Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Limb discomfort, Menstruation irregular, Paraesthesia, Vaccination site pain
Clinical narrative: missing period since first dose; Irregular menstrual period, got very little discharge on 22Feb2021; Tingling in left foot immediately after the injection/tingling more in right foot; Feels like ball is rolling around in the sole of foot; arm pain where she got the injection; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021), PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot), LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) and VACCINATION SITE PAIN (arm pain where she got the injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Patient is on thyroid medication). Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021), PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot), LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) and VACCINATION SITE PAIN (arm pain where she got the injection). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. In December 2020, VACCINATION SITE PAIN (arm pain where she got the injection) had resolved. At the time of the report, AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021) and PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot) had not resolved and LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included ibuprofen.  Consumer stated she had her period in Dec-2020, did not have it in Jan-2021, had very little discharge on 22-Feb-2021, did not have it in Mar-2021, and had not had it in Apr-2021. She visited a gynecologist, and blood tests performed to check her hormone levels had normal results. Consumer visited a physician for the tingling sensation. Blood tests from this visit also had normal results.  The patient also stated that she was emotionally distressed, it affects her a lot and it also changed her body.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: The patient information, 1st and 2nd dose of vaccine information along with batch number, concomitant drug, additional events amenorrhea and menstruation irregular were updated. On 26-Apr-2021: No new information was provided.; Sender's Comments: Based on the current available information and temporal association beteen the use of the product and the start date of the events  a causal relationship cannot be excluded.