Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Heart rate, Hypoaesthesia, Pain in extremity, Peripheral coldness
Clinical narrative: AORTIC DISSECTION; AORTIC ANEURYSM REPAIR; ARTERIOGRAM CORONARY ABNORMAL; ASYMPTOMATIC COVID-19; CAPILLARY NAIL REFILL TEST ABNORMAL; ECHOCARDIOGRAM; ENDOTRACHEAL INTUBATION; HYPOAESTHESIA; PERIPHERAL COLDNESS; PULSE ABSENT; SARS-COV-2 TEST POSITIVE; SENSORY LOSS; STERNOTOMY; PAIN IN EXTREMITY; This spontaneous report received from a health care professional via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 53 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included heart failure, concurrent conditions included ex-smoker, hypertension, obesity, and asthma and type A dissecting thoracic aortic aneurysm measuring up to 6.1. The patient's pre-existing medical conditions included that he had no allergies to medications, food, or other products. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 total was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Docusate, Ibuprofen, paracetamol (Acetaminophen), and salbutamol (Albuterol) for an unknown indication.  On 20-MAY-2021, the patient went to hospital via EMS (emergency medical services) for leg pain (pain in extremity) and numbness (hypoaesthesia). The patient's left lower extremity was cooler (peripheral coldness) to the touch. The patient's pulses were absent, and abnormal (difficult to palpate and doppler). The patient had capillary nail refill test which was slow and around 3 to 4 seconds. It was reported that he was unable to feel a sensation (sensory loss) but was able to wiggle his toes. The patient had arteriogram coronary which was abnormal, CT angiogram (computerized tomography angiography) which revealed dissecting aneurysm (aortic dissection) and had echocardiogram whose results were not reported. The patient had cardiothoracic surgery for aortic aneurysm repair. The patient underwent to median sternotomy for replacement of aorta with ascending hemashield platinum 34 mm. The patient had TEE (Transesophageal echocardiography) incubation (endotracheal intubation) and was postoperatively on high flow NC (Nasal cannula) oxygen Critical care. The patient had SARS-CoV-2 and Covid-19 test which came out positive and he experienced asymptomatic Covid-19. The patient was discharged to home. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aortic dissection, aortic aneurysm repair, arteriogram coronary abnormal, asymptomatic covid-19, capillary nail refill test abnormal, echocardiogram, endotracheal intubation, hypoaesthesia, pain in extremity, peripheral coldness, pulse absent, sars-cov-2 test positive, sensory loss and sternotomy. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183696. The suspected product quality complaint has been confirmed not to be voided based on the PQC evaluation/ Investigation performed. It was reported that a valid lot number was unavailable and due diligence to obtain product identification information and field sample availability was performed as applicable. In lieu of a batch specific review, an overall review of the manufacturing and packaging process, release process, and product quality review results was performed. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified.  Additional information was received from central complaint vigilance on 08-JUL-2021. The following information was updated and incorporated into the case narrative: investigation result added, event of clinical vaccination failure deleted.; Sender's Comments: V1: Additional information updated in this version includes deletion of event clinical vaccination failure and investigation results of PQC. This information doesn't alter causality of previously reported events. 20210640575-Covid-19 vaccine ad26.cov2.s -aortic dissection, aortic aneurysm repair, capillary nail refill test abnormal, hypoaesthesia, peripheral coldness, pulse absent, sensory loss. 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: MEDICAL HISTORY, UNDERLYING DISEASE 20210640575-Covid-19 vaccine ad26.cov2.s - arteriogram coronary abnormal, asymptomatic covid-19, echocardiogram, endotracheal intubation, sars-cov-2 test positive, sternotomy. 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). 20210640575-Covid-19 vaccine ad26.cov2.s -pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.