Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Diabetes mellitus, Eating disorder, Hypersensitivity, Sinus disorder
Clinical narrative: Sinus disorder; Allergy; Diabetic; Anxiety; Vaccination site joint pain; Eating disorder; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder), HYPERSENSITIVITY (Allergy), DIABETES MELLITUS (Diabetic), ANXIETY (Anxiety), VACCINATION SITE JOINT PAIN (Vaccination site joint pain) and EATING DISORDER (Eating disorder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Functional endoscopic sinus surgery in May 2018 and Functional endoscopic sinus surgery in September 2021. Concurrent medical conditions included Allergy (The patient had allergies). Concomitant products included METFORMIN for an unknown indication.   On 20-Feb-2019, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus disorder) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergy) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetic) (seriousness criterion medically significant), ANXIETY (Anxiety) (seriousness criterion medically significant), VACCINATION SITE JOINT PAIN (Vaccination site joint pain) (seriousness criterion medically significant) and EATING DISORDER (Eating disorder) (seriousness criterion medically significant). At the time of the report, SINUS DISORDER (Sinus disorder), HYPERSENSITIVITY (Allergy), DIABETES MELLITUS (Diabetic), ANXIETY (Anxiety) and EATING DISORDER (Eating disorder) had not resolved and VACCINATION SITE JOINT PAIN (Vaccination site joint pain) outcome was unknown.            The patient also had sinus issues. Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 47-year-old female patient with history of sinus surgery, who experienced the unexpected serious events of Sinus Disorder, Hypersensitivity, Diabetes Mellitus, Anxiety, Eating Disorder, and Vaccination Site Joint Pain. The events were medically significant and occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The medical history of Sinus Surgery may be a confounder for the event Sinus Disorder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47-year-old female patient with history of sinus surgery, who experienced the unexpected serious events of Sinus Disorder, Hypersensitivity, Diabetes Mellitus, Anxiety, Eating Disorder, and Vaccination Site Joint Pain. The events were medically significant and occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The medical history of Sinus Surgery may be a confounder for the event Sinus Disorder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.