Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 1 | LX2636 | OT / LA |
severe fainting episode/single severe syncope episode/syncopy; collapsed; This is a spontaneous report received from a Physician and a Consumer or other non HCP from medical information team. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 28Jul2025 as dose 1, 0.5 ml single (Lot number: LX2636, Expiration Date: 31Jan2027) at the age of 16 years intramuscular, in left deltoid for immunisation, Device Lot Number: LX2636, Device Expiration Date: 31Jan2027. The patient's relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications (The patient was not on any medication). The patient did not have any allergic to anything, had not had an illness in the month or got any other vaccines. The following information was reported: CIRCULATORY COLLAPSE (medically significant) with onset 28Jul2025, outcome "unknown", described as "collapsed"; SYNCOPE (medically significant) with onset 28Jul2025, outcome "unknown", described as "severe fainting episode/single severe syncope episode/syncopy". Clinical course: The patient had collapsed and get single severe syncope episode/severe fainting episode, and fell down in the room within like a minute later after due to syncopy and got hurt near the eye, they did not let her go and observed her for 0-40 minutes, she came to baseline, she was able to walk, everything so they let her go home. The physician had been using it for three years now and never had problems like this before. Physician expressed concern of this particular of lot of Trumenba, since he recognized the adverse reaction of two patients to same lot of vaccine as "uncommon". The physician wanted to return whole lot# LX2636 due to concern that the next patient will also get the same reaction. Had 14 remaining doses of this lot.; Sender's Comments: Based on known drug safety profile, and close temporal association the event syncope is assessed as related to the suspect drug MENINGOCOCCAL GROUP B RLP2086. The event circulatory collapse is conservatively assessed as related to the suspect drug based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Medical History/Concurrent Conditions: Scoliosis