Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Bedridden, Feeling abnormal, Headache, Immunisation
Clinical narrative: Lack of significant antibody response with prior 2 vaccines and booster; second booster; She is having a more robust reaction to her Covid booster, than her prior 3 shots; a little bit of a low grade fever; muscle aches; pain at the injection site; Body aches; headache; staying in bed; felt bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), administration date 16Jan2022 (Lot number: FL3209) at the age of 53 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Methotrexate, notes: She is immunocompromised and has been on Methotrexate, Prednisone, and other medications in the last 6 months; Prednisone, notes: She is immunocompromised and has been on Methotrexate, Prednisone, and other medications in the last 6 months. Vaccination history included: Bnt162b2 (Dose: 01), administration date: May2021, for Covid-19 immunization, reaction(s): "Headache", "sore arm"; Bnt162b2 (Dose: 02), for Covid-19 immunization, reaction(s): "Body aches"; Bnt162b2 (Dose: 03), for Covid-19 immunization, reaction(s): "she is having a more robust reaction to her Covid booster, than her prior 3 shots", "Lack of significant antibody response with prior 2 vaccines and booster". The following information was reported: IMMUNISATION (medically significant) with onset 16Jan2022, outcome "unknown", described as "second booster"; ANAPHYLACTIC REACTION (medically significant) with onset Jan2022, outcome "unknown", described as "She is having a more robust reaction to her Covid booster, than her prior 3 shots"; PYREXIA (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "a little bit of a low grade fever"; MYALGIA (non-serious) with onset Jan2022, outcome "unknown", described as "muscle aches"; VACCINATION SITE PAIN (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "pain at the injection site"; PAIN (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Body aches"; LOSS OF THERAPEUTIC RESPONSE (non-serious), outcome "recovered", described as "Lack of significant antibody response with prior 2 vaccines and booster"; HEADACHE (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "headache"; BEDRIDDEN (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "staying in bed"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "felt bad". Clinical course: The caller mentioned that she has an autoimmune disorder and is on a lot of medication. The caller said she has taken 4 Pfizer shots because of her immune deficiency. The caller said she has some good things to say since taking the shot and wants to tell Pfizer so it can help other people. Caller states that she is immunocompromised and has been on Methotrexate, Prednisone, and other medications in the last 6 months. States that on 16Jan2022 she finally managed to get a second dose of the Pfizer Covid booster shot. States that she had normal side effects, nothing else, and that is important so other people like her can have access to another booster. States that people like herself have immune systems that don't product antibodies at the same rate as everyone else. Caller states that after the second booster dose she had a little bit of a low grade fever, muscle aches, and pain at the injection site the next day. States she had no swelling at the site, and the pain went away. Caller says the muscle aches persisted a little bit longer. The second and third day she had a bit of a low grade fever. States that this tells her that her body had a more robust response to the vaccine than any of the previous vaccines. Caller verifies that this was her fourth dose of the Pfizer Covid Vaccine. Caller states that her reaction tells her that her body was producing antibodies. Caller states that she is an attorney. Caller says that she was not supposed to get the fourth shot yet, but her neurologist and internist insisted that it was necessary. Caller states that where she lives no one wears a mask. States she has taken more crap from people for actually putting on a mask. Caller states that she has a stack of questionnaires from Pfizer; none of the questions on them are pertinent. States they seem to be for people who had something worse that what she had, body aches and low grade fever. Caller states she was jubilant that she felt like crap because that means the vaccine was working. Caller states this is something that Research and Development need to know. States that high risk groups, such as herself who hit the genetic jackpot; may take a four shot regimen to adequately produce the antibodies needed to protect people who have autoimmune disorders. Caller says that she doesn't fall into the normal category, so the questions on the forms don't apply to her. Says that they don't get to the heart of the matter. Says Research and Development needs to know that they are going to have to give a higher dose booster or another booster. Caller states that giving someone like her the 2 shots and then a higher octane booster makes sense to her. Caller states for example if you got two shots at 100 then got another at 50; if you bumped that up to 75 and do two of them 5-6 months apart, you could have someone who is protected. Caller states that even with 2 doctors saying she needed the fourth shot she spent so many hours on the phone trying to get it arranged. Caller states that not everyone is the same. Caller says her immune system is wired differently and there are millions of people just like her. Caller says they had a conference of doctors at her local hospital concerning administration of the vaccines and she wasn't even allowed to send a representative. States she didn't even know when it was occurring. Caller states she had to fight it at the front end and now is having to fight it at the back end with this variant. Caller says that her first booster dose of the vaccine was in May2021. Her second booster dose of the vaccine was 16Jan2022. Caller says that she got her first booster as soon as it was available. Caller states that the CDC didn't think ahead. Says they didn't think about people who had it when it was first available and then 6 months down the line. Caller states they are administering fourth shots to hospital personnel. States she found that out through being persistent in calling the hospital systems. Caller says that she got her first booster the same time as hospital personnel; so why wasn't she included in the category for the second booster when they were. Caller states that leaves millions of people, mostly women who are 8 to 1 more likely to have an autoimmune disorder than men; unprotected. Caller says that sounds like a class action law suit. Caller says that a lot of people out there are probably going through their winter flares and they don't have the energy or tenacity to call and call and call so they can get another Booster. She is happy to discuss how she reacted to the second booster because it needs to go ahead and get emergency use approval from the FDA. Caller says can you imagine if someone is on like, Humira? Says it annihilates your immune system.States people on those drugs don't have a choice, its either let your joints be destroyed and don't take it or take it and have no natural defense during a pandemic to a potentially lethal virus. Caller states that would not be a fun place to be. Caller provides no specific information related to the Humira or any patient's as she used this as a hypothetical example. Caller states that is hospital personnel are being given a fourth dose on the sly because of the viral load they are exposed to; why didn't they include people with autoimmune diseases. Caller states that she is a great case. Says she had more of a robust reaction to this dose of the vaccine than she did with her first booster. Caller also states that she had practically no reaction with the first two doses of the vaccine. Says that with her second dose she might have had a low grade fever and a sore arm for an evening, but then she was fine. Caller states that she thinks the only thing that has saved her during the pandemic is she gardens and has stayed in her backyard gardening for the past years. Says she has not gone anywhere, she cannot remember the last time she was in a grocery store. States that is what she has to do to stay safe. Caller says that she is lucky enough to have a yard. What about people with autoimmune conditions who live in apartments? Caller states that the need to be able to be free. Says they will only be able to be free if they can get another booster. Caller says why not let them have another booster. Says they got it when the booster was first available to hospital workers, back in May, Jun, Jul, Aug. Caller states that was way before the general public was encouraged to get the booster. She doesn't understand why this time around they aren't including the immunocompromised. Caller states the only way she got her second booster was her doctor's sent out notes to the pharmacy saying it was medically necessary, so they finally gave her the vaccine. Caller states they even gave her a second vaccination card. Laughs and says its because they know she will be back. States she is going on three years confinement now. Says her husband has a convertible, when she needs to get out at least they can drive around with the top down until she feels less trapped. Caller says that she can be added to whatever other reports Pfizer has. She is willing to have blood drawn, antibody titers, whatever they need to prove that a fourth dose if effective for people in the same category as her. Caller state that people who are walking around with no masks are monsters and she may go to jail for killing one of them. Says the amount of jeering and bullying she has put up with, like people are in grade school. She cannot count the number of times that she has been publicly jeered by these creepy people because she is wearing a mask. Caller says what have we become as a society. Caller says that when she got her second booster she found out that they had 4 cancellations right before her appointment. States maybe that's why she was able to get it, people aren't showing up and they don't want the vaccines to go to waste. States she thinks Pfizer will learn that a second booster is probably a good thing to do with people who are immunocompromised. States that would be the seed for a trial, then there will be a stampede of immunocompromised patients begging for another booster. States Omicron is not the last variant. 25% of the population is a walking petri dish. Caller states who knows what the next variant is going to look like. States Pfizer needs to revamp the questionnaire. States they need a correlation between the severity of symptoms and the amount of antibodies a person is producing. States they need to ask better questions, to get better answers. Caller states its about quality, not quantity. States all it does is generate a bunch of statistics that are meaningless just because people don't feel 110%. Caller says that all four times, each time she got the shot; she wouldn't say that her muscle aches and sore arm and low fever got worse; but they were there a longer period of time. Caller states that tells her her body was working. States with the last shot she got, when she would wake up she was hungry. States that is excellent because her body was working overtime, working hard producing antibodies. Caller says if Pfizer could cut through the volume and get to some cases they might learn something that is good. Caller is calling about an adverse event, from a Pfizer Covid 19 vaccine trial. Later in report, Caller corrects this statement, as she is not in a vaccine trial. Caller got her 4th shot on 16Jan2022. Caller reports she was hungry, and felt like she wanted to sleep. Caller states she is not reporting any adverse events, other than minor events that are listed. Caller states she is immunocompromised and has 4 autoimmune disorders, and on 16Jan2022, received her fourth Covid shot, and clarifies as second booster shot. Caller states she had arranged with her doctors to get a second booster shot because of the lack of significant response to her prior shots. Caller clarifies she is not in a vaccine trial. Caller states because of the recent spike of Covid cases her doctors wanted her to get a second booster. Caller states she will complete a report if it is used for research and development. Caller states she would like to be transferred to the research and development department to see if they have any information on the vaccine with people that are immunocompromised either genetically or because of medications. Caller clarifies she has had no adverse events. Caller states that aside from a headache, fever, and not wanting to get out of bed, she had no events to report. Caller states that aside from a fever, headache, body aches, and staying in bed, she is feeling fine now. Caller states that it is important for the research and development department to know that for immunocompromised patients, the vaccine is proven to be safe and provokes a more robust reaction with the second booster shot, than the original two vaccines and booster. Caller states that the second booster provides a more robust reaction and better production of antibodies than the original two shots and booster. Caller states she is calling because people in her category get overlooked. Caller states she has called Pfizer research and development before, and was instructed to scan for trials to see if she would fit into one of the catagories, to get a second booster. Caller states her and her two doctors felt she was in imminent peril and wanted her to get a second booster. Caller states she finally got a second booster. Caller states she felt bad for 4 days. Caller clarifies that she does not want to report her event. Caller states as someone who is immunocompromised, and is on a tumor necrotizing factor drug, Methotrexate, and Prednisone for the last 6 months for her autoimmune disorders, she wants Pfizer to know that she is having a more robust reaction to her Covid booster, than her prior 3 shots. Caller does not provide product information for her other drugs.   No follow-up attempts are possible. No further information is expected.