Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
The last 4 nights the pain is in her right thigh; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; immediately experienced injection site pain that lasted 5 days; it makes her nauseous; She also has an oval rash around the injection site; She is struggling during the day though due to a lack of sleep; She is struggling during the day though due to a lack of sleep; This spontaneous report was received from a 71-year-old female patient, referring to herself. The patient's medical history and concomitant therapies were unknown. There were no drug reactions or allergies. On 13-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 168 mcg/ml injection 0.5 mL (lot #, expiration date and vaccination site were not reported) for prophylaxis. On the same day, immediately after the vaccination, the patient experienced vaccination site pain, it lasted 5 days. On 18-Aug-2025, when trying to sleep the patient experienced itching and full body aches and pains, including in her butt and back. Since 25-Aug-2025, the pain was in her right thigh. The patient stated that the pain has the intensity of labor pains, and on scale of 1-10 its a 12, and it makes her nauseous. Every night has been horrible and unbearable, but the pains mostly went away during the day and then got worse at night again. The patient was struggling during the day though due to a lack of sleep. The patient sought medical attention and was given treatment of acetaminophen (Tylenol) and Ibuprofen (Advil). On an unknown date in August 2025, the patient also had an oval rash around the vaccination site. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. At the time of this report, the outcome of vaccination site pain was considered as resolved on 17-Aug-2025. The outcome of other events was not recovered. The causal relationship between the suspect vaccine and all events was not provided.