Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENBRAYA) | PFIZER\WYETH | 1 | — | OT |
Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received meningococcal group abcwy vaccine (PENBRAYA), as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; INFLAMMATION (non-serious), outcome "unknown"; CELLULITIS (non-serious), outcome "unknown". Additional information: Pfizer employee stated, they wanted to report an adverse event that was passed to them by a Nurse. It was a vaccine called, Penbraya and the adverse report was skin issues. When probed for the skin issues, Pfizer employee stated, Redness, inflammation and cellulitis. Pfizer employee stated, they do not know Pfizer drug safety, it was through a call. The patient details were not provided. They did not know prescribing physician and remember that these are vaccines. So, they were not prescribed. Pfizer employee stated, the nurse has Product details they do not. Concomitant medication, Dosage were not known. It was unknown if any other vaccination on same date or other vaccination on 4 weeks prior to Penbraya. One patient visited a physician, a pediatrician for AE. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.