Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep study
Clinical narrative: PSORIASIS; COPD; AORTIC ANEURYSM; MINIMALLY DEPRESSED; SHOULDER SURGERY; This solicited report received from a patient through company representative, concerned a 66 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, psoriatic arthritis, and psoriasis vulgaris. The patient was treated with ustekinumab (Stelara) (solution for injection in pre-filled syringe, subcutaneous, batch number: 21M012MC and MFS0WME, expiry: UNKNOWN) 90 mg, frequency, and therapy dates were not reported, for psoriasis vulgaris. Product constituent parts included UltraSafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and UltraSafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). Also received non-company suspect drugs included: diphenhydramine hydrochloride (Benadryl) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  On an unspecified date, the patient experienced aortic aneurysm following treatment with ustekinumab (Stelara). The patient had previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series: 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 2 (first booster) administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old.  Concomitant medications included acetylsalicylic acid, atropine sulfate/diphenoxylate hydrochloride, azithromycin, benzonatate, betamethasone dipropionate, dicycloverine hydrochloride, diphenhydramine hydrochloride, escitalopram oxalate, evolocumab, ezetimibe, fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, fluticasone propionate, glyceryl trinitrate, hydrochlorothiazide/losartan potassium, metoprolol tartrate, potassium chloride, rosuvastatin calcium, and salbutamol sulfate. On 12-OCT-2022, the patient had shoulder surgery (dose number in series: 2) so she had to delay her last injection with Stelara by 14 days. On an unspecified date, the patient experienced psoriasis, had COPD (Chronic obstructive pulmonary disease) and that got sleep study test done, and patient was soon taken to the hospital, where scored minimally depressed on survey (dose number in series: 2). Laboratory data (dates unspecified) included: Sleep study scored minimally depressed on survey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with diphenhydramine hydrochloride was not reported; and treatment with ustekinumab for the event shoulder surgery was withdrawn, and action taken with ustekinumab for the events aortic aneurysm, psoriasis, minimally depressed and COPD was not reported. The outcome of the aortic aneurysm, shoulder surgery, psoriasis, minimally depressed and COPD was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and shoulder surgery, psoriasis, COPD, aortic aneurysm, and minimally depressed was not related; and between ustekinumab and shoulder surgery, COPD, aortic aneurysm, psoriasis, and minimally depressed was not related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20191222236.  This case was reassessed as serious based on additional information received from company representative on 21-DEC-2022. The following information was updated and incorporated into the case narrative: suspect and past vaccine (covid-19 vaccine ad26.cov2.s), events (shoulder surgery, psoriasis, minimally depressed and COPD), lab data and concomitant drug (Hydrochlorothiazide/losartan potassium) added, indication added for all the concomitant drugs.; Sender's Comments: V1: This version updates the case from non serious to serious and updates suspect and past vaccine (covid-19 vaccine ad26.cov2.s), events (shoulder surgery, psoriasis, minimally depressed and COPD), lab data and concomitant drug (Hydrochlorothiazide/losartan potassium) added, indication added for all the concomitant drugs.  20220941378-covid-19 vaccine ad26.cov2.s- shoulder surgery. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related. 20220941378-Stelara- shoulder surgery. 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 not related.