Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | — | OT |
Consumer called to report they received a PNEUMOVAX23 injection on 06/04/2025 and later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing painful burning and swelling at the injection site; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing painful burning and swelling at the injection site; This spontaneous report was received from a consumer and refers to a(n) 55-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), formulation: injection, administered by intramuscular route (lot #, expiration date, exact dose and anatomical location were not provided). On 04-Jun-2025, the patient experienced brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling (reported as: later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing brain fog). At the reporting time, the reported events. The causal relationship between the events of brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was unknown/not reported/not provided.