Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
fatigue; chills; redness at the injection site; swelling in the abdomen; blotchy redness on the abdomen; This spontaneous report has been received from a consumer, regarding to a 54-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 27-AUG-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) at a dose of 0.5 milliliter (ml) as prevention of Pneumonia (route of administration, anatomical site of injection, lot number and expiration date were not provided). On the same date, the patient experienced fatigue, chills, redness at the injection site (Vaccination site erythema), swelling in the abdomen (Abdominal distension) and blotchy redness on the abdomen (Rash macular). On an unknown date in August 2025, the patient recovered from aforementioned events. The causal relationship between the aforementioned events and suspect vaccine was not provided.