Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Illness, Maternal exposure during pregnancy, Pain, Pain in extremity
Clinical narrative: crumping (in pain); miscarriage; bleeding/ still bleeding "so heavy"/ still bleeding; felt dizzy; pain in her left calf; feared a blood clot; so much pain she couldn't walk/limping; whole body was sick; Maternal exposure during pregnancy; hand was hurting/hand was sore; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) in a 40-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included DVT (History of DVT with her first pregnancy 4 years ago but hasn't been taking blood thinners or presented any symptoms since) and Pregnancy (her first pregnancy 4 years ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Jul-2021, the patient experienced ILLNESS (whole body was sick), PAIN IN EXTREMITY (hand was hurting/hand was sore) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Jul-2021, the patient experienced GAIT DISTURBANCE (so much pain she couldn't walk/limping). On 01-Aug-2021, the patient experienced FEAR (feared a blood clot) and PAIN IN EXTREMITY (pain in her left calf). On 06-Aug-2021, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant), HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) (seriousness criterion medically significant) and DIZZINESS (felt dizzy). On 20-Aug-2021, the patient experienced PAIN (crumping (in pain)). The delivery occurred  on 06-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (miscarriage), ILLNESS (whole body was sick), FEAR (feared a blood clot), DIZZINESS (felt dizzy), GAIT DISTURBANCE (so much pain she couldn't walk/limping), PAIN (crumping (in pain)), PAIN IN EXTREMITY (hand was hurting/hand was sore) and PAIN IN EXTREMITY (pain in her left calf) outcome was unknown and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Deep vein thrombosis: negative (Negative) tested negative for DVT (Deep vein thrombosis).. On 01-Aug-2021, Pregnancy test: positive (Positive) She was three weeks a long, got pregnant between the two doses.. On 20-Aug-2021, Ultrasound scan: inconclusive (Inconclusive) confirmed that everything came out.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 01-Aug-2021, the patient went to emergency department. On 20-Aug-2021, she had a sonogram  and confirmed everything came out. Treatment medication were not reported.  Action taken was not applicable.  This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-303234 (Patient Link).; Sender's Comments: This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.