Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Decreased appetite, Hepatitis, Nausea, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIVER INFLAMMATION; SEVERE LOSS OF APPETITE; WEIGHT LOSS OF AROUND 18 LBS; MODERATE NAUSEA; This spontaneous report received from a patient and concerned a 64 year old male of unspecified ethnicity. The patient's weight was 86.18 kilograms, and height was 183 centimeters. The patient's concurrent conditions included: cancer and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total administered on 06-MAR-2021 at left arm for prophylactic vaccination.  The patient additionally received non-company suspect vaccine BNT 162 (dose number in series 2) (batch number: FH8027 expiry: unknown, form of admin, route of admin, and were not reported) dose was not reported, administered on 18-NOV-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient developed covid virus (suspected clinical vaccination failure, suspected covid-19 infection) (dose number in series 1) with associated symptoms. On 10-JAN-2022, the patient was treated with Paxlovid tablet (2 different tablets) for covid virus to minimize result of covid and his associated symptoms with the medication.  Around 25-JAN-2022, the patient experienced severe loss of appetite, weight loss of around 18 lbs, and moderate nausea (dose number in series 2). On an unspecified date, the patient experienced slightly jaundiced. On 08-FEB-2022, the patient experienced liver inflammation (dose number in series 2). The loss of appetite had improved slightly at a very slow rate. He did have an oncology appointment and they did blood work. He was called 3 days ago with results and they said he did have liver inflammation. He had no problem with the vaccines. Moderate nausea improved significantly, but the rate of improvement was very slow. He first noticed being slightly jaundiced 2 weeks ago. He did not have an exact date. His oncologist had scheduled for more labs in a week and a half. He also reported that associated with lack of appetite was weight loss of around 18 lbs., which had then stabilized. The action taken with covid-19 vaccine ad26.cov2.s, and bnt 162 was not applicable. The patient recovered from suspected covid-19 infection, was recovering from severe loss of appetite, moderate nausea, and weight loss of around 18 lbs, and the outcome of suspected clinical vaccination failure and liver inflammation was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000218644.; Sender's Comments: V0: 20220242568- covid-19 vaccine ad26.cov2.s- liver inflammation. 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). Therefore, this event(s) is considered unassessable.  20220242568- covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination failure. 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. Therefore, this event(s) is considered not related.