Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Red cell distribution width normal, SARS-CoV-2 test, SARS-CoV-2 test positive, Serum ferritin, Serum ferritin increased
Clinical narrative: Dyspnoea exertional; SUSPECTED CLINICAL VACCINE FAILURE; Tachypnoea; Blood chloride decreased; BASOPHIL PERCENTAGE DECREASED; Blood creatinine increased; Blood glucose increased; Blood lactate dehydrogenase increased; Blood potassium decreased; Blood sodium decreased; Blood urea increased; C-reactive protein increased; Carbon dioxide increased; Eosinophil percentage decreased; Immature granulocyte count; Lymphocyte percentage decreased; Neutrophil count increased; Neutrophil percentage increased; Oxygen saturation decreased; Platelet count decreased; Prothrombin time prolonged; Serum ferritin increased; White blood cell count increased; ALANINE AMINOTRANSFERASE NORMAL; ANION GAP; ASPARTATE AMINOTRANSFERASE NORMAL; BLOOD ALBUMIN NORMAL; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BILIRUBIN NORMAL; BLOOD CULTURE; BLOOD GLUCOSE NORMAL; BRAIN NATRIURETIC PEPTIDE NORMAL; CHEST X-RAY; FIBRIN D DIMER NORMAL; GLOMERULAR FILTRATION RATE; HAEMATOCRIT NORMAL; HAEMOGLOBIN NORMAL; INTERNATIONAL NORMALISED RATIO NORMAL; MEAN CELL VOLUME NORMAL; MONOCYTE PERCENTAGE; PROTEIN TOTAL NORMAL; RED BLOOD CELL COUNT NORMAL; RED BLOOD CELL NUCLEATED MORPHOLOGY; RED CELL DISTRIBUTION WIDTH NORMAL; SARS-COV-2 TEST POSITIVE; COVID-19 PNEUMONIA; COVID-19; Dyspnoea; PYREXIA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number 1678962) concerned a 51-year-old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hypertriglyceridemia, and nocturnal BiPAP(Bilevel Positive Airway Pressure), and concurrent conditions included: hypertension, fatty liver, Diabetes Mellitus Type 2 (DM2), obstructive sleep apnea (OSA) on intermittent continuous positive airway pressure therapy, and childhood asthma, and other pre-existing medical conditions included: Patient had no known allergy. The patient was previously treated with metformin for dm2. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) frequency one total , dose was not reported, administered at left arm on 24-MAR-2021 for an unspecified indication. Concomitant medications included chlortalidone, losartan and amlodipine for hypertension. On 24-AUG-2021, the patient experienced shortness of breath (dyspnoea) and fever, confirmed covid positive with home kit. On 31-AUG-2021, the patient experienced covid-19 confirm in laboratory 93 percent with tachypnea, on same day experienced covid-19 pneumonia, and was hospitalized. The patient was hospitalized for 5 days. Patient was started and completed a course of Remdesivir (31-AUG-2021 to 04-SEP-2021) and Decadron 6 mg which was tapered to 4 mg on discharge and he was discharged on a tapering course, he improved slowly throughout the course of his stay with sats dropping with ambulation to 89 percent, thus patient was prescribed home Oxygen for exertion. Patient was not on any DM2 medications prior to admission the metformin previously prescribed and had been discontinued, His blood sugars were elevated on Decadron and he required a sliding scale for coverage he was taught on insulin administration and will continue that at home it is expected his blood sugars will decrease as his decadron dosing decreases. Patient has HTN on chlorthalidone, losartan and amlodipine, Chlorthalidone and losartan were held and he was maintained on amlodpine and normotensive Thus he will not resume chlorthalidone or losartan until follow up with PMD pending his blood pressure trends. On 31-AUG-2021, the patient experienced dyspnoea exertional, blood chloride decreased, basophil percentage decreased, blood creatinine increased, blood glucose increased, blood lactate dehydrogenase increased, blood potassium decreased, blood sodium decreased, blood urea increased, c-reactive protein increased, carbon dioxide increased, eosinophil percentage decreased, immature granulocyte count, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, oxygen saturation decreased, platelet count decreased, prothrombin time prolonged, serum ferritin increased, white blood cell count increased, alanine aminotransferase normal, anion gap, aspartate aminotransferase normal, blood albumin normal, blood alkaline phosphatase normal, blood bilirubin normal, blood culture, blood glucose normal, brain natriuretic peptide normal, chest x-ray, fibrin D dimer normal, glomerular filtration rate, haematocrit normal, haemoglobin normal, international normalised ratio normal, mean cell volume normal, monocyte percentage, protein total normal, red blood cell count normal, experienced red blood cell nucleated morphology, red cell distribution width normal, SARS-COV-2 test positive. Additional treatment medications (dates unspecified) included: Albuterol (Proair, Proventil, Ventolin) 90 mcg actuation inhalation take occasionally 2 puffs by mouth every 4 hours. On 31-AUG-2021, the patient experienced suspected clinical vaccine failure, dyspnoea exertional, blood chloride decreased, basophil percentage decreased, blood creatinine increased, blood glucose increased, blood lactate dehydrogenase increased, blood potassium decreased, blood sodium decreased, blood urea increased, C-reactive protein (CRP) increased, carbon dioxide increased, eosinophil percentage decreased, immature granulocyte count, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, oxygen saturation decreased, platelet count decreased, prothrombin time prolonged, serum ferritin increased, White blood cell (WBC) count increased, alanine aminotransferase (ALT) normal, anion gap, aspartate aminotransferase (AST) normal, blood albumin normal, blood alkaline phosphatase normal, blood bilirubin normal, blood culture, blood glucose normal, brain natriuretic peptide (BNP) normal, chest x-ray, fibrin D dimer normal, glomerular filtration rate, haematocrit normal, haemoglobin (Hgb) normal, international normalised ratio normal, mean cell volume (MCV) normal, monocyte percentage, protein total normal, red blood cell (RBC) count normal, nucleated red blood cell (NRBC) morphology, red cell distribution width normal, SARS-COV-2 test positive. Laboratory data included: Absolute neutrophil count (ANC) 9.0, ALT 16, Anion gap 10, AST 22, Basophil percentage 0 percent, Bilirubin total (BT) 1.0, Blood albumin 39, Blood alkaline phosphatase 43, Blood chloride 94, Blood creatinine 129, Blood culture Not reported, Blood glucose 119, Blood lactate dehydrogenase 243, Blood potassium 3.4, Blood sodium 135, Blood urea 21, BNP 48, CRP 158, Carbon dioxide 31, Chest X-ray Not reported, Eosinophil percentage 0 percent, Fibrin D dimer 0.31, Glomerular filtration rate greater than 60, Haematocrit 43.9, Hgb 14.7, Immature granulocyte count Not reported, International normalised ratio 1.0, Lymphocyte percentage 11 percent, MCV 88, Monocyte percentage 7 percent, Neutrophil percentage 82 percent, Oxygen saturation Decreased, Platelet count 109, Protein total 7.1, Prothrombin time 13.1, Red blood cell (RBC) count 5.02, Red cell distribution width 12.4, SARS-CoV-2 test Positive, Serum ferritin 982, and WBC count 11.1. On 01-SEP-2021, Laboratory data included: ANC 7.1, ALT 16, Anion gap 9, AST 21, Basophil percentage 0 percent, BT 0.5, Blood alkaline phosphatase 41, Blood chloride 100, Blood creatinine 104, Blood glucose 181, Blood potassium 4.5, Blood sodium 138, Blood urea 22, CRP 146, Carbon dioxide 29, Eosinophil percentage 0 percent, Fibrin D dimer 0.28, Haematocrit 42.6, Hgb 14.5, Lymphocyte percentage 12 percent, MCV 88, Monocyte percentage 3 percent, Neutrophil percentage 85 percent, NRBC 0, 0, Platelet count 115, RBC count 4.66, Red cell distribution width 12.4, and WBC count 8.3. On 02-SEP-2021, Laboratory data included: ANC 11.1, ALT 16, Anion gap 9, AST 17, Basophil percentage 0 percent, BT 0.4, Blood alkaline phosphatase 44, Blood chloride 3.9, Blood creatinine 100, Blood glucose 182, Blood potassium 3.9, Blood urea 28, Carbon dioxide 27, Eosinophil percentage 0 percent, Haematocrit 40.7, Hgb 13.9, Lymphocyte percentage 8 percent, MCV 87, Monocyte percentage 6 percent, Neutrophil percentage 85 percent, NRBC red cells 0, Platelet count 154, Red cell distribution width 12.4, and WBC count 13.0. On 03-SEP-2021, Laboratory data included: ANC 11.2, ALT 17, Anion gap 9, AST 15, Basophil percentage 0 percent, BT 0.5, Blood alkaline phosphatase 39, Blood chloride 4.0, Blood creatinine 92, Blood glucose 194, Blood potassium 4.0, Blood urea 28, CRP 23, Carbon dioxide 26, Eosinophil percentage 0 percent, Fibrin D dimer less than 0.27, Haematocrit 40.8, Hgb 13.8, Lymphocyte percentage 8 percent, MCV 87, Monocyte percentage 5 percent, Neutrophil percentage 85 percent, NRBC 0, Platelet count 179, RBC count 4.68, Red cell distribution width 12.2, and WBC count 13.1. On 04-SEP-2021, Laboratory data included: ANC 7.7, ALT 20, Anion gap 7, AST 16, Basophil percentage 0 percent, BT 0.5, Blood alkaline phosphatase 39, Blood creatinine 90, Blood glucose 199, Blood urea 25, Carbon dioxide 29, Eosinophil percentage 0 percent, Haematocrit 42.1, Hgb 14.5, Lymphocyte percentage 12 percent, MCV 87, Monocyte percentage 8 percent, Neutrophil percentage 76 percent, NRBC 0, Platelet count 180, RBC count 4.84, Red cell distribution width 12.0, and WBC count 10.0.The normal reference range was not provided for any laboratory data. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, and the outcome of basophil percentage decreased, blood chloride decreased, blood creatinine increased, blood glucose increased, blood lactate dehydrogenase increased, blood potassium decreased, blood sodium decreased, blood urea increased, c-reactive protein increased, covid-19, carbon dioxide increased, dyspnoea, dyspnoea exertional, eosinophil percentage decreased, immature granulocyte count, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, oxygen saturation decreased, platelet count decreased, prothrombin time prolonged, pyrexia, serum ferritin increased, tachypnoea, white blood cell count increased, suspected clinical vaccine failure, alanine aminotransferase normal, anion gap, aspartate aminotransferase normal, blood albumin normal, blood alkaline phosphatase normal, blood bilirubin normal, blood culture, blood glucose normal, brain natriuretic peptide normal, chest x-ray, fibrin d dimer normal, glomerular filtration rate, haematocrit normal, haemoglobin normal, international normalised ratio normal, mean cell volume normal, monocyte percentage, protein total normal, red blood cell count normal, red blood cell nucleated morphology, red cell distribution width normal and sars-cov-2 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product complaint number 90000195064. 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 on 03-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:Additional information is regarding product quality complaint results, which does not alter the assessment of prior causality of previously reported serious events.  20210949882-Covid-19 vaccine ad26.cov2.s-Covid-19 pneumonia, Covid-19, Dyspnoea, Dyspnoea exertional,Tachypnoea,Blood chloride decreased,Basophil percentage decreased, Blood creatinine increased,Blood glucose increased,Blood lactate dehydrogenase increased, Blood potassium decreased,Blood sodium decreased,Blood urea increased,C-reactive protein increased,Carbon dioxide increased,Eosinophil percentage decreased,Immature granulocyte count,Lymphocyte percentage decreased,Neutrophil count increased,Neutrophil percentage increased,Oxygen saturation decreased,Platelet count decreased,Prothrombin time prolonged,Serum ferritin increased,White blood cell count increased,Alanine aminotransferase normal,Anion gap,Aspartate aminotransferase normal,Blood albumin normal,Blood alkaline phosphatase normal,Blood bilirubin normal,Blood culture,Blood glucose normal,Brain natriuretic peptide normal,Chest x-ray,Fibrin d dimer normal, Glomerular filtration rate,Haematocrit normal,Haemoglobin normal,International normalised ratio normal,Mean cell volume normal,Monocyte percentage,Protein total normal,Red blood cell count normal,Red blood cell nucleated morphology,Red cell distribution width normal , Sars-cov-2 test positive,Pyrexia. This events is considered unassessable. The events 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 events. 20210949882-Covid-19 vaccine ad26.cov2.s-Suspected 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