Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram, Electrocardiogram normal, Gastrooesophageal reflux disease, Glycosylated haemoglobin
Clinical narrative: ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; CHRONIC KIDNEY DISEASE; HYPERKALAEMIA; HYPOXIA; PNEUMONIA VIRAL; THROMBOCYTOPENIA; ANXIETY; AORTIC VALVE CALCIFICATION; BENIGN PROSTATIC HYPERPLASIA; CARDIOMEGALY; CHEST DISCOMFORT; CHEST PAIN; CONDITION AGGRAVATED; CONTINUOUS POSITIVE AIRWAY PRESSURE; RHONCHI; VIRAL INFECTION; BLOOD CREATININE INCREASED; BLOOD GLUCOSE INCREASED; C-REACTIVE PROTEIN INCREASED; CALCIUM IONISED DECREASED; CHEST X-RAY ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; GLYCOSYLATED HAEMOGLOBIN INCREASED; SARS-COV-2 TEST POSITIVE; TOTAL LUNG CAPACITY DECREASED; VITAMIN K DECREASED; WHITE BLOOD CELL COUNT INCREASED; BLOOD MAGNESIUM NORMAL; ELECTROCARDIOGRAM NORMAL; PULMONARY FUNCTION TEST NORMAL; TROPONIN; DYSPNOEA EXERTIONAL; GASTROOESOPHAGEAL REFLUX DISEASE; HYPERGLYCAEMIA; HYPOMAGNESAEMIA; HYPOCALCAEMIA; LUNG OPACITY; PANIC ATTACK; TACHYPNOEA; NAUSEA; DIARRHOEA; DYSPNOEA; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; PYREXIA; CHILLS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), concerned an 85 year old male patient of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included a percutaneous coronary intervention (PCI) in MAY-2017. On 19-MAY-2017, his chest X-ray showed cardiomegaly aortic vascular calcifications, low lung volumes, patchy left greater than right airspace opacities, no large pleural effusion, no significant pneumothorax, no acute osseous finding, no subdiaphragmatic free air. Concurrent conditions included gastroesophageal reflux disease (GERD), benign prostatic hyperplasia (BPH), obstructive sleep apnea (OSA), diabetes mellitus type II (DMII), chronic kidney disease (CKD), hypertension (HTN), hyperlipidemia (HLD), coronary artery disease (CAD), and myocardial infarction (status post PCI). The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included tamsulosin for benign prostatic hyperplasia, furosemide, enalapril, metoprolol tartrate, Aspirin (acetylsalicylic acid), atorvastatin, cetirizine, fluticasone, glipizide, nitroglycerin (glyceryl trinitrate), insulin glargine, potassium chloride, and pantoprazole for GERD. On an unspecified date, in AUG-2021 (over few days before hospital admission), the patient had fever/pyrexia [100.2 (unit not provided)] and chills. The patient was hypoxic at home with an oxygen saturation (SpO2) in the high 80s. On 02-AUG-2021, the patient experienced dyspnea and was diagnosed with coronavirus disease (COVID-19). On the same day,  patient presented to the emergency department for dyspnea. The patient  was alert, oriented but had a poor history and was exposed to COVID-19 by another family member a few weeks ago before presentation. His SpO2 was as low as 92% on room air on presentation with tachypnea (20-30s). The patient's dyspnea progressively worsened. It was reported that the dyspnea was worse on exertion and caused anxiety and panic attack with chest tightness (chest discomfort) when it occurred. On 07-AUG-2021, at 18:20, the patient was hospitalized and was tested positive for COVID-19/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (suspected clinical vaccination failure).  The patient was admitted with viral pneumonia secondary to SARS COVID-19 pneumonia and with acute hypoxic respiratory failure requiring supplemental oxygen secondary to COVID-19 viral infection. On admission, the patient was put on 3L nasal cannula with SpO2 97%. The patient had nausea and diarrhea but stated it was very little and denied vomiting abdominal pain, dysuria, cough, congestion, sore throat, heart palpitations or travel. On 07-AUG-2021, the patient experienced aortic valve calcification, benign prostatic hyperplasia, cardiomegaly, chest pain, chronic kidney disease (stage 3b), condition aggravated, gastrooesophageal reflux disease, hyperglycaemia (likely secondary to steroid use in the setting of uncontrolled type 2 diabetes), hyperkalaemia, hypocalcaemia, hypomagnesaemia (value was 1.4), lung opacity, thrombocytopenia (likely secondary to covid) and uses continuous positive airway pressure (CPAP). Laboratory data included: Blood creatinine increased to 1.7 (unit not provided), Blood glucose increased to 377, blood magnesium was normal, breath sounds revealed presence of rhonchi in the left upper lobe (LUL) and diminished throughout but no wheezing, C-reactive protein increased to 152, calcium ionised decreased to 4.4, chest X-ray showed dyspnea and was consistent with atypical or viral infection including COVID-19 (abnormal), computerised tomogram (CT) thorax showed no pulmonary embolism but bilateral ground glass airspace disease consistent with viral pneumonia (abnormal), electrocardiogram (ECG) showed normal sinus without acute ST changes, glycosylated haemoglobin (HbA1C) increased to 9.1% and 8.7% (last HbA1C was at 9%), pulmonary function test was normal, total lung capacity decreased, troponin was at 33, Vitamin K decreased, and white blood cell count increased to 10 and 57 (unit not provided for tests). The patient was on 3-4 L of nasal cannula and appeared to be progressing well. On 08-AUG-2021, his C-reactive protein values were at 46.9, 29.8, 17.1, 11.7, 8.2, 5.5 (baseline unknown; unit not provided) and completed remdesivir 200 mg on day 1 of hospitalization and then 100 mg daily for 4 days. On 08-AUG-2021, patient completed remdesivir (200mg) then 100 mg daily for 4 days. His Vitamin K values were 4.9, 4.5, 5.8 (unit not provided) and when hemolyzed the values were 4.3, 4.1 and 4.2 (during hospital stay; date unspecified). On 10-AUG-2021, the patient was started on oral dexamethasone 6 mg for 10 days. A recovery trial protocol was started which included oxygen per nasal canula (titrate oxygen for 92-96% on room air), precautionary use of N95 masks, face shields, gowns, gloves. Albuterol (salbutamol) HFA, every 4 hours as required (prn) and oral acetaminophen 650 mg every 6 hours prn for fever was started and the patient was on insulin lantus 24 units at bedtime and insulin lispro (during hospital stay). The patient glucose inpatient had been labile ranging between 80s and 300s which was worsened by the steroids. Serum creatinine values were 1.48, 1.72,1.58, 1.45, 1.43, 1.39 and after ACE inhibitor Enalapril was resumed, the values were 1.37, 1.44 (unit not provided).  On 19-AUG-2021 and 21-AUG-2021, the patient was tested positive for covid-19 patient  and his son both stated they use a mask all night while sleeping and CPAP humidifier at night starting with 5 cm pressure. On 22-AUG-2021, the patient was discharged from the hospital to home. On discharge, the patient was given enoxaparin 30 mg, subcutaneous, twice a day as prophylaxis and there was a plan to wean him off oxygen and  was put on on lantus 30 units and lispro 10 units 3 times a day with meals (at home). The patient was hospitalized for 15 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute respiratory failure, covid-19 pneumonia, chronic kidney disease, hyperkalaemia, hypoxia, pneumonia viral, thrombocytopenia, anxiety, aortic valve calcification, benign prostatic hyperplasia, covid-19, cardiomegaly, chest discomfort, chest pain, condition aggravated, continuous positive airway pressure, dyspnoea, dyspnoea exertional, gastrooesophageal reflux disease, hyperglycaemia, hypomagnesaemia, hypocalcaemia, lung opacity, panic attack, tachypnoea, nausea, chills, diarrhoea, pyrexia, rhonchi, viral infection, blood creatinine increased, blood glucose increased, c-reactive protein increased, calcium ionised decreased, chest x-ray abnormal, computerised tomogram thorax abnormal, glycosylated haemoglobin increased, sars-cov-2 test positive, total lung capacity decreased, vitamin k decreased, white blood cell count increased, blood magnesium normal, electrocardiogram normal, pulmonary function test normal, and troponin, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000193179. 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 21-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result was added.; Sender's Comments: V1: PQC result updated. This new information does not change the previous assessment. 20210920726-covid-19 vaccine ad26.cov2.s-  chronic kidney disease,  hyperkalaemia,  benign prostatic hyperplasia,  gastrooesophageal reflux disease,  hyperglycaemia,  Hypocalcaemia,  blood creatinine increased,  blood glucose increased,  calcium ionised decreased, glycosylated haemoglobin increased, cardiomegaly, aortic valve calcification. 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 20210920726-covid-19 vaccine ad26.cov2.s:  acute respiratory failure,  covid-19 pneumonia, covid-19, Hypoxia, pneumonia viral, thrombocytopenia,  anxiety, chest discomfort, chest pain, condition aggravated, continuous positive airway pressure, dyspnoea, dyspnoea exertional, hypomagnesaemia, lung opacity, panic attack, tachypnea, nausea, chills, diarrhea, pyrexia, rhonchi, viral infection,  c-reactive protein increased, chest x-ray abnormal, computerised tomogram thorax abnormal, sars-cov-2 test positive, total lung capacity decreased, vitamin k decreased, white blood cell count increased, blood magnesium normal, electrocardiogram normal, pulmonary function test normal, troponin. 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). 20210920467-Covid-19 vaccine ad26.cov2.s-suspected 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