Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypothyroidism, Platelet count decreased, Pyrexia, SARS-CoV-2 test positive, Sepsis
Clinical narrative: ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; ATRIAL FIBRILLATION; ATYPICAL PNEUMONIA; COVID-19 PNEUMONIA; CHRONIC KIDNEY DISEASE; HYPOTHYROIDISM; SEPSIS; VACCINE BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; TACHYCARDIA; HYPERLIPIDAEMIA; ANTICOAGULANT THERAPY; BENIGN PROSTATIC HYPERPLASIA; COVID-19; CONDITION AGGRAVATED; DEHYDRATION; HYPERTENSION; PYREXIA; BLOOD CREATININE INCREASED; C-REACTIVE PROTEIN INCREASED; CHEST X-RAY ABNORMAL; PLATELET COUNT DECREASED; SARS-COV-2 TEST POSITIVE; ULTRASOUND KIDNEY ABNORMAL; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1757168) concerned an 86 year old male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: atrial fibrillation, benign prostatic hyperplasia (BPH), hyperlipidemia (HLD), hypertension (HTN), and allergy to codeine. The patient was previously treated with apixaban (Eliquis) and showed deep vein thrombosis (DVT) prophylaxis, doxazosin mesilate (Doxazo); and experienced drug allergy when treated with codeine.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, frequency time 1 total was administered on 03-JUN-2021 on left arm for an unspecified indication. Concomitant medications included paracetamol/acetaminophen (Tylenol), dexamethasone (Decadron IV) no benefit in view of no hypoxemia. On 28-SEP-2021, the patient experienced thrombocytopenia and was treated with statin, 130 more than 113s in the setting of Covid-19 monitored as outpatient acute kidney injury (AKI) vs chronic kidney disease (CKD), chronic atrial fibrillation and treated with anticoagulant therapy. The patient also had atypical pneumonia, covid-19 pneumonia, hypothyroidism, sepsis, vaccine breakthrough infection, tachycardia, hyperlipidaemia and treated with statin, benign prostatic hyperplasia, blood creatinine increased, C-reactive protein increased, chest x-ray abnormal, condition aggravated, dehydration, hypertension, platelet count decreased, ultrasound kidney abnormal, and pyrexia. The patient tested positive for covid-19 (confirmed clinical vaccination failure) and developed covid-19 and was hospitalized on 28-SEP-2021 for 2 days. The patient was discharged on 30-APR-2021. The patient was discharged in stable condition with stable vital signs. Prescriptions for medications needed to be taken after discharge have been given to patient. The patient was instructed to follow up with primary care physician (PCP) within the next 7 days after discharge. The patient verbalized understanding all given instructions and has no further doubts regarding discharge. Laboratory data included: Blood creatinine (NR: not provided) increased, C-reactive protein (NR: not provided) Increased, Chest X-ray (NR: not provided) atypical pneumonia (PNA), Platelet count (NR: not provided) decreased, SARS-CoV-2 test (NR: not provided) Positive, and Ultrasound kidney (NR: not provided) abnormal (Bilateral echogenic kidneys was noted which may reflect medical renal disease. No evidence for hydronephrosis was found). Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 96 % on RA and Oxygen supplementation (NR: not provided) Reported (O2 as needed pulse Ox greater than ordered home O2 evaluate greater than no O2 required). Treatment medications (dates unspecified) included: remdesivir for borderline benefit, given for AKI (Acute kidney injury).and more than 10 days of symptoms onset, discussed risk and benefits with PR (public relation) who agreed to get it and received 2 doses. livothyroxine sodium (Synthroid) for Hypothyroidism, terazosin for BPH (benign prostatic hyperplasia). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombocytopenia, acute kidney injury, atrial fibrillation, atypical pneumonia, covid-19 pneumonia, chronic kidney disease, hypothyroidism, sepsis, vaccine breakthrough infection, tachycardia, hyperlipidaemia, anticoagulant therapy, benign prostatic hyperplasia, blood creatinine increased, c-reactive protein increased, covid-19, chest x-ray abnormal, condition aggravated, dehydration, hypertension, platelet count decreased, sars-cov-2 test positive, ultrasound kidney abnormal, and pyrexia, 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: 90000198163. The suspected product quality complaint has been confirmed to be 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 received from Central Complaint Vigilance department on 17-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result was added.; Sender's Comments: V1: This follow up version was created to update following information: The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. This updated information doesn't alter previous causality assessment made for the events in the case.   20211032254-COVID-19 vaccine Ad26.CoV2.S-. Acute kidney injury, thrombocytopenia, atypical pneumonia, covid-19 pneumonia, chronic kidney disease, hypothyroidism, sepsis, vaccine breakthrough infection, tachycardia, anticoagulant therapy, blood creatinine increased, c-reactive protein increased, covid-19, chest x-ray abnormal, condition aggravated, dehydration, platelet count decreased, sars-cov-2 test positive, ultrasound kidney abnormal, and pyrexia. 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).  20211032254 -COVID-19 VACCINE AD26.COV2.S-Atrial Fibrillation, benign prostatic hyperplasia, Hypertension, Hyperlipidemia . 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  20211032254-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