Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Poor quality product administered, Product temperature excursion issue, SARS-CoV-2 antibody test
Clinical narrative: received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later); severe headache; back pain; neck pain; nausea; diarrhea; weak; tired; not feeling well; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EM9809 and Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2002 and ongoing, NASH cirrhosis from 2006 and ongoing, hypertension from 2012 and ongoing, Mitral valve regurgitation disease from an unknown date and unknown if ongoing. There were no concomitant medications. She stated severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. It was reported that she was in the group of 81 people that received their first COVID vaccines at (Facility) on 15Feb2021 and there were vaccines that were compromised due to improper refrigeration. She received a call a few days later because the vaccine she received was compromised and she was scheduled for a second first vaccine re-take on 25Feb2021. She was scheduled for her actual second dose on 18Mar2021. She had gone to see her doctor because she was a little concerned and the doctor felt it probably was okay that she received the first vaccine and not get a re-take, and that they probably recalled it. She didn't think anything of that. After 2 or 3 days after getting the re-take of the first vaccine on 25Feb2021, she started getting very sick. She has been sick 8 days now. She went to the doctor again on Monday because she thought she had COVID. Her doctor is a very good doctor and thought what she was experiencing was more than likely because she had 2 shots together too soon and it was too much for her system to handle. The symptoms she has are similar to effects of COVID. The doctor did the COVID test and it came back negative. The doctor also did a test called the COVID Vaccine Antibody test referred to as SPIKE, which is different from a regular COVID antibody test, and her level was 9.31. It should be 1.0 or less. She confirms this test was done this past Monday, 08Mar2021. Her level was especially high. The doctor thinks all of symptoms were COVID related and now that he sees spike number was so high, he believes she is experiencing symptoms like she has COVID but she doesn't actually have COVID. She is assuming because there were 81 people who received a compromised vaccine, it has to be more than just her that had to be re-vaccinated and somebody else reported this problem. She is waiting for the doctor to call her back but the caller wants to know how serious is this? What is the risk of the SPIKE number being high at 9.31 and how does she lower it? Her doctor made her cancel her appointment scheduled for next week. She was currently rescheduled to receive her second vaccine on 25Mar2021, but this was before she knew her spike number was so high. The doctor told her to push it back another week. She wants to know is she going to get rid of symptoms. She is so sick that her daughter had to come out of state to take care of her. Her doctor has been giving her things to do and take but she doesn't believe her stomach can take anymore right now. There must be other people who have experienced this? She doesn't have COVID but might as well have COVID because she is experiencing all the terrible effects of COVID. It was reported that she had nausea, diarrhea, very severe headaches, and very bad neck, back, and shoulder pain. She has fatigue and weakness. She feels so weak. She confirms these symptoms began 3 days after receiving the second first vaccine (re-take) on 25Feb2021. She has improved a little. As of yesterday, she doesn't have diarrhea. She still has, nausea, headache, weakness, fatigue, and it's hard to keep food down. She clarifies she isn't having vomiting. She had general bloodwork done that she gets every 3 months the first time she visited her doctor on 25Feb2021. She mentions one number number was off during her routine blood work but this may have absolutely no bearing whatsoever. She clarifies it was under her iron, Iron/TIBC. Her level was 411, which was high. The range is 225-390. She also had other things but that's all related to her liver and diabetes. The outcome of the event was recovered for diarrhea and other events were unknown.  Description of complaint: The caller is calling in regards to the COVID vaccine. She was in the group of 81 people that received their first COVID vaccines at (Facility name) on 15Feb2021 and there were vaccines that were compromised due to improper refrigeration. She received a call a few days later because the vaccine she received was compromised and she was scheduled for a second first vaccine re-take on 25Feb2021. After 2 or 3 days after getting the re-take of the first vaccine on 25Feb2021, she started getting very sick. She has been sick 8 days now. She went to the doctor again on Monday because she thought she had COVID. Her doctor is a very good doctor and thought what she was experiencing was more than likely because she had 2 shots together too soon and it was too much for her system to handle. The symptoms she has are similar to effects of COVID. The doctor did the COVID test and it came back negative. The doctor also did a test called the COVID Vaccine Antibody test referred to as SPIKE, which is different from a regular COVID antibody test, and her level was 9.31. It should be 1.0 or less. She confirms this test was done this past Monday, 08 Mar 2021. Her level was especially high. The doctor thinks all of symptoms were COVID related and now that he sees spike number was so high, he believes she is experiencing symptoms like she has COVID but she doesn't actually have COVID.  No follow-up attempts are possible. No further information is expected.