Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y013009 | OT / LA |
INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; This spontaneous report was received from FDA and refers to an 81-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 29-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in left arm for an unknown indication. On 04-Feb-2025, the patient experienced redness (injection site erythema) and itching (injection site pruritus) at injection site. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.