Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; Aching pain in shoulder; This is a spontaneous report from a contactable reporter (Patient herself). A female patient of 32-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 19Jan2021 at 14:00 (Batch/Lot Number: EL9261, Expiry Date: Unknown) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on 01Mar2021 at 14:45 (Batch/Lot Number: EN6205, Expiry Date: Unknown) as DOSE 2, SINGLE both for covid-19 immunisation (at the age of 31-year-old) for the safety of her family. The patient's medical history and concomitant medications were not reported. Other products and patient History were reported as no. Vaccine was not administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Pfizer, vaccine for Covid 19, dose one. No additional vaccines were administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine and events following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to the event was not provided. On 18Aug2021, the patient had one positive covid test, one negative covid test, doctor treating as if she has covid, as she has a fever, after both vaccines. She had aching pain in shoulder (after second vaccine) on 10Mar2021 at 08:30. The patient underwent lab tests and procedures which included covid Blood Test, sars-cov-2 test that was positive on 17Aug2021 and sars-cov-2 test that was negative on 17Aug2021. Therapeutic measures were taken as a result of one positive covid test, one negative covid test, doctor treating as if she has covid, as she has a fever, after both vaccines (covid-19). Reporter stated she was reporting about the Pfizer, vaccine for Covid 19. She had some side effects from the vaccine, and she has some questions. Reporter stated she cannot tolerate the Covid nose swab test, and initially she went to the emergency room on 11Aug2021, to be tested for Covid. Reporter stated she refused the nose swab and was told to follow up with her doctor. Her doctor sent her for bloodwork to test her for Covid. The bloodwork was tested on 17Aug2021. Reporter reclarified that one test came back positive for Covid and a second test, came back negative. later in report, that her doctor is treating her as if she has Covid. Reporter asked how she could get those results, one positive and one negative? if she can get sick from Covid virus antibodies? her doctor was treating her, as if she has Covid. Reporter stated quarantined for 2 days, and since she was then negative, but her doctor treated her as if she had Covid. Reporter reads part of her doctor's notes and stated that she had symptoms, of a fever, and was fully vaccinated, and will quarantine according to her symptoms. Antipyretic Used (around the dates of Vaccination) included, Tylenol #3, given to Reporter by a friend. Strength was unknown to Reporter, by mouth on 02Mar2021 at 10:30 AM. A sample of the product was not available to be returned, if requested. Packaging sealed and intact was unknown. A notification generated from the gQTS system included, as part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252.Product Description (CR) reported as compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml multiple Dose vial x 1, Lot-# (CR): EL9261. Conclusion of Previously Completed Investigation was, the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9261was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9261, fill lot EL9252, and the formulated drug product lot EL9243. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to 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. It was reported as, when more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. For (Root Parent) Complaint Number, Date Opened on 30Mar2021, (Parent) Complaint Priority was normal. (Parent) Investigation was required. (Root Parent) was related to Potential AE. (Root Parent) Date of Contact was 16Mar2021. Product Complaint Exchange Product Complaint Exchange, Initial item with PRD/SRD 16Mar2021[Got Covid], (BNT162B2). Pfizer-Biontech Covid-19 Vaccine injectable  EL9261 - Lack of Effect. For (Root Parent) on 12Apr2021 at 11:39 AM (-4:00) and 31Mar2021 at 09:06 AM (-4:00) were added. Product quality investigation request LOE for Lot Number, EL9261 and EN6201, BNT162B2, QAEF COMPLAINT, FUP to PR ID. (Root Parent) G3 at 30Mar2021, no Rsnbly Suggest Device Malfunc. IDC - Level 1 was Quality, IDC - Level 2 was Product Complain, IDC - Level 3 was Complaint - Function / Therapeutic Properties. (Parent) Complaint Class was Product Use Attributes. (Parent) Complaint Sub-Class was Lack of Effect. (Parent) Brand/Trade Name was PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. (Parent) Product Family-API was BNT162B2. (Parent) Product-Description reported a COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. (Parent) Product-Type reported as RX. (Parent) Product-Category was INJECTABLE. (Parent) was Sterile-Product. (Parent) was no combination-Product or Medical-Device (Parent) Lot-#, EL9261, Batch-Expiry 31May 2021. Fill Date was 13Dec2020 and package Date was 13Dec2020. Related Lot Type was Fill, for Related Lot # EL9252 and Related Lot Type, Bulk For Related Lot # EL9243. Due Date was 14May2021 and original Due Date was 14May2021. Reported as, yes manufacturing Site, Packaging Site, Finished Product Release Site and Investigating Site as Internal Pfizer Site/Department, Primary Op-U as. Pfizer reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number was valid, and an investigation will be performed. Repeat Investigation was not done. CAPA was Previously not Idented. Full Investigation was required. The complaint and its classification had 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 was a complaint for lack of effect of lot EL9261 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EL9261 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Reviewed On 30Mar2021. Summary of Investigation included, The initial scope of the investigation was limited to the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records for the reported complaint batch were examined. Pfizer QO did not receive photographs or a complaint sample for examination. The complaint was 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 drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. No-NTM not required. NTM Rationale reported as other. Date NTM Decision Made was 07Apr2021. Complaint not expedited, or process related. Regulatory Impact was not there. Root Cause/CAPA was not process Related. Final confirmation status was confirmed was not Vendor Related Root Cause Analysis/Identif was, Pfizer 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 was unknown how the product was handled, stored, or administered after it left the Pfizer site. Impact Analysis included, based on the final scope of the investigation, which was limited to the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243, and that a root cause related to the production process was not identified, there was no impact to the product. No regulatory notification was required. Root Cause Category (Tier 1), Contributing Factor (Tier 1), Root Cause Category (Tier 2), Contributing Factor (Tier 2) was non-assignable (Complaint Not Confirmed). Common Cause Root Cause was always present to some degree in the process. Special Cause Root Cause was something different happening at a certain time or place in the process. Corrective / Preventive Action included that, 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. Conclusion included, no additional Approval(s) Req'd or Product Quality Impact or Market / Clinical Impact. No SQRT Review Required. Stability Impact was none and no AQRT Review Req'd. Conclusion was the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EL9261 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. 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. Submitted On 21Apr2021 and site QA Approval On on 23Apr2021. Closed By, Coordinator at 24Apr2021. Site Information given as, Plant Code. Operating unit was Established Products Quality. Operation- 2214120 Record & Doc Support (4K458). The scope of this investigation included the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. Acceptable review of related documentation, including manufacturing and packaging 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. Therefore, the scope was not expanded. There was no vendor Investigation and was not design Related. The records were not reviewed contain any comments or planned deviation that may have caused this type of complaint. There were ny controls in place to prevent or detect the reported complaint. all related in process checks completed satisfactorily? int? all line startup and end of batch challenges completed satisfactorily? all line were clearance and cleaning activities completed satisfactorily. There was not any unplanned occurrences or deviations that may have caused this type of complaint? There are no defects noted during inspections related to the potency of the drug product. Release testing met all specifications. The results of all tests and inspections met required specifications at the time of release for distribution on 09Jan2021.Deviations reported as 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 were Complete and Acceptable. The bulk and Fill manufacturing batch record for the complaint batch was 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 mate+G3rial 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 were Complete and was 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 in order to ensure that all required labelling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. A review of the audit results for the reported lot confirmed that all specifications were met. All labeller, tray label grader, and barcode grader checks and challenges passed at the beginning and end of the lot. 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 warmer than the previously recorded temperature, supervision is notified. Additionally, after the freezer temperature drops below -60 degree C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling to maintain the freezer set point, which is acceptable. 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 was Complete and Acceptable. The results of all tests and inspections met required specifications at the time of release for distribution on 09Jan2021. Reserve sample evaluation included, No Rsrv. Sample Evaluation was not Reqd. wRsrv. Sample Eval. Rationale was Visual examination of a reserve sample would not be expected to indicate the potency of the drug product. Reserve Sample Testing was not Req'd. Reserve Sample Testing Result contained; A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the comp+G1laint was 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. No Confirmed Reserve Defect or Lot-Specific Trend Identified. Lot Trend Attachment reported as 5799977_EL9261_lot trending_07Apr2021.xlsx. Lot Trend Assmt. & Rationale contained, the complaint history for the reported PFIZER-BIONTECHCOVID-19 VACCINE INJECTABLE lot EL9261 was reviewed. As of April 7, 2021, this is the only complaint that has been received for this lot and classification. No lot specific trend was identified that would require additional investigation. No Expedite Trend Identified. Other Trend was not Identified. (Parent) Sample Status was Not Available. Site Sample Status was Not Received. The Compl Sample Testing was not Recom. Confirmed Compl Sample Defect was Not Received. Outcome of pain was resolved on 10Mar2021 at 6:30 PM whereas, rest of the events were resolved in 2021.  Follow-up attempts completed. No further information expected.