Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral herpes, Peripheral swelling, Rash macular, Rash papular
Clinical narrative: Eye infection; Swelling of legs; Fever blister; Papular rash; Gland in neck; Aching in knees; Urticaria; Nauseous; Blotchy rash; Crohn's aggravated; Feeling unwell; Difficulty in walking; Scab; Raw mouth; Stress; Heat rash; Stiff knees; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated) 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) for Crohn's disease.    The patient's past medical history included Heart attack in December 2020, Headache from January 2021 to 2021, Exposure to COVID-19, Exposure to mold, Bowel resection in 1983 and Knee operation (another surgery don in 2009.) in 2004. Concurrent medical conditions included Blood pressure high, Depression, Hypercholesteremia, Indigestion, Crohn's disease, Anticoagulant therapy, Seasonal allergy, Vitamin supplementation, Smoker (3 to 4 packs per week of cigarettes) since 1976, Pneumonia since December 2020, Abstains from alcohol and Stomach cramps. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, LISINOPRIL for Blood pressure high, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ATORVASTATIN for Hypercholesteraemia, 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.   In January 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram once a day. In January 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram once a day. 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). In 2021, the patient experienced CROHN'S DISEASE (Crohn's aggravated) (seriousness criterion medically significant), MALAISE (Feeling unwell), GAIT DISTURBANCE (Difficulty in walking), SCAB (Scab), STOMATITIS (Raw mouth), STRESS (Stress), MILIARIA (Heat rash), JOINT STIFFNESS (Stiff knees), ANXIETY (Anxiety), PERIPHERAL SWELLING (Swelling of legs), ORAL HERPES (Fever blister), RASH PAPULAR (Papular rash), LYMPHADENOPATHY (Gland in neck), ARTHRALGIA (Aching in knees), URTICARIA (Urticaria), NAUSEA (Nauseous) and RASH MACULAR (Blotchy rash). The patient was treated with CLINDAMYCIN HYDROCHLORIDE at an unspecified dose and frequency; MORPHINE at an unspecified dose and frequency and ERYTHROMYCIN (ophthalmic) at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (Crohn's aggravated), MALAISE (Feeling unwell), JOINT STIFFNESS (Stiff knees), EYE INFECTION (Eye infection) and ARTHRALGIA (Aching in knees) had not resolved and GAIT DISTURBANCE (Difficulty in walking), SCAB (Scab), STOMATITIS (Raw mouth), STRESS (Stress), MILIARIA (Heat rash), ANXIETY (Anxiety), PERIPHERAL SWELLING (Swelling of legs), ORAL HERPES (Fever blister), RASH PAPULAR (Papular rash), LYMPHADENOPATHY (Gland in neck), URTICARIA (Urticaria), NAUSEA (Nauseous) and RASH MACULAR (Blotchy rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood zinc: low zinc.         On unknown date, Covid-19 test was performed with results not reported. Event Diarrhea subsumed under Crohn's disease  The reporter did not provide any causality assessment for the events with Humira and Moderna vaccine.  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 is a spontaneous case, reported by a consume, concerning a 62-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease, reported as Crohn's aggravated, which occurred on the same year of 2-dose primary series of mRNA-1273 vaccination. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient also experienced feeling unwell, walking difficulty, low blood zinc level, scab, mouth sores, stress wit anxiety, heat rash, eye infection, swelling of legs, oral herpes, popular rash, diarrhea, knee pain, neck lymphadenopathy, urticaria, nausea, and blotchy rash. The patient was treated with Clindamycin, Morphine, and Erythromycin ophthalmic ointment. It was reported that the event Crohn's aggravated was not resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Crohn's aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consume, concerning a 62-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease, reported as Crohn's aggravated, which occurred on the same year of 2-dose primary series of mRNA-1273 vaccination. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient also experienced feeling unwell, walking difficulty, low blood zinc level, scab, mouth sores, stress wit anxiety, heat rash, eye infection, swelling of legs, oral herpes, popular rash, diarrhea, knee pain, neck lymphadenopathy, urticaria, nausea, and blotchy rash. The patient was treated with Clindamycin, Morphine, and Erythromycin ophthalmic ointment. It was reported that the event Crohn's aggravated was not resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Crohn's aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.