Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
diagnosed with pots; MCAS; Temperature would be 94/95 and it would take 6hrs to get back to normal; Patient lost her baby / she was almost 24 weeks; severe pre-eclampsia; couldn't control her body temperature; weird gripping muscle tightening; feeling like on the top of a roller coaster; shivering uncontrollably; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of MAST CELL ACTIVATION SYNDROME (MCAS), ABORTION SPONTANEOUS (Patient lost her baby / she was almost 24 weeks) and PRE-ECLAMPSIA (severe pre-eclampsia) in a 41-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. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BODY TEMPERATURE ABNORMAL (couldn't control her body temperature), MUSCLE TIGHTNESS (weird gripping muscle tightening), FEELING ABNORMAL (feeling like on the top of a roller coaster), CHILLS (shivering uncontrollably) and NAUSEA (Nausea). In December 2024, the patient experienced PRE-ECLAMPSIA (severe pre-eclampsia) (seriousness criterion medically significant). On 16-Dec-2024, the patient experienced ABORTION SPONTANEOUS (Patient lost her baby / she was almost 24 weeks) (seriousness criterion medically significant). On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (MCAS) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (diagnosed with pots) and BODY TEMPERATURE DECREASED (Temperature would be 94/95 and it would take 6hrs to get back to normal). At the time of the report, MAST CELL ACTIVATION SYNDROME (MCAS), ABORTION SPONTANEOUS (Patient lost her baby / she was almost 24 weeks), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (diagnosed with pots), PRE-ECLAMPSIA (severe pre-eclampsia), BODY TEMPERATURE ABNORMAL (couldn't control her body temperature), MUSCLE TIGHTNESS (weird gripping muscle tightening), FEELING ABNORMAL (feeling like on the top of a roller coaster), BODY TEMPERATURE DECREASED (Temperature would be 94/95 and it would take 6hrs to get back to normal), CHILLS (shivering uncontrollably) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Increased, the patient's temperature was 94 to 95 degree Fahrenheit. and normal, took up to 6 hrs to get back to normal.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided. It was reported that the patient had received her first dose of a COVID-19 vaccine in 2021 during the pandemic while working as a nurse for 20 years, after her workplace offered vaccination and she believed that she was contributing to herd immunity. It was further reported that she later wished that she had discontinued vaccination after the first dose due to severe adverse effects following the second dose. It was reported that within approximately five minutes after the second dose, the patient began experiencing all kind of weird symptoms, including weird muscle tightening hugs/weird gripping muscle tightening, orthostatic sensations described as sudden drops similar to a roller coaster effect upon standing, and persistent, severe nausea. It was noted that the nausea was constant, terrible and exacerbated by positional changes such as bending or rolling in bed. It was reported that the patient was unable to control her body temperature, and experienced uncontrolled shivering despite working in extreme summer heat. Her body temperature reportedly dropped to approximately 94 to 95degree Fahrenheit and it took up to 6 hours to get back to normal. It was further reported that the patient was repeatedly informed that her symptoms were attributable to anxiety; however, she denied any personal history of anxiety and maintained strong conviction that her symptoms were not related to anxiety. She reported having extensive medical documentation supporting this assertion. It was noted that a functional medicine physician ultimately diagnosed her with postural orthostatic tachycardia syndrome (POTS) in August of the following year. It was reported that the patient had spent several months thinking of dying. She described that she used to leave doors unlocked at night due to concern that someone would find her dog and take care of him. It was further reported that the patient believed that her diagnosis of POTS contributed to the later development of mast cell activation syndrome (MCAS), which she reported that it might have been a contributing factor to the onset of severe pre-eclampsia in Dec-2024. It was reported that on 16-Dec-2024, the patient experienced fetal loss during her first pregnancy at nearly 24 weeks gestation period. She identified the fetus as her son. She stated that even a year later, she continued to have questions regarding the cause of the loss of baby. It was documented that she did not attribute blame to Moderna and continued to express belief that her actions were intended to protect public health. It was reported that the patient expressed a desire to pursue higher education in order to research pre-eclampsia, with a specific interest in studying the condition at the cellular level to improve prevention and treatment beyond current standards. She stated that existing research was insufficient and referenced publicly available data indicating significant maternal and neonatal mortality associated with pre-eclampsia annually. She expressed great distress regarding these outcomes of vaccination. Treatment medication information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2026: Live follow-up received contains significant information includes lab data added, events added, verbatim updated and updated narrative.; Reporter's Comments: Company comment: Causality for pre-eclampsia and spontaneous abortion is assessed as not related considering implausible temporal association with events occurring 3 years after vaccination. The benefit-risk relationship of product is not affected by this report.
Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Increased, the patient's temperature was 94 to 95 degree Fahrenheit.; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: normal, took up to 6 hrs to get back to normal.