05Mar2025 at 14:45 as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in left arm for immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: PROZAC, start date: 01Nov2024. No other vaccine was received on the same day. No other vaccine was received on in four weeks. Vaccination history included: Meningococcal vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering", described as "Light headed/Dizzy"; FATIGUE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; HEADACHE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; LOSS OF CONSCIOUSNESS (medically significant) with onset 05Mar2025 at 19:00, outcome "recovering", described as "passed out". Therapeutic measures were not taken as a result of loss of consciousness, dizziness, headache, fatigue, nausea. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
PROZAC