Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication, Vaccination site hypoaesthesia
Clinical narrative: Mischarge; arm went numb; dizzy; crampy; flu symptoms; felt like she was hit by a bus; nausea; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Mischarge) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043Lv0A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (arm went numb), DIZZINESS (dizzy), MUSCLE SPASMS (crampy), INFLUENZA LIKE ILLNESS (flu symptoms), VACCINATION COMPLICATION (felt like she was hit by a bus) and NAUSEA (nausea). In March 2021, the patient experienced ABORTION SPONTANEOUS (Mischarge) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Mischarge) outcome was unknown and VACCINATION SITE HYPOAESTHESIA (arm went numb), DIZZINESS (dizzy), MUSCLE SPASMS (crampy), INFLUENZA LIKE ILLNESS (flu symptoms), VACCINATION COMPLICATION (felt like she was hit by a bus) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Company Comment  This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea.  Based on the current available information and temporal association between the use of the product and the start date of the events  vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea, a causal relationship cannot be excluded.  For the event abortion spontaneous, very limited information have been provided at this time. Further information regarding temporal association has been requested.; Sender's Comments: This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea.  Based on the current available information and temporal association between the use of the product and the start date of the events  vaccination site hypoaesthesia, dizziness, muscle spams, influenza-like symptoms, vaccination related malaise and nausea, a causal relationship cannot be excluded.  For the event abortion spontaneous, very limited information have been provided at this time. Further information regarding temporal association has been requested.