Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | — | — |
First excursion reached 47.3 F for 11 minutes; second excursion occurred and reached 46.2 F for a duration of 10 to 20 minutes; there were 5 patients administered with Trumenba; First excursion reached 47.3 F for 11 minutes; second excursion occurred and reached 46.2 F for a duration of 10 to 20 minutes; there were 5 patients administered with Trumenba; This is a spontaneous report received from a healthcare professional from medical information team. A patient (age and gender not provided) received meningococcal serogroup B conjugate vaccine (TRUMENBA), in 2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 2025, outcome "unknown" and all described as "First excursion reached 47.3 F for 11 minutes; second excursion occurred and reached 46.2 F for a duration of 10 to 20 minutes; there were 5 patients administered with Trumenba". Additional Information: The healthcare professional called in regards temperature excursion that occurred for Trumenba and Penbraya vaccines before reconstitution. For Trumenba, the first excursion occurred on 02Oct2025 which reached 47.3 F for 11 minutes; no patient administration was involved after the excursion. The second excursion occurred on 02Oct2025 and reached 46.2 F for a duration of 10 to 20 minutes; no patient administration was involved. For Trumenba, the first excursion occurred on 02Oct2025 which reached 47.3 F for 11 minutes; no patient administration was involved after the excursion. The second excursion occurred on 02Oct2025 and reached 46.2 F for a duration of 10 to 20 minutes there were 5 patients administered with Trumenba. The information on the batch/lot number for meningococcal serogroup B conjugate vaccine will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500218829 Same reporter, product, and event; different patient;