Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Unknown | OT |
developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; This spontaneous report was received from a nurse and referred to a 55-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-Apr-2025, the patient was vaccinated with a single dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot# 2002626 was invalid, expiration date reported as 04-Sep-2026; dose considered as 1 dosage form; strength was not reported) via intramuscular route as vaccination by a health professional. About 36-48 hours after receiving Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), on an unknown date in April 2025, the patient developed very swollen, reddened area that was painful touch and limits his mobility in his left arm at the injection site. No other symptoms reported. The patient had sought medical attention. No treatment was provided at this time. No lab diagnostics/ studies were reported. Outcome of all events was not recovered. The causal relationship between Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) and all the events was not reported.