Age: 72.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Addison's disease, Blood sodium, Blood test, Pain in extremity
Clinical narrative: sore arm; ADDISON'S DISEASE; This spontaneous case was reported by a consumer and describes the occurrence of ADDISON'S DISEASE (ADDISON'S DISEASE) in a 72-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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and LEVOTHYROXINE SODIUM (SYNTHROID) tablet for Hashimoto's disease.    Family history included Diabetes (Diabetes ran in their family.) since an unknown date. Concurrent medical conditions included Hashimoto's disease and Rheumatoid arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks and LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) at an unspecified dose. In April 2021, the patient experienced ADDISON'S DISEASE (ADDISON'S DISEASE) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ADDISON'S DISEASE (ADDISON'S DISEASE) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Blood sodium (135-145): Low. In April 2021, Blood test: Addison's disease. In May 2021, Blood sodium (135-145): 130 microequivalent per litre.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications details were not reported.  On unknown dates, the patient had sore arm due to covid vaccine and off label use. In September 2020, patient had recurring low sodium level, trouble with balance, low energy and fatigue with Synthroid (levothyroxine) and Humira 40mg/0.4ml (adalimumab). In September 2020, patient was hospitalized for four days due to low sodium level. patient was given unspecified Intravenous fluids and unrecalled medications that was put in the intravenous fluids to manage the low sodium Level. Patient's low sodium level had improved and went higher but still not reached the normal range. Patient also had a kidney function test with normal result, the date of the test was not yet asked. In April 2021, patient had an Unspecified blood test by endocrinologist which confirmed that patient had Addison's disease. Patient had a routine Blood test from endocrinologist every quarter. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter does not had the lot number information, because the information was not available in the Patient's file for Synthroid and Humira.  The reporter's causality for the event of Addison's disease and vaccination site pain was not provided for Synthroid. The reporter's causality for the event of Addison's disease and vaccination site pain was reported as not related for Humira.  Company Comment: This spontaneous case concerns a 72-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) and medical history of Hashimoto's disease treated with the co-suspect product Synthroid (levothyroxine sodium), who experienced the unexpected, serious (medically significant) event of Addison's disease and an unexpected, non-serious event. The event Addison's disease occurred unknown number of days after receiving Humira, unknown number of days after receiving Synthroid, and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and Synthroid were not provided and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in Feb2021 while the event onset date was reported as unspecified date in Apr2021, hence, the onset latency could not be assessed. The onset date of the non-serious event pain in extremity was not provided, hence, the onset latency also could not be assessed. On an unspecified date in Apr2021, the patient had an unspecified blood test which confirmed that she had Addison's disease. The patient was treated with hydrocortisone (unspecified dose, frequency and duration). On an unspecified date in May2021, blood test showed low sodium level (130 mEq/L). On an unknown date, the patient's kidney function test was normal. The patient also experienced a sore arm after vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  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.; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) and medical history of Hashimoto's disease treated with the co-suspect product Synthroid (levothyroxine sodium), who experienced the unexpected, serious (medically significant) event of Addison's disease and an unexpected, non-serious event. The event Addison's disease occurred unknown number of days after receiving Humira, unknown number of days after receiving Synthroid, and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and Synthroid were not provided and the vaccination date of the second dose of the mRNA-1273 vaccine was reported as unspecified date in Feb2021 while the event onset date was reported as unspecified date in Apr2021, hence, the onset latency could not be assessed. The onset date of the non-serious event pain in extremity was not provided, hence, the onset latency also could not be assessed. On an unspecified date in Apr2021, the patient had an unspecified blood test which confirmed that she had Addison's disease. The patient was treated with hydrocortisone (unspecified dose, frequency and duration). On an unspecified date in May2021, blood test showed low sodium level (130 mEq/L). On an unknown date, the patient's kidney function test was normal. The patient also experienced a sore arm after vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.