Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus congestion, Sinusitis
Clinical narrative: Tested positive for COVID- 19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 10:30 (Lot number: FH8020) at the age of 69 years as dose 3 (booster), single, administered in arm left, administration date 29Mar2021 12:00 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and administered in arm left, administration date 05Mar2021 12:00 (Lot number: EN6206, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 09Dec2020 (unspecified if ongoing); "frequent UTIs" (unspecified if ongoing); "spinal fusion L4-L5" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Vitamin D3 insufficiency" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "coronary calcification" (unspecified if ongoing); "Known allergies: Yes: Penicillin" (unspecified if ongoing); "Known allergies: Yes: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 21Sep2021; ATORVASTATIN; BENAZEPRIL/HCTZ; METOPROLOL. Past drug history included: Erythromycin, reaction(s): "Known allergies: Yes: Erythromycin"; Flagyl, reaction(s): "Known allergies: Yes: Flagyl"; Ciprofloxacin, reaction(s): "Known allergies: Yes: Ciprofloxacin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Tested positive for COVID- 19"; COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "Tested positive for COVID-19". The events "tested positive for covid- 19" and "tested positive for covid-19" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab; COVID-19 Rapid molecular PCR test.  Description of complaint: Patient was calling about Pfizer vaccine. Her husband believed it was a clerical thing and the sticker was left over from the day before. The first injection was 18Feb2021 and there was a sticker that had lot and Pfizer. This one after they left they saw it said Pfizer 10Mar2021 and lot number EN6206. Patient clarified concern is if they defrosted it yesterday or if it was a clerical thing that was preprinted and left over. From patient's understanding patient stated they are supposed to use vaccine pretty quickly after being defrosted. Patient was unsure if it could be lack of efficacy or an old sticker. 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953; lot EN6206, fill lot EN5339, and the formulated drug product lot EN5327. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer (site name) 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 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 the (site name) site. Root Cause Analysis/Identif: Pfizer (site name) 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 (site name) site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and 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. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953; lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. 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 specification.