Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080748 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | IM / RA |
exhibiting symptoms of a stroke/ confusion; very sick; PYREXIA/ 104-degree fever; symptoms of COVID-19; NEUROLOGICAL SYMPTOM; very little recollection of the series of events; MALAISE; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion), ILLNESS (very sick), PYREXIA (PYREXIA/ 104-degree fever) and SUSPECTED COVID-19 (symptoms of COVID-19) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: penicillin (penicillin) and meperidine (meperidine). Past adverse reactions to the above products included Allergic reaction NOS with meperidine and penicillin. Concurrent medical conditions included Hypertension, Dry eye, Migraine, Hyperlipidemia, Hypokalemia, Urge incontinence, Dementia, Drug allergy (meperidine allergy), Penicillin allergy (penicillin allergy) and Allergy to antibiotic (sulfa antibiotics allergy). Concomitant products included Amitriptyline hydrochloride (Amitriptyline), Amlodipine besilate (Amlodipine), Galcanezumab gnlm (Emgality), Ezetimibe, Hydroxyzine hydrochloride (Hydroxyzine HCL), Potassium chloride (Klor-con/ef), Losartan potassium (Losartan), Mirabegron, Rizatriptan benzoate (Rizatriptan), Rosuvastatin calcium (Rosuvastatin), Topiramate and Lifitegrast (Xiidra) for an unknown indication. On 03-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 03-Apr-2025, the patient experienced CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion) (seriousness criteria hospitalization and medically significant), ILLNESS (very sick) (seriousness criterion hospitalization), PYREXIA (PYREXIA/ 104-degree fever) (seriousness criterion hospitalization), SUSPECTED COVID-19 (symptoms of COVID-19) (seriousness criterion hospitalization), NEUROLOGICAL SYMPTOM (NEUROLOGICAL SYMPTOM), AMNESIA (very little recollection of the series of events) and MALAISE (MALAISE). At the time of the report, CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion), ILLNESS (very sick), PYREXIA (PYREXIA/ 104-degree fever), SUSPECTED COVID-19 (symptoms of COVID-19), NEUROLOGICAL SYMPTOM (NEUROLOGICAL SYMPTOM), AMNESIA (very little recollection of the series of events) and MALAISE (MALAISE) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2025, Body temperature: 104 degree fever. It was reported that the patient received two vaccines. Several hours later, she was taken to the Emergency Department, and she had exhibited symptoms of a stroke, including confusion. She also had a 104-degree fever and felt very sick when she was taken to the hospital. She had very little recollection of the series of events. The physician reported that she exhibited symptoms of COVID-19 exposure, but no test was done to confirm this. On 04-Apr-2025, the patient felt well enough to discuss the incident and appeared to be coherent and in good spirits. She was discharged home, and no further treatments were apparent at that time. No treatment medications were reported.; Reporter's Comments: Co-suspect product included non-company product Pneumococcal vaccine. The benefit -risk relationship of product is not affected by this report.
Allergy to antibiotic (sulfa antibiotics allergy); Dementia; Drug allergy (meperidine allergy); Dry eye; Hyperlipidemia; Hypertension; Hypokalemia; Migraine; Penicillin allergy (penicillin allergy); Urge incontinence
Amitriptyline; Amlodipine; Emgality; Ezetimibe; Hydroxyzine HCL; Klor-con/ef; Losartan; Mirabegron; Rizatriptan; Rosuvastatin; Topiramate; Xiidra
Test Date: 20250403; Test Name: temperature; Result Unstructured Data: 104 degree fever