Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
Received from the AE Self-Service Portal: Report submitted by Merck Employee Provider stated today that this patient experienced 7-10 days of redness at the injection site after receiving a dose of Capvaxive. "Case assigned/processed; This spontaneous report was received from a physical assistant and refers to a(n) 50-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown exact day in January 2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown exact day in January 2025, the patient experienced vaccination site erythema (experienced 7-10 days of redness at the injection site after receiving a dose of vaccine). At the reporting time, the outcome of the event was unknown. The causal relationship between the event of vaccination site erythema and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.