Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ultrasound foetal
Clinical narrative: pregnant; Pemphigoid gestationis; Body Aches; Headaches; CHILLS; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES GESTATIONIS (Pemphigoid gestationis), PAIN (Body Aches), HEADACHE (Headaches), CHILLS (CHILLS) and EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Premature ovarian failure on 01-Jun-2003, Alcohol use (Prior Use), Pemphigoid (improved with delivery) on 30-Dec-2020 and In vitro fertilization (pregnancy with donor egg). Previously administered products included for an unreported indication: MMR VACCIN on 15-Jan-2021. Concurrent medical conditions included Alopecia since 01-Jun-2014. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jul-2020 to an unknown date for In vitro fertilization, ANTI-D IMMUNOGLOBULIN (RHOGAM) from 15-Jan-2021 to an unknown date for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, 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 an unknown date and the estimated date of delivery was 25-Mar-2021. On 29-Dec-2020, the patient experienced PAIN (Body Aches), HEADACHE (Headaches) and CHILLS (CHILLS). On 30-Dec-2020, the patient experienced HERPES GESTATIONIS (Pemphigoid gestationis). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The vaginal delivery occurred on 11-Feb-2021, which was reported as Premature. For neonate 1, the birth weight was 1760 grams (3lbs 14oz) with an APGAR score of 10 and 10 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. Delivered at 34 weeks gestation Live/Preterm Birth. Uncomplicated delivery reported. Length 50.8 cm. Mother is breastfeeding the infant. One month post-partum infant abnormality identified as Ventricular Septal Defect. At the time of the report, HERPES GESTATIONIS (Pemphigoid gestationis) was resolving, PAIN (Body Aches), HEADACHE (Headaches) and CHILLS (CHILLS) outcome was unknown and EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, Ultrasound foetal: wnl (normal) WNL. On 30-Dec-2020, Blood glucose: wnl (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no treatment medication reported by the reporter.  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. Causality for the event Pregnancy exposure during pregnancy is not applicable.   This case was linked to MOD-2021-272062 (Parent-Child Link).   See case MOD-2021-272062 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant Follow-up included updates of reporter's address, race, ethnicity, medical history, tests, concomitant medications, delivery information, and events.; Sender's Comments: 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. Causality for the event Pregnancy exposure during pregnancy is not applicable.