Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, COVID-19, Gastrointestinal infection, Inappropriate schedule of product administration, Off label use
Clinical narrative: PAINFUL KNEE; HAND PAIN; GASTROINTESTINAL INFECTION; COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s. (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination which reported for off label use and inappropriate schedule of vaccine administered. (dose number in series 2). On DEC-2021, the patient experienced gastrointestinal infection. (dose number in series 2). On an unspecified date, the patient had covid-19, Patient got covid after left hospital. Missed doses of Humira while in hospital and during covid and had painful knee and hand pain(dose number in series 2). The patient was hospitalized on an unknown date for five days. The patient received adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date therapy with adalimumab was discontinued. No concomitant medications were reported.  Patient received additional dose of Moderna (dose number in series was 3) (form of admin, intramuscular, and batch number were not reported) dose was not reported, administered on 04-DEC-2021 for covid-19 vaccination. It was unknown if patient experienced any adverse reactions following vaccination with Moderna vaccine (dose number in series was 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with mrna 1273 was not reported. The patient was recovering from painful knee, gastrointestinal infection, and covid-19, and the outcome of hand pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220152328-COVID-19 VACCINE AD26.COV2.S-gastrointestinal infection. 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). 20220152328-COVID-19 VACCINE AD26.COV2.S-painful knee, hand pain. This event(s) is labeled per RA and is therefore considered potentially related.