Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2523 | — |
huge red-hot knot in the arm spreading around and down arm; was just having pain in the arm; aching all over; fever; This is a spontaneous report received from a Nurse from medical information team. A 62-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Sep2025 as dose number unknown, single (Lot number: MA2523, Expiration Date: 30Sep2026) at the age of 62 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "huge red-hot knot in the arm spreading around and down arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "was just having pain in the arm"; PAIN (non-serious), outcome "unknown", described as "aching all over"; PYREXIA (non-serious), outcome "unknown", described as "fever". The reporter stated that she has already spoken to Pfizer Safety to report that 2 adult patients were administered Prevnar-20 and both had reactions. One patient was administered the vaccine on 05Sep2025 and the other on 08Sep2025. She wanted to find out if Pfizer had identified any current issues with a LOT of the vaccine.