Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal distension, Bacterial infection, Blood pressure measurement, Flatulence, Gastrointestinal disorder
Clinical narrative: BLOATING; BACTERIAL INFECTION; SWELLING FACE; BLOOD PRESSURE HIGH; SINUS INFECTION; PSORIATIC ARTHRITIS AGGRAVATED/PSORIATIC ARTHRITIS  OUTBREAK FOR TWO FINGERS AND TOES; UNSPECIFIED DISORDER OF INTESTINE/EXPLOSIVE INTESTINAL PROBLEM; GAS; This spontaneous report received from a patient via other manufacturer concerned an 88 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: Humira/adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 10-AUG-2022 for psoriatic arthritis.  No concomitant medications were reported.  On AUG-2022, the patient experienced gas.  On 12-AUG-2022, the patient experienced psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes. On 12-AUG-2022, the patient experienced unspecified disorder of intestine/explosive intestinal problem.  On 20-AUG-2022, the patient experienced sinus infection.  On 26-AUG-2022, the patient experienced blood pressure high, bacterial infection, and swelling face. Laboratory data included: Blood pressure Over 200/100.  On an unspecified date, the patient experienced bloating.  Treatment medications (dates unspecified) included: Augmentin (amoxicillin trihydrate/clavulanate potassium). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from blood pressure high, and swelling face on 26-AUG-2022, unspecified disorder of intestine/explosive intestinal problem on 16-AUG-2022, and gas on 2022, was recovering from sinus infection, and the outcome of psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes, bloating and bacterial infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916512-covid-19 vaccine ad26.cov2.s-Psoriatic Arthritis Aggravated/Psoriatic Arthritis  Outbreak For Two Fingers And Toe. The event(s) has an unknown/unclear 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. 20220916512-covid-19 vaccine ad26.cov2.s -Blood pressure high. 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.