Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: miscarriage at week 14; sleepiness; heaviness; spots on face/spots on breast area/spots on face arms (ongoing); itching; tenderness in arm; arm discomfort/ pain in the arm; swelling in the arm/swelling; redness in the arm; allergic reaction after doses 1 and 2, three days after the doses were administered; tiredness; headache; pregnant after the vaccine; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage at week 14) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In February 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant after the vaccine). On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage at week 14) (seriousness criterion medically significant), VACCINATION SITE PAIN (arm discomfort/ pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/swelling), VACCINATION SITE ERYTHEMA (redness in the arm), DISCOMFORT (heaviness), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), PRURITUS (itching), TENDERNESS (tenderness in arm), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache). The vaginal delivery occurred on 30-Sep-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. In February 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant after the vaccine) had resolved. At the time of the report, ABORTION SPONTANEOUS (miscarriage at week 14), VACCINATION SITE PAIN (arm discomfort/ pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/swelling), VACCINATION SITE ERYTHEMA (redness in the arm), DISCOMFORT (heaviness), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), PRURITUS (itching), TENDERNESS (tenderness in arm), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.            Concomitant medications were not provided  Treatment information was not provided.  This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of abortion spontaneous at 14 weeks of gestational age. The patient was exposed to the vaccine before getting pregnant. The event of abortion spontaneous occurred approximately 7 months after the first dose of mRNA-1273 and 6 months after the second dose of mRNA-1273. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378007 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up document received on 08-Nov-2021 contains new events, hence added and updated.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of abortion spontaneous at 14 weeks of gestational age. The patient was exposed to the vaccine before getting pregnant. The event of abortion spontaneous occurred approximately 7 months after the first dose of mRNA-1273 and 6 months after the second dose of mRNA-1273. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.