Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z004301 | — |
cellulitis; injection site reaction; This spontaneous report was received from a Physician and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Jul-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Z004301, expiration date: 07-Sep-2026), dose was not provided for prophylaxis. On 07-Jul-2025, the patient experienced injection site reaction site with fever and fatigue. Patient was admitted to the hospital with cellulitis. At the reporting time, the outcome of cellulitis and injection site reaction was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of cellulitis and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of injection site reaction and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.