Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y019158 | OT / RA |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
"small bump" on her right arm; a fever and feeling chilly, cold, and warm; having redness and swelling on her right arm; having redness and swelling on her right arm; This spontaneous report has been received from a pharmacist, regarding to a 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 26-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine, administered intramuscularly (IM) in the right arm, lot number Y019158, expiration date 20-MAY-2026 as routine administration (dosage, route of administration, and vaccination scheme frequency), on the same date, the patient received Boostrix (Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (dose, route of administration, anatomical site of injection, vaccination scheme frequency, lot number, indication, and expiration date were not reported) . On 27-JUN-2025, the patient experienced a fever and feeling chilly, cold, and warm (Pyrexia), on the same date, the patient developed small bump (Vaccination site mass) on her right arm, also, she had redness and swelling (Vaccination site swelling and Vaccination site erythema). On an unknown date in 2025, the patient recovered from pyrexia. At the time of the report, the patient had not recovered from Vaccination site mass and Vaccination site erythema. The outcome of Vaccination site swelling was not provided. The causal relationship between the aforementioned events and the suspect vaccines was not provided.