Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Hot flush, Mental disorder
Clinical narrative: After the first vaccine, she started getting them a little/after the first vaccine, caller started to have hot flashes again; She had a hormone reaction to it; affecting her mental health; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration on 29Dec2021 at single dose for covid-19 immunization. Medical history included ongoing artificial menopause (Surgical menopause, since she was 36). The patient's concomitant medications were not reported. After the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. She had a reaction to the vaccine. She had a hormone reaction to it. The caller did research herself to look up hormonal things about the Pfizer vaccine, but she could not find anything. The only information she found was on pregnancy and breast feeding, and low estrogen with COVID. They had significantly subsided over the last year and half to two years. After the first vaccine, she started getting them a little. Then, after second vaccine her hot flashes started being unbearable. She was unsure if it had to do with the vaccine, but she felt like it did. She spoke with nurses she works with. They too had hormonal issues after the vaccine. One had difficulty getting her period for 9 months to a year, but then got their period. She talked to people in menopause who have not had their period for a year, and had one after the vaccine. She talked to women with PCOS that had difficulty getting their period, but got their period after the vaccine. She also talked to women who had normal menopause, that hadn't had their period in a long time get a period. She said this was all generalized information. She doesn't have the specifics for the people that reported it. There was something hormonal going on. It was literally driving her nuts. Her first vaccine she got on the 29Dec2020, Lot number: EJ1686. Her second vaccine she got on 19Jan2021, lot number: EL9261. This all started a week after the first shot, and got worse after the second. She felt like this was medically significant. There was a fine line between medical issues and mental health, and she felt like this was affecting her mental health. Outcome of events was not recovered.   Reaction assessed: after the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.