Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Menopausal disorder, Nausea, Ovulation disorder, Pregnancy test, Pyrexia
Clinical narrative: hormone levels back to pre menopause; feeling strange / felt like something going on in body; breasts swollen; very painful / difficult to touch; very bloated; heavy feeling in the gut; nausea; discomfort in uterine area; dizziness; pretty bad reaction; feels like she had COVID; bleeding; body sending signals of ovulation / tested positive for ovulation; headache; fever; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D27A and 088D2H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020. Concomitant products included LOSARTAN for Blood pressure high, METFORMIN for Diabetes.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and DYSPNOEA (shortness of breath). On 21-Sep-2021, the patient experienced OVULATION DISORDER (body sending signals of ovulation / tested positive for ovulation). On 15-Oct-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE REACTION (pretty bad reaction), SUSPECTED COVID-19 (feels like she had COVID), MENOPAUSAL DISORDER (hormone levels back to pre menopause), FEELING ABNORMAL (feeling strange / felt like something going on in body), BREAST SWELLING (breasts swollen), BREAST PAIN (very painful / difficult to touch), ABDOMINAL DISTENSION (very bloated), ABDOMINAL DISCOMFORT (heavy feeling in the gut), NAUSEA (nausea), UTERINE DISORDER (discomfort in uterine area) and DIZZINESS (dizziness). At the time of the report, HAEMORRHAGE (bleeding), VACCINATION SITE REACTION (pretty bad reaction), SUSPECTED COVID-19 (feels like she had COVID), HEADACHE (headache), PYREXIA (fever), DYSPNOEA (shortness of breath), MENOPAUSAL DISORDER (hormone levels back to pre menopause), FEELING ABNORMAL (feeling strange / felt like something going on in body), BREAST SWELLING (breasts swollen), BREAST PAIN (very painful / difficult to touch), ABDOMINAL DISTENSION (very bloated), ABDOMINAL DISCOMFORT (heavy feeling in the gut), NAUSEA (nausea), UTERINE DISORDER (discomfort in uterine area), DIZZINESS (dizziness) and OVULATION DISORDER (body sending signals of ovulation / tested positive for ovulation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: positive (Positive) positive for pregnancy.. On an unknown date, Pregnancy test: positive (Positive) She took about 20 pregnancy tests, they were positive.. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) antibodies present in patient's blood work.         No Treatment Medication reported.  Patient had been post menopausal for 5.5 years. She tested positive for ovulation, and her doctor confirmed hormone levels back to pre menopause.  She took an ovulation and pregnancy tests. She felt like she was ovulating or pregnant, but thought there was no way she could be pregnant. The doctor ordered a blood test to confirm if pregnant. It came up with a positive for pregnancy.  She was testing her antibodies monthly, she still had antibodies in her blood work, but because delta got strong, she decided to get the vaccine.  Company comment: This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred approximately 1 month after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred approximately 1 month after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.