Breast cancer; A PHASE II TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-COV-2 MONOVALENT AND MULTIVALENT RNA-BASED VACCINES IN HEALTHY SUBJECTS  Initial information received on 19Dec2022: This is a serious case of breast cancer (MedDRA PT: breast cancer) from clinical trial. An 85-year-old female healthy subject received one injection with study drug BNT162b2 (BNT162b2) with a dose of 30 mcg on 30Jun2022 for SARS-CoV-2 vaccination, also presenting the last administration before start of event. Previously, the patient had received three injections of 30 mcg Comirnaty (BNT162b2) on 11Aug2020, 01Sep2020 and 28May2021 for COVID-19 prophylaxis. 156 days after vaccination with BNT162b2 (BNT162b2) the patient was diagnosed with breast cancer (breast cancer) of severe intensity (FDA Guidance 2007. FDA Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) on 03Dec2022. This case is serious due to being 'other medically important condition'. Relevant past medical history includes ovarian cyst in 1980, bilateral oophorectomy in 1980, partial hysterectomy in 1975, menorrhagia in 1975 and caesarean section in 1969. Relevant medical history includes coronary artery disease since 2007, hypertension since 2004, urinary incontinence since 2001, gastric reflux since 2000, osteopenia since 1970 and arterial peripheral vascular disease since 2008. Relevant past medication includes unspecified Influenza vaccine on 22Sep2020 as well as Versed (midazolam), Fentanyl (fentanyl), Propofol (propofol) and Ketamine (ketamine), the latter four were administered for pre-procedure on 01Sep2022. Relevant concomitant medication includes Lisinopril (lisinopril) for hypertension, Vesicare (solifenacin) for urinary incontinence, Aspirin (acetylsalicylic acid) for prophylaxis, Calcium + Vitamin D (calcium carbonate, colecalciferol) for osteopenia, Metoprolol (metoprolol) for coronary artery disease, COQ10 (ubidecarenone) for supplementation therapy, Omeprazole (omeprazole) for gastric reflux, Preservision Vitamins Areds 2 (vitamins, minerals) for ocular supplementation and Xarelto (rivaroxaban) for arterial peripheral vascular disease. On 16-Dec-2022 during subject's visit 5 she advised that a lump was found on her right breast with suspicion of malignancy and that a biopsy was performed. On 19Dec2022 (start date of seriousness), the subject contacted the site and confirmed the malignancy. Medical records were requested by the site. At the time of reporting, the event was recovering/resolving. No further information is available at that time. Additional information has been requested. Follow-up information received 11May2023 and 19May2023 (FU1): According to the Investigator, the patient began radiation treatment on unk-Feb-2023, and remains ongoing at this time. Further information is not available at this time. Additional information has been requested.  Causality Assessment: The reporter considered the event Breast cancer had non reasonable possibility with suspect vaccine. The Company (BioNTech SE) considered the event Breast cancer had non reasonable possibility with suspect vaccine.  Follow-up (11May2023): This is a non-Pfizer sponsored interventional study follow up report from License Party (BioNTech SE) for protocol. Other Case identifier: 2022FOS005235, US-BNTAG-1627 (BioNTech SE).  Updated information included: medical history added, product indication updated, and clinical details.  BioNTech SE Comment: The reporting investigator considers the event breast cancer to be serious due to being an other medically important condition. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (BNT162b2). The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. Breast cancer confirmed by biopsy occurred 156 days after last vaccination. Patient had medical history of e.g. ovarian cyst, oophorectomy bilateral, hysterectomy, heavy menstrual bleeding and caesarean section with an advanced age of 85-years presenting one the main risk factors for the development of breast cancer. Further information concerning medical records is requested. The benefit-risk profile of BNT162b2 (BNT162b2) is not affected by this event and no change in the reference safety information is required at that time. Medical re-assessment after follow-up information received 11-May-2023 and 19-May-2023 (FU1): With the follow-up information received, the previous medical assessment provided on 27-DEC-2023 has not changed. The information in this single case does not change the benefit-risk profile of BNT162b2 or warrant any changes to the conduct of this trial.  Causality Assessment: The reporter considered the event Breast cancer had non reasonable possibility with suspect vaccine. The Company (BioNTech SE) considered the event Breast cancer had non reasonable possibility with suspect vaccine.  BNT162b2 is under agreement with BIONTECH SE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: BioNTech SE Comment: The reporting investigator considers the event breast cancer to be serious due to being an other medically important condition. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (BNT162b2). The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. Breast cancer confirmed by biopsy occurred 156 days after last vaccination. Patient had medical history of e.g. ovarian cyst, oophorectomy bilateral, hysterectomy, heavy menstrual bleeding and caesarean section with an advanced age of 85-years presenting one the main risk factors for the development of breast cancer. Further information concerning medical records is requested. The benefit-risk profile of BNT162b2 (BNT162b2) is not affected by this event and no change in the reference safety information is required at that time. Medical re-assessment after follow-up information received 11May2023 and 19May2023 (FU1): With the follow-up information received, the previous medical assessment provided on 27DEC2023 has not changed. The information in this single case does not change the benefit-risk profile of BNT162b2 or warrant any changes to the conduct of this trial.