Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test, Liver function test increased, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: DEATH; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; HYPOXIA; FALL; BLOOD CREATINE PHOSPHOKINASE INCREASED; BRAIN NATRIURETIC PEPTIDE INCREASED; LIVER FUNCTION TEST INCREASED; SARS-COV-2 TEST POSITIVE; COVID-19; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 72 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: PAF (paroxysmal atrial fibrillation), stage 3 severe COPD (chronic obstructive pulmonary disease), CAD (coronary artery disease), HLD (hyperlipidemia), drug allergy to isoflurane and codeine, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 to right arm for an unspecified indication. The drug start period (latency) was 298 days. Concomitant medications included oxygen for stage 3 severe COPD, amitriptyline, azithromycin, bismuth subsalicylate (Pepto bismol), budesonide, diltiazem, ezetimibe (Zetia), fluticasone, formoterol, furosemide, gabapentin, glycopyrronium bromide (Glycopyrrolate), ipratropium, methocarbamol, ondansetron, prednisone, rosuvastatin, salbutamol (albuterol), and tizanidine. On 18-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The sample was analyzed using the Roche LIAT SARS (severe acute respiratory syndrome) assay platform using PCR (polymerase chain reaction) or equivalent NAA (nucleic acid amplification technology). The patient had experienced covid-19. On 22-JAN-2022, the patient had presented to the emergency department after falling out of bed and was found down without oxygen (hypoxia). The patient was admitted for acute hypoxemic respiratory failure and covid-19 pneumonia complicated by elevated liver function test (LFT), troponin brain natriuretic peptide (BNP) and creatine kinase (CK). The patient was placed on 2 liter nasal cannula oxygen (O2). The hypoxia had worsened throughout admission. The patient was treated with Paxloid, methylprednisolone sodium succinate (Solumedrol) and remdesivir. The patient was transitioned to comfort care. On 31-JAN-2022, Laboratory data included: Blood creatine phosphokinase (NR: not provided) Increased, Brain natriuretic peptide (NR: not provided) Increased, Liver function test (NR: not provided) Increased, and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test (NR: not provided) Positive. On 31-JAN-2022, the patient died from an unknown cause of death. It was unknown if an autopsy was performed. The patient was hospitalized for 9 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, acute respiratory failure, covid-19 pneumonia, hypoxia, covid-19, fall, blood creatine phosphokinase increased, brain natriuretic peptide increased, liver function test increased and sars-cov-2 test positive on 31-JAN-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000219432. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. 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 04-MAR-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event. 20220258559-COVID-19 VACCINE AD26.COV2.S-death, acute respiratory failure, covid-19 pneumonia, hypoxia, covid-19, fall, blood creatine phosphokinase increased, brain natriuretic peptide increased, liver function test increased and sars-cov-2 test positive. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH