Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Device occlusion, Electrocardiogram, Electrocardiogram abnormal, Endotracheal intubation, Mechanical ventilation
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CATHETERISATION CARDIAC ABNORMAL; ELECTROCARDIOGRAM ABNORMAL; CARDIAC ARREST; CHEST DISCOMFORT; DEVICE OCCLUSION; ENDOTRACHEAL INTUBATION; MECHANICAL VENTILATION; RESUSCITATION; STENT PLACEMENT; COVID-19 PNEUMONIA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER ID 1628639) concerned a 78 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 15-AUG-2021, two days ago the patient was admitted with COVID-19 pneumonia. On 24-AUG-2021, in the morning around 9:30 AM, the patient developed chest discomfort which was progressed. The patient's Electrocardiogram (EKG) progressed over time (Electrocardiogram abnormal). On the same day, the patient had catheterisation cardiac which showed abnormal result. It was reported that, the patient underwent a cardiac arrest and was resuscitated after three rounds of epinephrine 300 mg, amiodarone IV (amiodarone) and debrillation x1 (Defibrillation). Patient was intubated (Endotracheal intubation) and put on a ventilator (Mechanical ventilation). The patient was transferred to another Hospital via helicopter and taken to emergently to cardiac cath lab (Cardiac catheterization laboratories). patient lab was occluded with (Device occlusion) and stented (Stent placement). On an unspecified date, the patient experienced suspected clinical vaccination failure. The patient was hospitalized for 9 days. At the time of this report, the patient was continues to be inpatient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 pneumonia, cardiac arrest, catheterisation cardiac abnormal, chest discomfort, device occlusion, electrocardiogram abnormal, endotracheal intubation, mechanical ventilation, resuscitation, stent placement and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint: 90000192511. 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 23-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:The additional information in this version is Product quality complaint investigation result.This does not alter causality of previously reported events.  20210908194-COVID-19 VACCINE AD26.COV2.S-  COVID-19 pneumonia, Cardiac arrest, Chest discomfort, Device occlusion, Endotracheal intubation, Mechanical ventilation, Resuscitation, Stent placement, Catheterisation cardiac abnormal,  Electrocardiogram abnormal. 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). 20210908194-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