Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | — |
fever; itchy rash; welts; This spontaneous report was received from a health professional referring to a 56-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis, lot number Y013009, which has been verified to be valid, expiration date reported and validated as 17-NOV-2025. (formulation, strength, dose, scheme, route of administration and anatomical location not provided). On the same date the patient developed itchy rash that was hot to touch, welts and fever. The reporter stated that the fever was currently resolved, but the patient was still experiencing the rash and itchiness. The causal relationship between the events and the suspect vaccine was unknown.