Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, COVID-19 pneumonia, Cardiac failure congestive, Cellulitis
Clinical narrative: ORAL CANDIDIASIS; TRACHEOSTOMY; GASTROSTOMY; MECHANICAL VENTILATION; ENDOTRACHEAL INTUBATION; BLOOD CREATININE INCREASED; BLOOD GLUCOSE INCREASED; BLOOD POTASSIUM INCREASED; BLOOD SODIUM DECREASED; BLOOD UREA INCREASED; CHEST X-RAY ABNORMAL; SARS-COV-2 TEST POSITIVE; HAEMOGLOBIN DECREASED; TRANSAMINASES INCREASED; HYPERKALAEMIA; TACHYCARDIA; CONFIRMED CLINICAL VACCINE FAILURE; HYPERGLYCAEMIA; HYPONATRAEMIA; HYPOTENSION; LIMB INJURY; COVID-19; ANAEMIA; COUGH; DIZZINESS; DYSPNOEA; DYSPNOEA EXERTIONAL; MYOCARDITIS; PAIN; POLYURIA; ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; CARDIAC FAILURE CONGESTIVE; CELLULITIS; BLOOD MAGNESIUM; VENTRICULAR EXTRASYSTOLES; MALAISE; VOMITING; HEADACHE; DIARRHOEA; NAUSEA; PYREXIA; This spontaneous report received from a health care professional via a Regulatory Authority (Vaccine Adverse Event Reporting System) (VAERS ID: 1821349) concerned a 51 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: BPH (Benign prostatic hyperplasia), hypertension, type 2 diabetes mellitus, GERD (Gastroesophageal reflux disease), and morbid obesity. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, frequency time 1 total administered on 02-JUN-2021 for an unknown indication. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included alprazolam, amlodipin, bisacodyl, celecoxib, clonidine, cyclobenzaprine, duloxetine, gabapentin, lisinopril, Albuterol (salbutamol) for unknown indication, and insulin glargine (Lantus) for type 2 diabetes. Patient was on GlucoStabilizer protocol, but eventually transitioned to Lantus 35U BID (twice a day) with correctional dose of insulin. On 24-AUG-2021, the patient started feeling unwell (malaise). He had fever, dizziness, body aches, headache, and vomiting. The vomiting was persistent since 24-AUG-2021 (Tuesday). He had chronic bilateral lower extremities wounds (limb injury), and had been seen by wound care. He was seen in urgent care with concerns for cellulitis and was placed on ciprofloxacin. His symptoms worsened and he developed severe shortness of breath, which was worse on exertion (dyspnea and dyspnoea exertional) and a dry cough. He developed some nausea with diarrhea. He wore a BIPAP (Bilevel Positive Airway Pressure) at home. He was not on any diuretics. He believed he might have been told in the past that he has congestive heart failure, but was unsure. On 29-AUG-2021 patient presented to emergency room with a chief complaint of vomiting. On arrival to emergency room patient was febrile with body temperature 101.3, tachycardic with heart rate 113, hypotensive with blood pressure 99/66. Laboratory data included: Blood creatinine 2.84 (increased), Blood glucose (NR: not provided) 422 (increased/hyperclycemia), Blood potassium 5.4 (increased/hyperkalemia), Blood sodium 126 (decreased/hyponatremia), Blood urea nitrogen 27 (increased), Chest X-ray abnormal (showed CHF superimposed pneumonia not excluded), Haemoglobin 11.3 (decreased/anemia), SARS-CoV-2 test positive (COVID-19 and confirmed clinical vaccination failure), and Transaminases 51 (increased). Intravenous (IV) Levaquin was initiated, and IV hydration NS 0.9 percent 1 litre bolus given in emergency room. The patient had acute kidney injury and COVID-19 pneumonia. Patient was admitted to hospital on 29-AUG-2021 for acute hypoxic respiratory failure due to COVID-19 PNA (peptide nucleic acid). Patient was intubated on 30-AUG-2021. He was given remdesivir, Actemra (tocilizumab), dexamethasone, Rocephin (ceftriaxone), azithromycin, ceftazidime, vancomycin, and Zosyn (piperacillin sodium/tazobactam sodium). He was diuresed with Lasix (furosemide). He remained on mechanical ventilation throughout hospitalization. Patient was removed from precautions on 17-SEP-2021, tracheostomy and PEG (percutaneous endoscopic gastrostomy) tube (gastrostomy) were placed at that time. He was weaned from his paralytic on 18-SEP-2021. He was continued with on Lovenox (Enoxaparin sodium) 40 mg subcutaneous daily for VTE (venous thromboembolism) prophylaxis. Patient had multifocal ventricular ectopy while he was hospitalized. Cardiology was consulted, and suspected etiology was COVID myocarditis. Patient was unable to tolerate beta-blockers. His magnesium levels and potassium levels were optimized. Patient was on tube feeds via PEG tube. Patient had oral candidal lesions (oral candidiasis) on 22-SEP-2021 and was started on nystatin oral solution 4 times daily for 7 days. Patient was accepted by privacy and discharged on 22-SEP-2021 to local HCF (health care facility) after 24 days of hospitalization. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, acute respiratory failure, anaemia, blood creatinine increased, blood glucose increased, blood magnesium, blood potassium increased, blood sodium decreased, blood urea increased, covid-19, covid-19 pneumonia, cardiac failure congestive, cellulitis, chest x-ray abnormal, cough, diarrhoea, dizziness, dyspnoea, dyspnoea exertional, endotracheal intubation, gastrostomy, haemoglobin decreased, headache, hyperglycaemia, hyperkalaemia, hyponatraemia, hypotension, limb injury, malaise, mechanical ventilation, myocarditis, nausea, oral candidiasis, pain, polyuria, pyrexia, sars-cov-2 test positive, tachycardia, tracheostomy, transaminases increased, ventricular extrasystoles, vomiting and confirmed clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000201382. 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 16-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1-Additional information received updates Product Quality complaint investigation result. This updated information does not alter prior causality assessment of reported events 20211115148 - covid-19 vaccine ad26.cov2.s Acute kidney injury, Acute respiratory failure, Covid-19, Covid pneumonia, Cardiac failure congestive, Hyperkalemia, Myocarditis, Anaemia, Cough, Dizziness, Dyspnea, Dyspnea exertional, Hyponatremia, Hypotension, Limb injury, Pain, Tachycardia, Ventricular extrasystole, Malaise, vomiting, Headache, Nausea, Diarrhoea, Pyrexia, Tracheostomy, Gastrostomy, mechanical ventilation, endotracheal intubation, blood creatinine increased, blood magnesium, blood potassium increased, blood sodium decreased, blood urea increased, chest x-ray abnormal, sars-cov-2 test positive, transaminases increased, haemoglobin 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).   20211115148 - 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   20211115148 - covid-19 vaccine ad26.cov2.s- Cellulitis, Hyperglycemia, oral candiasis, Polyuria, blood glucose increased. 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