Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Blood potassium, Blood pressure measurement, Blood test, Chills
Clinical narrative: migraine; headache; chills; the vaccine cause this illness or adrenal crisis; very large bruise in the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ADRENOCORTICAL INSUFFICIENCY ACUTE (the vaccine cause this illness or adrenal crisis), CONTUSION (very large bruise in the arm), CHILLS (chills), MIGRAINE (migraine) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 022M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Adrenal crisis. Concurrent medical conditions included Autoimmune adrenal insufficiency (autoimmune disease, which attack adrenal glands) and Autoimmune thyroid disorder (autoimmune disease, which attack the thyroid glands).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ADRENOCORTICAL INSUFFICIENCY ACUTE (the vaccine cause this illness or adrenal crisis) (seriousness criteria hospitalization and medically significant) and CONTUSION (very large bruise in the arm) (seriousness criterion hospitalization). On 21-Sep-2021, the patient experienced CHILLS (chills) (seriousness criterion hospitalization). On 23-Sep-2021, the patient experienced MIGRAINE (migraine) (seriousness criterion hospitalization) and HEADACHE (headache) (seriousness criterion hospitalization). The patient was hospitalized on 22-Sep-2021 due to ADRENOCORTICAL INSUFFICIENCY ACUTE, CHILLS, CONTUSION, HEADACHE and MIGRAINE. The patient was treated with HYDROCORTISONE (intravenous) for Adverse event, at a dose of UNK (stress dose) and PARACETAMOL (TYLENOL) for Migraine and Headache, at an unspecified dose and frequency. At the time of the report, ADRENOCORTICAL INSUFFICIENCY ACUTE (the vaccine cause this illness or adrenal crisis), CONTUSION (very large bruise in the arm) and CHILLS (chills) was resolving and MIGRAINE (migraine) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood potassium: low (Low) Low. In September 2021, Blood pressure measurement: low (Low) Low. In September 2021, Blood test: very unusual (abnormal) very unusual.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication includes corticosteroids for autoimmune diseases.  Treatment medication includes Antiemetic medication. Hydrocortisone stress dose (IV), replacement fluids (IV). Tylenol for migraine and headache.  Morning after 3rd dose patient woke up lethargic, fatigued, with chills, nausea, unable to eat anything and threw up. On 22Sep2021 patient was hospitalized. After a night was transferred to another hospital for 3 more nights. Received emergency treatments and was given fluids and medication IV. On 23Sep2021 had migraine and headache. This lasted for the next couple of days. Patient has been recovering at home since 27Sep2021. Not fully recovered yet. A lot of fatigue, potassium was low. Bloodwork was very unusual according to HCP of the patient. Low blood pressure. Patient was in a dangerous position because has 2 autoimmune disease, which attack the thyroid and adrenal glands. Patient HCP said that the vaccine causes this illness or adrenal crisis. Patient had once adrenal crisis before, but it was nothing like this one. Patient had pictures of the bruise, so agent gave email address for pictures.   This case was linked to MOD-2021-342673 (Patient Link).; Sender's Comments: This case concerns a 48-year-old male/female patient with a history of autoimmune  adrenal insufficiency, autoimmune thyroid disorder and previous adrenal crisis, who experienced the unexpected, serious (hospitalization and medically significant) events of adrenocortical insufficiency acute, contusion, chills, headache and migraine. The event occurred approximately 9 months after the first dose of mRNA-1273, 8 months after the second dose of mRNA-1273 and 1 to 3 days after the third dose of mRNA-1273. The rechallenge was not applicable. The medical history of autoimmune  adrenal insufficiency, autoimmune thyroid disorder and previous adrenal crisis are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.