Received May 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z013052 | OT / LA |
the patient involved has not report any medical concerns or symptoms after being administered the improperly stored dose of CAPVAXIVE; a dose of CAPVAXIVE was administered to a patient on 3/18/2026 after being exposed to a temperature excursion on 3/14/2026; This spontaneous report was received from a nurse and refers to a 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 14-MAR-2026, Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccine experienced temperature excursion. On 18-MAR-2026, the patient was vaccinated with an improperly storage dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z013052, expiration date: 30-MAY-2027) 0.5 ml, single dose for prophylaxis (Improper storage of product in use). The patient involved had not report any medical concerns or symptoms after being administered the improperly stored vaccine. Follow-up information has been received from the nurse on 22-APR-2026. Demographic information about the patient was added. The patients' concurrent conditions included allergy to minocycline, morphine, penicillin and sulfa, hypertension (HTN), hyperlipidemia, atherosclerotic cardiovascular disease (ASCVD), lung nodules, smoker, emphysema, restless legs, chronic kidney disease stage 2 (CKD II), common bile duct dilation, gastric polyps, internal hemorrhoids, dysphagia, melena, allergic rhinitis and dysthymic disorder. The patient drug history included minocycline, morphine, penicillin and sulfa. On 15-MAR-2026, staff reported that the medication refrigerator temperature was 78°F. A sign was placed on the refrigerator door that said, "do not use, temperature out of range". The temperature was last documented at 37.8°F on 14-MAR-2026. It was assumed there was a power outage that caused the refrigerator to glitch. On 16-MAR-2026, the temperature was documented at 37°F. The temperature had remained within the recommended range since 19:30 on 16-MAR-2026. The medications were left in the refrigerator as there was question of possible reimbursement, and no medication disposal bin at that time to dispose of them. The sign remained on the refrigerator door until after the incident on 20-MAR-2026; on that date it was discovered that the vaccine was administered on 18-MAR-2026. The patient was administered the vaccine intramuscularly in the left deltoid. After the administration, the device was disposed of in sharps. It was also stated that, as far as adverse reactions from being administered a vaccine that was out of temperature range, would be no different than the possible reactions from receiving the vaccine itself (injection site redness, pain at the site etc.), although, the vaccine may not be as effective. There were no known reactions reported by the patient but according to the company's information, the patient would need to be revaccinated as soon as possible; the patient understood the need for revaccination.
Allergic rhinitis; Allergy to antibiotic; Atherosclerotic cardiovascular disease; Bile duct stenosis; Chronic kidney disease stage 2; Drug allergy; Dysphagia; Dysthymic disorder; Emphysema; Gastric polyps; Hyperlipidemia; Hypertension; Internal hemorrhoids; Lung nodule; Melena; Penicillin allergy; Restless legs; Smoker; Sulfonamide allergy