Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
a redness rash at the injection site; redness rash at the injection site / a 7x7 section of erythema around the patient's injection site; This spontaneous report was received from a physician and refers to an 83-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included vitamin B12. The patient was not immunocompromised. On 03-SEP-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, administered on an unspecified arm (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 04-SEP-2025, the patient had a redness rash at the injection site. The health professional directed the patient to take acrivastine (BENADRYL) and the rash was getting better over the weekend. On 08-SEP-2025 (on Monday), the patient reached out to the health professional complaining of the same symptoms. That day, examination showed a 7x7 section of erythema around the patient's injection site. Health professional informed the patient to continue treating symptoms with acrivastine (BENADRYL). At the reporting time, the outcome of the events was unknown (reported as "okay/fine"). Causality assessment was not provided. Lot# is being requested and will be submitted if received.
B12 shot
Test Date: 20250908; Test Name: examination; Result Unstructured Data: a 7x7 section of erythema around the patient's injection site