Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical ventilation, Oxygen saturation, Pulmonary embolism, Respiratory failure, SARS-CoV-2 test
Clinical narrative: SINUS TACHYCARDIA; LUNG OPACITY; CONDITION AGGRAVATED; ENDOTRACHEAL INTUBATION; MECHANICAL VENTILATION; INTENSIVE CARE; TROPONIN INCREASED; ANGIOGRAM PULMONARY ABNORMAL; C-REACTIVE PROTEIN INCREASED; COMPUTERISED TOMOGRAM THORAX ABNORMAL; LEUKOCYTOSIS; SARS-COV-2 TEST POSITIVE; ACUTE KIDNEY INJURY; PULMONARY EMBOLISM; CHRONIC KIDNEY DISEASE; INTERSTITIAL LUNG DISEASE; RESPIRATORY FAILURE; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1909661) concerned a 67 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: calculus of kidney, and myocardial infarction, and concurrent conditions included: chronic kidney disease, coronary artery disease status post stent 2016 and left carotid endarterectomy 2019, hyperlipidemia, and hypertension, and other pre-existing medical conditions included: The patient had diseases of the circulatory system. The patient had no known drug allergy. The patient was previously treated with ipratropium bromide/salbutamol sulfate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: unknown) dose was not reported, 1 total administered to the left arm on 11-MAR-2021 for an unspecified indication. Concomitant medications included acetylsalicylic acid, allopurinol, atorvastatin, bisoprolol, clopidogrel, lisinopril, piperacillin sodium/tazobactam sodium, prednisone and steroid tapered (60mg for 7 days, 50mg for 7 days, 40mg for 7 days, 30mg for 7 days, 20mg for 7 days, and 10mg for 7 days).  On 02-OCT-2021, Laboratory data included: Computerised tomogram thorax (NR: not provided) lesser radiographically dense. Patient was diagnosed with covid-19, which was treated outpatient with supplemental oxygen over the last month patient was able to wean his oxygen to 4 liter NC (nasal cannula) until a few days ago, on admission patient on 8 on 10 liter NC at home with oxygen saturation no better than 90 percent. On 04-NOV-2021, Laboratory data included: Computerised tomogram thorax (NR: not provided) Abnormal.  On arrival to Emergency department (ED) patient was alert but hypoxic with initial work up, significant for small subsegmental Pulmonary Embolism (PE), on computerised tomogram thorax abnormal (CTA), elevated troponins, leukocytosis, acute kidney injury (AKI), on chronic kidney disease (CKD) and elevated (c-reactive protein) CRP. He was admitted and started on therapeutic lovenox, levaquin and steroids. On 06-NOV-2021, the patient experienced acute kidney injury, chronic kidney disease, interstitial lung disease, pulmonary embolism, respiratory failure, angiogram pulmonary abnormal, c-reactive protein increased, computerised tomogram thorax abnormal, condition aggravated, endotracheal intubation, intensive care, leukocytosis, lung opacity, mechanical ventilation, sars-cov-2 test positive, sinus tachycardia, troponin increased and was hospitalized (date unspecified) for 24 days. During hospitalization patient was continued to have increasing oxygen requirements and was placed on HFNC (High flow nasal cannula) 100 percent 30 liter. Consulted for transfer to higher level of care per family request Upon exam patient was intubated and sedated on 100 percent on the vent. Outpatient pulm follow up encourage incentive spirometry daily 1hrs chest physiotherapy scheduled. Discontinued Duoneb since patient did not feel much significant improvement and had sinus tachycardia. Laboratory data included: C-reactive protein (NR: not provided) elevated, CT angiography (NR: not provided) Subsegmental Pulmonary Embolism, Cardiac troponin (NR: not provided) elevated, Computerised tomogram thorax (NR: not provided) Abnormal, and SARS-CoV-2 test (NR: not provided) positive. On 22-NOV-2021, Laboratory data included: Computerised tomogram thorax (NR: not provided) lesser radiographically dense. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) no better than 90 percent. Treatment medications (dates unspecified) included: levofloxacin.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute kidney injury, pulmonary embolism, chronic kidney disease, interstitial lung disease, respiratory failure, covid-19, sinus tachycardia, lung opacity, condition aggravated, endotracheal intubation, mechanical ventilation, intensive care, troponin increased, angiogram pulmonary abnormal, c-reactive protein increased, computerised tomogram thorax abnormal, leukocytosis, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged).  This report was associated with product quality complaint: 90000207062. 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 received from Central Complaint Vigilance Department on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: dose number in series was 1 removed from narrative and confirmed clinical vaccination failure removed as event.; Sender's Comments: V1: The additional information in this version is Product quality complaint investigation result, dose number in series was 1 removed from narrative and confirmed clinical vaccination failure removed as event. This doesnot alter causality of previously reported events.  20211225843-JANSSEN COVID-19 VACCINE Ad26.COV2.S-acute kidney injury, chronic kidney disease. 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: MEDICAL HISTORY, UNDERLYING DISEASE  20211225843-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism, interstitial lung disease, respiratory failure,covid-19,sinus tachycardia, lung opacity, condition aggravated, endotracheal intubation, mechanical ventilation, intensive care,troponin increased, angiogram pulmonary abnormal, c-reactive protein increased, computerised tomogram thorax abnormal,  leukocytosis, sars-cov-2 test positive, -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).