Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, Vaccination failure
Clinical narrative: NEAR DEATH EXPERIENCE; GASTROINTESTINAL HAEMORRHAGE; THROMBOSIS; COVID-19; CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; INTENSIVE CARE; MECHANICAL VENTILATION; OESOPHAGOGASTRODUODENOSCOPY; ULTRASOUND DOPPLER ABNORMAL; This spontaneous report received from a health care professional by a Regulatory Authority (Vaccine Adverse Event Reporting System) concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: kidney transplant, post heart bypass surgery, and amputation below knee, and concurrent conditions included: type 1 diabetes, kidney failure, and hypertension. The patient had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: Unknown) dose was not reported, (dose number in series was 1), 1 in total was administered on 21-OCT-2021 for an unspecified indication. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-NOV-2021, following the vaccination with covid-19 vaccine ad26.cov2.s, the patient had major GI Bleed (gastrointestinal haemorrhage) within a month and blood clots (thrombosis) bilateral arms. He was still inpatient. Doctors were not saying anything about vaccine but he had vaccine and then tested positive for COVID (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive) which resulted in confirmed clinical vaccination failure. Inpatient for one month and then transferred where GI (gastro intestinal) bleed and clots were found. He was inpatient almost to the 2 month mark. He almost died from bleed (near death experience) and they were still dealing with the clots. Physicians do not like to talk about vaccine issues. Ultrasound doppler of arms DVT (deep vein thrombosis) was abnormal, EGD (Oesophagogastroduodenoscopy) was performed to stop GI Bleed and 1 week following on a vent (mechanical ventilation) in ICU (intensive care unit) (dose number in series was 1). He was hospitalized on an unspecified date. He was hospitalized for 48 days and discharge date was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from COVID-19, gastrointestinal haemorrhage, intensive care, mechanical ventilation, near death experience, oesophagogastroduodenoscopy, SARS-COV-2 test positive, thrombosis, and ultrasound doppler abnormal, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused/Prolonged and Life Threatening). This report was associated with product quality complaint: 90000210097. 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 10-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Follow up information updated : Product quality complaint investigation result. This updated information does not alter the causality of previously reported event. 20220100131-COVID-19 VACCINE AD26.COV2.S-Near death experience, Gastrointestinal haemorrhage, Thrombosis, COVID-19, Mechanical ventilation, Intensive care, , SARS-CoV-2 test positive, Oesophagogastroduodenoscopy, Ultrasound Doppler abnormal. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20220100131-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination  failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS