Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Crohn's disease, Lymphadenopathy, Neuropathy peripheral
Clinical narrative: NEUROPATHY IN FEET AND LEGS; A LITTLE BIT OF THE CROHN'S EFFECTED PATIENT; SWELLING OF LEFT GLAND; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (NEUROPATHY IN FEET AND LEGS) and CROHN'S DISEASE (A LITTLE BIT OF THE CROHN'S EFFECTED PATIENT) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (NEUROPATHY IN FEET AND LEGS) (seriousness criterion medically significant), CROHN'S DISEASE (A LITTLE BIT OF THE CROHN'S EFFECTED PATIENT) (seriousness criterion medically significant) and LYMPHADENOPATHY (SWELLING OF LEFT GLAND). At the time of the report, NEUROPATHY PERIPHERAL (NEUROPATHY IN FEET AND LEGS) and CROHN'S DISEASE (A LITTLE BIT OF THE CROHN'S EFFECTED PATIENT) had not resolved and LYMPHADENOPATHY (SWELLING OF LEFT GLAND) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Showing a little bit of the Crohn's effected.         No concomitant medications were reported.  Patient was administered HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), 1160679, 1160679, 1160836.  Daily dose of SPIKEVAX reported was 1 in 1 once.  The reporter's causality for the events of swelling of left gland, neuropathy in feet and legs and a little bit of the crohn's effected patient with HUMIRA was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. Company comment- This spontaneous case concerns a 69-year-old male patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) events of neuropathy peripheral (in feet and legs) and Chron´s disease. Two doses of mRNA-1273 vaccine, given as a first and booster dose (no information regarding second dose) of COVID vaccine schedule, were administered. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. It was reported that a colonoscopy was performed which showed ¨ little bit of the Crohn's effected¨. Details of symptoms, clinical course, investigation reports and treatment were not provided. Treatment with Adalimumab remains as a confounder for the event neuropathy peripheral. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) events of neuropathy peripheral (in feet and legs) and Chron´s disease. Two doses of mRNA-1273 vaccine, given as a first and booster dose (no information regarding second dose) of COVID vaccine schedule, were administered. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. It was reported that a colonoscopy was performed which showed ¨ little bit of the Crohn's effected¨. Details of symptoms, clinical course, investigation reports and treatment were not provided. Treatment with Adalimumab remains as a confounder for the event neuropathy peripheral. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.