Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT / LA |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT / LA |
arm pain; "throbbing headache"; This spontaneous report was received from a consumer and refers to a 36-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAY-2025 around 5:40 PM, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection at a dose of 0.5 mL, once, administered by intramuscular route in left arm (lot # and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP), administered by intramuscular route in left arm (dose, lot # and expiration date were not reported); both vaccines were administered for prophylaxis. On the same day, roughly a hour later, at 6:47 PM, the patient started to have a "throbbing headache" and arm pain. His headache continued to get worse, but he stated he had no severe redness or swelling in the vaccinated arm. At the reporting time, the outcome of "throbbing headache" and arm pain was unknown. Causality assessment was not provided. Additional information is not expected.