Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Scab, Stomatitis, Stress, Urticaria
Clinical narrative: eye infection/thrush/stye eye; left leg might be swollen; mold on left eyebrow/stomach/mold spots on breast; Fever blister; whelp on breast was heat/hot; thought fungal; Scabies/rash right under both of breast/around nipples/like ulcers/ Blotchy rash/ whelp on breast was heat/hot/it started out as rash/stinging/itchy/it looked like little bumps/big welt/red/split right under breast/thought fungal; rash right under both of breast/around nipples/like ulcers; lymphnoid in neck/bump on neck; knees pain; possible crohn's flare ups/wearing diapers as patient had not been able to control crohn's; trouble walking; low zinc; scabs in hair; mouth stays raw; covid/not feeling well/ Nauseous/Headache/ Diarrhea; Stress; knees pain/bothering/just felt so stiff; possible anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (possible crohn's flare ups/wearing diapers as patient had not been able to control crohn's) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Pneumonia in December 2020, Heart attack in 2020, Bowel resection in 1983, Total knee replacement in 2004 and Total knee replacement in 2009. Concurrent medical conditions included Crohn's disease (Moderate to severe), Cigarette smoker (three to four packs per week) since 1976, Abstains from alcohol, Hypertension, Stomach cramps, Depression, Cholesterol, Indigestion and Seasonal allergy. Concomitant products included LISINOPRIL for Blood pressure high, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ATORVASTATIN for High cholesterol, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for Indigestion, ACRIVASTINE (BENADRYL [ACRIVASTINE]) for Seasonal allergy, DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Stomach cramps, VITAFUSION WOMEN'S for Vitamin supplementation, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In January 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. In January 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced EYE INFECTION (eye infection/thrush/stye eye). In 2021, the patient experienced CROHN'S DISEASE (possible crohn's flare ups/wearing diapers as patient had not been able to control crohn's) (seriousness criterion medically significant), GAIT DISTURBANCE (trouble walking), BLOOD ZINC DECREASED (low zinc), SCAB (scabs in hair), STOMATITIS (mouth stays raw), COVID-19 (covid/not feeling well/ Nauseous/Headache/ Diarrhea), STRESS (Stress), JOINT STIFFNESS (knees pain/bothering/just felt so stiff), ANXIETY (possible anxiety), PERIPHERAL SWELLING (left leg might be swollen), EXPOSURE TO FUNGUS (mold on left eyebrow/stomach/mold spots on breast), ORAL HERPES (Fever blister), FEELING HOT (whelp on breast was heat/hot), FUNGAL INFECTION (thought fungal), ACARODERMATITIS (Scabies/rash right under both of breast/around nipples/like ulcers/ Blotchy rash/ whelp on breast was heat/hot/it started out as rash/stinging/itchy/it looked like little bumps/big welt/red/split right under breast/thought fungal), URTICARIA (rash right under both of breast/around nipples/like ulcers), LYMPHADENOPATHY (lymphnoid in neck/bump on neck) and ARTHRALGIA (knees pain). The patient was treated with MORPHINE at an unspecified dose and frequency; CLINDAMYCIN HYDROCHLORIDE at an unspecified dose and frequency and ERYTHROMYCIN (ocular use) at an unspecified dose and frequency. In 2021, FEELING HOT (whelp on breast was heat/hot), FUNGAL INFECTION (thought fungal), ACARODERMATITIS (Scabies/rash right under both of breast/around nipples/like ulcers/ Blotchy rash/ whelp on breast was heat/hot/it started out as rash/stinging/itchy/it looked like little bumps/big welt/red/split right under breast/thought fungal) and URTICARIA (rash right under both of breast/around nipples/like ulcers) had resolved. At the time of the report, CROHN'S DISEASE (possible crohn's flare ups/wearing diapers as patient had not been able to control crohn's), JOINT STIFFNESS (knees pain/bothering/just felt so stiff), EYE INFECTION (eye infection/thrush/stye eye) and ARTHRALGIA (knees pain) had not resolved and GAIT DISTURBANCE (trouble walking), BLOOD ZINC DECREASED (low zinc), SCAB (scabs in hair), STOMATITIS (mouth stays raw), COVID-19 (covid/not feeling well/ Nauseous/Headache/ Diarrhea), STRESS (Stress), ANXIETY (possible anxiety), PERIPHERAL SWELLING (left leg might be swollen), EXPOSURE TO FUNGUS (mold on left eyebrow/stomach/mold spots on breast), ORAL HERPES (Fever blister) and LYMPHADENOPATHY (lymphnoid in neck/bump on neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood zinc: Low.         Lab test included COVID TEST in 2021 with unknown results. Indication of drug ASPIRIN was mentioned as Blood thinners. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 62-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's aggravated) and unexpected, non-serious AESI event of COVID-19 and other non-serious events that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The patient was treated with MORPHINE ,CLINDAMYCIN HYDROCHLORIDE and ERYTHROMYCIN (ocular use). The co-suspect Adalimumab (Humira) could be the risk factor for the event Chron's aggravated. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 62-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's aggravated) and unexpected, non-serious AESI event of COVID-19 and other non-serious events that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The patient was treated with MORPHINE ,CLINDAMYCIN HYDROCHLORIDE and ERYTHROMYCIN (ocular use). The co-suspect Adalimumab (Humira) could be the risk factor for the event Chron's aggravated. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.