Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
swelling and a rash at the injection site; swelling and a rash at the injection site; no energy, fatigue; no energy, fatigue; no appetite; headache; body aches; feeling feverish; she is now starting to develop laryngitis; This spontaneous report was received from a female patient of unknown age who refers to herself. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 06-Aug-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) prefilled syringe (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 09-Aug-2025, the patient developed swelling and a rash at the injection site. On 09-Aug-2025, the patient experienced swelling and a rash at the injection site. She stated that the swelling and rash spread to around 6 inches away from the injection site as well. On an unknown day in August 2025, the patient also experienced no energy, fatigue, no appetite, headache, body aches, and feeling feverish. On an unknown day in August 2025, she was also starting to develop laryngitis. The patient stated that she would not recommend Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) to anyone. The patient spoke with her doctor, but did not want to disclose what her doctor said. She refused to provide any demographic information. No further details were provided. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine was as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided. Additional information is not expected.