Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Blood test, Feeling abnormal
Clinical narrative: Graves disease & autoimmune hyperthyroidism; She is concerned, alarmed and scared due to this; This spontaneous case was reported by a consumer and describes the occurrence of BASEDOW'S DISEASE (Graves disease & autoimmune hyperthyroidism) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 030L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Asthma all her life). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-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 experienced BASEDOW'S DISEASE (Graves disease & autoimmune hyperthyroidism) (seriousness criterion medically significant) and FEELING ABNORMAL (She is concerned, alarmed and scared due to this). The patient was treated with METHIMAZOLE for Graves' disease, at an unspecified dose and frequency. At the time of the report, BASEDOW'S DISEASE (Graves disease & autoimmune hyperthyroidism) and FEELING ABNORMAL (She is concerned, alarmed and scared due to this) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) diagnosed autoimmune hyperthyroidism after the blood draw.         Patient had never COVID before and AE cause patient to seek medical care Regular physician's office visit Patient had not experienced a similar event in the past. The patient stated that she did not have any bad reactions to any of the shots and was generally in good health and did not take any daily medications for anything.   Company comment: This spontaneous case concerns a 42-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of Basedow´s disease after the third dose of mRNA-1273. It was reported that 7 weeks after receiving the booster dose, she started having strange symptoms and severe symptoms that lingered for a month. The patient stated that she went to the family doctor who did blood tests and was diagnosed autoimmune hyperthyroidism after the blood draw and was referred to a specialist where they did series of tests with nuclear medicine and determined it was Graves disease. Patient´s age and gender could be risk factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected event of Basedow´s disease after the third dose of mRNA-1273. It was reported that 7 weeks after receiving the booster dose, she started having strange symptoms and severe symptoms that lingered for a month. The patient stated that she went to the family doctor who did blood tests and was diagnosed autoimmune hyperthyroidism after the blood draw and was referred to a specialist where they did series of tests with nuclear medicine and determined it was Graves disease. Patient´s age and gender could be risk factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.