Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Foetal death, Haemorrhage, Heart rate increased, Hemianaesthesia
Clinical narrative: Her unborn baby's heartbeat stopped; Heartbeat went through the roof - from 140 to 180; She was panting; Had to get an emergency DNC; She was bleeding out/She lost a lot of blood; Had to get a blood transfusion; Whole left arm turned red; Left side of her body became numb; maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of FOETAL DEATH (Her unborn baby's heartbeat stopped), HEART RATE INCREASED (Heartbeat went through the roof - from 140 to 180), DYSPNOEA (She was panting), HEMIANAESTHESIA (Left side of her body became numb), UTERINE DILATION AND CURETTAGE (Had to get an emergency DNC), HAEMORRHAGE (She was bleeding out/She lost a lot of blood) and TRANSFUSION (Had to get a blood transfusion) in a 31-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (she had to have 2 more surgeries).    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 09-Sep-2021, the patient experienced FOETAL DEATH (Her unborn baby's heartbeat stopped) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Heartbeat went through the roof - from 140 to 180) (seriousness criterion hospitalization), DYSPNOEA (She was panting) (seriousness criterion hospitalization), UTERINE DILATION AND CURETTAGE (Had to get an emergency DNC) (seriousness criterion hospitalization), HAEMORRHAGE (She was bleeding out/She lost a lot of blood) (seriousness criteria hospitalization and medically significant) and TRANSFUSION (Had to get a blood transfusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEMIANAESTHESIA (Left side of her body became numb) (seriousness criterion medically significant) and VACCINATION SITE ERYTHEMA (Whole left arm turned red). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient was treated with Surgery for Uterine dilation and curettage. On 26-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, FOETAL DEATH (Her unborn baby's heartbeat stopped), HEART RATE INCREASED (Heartbeat went through the roof - from 140 to 180), DYSPNOEA (She was panting), HEMIANAESTHESIA (Left side of her body became numb), UTERINE DILATION AND CURETTAGE (Had to get an emergency DNC), HAEMORRHAGE (She was bleeding out/She lost a lot of blood), TRANSFUSION (Had to get a blood transfusion) and VACCINATION SITE ERYTHEMA (Whole left arm turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient went to emergency room 09-Sep-2021 the doctors told her the baby's heartbeat stopped. They performed an emergency DNC.  Patient had to get a blood transfusion because she was bleeding out. She stated she lost a lot of blood.  Patient further reported that she had to have two more surgeries after the DNC. She first went to hospital 09-Sep-2021 then back again 11-Sep-2021 to 15-Sep-2021 for two more surgeries. Patient has 3 children and the baby she lost would have been the 4th child.  Patient also stated she won't be able to go to work unless she gets the 2nd dose.  Treatment medication use was not provided by the reporter  Company Comment: This case concerns a 31-year-old female patient with no relevant medical history reported, who experienced the Serious unexpected events of foetal death, uterine dilation and curettage, haemorraghe, transfusion and hemianesthesia (hospitalized and medically significant). The unexpected situation of Maternal exposure during pregnancy was also reported. The patient received the first dose of vaccine at 12 weeks of gestation. Spontaneous abortion occurred approximately 15 days after the first dose of an unknown schedule of Covid-19 vaccine moderna. Rechallenge is unknown since the patient has not received the second dose of the vaccine. The benefit-risk relationship of Moderna Covid 19 vaccine in not affected by this report.; Sender's Comments: This case concerns a 31-year-old female patient with no relevant medical history reported, who experienced the Serious unexpected events of foetal death, uterine dilation and curettage, haemorraghe, transfusion and hemianesthesia (hospitalized and medically significant). The unexpected situation of Maternal exposure during pregnancy was also reported. The patient received the first dose of vaccine at 12 weeks of gestation. Spontaneous abortion occurred approximately 15 days after the first dose of an unknown schedule of Covid-19 vaccine moderna. Rechallenge is unknown since the patient has not received the second dose of the vaccine. The benefit-risk relationship of Moderna Covid 19 vaccine in not affected by this report.