Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation in her arm/on the inside of her arm it feels like it is burning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: FC3183, Expiration Date: 31Oct2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid", start date: 2021, stop date: 2021, notes: Caller states around like the month of May or the end of Apr2021 she got covid at that time and is recovered from that; no further details provided by the caller. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (States she had the 1st dose of the Pfizer Covid vaccine on 04Aug2021 with lot number that she thinks is EW0173), administration date: 04Aug2021, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation in her arm/on the inside of her arm it feels like it is burning".  Additional information: Caller on the line who is age 19 and she had the Pfizer covid vaccine on Saturday and had a burning sensation in her arm and her arm is not hot but on the inside of her arm it feels like it is burning. Stated she had the 1st dose of the Pfizer Covid vaccine on 04Aug2021 with lot number that she thinks is EW0173 and had the 2nd dose of the vaccine on 28Aug2021 with lot FC3183; stated her patient card does not have the expiry date or NDC number written on it. Caller stated around like the month of May or the end of Apr2021 she got covid at that time and is recovered from that; no further details provided by the caller.  Conclusion of Previously Completed Investigation. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. 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. All release testing performed prior to the release of the reported batch was within specifications. 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 FC3183 of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot. It was reported that QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. 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. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left. 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 meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer. Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and bulk formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. 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 reported the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. 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. All release testing performed prior to the release of the reported batch was within specifications. The scope of this investigation included the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. 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 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. The bulk and fill manufacturing batch records for the complaint batch were reviewed as part of this investigation and were 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, filter integrity tests, 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. 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. A review of the audit results for the reported lot confirmed that all specifications were met. All labeler, 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°C and -73°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°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.  No follow-up attempts are possible. No further information is expected.