Received Jun 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENBRAYA) | PFIZER\WYETH | 1 | — | — |
patinet age 51 years; had brief syncopal episode; injection site feeling strangely cold; This is a spontaneous report received from a Physician. A 51-year-old female patient (not pregnant) received meningococcal group abcwy vaccine (PENBRAYA), on 02Jun2026 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; SPRINTEC. The following information was reported: SYNCOPE (medically significant) with onset 02Jun2026, outcome "recovered" (02Jun2026), described as "had brief syncopal episode"; VACCINATION SITE COLDNESS (non-serious) with onset 02Jun2026, outcome "recovered" (02Jun2026), described as "injection site feeling strangely cold"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 02Jun2026 at 12:00, outcome "unknown", described as "patinet age 51 years". Therapeutic measures were not taken as a result of syncope, vaccination site coldness. Clinical course: Patient was not pregnant. Patient occupation was Physician. No other vaccine same date and no other vaccine in four weeks. Other medications 2 weeks product included Fluoxetine and Sprintec. Reported injection site feeling strangely cold and then had brief syncopal episode. No Known allergies. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.; Sender's Comments: The event of syncope is considered possibly related to meningococcal group abcwy vaccine (PENBRAYA )based on their close temporal relationship to vaccine administration and the known occurrence of vasovagal reactions following vaccination 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
FLUOXETINE; SPRINTEC