Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cerebral congestion, Cough, Ear congestion
Clinical narrative: if she does anything slightly laborious, she will start sweating profusely; lost her sense of smell; pressure in her sinuses and ears/constant pressure and blockage; pressure in her sinuses and ears/constant pressure and blockage; congestion in her sinuses; congestion in her ears; congestion in her nose; congestion in her head; PCR Covid nasal swab, Tested positive; PCR Covid nasal swab, Tested positive; constant tickle in her throat; sneezing; coughing; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8727, expiration date 31Jul2021), via an unspecified route of administration, administered in Arm Left on 24Mar2021 around 17:30-18:00 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm right on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization (32 year when vaccinated). On an unknown date in Jul2021, the patient presented with fatigue. On 13Jul2021, the patient developed constant tickle in her throat along with coughing. On 14Jul2021, the patient was tested positive for covid-19 via PCR covid-19 nasal swab. On 16Jul2021, the patient started experiencing congestion in her sinuses, congestion in her ears, congestion in her nose, congestion in her head accompanied by pressure in her sinuses and ears/constant pressure and blockage. On 17Jul2021, the patient lost her sense of smell. On an unknown date the patient also reported that if she does anything slightly laborious, she will start sweating profusely. The patient also informed that it has been a long time since she has weighed herself. The patient did not hospitalize for the events. The outcome of the events was reported as resolving for congestion in her sinuses, congestion in her ears, congestion in her nose, congestion in her head, pressure in her sinuses and ears/constant pressure and blockage, fatigue while it was reported as resolved for constant tickle in her throat, coughing and not recovered for Loss of smell and unknown for PCR Covid nasal swab, tested positive, sneezing, and if she does anything slightly laborious, she will start sweating profusely  This is a notification generated from the gQTS system. 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. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI):  [Truncated Conclusion - See PR ID of Previously Completed Inv for full text] The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8727 was 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 ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may. 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. Description of complaint: Caller reporting her experience with the Pfizer COVID 19 vaccine. While reporting she says her fever began 25Mar it was 99.3 and that is ongoing, its gotten higher. She took Tylenol about 2 hours ago when it was 101.7. She would say the fever has worsened because it went up to 101.7. No further information provided. Investigation decision: (Parent) Evaluation Comment: This is a complaint for Lack Of Effect of lot ER8727 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. Pfizer (site 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. QA Review & Rationale: This is a complaint for Lack Of Effect of lot ER8727 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. 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 The initial scope of this investigation is limited to ER8727 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. Manufacturing and packaging batch records were reviewed for the reported complaint lot. (site name withheld) 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 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. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. It is unknown how the product was handled, stored, or administered after it left the Pfizer site. Root Cause Analysis/Identif: (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 was handled, stored, or administered after it left the (site name withheld). Impact Analysis: Based on the scope 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. 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. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was 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 ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of Compl. Investigation : The scope of this investigation included the reported finished goods lot ER8727, the fill lot EP8679, and the bulk formulated drug product lot EP8566. 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. 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 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 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 in order 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 warmer than the expected freezer 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 10Mar2021.A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint 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.  Confirmed Reserve Defect?: No The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was reviewed for the complaint class 'Product Use Attributes', and subclass 'Lack Of Effect'. As of 16Apr2021, there have been two complaints received for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation.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.) Conclusion of Previously Completed Investigation:  [Truncated Conclusion - See PR ID of Previously Completed Inv for full text] The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6205 was 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 EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during 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.  Follow-up attempts are completed. No further information is expected.