Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z004301 | OT / LA |
Injection site erythema; Injection site rash; Information has been received from FDA (agency #2843894-1) and refers to a 69-year-old female patient. The patient's medical history included history of malignant neoplasm of breast. The patient's concurrent conditions included allergic rhinitis, cervical spondylosis, gastroesophageal reflux disease without esophagitis, hyperlipidemia, hypertension with disorder of left retina, hypertension with disorder of left retina, hypertensive heart disease without congestive heart failure, long-term drug therapy, neck pain, obese, class II osteopenia, polyp of nasal sinus, sleep apnea, vitamin D deficiency, and albuterol, lisinopril, Motrin allergy. Concomitant medications included Cephalexin (Cefalexin), Fluticasone propionate (Fluticasone propionate), Klor-con m10 (Potassium chloride), 2.5 mg Letrozole (Letrozole), Losartan potassium and hydrochlorothiazide (Hydrochlorothiazide;Losartan potassium), Metoprolol tartrate (Metoprolol tartrate), 10 mg Montelukast (Montelukast sodium), Potassium chloride (Potassium chloride), 10 mg Pravastatin (Pravastatin sodium), Tylenol (Paracetamol), 5000 IU Vitamin d3 (Colecalciferol), Zyrtec (Cetirizine hydrochloride) . On 27-May-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (lot #Z004301, expiration date: 07-Sep-2026), dose number 1, administered by Intramuscular route in Left Arm for an unknown indication. On 02-JUN-2025, the patient's entire upper left arm has a redness rash down to the elbow. On 03-Jun-2025, the patient experienced Injection site rash. On 03-Jun-2025, the patient experienced Injection site erythema. At the reporting time, the outcome of Injection site rash and Injection site erythema was unknown. The causal relationship between the event of injection site erythema and injection site rash and Pneumococcal 21-valent Conjugate Vaccine was not provided.
Allergic rhinitis; Benign hypertensive heart disease without congestive heart failure; Cervical spondylosis; Drug allergy; Drug therapy; Gastroesophageal reflux disease; Hyperlipidemia; Hypertension; Neck pain; Obesity; Osteopenia; Retinal disorder; Sinus polyp; Sleep apnea; Vitamin D deficiency
Medical History/Concurrent Conditions: Malignant breast neoplasm
cephalexin; fluticasone propionate; Klor-Con M10; letrozole; losartan-hydrochlorothiazide; metoprolol tartrate; montelukast; potassium chloride; pravastatin; Tylenol; Vitamin D3; Zyrtec