Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
rash on her face, back and arms; This spontaneous report was received from a 83-year-old female patient, concerning herself. The patient's medical history was not reported. The patient's concurrent conditions included Hypertension, Penicillin allergy, and whole wheat grains, dairy pine nuts and pistachio nut, oysters' muscles clams allergy. Historical drugs included Penicillin not otherwise specified (NOS). In addition, a blood work was performed in October (details/result not provided). Concomitant medications included atenolol and bilastine (ALLEGRA) . On 22-Nov-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection in pre-filled syringe, administered by unknown route in the right upper arm (dose, lot # and expiration date were not reported) for prophylaxis. On 23-Nov-2025 (reported as a day and a half after vaccination), the patient experienced rash on her face, back and arms. The reporter mentioned that she contacted her health care professional (HCP) and they advised her to allow 4 days for the rash to heal. No treatment was provided. Then on 27-Nov-2025, the rash went away. Therefore, on that day, she recovered from the event. The causal relationship between the event and the suspect vaccine was not provided. Batch/Lot number is being requested and will be submitted if received.
Food allergy; Hypertension; Penicillin allergy
Atenolol; Allegra