Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019158 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y019158 | OT / LA |
heavy fatigue; painful raised welt approx 2 x 4 inches centered on left deltoid injection site with 1 inch diameter rash; painful raised welt approx 2 x 4 inches centered on left deltoid injection site; This spontaneous report was received from a Patient on 02-Jul-2025 concerning his/herself of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-Jul-2025, the patient was vaccinated with a Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y019158, expiration date: 20-May-2026) (1 time), administered by Intramuscular route in the left deltoid for prophylaxis. On 02-Jul-2025, the patient experienced heavy fatigue, painful raised welt approximately 2 x 4 inches (Vaccination site urticaria, Vaccination site pain) centered on left deltoid injection site with 1 inch diameter rash on upper edge of armpit. The patient recovered from the events approximately on 07-Jul-2025, reported as lasted for lasted for 4-5 days. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.