Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms, Night sweats, Ovulation delayed, Paraesthesia
Clinical narrative: Delayed Menstrual cycle; Menstural cycle affected with ovulation day; Numbness and tingling in the arm; Tingling in the arm; Night sweats; Cramp from one part of the leg to the hip; Develop hormonal imbalance symptoms; Slept all day Thursday; Arm of injection site was sore; Soreness from shoulder up to the head; Felt tired and went to sleep, still kind of tired; 100 degree fever; sinus pain; Estrogen higher than it should be, felt pregnant when they went for the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp from one part of the leg to the hip), HORMONE LEVEL ABNORMAL (Develop hormonal imbalance symptoms), BLOOD OESTROGEN INCREASED (Estrogen higher than it should be, felt pregnant when they went for the vaccine), MENSTRUAL DISORDER (Delayed Menstrual cycle) and OVULATION DELAYED (Menstural cycle affected with ovulation day) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], DOCOSAHEXAENOIC ACID (DHA), PROBIOTICS NOS and INOSITOL for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced BLOOD OESTROGEN INCREASED (Estrogen higher than it should be, felt pregnant when they went for the vaccine), SINUS PAIN (sinus pain), VACCINATION SITE PAIN (Arm of injection site was sore), ARTHRALGIA (Soreness from shoulder up to the head), FATIGUE (Felt tired and went to sleep, still kind of tired) and PYREXIA (100 degree fever). On 15-Apr-2021, the patient experienced SOMNOLENCE (Slept all day Thursday). On 16-Apr-2021, the patient experienced MUSCLE SPASMS (Cramp from one part of the leg to the hip). 16-Apr-2021, the patient experienced HORMONE LEVEL ABNORMAL (Develop hormonal imbalance symptoms), HYPOAESTHESIA (Numbness and tingling in the arm), PARAESTHESIA (Tingling in the arm) and NIGHT SWEATS (Night sweats). On an unknown date, the patient experienced MENSTRUAL DISORDER (Delayed Menstrual cycle) and OVULATION DELAYED (Menstural cycle affected with ovulation day). On 16-Apr-2021, SINUS PAIN (sinus pain), VACCINATION SITE PAIN (Arm of injection site was sore), ARTHRALGIA (Soreness from shoulder up to the head), FATIGUE (Felt tired and went to sleep, still kind of tired) and PYREXIA (100 degree fever) had resolved. On 18-Apr-2021, MUSCLE SPASMS (Cramp from one part of the leg to the hip), HORMONE LEVEL ABNORMAL (Develop hormonal imbalance symptoms) and NIGHT SWEATS (Night sweats) had resolved. On 22-Apr-2021, HYPOAESTHESIA (Numbness and tingling in the arm) and PARAESTHESIA (Tingling in the arm) had resolved. At the time of the report, BLOOD OESTROGEN INCREASED (Estrogen higher than it should be, felt pregnant when they went for the vaccine), MENSTRUAL DISORDER (Delayed Menstrual cycle) and SOMNOLENCE (Slept all day Thursday) outcome was unknown and OVULATION DELAYED (Menstural cycle affected with ovulation day) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 in March 2020.. On 17-Apr-2021, Ultrasound scan: (normal) The ultrasound for blood clots to check for markers came back and found that they were fine..         Patient reported that the menstrual cycle was affected with the ovulation day.  Relevant concomitant medications also included Chinese herbs.  No treatment details were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04 Jun 2021 included details on: Patient contact address, demographics, race , ethnicity, second dose information, lab tests details, concomitant medications details, additional event,  status on events, event outcome.