Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Blood pressure measurement, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: 1st dose in JAN2021 and stated that her arm hurt and the sore arm only lasted for a few hours; adrenal insufficiency crashed/she started to feel unwell./blood pressure/ got violently sick/ throwing up/couldn't keep anything down/ nausea; Her fever spiked to 104F; This spontaneous case was reported by a patient and describes the occurrence of ADRENAL INSUFFICIENCY (adrenal insufficiency crashed/she started to feel unwell./blood pressure/ got violently sick/ throwing up/couldn't keep anything down/ nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine and information on previous COVID-19 vaccination doses were unknown. No parental vaccine exposure was reported.  Concurrent medical conditions included Adrenal insufficiency (diagnosed when patient was 18 years old).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ADRENAL INSUFFICIENCY (adrenal insufficiency crashed/she started to feel unwell./blood pressure/ got violently sick/ throwing up/couldn't keep anything down/ nausea) (seriousness criterion medically significant) and PYREXIA (Her fever spiked to 104F). On an unknown date, the patient experienced VACCINATION SITE PAIN (1st dose in JAN2021 and stated that her arm hurt and the sore arm only lasted for a few hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 15-Feb-2021, ADRENAL INSUFFICIENCY (adrenal insufficiency crashed/she started to feel unwell./blood pressure/ got violently sick/ throwing up/couldn't keep anything down/ nausea) and PYREXIA (Her fever spiked to 104F) had resolved. At the time of the report, VACCINATION SITE PAIN (1st dose in JAN2021 and stated that her arm hurt and the sore arm only lasted for a few hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressure decreased. On an unknown date, Body temperature: fever spiked to 104F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that with dose 1 patient had arm hurt and the sore arm only lasted for a few hours. With dose 2 patient started to feel unwell, fever spiked to 104 F, started throwing up and couldn't keep anything down, even the regular medications, blood pressure went down, and adrenal insufficiency crashed. Patient also slept for couple of hours, felt violently sick for only a couple of hours, after which started feeling better. Patient was told by the HCP to go to the hospital if symptoms got worse but was able to start keeping things down and started feeling better and then decided not go to the hospital. It was determined by the HCPs that patient reacted to the vaccine due to the underlying adrenal insufficiency. Patient had something for nausea.  Company Comment : This spontaneous case concerns a 57-year-old female patient, with relevant medical history of Adrenal insufficiency, who experienced the unexpected serious (medically significant) event of Adrenal insufficiency (reported as adrenal insufficiency crashed) that occurred in the same month of receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had received first dose of Moderna vaccine approximately one month prior to the second dose. After receiving the first dose patient experienced pain in arm which lasted  for a few hours. After second dose of vaccination, she got violently sick for few hours, her fever spiked to 104F, she experienced nausea and vomiting. Her blood pressure went down, and her adrenal insufficiency crashed. She started feeling better after few hours. she took Tylenol for the fever as well as something for nausea. No further information regarding detailed lab reports and management were provided. The outcome of the event was recovered. Patients' medical history of adrenal insufficiency remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient, with relevant medical history of Adrenal insufficiency, who experienced the unexpected serious (medically significant) event of Adrenal insufficiency (reported as adrenal insufficiency crashed) that occurred in the same month of receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had received first dose of Moderna vaccine approximately one month prior to the second dose. After receiving the first dose patient experienced pain in arm which lasted  for a few hours. After second dose of vaccination, she got violently sick for few hours, her fever spiked to 104F, she experienced nausea and vomiting. Her blood pressure went down, and her adrenal insufficiency crashed. She started feeling better after few hours. she took Tylenol for the fever as well as something for nausea. No further information regarding detailed lab reports and management were provided. The outcome of the event was recovered. Patients' medical history of adrenal insufficiency remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.