Received Jul 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | OT / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9L944 | OT |
CHEST PAIN; INFLAMMATION OF THE CHEST; INJECTION SITE SWELLING; SWELLING OF THE CHEST; This spontaneous report was received from a Physician and refers to a 52-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and. The patient's concomitant medication included hydroxyzine 25mg, metoprolol tart 25mg, atorvastatin 10mg. The patient's concurrent conditions included high cholesterol, high blood pressure (HBP) and allergy to penicillin - hives. On 11-Apr-2025, the patient was vaccinated with the first dose of pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) lot number Y011819 and expiration date of 01-Oct-2025, intramuscularly in left arm and the first dose of Varicella zoster vaccine rgE (CHO) (SHINGRIX) intramuscularly in right arm, lot number 9L944 (expiration date was not reported) both for prophylaxis. On 12-Apr-2025, the patient experienced swelling/inflammation of the chest, severe chest pain, swelling of the left arm around injection site, currently wearing a heart monitor was prescribed famotidine recently. On that date, the patient was hospitalized for 3 days. The patient was order echography, magnetic resonance image (MRI), echocardiogram (EKG) and electrocardiogram. On 14-APR-2025, the patient was prescribed aspirin, ibuprofen and colchicine. The outcome of the events and the causal relationship between the events and the suspect vaccines were not provided.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2840364 , Central date : 2025-07-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Blood pressure high; High cholesterol; Penicillin allergy (Hives)
Hydroxyzine 25 mg; Metoprolol tart 25mg; Atorvastatin 10mg