Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Blood cortisol, Laboratory test
Clinical narrative: Adrenal crisis; This literature-non-study case was reported in a literature article and describes the occurrence of ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) in a 75-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   Concurrent medical conditions included Hypothyroidism since 2006 and Adrenal insufficiency since 2006. Concomitant products included LEVOTHYROXINE, PREDNISONE and FLUDROCORTISONE for Hypothyroidism.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to ADRENOCORTICAL INSUFFICIENCY ACUTE. At the time of the report, ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cortisol: 0.1 mcg/dl Cortisol level was 0.1 mcg/dl suggesting that patient was in adrenal crisis.. On an unknown date, Laboratory test: dehydration, hypotension, moderate hyponatremia Clinical and biochemical evaluation in a local medical center had demonstrated the presence of dehydration, hypotension and moderate hyponatremia..     For mRNA-1273 (Spikevax) (Unknown), the reporter considered ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) to be related.    Patient had developed a subjective fever, nausea, fatigue, and weakness following 2nd dose of Moderna vaccine. Following the admission, patient was treated with stress dose steroids and intravenous fluids for 3 days and was discharged home in stable condition.  Company Comment: This is a literature non-study case concerns   a  75-year-old male patient  with relevant medical history of optimally controlled hypothyroidism and primary adrenal insufficiency since 2006 on levothyroxine 150 mcg, prednisone 4 mg, and   fludrocortisone 0.1 mg daily  , who experienced Serious ( Medically Significant, Hospitalization )  Unexpected event  of  Adrenocortical  Insufficiency , Acute  (Adrenal Crisis )  which  occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine. The details of the dose 1 Covid 19 of this patient was not reported This patient  developed  fever, nausea, fatigue, and weakness following 2nd dose of Moderna vaccine. Clinical and biochemical evaluation in a local medical center demonstrated the presence of dehydration, hypotension, moderate hyponatremia, and cortisol level of 0.1mcg/dl suggesting that he was in adrenal crisis. Following the admission, he was treated with stress dose steroids and intravenous fluids for 3 days and was discharged home in stable condition.  Outcome of the event reported as resolved. The above mentioned medical history of hypothyroidism and primary adrenal insufficiency  are considered as confounders  for the event. . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case since the full text was not available at the time of the medical review.   This case was linked to US-MODERNATX, INC.-MOD-2022-569445 (Linked Report).; Sender's Comments: This is a literature non-study case concerns   a  75-year-old male patient  with relevant medical history of optimally controlled hypothyroidism and primary adrenal insufficiency since 2006 on levothyroxine 150 mcg, prednisone 4 mg, and   fludrocortisone 0.1 mg daily  , who experienced Serious ( Medically Significant, Hospitalization )  Unexpected event  of  Adrenocortical  Insufficiency , Acute  (Adrenal Crisis )  which  occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine. The details of the dose 1 Covid 19 of this patient was not reported This patient  developed  fever, nausea, fatigue, and weakness following 2nd dose of Moderna vaccine. Clinical and biochemical evaluation in a local medical center demonstrated the presence of dehydration, hypotension, moderate hyponatremia, and cortisol level of 0.1mcg/dl suggesting that he was in adrenal crisis. Following the admission, he was treated with stress dose steroids and intravenous fluids for 3 days and was discharged home in stable condition.  Outcome of the event reported as resolved. The above mentioned medical history of hypothyroidism and primary adrenal insufficiency  are considered as confounders  for the event. . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case since the full text was not available at the time of the medical review. US-MODERNATX, INC.-MOD-2022-569445:Same article, 76 years male