Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy
Clinical narrative: Headache; Received the Moderna Vaccine for primary series whilst pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna Vaccine for primary series whilst pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Hemangioma removal) in March 2019. Concurrent medical conditions included Obsessive-compulsive disorder, Anaemic and Hemangioma. Concomitant products included IRON SULPHATE (IRON SUPPLEMENT) for Anaemic, SERTRALINE for Obsessive-compulsive disorder.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Sep-2020 and the estimated date of delivery was 12-Jun-2021. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna Vaccine for primary series whilst pregnant). On an unknown date, the patient experienced HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred  on 07-Jun-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 05-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna Vaccine for primary series whilst pregnant) had resolved. On 03-May-2021, HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Received the Moderna Vaccine for primary series whilst pregnant; delivered and was breastfeeding when booster shot was received.  Company comment: This is a case of Maternal exposure during pregnancy for this 27-year-old female patient with medical history of Obsessive-compulsive disorder and Anaemia. The patient received the first dose of mRNA-1273 vaccine during the 29th week of pregnancy. Reportedly, the patient reported that her course of pregnancy and delivery was smooth and without complications, however, the delivery type was not specified. In addition, the patient experienced the non-serious expected event of Headache after receiving the first dose of mRNA vaccine. The exact temporal relationship between the event of Headache and vaccine administration cannot be determined as the start date of the event was not provided. The patient took Tylenol for headache. The rechallenge for the event of Headache is considered positive, having in mind that it was confirmed that the patient experienced the same event after the first and after the second dose of the vaccine. The underlying Anemia remains a confounder for the event of Headache. The company causality for the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-384858, MOD-2021-384883 (Patient Link).; Sender's Comments: This is a case of Maternal exposure during pregnancy for this 27-year-old female patient with medical history of Obsessive-compulsive disorder and Anaemia. The patient received the first dose of mRNA-1273 vaccine during the 29th week of pregnancy. Reportedly, the patient reported that her course of pregnancy and delivery was smooth and without complications, however, the delivery type was not specified. In addition, the patient experienced the non-serious expected event of Headache after receiving the first dose of mRNA vaccine. The exact temporal relationship between the event of Headache and vaccine administration cannot be determined as the start date of the event was not provided. The patient took Tylenol for headache. The rechallenge for the event of Headache is considered positive, having in mind that it was confirmed that the patient experienced the same event after the first and after the second dose of the vaccine. The underlying Anemia remains a confounder for the event of Headache. The company causality for the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.