Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I, Urine analysis, Vaccination failure, Vitamin D
Clinical narrative: ANGIOGRAM PULMONARY ABNORMAL; SCAN WITH CONTRAST ABNORMAL; SARS-COV-2 TEST POSITIVE; FULL BLOOD COUNT NORMAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; ANGIOGRAM; ANGIOGRAM PULMONARY; BLOOD GASES; BLOOD MAGNESIUM; BLOOD PHOSPHORUS; BLOOD THYROID STIMULATING HORMONE; CHEST X-RAY; COMPUTERISED TOMOGRAM; COMPUTERISED  TOMOGRAM HEAD; COMPUTERISED TOMOGRAM THORAX; ECHOCARDIOGRAM; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; GLYCOSYLATED HAEMOGLOBIN; MAGNETIC RESONANCE IMAGING HEAD; MAGNETIC RESONANCE IMAGING SPINAL; METABOLIC FUNCTION TEST; SCAN WITH CONTRAST; TROPONIN; LIPIDS; PULMONARY EMBOLISM; TRANSIENT ISCHAEMIC ATTACK; AGEUSIA; AMNESIA; ANOSMIA; BALANCE DISORDER; CHEST PAIN; COVID-19; DIZZINESS; DYSARTHRIA; DYSPNOEA; EXPOSURE TO SARS-COV-2; PRESYNCOPE; RHINORRHOEA; SNEEZING; PARANASAL SINUS DISCOMFORT; HYPOAESTHESIA; SPEECH DISORDER; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1347147), concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol. The patient had no known allergies. The patient had no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced pulmonary embolism, ageusia, amnesia, anosmia, balance disorder, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, dizziness, hypoaesthesia, angiogram, angiogram pulmonary, angiogram pulmonary abnormal, blood gases, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin D dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive and troponin. More than 30 days after receiving the Janssen vaccine (on 06-APR-2021) the patient tested positive for COVID-19 (Confirmed COVID-19 Infection) and was confirmed Clinical Vaccination Failure, the patient experienced symptoms runny nose, sneezing, and sinus pressure/burning. Laboratory data included: Angiogram (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Abnormal, Blood gases (NR: not provided) Not reported, Blood magnesium (NR: not provided) Not reported, Blood phosphorus (NR: not provided) Not reported, Blood thyroid stimulating hormone (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Not reported, Electroencephalogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported, Full blood count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) Not reported, Glycosylated haemoglobin (NR: not provided) Not reported, Lipids (NR: not provided) Not reported, Magnetic resonance imaging head (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Metabolic function test (NR: not provided) Not reported, SARS-CoV-2 antibody test (NR: not provided) Negative, SARS-CoV-2 test (NR: not provided) Positive, Scan with contrast (NR: not provided) Abnormal, Covid-19 virus test (NR: not provided) Positive and Troponin (NR: not provided) Not reported. On 11-APR-2021 tested for COVID-19 (nasal swab, PCR test) after a family member tested positive (confirmed covid-19 infection). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 13-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (NR: not provided) Not reported, and EKG (electrocardiogram) was normal. On 12-APR-2021 symptoms worsened including shortness of breath, chest pain, complete loss of taste and smell. On 13-APR-2021 the patient received sought treatment for breathing difficulty at ER (emergency room) and was instructed to rest at home. On 14-APR-2021 the patient received sought treatment for breathing difficulty at PCP (primary care physician) medical center and was prescribed prednisone. On 15-APR-2021 symptoms worsened including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting and patient received sought treatment at emergency room. The patient was held in hospital for three days and was treated with remdesivir (3 doses) and supplemental oxygen. Laboratory data included: CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, EKG (electrocardiogram) Normal, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, TSH (thyroid stimulating hormone) Not reported, Troponin I (NR: not provided) Not reported, and Urine analysis (NR: not provided) Not reported. On 16-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Computerised tomogram scan (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Lipids (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, Troponin I (NR: not provided) Not reported, and Vitamin D (NR: not provided) Not reported. On 17-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported, and Fibrin D dimer (NR: not provided) Not reported. On 18-APR-2021 the patient was discharged from hospital. The patient reports that the symptoms did not improve following discharge. On 18-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. On 21-APR-2021, the patient undergone sought treatment for ongoing symptoms and was instructed to rest at home. Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram thorax was found to be pulmonary embolism with contrast, EKG (electrocardiogram) Not reported, Estimated glomerular filtration rate (NR: not provided) Not reported, and Troponin I (NR: not provided) Not reported. On 24-APR-2021 the patient reports that the symptoms were continued to worsen including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Laboratory data included: Arterial blood gases (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, EKG (electrocardiogram) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Positive, and Troponin I (NR: not provided) Not reported. On 25-APR-2021 the patient received sought treatment at emergency room and admitted to hospital on the same day again, patient was diagnosed with probable TIA (transient ischaemic attack) and was treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Laboratory data included: CBC (complete blood count) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram neck (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Magnetic resonance imaging brain (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 26-APR-2021, Laboratory data included: CBC (complete blood count) Not reported, and Lipids (NR: not provided) Not reported. On 27-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and electroencephalogram (EEG) (NR: not provided) Not reported. On 28-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Fibrin D dimer (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Magnetic resonance imaging thoracic (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, and SARS-CoV-2 IgG antibody test (NR: not provided) Positive. On 30-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and SARS-CoV-2 PCR test (NR: not provided) Positive. On 01-MAY-2021 The patient was transferred to in-patient rehabilitation for physical and occupational therapy, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 03-MAY-2021, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 06-MAY-2021 patient was discharged from in-patient rehabilitation and was prescribed with out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits. The patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ageusia, amnesia, angiogram pulmonary abnormal, anosmia, balance disorder, blood gases, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, pulmonary embolism, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, transient ischaemic attack, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, angiogram, angiogram pulmonary, and scan with contrast, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000181966. The suspected product quality complaint has been confirmed to be not confirmed. 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 was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.; Sender's Comments: V1. The follow-up information in this version updates Product complaint investigation result. This updated information does not alter causality of previously reported events. 20210609990 -covid-19 vaccine ad26.cov2.s - Pulmonary embolism , transient ischaemic attack, Ageusia, amnesia, angiogram pulmonary abnormal, angiogram pulmonary , anosmia, balance disorder, blood gases, chest pain,dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, and angiogram. 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). 20210609990-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