Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y011819 | OT / LA |
FLUSHING; FATIGUE; TINGLING; HEADACHE; This spontaneous report was received from a regulatory authority, CDC Wonder on 22-Apr-202, referring to a 59-year-old male patient. The patient's medical history included allergy to sulfa. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as 27-Feb-2025, conflicting information), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025), administered by intramuscular route in left arm as prophylaxis. On 01-Feb-2025, the patient experienced fatigue, tingling, flushing and headache. At the reporting time, the outcome of the events was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was reported as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.
Medical History/Concurrent Conditions: Sulfonamide allergy