Sex: F
Vaccine: COVID19
Symptoms: Adenoma benign, Colonoscopy, Psoriatic arthropathy, Rash
Clinical narrative: This spontaneous report received from a physician via Other manufacturer (RA) concerned a 51 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received non-company suspect drugs included: adalimumab (Humira) (solution or injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) 40mg/0.4ml, 40 mg, 1 time every 2 weeks from SEP-2020 for psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 total, dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included methotrexate. The patient received ustekinumab (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUL-2021 for psoriatic arthritis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date around in MAY 2021 or JUN 2021, the patient experienced thickened postural rash on palm, hand and feet. Physician tried to increase adalimumab (Humira) to 40 mg, 1 time every 1 week (every week dosage for a month) on JUN-2021 but it gotten worse and physician decided to stop adalimumab (Humira). Physician prescribed prednisone and it got better. She switched to ustekinumab (Stelara). Physician clarified that there was no lymphocytic colitis that she mentioned. She might have learned of it while writing the letter. Physician clarified that patient had colonoscopy in JAN 2022 as a follow up on the previous colonoscopy (prior to Humira). Physician also stated there was one five millimeter polyp adenomatous that was removed during the colonoscopy and mentioned it was an adenoma. On MAR-2022, the patient experienced psoriatic arthritis flare up. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; action taken with ustekinumab was not reported; and treatment with adalimumab was withdrawn on JUL-2021. The patient recovered from adenoma/adenomatous polyp on JAN-2022, was recovering from thickened postural rash on palm, hand and feet, and had not recovered from psoriatic arthritis flare up. This report was serious (Other Medically Important Condition). Sender's Comments: V0-20220437940 -STELERA -PSORIATIC ARTHRITIS FLARE-UP. This event(s) is labeled by standard procedures. Therefore, the event(s) is considered not related. 20220437940-Stelara - ADENOMA/ADENOMATOUS POLYP. The event(s) has an unknown/unclear 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. V0: 20220437940 -covid-19 vaccine ad26.cov2.s -ADENOMA/ADENOMATOUS POLYP. 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. 20220437940 -Covid-19 vaccine ad26.cov2.s -PSORIATIC ARTHRITIS FLARE-UP. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.