Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Human chorionic gonadotropin negative, Intensive care, International normalised ratio, International normalised ratio normal, Lymphocyte percentage
Clinical narrative: INTENSIVE CARE; ALANINE AMINOTRANSFERASE INCREASED; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD LACTATE DEHYDROGENASE INCREASED; GLYCOSYLATED HAEMOGLOBIN INCREASED; C-REACTIVE PROTEIN INCREASED; BLOOD UREA DECREASED; HAEMATOCRIT DECREASED; HAEMOGLOBIN DECREASED; NEUTROPHIL PERCENTAGE INCREASED; ANION GAP; BAND NEUTROPHIL PERCENTAGE; BLOOD ALBUMIN NORMAL; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BILIRUBIN NORMAL; BLOOD CHLORIDE NORMAL; BLOOD CREATININE NORMAL; BLOOD GLUCOSE NORMAL; BLOOD LACTIC ACID; BLOOD POTASSIUM NORMAL; BLOOD SODIUM NORMAL; BRAIN NATRIURETIC PEPTIDE NORMAL; CARBON DIOXIDE NORMAL; DIFFERENTIAL WHITE BLOOD CELL COUNT; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; HUMAN CHORIONIC GONADOTROPIN NEGATIVE; INTERNATIONAL NORMALISED RATIO NORMAL; LYMPHOCYTE PERCENTAGE DECREASED; MEAN CELL VOLUME DECREASED; PLATELET COUNT DECREASED; PLATELET MORPHOLOGY NORMAL; PROTEIN TOTAL NORMAL; PROTHROMBIN TIME NORMAL; RED BLOOD CELL ANALYSIS; RED BLOOD CELL COUNT INCREASED; RED BLOOD CELL MICROCYTES; RED BLOOD CELL NUCLEATED MORPHOLOGY; RED BLOOD CELL SPHEROCYTES; RED CELL DISTRIBUTION WIDTH INCREASED; TRANSAMINASES INCREASED; WHITE BLOOD CELL COUNT INCREASED; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 PNEUMONIA; NON-ALCOHOLIC STEATOHEPATITIS; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority (VAERS ID 1768540) concerned a 54 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had HTN (Hypertension), HLD (Hyperlipidaemia), Obesity, and prediabetes for which an A1C (Glycated hemoglobin) was performed with a result of 5.7 (units unspecified), and the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: Unknown) dose was not reported, 1 total administered in left arm on 10-APR-2021 for an unknown indication. Concomitant medications included salbutamol (Albuterol) sulfate (Proair) HFA (hydrofluoroalkane), (Ventolin) HFA and salbutamol (Proventil) HFA for cough, and ciclesonide (ALVESCO) for unknown indication. The patient was on unspecified (prior to admission) and (outpatient) medications. On 21-SEP-2021, the patient experienced covid-19 pneumonia, non-alcoholic steatohepatitis and COVID-19 (Corona virus) resulting in (Suspected clinical vaccination failure), on the same day a number of Laboratory tests (at 12:35) were performed including: Alanine aminotransferase (NR: not provided) increased 44 (units unspecified), Anion gap (NR: not provided) 4 (units unspecified), Aspartate aminotransferase (NR: not provided) increased 62 (units unspecified), Band neutrophil percentage (NR: not provided) 3 %, Blood albumin normal (NR: not provided) 3.5 (units unspecified), Blood alkaline phosphatase normal (NR: not provided) 54 (units unspecified), Blood bilirubin normal (NR: not provided) 0.3 (units unspecified), Blood chloride normal (NR: not provided) 99 (units specified), Blood creatinine normal (NR: not provided) 0.56 (units unspecified), Blood glucose normal (NR: not provided) 194 (units unspecified), Blood lactate dehydrogenase decreased (NR: not provided) 488 (units unspecified), Blood lactic acid (NR: not provided) 1.9 (units unspecified), Blood potassium normal (NR: not provided) 3.6 (units unspecified), Blood sodium normal (NR: not provided) 137 (units unspecified), Blood urea decreased (NR: not provided) 6 (units unspecified), Brain natriuretic peptide normal (NR: not provided) 63 (units unspecified), C-reactive protein increased (SER QL) (NR: not provided) 15.3 (units unspecified), Carbon dioxide normal (NR: not provided) 29 (units unspecified), Differential white blood cell count (NR: not provided) not reported, Fibrin D dimer (NR: not provided) 1.03 (units unspecified)., Glomerular filtration rate (NR: not provided) Unspecified, Haematocrit decreased (NR: not provided) 33.3 (units unspecified), Haemoglobin decresed (NR: not provided) 11.4 (units unspecified), Human chorionic gonadotropin (NR: not provided) Intact (Negative), International normalized ratio (NR: not provided) 1:0 (Normal), Lymphocyte percentage decreased (NR: not provided) 14 %, Mean cell volume decreased (NR: not provided) 57 (units unspecified), Neutrophil percentage decreased (NR: not provided) 83 %, Platelet count decreased (NR: not provided) 143 (units unspecified), Platelet morphology (NR: not provided) Normal, Protein total normal (NR: not provided) 6.5 (units unspecified), Prothrombin time (NR: not provided) 12.3 (units unspecified), Red blood cell analysis (NR: not provided) 1 plus (abnormality grade) Target cells and Ovalocytes were analyzed, one quarter of cells were affected, Red blood cell count increased (NR: not provided) 5.80 (units unspecified), Red blood cell microcytes (NR: not provided) 1plus (abnormality grade) one quarter of cells were affected, Red blood cell nucleated morphology (NR: not provided) 0, Red blood cell spherocytes (NR: not provided) 1plus (abnormality grade) one quarter of cells were affected, Red cell distribution width increased (NR: not provided) 15.6 (units unspecified) and White blood cell count increased (NR: not provided) 10.3 (units unspecified). The patient's Transaminases were slightly elevated (mild) and were measured to be at 2.2 (units unspecified) and underlying Non-alcoholic steatohepatitis (NASH) raised (increased) the HbA1c (Glycosylated haemoglobin) to 6.6 (units unspecified), otherwise the patient was stable during hospitalization (hospitalization dates were unspecified). The patient was treated with remdesivir from 21-SEP-2021 through 25-SEP-2021 (Five days). On 22-SEP-2021, the patient was treated with 2 doses of tocilizumab until 23-SEP-2021 along with a high dose of steroids taper. On 24-SEP-2021, the patient was shifted to the ICU (Intensive Care Unit) due to INO (Internuclear ophthalmoplegia) but was never intubated. The condition improved after 5 days of treatment, the administered oxygen through nasal cannulation was lowered to 2 Liters at rest and 3-4 Liters at exertion. The patient had required a few more days of steroids to taper from 6mg on 01-OCT-2021 and 3mg from 02-OCT-2021 to 04-OCT-2021 and then stopped notably. On 26-SEP-2021, the patient was released from the ICU and on 11-OCT-2021, the patient was fine to be de-isolated from COVID standpoint. The patient was hospitalized for 9 days, and discharge dates were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intensive care on 26-SEP-2021, and the outcome of alanine aminotransferase increased, anion gap, aspartate aminotransferase increased, band neutrophil percentage, blood albumin normal, blood alkaline phosphatase normal, blood bilirubin normal, blood chloride normal, blood creatinine normal, blood glucose normal, blood lactate dehydrogenase increased, blood lactic acid, blood potassium normal, blood sodium normal, blood urea decreased, brain natriuretic peptide normal, c-reactive protein increased, covid-19, covid-19 pneumonia, carbon dioxide normal, differential white blood cell count, fibrin d dimer, glomerular filtration rate, glycosylated haemoglobin increased, haematocrit decreased, haemoglobin decreased, human chorionic gonadotropin negative, international normalised ratio normal, lymphocyte percentage decreased, mean cell volume decreased, neutrophil percentage increased, non-alcoholic steatohepatitis, platelet count decreased, platelet morphology normal, protein total normal, prothrombin time normal, red blood cell analysis, red blood cell count increased, red blood cell microcytes, red blood cell nucleated morphology, red blood cell spherocytes, red cell distribution width increased, transaminases increased, white blood cell count increased and suspected clinical vaccination failure was not reported.  This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000198432 The suspected product quality complaint has been confirmed not to be voided based as 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 19-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: This F/U updates about Product quality complaint investigation result. This does not alter previous causality. 20211032188-covid-19 vaccine ad26.cov2.s-covid-19 pneumonia, non-alcoholic steatohepatitis, covid-19, intensive care, alanine aminotransferase increased, anion gap, aspartate aminotransferase increased, band neutrophil percentage, blood albumin normal, blood alkaline phosphatase normal, blood bilirubin normal, blood chloride normal, blood creatinine normal, blood glucose normal, blood lactate dehydrogenase increased, blood lactic acid, blood potassium normal, blood sodium normal, blood urea decreased, brain natriuretic peptide normal, c-reactive protein increased, carbon dioxide normal, differential white blood cell count, fibrin d dimer, glomerular filtration rate, glycosylated haemoglobin increased, haematocrit decreased, haemoglobin decreased, human chorionic gonadotropin negative, international normalised ratio normal, lymphocyte percentage decreased, mean cell volume decreased, neutrophil percentage increased, platelet count decreased, platelet morphology normal, protein total normal, prothrombin time normal, red blood cell analysis, red blood cell count increased, red blood cell microcytes, red blood cell nucleated morphology, red blood cell spherocytes, red cell distribution width increased, transaminases increased, white blood cell count increased. 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). 20211032188-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