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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: White blood cells were below 1 on Monday, repeat labs Wednesday they were above 1; Worsening lymphedema since Jan2021 or Feb2021; Joints hurt; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 02Jun2021 (age at vaccination: 57-year-old) as dose number unknown, single for COVID-19 immunization. Medical history of the patient included adhesive tape allergy, iodine tincture allergy, lymphedema (worsening lymphedema since Jan2021 or Feb2021). Concomitant medications included Tocopherol (Vitamin E), naproxen sodium (Aleve), fulvestrant (Faslodex), Levothyroxine, Multivitamin capsule, Vitamin D for unspecified indication, started and stopped on an unspecified date. Patient previously took Macrobid on an unspecified date for an unspecified indication and experienced allergy. On an unspecified date in Jun2021, patient white blood cells were below 1 on Monday and her white blood cells were above 1 on Wednesday, worsening lymphedema since Jan2021 or Feb2021, joints hurt. MD is aware. Outcome of the events were unknown. Information about lot/batch number has been requested.; Sender''s Comments: Limited information of white blood cell count prior to vaccine preclude a comprehensive causality assessment, underlying medical conditons of lymphedema and allergy may be contributory to events. 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
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