Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abortion spontaneous, Fatigue, Gait disturbance, Maternal exposure during pregnancy
Clinical narrative: Sore arm after vaccination; tiredness; Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt she had to grab on to something.; vertigo; Seven weeks pregnant and had Moderna vaccine administered; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 38-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 02021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]) and CITRANATAL ASSURE for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-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. On 24-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Seven weeks pregnant and had Moderna vaccine administered). On 13-May-2021, the patient experienced VERTIGO (vertigo). On 01-Jun-2021, the patient experienced GAIT DISTURBANCE (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt she had to grab on to something.). On 06-Jul-2021 at 4:00 AM, the patient experienced ABORTION SPONTANEOUS  (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN, MYALGIA (Sore arm after vaccination) and FATIGUE (tiredness). On 24-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Seven weeks pregnant and had Moderna vaccine administered) had resolved. At the time of the report, ABORTION SPONTANEOUS, VERTIGO (vertigo), GAIT DISTURBANCE (Today she woke up and felt she wasn't going to be able to walk with her normal balance, she felt she had to grab on to something.), ABDOMINAL PAIN, MYALGIA (Sore arm after vaccination) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. concomitant products included vitapol ultra.  Company Comment: This case concerns a 38-year-old female patient who received mRNA-1273 while 7 weeks pregnant. Obstetric and gynecological history was not provided. Maternal exposure during pregnancy is assessed as not applicable.  The other events show temporal association between the use of mRNA-1273 and the onset. Hence causal relationship cannot be excluded. Fatigue and myalgia are consistent with product known safety profile.   This case was linked to MOD-2021-193546 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information was received 21 Jul 2021 wherein ADR form received. Patient demographics updated, concomitant medications, vaccination details, new events added. HCP contact details provided, updated pregnancy information :Birth type and fetal out come and gestation period details.; Sender's Comments: This case concerns a 38-year-old female patient who received mRNA-1273 while 7 weeks pregnant. Obstetric and gynecological history was not provided. Maternal exposure during pregnancy is assessed as not applicable.  The other events show temporal association between the use of mRNA-1273 and the onset. Hence causal relationship cannot be excluded. Fatigue and myalgia are consistent with product known safety profile