Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Injection site pain, Memory impairment, Mouth swelling
Clinical narrative: Tick bite; Forgetful occasionally; Chemical or abrasion irritation of skin; Obesity; Swollen mouth; Anxiety due to concerns about not getting medication; Blood pressure high; Asthma flareups/asthma symptoms when it gets cold,; Alpha gal syndrome; Rash; Chills; Injection site burning; Crohn's disease aggravated; interval between 2nd and 3rd dose is 7 days; Diabetes; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) and DIABETES MELLITUS (Diabetes) in a 67-year-old male 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 aggravated.    Concurrent medical conditions included Asthma, Frequent bowel movements, Type 2 diabetes mellitus since 2018 and Crohn's disease.   In January 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between 2nd and 3rd dose is 7 days). In 2021, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant), ARTHROPOD BITE (Tick bite), MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (Chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), ANXIETY (Anxiety due to concerns about not getting medication), HYPERTENSION (Blood pressure high), ASTHMA (Asthma flareups/asthma symptoms when it gets cold,), FOOD ALLERGY (Alpha gal syndrome), RASH (Rash), CHILLS (Chills) and INJECTION SITE PAIN (Injection site burning). The patient was treated with ALPRAZOLAM at an unspecified dose and frequency; BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OXYGEN at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated), DIABETES MELLITUS (Diabetes), ARTHROPOD BITE (Tick bite), MEMORY IMPAIRMENT (Forgetful occasionally), ANXIETY (Anxiety due to concerns about not getting medication), ASTHMA (Asthma flareups/asthma symptoms when it gets cold,), FOOD ALLERGY (Alpha gal syndrome), RASH (Rash), CHILLS (Chills), INJECTION SITE PAIN (Injection site burning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between 2nd and 3rd dose is 7 days) outcome was unknown, SKIN IRRITATION (Chemical or abrasion irritation of skin), OBESITY (Obesity) and MOUTH SWELLING (Swollen mouth) had resolved and HYPERTENSION (Blood pressure high) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Positive) Positive Alpha Gal. On an unknown date, Glycosylated haemoglobin: 14.6. On an unknown date, Heart rate: elevated. On an unknown date, Spotted fever rickettsia test positive: (Positive) positive.         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  Frequent bowel movements (five to six bowel movements) was the reported symptom to Crohn's disease and Burning foot was the reported symptom  to Type 2 diabetes mellitus.  Oxygen used as treatment gas.  The reporter causality DIABETES MELLITUS (Diabetes), FREQUENT BOWEL MOVEMENTS (five to six bowel movements). , CROHN'S DISEASE (Crohn's disease aggravated), ARTHROPOD BITE (Tick bite), MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (Chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), BURNING SENSATION (Burning foot), CHILLS (Chills), RASH (Rash), ANXIETY (Anxiety due to concerns about not getting medication), HYPERTENSION (Blood pressure high), ASTHMA (Asthma flareups/asthma symptoms when it gets cold,), FOOD ALLERGY (Alpha gal syndrome) and INJECTION SITE PAIN (Injection site burning) were as Reported with Humira.  No concomitant medications were reported.  Company comment: This spontaneous case concerns a male patient aged  67 years with relevant medical history of Crohn's disease and diabetes mellitus reported, who experienced unexpected serious (medically significant) events of Crohn's disease(reported as Crohn's disease aggravated) and Diabetes mellitus (2021) that occurred on unknown dates in the context of mRNA-1273 vaccine. Additionally Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of same vaccine at an interval of 28 days and third dose 7 days later. Patient also experienced multiple non serious events of Tick bite, asthma, food allergy and rash. Glycosylated haemoglobin done on unknown date was 14.6. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains confounder to the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow up document contains event information, reporter causality, suspect drug information, Treatment drug information and narrative description were updated.; Sender's Comments: This spontaneous case concerns a male patient aged  67 years with relevant medical history of Crohn's disease and diabetes mellitus reported, who experienced unexpected serious (medically significant) events of Crohn's disease(reported as Crohn's disease aggravated) and Diabetes mellitus (2021) that occurred on unknown dates in the context of mRNA-1273 vaccine. Additionally Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of same vaccine at an interval of 28 days and third dose 7 days later. Patient also experienced multiple non serious events of Tick bite, asthma, food allergy and rash. Glycosylated haemoglobini done on unknown date was 14.6. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains confounder to the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.