Reporte zur Charge EP6955 6023162

Symptomtext

The colitis has been controlled with Simponi for 5 years/had a flare up with rectal bleeding; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received dose 1 of bnt162b2 (covid 19 VCCINE; manufacturer not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 11:15 (Batch/Lot Number: EP6955 6023162) as SINGLE DOSE for covid-19 immunization. Medical history included hemophilia B and ulcerative colitis. The colitis has been controlled with Simponi for 5 years. The patient also had sulfa allergy since an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included multivitamins taken for an unspecified indication, start and stop date were not reported; and golimumab (SIMPONI) taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 22:30, the patient had a flare up with rectal bleeding had a flare up with rectal bleeding. He had to infuse with factor (BENEFIX) overnight and also take prednisone he had on hand. He will see the GI doctor tomorrow. The outcome of event was unknown. The reporter considered the event as serious, life threatening. Follow-up attempts are completed. The information on the batch/lot number has been obtained.