Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme increased, Jaundice, Laboratory test abnormal, Liver scan normal, Magnetic resonance imaging
Clinical narrative: DIABETES; NON-ALCOHOLIC CIRRHOSIS; AUTOIMMUNE HEPATITIS; HEADACHE; BAD SORE THROAT; This spontaneous report received from a patient concerned a 58 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: fatty liver, and patient had no known allergies. On 10-FEB-2021 patient had her annual checkup and the doctor told her that the everything was great but patient needed to keep an eye on fatty liver. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) .5 ml, 1 total, administered on 10-APR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested.  On 14-APR-2021, the patient experienced headache, diarrhea, and vomiting. Patient's doctor thought that patient needs to get tested for Covid. On APR-2021 Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Then patient started having bad sore throat and got tested for Strep throat. On APR-2021 Laboratory data included: Streptococcus identification test (NR: not provided) Negative. On APR-2021, patient sent to do blood work Laboratory data included: Blood test (NR: not provided) noticed high liver enzymes, so patient was sent for a scan thinking that she might have hepatitis. On APR-2021 Laboratory data included: Scan (NR: not provided) not reported. On 29-APR-2021, the patient developed severe jaundice. Patient said that first two weeks of MAY-2021 Patient's health started to deteriorate. Patient had chills, diarrhea, fever, vomiting, and fatigue. Patient was delusional and very confused. On 14-MAY-2021, the patient experienced got really sick. Patient was taken to emergency room and were hospitalized in an emergency status. During patient stay at hospital patient had Laboratory data included: Computed tomography (CT) scan (NR: not provided) not reported, Nuclear Scan (NR: not provided) not reported. Every 4 hours'blood was drawn to check for liver enzymes and bilirubin. Laboratory data included: Blood test (NR: not provided) glucose and cholesterol the numbers were high and they did jugular biopsy Laboratory data included: Transjugular liver biopsy (NR: not provided) autoimmune hepatitis and they came with the result around 19-MAY-2021 that patient had autoimmune hepatitis due to non-alcoholic cirrhosis. Patient was hospitalized for 8 days and discharged on 21-MAY-2021. Patient stated this was the reason patient was taking several medications and one of them was prednisone. Patient started with 40mg and because of this medication patient developed diabetes and now using insulin. As per patient she was healthy and the vaccine must have triggered something in her body.  The patient was visited to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of autoimmune hepatitis, bad sore throat, diabetes and non-alcoholic cirrhosis was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211108532-covid-19 vaccine ad26.cov2.s-autoimmune hepatitis, non-alcoholic cirrhosis, Diabetes, bad sore throat. 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).  20211108532-covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.