Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Blood pressure measurement, Heart rate
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 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       The patient's past medical history included Androgen replacement therapy since an unknown date. Concurrent medical conditions included Panhypopituitarism since 2003. Concomitant products included LEVOTHYROXINE from 2003 to an unknown date and HYDROCORTISONE from 2003 to an unknown date for Panhypopituitarism.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 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 pressure measurement: 84/47 mmhg 84/47 mmHg. On an unknown date, Heart rate: 130 bpm 130 bpm suggesting he was in adrenal crisis.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ADRENOCORTICAL INSUFFICIENCY ACUTE (Adrenal crisis) to be related.    Patient presented to emergency department complaining of fatigue, generalized weakness, and chills 1 day after he received 2nd dose of Moderna vaccine.  Following the admission, patient was treated with stress dose steroids and intravenous fluids for 4 days and was discharged home in stable condition.  Company Comment: This literature non-study case concerns a  76 year old male patient with relevant medical history of Panhypopituitarism since 2003 on levothyroxine 150 mcg, hydrocortisone 20 mg in am and 10 mg in pm, and testosterone replacement therapy ,who experienced Serious ( Medically significant , Hospitalization ) , unexpected event of Adrenocortical insufficiency , Acute ( adrenal crisis )which occurred one day post vaccination with the 2nd dose of mRNA-1273 vaccine. The information regarding the 1st dose of mRNA-1273 vaccine was not reported. It was reported that this patient  presented to emergency department complaining of fatigue, generalized weakness, and chills 1 day after he received 2nd dose of Moderna vaccine. Vital signs reported were  BP = 84/47 mmhg  and HR pf 130 bpm   On admission he was treated with  with stress dose steroids and intravenous fluids for 4 days and was discharged home in stable condition.  Results of  laboratories/diagnostic procedures were reported. Outcome of the event was reported as resolved. Event was reported as related by the reporter. The above mentioned medical history and his maintenance medications 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 as mentioned since the full text was not available at the time of the medical review.   This case was linked to MOD-2022-569430.; Sender's Comments: This literature non-study case concerns a  76 year old male patient with relevant medical history of panhypopituitarism since 2003 on levothyroxine 150 mcg, hydrocortisone 20 mg in am and 10 mg in pm, and testosterone replacement therapy,who experienced Serious ( Medically significant , Hospitalization ) , unexpected event of Adrenocortical insufficiency , Acute ( adrenal crisis )which occurred one day post vaccination with the 2nd dose of mRNA-1273 vaccine. The information regarding the 1st dose of mRNA-1273 vaccine was not reported. It was reported that this patient  presented to emergency department complaining of fatigue, generalized weakness, and chills 1 day after he received 2nd dose of Moderna vaccine. Vital signs reported were  BP = 84/47 mmhg  and HR pf 130 bpm   On admission he was treated with  with stress dose steroids and intravenous fluids for 4 days and was discharged home in stable condition.  Results of  laboratories/diagnostic procedures were reported. Outcome of the event was reported as resolved. Event was reported as related by the reporter. The above mentioned medical history and his maintenance medications 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 as mentioned since the full text was not available at the time of the medical review.