Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT / LA |
vaccination site movement impairment; it was administered subcutaneously rather than intramuscularly; warmth at the injection site; fatigue; weakness in legs; a little soreness, but less pain; still a bit red; rash; This spontaneous report was received from a consumer regarding a 56-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 16-JUL-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered subcutaneously in the left arm for vaccination (strength, dose, vaccination scheme, lot number, and expiration date were not reported) (Incorrect route of product administration). Later that evening, the patient experienced warmth at the injection site (Vaccination site warmth), and began to have fatigue (Fatigue), weakness in legs (Muscular weakness), it was not easy to lift her arm (Vaccination site movement impairment), and she broke out in a rash on hear arm that spread (Vaccination site rash). Her doctor prescribed her antibiotics. On an unknown date in July 2025, the patient also experienced a little soreness, but less pain (Pain) and reported that she was still a bit red (Erythema), but much smaller surface area remaining affected. At the time of the reporting, the patient was getting better from the events (recovering). The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.