Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatine phosphokinase, Blood creatine phosphokinase increased, COVID-19, Condition aggravated
Clinical narrative: RHABDOMYOLYSIS; COVID-19; CONDITION AGGRAVATED; FALL; ASTHENIA; SARS-COV-2 TEST POSITIVE; BLOOD CREATINE PHOSPHOKINASE INCREASED; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2092578) and concerned a 73 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: heart murmur, and Transient ischaemic attack (TIA), and concurrent conditions included: hypertension, hyperlipidemia, carotid artery stenosis, hypothyroidism, diabetes, Cerebrovascular accident (CVA), seizure, traumatic rhabdomyolysis, and drug allergy of lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 for an unspecified indication. Concomitant medications included clopidogrel bisulfate, glipizide, insulin glargine, lovastatin, metformin, and terazosin hydrochloride.  On 22-JAN-2022, the patient was hospitalized due to recurrent mechanical fall sec to generalized weakness (asthenia) with COVID-19 infection (severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test positive) and rhabdomyolysis without respiratory symptoms Infection was treated with vitamin-C, vitamin-D and zinc. On the same day the patient condition aggravated. He was on IV hydration 7 days after hospitalization and then he was transferred into rehab for an additional 7 days. Laboratory data included: Creatine Phosphokinase Increased (CPK) (NR: not provided) Increased-1415. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rhabdomyolysis, covid-19, condition aggravated, fall, asthenia, sars-cov-2 test positive, and blood creatine phosphokinase increased. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000218244. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.   Additional information was received from Central Complaint Vigilance on 23-FEB-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1 Additional information in this version updates of product quality complaint investigation result. This updated does not change the prior causality assessment or reported events.  20220243705-Covid-19 vaccine ad26.cov2.s- rhabdomyolysis, blood creatine phosphokinase increased. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY, Therefore, this event(s) is considered not related. 20220243705-Covid-19 vaccine ad26.cov2.s- covid-19, condition aggravated, fall, asthenia, sars-cov-2 test positive. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.