Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myopathy, Positive airway pressure therapy, Respiratory failure, Vaccination failure
Clinical narrative: DEATH; CLOSTRIDIUM DIFFICILE INFECTION; RESPIRATORY FAILURE; COVID-19; HYPERCAPNIA; POSITIVE AIRWAY PRESSURE THERAPY; MYOPATHY; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1909805), concerned a 68 year old male of unspecified race and ethnicity. Initial information processed, with additional information received from Complaint Department on 13-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cataract, type 2 diabetes mellitus, hypertension, paroxysmal atrial fibrillation, renal insufficiency, obstructive sleep apnea syndrome/sleep apnea, glaucoma, bipolar disorder, chronic kidney disease, congestive heart failure, hemorrhoids, chronic diastolic mass of right hand, heart failure with preserved ejection fraction, and presbyopia. The patient experienced swelling when treated with atenolol, drug allergy when treated with colchicine, and metformin. The patient received covid-19 vaccine ad26.cov2.s (Dose series number: 1) (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 to right arm for an unspecified indication. Concomitant medications included amiodarone hydrochloride, astragalus spp, extract/avena sativa extract/crataegus spp, extract/cynara cardunculus extract/echinacea purpurea extract/eleutherococcus senticosus extract/gentiana lutea extract/glycyrrhiza glabra extract/urtica dioica extract, docusate sodium, hydrocortisone, iron, lycopene, paracetamol, and rivaroxaban. On AUG-2021, the patient experienced myopathy (proximal myotonic myopathy), colchicine-induced myopathy. On 27-SEP-2021, the patient experienced covid-19 (nosocomial covid-19), clostridium difficile infection, hypercapnia, respiratory failure and which resolved with positive airway pressure therapy (BiPAP (bi-level positive airway pressure)). On an unspecified date, the patient experienced suspected clinical vaccination failure. On 05-NOV-2021, the patient died from covid-19, clostridium difficile infection, hypercapnia, myopathy, positive airway pressure therapy, and respiratory failure. The patient was hospitalized for 38 days, date of hospital admission was not reported. It was unknown an autopsy performed. It was reported that the patient used free style Lite Test strips for blood sugar diagnostics. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19, clostridium difficile infection, hypercapnia, myopathy, positive airway pressure therapy, and respiratory failure on 05-NOV-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed. This report was associated with product quality complaint number: 90000206896.  Additional information was received from Complaint Department on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation results added.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: Product quality complaint investigation results added.This added information does not alter the causlity of previous reported events. 20211225551-covid-19 vaccine ad26.cov2.s-Death, covid-19 ,clostridium difficile infection, hypercapnia, myopathy, positive airway pressure therapy, respiratory failure. 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). 20211225551-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.; Reported Cause(s) of Death: COVID-19; CLOSTRIDIUM DIFFICILE INFECTION; HYPERCAPNIA; MYOPATHY; POSITIVE AIRWAY PRESSURE THERAPY; RESPIRATORY FAILURE