Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Poor quality product administered, Product temperature excursion issue, Suspected COVID-19
Clinical narrative: knocked her on her butt; she felt like she had COVID again; knocked her on her butt; she felt like she had COVID again; it knocked her on her butt and she felt like she had COVID again; vaccine was stored after dilution in the vial in the fridge for 7 hours before being administered to the patient; vaccine was stored after dilution in the vial in the fridge for 7 hours before being administered to the patient; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Sep2021 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE, and dose 1 via intramuscular route of administration, administered in left deltoid on 03Sep2021 (Batch/Lot Number: EW0185) as DOSE 1, 0.3 ML SINGLE, both for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing; she has already had COVID in the past. Additional vaccines administered on the same date of the Pfizer suspect were none. There were no prior vaccinations (within 4 weeks). There were no concomitant medications. It was reported that patient received her second dose of the Pfizer BioNtech COVID 19 vaccine on 24Sep2021. The vaccine was stored after dilution in the vial in the fridge for 7 hours before being administered to the patient. Nurse reported that the patient after being notified of the storage error stated that she felt like the vaccine really worked because it knocked her on her butt and she felt like she had COVID again as she has previously had COVID in the past. The reporter confirmed the patient had her second dose on 24Sep2021. The patient informed the reporter that on that Friday evening, and 25Sep2021 and 26Sep2021 is when she had her symptoms. The reporter explained once her facility found out what happened, they called the patient immediately on Monday, 27Sep2021. She stated that the patient informed her that she felt fine at that point, it was just those few days she felt that way. Reporter confirmed the Lot number is the same for both the first and second doses. The events did not require emergency room visit and physician office visit. Reporter seriousness for knocked her on her butt; she felt like she had COVID again was Medically significant.Causality: The reporter confirmed she does believed it is related because in the patient's words she said she felt like she had COVID. The outcome of the events was unknown. On 17Oct2021, investigation result was received from Product Quality Complaints. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE for lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the formulated drug product lot EP8616. 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 specifications.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events suspected Covid-19,drug ineffective,fatigue . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate