Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Papilloma viral infection, Pelvic pain, Precancerous condition, Sensory disturbance
Clinical narrative: PRE-CANCEROUS LESIONS ON UTERINE CERVIX; Human papilloma virus infection; Abnormal physical sensation; WORSENING PELVIC PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PRECANCEROUS CONDITION (PRE-CANCEROUS LESIONS ON UTERINE CERVIX) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ELAGOLIX SODIUM (ORILISSA) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient started ELAGOLIX SODIUM (ORILISSA) (Oral) 1 dosage form twice a day. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PRECANCEROUS CONDITION (PRE-CANCEROUS LESIONS ON UTERINE CERVIX) (seriousness criterion medically significant), PAPILLOMA VIRAL INFECTION (Human papilloma virus infection), SENSORY DISTURBANCE (Abnormal physical sensation) and PELVIC PAIN (WORSENING PELVIC PAIN). At the time of the report, PRECANCEROUS CONDITION (PRE-CANCEROUS LESIONS ON UTERINE CERVIX), PAPILLOMA VIRAL INFECTION (Human papilloma virus infection) and PELVIC PAIN (WORSENING PELVIC PAIN) had not resolved and SENSORY DISTURBANCE (Abnormal physical sensation) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She described a new pain that felt like a muscle stretch from her vagina to the pelvis.  Patient had Lack of improvement in pelvic pain on orilissa. Due to lack of improvement (LOE) in pelvic pain she had been scheduled for a hysterectomy. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 34-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Pre-cancerous lesions after receiving a dose of mRNA-1273 vaccine and co-suspect drug Elagolix sodium (unknown indication). The event occurred within the same year of administration of mRNA-1273 vaccine along with the non-serious events of papilloma viral infection, sensory disturbance, and pelvic pain. Patient experienced pre-cancerous lesions on uterine cervix resultant of high-risk human papillomavirus, worsening of pelvic pain since receiving Moderna COVID-19 vaccine which felt like muscles stretch from vagina to pelvis. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 2 doses of mRNA-1273 vaccine. The co-suspect Elagolix sodium could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Pre-cancerous lesions after receiving a dose of mRNA-1273 vaccine and co-suspect drug Elagolix sodium (unknown indication). The event occurred within the same year of administration of mRNA-1273 vaccine along with the non-serious events of papilloma viral infection, sensory disturbance, and pelvic pain. Patient experienced pre-cancerous lesions on uterine cervix resultant of high-risk human papillomavirus, worsening of pelvic pain since receiving Moderna COVID-19 vaccine which felt like muscles stretch from vagina to pelvis. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Patient received 2 doses of mRNA-1273 vaccine. The co-suspect Elagolix sodium could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.