Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After her 1st dose her compliments were normal, they have almost never been normal so she guesses that the 1st dose fixed that for her; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Jul2021 (Lot number: FA7484) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (ongoing), notes: had this since she was about 18 years old. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After her 1st dose her compliments were normal, they have almost never been normal so she guesses that the 1st dose fixed that for her".  Additional information regarding 2nd dose: The patient took the took the COVID 19 vaccine, 2nd dose, (lot number: FC3680), Anatomical location: left deltoid, on 11Aug2021, and now she developed reactive arthritis and she was wondering if she can get an exemption for not getting the booster dose since she has developed the reactive arthritis to the vaccine. Caller says, as far as an exemption they are not giving them out except for if you were to have an anaphylactic reaction. They are not trying to give anyone an exemption so she was wondering that if maybe the pharmaceutical company feels like it might not be a good idea for her to get the booster considering what she has experienced then that may account for something. She had clinical documents, pictures and all of that. She had a pristine medical history; she was on and off of medications and they don't care but she cares. It took her 6 months to actually get this problem under control and of course now it is time for her to get the booster dose. They are connecting her employment to getting the booster dose. She lives in (withheld) and they put off this mandate for 3 months but what is she supposed to do in three months from now? Take the booster or lose her job? She had spent so much time to get this under control and patient was on medication because she took a booster, she meant to say because she took a vaccine, not a booster. She was told that she can get a reaction and that it could happen, but she was not told that it was definite. She gets the reason on why she had to take the vaccine but now that she has had a reaction, she doesn't see why there's a debate as to whether she should have to be forced to take a booster or not. Event Details: This happened the very first week after she had her 2nd dose. When she had the 1st dose, she was fine, nothing happened. If she was tired after the 1st dose she didn't even notice because she took it after her shift. She had her 2nd dose on 11Aug2021 and that very weekend she had worked and that is when she started having issues. Confirmed sometime in Aug2021 to be when her adverse reaction had occurred. She adds that she has an underlying diagnosis of lupus, so she didn't know if what was going on was just a flare from her lupus. She was told that she could take the vaccine and get a lupus flare, but they thought that the chances were low for that. She disagreed with them but that was just her opinion so she couldn't risk her job over a chance that she could be wrong, and they could be right. So, she took the vaccine. At first, she thought that the symptoms were a lupus flare, but it wasn't. When she went to see her rheumatologist her inflammatory markers and her compliment levels were not reflective of a lupus flare. Her compliments were low and so were her inflammatory markers. Her labs were not meeting the criteria that you would see for a lupus flare, and it wasn't like anything that she had experienced before. The lupus is not a new diagnosis for her, she has had it since she was about 18 years old, and this is not like anything that she has had before. It was bilateral in both of her hands, and it was everywhere. It was in her feet, her knees, her lips were swelling and everywhere else. She was on steroids on and off and the steroids didn't stop it but it did make it manageable for her. The last thing that she was put on was Plaquenil, which she is still on now and she is still on the steroids. The reactive arthritis has gone down, she wants to say it has cleared up about 99.5%. But now they are telling her that she needs the booster, and she was not trying to take the booster. Since patient was on medications now it may not be as bad but that is not something that she really wants to experiment with. It is not fair to subject someone to that and that's all the government wants. Seriousness: What she experienced wasn't life threatening, which is her only problem because they consider that to be the only criteria for an exemption, but what she experienced was very debilitating. She is a registered nurse, and this affected her wrists, her actual hand, 8 of her fingers were swollen and she had inflammation. By the end of her shift this is very debilitating for having to work with that. Some days she couldn't walk because the swelling in both of her knees was so bad, she has pictures of all of this. It was very debilitating, but it was not life threatening. She doesn't think that in order to get an exemption you should be near death. The problem is that she has an established immune dysfunction and when Pfizer initially ran their test, they did not include people with immune dysfunctions. The rheumatology societies have said that based on their studies they didn't notice it to be a big problem with the vaccine putting people into a flare however there was a small segment, like maybe 10%, that may have symptoms or experience a flare. She had an established immune dysfunction and wasn't on any antirheumatic medications at the time, so she felt as if she was already a higher risk than normal. The rheumatology societies already know that someone can have a reaction but a lot of the people within the studies that they were doing weren't having severe reactions. Most people with issues like lupus or rheumatoid arthritis are already on a medication to suppress inflammation but she wasn't on anything and that could be the reason why she had more of a significant reaction. She doesn't really care about the reason for why this happened to her per say. She wouldn't say to someone to not take this vaccine and she wouldn't not recommend taking it but for people with immune issues who are not on any kind of immunosuppressive therapy it should be known that they may have a reaction such as this kind that she had. You can have these types of reaction with any vaccine, it doesn't have to just be the COVID vaccine, it can occur with other ones and there have been journal articles about that. The problem here is that the government doesn't seem to care that she had a reaction, and her job doesn't care since the government doesn't care. She believes that the company that makes these products should caution about this and say that these types of people should be able to have an exemption from this. She is not saying to not take the vaccine, but she thinks that there should be a heightened caution or an awareness that this can happen, and it should count for an exemption. She still recommends for people taking the vaccine because she works with COVID patients, and she knows the risk. She actually had a teenage daughter who took both doses and had no issues, so this only affects certain people in this type of way. Causality: It is really hard to say because she does have an established underlying condition and the vaccine targets the immune system. The vaccine was new and there were tests, but they are relatively young tests that weren't completed on someone who has an immune dysfunction. She thinks that the vaccine contributed to what she experienced but it is not the vaccine itself, per say. When you are giving this to someone who has an underlying immune dysfunction already and it targets that anything can happen. Even with something like Tylenol, for some people some things can happen and there are reasons to not take this or not take that as an example. But for her the vaccine was a problem because she already had an underlying diagnosis and was not on immunosuppressive therapy. She doesn't want to generalize her experience onto other people. History Investigations: She says that she was on the steroids, Prednisone, twice and she is on Plaquenil, also known as hydroxychloroquine. Her rheumatologist doesn't know what she had experienced is exactly, but the caller feels as if it is a reaction to the vaccine and is reactive arthritis. With arthritis essentially you would have joint swelling and pain and discomfort. Her compliments were essentially low pre-vaccine but that was her baseline. After her 1st dose her compliments were normal, they have almost never been normal, so she guesses that the 1st dose fixed that for her. On 14Sep2021, her compliments were normal, her CRP was a little elevated at 20 which wasn't crazy. Her white count and everything else were normal. On Dec2021, her last set of labs were all normal, but her presentation was not normal. Her labs were the most normal that she has ever had. She originally provided that her first set of labs were in Dec2021, but she is confused but that's a long time for her to have waited. She then clarifies and says that her last set of labs was in Dec2021 she has no idea when her 1st set of labs were, but it was before Dec2021. Inquired for doses, NDC, lot number and expiry date for the caller's Prednisone and Plaquenil and she says she does not have all of that information to provide. She does have the information for when she was first on the steroids, Prednisone, because she thought that she was only going to be on it for a month and that it would go away but it got worse. The first time she started on it was 16Sep2021 and it was a 20 mg taper. It helped a little bit but then it came back and was just as bad. Then she was on the Prednisone again, another 20 mg taper, she wants to say on 20Jan2022 and that's when she also started on the Plaquenil 200 mg once a day. She has the Plaquenil with her, but it was in an orange pharmacy bottle from Pharmacy so she doesn't have the NDC, lot number and expiry date for that.  Relatedness of drug to reaction(s)/event(s); Reaction assessed: Reactive arthritis; Source of assessment: Primary Source Reporter; Method of assessment: Agency; Drug result: Related.  No follow-up attempts are possible. No further information is expected