Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: PULMONARY EMBOLISM; ABDOMINAL PAIN; ANTICOAGULANT THERAPY; BLOOD LACTIC ACID INCREASED; COVID-19; CHEST PAIN; COMPUTERISED TOMOGRAM THORAX; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; TROPONIN INCREASED; CONFIRMED CLINICAL VACCINATION FAILURE; ACUTE MYOCARDIAL INFARCTION; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1885754) concerned a 74 year old male. Initial information was processed along with additional information received on 02-DEC-2021.  The patient's height, and weight were not reported. The patient's past medical history included percutaneous coronary intervention (PCI) to ungrafted left circumflex in the setting of prior coronary artery bypass graft (CABG) in 2014. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm, on 17-MAY-2021 for an unspecified indication. No concomitant medications were reported.  In OCT-2021, the patient experienced Non-ST-Elevation Myocardial Infarction (NSTEMI, acute myocardial infarction). On 10-NOV-2021, the patient experienced submassive pulmonary embolism and admitted to intensive care unit. On the same date, the patient also received a diagnosis of COVID-19 (sars-cov-2 test positive). The test done was PCR (polymerase chain reaction) and detected as symptomatic positive (confirmed clinical vaccination failure). Over the course of the last week, patient experienced stuttering episodes of chest and abdominal pain abrupt in onset and progressive in nature. The patient had a significant event which prompted his presentation to the emergency department where computerised tomogram (CT) pulmonary angiogram (computerised tomogram thorax) demonstrated extensive bilateral thromboembolism. On initial presentation his blood pressure was 70 systolic and he had an elevated lactate and troponin but rapidly stabilized with 1 liter of crystalloid resuscitation and heparin infusion (anticoagulant therapy). Due to the lack of PCU (progressive care unit) beds he was transferred for telemetry monitoring. The patient was hospitalized for unspecified days.  Laboratory data included: Blood lactic acid (NR: not provided) Increased, Computerised tomogram thorax (NR: not provided) bilateral thromboembolism, SARS-CoV-2 PCR test (NR: not provided) Positive, and Troponin (NR: not provided) Increased, Systolic blood pressure (NR: not provided) 70 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, acute myocardial infarction, anticoagulant therapy, blood lactic acid increased, covid-19, chest pain, computerised tomogram thorax, intensive care, pulmonary embolism, sars-cov-2 test positive, and troponin increased, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint 90000205237. 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 09-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number and investigation result.; Sender's Comments: V1: This follow up version was created to update PQC investigation result. This updated information doesn't alter previous causality assessment made for the events in the case.   20211202323- COVID-19 VACCINE AD26.COV2.S- Acute myocardial infarction . 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: MEDICAL HISTORY 20211202323-COVID-19 VACCINE AD26.COV2.S- Pulmonary embolism, Abdominal pain, Anticoagulant therapy, Blood lactic acid increased, Covid-19, Chest pain, Computerised tomogram thorax, Intensive care, Sars-cov-2 test positive, Troponin increased. 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). 20211202323-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