Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure, X-ray
Clinical narrative: ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; LUNG INFILTRATION; ANGIOGRAM PULMONARY ABNORMAL; CHEST X-RAY ABNORMAL; COMPUTERIZED TOMOGRAM HEAD ABNORMAL; BLOOD CREATININE INCREASED; LUNG OPACITY; CEREBRAL INFARCTION; COVID-19; BLOOD SODIUM DECREASED; SARS-COV-2 TEST POSITIVE; X-RAY; EPIDURAL INJECTION; CONFIRMED CLINICAL VACCINATION FAILURE; MUSCULAR WEAKNESS; BALANCE DISORDER; GAIT DISTURBANCE; CHEST PAIN; COUGH; DYSPNOEA; FIBRIN D DIMER INCREASED; EXPOSURE TO SARS-COV-2; RESPIRATORY TRACT CONGESTION; FALL; HEAD INJURY; ATAXIA; MYALGIA; FATIGUE; PYREXIA; CHILLS; This spontaneous report received from a health care professional via a Regulatory Authority (ID 1804111) concerned a 67-year-old male. The patient's height, and weight were not reported. The patient underwent a back surgery on an unspecified date in 2019 and had post-operative cryptogenic cerebrovascular accident (CVA), and a coronary artery bypass graft (CABG), and concurrent conditions included: erectile dysfunction, insomnia, former smoker (48 pack-year), glaucoma, spinal stenosis of thoracolumbar region, gastroesophageal reflux disease, esophagitis, tubular adenoma of colon (presence unspecified), angina pectoris, chronic lower back pain (LBP), backache, arthritis, Hypertension (HTN), hypersensitivity lung disease (HLD), vision changes (right eye), paresthesia, dysphagia, dysarthria, carotid artery stenosis, Coronary Artery Disease (CAD) and depression. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: unknown) dose was not reported, 01 total, administered on 27-APR-2021 for an unknown indication. Concomitant medications included Aspirin (acetylsalicylic acid), Lipitor (atorvastatin calcium), Celexa (citalopram hydrobromide), Plavix (clopidogrel bisulfate), Mucinex (guaifenesin), hydrocodone bitartrate/paracetamol, and paracetamol used for unknown indication.  On an unspecified date in JAN-2018, the patient underwent a Magnetic resonance imaging (MRI) which was abnormal and showed acute evolution of multiple areas of infarction. On 01-OCT-2021, the patient was scheduled for a Pain management appointment - Procedure: right third lumbar spine vertebra (L3) transforaminal Epidural Steroid Injection under biplanar fluoroscopy. On 05-OCT-2021, the patient had started experiencing some symptoms but was in his usual state of health. On an unspecified date in OCT-2021, the patient experienced respiratory tract congestion, fatigue, myalgias, chills and pyrexia. The patient was recently exposed to his wife who was Corona virus disease (COVID) positive (exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) which worsened the symptoms leading to cough and mild shortness of breath (dyspnoea). The patient also experienced ataxia, gait disturbances which worsened resulting in multiple falls at home. On 09-OCT-2021 (4 days prior admission), the patient developed worsening bilateral lower extremity weakness (muscular weakness) leading to balance disorder resulting in 4-6 falls in 24 hours. During one of his falls the patient had hit his head causing (head injury). Due these worsening falls and gait the patient was presented to the emergency department (ER visit). The patient denied any dizziness, headache, nuchal rigidity neck pain or lightheadedness but felt that he cannot maintain balance while walking, the patient had no other focal numbness, tingling and weakness of his arms or legs, he had mild chest pain but not unless the patient coughed and had no shortness of breath at rest. The patient was afebrile and was saturating (oxygen saturation) at 90-93 percentage. Due to the patients recurrent falls and inability to ambulate, he was administered 500 ml bolus of Intravenous (IV) fluids and admitted to Internal Medicine for further management. On 13-OCT-2021, the patient was hospitalized (admitted) due to ataxia and COVID-19. The patient underwent a number of laboratory tests on admission, including SARS-CoV-2 test (NR: not provided) Positive confirming COVID-19 (confirmed clinical vaccination failure), Computerized tomogram (CT) head which was abnormal and showed Interval evolution of multiple areas of infarction but no acute hemorrhage mass effect or acute infarct which lead to the diagnosis of cerebral infarction, a Chest X-ray which was abnormal and showed subtle areas of hazy opacities in the right upper lobe and left lower lobe which could represent early inflammatory changes secondary to COVID-19, which lead to the diagnosis of lung opacity The patient also underwent blood analysis for Blood creatinine (NR: not provided) 1.23 (units unspecified) from a baseline of 0.98 (units unspecified) and Blood sodium (NR: not provided) which was decreased to be at 130 (units unspecified). Fibrin D dimer (NR: not provided) Normal. The patient was administered an epidural injection. On 14-OCT-2021, the patient underwent an Angiogram pulmonary (NR: not provided) which was abnormal, it ruled out pulmonary embolism but revealed infiltrates (lung infiltration) consistent with COVID-19 pneumonia confirming diagnosis. Over the weekend post admission, the respiratory status of the patient had worsened and was on 15 Liter Oxymizer. Fibrin D-dimer was measured to be elevated and CT angiogram, thorax was repeated to ensure no pulmonary embolism was developed in order to account for his decompensation. The patient was administered dexamethasone and remdesivir (course completed), completed 5 day course of empiric Rocephin and doxycycline. On 20-OCT-2021, the patient experienced acute hypoxemic respiratory failure due to COVID-19 which was assessed to be secondary to COVID-19 pneumonia. On an unspecified date, some laboratory data showed Bilateral Carotid Bruits heard through Auscultation and Lipids chronically elevated. The patient was hospitalized for 9 days and discharge dates were not reported as the patient had remained hospitalized. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory failure, angiogram pulmonary abnormal, ataxia, balance disorder, blood creatinine increased, blood sodium decreased, covid-19, covid-19 pneumonia, cerebral infarction, chest x-ray abnormal, chest pain, chills, computerized tomogram head abnormal, cough, dyspnoea, epidural injection, exposure to sars-cov-2, fall, fatigue, fibrin d dimer increased, gait disturbance, head injury, lung infiltration, lung opacity, muscular weakness, myalgia, pyrexia, respiratory tract congestion, sars-cov-2 test positive, and x-ray, 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: 90000200287. The suspected product quality complaint has been confirmed to be void: N, 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 was received from central complaint vigilance department on 04-NOV-2021. The following information was updated and incorporated into case narrative: product quality complaint investigation result added.; Sender's Comments: V1: Additional information received is regarding product quality complaint investigation result. The follow up information received does not alter the assessment of prior causality of previously reported serious events. : 20211061590-Covid-19 vaccine ad26.cov2.s-  Acute respiratory failure,COVID-19 Pneumonia, cerebral infarction,  covid-19, exposure to sars-cov-2, lung infiltration,  lung opacity,  respiratory tract congestion,  fall,  head injury,  ataxia,  balance disorder, gait disturbance, chest pain, cough, dyspnoea,  angiogram pulmonary abnormal,   chest x-ray abnormal, computerized tomogram head abnormal, blood creatinine increased,  fibrin d dimer increased,  blood sodium decreased, sars-cov-2 test positive, x-ray, epidural injection, . 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).  20211061590-Covid-19 vaccine ad26.cov2.s-chills, muscular weakness,  myalgia,  fatigue, pyrexia,. This event(s) is labeled per regulatory authority and is therefore considered potentially related.  20211061590-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