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VAERS Report 2156870

Case Report Section

Vaer Report Details

Age: 30 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (MODERNA))

Type: Coronavirus 2019 vaccine

Manufacturer: MODERNA

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2022-02-10
Date of Onset
7
Number of days (onset date – vaccination date)
7
Adverse Event Description

flu symptoms; menstrual cycle abnormal; this case was received via the regulatory authority ra (reference number: gb-mhra-adr 26633318) on 23-feb-2022 and was forwarded to moderna on 23-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of influenza (flu symptoms) and menstrual disorder (menstrual cycle abnormal) in a 30-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. no medical history information was reported. on 10-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 17-feb-2022, the patient experienced menstrual disorder (menstrual cycle abnormal) (seriousness criterion medically significant). on an unknown date, the patient experienced influenza (flu symptoms) (seriousness criterion medically significant). at the time of the report, influenza (flu symptoms) had resolved and menstrual disorder (menstrual cycle abnormal) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, sars-cov-2 test: negative (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. concomitant medications were not provided. patient had a lot of soreness and flu symptoms immediately after booster, followed by menstruation 10 days earlier than expected. usually very regular 28 day cycle. patient has not had symptoms associated with covid-19 and was not tested positive for covid-19 since having the vaccine. patient was not pregnant and was not currently breastfeeding. patient was not enrolled in clinical trial. patient had no possible inflammation of the heart like myocarditis or pericarditis. treatment information was not provided. company comment: this is a regulatory authority case concerning a 30-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant according to regulatory authority) events of flu symptoms and abnormal menstrual cycle. the event flu symptoms exact occurrence unknown but stated that it occurred immediately after the third dose of mrna-1273 vaccine administration accompanied by a lot of soreness while the event abnormal menstrual cycle occurred approximately 7 days after the third dose of mrna-1273 vaccine administration. the events were described as, patient experienced a lot of soreness and flu symptoms immediately after booster, followed by menstruation 10 days earlier than expected. the patient's menstrual cycle is usually very regular with 28-day cycle. no reported treatment information. the outcome of the event flu symptoms was resolved, abnormal menstrual cycle was not resolved from the time of last observation while a lot of soreness the outcome was unknown. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this is a regulatory authority case concerning a 30-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant according to regulatory authority) events of flu symptoms and abnormal menstrual cycle. the event flu symptoms exact occurrence unknown but stated that it occurred immediately after the third dose of mrna-1273 vaccine administration accompanied by a lot of soreness while the event abnormal menstrual cycle occurred approximately 7 days after the third dose of mrna-1273 vaccine administration. the events were described as, patient experienced a lot of soreness and flu symptoms immediately after booster, followed by menstruation 10 days earlier than expected. the patient's menstrual cycle is usually very regular with 28-day cycle. no reported treatment information. the outcome of the event flu symptoms was resolved, abnormal menstrual cycle was not resolved from the time of last observation while a lot of soreness the outcome was unknown. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.

Lab Data
test name: covid-19 virus test; test result: negative ; result unstructured data: no - negative covid-19 test
List of symptoms
menstrual disorder influenza sars-cov-2 test
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Unknown
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na