COVID-19; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINE FAILURE; Blood creatine phosphokinase MB increased; Blood creatine phosphokinase increased; Brain natriuretic peptide increased; Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood calcium decreased; White blood cell count decreased; Red blood cell count decreased; Haematocrit decreased; Haemoglobin decreased; Mean cell haemoglobin concentration decreased; Protein total decreased; Platelet count normal; Full blood count; Troponin normal; Blood glucose normal; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 59 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus, history of cancer, and peaches allergy. The patient experienced drug allergy when treated with azithromycin. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency time 1 total was administered on 10-MAR-2021 for drug use for unknown indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included allopurinol, alprazolam, atorvastatin, bisoprolol, codeine phosphate/paracetamol, cyanocobalamin, dulaglutide, fish oil, gabapentin, glipizide, isosorbide mononitrate, nicotinic acid, pantoprazole sodium sesquihydrate, pramipexole, prasugrel hydrochloride, ranolazine, tramadol hydrochloride, and zolpidem. On 27-APR-2021, the patient experienced covid-19, sars-cov-2 test positive via Polymerase chain reaction (PCR), blood creatine phosphokinase mb increased, blood creatine phosphokinase increased, brain natriuretic peptide increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood calcium decreased, white blood cell count decreased, red blood cell count decreased, haematocrit decreased, haemoglobin decreased, full blood count, mean cell haemoglobin concentration decreased, troponin normal, platelet count normal, protein total decreased and blood glucose normal. On 27-APR-2021, Laboratory data included: Alanine aminotransferase (NR: not provided) 59, Aspartate aminotransferase (NR: not provided) 111, Brain natriuretic peptide (BNP) (NR: not provided) 222, Calcium (NR: not provided) 8.5, Creatine kinase (NR: not provided) more then 2000, Creatine kinase myocardial band (MB)(NR: not provided) 31.53, Glucose (NR: not provided) 137 (units unspecified), Hematocrit abnormal (NR: not provided) 0.327, Hemoglobin abnormal (NR: not provided) 10.2, mean corpuscular hemoglobin concentration (MCHC) (NR: not provided) 31.2, Platelet count (NR: not provided) 185, Protein (NR: not provided) 6.3, Red blood cell count (NR: not provided) 3.35, SARS-CoV-2 test positive (NR: not provided) Positive, Troponin (NR: not provided) Negative, and white blood cells (WBCs) (NR: not provided) 3.9. The patient was hospitalized (date unspecified) for an unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19, sars-cov-2 test positive, blood creatine phosphokinase mb increased, blood creatine phosphokinase increased, brain natriuretic peptide increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood calcium decreased, white blood cell count decreased, red blood cell count decreased, haematocrit decreased, haemoglobin decreased, full blood count, mean cell haemoglobin concentration decreased, troponin normal, platelet count normal, protein total decreased and blood glucose normal and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194342. The suspected product quality complaint has been confirmed to be not voided, the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the product quality complaint evaluation and investigation performed.  Additional information received from a regulatory authority department on 01-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information updated includes: Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20210934879-COVID-19 VACCINE AD26.COV2.S- Covid-19, Sars-cov-2 test positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood calcium decreased, Blood creatine phosphokinase mb increased, Blood creatine phosphokinase increased, Blood glucose normal, Brain natriuretic peptide increased, Full blood count, Haematocrit decreased, Haemoglobin decreased, Mean cell haemoglobin concentration decreased, Platelet count normal, Protein total decreased, Red blood cell count decreased, Troponin normal, White blood cell count decreased. This event(s) is considered unassessable. 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). 20210934879-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure,. This event(s) is considered not related. 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: SPECIAL SITUATIONS