Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
injection site reaction: developed extreme itching; aching at injection site; injection site reaction: developed swelling; injection site reaction: developed redness; This spontaneous report was received from a physician and refers to an 88-year-old female patient. The patient's concomitant medication included "flue shot". No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided. On 03-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, intramuscularly in unspecified arm (dose, lot #, expiration date and site of administration was not reported) for prophylaxis. On the same day, she experienced injection site reaction described as aching and then developed swelling, redness, and extreme itching. It was reported that the patient sought medical attention, however no details was reported. She was using cool, wet compress at the site, however no treatment was given. On an unknown date in February 2025, the patient recovered from the pain at the vaccination site. The outcome of the rest of the events was reported as not recovered. The causality assessment was not provided.