Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Glucose tolerance test, Myalgia, Pregnancy test
Clinical narrative: Fever; chills; body aches; Vaccine exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ex-alcohol user (1-3 drinks/week prior to conceiving), Subfertility (treated with 2 cycles of Femara April and May 2020), Subacute thyroiditis and Hypothyroidism. Family history included Developmental hip dysplasia (maternal grandmother , maternal aunt and mother of patient). Concurrent medical conditions included Ehlers-Danlos syndrome, Postural orthostatic tachycardia syndrome (Postural orthostatic tachycardia), Polyneuropathy, Sleep apnea (complex sleep apnea), Fruit allergy (pomegranate), Fragrance sensitivity, Drug allergy (Teriparatide) and Allergy (seminal plasma). Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) and ONDANSETRON for Nausea, LEVOTHYROXINE from an unknown date to 15-Jul-2021 for Subacute thyroiditis and Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D3 and MAGNESIUM for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-May-2020 and the estimated date of delivery was 24-Feb-2021. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 12-Feb-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Live, full-term birth. At the time of the report, PYREXIA (Fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2020, Pregnancy test: positive (Positive) Positive pregnancy test. On 07-Aug-2020, Ultrasound uterus: normal (normal) normal. On 19-Nov-2020, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound uterus: normal (normal) normal ultrasounds at MFM OB every 1-2 weeks.         No treatment medication was provided.  After second dose patient had fever, chills, body aches and once had decreased fetal movement in the middle of the night after receiving second Moderna dose earlier that morning. Patient called the doctor and was instructed to go to ER where fetal ultrasound was normal, and was not admitted after several hours of monitoring.   Baby was induced 1 week later continued decreased fetal movement and patient also had neuropathy so it wasn't clear whether it was actually decreased fetal movement or whether could not detect it. Either way, there was a marked decrease in fetal movement towards the end of pregnancy.  This is a regulatory case concerning a 34-year-old  female patient with medical history of Subfertility (treated with 2 cycles of Femara April and May 2020), Subacute thyroiditis and Hypothyroidism,  who experienced vaccine exposure during pregnancy and the non serious expected events  of pyrexia and myalgia after receiving the second  dose of mRNA-1273 (time to onset is unknown). Patient received both doses during pregnancy. Information regarding the child case can be seen in  case MOD-2021-259303. The benefit-risk relationship of mRNA-1273 is not affected by this report   This case was linked to MOD-2021-259303 (Parent-Child Link). This case was linked to MOD-2021-011577 (Patient Link).   See case MOD-2021-259303 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Upon internal review on 17-Nov-2021, Updated fetal outcome; Sender's Comments: This is a regulatory case concerning a 34-year-old  female patient with medical history of Subfertility (treated with 2 cycles of Femara April and May 2020), Subacute thyroiditis and Hypothyroidism,  who experienced vaccine exposure during pregnancy and the non serious expected events  of pyrexia and myalgia after receiving the second  dose of mRNA-1273 (time to onset is unknown). Patient received both doses during pregnancy. Information regarding the child case can be seen in  case MOD-2021-259303. The benefit-risk relationship of mRNA-1273 is not affected by this report