Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case; was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) in an 81-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Ustekinumab (Stelara) for Crohn's disease. Concurrent medical conditions included Crohn's (diagnosed from before the vaccines (when he was 76 years old)) since 2020. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and Ustekinumab (Stelara) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) (seriousness criterion medically significant) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving). The patient was treated with Risankizumab rzaa (Skyrizi) at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (has Crohn's disease, diagnosed from before the vaccines/ one section that is not improving and so his HCP switched him to Skyrizi - AE reported because vaccines may have worsened his case) had not resolved and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that is not improving) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: while Stelara was improving most of the colon there was one section that was not improving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, HCP recommended the patient to take Covid vaccine every 6 months - off label usage. He had Crohn's disease, diagnosed from before the vaccines (when he was 76 years old) and was on Stelara but then the colonoscopy showed that while Stelara was improving most of the colon there was one section that was not improving and so his HCP switched him to Skyrizi. On 05-May-2025, he received Spikevax 2024-2025 (Lot number: 3046731) at a dose of 0.5 ml. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Crohn's (diagnosed from before the vaccines (when he was 76 years old))
Stelara
Test Name: colonoscopy; Result Unstructured Data: while Stelara was improving most of the colon there was one section that was not improving