ACUTE RESPIRATORY DISTRESS SYNDROME; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; DEEP VEIN THROMBOSIS; SEPSIS; ANTICOAGULANT THERAPY; ENDOTRACHEAL INTUBATION; COVID-19; COUGH; DYSPNOEA; EXPOSURE TO SARS-COV-2; LUNG OPACITY; PRODUCTIVE COUGH; LYMPHOPENIA; SNORING; SPUTUM DISCOLOURED; SLEEP DISORDER; MYALGIA; DIARRHOEA; PYREXIA; ALANINE AMINOTRANSFERASE INCREASED; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD SODIUM DECREASED; CHEST X-RAY ABNORMAL; FLUID BALANCE NEGATIVE; SARS-COV-2 TEST POSITIVE; THYROXINE FREE NORMAL; ULTRASOUND DOPPLER ABNORMAL; WHITE BLOOD CELL COUNT DECREASED; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number 1754036) concerned a 46 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: goiter, plantar fasciitis and concurrent conditions included: graves disease, hashimoto's thyroiditis, arthritis, psoriasis, psoriatic arthritis, light tobacco use and other pre-existing medical conditions included that he had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) 0.5 ml, 1 total, administered on 13-MAR-2021 at right arm for an unknown indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included benzonatate, ibuprofen, leflunomide, meloxicam, salbutamol, salbutamol sulfate and thiamazole all for an unknown indication. On DEC-2020, Laboratory data included: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Immunoglobulin G (IgG) antibody test (NR: not provided) negative.  On 18-SEP-2021, patient presented to emergency room with severe worsening of cough, fever and increasing shortness of breath (SOB), acute respiratory distress syndrome, acute respiratory failure, deep vein thrombosis, Covid-19 infection, lung opacity, lymphopenia and myalgia. Patient had a 14 year old son that was recently sick with Covid. He was in school and unmasked and has completed his isolation. Patient's spouse was also sick with Covid-19. Patient was unable to sleep for the last two nights due to severe cough. His cough was productive at times with greenish yellow secretions. He denied wheezing, chest pain, edema and orthopnea. He did snore sometimes. Patient denied obstructive sleep apnea (OSA). Patient had been alternating taking acetaminophen and ibuprofen at home for his fevers and myalgias. Patient reports that he was having watery diarrhea about 2 to 3 in last 24 hours. In the emergency room patient was given dexamethasone 6 mg Intravenous (IV), tessalon perles, albuterol metered dose inhaler (MDI) and acetaminophen. On 18-SEP-2021, the patient experienced thyroxine free normal. On 24-SEP-2021, patient was admitted to hospital for acute hypoxia due to Covid pneumonia with sepsis. The patient was hospitalized for 8 days. On 27-SEP-2021, patient was intubated, tolerated prone positioning, slight negative fluid balance tolerated heparin and no evidence of bleeding. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data included: Alanine aminotransferase (NR: not provided) 77 (increased), Aspartate aminotransferase (NR: not provided) 86 (increased), Blood sodium (NR: not provided) 131 (decreased), Chest X-ray (NR: not provided) abnormal (bilateral lung opacities consistent with covid pneumonia), Fluid balance assessment (NR: not provided) negative, SARS-CoV-2 test (NR: not provided) positive, Thyroxine free (NR: not provided) normal, Ultrasound Doppler (NR: not provided) abnormal, and White blood cell count (NR: not provided) decreased. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.4 C, Heart rate (NR: not provided) 105 and Oxygen saturation (NR: not provided) 87 percent.  Treatment medications (dates unspecified) included: ibuprofen, paracetamol, salbutamol, heparin, dexamethasone, benzonatate, remdesivir, and chlorhexidine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome, acute respiratory failure, covid-19 pneumonia, deep vein thrombosis, sepsis, anticoagulant therapy, endotracheal intubation, covid-19, cough, dyspnoea, exposure to sars-cov-2, lung opacity, productive cough, lymphopenia, snoring, sputum discoloured, sleep disorder, myalgia, diarrhea, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased, blood sodium decreased, chest x-ray abnormal, fluid balance negative, sars-cov-2 test positive, thyroxine free normal, ultrasound doppler abnormal and white blood cell count decreased and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000198865 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from central complaint vigilance department on 01-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result (Void: N) was added.; Sender's Comments: V2: Additional information received is regarding product quality complaint results. The follow up information received does not alter the assessment of prior causality of previously reported serious events.  :20211032294-Covid-19 vaccine ad26.cov2.s - Acute respiratory distress syndrome, acute respiratory failure, covid-19 pneumonia, deep vein thrombosis, sepsis, anticoagulant therapy, endotracheal intubation, covid-19, cough, dyspnoea, exposure to sars-cov-2, lung opacity, productive cough, lymphopenia, snoring, sputum discoloured, sleep disorder, myalgia, diarrhea, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased, blood sodium decreased, chest x-ray abnormal, fluid balance negative, sars-cov-2 test positive, thyroxine free normal, ultrasound doppler abnormal, and 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). 20211032294-covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event is considered not related. 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 than the drug. Specifically: SPECIAL SITUATIONS