Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gynaecological examination, Inappropriate schedule of product administration, Polyp, Postmenopausal haemorrhage, Ultrasound scan
Clinical narrative: Polyp 1.3 centimeter with blood clot beside polyp; Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago; Since then, she had spotting every day; 22 days gap; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia iron deficiency (because she is vegan), Attention deficit disorder, Cold sores, Migraine (menstrual related), Hypertension (mild) and Drug allergy (sensitive to some medication, as per patient; might not be significant). Concomitant products included IRON for Anemia iron deficiency, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]) for Attention deficit disorder, LOSARTAN for Blood pressure high, ACICLOVIR (ACYCLOVIR ALPHARMA [ACICLOVIR]) from an unknown date to 09-Feb-2021 for Cold sore (herpetic), TROPICAMIDE (MIDRIN M) for Migraine, ESTROGENS CONJUGATED (PREMARIN) for Vaginal dryness, COLECALCIFEROL (VITAMIN D3), FISH OIL from an unknown date to 09-Feb-2021 and PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) from an unknown date to 09-Feb-2021 for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (22 days gap). On 16-May-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (Since then, she had spotting every day). On 27-May-2021, the patient experienced POLYP (Polyp 1.3 centimeter with blood clot beside polyp). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (22 days gap) had resolved. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) and POLYP (Polyp 1.3 centimeter with blood clot beside polyp) outcome was unknown and VAGINAL HAEMORRHAGE (Since then, she had spotting every day) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Gynaecological examination: normal (normal) Normal. On 27-May-2021, Ultrasound scan: abnormal (abnormal) found to have a polyp measuring 1.3 centimeters and a little blood clot was beside the polyp.         Treatment included hysteroscopy, dilatation and curettage to remove polyp and clot, and specimens were sent to pathology, results not provided. She will be having a post-operation follow up consultation on 8 Jun 2021 with her gynecologist.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.