Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vulvovaginal burning sensation
Clinical narrative: vaginal discomfort, raw burning sensation when urinating; a reddish tinge when wiped once; soreness just in her lower back; Body aches; Injection site feels better, some pain is she pushes on it; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL BURNING SENSATION (vaginal discomfort, raw burning sensation when urinating), VAGINAL DISCHARGE (a reddish tinge when wiped once), BACK PAIN (soreness just in her lower back), PAIN (Body aches) and VACCINATION SITE PAIN (Injection site feels better, some pain is she pushes on it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination.     The patient's past medical history included Adverse reaction to antibiotics (Patient states she has this same sort of effect when taking antibiotics. She describes discomfort at raw, burning sensation when urinating, no discharge, no odor, wiped once some redness tint, not period.). Previously administered products included for an unreported indication: DIFLUCAN (Patient states she has this same sort of effect when taking antibiotics.).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VULVOVAGINAL BURNING SENSATION (vaginal discomfort, raw burning sensation when urinating), VAGINAL DISCHARGE (a reddish tinge when wiped once), BACK PAIN (soreness just in her lower back), PAIN (Body aches) and VACCINATION SITE PAIN (Injection site feels better, some pain is she pushes on it). At the time of the report, VULVOVAGINAL BURNING SENSATION (vaginal discomfort, raw burning sensation when urinating), VAGINAL DISCHARGE (a reddish tinge when wiped once), BACK PAIN (soreness just in her lower back) and PAIN (Body aches) had not resolved and VACCINATION SITE PAIN (Injection site feels better, some pain is she pushes on it) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Culture urine: unk Results are pending.. On 30-Dec-2020, Urine analysis: unk Results are pending..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. Treatment included phenazopyridine (Pyridium).  This report concerns a 44-year old female patient who experienced non-serious events of vaginal discomfort, a raw burning sensation when urinating, a reddish tint when wiped once, body aches,  soreness in lower back, injection site pain when pushed, occurring within 3 days of her receiving the mRNA-1273 (Lot # 039k20a). Vaccination site pain is possibly related to the product while other events are assessed as unlikely related to mRNA-1273 but possibly caused by a UTI infection. No new information received on follow up, therefore, causality assessment is unchanged.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: NNI On 03-Mar-2021: NNI On 24-Mar-2021: NNI; Sender's Comments: This report concerns a 44-year old female patient who experienced non-serious events of vaginal discomfort, a raw burning sensation when urinating, a reddish tint when wiped once, body aches,  soreness in lower back, injection site pain when pushed, occurring within 3 days of her receiving the mRNA-1273 (Lot # 039k20a). Vaccination site pain is possibly related to the product while other events are assessed as unlikely related to mRNA-1273 but possibly caused by a UTI infection. No new information received on follow up, therefore, causality assessment is unchanged.