Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENBRAYA) | PFIZER\WYETH | UNK | — | — |
Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse and a Company Representative. A patient (age and gender not provided) received meningococcal group abcwy vaccine (PENBRAYA), 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: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; INFLAMMATION (non-serious), outcome "unknown"; CELLULITIS (non-serious), outcome "unknown". Additional information: The company representative reported an adverse event that was passed by a Nurse for vaccine called, Penbraya and the adverse reported was skin issues. When probed for the skin issues, company representative stated redness, inflammation and cellulitis. It was unknown if patient had an emergency room visit. One patient visited a Physician, a pediatrician due to adverse event. The company representative did not know the Prescribing Healthcare Professional details, product details, vaccination details, medical history, concomitant medications, lab work, treatment, date and time, dosage, route of administration, formulation, indication, causality, vaccination facility details. It was unknown if any other vaccination on same date or other vaccination on 4 weeks prior to Penbraya. The company representative stated yes about the causality. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.