Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac pacemaker insertion, Chest X-ray abnormal, Cognitive disorder, Cough, Dyspnoea
Clinical narrative: COVID-19; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; ELECTROCARDIOGRAM NORMAL; HEADACHE; ASTHENIA; DYSPNOEA; COUGH; APHASIA; COGNITIVE DISORDER; PAIN; NASAL CONGESTION; FALL; CARDIAC PACEMAKER INSERTION; TROPONIN INCREASED; ECHOCARDIOGRAM; EJECTION FRACTION; BLOOD PRESSURE INCREASED; CHEST X-RAY ABNORMAL; WEIGHT INCREASED; MYOCARDIAL INFARCTION; GASTROINTESTINAL HAEMORRHAGE; HYPOXIA; FLUID OVERLOAD; PLEURAL EFFUSION; HYPERTENSION; BUNDLE BRANCH BLOCK RIGHT; LEFT VENTRICULAR HYPERTROPHY; INFECTION; This spontaneous report received from a health care professional via a regulatory authority (VAER reference number 1658886) concerned a 83 year old female of unknown race and ethnicity.   The patient's height, and weight were not reported. The patient's past medical history included: gastroesophageal reflux disease, and gout, and concurrent conditions included:  weakness, UTI (urinary tract infection), fall, seizure, loss of consciousness, nose bleed, headaches, ESRDn (End-Stage Renal Disease), left adrenal mass, HCC (Hepatocellular carcinoma), diabetes mellitus type 2, unspecified hypothyroidism, HTN (hypertension), chronic diastolic congestive heart failure, mixed hyperlipidemia, bifascicular block, anemia, expressive aphasia, AF (Atrial fibrillation), and paroxysmal atrial fibrillation, and other pre-existing medical conditions included: uncontrolled HCC (Hepatocellular carcinoma). The patient experienced drug allergy when treated with gabapentin for seizures.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: was not reported) dose was not reported, one total administered on right arm on 16-MAR-2021 for prophylactic vaccination.  Concomitant medications included allopurinol, amlodipine besilate, ascorbic acid/biotin/folic acid/mecobalamin/nicotinic acid/pantothenic acid/pyridoxine hydrochloride/riboflavin/thiamine, atorvastatin calcium, carvedilol, dexamethasone, fentanyl, isosorbide mononitrate, salbutamol, and salbutamol sulfate. On 21-AUG-2021, the patient experienced aphasia, blood pressure increased, bundle branch block right, covid-19, cardiac pacemaker insertion, chest x-ray abnormal, cognitive disorder, cough, dyspnea, echocardiogram, ejection fraction, electrocardiogram normal, fall, fluid overload, gastrointestinal haemorrhage, hypertension, hypoxia, infection, left ventricular hypertrophy, myocardial infarction, nasal congestion, pain, pleural effusion, troponin increased, asthenia, headache. Laboratory data included: Blood pressure increased (NR: not provided) increased, Chest X-ray abnormal (NR: not provided) congestion and small bilateral pleural effusions, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Normal, and Weight increased (NR: not provided) being 5 kg (kilogram) above dry weight. On 24-AUG-2021, the patient experienced sars-cov-2 test positive (confirmed clinical vaccination failure). Volume overload secondary to missed dialysis on 23-AUG-2021. Break through Covid -19 infection continued isolation per infection control, breathing elevated troponin mostly due to End-Stage Renal Disease and volume overload Asymptomatic History of expressive aphasia, patient had guardian per Nephrology Shortness of breath Volume overload End-Stage Renal Disease in setting of missed dialysis and patient being 5 kg above dry weight Chest x-ray with evidence of congestion and small bilateral pleural effusions Differentials also include breakthrough COVID-19 infection and possibility of flash pulmonary edema. History defers from patient shortness of breath worsening compared to facility awareness of acutely short of breath. Consulted nephrology and discussed with Doctor regarding dialysis who assess SOB (shortness of breath) hypoxia with activity after. The patient had Hypertensive urgency in setting of volume overload with no anti-hypertensives given on day of dialysis even though missed dialysis and without blood pressure medications. On an unspecified date the patient was hospitalized for 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aphasia, asthenia, blood pressure increased, bundle branch block right, covid-19, cardiac pacemaker insertion, chest x-ray abnormal, cognitive disorder, cough, dyspnoea, echocardiogram, ejection fraction, electrocardiogram normal, fall, fluid overload, gastrointestinal haemorrhage, headache, hypertension, hypoxia, infection, left ventricular hypertrophy, myocardial infarction, nasal congestion, pain, pleural effusion, sars-cov-2 test positive, troponin increased, and weight increased, 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: 90000194108. The suspected product quality complaint has been confirmed to be 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 regulatory reporting authority on 21-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: suspected clinical vaccination failure was rephrased to confirmed clinical vaccination failure.; Sender's Comments: V3: This version updates: : Product quality complaint investigation result,  suspected clinical vaccination failure was rephrased to confirmed clinical vaccination failure. Medical assessment comment updated for RRT -Confirmed clinical vaccination failure. The prior causality assessment remains unaltered. 20210920909-COVID-19 VACCINE AD26.COV2.S-Myocardial infarction, Gastrointestinal hemorrhage, Hypoxia, Pleural effusion, Left ventricular hypertrophy, Infection, COVID-19, Dyspnea, Cough, Pain, Nasal congestion, Cognitive disorder, Fall, Cardiac pacemaker insertion, Echocardiogram, Ejection fraction, Chest X-Ray abnormal, SARS COV-2 test positive, Electrocardiogram normal, Troponin increased, Headache,. 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). 20210920909-COVID-19 VACCINE AD26.COV2.S-Fluid overload, Weight increased, Hypertension, Bundle branch block right, Aphasia, Blood pressure increased,. 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 20210920909-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 20210920909-COVID-19 VACCINE AD26.COV2.S-Asthenia. This event(s) is labeled per RSI and is therefore considered potentially related.