Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal erythema
Clinical narrative: I have no feeling,no pain, no cuts, no uncomfortability, except sometimes my vagina feels like it's contracting; My heart palpitates a little; It's red, like I just got cut or something; Anemic; Urine was not clear, but red; Totally out of breath, Shortness of breath; Fluttering (heart); bleeding from my vagina and rectum/I'm bleeding like I'm on my period/I've been bleeding for about a week now, bleeding vaginally; bleeding from my vagina and rectum/I'm bleeding from my rectum, like something is going on/I've been bleeding for about a week now,bleeding from amy rectum; I'm now getting clots coming out of my vagina and my anal; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding from my rectum, like something is going on/I've been bleeding for about a week now,bleeding from amy rectum), THROMBOSIS (I'm now getting clots coming out of my vagina and my anal), CARDIAC FLUTTER (Fluttering (heart)) and VAGINAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding like I'm on my period/I've been bleeding for about a week now, bleeding vaginally) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 007B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Date of positive COVID-19 test: 01-NOV-2020 or 02-NOV-2020) on 01-Nov-2021 and Hospitalization (Hospitalization due to COVID-19, stayed for 10 days.).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding from my rectum, like something is going on/I've been bleeding for about a week now,bleeding from amy rectum) (seriousness criterion medically significant), THROMBOSIS (I'm now getting clots coming out of my vagina and my anal) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding like I'm on my period/I've been bleeding for about a week now, bleeding vaginally) (seriousness criterion medically significant). On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FLUTTER (Fluttering (heart)) (seriousness criterion medically significant) and DYSPNOEA (Totally out of breath, Shortness of breath). On 24-Nov-2021, the patient experienced CHROMATURIA (Urine was not clear, but red). On 29-Nov-2021, the patient experienced ANAEMIA (Anemic). On an unknown date, the patient experienced VULVOVAGINAL DISCOMFORT (I have no feeling,no pain, no cuts, no uncomfortability, except sometimes my vagina feels like it's contracting), PALPITATIONS (My heart palpitates a little) and VULVOVAGINAL ERYTHEMA (It's red, like I just got cut or something). The patient was treated with Manual therapy (Patient used a "breathing apparatus", but no oxygen) for Dyspnoea. On 02-Dec-2021, RECTAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding from my rectum, like something is going on/I've been bleeding for about a week now,bleeding from amy rectum), THROMBOSIS (I'm now getting clots coming out of my vagina and my anal), VAGINAL HAEMORRHAGE (bleeding from my vagina and rectum/I'm bleeding like I'm on my period/I've been bleeding for about a week now, bleeding vaginally) and CHROMATURIA (Urine was not clear, but red) had resolved. At the time of the report, CARDIAC FLUTTER (Fluttering (heart)), VULVOVAGINAL DISCOMFORT (I have no feeling,no pain, no cuts, no uncomfortability, except sometimes my vagina feels like it's contracting), PALPITATIONS (My heart palpitates a little), VULVOVAGINAL ERYTHEMA (It's red, like I just got cut or something), DYSPNOEA (Totally out of breath, Shortness of breath) and ANAEMIA (Anemic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Full blood count: unknown (abnormal) (bloodwork) some numbers were high, some were low. On an unknown date, Colonoscopy: unknown (Inconclusive) Unknown. On an unknown date, Electrocardiogram: unknown (Inconclusive) She has not mentioned the fluttering of heart and shortness of breath. On an unknown date, Myocardial necrosis marker: unknown (Inconclusive) cardiac test. On an unknown date, Ultrasound kidney: unknown (Inconclusive) Unknown. On an unknown date, Ultrasound pelvis: unknown (Inconclusive) Unknown.         No concomitant medication details was reported. Patient Can't remember the name of the antibiotic or the medications given  Patient don't have a uterus. Patient had received the Moderna COVID-19 Vaccine and experienced a side effect.  This Spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of rectal haemorrhage, thrombosis, cardiac flutter and vaginal haemorrhage, among others. The patient experienced anal and vaginal bleeding with clots after booster dose of mRNA-1273 vaccine.  She states she first noticed her urine was not clear, but red about one week after receiving the booster shot.  Complicated with  palpitations that she reports as having a "fluttering" of her heart a couple of days after and it occurs intermittently. She was diagnosed with anaemia.  She did not report her tests results.  By the time of the report, the bleeding was recovered, however the outcome of  cardiac flutter was unknown. The rechallenge is not applicable, as no additional dose information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains Non significant information. Reporter details added. On 02-Dec-2021: Significant Follow-up received on 2-Dec-2021 contains significant information, Medical history added, Lab data added, 1st and 2nd dosage regimen added, New events added, Outcome of the events updated. stop dates added.; Sender's Comments: This Spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of rectal haemorrhage, thrombosis, cardiac flutter and vaginal haemorrhage, among others. The patient experienced anal and vaginal bleeding with clots after booster dose of mRNA-1273 vaccine.  She states she first noticed her urine was not clear, but red about one week after receiving the booster shot.  Complicated with  palpitations that she reports as having a "fluttering" of her heart a couple of days after and it occurs intermittently. She was diagnosed with anaemia.  She did not report her tests results.  By the time of the report, the bleeding was recovered, however the outcome of  cardiac flutter was unknown. The rechallenge is not applicable, as no additional dose information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.