Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Deafness, Drug level, Immunisation reaction, Psoriasis
Clinical narrative: got back with Crohn's/Crohn's had come out with vengeance; lost hearing; Bad reaction to Moderna Covid-19 vaccine; psoriasis got cystic; This spontaneous case was reported by a patient and describes the occurrence of CROHN'S DISEASE (got back with Crohn's/Crohn's had come out with vengeance) and DEAFNESS (lost hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication, INFLIXIMAB (REMICADE) for an unknown indication, ADALIMUMAB (HUMIRA) for an unknown indication and USTEKINUMAB (STELARA) for Psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 10 milligram twice a day, INFLIXIMAB (REMICADE) (unknown route) at an unspecified dose once a month, ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. and USTEKINUMAB (STELARA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (got back with Crohn's/Crohn's had come out with vengeance) (seriousness criterion medically significant), DEAFNESS (lost hearing) (seriousness criterion medically significant), IMMUNISATION REACTION (Bad reaction to Moderna Covid-19 vaccine) and PSORIASIS (psoriasis got cystic). At the time of the report, CROHN'S DISEASE (got back with Crohn's/Crohn's had come out with vengeance), DEAFNESS (lost hearing), IMMUNISATION REACTION (Bad reaction to Moderna Covid-19 vaccine) and PSORIASIS (psoriasis got cystic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Drug level: did not have any of it in system..         No concomitant medication was reported. Treatment information was not provided.  For many years the patient had been taking Remicade (infusion, monthly), then moved Humira and then Stelara (reporter spelled drug as Starlar), patient only took it for a few weeks because psoriasis got  cystic and lost hearing, so patient was moved back to Humira and had been on it ever since. Then recently things got back with Chron's, the frequency and pain were terrible and the mucus was awful. As per patient these drugs were autoimmune drugs, they stopped working and patient was moved to Xeljanz. Since the other drugs were immunosuppressant, patient was restricted on things, specially about Covid, patient received both doses of the Moderna Covid-19 vaccine however doctor advised not to receive a booster because patient had a bad reaction to it. Every time patient had a shot of the Moderna vaccine on Friday and on Monday, it was time for Humira but Crohn's had come out with vengeance, after a few days it settled down and was fine until had the other shot of Moderna and the same thing happened.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of unspecified aged with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Deafness that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received initial two doses of same vaccine on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient of unspecified aged with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Deafness that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received initial two doses of same vaccine on unknown dates. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement