Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
confusion; severe lethargy; weakness; fatigue; This spontaneous report was received from a physician assistant and refers to an adult male patient in his 50's. The patient's medical history was not reported. The patient's concurrent conditions were not specified. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, strength: 168 mcg/mL, at a dose of 0.5 mL, administered by intramuscular route for prophylaxis (anatomical location, lot # and expiration date were not reported). On an unknown date, within an hour of receiving the vaccine, the patient experienced confusion, severe lethargy, fatigue and weakness. On the following day, the patient had an office visit. At the time of reporting, the patient recovered from all reported events. Causality assessment was not provided. Lot# has been requested and will be submitted if received.