Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Histology, Impaired work ability, Loss of personal independence in daily activities, Postmenopausal haemorrhage
Clinical narrative: COVID-19 infection; Had to take time off work due to this traumatic event; Had to take time off work due to this traumatic event and that it is affecting her everyday life; In 2014 she went through menopause and the third or fourth week in January 2022, she started having menstrual bleeding,Bleeding starts and stops; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (In 2014 she went through menopause and the third or fourth week in January 2022, she started having menstrual bleeding,Bleeding starts and stops) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00U212A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ovary removal (she had one ovary removed in 2007) in 2007. Concurrent medical conditions included Hypothyroidism (No change reported), High cholesterol (No change reported), Seasonal allergy (No change reported) and Menopause since 2014. Concomitant products included ROSUVASTATIN for High cholesterol, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19 infection). In January 2022, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (In 2014 she went through menopause and the third or fourth week in January 2022, she started having menstrual bleeding,Bleeding starts and stops) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (Had to take time off work due to this traumatic event) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to take time off work due to this traumatic event and that it is affecting her everyday life). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (In 2014 she went through menopause and the third or fourth week in January 2022, she started having menstrual bleeding,Bleeding starts and stops) had not resolved, COVID-19 (COVID-19 infection) had resolved and IMPAIRED WORK ABILITY (Had to take time off work due to this traumatic event) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to take time off work due to this traumatic event and that it is affecting her everyday life) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On 25-Mar-2022, Histology: results not reported Results were currently unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no allergies to medications, food, and other products. Concomitant medication included unspecified thyroid medication to treat hypothyroidism. The patient have not received any other vaccines prior to Moderna. It was reported that the third or fourth week in Jan 2022, the patient started having menstrual bleeding, which was so bad, consistent, and heavy. The patient never had a similar event in the past.Patient mentioned that her brain can not cope with it. It was reported that the patient had seen gynecologist concerning the bleeding events and stated that the gynecologist referred the patient to a specialist. On 25 Mar 2022, the patient had an office visit with the specialist and had a histology test performed. The results were currently unknown.   It was mentioned that the symptoms were worsened. No treatment information was reported. Company comment: This spontaneous case concerns a 47-year-old female, with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19 and unexpected serious event of Postmenopausal hemorrhage (seriousness criteria medically significant). The event COVID-19 occurred 4 days after the booster dose of mRNA-1273 vaccine and 9 months 16 days after the second dose. SARS-CoV-2 test was positive as on 4-Jan-2022. It was reported that had menstrual bleeding which was consistent and heavy in third or fourth week in January 2022, consulted with a specialist wherein a histology test was done but with unknown result.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-524018 (Patient Link).; Sender's Comments: This spontaneous case concerns a 47-year-old female, with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19 and unexpected serious event of Postmenopausal hemorrhage (seriousness criteria medically significant). The event COVID-19 occurred 4 days after the booster dose of mRNA-1273 vaccine and 9 months 16 days after the second dose. SARS-CoV-2 test was positive as on 4-Jan-2022. It was reported that had menstrual bleeding which was consistent and heavy in third or fourth week in January 2022, consulted with a specialist wherein a histology test was done but with unknown result.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.