Received Aug 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 2 | 2004301 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 2 | Unknown | OT / LA |
ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium. On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis. 18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit. On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02. At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Allergic cough; Drug allergy; High cholesterol; Hypertension; Lumbar pain; Prediabetes; Seafood allergy
Naproxen; Valsartan; Nifedipine; Cyclobenzaprine; Vitamin B12; Vitamin D3; Atorvastatin
Test Date: 202506; Test Name: UA; Result Unstructured Data: UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria. Current illness: Acute on chronic lumbar back pain; Test Date: 202506; Test Name: Creatinine; Result Unstructured Data: increased from 0.7 to1.02. Current illness: Acute on chronic lumbar back pain