Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Tryptase, Vaccination site pain
Clinical narrative: She notes that a couple of months after I had the vaccines by fall I was able to tolerate a lot more foods than I was able to previously/ Tryptasemia have remarkably improved; if she touched her arm she might feel a little soreness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.A 64-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31Jul2021) at the age of 63 years, in left arm and on 17Apr2021 at 08:40 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Mast cell disorder", start date: 2015 (unspecified if ongoing), notes: I have a mast cell disorder. I was born with a hereditary extra alphatryptase copy; "Tryptasemia" (unspecified if ongoing), notes: I was born with a hereditary extra alphatryptase copy/Tryptasemia; "Food intolerance" (unspecified if ongoing), notes: Now there's only few can't eat like pizza. Dairy can only do cream, butter, most cheeses can't do; only really tiny amounts cheese; can't do concentrated tomatoes; "Sleep disorder" (unspecified if ongoing), notes: REM sleep behavior disorder, sleep movement, attempting or succeeding in getting out of bed; "Hypermobility" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Restless leg syndrome", start date: 2015 (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "Sleep walking" (unspecified if ongoing), notes: incidents of sleep walking; "Hypnopompic hallucination", start date: Feb2017 (unspecified if ongoing); "Hypnagogic hallucination", start date: Feb2017 (unspecified if ongoing); "GERD" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Esophageal spasm" (unspecified if ongoing); "Laryngospasm" (unspecified if ongoing), notes: She had been having laryngospasms where her throat would close; "Fruit allergy" (unspecified if ongoing), notes: She had tested for citrus fruit because she knew she had been having reactions; "Hypercholesterolemia" (unspecified if ongoing); "Couldn't do nuts" (unspecified if ongoing), notes: Couldn't do nuts, could do peanuts; tested to see if could eat nuts again; "Alcohol" (unspecified if ongoing), notes: She does not drink alcohol because alcohol has very high histamine.; "just wheezing that "sounds like a cat's 'mew'" (unspecified if ongoing), notes: She adds that she "never had asthmatic breathing" just wheezing that "sounds like a cat's 'mew'"; but "I do have an inhaler that I use occasionally, also an epipen, and benadryl" incase of an emergency; "her hypermobility she gets really sore from working outdoors" (unspecified if ongoing); "joints usually so loose has difficulty supporting self" (unspecified if ongoing); "she already had a preexisting left hand problem" (unspecified if ongoing); "had swelling to her arm" (unspecified if ongoing), notes: She didn't have anaphylaxis in traditional sense, but had swelling to her arm and elbow which were red, and nothing that she had had before.; "elbow which were red" (unspecified if ongoing), notes: She didn't have anaphylaxis in traditional sense, but had swelling to her arm and elbow which were red, and nothing that she had had before. "She had massive coughing" (unspecified if ongoing); "She never passed out, but it can happen" (unspecified if ongoing); "Hashimotos thyroid disease" (unspecified if ongoing); "she started sneezing wildly whenever she drank alcohol so alcohol went out the window" (unspecified if ongoing); "She is not a smoker, never been a smoker" (unspecified if ongoing); "Sleep talking" (unspecified if ongoing); "wasp sting", start date: Jul2017 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; NIFEDIPINE; MODAFINIL taken for narcolepsy; LOSARTAN taken for hypertension; MEMANTINE taken for gastrooesophageal reflux disease, oesophageal spasm; PANTOPRAZOLE taken for gastrooesophageal reflux disease; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AZELASTINE nasal taken for mastocytosis; OLOPATADINE ophthalmic taken for mastocytosis; FAMOTIDINE taken for gastrooesophageal reflux disease; NICOTINE topical taken for restless legs syndrome; CLONAZEPAM; MELATONIN; CROMOLYN [CROMOGLICATE SODIUM] oral taken for food intolerance. Past drug history included: Epipen, reaction(s): "Wheezing"; Benadryl, reaction(s): "Wheezing"; Medrol, start date: Jul2017, for Wasp sting, reaction(s): "Blown symptom", notes: She was stung by a black wasp Jul2017; Prednisone, start date: Jul2017, for Wasp sting, notes: She was stung by a black wasp Jul2017. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "She notes that a couple of months after I had the vaccines by fall I was able to tolerate a lot more foods than I was able to previously/ Tryptasemia have remarkably improved"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "if she touched her arm she might feel a little soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional information: Patient received dose 2 on 17Apr2021 (terrible writing on vaccine record card, but believes it is 17Apr2021) Lot: terrible handwriting on vaccine record card, caller can't make it out, it might be 621EOX64 or 021EOX64. Caller stated she had multiple diagnosed conditions. Patient was born with a hereditary extra alphatryptase copy which caused her to have a variety of symptoms including "food intolerances are the most notable" and her disease state also affects "most daily things, sleep disorders, hypermobility". She adds that she never had asthmatic breathing just wheezing that sounds like a cat's 'mew'; but patient does have an inhaler that she use occasionally, also an epipen, and benadryl incase of an emergency. She notes that her condition was first identified by the (institute name withheld) in 2015 and that she was diagnosed in 2017 and had 4 years with horrible symptoms, that her doctor told her she would have to manage. Other relevant history included sleep disorders, REM sleep behavior disorder, incidents of sleep walking. One of those episodes sent her to ER because ran out of bed, ran into something, cut her eye. Sometimes has had serious incidents with sleep walking. Also has lots of sleep talking, sleep movement, attempting or succeeding in getting out of bed. Hypnopompic hallucinations and Hypnagogic hallucinations; does not remember which of those conditions is the one that happens at the start or end. Historical information: Tryptasemia: Mast cell disorder which is hereditary. She was stung by a black wasp Jul2017. She had a large local reaction. She had been stung by wasps before and not had that reaction; but had never been stung by a black wasp before. She had never had reaction like that. She went to the urgent care and they gave her a shot of Solu-Medrol in the urgent care and they gave her a prescription for Prednisone just in case. She had Prednisone already available the morning after she had the shot of Solu-Medrol. She had some relief from the Solu-Medrol, but then she immediately had the same full blown symptoms she had experienced prior to the shot of Solu-Medrol. She didn't have anaphylaxis in traditional sense, but had swelling to her arm and elbow which were red, and nothing that she had had before. She called the doctor and they advised her to immediately start taking the Prednisone which she did. Solu-Medrol: Lot/NDC/Expiry: Unknown, did not have product with them. Prednisone: Lot/NDC/Expiry: Unknown, did not have product with them. That sting by the black wasp seemed to trigger exactly the dividing line where her condition went from carrying the extra gene for Tryptasemia with no real symptoms to full Tryptasemia syndrome. She became intolerant to masses amounts of food. Almost anything she put in her mouth caused a reaction like stinging, burning, asthmatic breathing. She had to limit her diet extremely and that continued for years. She was already a patient in the (facility name withheld) in (state and city name withheld) for sleep disorders. Those were diagnosed and had been a life-long thing; it was just that the diagnosis was missed for years. Finally (facility name withheld) diagnosed it, and her narcolepsy was diagnosed. She had already been diagnosed with restless leg syndrome in 2015. Finally the narcolepsy and sleep people were furious that the (institute name withheld) Medicine had not diagnosed her sleep disorders despite them showing on sleep tests. Her sleep tests she found out that at one of them she woke up saying that gremlins were pulling her out of bed, she even accused the nurse of doing it because she had hallucinations in pre-wake time. Doctor in (facility name withheld) felt they should have easily been able to diagnose this. She has 2 narcolepsy genes so it was more likely to happen. Feb2017 she has a very good GI doctor at (facility name withheld) Clinic who explained they usually never saw in the same patient simultaneously a neurological blockage of the ECG or ECJ valve at the bottom of the esophagus that wouldn't open appropriately. During a test they found the neurological blockage would not open in the presence of liquid squirting in while there was a simultaneously massive amount of GERD. She had been having laryngospasms where her throat would close. That was probably related to food intolerance. She had massive coughing, would expel all the air in her lungs. She never passed out, but it can happen. The coughing would resolve, and she would suck in breath again. These were going on so she saw a local doctor who put her on Omeprazole which didn't help, she elevated her bed which didn't help. That's when she saw the GI doctor at (facility name withheld). Omeprazole: Lot/NDC/Expiry: Unknown, caller did not have product with them. Jan2017 she had additional food intolerance tests done which were all negative because of her having laryngospasms after eating certain foods. When she saw GI doctor in (facility name withheld) she thinks that was in Oct2017 when saw him after this black wasp sting had initiated all these food intolerances. She spoke to him by phone and he ordered tests at a local site for her. Her tryptase levels were high at 22, abnormal; the top of the range for tryptase is supposed to be 11.5. She wasn't in a reaction at that time, but her tryptase was at 22. They also ran urine histamine test, she forgets the whole name of that test, but that was normal. He mentioned there was an unusual known condition they didn't have a test for it yet that she was aware of; only research but it was Tryptasemia. She had called him because of an extreme reaction she had when she added a lot of lemon juice to homemade ice tea. She had tested for citrus fruit because she knew she had been having reactions. She started limiting histamine foods and taking extra zyrtec and suffered very badly for a couple of years. She was so restricted so many foods she couldn't eat. She does not drink alcohol because alcohol has very high histamine. She stopped drinking alcohol way back in maybe 2012 because she started sneezing wildly whenever she drank alcohol so alcohol went out the window. There were some signs and symptoms where everything went back to the black wasp sting. Caller mentioned separately that her husband was vaccinated too, earlier than caller, but he wasn't offered a booster until much later than caller. He was a little annoyed about that, but he doesn't have the immune issues that caller does. He did have fever and headache. In fact they wonder if he was, he was very sick in January prior to the company issuing this information. There had been someone that came in incredibly sick from and continued to be sick the entire time. Caller kept telling her husband he could not go to the office like this; he said everyone at the office were like that. If she had it she didn't have the symptoms he did. They had heard that 100,000-200,000 people were predicted to potentially die and they passed that. Because of all the international travel, there is a 5 county area, hers being one, where the caseloads were very high in (state name withheld). Based on population there were far greater cases in the early weeks and months than other more populated areas. That was pretty terrifying so she wanted to certainly protect herself; and her husband wanted to protect himself. Patient height: she mentioned she is shrinking a little bit. Concomitant drugs included, CROMOLYN also called GASTROCROM, gastric oral solution; UNKNOWN Product for Raynauds. She noted that a couple of months after she had the vaccines by fall patient was able to tolerate a lot more foods than patient was able to previously, noting that she's constantly testing food and patient can now eat almost everything noting that some people with this disease are down to only 10 foods they can eat. She would like to know if the Covid19 vaccine affects Mast cells? If so, the vaccine could have caused her improved condition. She noted that she read online that "people who have very severe cases of Covid, it is the Mast cells that start a cytokine storm" and thinks that the vaccine may stabilize mast cells to keep this from happening. She stated that she had been looking online to see if anyone else is reporting this type of positive reaction. Patient just looked again today and saw reports of people seeing improvements that they didn't expect. Caller is a consumer who credits the Pfizer Covid19 vaccine for improvements in her health condition, a hereditary extra copy of Alpha Tryptase. She adds that "if the vaccine can target a protein, and her condition is caused by an extra protein, maybe Pfizer can come up with a medication to treat this and that she looks forward to new developments and medicines. Caller wondered if there is research or if she could talk to someone about unexpected positive side effects of the Covid-19 vaccine or received effects beyond the obvious protection against Covid. Patient believed that her symptoms of Tryptasemia have remarkably improved since she received the Pfizer Covid-19 Vaccine. Since after getting the Pfizer Covid-19 Vaccine her symptoms for the other condition mast cell disorder were remarkably improved. She clarified that prior to ever receiving any dose of Pfizer Covid-19 Vaccine she had other condition which is Tryptasemia, a mast cell disorder. She believes that her symptoms of Tryptasemia have remarkably improved since she received the Pfizer Covid-19 Vaccine, but is not sure which dose the improvement started after. She called to ask if Pfizer has seen other people have improvement like her with mast cell disorders after receiving Pfizer Covid-19 Vaccine. Event onset date/time: Gradually a couple months after, there were 5 months total between first second and booster doses of Pfizer Covid-19 Vaccine; she does not recall if she probably wouldn't have noticed a difference in the summer of 2021 because of so much physical activity. They do outdoors activity a lot in the summer and she probably wasn't paying too much attention to things because with her hypermobility she gets really sore from working outdoors. Her joints get a little out of whack, realignments and that sort of thing are needed. She has gone to physical therapy and knows tricks too. What had been happening was that with physical exertion and food she may be able to tolerate certain foods in a very small amount, but if she knows she is having a food in very small amount that could trigger reaction she is careful not to eat anything else that could be problem food at same time. The combination of exertion which by that she means cutting down trees, rolling logs, a lot of things, constantly maintaining their property; with food plus exertion even small amounts of food cause big reactions and very loose joints. She is not sure when she started to notice the improvement in her Tryptasemia symptoms. She didn't challenge herself with food; her reactions were so extreme she didn't want to take any chances so she wouldn't eat until she was done with exertion outside. She noticed improvement, able to eat oranges; maybe some intolerances; so many different allergists that couldn't explain why this happened; learned on her own big reaction to a thing will cause the Tryptasemia to become symptomatic. Allergists were no help, had to figure out herself. Couldn't do nuts, could do peanuts; tested to see if could eat nuts again; there are very few foods can't tolerate at least in small quantities now. Fall season of 2021 she realized that; got bolder after that. Now there's only few can't eat like pizza. Dairy can only do cream, butter, most cheeses can't do; only really tiny amounts cheese; can't do concentrated tomatoes. There is still a hold out with a handful of other foods she experimented with. She does not have same reaction with exertion or more nowhere as pronounced; joints usually so loose has difficulty supporting self at least half of next day being stable; joints unstable, couldn't lift and carry laundry basket or walk stairs without fear. Was doing a lot of sleep disruptive behaviors which have calmed down. Think it could have just naturally gone away; one allergist said cells reproduce over 7 years in body; said maybe look for relief in 7 years; but she does think such improvements are tied to Pfizer Covid-19 Vaccine. She had all 3 doses of Pfizer Covid-19 Vaccine administered to the upper left arm because she already had a preexisting left hand problem; so her left arm is the one she has trouble in so if there was going to be a problem it was better to be the left arm. She had no fever or side effects with the vaccine doses other than an incredibly minor headache and if she touched her arm she might feel a little soreness but she didn't need to take any medications, didn't take any Tylenol. She would call it no side effects from any of the vaccine doses. She then explained that the one thing she noted after the booster dose was that she had to go to doctor for something different and they noticed a little lump on her collarbone. Doctor told her it could be an inflamed lymph node because she had just had the booster dose of the Pfizer Covid-19 Vaccine a week before that; the little lump was inflamed a little bit, but movable and doctor told her it will go down and it did; she does not really feel it now so it recovered itself. Case was reported as non serious. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.