Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable. The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316262).; Reporter's Comments: