Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Endocrine disorder, Fatigue, Headache, Menstruation irregular
Clinical narrative: Chest pain and soreness; Chest pain and soreness; her period had not come; Slight Headache; More Tired; Effecting her hormones; it is doing something; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Sep2021 09:30 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. Medical history included ovarian cancer and breast pain with her period when she was younger. The patient stated ovarian cancer just worried her because if it was  having an effect on her sex organs. She stated she was hoping that the shot wasn't messing with her hormones and increasing her chance of any cancer. Family Medical History was none. There were no concomitant medications. There was no additional vaccine administered on same date of BNT162B2. The patient did not receive any other vaccine within 4 weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3182) on 25Aug2021 (at the age of 41-year-old) as single dose for COVID-19 immunization and experienced headache, low grade fever of 99.6/ fever was not breaking 100.5, swollen lymph nodes, sore throat, muscle aches, swollen tonsils, body aches, sore arm, fatigue, body chills and a lot of discomfort. The patient stated she lost 5 pounds because she couldn't eat, her left tonsil was bleeding and it was very swollen so much that she couldn't swallow and when she spits, it was bloody / dry blood. The tonsil on the opposite side of injection was far more swollen noting it was blackish red and her tonsil was completely swollen and inflamed after first vaccination. The patient also woke up in the middle of the night after first vaccination. The patient stated following her second dose on 17Sep2021, her period was absent on 19Sep2021, she was having chest pain and soreness on 19Sep2021. She stated that she was of childbearing age, and she had always had regular periods. She stated the two vaccine series was completed and now her period had not come, clarifying it was a week late, which was abnormal for her on 19Sep2021. The patient stated she was also experiencing chest pain and soreness on 19Sep2021. She stated she spoke to her PCP about it because she was concerned, and she said it sounds like something that she should report. For chest pain and soreness, the patient stated she thought she was getting her period although she normally didn't get any breast pain with her period, but she used to when she was younger. The patient stated that it had stayed the same, it was a constant soreness. The patient stated that she wasn't given a choice to get the vaccine or not since she was a nurse. She stated it was effecting her hormones, it was  doing something in Sep2021. The patient stated with the second one, she thought great, she only had the day of the vaccine a slight headache and she was more tired on 17Sep2021. The nurse considered the events chest pain and soreness, effecting her hormones; it is doing something, her period had not come as medically significant (serious) and considered the events slight headache and more tired as non-serious. She stated she had the vaccine in the morning at 9:30 and by the end of the night she was better. Treatment of the events included antibiotic. The events required a visit to physician office (Urgent Care and mentioned it to her doctor). The patient asked if missing periods was being reported as a side effect of the Covid vaccine or if it had shown to effect the hormones. The outcome of the events slight headache and more tired was recovered on 17Sep2021, of the other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate