Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Condition aggravated, Craniotomy, Death
Clinical narrative: DEATH; CRANIOTOMY; ANTICOAGULANT THERAPY; PULMONARY EMBOLISM; METASTASES TO CENTRAL NERVOUS SYSTEM; CONDITION AGGRAVATED; COVID-19; SARS-COV-2 TEST POSITIVE; MALAISE; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority, concerned a 66-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: resection of large bowel due to Crohn's disease on an unspecified date in 1995, 04 retinal surgery, craniotomy and status/post Inferior Vena Cava (IVC) filter placement (unspecified date). Concurrent conditions included: metastatic neoplasm of lung, primary malignant neoplasm of lung with metastasis to brain, Crohn's disease of small intestine with complication, Sensorineural hearing loss (SNHL) of both ears, retinal disease bilateral, kidney stones, chronic pain disorder due to Crohn's disease, intermediate stage no exudative age-related macular degeneration of both eyes, family history of early Coronary Artery Disease (CAD) with Mother, smoker, squamous cell left lung cancer on an unspecified date in MAY-2020, hydronephrosis of left kidney, Vitamin B12 (Cyanocobalamin) deficiency, hyperkalemia, hypomagnesemia, weakness of left upper extremity, herpes zoster with complication, protein-calorie malnutrition (unspecified severity), inability to walk, metastatic cancer to brain, partial seizure, elevated troponin, malignant neoplasm of lung (laterality unspecified), seizure, brain tumor, brain mass, pulmonary embolism and impaired consciousness due to partial seizure. Laboratory data (dates unspecified) included: Troponin (NR: not provided) Elevated.  The patient experienced rash when previously treated with Cefalexin (cephalexin) and experienced nausea when treated with (Bactrim) sulfamethoxazole/trimethoprim, both when used for an unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: unknown) dose was not reported, dose number in series was 1, 01 total, administered on 08-APR-2021 for an unspecified indication. Concomitant medications included (Norvasc) amlodipine besilate, hydrocodone bitartrate/paracetamol (Norco), levetiracetam (Keppra), magnesium hydroxide (Milk of magnesia) and nystatin/triamcinolone acetonide (Mycolog-II), all used for unknown indication and Durvalumab for metastatic neoplasm of lung.  On 01-NOV-2021, the patient was scheduled to have a craniotomy, but it was found that he had metastases to central nervous system (brain), and hence the procedure was postponed. On the same day, the patient experienced malaise and it was found that the patient tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, and had coronavirus disease (COVID-19), hence confirmed clinical vaccination failure. On 01-NOV-2021 his condition aggravated and he subsequently developed pulmonary embolism. He received monoclonal antibodies, his symptoms remained mild requiring no other treatment and was put on anticoagulant therapy on 01-NOV-2021. He was hospitalized on an unspecified date for all the above events. On 23-NOV-2021 the procedure was uneventful and he was discharged to inpatient rehabilitation on 30-NOV-2021. Patient was hospitalized for 12 days and was discharged on an unspecified date, with 14 days of anticoagulation. On 04-DEC-2021, the patient died from an unknown cause (dose number in series was 1). It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death, pulmonary embolism, metastases to central nervous system, condition aggravated, COVID-19, SARS-CoV-2 test positive, malaise, anticoagulant therapy and craniotomy was fatal and confirmed clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report is associated with product quality complaint: 90000207903. The suspected product quality complaint has been confirmed to be not voided (The reported allegation could not be confirmed. A manufacturing related root cause could not be identified.)  Additional information received from Regulatory Authority on 27-DEC-2021 The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: The follow up information in this version updates Product quality complaint investigation result added. This updated information does not alter the causality of previously reported events.  20211240538-COVID-19 VACCINE AD26.COV2.S-Death,Pulmonary embolism,Codition aggravated,Covid-19,SARS-COV2-Test positive,Malaise,Anticoagulant therapy,Craniotomy. 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).  20211240538-COVID-19 VACCINE AD26.COV2.S-Metastasis to central nervous system. 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  20211240538-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: UNKNOWN CAUSE OF DEATH