Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Fatigue
Clinical narrative: Tired/Fatigued; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 21Jan2021 as single for covid-19 immunisation. The patient medical history was not reported. The patient received concomitant medications. The patient experienced tired fatigued for 2 weeks on an unspecified date. She has already had both doses of the vaccine, her second dose was 11Feb2021 and her first dose was 21Jan2021. She went to a facility in her neighborhood. She just had bloodwork done last Thursday the 18Feb202, her primary doctor checks it every 3 months since she was on medications, they have to check her blood work to check her liver enzymes to see if they are elevated or not since she takes statins. She spoke to her doctor yesterday, she asked for an antibody test to be drawn. She knows that when they get the vaccine, both times with Pfizer, they have to get Pfizer the first time and Pfizer the second time, same with the Moderna. The caller's antibodies were showing negative, which the doctor has seen other patients who are elderly who have had negative antibodies too. When she had the blood work done it would have already been 3-4 weeks from the first dose. The caller's doctor was not sure why that was, he seems to think that after the first dose there should be some sign but however he was saying, an article said it may take older people a little longer before there was an immunity against the virus from the vaccine. She doesn't know if it should be from the time you take the second shot or the time of the first shot? She wanted to know did she get the shot right? Did they give her water? What's going on? She was a nervous wreck because she knows she can't go get it again. She wanted to know how can they say its 95% effective? Did the people in the trials get a blood test for antibodies? How many were her age that were in the trials? The patient underwent lab tests and procedures which included antibody test: negative on 18Feb2021, planning on repeating the antibody test again in April, blood test: unknown result on 18Feb2021. The outcome of event was recovered on an unspecified date.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9262 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 EL9262, fill lot EL9253, and the formulated drug product lot EL9244. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.  No follow up attempts are possible. No further information is expected.