Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Laparoscopy, Malaise, Mood swings, Muscle spasms, Pyrexia
Clinical narrative: Abdominal pain; Back pain; Fatigue; Malaise; Mood swings; Muscle spasms; Pyrexia; Uterine dilation and curettage; Vaginal haemorrhage; This case was received via FDA VAERS (Reference number: 1558254) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021.     This regulatory authority case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), BACK PAIN (Back pain), FATIGUE (Fatigue), MALAISE (Malaise), MOOD SWINGS (Mood swings), MUSCLE SPASMS (Muscle spasms), PYREXIA (Pyrexia), UTERINE DILATION AND CURETTAGE (Uterine dilation and curettage) and VAGINAL HAEMORRHAGE (Vaginal haemorrhage) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Bell peppers, pimento peppers), Depression, Anxiety and Heartburn. Concomitant products included FENOFIBRATE, VENLAFAXINE, ALPRAZOLAM (XANAX), OMEPRAZOLE, LISDEXAMFETAMINE MESILATE (VYVANSE) and ETONOGESTREL (NEXPLANON) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion congenital anomaly), BACK PAIN (Back pain) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), MALAISE (Malaise) (seriousness criterion congenital anomaly), MOOD SWINGS (Mood swings) (seriousness criterion congenital anomaly), MUSCLE SPASMS (Muscle spasms) (seriousness criterion congenital anomaly), PYREXIA (Pyrexia) (seriousness criterion congenital anomaly), UTERINE DILATION AND CURETTAGE (Uterine dilation and curettage) (seriousness criterion congenital anomaly) and VAGINAL HAEMORRHAGE (Vaginal haemorrhage) (seriousness criterion congenital anomaly). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1000 mg and IBUPROFEN ongoing since an unknown date for Fever, at a dose of 600 mg. At the time of the report, ABDOMINAL PAIN (Abdominal pain), BACK PAIN (Back pain), FATIGUE (Fatigue), MALAISE (Malaise), MOOD SWINGS (Mood swings), MUSCLE SPASMS (Muscle spasms), PYREXIA (Pyrexia), UTERINE DILATION AND CURETTAGE (Uterine dilation and curettage) and VAGINAL HAEMORRHAGE (Vaginal haemorrhage) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 101 (High) 101 F temperarture. On 19-Mar-2021, Hysteroscopy: normal (normal) normal. On 19-Mar-2021, Laparoscopy: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient used Nexplanon implant (since Feb-2016) and not had any vaginal bleeding or symptoms relating to  menstrual cycle since the original implant nor the replacement implant in Mar-2019. She  scheduled an appointment with an OB-GYN to follow up with those concerns. On 19-Mar-2021, prior to the exam she noticed she had vaginal bleeding, which  she had not experience before in 3+ years, she had a transvaginal ultrasound. She came out of the bathroom into the exam room and stated to the ultrasound technicians. Following that, she decided  to go to a larger facility for continuation of care, thinking there was something very wrong. On 16-Apr-2021 she patient had a diagnostic laparoscopy, multiple ultrasounds, D1: C and hysteroscopy relating to the persisting symptoms relating to her reproductive system. Nothing was found to explain  symptoms, her symptoms had progressively gotten worse since then and were still continuing.  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.