Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Urine analysis
Clinical narrative: I got my shot my 1st shot back in May and I ended up catching COVID a week after; This is a spontaneous report received from a contactable consumer or other non hcp. A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) via an un-specified route of administration in Arm Left on 01May2021 (age at vaccination 47years old) as single dose for covid-19 immunisation. Medical history included cerebrovascular accident from an un-known date and unknown if ongoing Verbatim: Stroke, pain from an unknown date and unknown if ongoing Verbatim: Pain disorder, depression from an unknown date and unknown if ongoing Verbatim: Depression, migraine from an unknown date and unknown if ongoing Verbatim: Migraine, hiatus hernia from an unknown date and unknown if ongoing Verbatim: Hiatal hernia, asthma from an unknown date and unknown if ongoing Verbatim: Asthma, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Verbatim: COPD, gastroesophageal reflux disease from an unknown date and unknown if ongoing Verbatim: Acid reflux, bursitis from an unknown date and unknown if ongoing Verbatim: Bursitis, osteoarthritis from an unknown date and unknown if ongoing Verbatim: Osteoarthritis. The patient experienced i got my shot my 1st shot back in May and i ended up catching covid a week on an unspecified date. Additional information she had got her first shot in May2021, and I ended up catching COVID a week later from my daughter she got it at her job but within 2 and a half month and then I was trying to find out my doctor gave me clinic yesterday to get my second shot, he told me it was okay for me to get my second shot now. The patient underwent lab tests and procedures which included blood test: unknown results on 05Oct2021 Unknown, urine analysis: unknown results on 05Oct2021 Unknown. The clinical outcome of the event was unknown. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot EW0150, fill lot EP8690, and the bulk formulated drug product lot EP8587. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history were examined for the reported complaint lot. Pfizer  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 elapsed time tracking logs indicated that the batch did exceed Time Out of Refrigeration limits. To analyse whether this impacted the quality of the batch, a  assessment was conducted. The assessment concluded that the RNA integrity result from Covid-19 vaccine lot EW0150 is comparable to the standard validation limits. All release testing results from EW0150 are within product release specifications. It has been identified that the product quality attribute of RNA integrity may decline as a function of temperature, the results of this product assessment has concluded that there is no impact to the product quality attributes of the complaint lot as a result of exceeding  limits. The product also requires storage in ultralow temperature freezers following the packaging of the product. A review of the freezer storage logs confirmed that all times and temperatures were within allowable limits. 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. Reserve Sample Testing Result: 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.  Follow-up attempts are completed. No further information is expected.