Sex: M
Vaccine: COVID19, UNK
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: RECURRENT SEVERE THROMBOCYTOPENIA; This spontaneous report received from a physician concerned a 75 year old male of unspecified race and ethnicity. The patient's weight was 148 kilograms, and height was 179 centimeters. The patient's concurrent conditions included: crohn's disease, non smoker, alcohol user (moderate), high blood pressure, indigestion, nausea, and sleep, and other pre-existing medical conditions included: Patient had no allergies and no history of drug abuse. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: KE5071OH expiry: 20-APR-2023, batch number: 21AO12MB expiry: 28-FEB-2024, batch number: LO57KMA expiry: 03-JAN-2024, and batch number: 21A142MC expiry: 04-JAN-2024) 90 mg, 1 time every 2 months, from 02-JUN-2021, 90 mg, 1 time every 2 months, from 07-OCT-2021, 90 mg, 1 time every 2 months, from 19-OCT-2021, and 90 mg, 1 time every 2 months, from 21-JUN-2022 for crohn's disease. 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). All required follow-up attempts have been made. The Batch number for ustekinumab has not been provided. No concomitant medications were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included losartan for blood pressure, omeprazole for indigestion, ondansetron for nausea, and trazodone for sleep.  Physician stated that 10 to 14 days after his patient takes his STELARA 90 mg injection, his platelet levels go down. The physician stated that the patient platelet levels were 125,000 prior to receiving ustekinumab. On 21-APR-2022, 10 days after receiving ustekinumab injection, patient's levels were at 28,000. On 25-APR-2022, patient's levels were at 34,000. On 20-MAY-2022, Laboratory data included: Platelet count 103. Physician stated that patient has shown signs of severe thrombocytopenia with platelet counts of 8000 and 10,000 (coded as recurrent severe thrombocytopenia). This has happened three times after three doses of ustekinumab.  Patient had severe thrombocytopenia after the third maintenance dose of Stelara with platelet count dropping to 25000. It was initially attributed to covid vaccination and it returned to normal 120000 but after the fourth maintenance dose his platelet count dropped to 14. Patient developed thrombocytopenia after each of 3 subcutaneous injections of stelara 8 weeks apart. Stelara was discontinued and platelet count improved up to 103 on 20-MAY-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with ustekinumab was withdrawn. The patient had not recovered from recurrent severe thrombocytopenia. This report was serious (Life Threatening). This case, from the same reporter is linked to 20120512531, 20111202680 and 20040600797.  Additional information received from nurse on 09-AUG-2022. The following information was updated and incorporated into the case narrative: All required follow-up attempts have been made. The Batch number for ustekinumab has not been provided, reporter (nurse as contact) added, Patient demographics (height weight) added, Lab data added, suspect product (Janssen covid-19 vaccine) addded, product Stelara information (therapy dates, expiry dates, batch number for 4 doses added), concomitant drugs added, narrative updated.; Sender's Comments: V3: This follow up version updates- All required follow-up attempts have been made. The Batch number for ustekinumab has not been provided, reporter (nurse as contact) added, Patient demographics (height weight) added, Lab data added, suspect product (Janssen covid-19 vaccine) addded, product Stelara information (therapy dates, expiry dates, batch number for 4 doses added), concomitant drugs added, narrative updated. MAC updated.  20220457359-covid-19 vaccine ad26.cov2.s-Recurrent severe thrombocytopenia. Follow-up received regarding Clinical Details. 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.  20220457359-Stelara-Recurrent severe thrombocytopenia. Follow-up received regarding Clinical Details. 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.