Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coordination abnormal, Hemiparesis, Muscular weakness, SARS-CoV-2 test
Clinical narrative: HEMIPARESIS; COVID-19; COVID-19; COORDINATION ABNORMAL; COORDINATION ABNORMAL; HEMIPARESIS; SARS-COV-2 TEST POSITIVE; MUSCULAR WEAKNESS; TROPONIN INCREASED; SARS-COV-2 TEST POSITIVE; MUSCULAR WEAKNESS; TROPONIN INCREASED; This spontaneous report received from a health care professional by a Regulatory Authority concerned a 73 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: fall, anemia, transient ischaemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI), atrial fibrillation (AFIB), and seizures, and concurrent conditions included: chronic obstructive pulmonary disease (COPD), hypertension (HTN), parkinson disease, sleep apnea, smoker, penicillin allergy, and drug allergy (allegra, darvocet, erythromycin), and other pre-existing medical conditions included: The patient previously used the oxygen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 22-NOV-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 73 years old. No concomitant medications were reported.  On 02-MAY-2022, the patient experienced hemiparesis (weakness of left arm and leg), covid-19, coordination abnormal (dis-coordination), SARS-CoV-2 ( (Severe acute respiratory syndrome coronavirus 2) test positive, and troponin elevated (troponin increased) and muscular weakness, and was hospitalized. On 04-MAY-2022, the patient was discharged from the hospital. The number of days of hospitalization was 2 days. The latency was 161 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, coordination abnormal, hemiparesis, muscular weakness, sars-cov-2 test positive and troponin increased was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.  Additional information received from Regulatory authority on 24-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The follow up updates Product quality complaint investigation result. This doesnot alter the causality of previously reported events.  20230244487- hemiparesis, coordination abnormal, muscular weakness, troponin increased. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.  20230244487-covid-19, SARS-CoV-2 test positive. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.