Worsening of right pilon fracture; A PHASE II TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-COV-2 MONOVALENT AND MULTIVALENT RNA-BASED VACCINES IN HEALTHY SUBJECTS  This is a non-Pfizer sponsored interventional study report from License Party for protocol BNT162-17. Other Case identifier(s): 2023FOS000300, US-BNTAG-1640. Initial information received on 10 MAY 2023: This is a serious case of Worsening of right pilon fracture (MedDRA PT: Comminuted fracture) from clinical trial BNT162-17. A 22-year-old female patient was diagnosed with Grade 3 Worsening of right pilon fracture on 19OCT 2022 due upon attending a post-op follow-up appointment, patient exhibited positive wrinkle sign and was admitted to the hospital on 19 OCT 2022. Patient underwent open reduction and internal fixation of the right tibia. Fracture fragments and ankle external fixator were removed. Bone loss was noted and filled with antibiotic cement spacer including a mixture of cement, 1g vancomycin, 2g tobramycin, and 1 vial of methylene blue. Patient was transferred to post-anasthesia care unit for recovery without complications. On 21 OCT 2022, patient was discharged from the hospital with well controlled pain and instructed to return for follow-up in 2 weeks. On 07 DEC 2022, patient underwent bone graft at the segmental defect tibia without complications. The patient was treated with BNT162b2 (B.1.1.529) on 15 AUG 2022. Two months after start of treatment BNT162b2 (B.1.1.529) the patient developed Worsening of right pilon fracture (MedDRA PT: Comminuted fracture) on 19OCT 2022. Last BNT162b2 (B.1.1.529) administration before start of seriousness was on 15 AUG 2022. This case is serious due to hospitalization. Relevant medical history includes a fractured right tibia on 04 OCT 2022. The patient fell 15 feet during an indoor rock climbing incident on 04-Oct-2022 and was taken to the emergency department for orthopedic surgeons evaluation. Subject was admitted and diagnosed with a Gustillo Anderson type II open distal tibia pilon fracture in need of irrigation, debridement, stabilization and fixation. The fibular shaft fracture was found to be displaced. The open reduction and internal fixation were completed on 05-Oct-2022 and length, rotation, and alignment were restored. The subject was transferred to recovery and then to a hospital room in stable condition. Subject was discharged from the hospital on 09-Oct-2022 with well-controlled pain, wound care instructions, and activity restrictions. Relevant concomitant medication was not reported. At the time of reporting, the main event has recovered. No further information is available at that time. Additional information has been requested. Additional information dated on 19-May-2023: Administrative update: The dosage unit of suspect product BNT162b2 was corrected from '30 Milligram' to '30 Microgram' via creation of a subversion. The medical assessment remained unchanged. Follow-up information received 24-May-2023: Site corrected the cohort assignment as Part C Cohort 8. The end date of seriousness 07-Dec-2022 was confirmed to be correct. No further information is available at this time. Additional information dated on 07-Jun-2023: Site corrected the study drug to BNT162b2 and updated the stop date of event seriousness to 21-Oct-2022. No further information is available at this time.  BioNTech SE Comment: Initial Medical Assessment: The reporting investigator considers the event to be serious due to hospitalization. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (B.1.1.529). 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. The benefit-risk profile of BNT162b2 (B.1.1.529) is not affected by this event and no change in the reference safety information is required at this time. Medical re-assessment after follow-up information received 24-May-2023/07-Jun-2023 (FU1): With the follow-up information received on 24-MAY-2023, the study vaccine has been corrected to BNT162b2 due to the cohort correction. The previous medical assessment with regards to causality between the event and study vaccine provided on 10-MAY-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. The additional information received on 07-Jun-2023 has not changed the previous medical assessment. 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.  The investigator considered there was not a reasonable possibility that the event "worsening of right pilon fracture" was related to BNT162b2.  BNT162B2 is under agreement with BIONTECH SE.  No follow-up attempts are possible. No further information is expected.  Follow-up (19May2023): This is a follow-up report from an interventional study source for Protocol BNT162-17 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. Other Case identifier(s): US-BNTAG-1640. Updated information: The dosage unit of suspect product BNT162b2 was corrected from '30 Milligram' to '30 Microgram' via creation of a subversion. The medical assessment remained unchanged.  BNT162B2 is under agreement with BIONTECH SE.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Jun2023): This is a follow-up report from an interventional study source for Protocol BNT162-17 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. Other Case identifier(s): US-BNTAG-1640. Query response includes: US-BNTAG-1632 (Pfizer case) and US-BNTAG-1640 (Pfizer case) were for same patient but not duplicates.  BNT162b2 is under agreement with BioNTech SE.  Follow-up (24May2023): This is a follow-up report from an interventional study source for Protocol BNT162-17 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. Other Case identifier(s): 2023FOS000300, 185534714 (Pfizer Inc), US-BNTAG-1640. Updated information: referenced numbers, medical history (SARS-CoV-2 vaccination, clinical trial participant).   BNT162b2 is under agreement with BioNTech SE.  Follow-up (09Jun2023): This is a Pfizer sponsored interventional study follow-up report from License Party (BioNTech SE) for protocol BNT162-17. Other Case identifier(s): US-BNTAG-1640. Follow-up information received 09-Jun-2023 (FU2): Site corrected the start date of event seriousness to 19-Oct-2022. No further information is available at this time.  BioNTech SE Comment: Medical re-assessment after follow-up information received 09-Jun-2023 (FU2): With the follow-up information received on 09-Jun-2023, the start date of seriousness of the event has been corrected to 19-Oct-2022. The information has not changed the previous medical assessment. 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.  BNT162b2 is under agreement with BioNTech SE.  Causality Assessment for Drug: bnt162b2 with Comminuted fracture, Per Reporter = No reasonable possibility, Per Company (BioNTech SE) = No reasonable possibility.  Follow-up (09Jun2023): This is a non-Pfizer sponsored interventional study report from License Party for protocol BNT162-17. Other Case identifier(s): 2023FOS000300, US-BNTAG-1640. Updated information included: reaction data (correction dated 17Jul2023: Following SAE reconcilation, for the event 'worsening of right pilonfracture' the was updated from 'comminuted fracture' to 'tibia fracture' via creation of a subversion. The medical assessment remained unchanged.  BNT162b2 is under agreement with BioNTech SE.; Sender's Comments: BioNTech SE Comments: Initial Medical Assessment: The reporting investigator considers the event to be serious due to hospitalization. The sponsor agrees to the investigator's assessment. The reporting investigator assessed the event as not related to treatment with BNT162b2 (B.1.1.529). 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. The benefit-risk profile of BNT162b2 (B.1.1.529) is not affected by this event and no change in the reference safety information is required at this time.