Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Off label use, Systemic lupus erythematosus
Clinical narrative: LUPUS ERYTHEMATOSUS; BLOOD PRESSURE INCREASED; ELEVATED LIVER ENZYMES; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; TIREDNESS; This spontaneous report received from a patient concerned a 51 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: stroke. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The reporter did not report any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received the second dose of covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose, 1 total, administered around 16:00 on unspecified date for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number.  On an unspecified date, the day after vaccination, the patient felt tired. On an unspecified date, her liver enzymes were elevated but she thought it was because of another medication. If liver enzymes were remain elevated then she will do scan of liver. She also had elevated blood pressure 160/109. On an unspecified date, the blood pressure came down. On an unspecified date, the patient also experienced lupus erythematosus. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 160/109 mmHg, come down, and Hepatic enzyme (NR: not provided) elevated (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis, and moderate to severe rheumatoid arthritis.  The patient received non-company suspect vaccine included: BNT 162 (dose number in series: 2) (form of admin unknown, intramuscular, batch number was not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  The action taken with adalimumab, and BNT 162 was not reported. The patient was recovering from tiredness, elevated liver enzymes, and blood pressure increased, and the outcome of lupus erythematosus, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220136025-covid-19 vaccine ad26.cov2.s- lupus erythematosus, blood pressure 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).