Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Stoma site haemorrhage, Systemic lupus erythematosus, Viral infection
Clinical narrative: ILEOSTOMY BAG; SICKNESS; SLEEPY; INFLAMMATION; DEHYDRATION; HAIR LOSS; LOST 10 POUNDS; LOW IRON; BLEEDING IN ILEOSTOMY BAG; STOMACH PAIN; BURNING PAIN IN FEET/LEGS/HIPS/ BACK/BODY PAIN; PAINFUL HIPS; CROHN'S DISEASE AGGRAVATED/FLARE UP; SLE FLARE/TRIGGERED; LEG PAIN; FEVER; HEADACHE; DIARRHEA; VIRAL INFECTION; BACK PAIN; SKIN PAIN; COULD NOT GET UP IN BED; FIBROMYALGIA FLARE/TRIGGERED; This spontaneous report received from a patient via a company representative concerned a 54 year old female of an unspecified race and ethnic origin. The patient's weight was 138 pounds, and height was 65 inches. The patient's concurrent conditions included: no tobacco user, sleepy all the time, abstains from alcohol, egg allergy, milk allergy, and moderate to severe adult crohn's disease. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 30-MAR-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Protonix (pantoprazole sodium sesquihydrate) for acid reflux, Ritalin (methylphenidate hydrochloride) for attention- deficit hyperactivity disorder, Prozac (fluoxetine hydrochloride) for depression, Ferozorb (cyanocobalamin/ferrous ascorbate/folic acid) for drug used for supplement, DL-phenylalanine for joint pain, Flomax (morniflumate) for kidney stone, Medrol (methylprednisolone) for lupus, Calcitriol for osteoporosis, Hydrocodone for pain, Diflucan (fluconazole) for stomach cramps, Vitamin b12 nos for supplement, Acetylcysteine for supplement, Perfusia (arginine) for supplement, Omegagenix EPA DHA 2400 (fish oil) for supplement, theanine for supplement and Humira (adalimumab) for moderate to severe adult chrohn's disease.  On APR-2021, the patient experienced sle flare/triggered, fibromyalgia flare/triggered, viral infection, back pain, skin pain, could not get up in bed, leg pain, fever, headache, and diarrhea. On OCT-2021, the patient experienced crohn's disease aggravated/flare up. On DEC-2021, the patient experienced burning pain in feet/legs/hips/ back/body pain, and painful hips. On JAN-2022, the patient experienced bleeding in ileostomy bag, and stomach pain. On 07-JAN-2022, the patient experienced low iron. Laboratory data included: Serum iron (NR: not provided) unknown. On FEB-2022, Laboratory data included: Magnetic resonance imaging (NR: not provided) unknown. On an unspecified date, the patient experienced ileostomy bag, sickness, sleepy, inflammation, dehydration, hair loss, and lost 10 pounds. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown, and Weight (NR: not provided) unknown. The action taken with covid-19 vaccine was not applicable. The patient was recovering from sle flare/triggered, fibromyalgia flare/triggered, viral infection, back pain, skin pain, and could not get up in bed, had not recovered from sickness, bleeding in ileostomy bag, crohn's disease aggravated/flare up, leg pain, and painful hips, and the outcome of ileostomy bag, sleepy, inflammation, dehydration, hair loss, burning pain in feet/legs/hips/ back/body pain, fever, headache, diarrhea, lost 10 pounds, stomach pain and low iron was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220251183 - COVID-19 VACCINE -Sle flare/triggered, bleeding in ileostomy bag, Crohn's disease aggravated/flare up. 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. Therefore, this event(s) is considered not related.