Received Aug 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | Y016291 | OT |
patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; This spontaneous report was received from an Office manager and refers to a 27-year-old female patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were reported as none. On 03-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE 0.5 mL administered by Intramuscular route, lot # Y016291 has been verified to be valid, expiration date reported as 31-DEC-2026 but upon internal validation established as 06-DEC-2026, given for Low IG level vaccination [Immunoglobulins decreased (Considered as concurrent condition)]. On 05-Jun-2025, the patient was evaluated at an urgent care clinic on with arrythmia, edema at the injection site (Vaccination site edema), and arm soreness (Vaccination site pain) to the point the patient could not lift their arm (Injected limb mobility decreased). Unspecified treatment was given for the adverse events and on an unspecified date in 2025, the patient recovered from all the events. The causal relationship between all the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE was not reported. Upon internal review, the event of arrythmia was considered medically significant. This is one of four reports from the same reporter.
Immunoglobulins decreased