Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID -19 test; COVID-19; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This is report 1 of 3. A 39-years-old female patient non-pregnant received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 16Mar2021 (Batch/Lot Number: EN6206, Expiry date was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm on 12Apr2021 (Batch/Lot Number: EW0153, Expiry date 31Jul2021) (at the age of 39-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug allergy to Sulfa and penicillin (Onset dates: Sulfa maybe like 13 years of age and penicillin unknown, found out with her first kid so 35 years of age).Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. There were no other vaccines administered on same date of the Pfizer Suspect. On 05Jul2021, the patient experienced symptoms of cough, chills, loss of smell, red crusty eyes, congestion and achy. On 09Jul2021, the patient experienced covid-19. Symptom onset 05Jul2021 in the morning, further details regarding time of onset was unknown. Laboratory tests on an unspecified date included sars-cov-2 test: positive and on 09Jul2021 included sars-cov-2 test: positive (COVID nasal swab test with positive result for COVID was performed on 09Jul2021). She reported having been diagnosed with COVID after having been administered both doses of Pfizer Covid Vaccine. It was reported that the patient's husband and sister were also having positive COVID tests after they had been together. 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 EW0153 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EW0153 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. 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 EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer 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 continues to meet potency specifications. Pfizer Kalamazoo 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 Pfizer site. 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. 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. The complaint for Lack of Effect with the product for the COVID-19 Vaccine was 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 was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. 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. The outcome of the event was recovering.