Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Injection site bruising, Injection site swelling, Intervertebral disc protrusion, Lymphadenopathy, Malaise
Clinical narrative: Colon inflammation; Intervertebral disc bulging/ Bulge in back; Flaking skin/Flaky on arm and back of hands; Rash psoriaform; Taste peculiar/Sick taste in mouth; Stress; Gut pain; Pain localized, Stabbing pain in his side and it hurts when he went to the bathroom; Back pain; Injection site bruising; Feeling sick/not feeling well; Red spotty rash/Red spots on hands that were line psoriasis; Tiredness; Swollen lymph nodes; Nauseous; Headache; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colon inflammation), INTERVERTEBRAL DISC PROTRUSION (Intervertebral disc bulging/ Bulge in back), SKIN EXFOLIATION (Flaking skin/Flaky on arm and back of hands) and DERMATITIS PSORIASIFORM (Rash psoriaform) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease (Moderate to severe adult Crohn's disease.). Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced COLITIS (Colon inflammation) (seriousness criterion medically significant), INTERVERTEBRAL DISC PROTRUSION (Intervertebral disc bulging/ Bulge in back) (seriousness criterion medically significant), SKIN EXFOLIATION (Flaking skin/Flaky on arm and back of hands) (seriousness criterion medically significant), DERMATITIS PSORIASIFORM (Rash psoriaform) (seriousness criterion medically significant), DYSGEUSIA (Taste peculiar/Sick taste in mouth), STRESS (Stress), GASTROINTESTINAL PAIN (Gut pain), PAIN (Pain localized, Stabbing pain in his side and it hurts when he went to the bathroom), BACK PAIN (Back pain), INJECTION SITE BRUISING (Injection site bruising), MALAISE (Feeling sick/not feeling well), RASH MACULAR (Red spotty rash/Red spots on hands that were line psoriasis), FATIGUE (Tiredness), LYMPHADENOPATHY (Swollen lymph nodes), NAUSEA (Nauseous), HEADACHE (Headache) and INJECTION SITE SWELLING (Injection site swelling). The patient was treated with Surgery (patient underwent surgery (unspecified) and narrow the colon) for Colitis. At the time of the report, COLITIS (Colon inflammation), DERMATITIS PSORIASIFORM (Rash psoriaform), DYSGEUSIA (Taste peculiar/Sick taste in mouth), PAIN (Pain localized, Stabbing pain in his side and it hurts when he went to the bathroom), INJECTION SITE BRUISING (Injection site bruising), MALAISE (Feeling sick/not feeling well), RASH MACULAR (Red spotty rash/Red spots on hands that were line psoriasis), NAUSEA (Nauseous) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown, INTERVERTEBRAL DISC PROTRUSION (Intervertebral disc bulging/ Bulge in back), SKIN EXFOLIATION (Flaking skin/Flaky on arm and back of hands), STRESS (Stress), GASTROINTESTINAL PAIN (Gut pain), BACK PAIN (Back pain), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved and LYMPHADENOPATHY (Swollen lymph nodes) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: negative (Negative) Negative for cancer and negative (Negative) Negative for cancer. On an unknown date, Body temperature: elevated (High) Elevated. On an unknown date, Colonoscopy: abnormal (abnormal) Not major inflammation. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         It was reported that patient took alprazolam and usually when it dissolved in his mouth and it tastes horrible right now but now patient did not taste anything. The patient had weird patches of skin that were flaky on his and back, hands/flaking skin. The patient had stabbing pain in his side, and it hurts when he went to the bathroom and he thought that might be started to get a hernia.  It stated that patient had missed doses couple days last time (medication not specified) and started co have gut pain really bad and had to start back on medication. The patient 's lymph nodes were swollen, and physician prescribed medications (physician office visit) and things got better.  The reporter considered the causality as possible for the Co-suspect JANSSEN COVID-19 Vaccine and with all the events.  Company comment: This case concerns an adult male patient with medical history of Ankylosing spondylitis and Crohn's disease, who experienced serious, unexpected serious unexpected COLITIS, INTERVERTEBRAL DISC PROTRUSION,  SKIN EXFOLIATION and DERMATITIS PSORIASIFORM after received the second dose of mRNA-1273. Temporal relationship is unknown. The patient experienced additional non-serious events. Concomitant products included ALPRAZOLAM for an unknown indication. Causality is strongly confounded by the patient's medical history of Ankylosing spondylitis and Crohn's disease, as well as concomitant use of alprazolam. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an adult male patient with medical history of Ankylosing spondylitis and Crohn's disease, who experienced serious, unexpected serious unexpected COLITIS, INTERVERTEBRAL DISC PROTRUSION,  SKIN EXFOLIATION and DERMATITIS PSORIASIFORM after received the second dose of mRNA-1273. Temporal relationship is unknown. The patient experienced additional non-serious events. Concomitant products included ALPRAZOLAM for an unknown indication. Causality is strongly confounded by the patient's medical history of Ankylosing spondylitis and Crohn's disease, as well as concomitant use of alprazolam. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.