Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Nausea, Pregnancy test, Prenatal screening test
Clinical narrative: VERY DRY MOUTH; Pain at injection site; SEVERE BODY ACHES; Chills/Shivering; fever 100.1 F; Nausea; Headache; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY), DRY MOUTH (VERY DRY MOUTH), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (SEVERE BODY ACHES) and CHILLS (Chills/Shivering) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Alcohol use (2 Drinks per Month) from 25-Feb-2006 to 15-Aug-2020 and Delivery (Outcome-live, full-term birth Complication: Cephalopelvic disproportion: resulted in significant blood loss and emergency C-section) on 19-Sep-2018. Previously administered products included for Diphtheria immunization: DTP vaccine (Anatomical Location : Upper left arm) on 19-Mar-2021. Past adverse reactions to the above products included No adverse reaction with DTP vaccine. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 04-Jan-2021 to an unknown date and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 04-Jan-2021 to an unknown date for Allergy, PROMETHAZINE from 10-May-2020 to 11-May-2020 for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 09-Jun-2020 to an unknown date for Pregnancy.   On 22-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 16-May-2021. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY). On 26-Feb-2021, the patient experienced DRY MOUTH (VERY DRY MOUTH), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (SEVERE BODY ACHES), CHILLS (Chills/Shivering), PYREXIA (fever 100.1 F), NAUSEA (Nausea) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The cesarean delivery occurred on 12-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3100 grams (6lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Maternal patient delivered baby boy on 12-MAY-2021 (39 weeks 3 days gestation) weighing 3100 gram and 49 cm in length with nuchal cord. On an unknown date, during delivery, the mother experienced thrombocytopenia with low platelet count (80 unknown units). Thus, on an unknown date, the mother was given platelets prior to delivery, and blood transfusion after delivery. The mother was reported to be breastfeeding following the delivery. No fetal/infant abnormalities were identified upon delivery or at one-month post-partum. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and Manual therapy (Ice Pack) for Vaccination site pain. On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) had resolved. On 27-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 28-Feb-2021, DRY MOUTH (VERY DRY MOUTH), MYALGIA (SEVERE BODY ACHES), CHILLS (Chills/Shivering), PYREXIA (fever 100.1 F), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) Positive. On 18-Sep-2020, Sexually transmitted disease test: negative (Negative) Sexually transmitted disease test results are negative. On 23-Dec-2020, Blood glucose: normal (normal) normal. On 23-Dec-2020, Ultrasound abdomen: normal (normal) normal. On 02-Feb-2021, Prenatal screening test: normal (normal) Prenatal screening test results are normal. On 02-Feb-2021, Ultrasound abdomen: normal (normal) normal. On 26-Feb-2021, Body temperature: 101 (High) Fever of 101 degrees Fahrenheit temperature. On 05-Mar-2021, Blood glucose: 91 (Low) Blood glucose result shows 91. On 21-Apr-2021, Streptococcus test: negative (Negative) Negative.         Additional information includes for laboratory data for NIPT test on 05 Nov 2020 with Inconclusive results mentioned as LOW RISK.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04 May 2021 and does not contain no new information. On 07-May-2021: Follow up received on 07 May 2021 where Patient Medical History, lab data, added new events  Nausea, Headache, Injection site Pain, details of dose 1 added, Concomitant products, reporter causality changed from Not Provided to Possible were updated. On 23-Jun-2021: Follow up received on 23 Jun 2021 and contains new significant information where Concomitant product details and Child related information were provided.