Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nucleic acid test
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL9266, Expiry date: unknown), via an unspecified route of administration on 12Feb2021 as dose 2, single for covid-19 immunisation. Patient medical history included ongoing diabetes, asthma and heart condition from an unspecified date. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot: EN5318), via an unspecified route of administration on 23Jan2021 as dose 1, single for covid-19 immunisation. The patient concomitant medications were not reported. Facility of vaccination was health department. It was unknown whether patient was pregnant at the time of vaccination. Caller stated they were monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller stated, reclarified later in report, she had 37 patients with partial identifiers. She could not provide some identifying details and that she would need to check with her legal department first. She could provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of Covid test utilized. BMI of patient was reported as 28.9. The patient underwent lab test for NAAT Covid test: with positive results on 16Aug2021, The outcome of the events was unknown.  Description of Product Complaint: Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. Some identifying details provided. Product strength and count size dispensed was not applicable. Additional lot numbers was not applicable. There was no sample of the product available to be returned. Packaging sealed and intact? unknown COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot-# (CR): EN5318.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Report Executed By: (Name withheld), Report Executed On: 23Aug2021, PR ID: # PR State: Closed , Parent ID: #, Since: 04May2021, Date Created: 05Apr2021 , Division: Product Quality Complaints, Intake / Triage Process: Record details: Date Opened: 05Apr2021, (Parent) Date of Contact: 31Mar2021, Originator: (Name withheld), (Parent) Intake Receipt Date: 02Apr2021 , (Parent) Date Received by Triage Country: 02Apr2021, Responsible Person: (Name withheld), Triage Completion Due Date: 09Apr2021, Original Due Date: 09Apr2021, Triage Processing Completed On: 05Apr2021. Priority / Classification / Products: Recommended Priority: Normal , Complaint Priority: Normal, Additional Instruction: N/A, High Priority Time-frame: N/A, High Priority Justification, Priority Change Justification: , Complaint Class: Product Use Attributes, Complaint Sub-Class: Lack Of Effect (Parent) Description of Complaint:  Description of complaint: Positive for Covid 19 after receiving both doses of vaccine. Additional lot numbers: Lot EL3249: first vaccine Lot difficult to read, assuming it starts with EL or EN, then states she thinks it may say #, states numbers are definitely # but the beginning is what she cannot make out. Intended-Market: Brand/Trade-Name Request: No , Product-Category: INJECTABLE, Product-Description Request: No, Brand/Trade-Name: PFIZ-ER-BIONTECH COVID-19 VACCINE INJECTABLE  Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRA-MUSCULAR 2ML MULTIPLE DOSE VIAL X 1, New-Product-Description: Sterile-Product: Yes Product Info Request Sent: N/A, Medical-Device: No, New Product-Device or Combo: Combination-Product: No ,Combination-Product-Type: N/A, Product-Type: RX, Business-Unit: Other, Detailed-Product-Category: INJECTABLE  LIQUID  PR ID: # PR State: Closed, Parent ID: #, Since: 04May2021, Date Created: 05Apr2021, Division: Product Quality Com-plaints. Product Family-API: BNT162B2, UDI-(if appl): N/A, Serialization-#: Lot/Sample De-tails and Investigation Decision: Lot-#: EN5318, Lot-#-Status: Verified by ERP, Lot-#-Unknown-Reason: Lot-#-Unknown-Reason-Other: Caller was uncertain of what the lot number for her second dose says, reported as #. Batch-Expiry Year: 2021, Batch-Expiry Month: May, Batch-Expiry Day: 31 \, # of Impacted Units: LHR & Logic Launch: Please click on the completing the "Product Information" and "Classification and Priority" sections. Launch but-ton after Launched LHR & Inv Reqd Logic: Yes, Lot History Report: # Complaints w/ Same Lot/Class: QTL: N/A Samples Available: Unknown, Sample Status: Sample Availability Un-known, Photos Available: No, Sample Photos: Related Sample Tracking: Investigation Required: Yes, Inv Decision Rationale: Per Rule Execution, Investigation is required, Other Inv Decision Rationale:  Site Assignment (Grid): Row #: 1, Complaint Investigation PR ID: #, Site Name Selection: (Name withheld), Site Name: (Name withheld), Manufacturing Site: Yes, Packaging site: Yes, Finished Product Release Site: Yes, Investigating Site: Yes, Investigating Site Type: Inter-nal Pfizer Site/Department, Primary Op-U: AS Additional Information: PR ID: #, PR State: Closed, Parent ID: #, Since: 04May2021, Date Created: 05Apr2021, Division: Product Quality Complaints. (Parent) Addit'l Information: 27May2021 01:38 PM (4:00) added by (Name withheld) (PID-#): Attached received in follow up PR #. 19May2021 02:32 PM (4:00) added by (Name withheld) (PID-#): follow-up received under PR #; source document attached. 06Apr2021 10:36 AM (4:00) added by (Name withheld) (PID-#): Rec'd duplicate report in PR #, attached source doc: Product Complaint Exchange: I received my 2nd vaccine on 08Feb2021 and just tested positive for Covid. BNT162B2. 02Apr2021 09:16 AM (04:00) added by Admin Import (PID-#): Client Report Type: initial, Product Name: Vaccine for Covid, NDC Number: Unknown, (Parent) Triage Location / Country: Country of Purchase/Source: Unknown, Triage Region: Unknown, If Priority is 'Expedited', an e-mail notification will be automatically sent to the Expedite distribution list by the tracking System. (Parent) Regulatory Authority Involved: No, (Parent) Regulatory Authority: Not Applicable. Site Evaluation: When Investigation Decision is "No", the site is required to perform an acknowledgment of the class, priority, and investigation decision. Closed By: Tracking Coordinator, Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EN5318 - Lack Of Effect, Lot size: #, Fill Lot: EN5317, Manufacturing Date: 19Dec2020, Package Date: 21Dec2020, Release Date: 18Jan2021, Evaluation Comment: (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. PR ID: # PR State: Closed, Parent ID: # Since: 04May2021, Date Created: 05Apr2021, Division: Product Quality Complaints, Lot-#: EN5318, F-Code: #, Lot-#-Status: Verified by, F-Code Material Desc: PFE-BNT 0.5MG/ML COVIDVX 195X2ML GVL EUA. (Parent) Complaint Number: PQC-Apr2021-#-US, Review Required: No, Rsn for Triage Cmpl Delay: N/A, Closed By: Tracking Coordinator, Process-Related Unique: No, Contact(s): (Name withheld), complaint Confirmed Unique: Not Confirmed, Lot History Report as of Mon 05Apr 13:46:27 2021 for PR# Number of Complaints With Same Complaint Class - 0 Number of Complaints With Same Complaint Sub-Class  0. Identification: Brand Trade Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE, Complaint Class: Product Use Attributes, Com-plaint Sub Class: Lack Of Effect, Lot Number: EN5318. Description: Description of complaint: Positive for Covid 19 after receiving both doses of vaccine. Additional lot numbers: Lot EL3249: first vaccine, lot difficult to read, assuming it starts with EL or EN, then states she thinks it may say #, states numbers are definitely # but the beginning is what she cannot make out. AE Ref No. (CC): # PR ID (CR): # Product Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot-# (CR): EJ1686 Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. TA sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID # (see File attachment in this investigation record) The complaint for a positive COVID test after vaccination of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ1686. A complaint sample was not returned. No related quality issues were identified during the investigation.PR ID of Previously Completed Inv: # PR Link (Previously Investigated CR): # Report Executed By: (Name withheld), Report Executed On: 23Aug2021, PR ID: #, PR State: Closed, Parent ID: #, Since: 08Apr2021,Date Created: 25Feb2021, Division: Product Quality Complaints, Record details: Date Opened: 25Feb2021, (Parent) Date of Contact: 11Feb2021, Originator: (Name withheld), (Parent) Intake Receipt Date: 25Feb2021, (Parent) Date Recv'd by Triage Country: 25Feb2021, Responsible Person: (Name withheld), Triage Completion Due Date: 04Mar2021, Original Due Date: 04Mar2021, Triage Processing Completed On: 25Feb2021, Priority / Classification / Products: Recommended Priority: Normal Complaint Priority: Normal, Additional Instruction: N/A, High Priority Time-frame: N/A, Priority Change Justification: Complaint Class: Product Use Attributes, Com-plaint Sub-Class: Lack Of Effect, (Parent) Description of Complaint: Product Complaint Ex-change: [Positive for Covid after receiving the vaccine/ Follow-up item #01 with PRD/SRD 11Feb2021], Brand/Trade-Name Request: No, Product-Category: INJECTABLE, Product-Description Request: No, Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE IN-JECTABLE, New-Brand/Trade-Name: Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. New-Product-Description: Sterile-Product: Yes, Product Info Request Sent: N/A, Medical-Device: No, Com-bination-Product: No, Combination-Product-Type: N/A, Product-Type: RX, Business-Unit: Other, Detailed-Product-Category: INJECTABLE  LIQUID, Product Family-API: BNT162B2, UDI-(if appl): N/A. PR ID: #, PR State: Closed, Parent ID: # Since: 08Apr2021, Date Created: 25Feb2021, Division: Product Quality Complaints Serialization-#: Lot/Sample Details and Investigation decision: Lot-#: EJ1686, Lot-#-Status: Verified by ERP, Lot-#-Unknown-Reason: Lot-#-Unknown-Reason-Other:, Batch-Expiry Year: 2021, Batch-Expiry Month: Mar, Batch-Expiry Day: 31, # of Impacted Units: LHR & Logic Launch: Please click on the completing the "Product Information" and "Classification and Priority" sections. Launch button after Launched LHR & Inv Reqd Logic: Yes, Lot History Report: # Complaints w/ Same Lot/Class: QTL: N/A Samples Available: Unknown Sample Status: Sample Availability Un-known, Photos Available: No, Sample Photos: Related Sample Tracking: Investigation Required: Yes, Inv Decision Rationale: Per Rule Execution, Investigation is Required, Other Inv Decision Rationale: Site Assignment (Grid): Row #: 1 Complaint 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 Pfizer Site/Department, Primary Op-U: SB, PR ID: # PR State: Closed, Parent ID: #, Since: 08Apr2021, Date Created: 25Feb2021, Division: Product Quality Complaints. Market Information: (Parent) Triage Location / Country: Unknown, Country of Purchase/Source: Unknown. Triage Region: Unknown, Triage Region Leaders: If Priority is 'Expedited', an e-mail notification will be automatically sent to the Expedite distribution list by the Tracking System, (Parent) Regulatory Authority Involved: No, (Parent) Regulatory Authority: Not Applicable, Site Evaluation: When Investigation Decision is "No", the site is required to perform an acknowledgment of the class, priority, and investigation decision. Closed By: Tracking Coordinator  Brief Complaint Description: Positive for Covid after receiving the vaccine , Lot Size: N/A, Fill Lot: EJ1686 , Manufacturing Date: 01Jan1900, Package Date: 01Jan1900, Release Date: 01Jan1900 Evaluation Comment: (Name withheld), agrees with the evaluation made by triage to investigate the involved complaint record. Lot-#: EJ1686, F-Code: #, Lot-#-Status: Verified by ERP, F-Code Material Desc: # 195x0.45ml GVL EXT-BNT EUA Delay, Cancellation, Re-open Reasons and Record Approvals: (Parent) Com-plaint Number: PQC-Feb2021-#, Review Required: No , Rsn for Triage Cmpl Delay: N/A PR ID: #, PR State: Closed, Parent ID: #, Since: 08Apr2021 , Date Created: 25Feb2021 , Division: Product Quality Complaints Closed By: Tracking Coordinator, Closed On: 08Apr2021 , Process-Related Unique: No, PR ID: # PR State: Closed Parent ID: # Since: 08Apr2021, Date Created: 25Feb2021 , Division: Product Quality Complaints (Names Withheld) Complaint Confirmed Unique: Not Confirmed Lot History Report as of Thu 25Feb 12:56:24 2021 for PR# Number of Complaints With Same Complaint Class - 1 Number of Complaints With Same Complaint Sub-Class  1 Identification: Brand Trade Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE , Complaint Class: Product Use Attributes, Complaint Sub Class: Lack Of Effect , Lot Number: EJ1686, Description: Product Complaint Exchange: [Positive for Covid after receiving the vaccine/ Follow-up item #01 with PRD/SRD 11Feb2021] Related Lot Complaints: PR ID: # Brand Trade Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE Complaint Class: Product Use At-tributes Complaint Sub Class: Lack Of Effect Lot Number: EJ1686 Description: Product Com-plaint Exchange: [She received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021.] initial item 13Jan2021 Investigation Required: No PR Status: Closed (No Investigation)  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients