Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood oestrogen, Blood test, Menstrual disorder, Syncope
Clinical narrative: Daughter fainted as a result of having blood drawn; her daughter has not had a menstrual cycle since receiving both  primary doses in June2021/Her daughter has not had her menstrual cycle since JUN 2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 11:00 (Lot number: EW0186) at the age of 13 years as dose 1, single and administered in arm left, administration date 17Jun2021 13:00 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Daughter fainted as a result of having blood drawn"; MENSTRUAL DISORDER (non-serious) with onset Jun2021, outcome "not recovered", described as "her daughter has not had a menstrual cycle since receiving both primary doses in June2021/Her daughter has not had her menstrual cycle since JUN 2021.". The event "her daughter has not had a menstrual cycle since receiving both primary doses in june2021/her daughter has not had her menstrual cycle since jun 2021." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood oestrogen: unknown result, notes: had all the hormones checked, nothing adverse or hormonal going on that would trigger why she isn't getting her period patient thinks its the vaccine; blood test: unknown result, notes: Her daughter had blood work done. Caller is patient's mother. She states her daughter has not had a menstrual cycle since receiving both primary doses in Jun2021.  Her PCP has checked her Hormone levels and they were normal. Is there any more information available. Will there be any special studies of prepubescent children and the vaccine? There really needs to be more studies done. Her daughter has not had her menstrual cycle since Jun2021. Her last vaccine was on 06Jun2021. Her daughter had blood work done, had all the hormones checked nothing adverse or hormonal going on that would trigger why she isn't getting her period, patient thinks it's the vaccine. Prescribing HCP: When querying HCP name, caller states the last time the were there it was a different one than they usually see. Caller provided Practice Information. No HCP email address to provide. Indication: immunity, caller states it's the best thing to do. Caller states daughter had blood work, a series of hormones. Daughter fainted as a result of having blood drawn. They were trying to see if there everything was working as it should, making sure everything in the brain that is responsible for the hormones. Caller states she is looking at the description on the bill, not sure what it all means. There is a synopsis listed, the doctor said it was all normal. Caller states she is at least, glad, not sure who to reach out to, since it has been abnormal ever since getting the vaccine. The doctor pushed it off like how can it be an adverse reaction. Time the Vaccination Was Given: First dose: unknown, roughly 11:00. Second dose: may have been 13:00. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Both doses received in the Left Arm. Caller confirms both vaccines received at same location. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Adverse Event (AE) Details: Provide the time of onset of AE(s): Her daughter has not had her menstrual cycle since JUN 2021.  Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Caller states her daughter started her menstrual cycle at age 10 and it was fairly regular.  The blood tests would have shown diabetes or cholesterol, everything was fine. Relevant Tests: None or Unknown, List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI) Test: Date: Result: Units: Normal Range: Low: High: Caller states not that she knows of. They tried to take 7 vials of blood.