Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Tumour marker increased, Tumour marker test
Clinical narrative: tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer; tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2020, for Covid 19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), TUMOUR MARKER INCREASED (medically significant), outcome "unknown" and all described as "tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer". The patient underwent the following laboratory tests and procedures: tumor marker test: 0, notes: were at 0 prior to the vaccine; tumor marker shot back up, notes: she went in for blood work and her tumor marker shot back up and she had stage 4 cancer.  Clinical course: Patient got her 1st dose of the vaccine in Dec2020 and her 2nd dose of the vaccine in Jan2021, where 6 months later she was diagnosed with breast cancer on the same side she received the vaccines. Caller would like to know if breast cancer has been reported after receiving the vaccine and if it is contraindicated to receiving the booster and they are mandating the booster. Caller stated she has no history of breast cancer on either side of her family, and she is nervous to receive the booster since she is uncertain if the breast cancer is related to the vaccine. Caller stated she is a Nurse that works in hospital and deals with cancer patients. Caller stated one of her patients held off on getting the Covid 19 vaccine and tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid 19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer, which is why the caller is nervous about receiving the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events Neoplasm malignant, tumour marker increased and suspect drug BNT162B2 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