Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: concerned vaccine defrosted yesterday; This case has been considered invalid as there is no indication that d ptient experienced an event under suspect product BNT162B2. This is a spontaneous report from a contactable consumer(pt)via a Pfizer Sponsered program. A contactable consumer (female pt age unspecified) reported for a herself that: she received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Lot Number: EN6206) as SINGLE DOSE for covid-19 immunization. D pt medcl history and cnmed medications wr nt reported. D pt experienced product use issue. Rprtr called about Pfizer vaccine and stated and husband got second dose today. Dirst injection ws 18Feb2021 and thr is a sticker that had lot and Pfizer. This one after they left they saw it said Pfizer 10Mar2021 and lot number EN6206. They wondered if they defrosted it on 10Mar2021.D 1st injection ws 18Feb2021 and thr is a sticker that had lot and Pfizer. This one after they left they saw it said Pfizer 10Mar2021 and lot number EN6206. FU 1(PRD 31Mar2021): Prdct quality complaint: no new information added. FU(31Mar2021): This is a fu spontaneous rprt eived from a Prdct Quality Complaint Grp. This rprt uded that: This is a daily notification generated from DTS system. You are receiving this notification because an Investigation child has been completed for a Complaint. PR ID (Inv): # PR ID (CR): # PR State (CR): Pending Investigation Responsible Site Notif. Date: 15Mar202(Parent) Brand/Trade-Name: Pfizer-Biontech Covid-19 Vaccine Injectable (Parent) Complaint Class: Product Use Attributes (Parent) Complaint Sub-Class: Lack Of Effect (Root Parent) AE Reference Number: # Device or Combo? No Full Complaint Investigation- Detail Report Executed By: (name withheld) Report Executed On: 05Apr2021 PR ID:PR State: Closed Parent IDSince (GMT): 01Apr2021 Date Created (GMT): 15Mar2021 Division: (name withheld) Compliant Inv. Information: (Root Parent) Complaint Number: PQC#US Originator: (name withheld) Date Opened (GMT): 15Mar2021 SAP ID(Parent) Complaint Priority: Normal (Parent) Investigation Required?:Yes (Root Parent) Related to Potential AE?: Yes (Root Parent) Date of Contact (GMT): 11Mar2021 (Root Parent) Description of Complaint: Description of complaint: Caller wscalling about Pfizer vaccine. Her husband believes it is a clerical thing and the sticker ws left over from the day before. The first injection ws18Feb2021 and there is a sticker that had lot and Pfizer. This one after they left they saw it said Pfizer 10Mar2021 and lot number EN6206.roduct strength and count size dispensed: Additional lot numbers: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact? Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE-EN6206-Lack Of Effect (Root Parent) Addit'l Information: 15Mar2021 02:13 PM (GMT-4:00) added by (name withheld)(PID):Efficacy letter sent. 12Mar2021 09:16 AM (GMT-05:00) added by CITI Admin Import (PID#): Client Report Type: initial Product Name: unspecified vaccine NDC Number: Not Provided (Root Parent) Triage Location / Country: Responsible Site Notif. Date (GMT): 15Mar2021 Rsnbly Suggest Device Malfunc-No Severity of Harm:N/A Failure Mode: N/A IDC - Level 1:Quality IDC - Level 2:Product Complaint IDC-Level 3: Complaint-Function/Therapeutic Properties (Parent) Complaint Class: Product Use Attributes (Parent) Complaint Sub-Class: Lack Of Effect (Parent) Brand/Trade-Name: Pfizer-Biontech Covid-19 Vaccine Injectable (Parent) Product Family-API: BNT162B2 (Parent) Product-Description: Compound BNT 162 Covid-19 Vaccine Suspension For Im 2ml Multiple Dose Vial x 1(Parent) Product-Type: RX(Parent) ProductCategory: Injectable (Parent) Sterile-Product: Yes (Parent) Combination-Product: No (Parent) Medical-Device: No (Parent) Combination-Product-Type: N/A (Parent) Lot:EN6206(Parent)UDI-(if appl): N/A (Parent) Batch-Expiry Year: 2021 (Parent) Batch-Expiry Month: Jun (Parent) Batch-Expiry Day: 30Fill Date (GMT): This is the date the formulation product is filled into the primary container 30Jan2021Package Date (GMT): This is the start date when the finished product is packaged into the commercial presentation 30Jan2021 Related Lot#(s) (Grid):Row#1Related Lot Type: Fill Related Lot: EN5339Row#2 Related Lot Type: Bulk Related Lot#EN5327 Note: In Material Information (CI grid), Material # and Material Description fields are applicable to non-SAP sites and will be blank on the report for investigation records created under SAP sites. Material#(SAP) and Material Description (SAP) fields are applicable to SAP sites and will be blank on the report for investigation records created under non-SAP sites. Responsible Person: (name withheld) SQA Approver: (name withheld) Preliminary Due Date (GMT): For Expedited Complaints Due Date (GMT): 29Apr2021Original Due Date (GMT):9Apr2021 Contractor Due Date (GMT): Only applies to Online Contractor Investigations Number of Approved Extensions: 0 (Parent) Site Assignment (Grid):Row3Complaint Investigation PR ID: # Site Name Selection: (name withheld) QTS Site Name: (name withheld) Manufacturing Site: Yes Packaging Site: Yes Finished Product Release Site: Yes Investigating Site: Yes Investigating Site Type: Internal PfizerSite/ Department Primary Op-U:AS Investigation decision: (Parent) FPRS Evaluation Comment: Pfizer (name withheld) reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. Repeat Investigation?: No Ws CAPA Previously Identif'd?: No CAPAs in Place?: N/A CAPA Reference: N/A Manufactured Post-CAPA:N/A Full Investigation Required:YesQA Review&Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6206 of the PFIZER-BIONTECH COVID-19 VACCINE.The initial scope of this investigation is limited to the reported finished goods lot EN6206 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary.Reviewed By: (name withheld) Reviewed On (GMT): 15Mar2021Investigation findings:Summary of investigation: The initial scope of the investigation ws limited to the reported finished goods lot. The final scope ws expanded to include the reported finished goods lot EN6206, fill lot EN5339, and the formulated drug product lot EN5327. Manufacturing and packaging batch records were reviewed for the reported complaint lot.Pfizer (site name withheld) QO did not receive photographs or a complaint sample for examination. The complaint ws not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits.Regulatory/Market Assessment:NTM Decision: No-NTM not required NTM Rationale: Other Date NTM Decision Made (GMT): This should reflect the most current decision date 30Mar2021 Other NTM Rationale: This complaint is not confirmed or considered process related. Regulatory Impact: No Other Regulatory Notification: N/A AQRT/MACC Ref Number: N/A Root Cause/CAPA: Process Related?: No Final Confirmation Status: Not Confirmed Vendor Related?: No Site Quality Lead: (name withheld) Root Cause Analysis/Identif: Pfizer (site name withheld) Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product ws handled, stored, or administered after it left the Pfizer (site name withheld). Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Root Cause Category (Tier 1): Non assignable (Complaint Not Confirmed) Contributing Factor (Tier 1): Non-assignable (Complaint Not Confirmed) Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed) Contributing Factor (Tier 2): Non-assignable (Complaint Not Confirmed) Root Cause Category (Tier 3): N/A Contributing Factor (Tier 3): N/ASpecial or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process.Improve/Control: Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation.The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution.Conclusions & Approvals: Additional Approval(s) Req'd? No Product Quality Impact: No Market / Clinical Impact: No SQRT Review Required?: No Stability Impact: No AQRT Review Req'd: NO Conclusion:The complaint for Lack of Effect with the product for the COVID-19 Vaccine ws investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope ws limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample ws received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there ws no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint ws not confirmed.FINAL SIGNATURES: Submitted By: (name withheld) Submitted On (GMT): 30Mar2021 Site QA Approval By: (name withheld) Site QA Approval On (GMT): 31Mar2021 Site Quality Lead Approved By: This approval is only applicable when the record has been escalated by Site Quality Authority.Site Quality Lead Approved On (GMT): This approval is only applicable when the record has been escalated by Site Quality Authority.OpU Quality Lead Approved By: This approval is only applicable when the record has been escalated by Site Quality Lead.OpU Quality Lead Approved On (GMT): This approval is only applicablewhen the record has been escalated by Site Quality Lead.COQA Approval By: Only applies to Online Contractor Investigations COQA Approval On (GMT): Only appliesto Online Contractor InvestigationsClosed By: (name withheld)Closed On (GMT): 01Apr2021Site Information: Plant Code: US06 Operating Unit: Established Products B.U.Area: (name) - Quality Operation: (Name)#Record & Doc Support (#)Site Trending (Multi): N/A Site Trending: N/AThe following fields are only applicable to Pharm Sci sites. Scope of Compl. Investigation: The scope of this investigation included the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product EN5327. Acceptable review of related documentation, including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature.Vendor Investigation?: No Action Title / Short Descript.: N/A Design Related?: This Relates to Medical Devices. N/A 1. Do the records reviewed contain any comments or planned deviation that may have caused this type of complaint? Review Q1: No Review Q1 Findings: See summary below 2. Are there any controls in place to prevent or detect the reported complaint? Review Q2: Yes Review Q2 Findings: See summary below 3. Were all related in process checks completed satisfactorily? int? Review Q3: Yes Review Q3 Findings: See summary below4. Were all line startup and end of batch challenges completed satisfactorily? Review Q4: Yes Review Q4 Findings: See summary below5. Were all line clearance and cleaning activities completed satisfactorily? Review Q5: Yes Review Q5 Findings: See summary below6. Were there any unplanned occurrences or deviations that may have caused this type of complaint? Review Q6: No Review Q6 Findings: See summary below7. If complaint is related to mixed products, could the sequence of processing have contributed to this complaint? Review Q7: N/A Review Q7 Findings: N/A8.During inspections, were similar defects identified? Review Q8: No Review Q8 Findings: There are no defect noted during inspection related to the potency of the drug product.9. Did release testing meet all specifications? Review Q9: Yes Review Q9 Findings: The results of all tests and inspections met required specifications at the time of release for distribution on 20Feb2021.Document Review Summary: DEVIATIONS: Complete - Acceptable There were no planned or unplanned deviations recorded during the manufacturing of the reported lot or associated batches that may have caused a complaint of this nature.MANUFACTURING BATCH RECORDS: Complete - Acceptable The bulk manufacturing batch record for the complaint batch ws reviewed as part of this investigation and found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. A review of the solution filtration documentation confirmed that all materials, filters, and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits.PACKAGING BATCH RECORDS: Complete - Acceptable. The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects.The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between 67 Degree C and 73 Degree C. Freezer shelves were then loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is greater than the expected temperature, supervision is notified. A review of the log for the reported batch confirmed that all freezer temperatures were acceptable. Samples are then stored until the product is released for distribution. There were no issues recorded during the packaging or storage process which may have impacted the quality of the batch and potency of the drug product. LOT HISTORY:Complete-Acceptable The results of all tests and inspections met required specifications at the time of release for distribution on 20Feb2021.Reserve Sample Evaluation:Rsrv. Sample Evaluation Reqd?: NoRsrv. Sample Eval. Rationale: Visual examination of a reserve sample would not be expected to indicate the potency of the drug product.Visual Resrv Sample Eval Desc.: N/AReserve Sample Testing Req'd?: NoReserve Sample Testing Result: A reserve sample ws not sent to the QC-lab to determine the amount of active ingredient since the complaint ws received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product.Confirmed Reserve Defect?: No Lot-Specific Trend:Lot-Specific Trend Identified?: No Lot Trend Attachment: PR# EN6206 Lot Trending Report 17Mar2021.xlsx Lot Trend Assmt. & Rationale: The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL9269 ws reviewed. As of 17Mar2021, there ws only one complaint for this lot and classification. No lot specific trend ws identified that would require additional investigation.Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation. Expedite trends:Expedite Trend Identified?: No Exped Trend Assmt. & Rationale: N/A Exped Trend ActionsTaken: N/A Other Trending:These fields are provided for investigating sites to document other trending requirements as needed. (i.e.,A review of Site Investigations related to the lot(s) in scope, and any broader trend investigations related to this Complaint, etc.)Other Trend Identified?: NoOther Trend Assmt. & Rationale: N/AComplaint Sample Evaluation:(Parent) Sample Status: Sample Availability Unknown Site Sample Status: Not ReceivedReturn Sample Evaluation: N/AIs Compl Sample Testing Recom?: NoConfirmed Compl Sample Defect?: N/A - Not Received Drug lot number and expiration date: Pfizer EN6206 10Mar2021 (or 11Mar2021)Country of Occurrence: United states Pfizer/BioNTech COVID-19 Vaccine fu Questionnaire: Ptdetails: pt Age at Time of Vaccination: 71 yearsPfizer/BioNTech COVID-19 Vaccine Details: Dose: 1s Date / Time: Date: 18Feb2021Time (24 hr): 09:15 AMSite and Route of injection: Route of administration: IM Batch/Lot number:Unable to locate or read the details EN6200(name and address withheld)Dose: 2ndDate / Time: Date: 11Mar2021Time (24 hr):09:15 AMSite and Route of injection: Route of administration: IM Batch/Lot number: EN6206(name and address withheld)Vaccination facility type: Other, please specify: (name and address withheld)Prior vaccinations: NoneConcomitant drugsThe facility believes that wsonly clerical (I called them after the fact) since they receive new vaccine daily. They didnt blv it would have been left over from prior day. fu and amendment (02Apr2021): This is a fu spontaneous report from a contactable consumer. This consumer reported in response to the Non-HCP fu letter that included: Amended case as invalid due to no adverse event.fu attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285134 same drug/reporter different patient