Sex: M
Vaccine: COVID19
Symptoms: Back pain, Biopsy skin, Body temperature, Body temperature increased, Colitis
Clinical narrative: COLON INFLAMMATION; INTERVERTEBRAL DISC BULGING/BULGE IN BACK; TASTE PECULIAR/SICK TASTE IN MOUTH; FLAKING SKIN/FLAKY ON ARM AND BACK OF HANDS; STRESS; GUT PAIN; RASH PSORIAFORM; PAIN LOCALISED; BACK PAIN; INJECTION SITE BRUISING; FEELING SICK/NOT FEELING WELL; RED SPOTTY RASH/RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; TIREDNESS; SWOLLEN LYMPH NODES; NAUSEOUS; TEMPERATURE ELEVATION; HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a consumer concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and ankylosing spondylitis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 7 days, therapy dates were not reported for moderate to severe adult crohn's disease and ankylosing spondylitis.  Non-company suspect vaccine included: MRNA 1273 (dose number in series 02) (form of admin unknown, intramuscular, batch number was not reported), dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included alprazolam. On an unspecified date, the patient experienced colon inflammation, intervertebral disc bulging/bulge in back, taste peculiar/sick taste in mouth, stress, gut pain, rash psoriaform, pain localised, back pain, injection site bruising, feeling sick/not feeling well, red spotty rash/red spots on hands that were like psoriasis, tiredness, swollen lymph nodes, nauseous, temperature elevation, headache and injection site swelling (dose number in series 01). It was reported that patient took alprazolam and usually when it dissolved in his mouth it tastes horrible right now but now patient did not taste anything. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative. The patient had weird patches of skin that were flaky on his arms and back of hands/flaking skin (dose number in series 01). The patient had two skin biopsy on an unknown date which showed (NR: not provided) Negative for cancer. On an unknown date, Colonoscopy (NR: not provided) showed not major inflammation and patient underwent surgery (unspecified) and narrow the colon. The patient had stabbing pain in his side, and it hurts when he went to the bathroom and he thought that might be start to get a hernia. It stated that patient had missed doses couple days last time (medication not specified) and started to 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 action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with adalimumab was withdrawn. The patient had not recovered from intervertebral disc bulging/bulge in back, tiredness, flaking skin/flaky on arm and back of hands, stress, gut pain, temperature elevation, back pain, and headache, and the outcome of colon inflammation, feeling sick/not feeling well, swollen lymph nodes, taste peculiar/sick taste in mouth, nauseous, red spotty rash/red spots on hands that were like psoriasis, rash psoriaform, pain localised, injection site bruising and injection site swelling was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220152364-Covid-19 vaccine ad26.cov2.s-Colon inflammation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE