Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaginal haemorrhage
Clinical narrative: Very heavy vaginal bleeding, it was a whole lot of blood; Very Tired; weak; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaemia.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced ASTHENIA (weak). On 17-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood) (seriousness criteria hospitalization and medically significant) and FATIGUE (Very Tired). The patient was hospitalized from 24-Jun-2021 to 26-Jun-2021 due to VAGINAL HAEMORRHAGE. The patient was treated with TRANEXAMIC ACID on 23-Jun-2021 for Vaginal bleeding, at a dose of 1 dosage form and Surgery (hysterectomy) for Vaginal haemorrhage. At the time of the report, VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood), ASTHENIA (weak) and FATIGUE (Very Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications were not reported.   On 02-Jun-2021, the patient had her normal period and was not pregnant at the time of the report. On 17-Jun-2021, the patient called her gynecologist and made an appointment for 06-Jul-2021 to do an ultrasound. On 23-Jun-2021, Wednesday, the patient stated that she could not wait to see the doctor and went to the emergency room at night. It was reported that the patient was discharged at 2 am, as the bleeding stopped for a little bit. On 24-Jun-2021, Thursday morning, the patient woke up with whole lot of blood and went to her obstetrician/ gynecologist (OBGYN). The patient's OBGYN could not believe the amount of blood patient had lost and stated that if the patient had lost any more blood, she could possibly have died as the patient's blood was so low. The patient was hospitalized, and an emergency hysterectomy was performed. On 26-Jun-2021, the patent was discharged from the hospital. It was reported that the patient's second shot was due on 30-Jun-2021.  Company comment: This case concerns a 42-year-old female hospitalized with a serious unexpected event of vaginal hemorrhage, and nonserious asthenia and fatigue. Event latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-jun-2021 contains significant information regarding seriousness and surgery, medical history and event details.; Sender's Comments: This case concerns a 42-year-old female hospitalized with a serious unexpected event of vaginal haemorrhage, and nonserious asthenia and fatigue. Event latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.