Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Treatment noncompliance, Ultrasound Doppler, Ultrasound Doppler abnormal, Vitamin B12, Vitamin B12 decreased
Clinical narrative: ACUTE KIDNEY INJURY; POLYNEUROPATHY; CHEST X-RAY ABNORMAL; HYPERKALAEMIA; BLOOD CREATININE INCREASED; DEEP VEIN THROMBOSIS; FALL; LUNG OPACITY; BLOOD GLUCOSE INCREASED; AGGRESSION; POLYNEUROPATHY; COVID-19; AGGRESSION; CONDITION AGGRAVATED; FALL; HYPERGLYCAEMIA; HYPERGLYCAEMIA; VITAMIN B12 DEFICIENCY; NASAL CONGESTION; BLOOD POTASSIUM INCREASED; VITAMIN B12 DEFICIENCY; WHITE BLOOD CELL COUNT NORMAL; BLOOD CREATININE INCREASED; HYPERKALAEMIA; BLOOD GLUCOSE INCREASED; DEEP VEIN THROMBOSIS; BLOOD POTASSIUM INCREASED; LUNG OPACITY; CHEST X-RAY ABNORMAL; COVID-19; GLYCOSYLATED HAEMOGLOBIN INCREASED; NASAL CONGESTION; SARS-COV-2 TEST POSITIVE; GLYCOSYLATED HAEMOGLOBIN INCREASED; ULTRASOUND DOPPLER ABNORMAL; VITAMIN B12 DECREASED; WHITE BLOOD CELL COUNT NORMAL; TREATMENT NONCOMPLIANCE; TREATMENT NONCOMPLIANCE; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System, VAERS ID: Unknown) concerned a 52 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psychiatric disorder NOS, and other pre-existing medical conditions included: The patient had past medical history (PMH) significant for type 2 insulin-dependent diabetes mellitus (T2IDDM), deep vein thrombosis/pulmonary embolism (DVT/PE) and polyneuropathy. The patient was previously treated with lithium and bupropion for psychiatric disorder NOS (patient stated he did not like the side effects and did not take them. He did not want to restart those medications. Psychiatry was consulted, no new medication was advised).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 01 total, administered on 25-MAY-2021 for an unspecified indication. Age at time of vaccination 52 years old. No concomitant medications were reported. On 28-SEP-2022 (491 days after vaccination), the patient was hospitalized for deep vein thrombosis/pulmonary embolism (DVT/PE) and polyneuropathy. Patient presented hospital with fall, found to be hyperglycemic (hyperglycaemia) by EMS (emergency medical service) (aggression, condition aggravated). On the same day, the patient's blood glucose was increased (891 without anion gap or acidosis), hematocrit (HCT) was done which showed no acute process, chest x-ray (CXR) was abnormal showed right lower lobe (RLL) lung opacity. Patient also had ultrasound doppler abnormal. Patient was given IV (intravenous infusion), started on insulin infusion, and received doxycycline/ceftriaxone for possible community-acquired pneumonia (CAP). It was reported as concern for CAP was low as patient was afebrile with normal white blood cells (WBC) and differential throughout admission, empiric antibiotics were discontinued. Patient had reportedly been out of his medications including insulin for one month. Patient's glycosylated hemoglobin (HbA1c) was increased (13.0). It was further reported that, endocrinology was consulted and Insulin glucose tolerance test (GTT) was changed to subcutaneous insulin. Diabetes was difficult to manage due to dietary indiscretions. Patient had prerenal acute kidney injury (AKI) on admission with increased creatinine (blood creatinine increased) to 1.45 and hyperkalemia to 5.3 (blood potassium increased). It was resolved with intravenous infusion (IV) and glycemic control. Patient was also found to have significant vitamin B12 deficiency with vitamin B12 less than 146 (vitamin B12 decreased), likely contributing to polyneuropathy and frequent mechanical falls. Patient had intramuscular (IM) vitamin B12 1000 mcg daily and patient was ready to be discharged with prescription for oral vitamin B12. Patient had DVT/PE, was off anticoagulation for months. It was reported that, LEVD (left ventricular assist device) ordered and demonstrated chronic RLE (right lower extremity) proximal DVTs and acute left peroneal vein DVT. Patient was not an ideal candidate for anticoagulation due to falls, noncompliance (treatment noncompliance). Hematology/oncology was consulted and recommended lifelong Eliquis at a prophylactic dose (2.5 mg two times a day) to decrease risk of bleeding, and advised repeat LEVD in 2 weeks. On an unspecified date (the morning of discharge), patient complained of nasal congestion, he denied other respiratory symptoms, was afebrile. Patient had covid-19 test. Further psychiatry evaluated patient and cleared for discharge. Given frequent falls, PT/OT (Physical therapy/ occupational therapy) consulted. Physical therapist made several attempts to work with patient, had difficulties evaluating patient due patient's refusal. Physical therapist referred to occupational therapy (note from 30-SEP-2022) who recommended home with supervision. Patient had rolling walker (RW) and shower chair ordered. Covid-19 test resulted positive after discharge on an unspecified date (sars-cov-2 test positive by qualitative nucleic acid amplification (NAA) (micro detected). Number of days of hospitalization was not reported. Doctor explained to consumer that his father had no respiratory symptoms or complaints when he reevaluated him, and efforts were made to discharge as per his request. Infectious disease specialist recommended monoclonal antibody (mAb) or antiviral treatment if patient want to get treatment for covid-19, would avoid paxlovid and given eliquis. Also stated that readmission for remdesivir was not necessary, but if patient elects to return to the hospital, doctors decide to prescribe remdesivir. Consumer was informed and recommended for urgent care near patient's home where mAb can be administered (get well urgent care). Doctor called patient to follow up on decision of re treatment, patient stated he was not having nasal congestion, sore throat, cough. Consumer stated he will see how his father feels and will call urgent care next day, he was not sure about treatment and possible side effects since his father had no symptoms. ED (emergency department) notified of possible readmission for remdesivir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   The patient recovered from acute kidney injury, deep vein thrombosis, aggression, covid-19, condition aggravated, fall, hyperglycaemia, hyperkalaemia, lung opacity, nasal congestion, polyneuropathy, treatment noncompliance, vitamin B12 deficiency, blood creatinine increased, blood glucose increased, blood potassium increased, chest x-ray abnormal, glycosylated haemoglobin increased, sars-cov-2 test positive, ultrasound doppler abnormal, vitamin B12 decreased, and white blood cell count normal. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: Unknown. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint department on 08-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information received updates Product Quality complaint investigation result. This updated information does not alter prior causality assessment of reported events  Acute kidney injury, polyneuropathy, hyperkalaemia, deep vein thrombosis, lung opacity, aggression, condition aggravated, fall, hyperglycaemia, Vitamin b12 deficiency, blood creatinine increased,  blood glucose increased,  blood potassium increased, chest x-ray abnormal, glycosylated haemoglobin increased, ultrasound doppler abnormal, vitamin B12 decreased, white blood cell count normal, treatment noncompliance. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  V0: 20230101157- Nasal congestion, Covid 19, Sars Cov 2 test positive-  The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration..