Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Headache, Insomnia, Maternal exposure during pregnancy, Myalgia
Clinical narrative: loss of appetite; body aches; headache; soreness at injection site; could not sleep at all that night (I woke up every 15 minutes); Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep at all that night (I woke up every 15 minutes)), DECREASED APPETITE (loss of appetite), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), MYALGIA (body aches) and HEADACHE (headache) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Alcohol use (Prior use, 1-2 drinks, 3 times per week) in 2001 and Marijuana use (Prior use on occasion) from 2002 to 2015. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 03-Aug-2020 to an unknown date for an unknown indication.   On 26-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 31-Aug-2020 and the estimated date of delivery was 27-May-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 26-Mar-2021, the patient experienced INSOMNIA (could not sleep at all that night (I woke up every 15 minutes)) and VACCINATION SITE PAIN (soreness at injection site). On 26-Mar-2021 at 7:00 PM, the patient experienced DECREASED APPETITE (loss of appetite), MYALGIA (body aches) and HEADACHE (headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 26-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 28-Mar-2021, INSOMNIA (could not sleep at all that night (I woke up every 15 minutes)), DECREASED APPETITE (loss of appetite), MYALGIA (body aches), HEADACHE (headache) and VACCINATION SITE PAIN (soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: Positive. In September 2020, Treponema test:. On 03-Mar-2021, Full blood count: normal (normal) Blood count normal. On 03-Mar-2021, Glucose tolerance test: normal (normal) Passed glucose. On 03-Mar-2021, HIV test: negative (Negative) Negative for HIV. On 03-Mar-2021, Treponema test: negative (Negative) Negative for syphilis. On 11-Mar-2021, Chromosomal analysis: normal (normal) Chromosome 13+18+21+x+y aneuploidy blood normal. On 12-Mar-2021, Alpha 1 foetoprotein amniotic fluid: normal (normal) AFP panel normal.         Treatment information not provided.  Patient's previous pregnancy end date was 10 NOV 2017.   This case was linked to MOD-2021-059617 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Internal review on 28-JUL-2021, resulted in the Updates birth type ,fetal outcome and pregnancy test