Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Myalgia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Chrones flare/ Chrohns symptom flares; neuropathy; ecchymosis; Swollen ankle/ Swelling ankle; pain in left leg; malaise; Shortness of breath can't exert self physically; disorientation; vertigo; worsening memory/Memory issues; cold; loss of appetite; weight loss; depression; sleep apnea; worsening Insomnia; metallic taste/change taste; loss of taste; Burning sensations; migraines; hematuria; increased Upper respiratory infection; uncontrolled hypertension; GI Pain; brain fog; anxiety; Loss of smell; change smell; smell on breath Phantom smells- ammonia, gas, sweet smells; cognitive issues; bruising; Swollen left leg/ Swelling in left leg; cough; tingling; dizziness; painful joints/pain in ankle; head pain/ Stronger headaches; chills; Allergy symptoms uncontrolled; fatigue/More fatigue; Achy/painful muscles; This spontaneous case was reported by a patient and describes the occurrence of CROHN'S DISEASE (Chrones flare/ Chrohns symptom flares) and NEUROPATHY PERIPHERAL (neuropathy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CROHN'S DISEASE (Chrones flare/ Chrohns symptom flares) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), ECCHYMOSIS (ecchymosis), JOINT SWELLING (Swollen ankle/ Swelling ankle), PAIN IN EXTREMITY (pain in left leg), MALAISE (malaise), DYSPNOEA EXERTIONAL (Shortness of breath can't exert self physically), DISORIENTATION (disorientation), VERTIGO (vertigo), MEMORY IMPAIRMENT (worsening memory/Memory issues), NASOPHARYNGITIS (cold), DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (weight loss), DEPRESSION (depression), SLEEP APNOEA SYNDROME (sleep apnea), INSOMNIA (worsening Insomnia), DYSGEUSIA (metallic taste/change taste), AGEUSIA (loss of taste), BURNING SENSATION (Burning sensations), MIGRAINE (migraines), HEMATURIA (hematuria), UPPER RESPIRATORY TRACT INFECTION (increased Upper respiratory infection), HYPERTENSION (uncontrolled hypertension), GASTROINTESTINAL PAIN (GI Pain), FEELING ABNORMAL (brain fog), ANXIETY (anxiety), ANOSMIA (Loss of smell), PAROSMIA (change smell), BREATH ODOUR (smell on breath Phantom smells- ammonia, gas, sweet smells), COGNITIVE DISORDER (cognitive issues), CONTUSION (bruising), PERIPHERAL SWELLING (Swollen left leg/ Swelling in left leg), COUGH (cough), PARAESTHESIA (tingling), DIZZINESS (dizziness), ARTHRALGIA (painful joints/pain in ankle), HEADACHE (head pain/ Stronger headaches), CHILLS (chills), HYPERSENSITIVITY (Allergy symptoms uncontrolled), FATIGUE (fatigue/More fatigue) and MYALGIA (Achy/painful muscles). At the time of the report, CROHN'S DISEASE (Chrones flare/ Chrohns symptom flares), NEUROPATHY PERIPHERAL (neuropathy), ECCHYMOSIS (ecchymosis), JOINT SWELLING (Swollen ankle/ Swelling ankle), PAIN IN EXTREMITY (pain in left leg), MALAISE (malaise), DYSPNOEA EXERTIONAL (Shortness of breath can't exert self physically), DISORIENTATION (disorientation), VERTIGO (vertigo), MEMORY IMPAIRMENT (worsening memory/Memory issues), NASOPHARYNGITIS (cold), DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (weight loss), DEPRESSION (depression), SLEEP APNOEA SYNDROME (sleep apnea), INSOMNIA (worsening Insomnia), DYSGEUSIA (metallic taste/change taste), AGEUSIA (loss of taste), BURNING SENSATION (Burning sensations), MIGRAINE (migraines), HAEMATURIA (hematuria), UPPER RESPIRATORY TRACT INFECTION (increased Upper respiratory infection), HYPERTENSION (uncontrolled hypertension), GASTROINTESTINAL PAIN (GI Pain), FEELING ABNORMAL (brain fog), ANXIETY (anxiety), ANOSMIA (Loss of smell), PAROSMIA (change smell), BREATH ODOUR (smell on breath Phantom smells- ammonia, gas, sweet smells), COGNITIVE DISORDER (cognitive issues), CONTUSION (bruising), PERIPHERAL SWELLING (Swollen left leg/ Swelling in left leg), COUGH (cough), PARAESTHESIA (tingling), DIZZINESS (dizziness), ARTHRALGIA (painful joints/pain in ankle), HEADACHE (head pain/ Stronger headaches), CHILLS (chills), HYPERSENSITIVITY (Allergy symptoms uncontrolled), FATIGUE (fatigue/More fatigue) and MYALGIA (Achy/painful muscles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter. Patient took medication for uncontrolled hypertension. Company comment- This spontaneous case concerns a 41-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of neuropathy, Chron´s disease and the unexpected non-serious AESIs ageusia and anosmia along with several other non-serious events 3 days after a first dose of mRNA-1273 vaccine was administered. It was reported patient experienced Chron´s symptoms flare but no more details of symptoms, clinical course, investigation reports and treatment were provided. Outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 41-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of neuropathy, Chron´s disease and the unexpected non-serious AESIs ageusia and anosmia along with several other non-serious events 3 days after a first dose of mRNA-1273 vaccine was administered. It was reported patient experienced Chron´s symptoms flare but no more details of symptoms, clinical course, investigation reports and treatment were provided. Outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.