Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z006076 | OT |
No adverse events reported; HCP called and reported Improperly stored CAPVAXIVE administered to one patient with unknown demographics on unknown date and confirmed no symptoms or side effects reported. No additional AE/no PQC. CAPVAXIVE z006076 exp 9/11/2026 0 hours 51 minutes; This spontaneous report was received from a/an Nurse and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with unknown dosage. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #z006076, expiration date: 11-Sep-2026) 0.5 mL (0.5mL/once). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. On an unknown date, the patient experienced HCP called and reported Improperly stored CAPVAXIVE administered to one patient with unknown demographics on unknown date and confirmed no symptoms or side effects reported. No additional AE/no PQC. CAPVAXIVE z006076 exp 9/11/2026 0 hours 51 minutes. On an unknown date, the patient experienced No adverse events reported. Follow up information was received from the nurse on 12-Aug-2025. This spontaneous report was referring to a(n) 66-year-old male patient. This case become valid upon follow up information. The patient's medical history included History of nephrolithiasis, History of dissection of artery, and Rash. The patient's concurrent conditions included Essential hypertension, Asymptomatic varicose veins of left lower extremity, Overweight (BMI 25.0-29.9), Mixed hyperlipidemia, Elevated prostate specific antigen (PSA), Benign prostatic hyperplasia with weak urinary stream, and Allergy to Penicillins. Historical drugs included Penicillin (Penicillin nos). Concomitant medications included Amlodipine (Amlodipine maleate), Tamsulosin (Tamsulosin hydrochloride). Vaccines were delivered to the office by courier. During transport vaccines were stored at an outof range temperature of 33F for 51 minutes (Product storage error). This was not immediately identified (The temperature excursion occurred as a result of a reading from a Digital Data Logger). Then On 14-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, 0.5 mL (0.5mL/once, concentration:168 mcg/ml), (lot #Z006076, expiration date: 11-Sep-2026), administered by Intramuscular route for prophylaxis. No adverse events reported (No adverse event). Vaccines were then labeled do not use while they investigated the situation. The stability data provided supported use of the vaccine. The dose given was valid and was not repeated. The remaining nine doses were then released for use (Remaining 9 vaccines were held as do not use until stability data was obtained; those doses were then made available for use and have been administered) (capture in case 2322076). This is one of two reports received from the same reporter.
Benign prostatic hyperplasia; Elevated prostate specific antigen [PSA]; Essential hypertension; Mixed hyperlipidemia; Overweight; Penicillin allergy; Varicose veins
Medical History/Concurrent Conditions: Artery dissection; Nephrolithiasis; Rash
Amlodipine; tamsulosin