Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urine output
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A 64-year-old female patient received BNT162b2 (COMIRNATY), on 27Aug2021 as dose 3 (booster), single (Lot number: EWO179) at the age of 63 years for covid-19 immunization. The patient's relevant medical history included: "Tryptasemia" (unspecified if ongoing); "Hypermobility" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Restless leg syndrome", start date: 2015 (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "Sleep disorders" (unspecified if ongoing); "sleep walking" (unspecified if ongoing); "Hypnopompic hallucinations", start date: Feb2017 (unspecified if ongoing); "Hypnagogic hallucinations", start date: Feb2017 (unspecified if ongoing); "GERD" (unspecified if ongoing); "Food intolerance" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Esophageal spasm" (unspecified if ongoing); "Left hand problem" (unspecified if ongoing), notes: she already had a preexisting left , hand problem; "laryngospasms" (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); "Allergy to nuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; NIFEDIPINE; MODAFINIL taken for narcolepsy; LOSARTAN taken for hypertension; MEMANTINE taken for gastroesophageal reflux disease, esophageal pain; PANTOPRAZOLE taken for gastroesophageal reflux disease; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AZELASTINE nasal taken for mast cell activation syndrome; OLOPATADINE ophthalmic taken for mast cell activation syndrome; FAMOTIDINE taken for gastroesophageal reflux disease; NICOTINE topical taken for restless legs syndrome; CLONAZEPAM taken for restless legs syndrome; MELATONIN taken for restless legs syndrome; CROMOLYN SOD oral taken for food intolerance. Past drug history included: Medrol, start date: Jul2017, for Wasp sting, reaction(s): "Blown symptom"; Prednisone for Wasp sting. Vaccination history included: BNT162b2 (DOSE:1, Manufacture: Pfizer, Expiry: 31Jul2021, Lot/NDC: Unknown, not on vaccine record card., Dose: Unknown strength/volume/dose injection to upper left arm. , mast cell disorder were remarkably improved after getting the Pfizer Covid-19 Vaccine.), administration date: 27Mar2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "mast cell disorder were remarkably improved after getting the Pfizer Covid-19 Vaccine.", "if she touched her arm she might feel a little soreness", "Headache"; BNT162b2 (DOSE: 2, Manufacturer: Pfizer, Lot no. 621EOX64 or 021EOX64. , Expiry/NDC: Unknown, not on vaccine record card. , Dose: Unknown strength/volume/dose injection to upper left arm at 08:40 , mast cell disorder were remarkably improved after getting the Pfizer Covid-19 Vaccine.), administration date: 17Apr2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "mast cell disorder were remarkably improved after getting the Pfizer Covid-19 Vaccine.", "if she touched her arm she might feel a little soreness", "Headache". The following information was reported: MASS (non-serious), outcome "unknown", described as "doctor noticed a little lump on her collarbone". The event "doctor noticed a little lump on her collarbone" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: 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. Warm transfer from (name) with Support, CEP: 159558 with a caller on the line who already had the primary series of Pfizer Covid-19 Vaccine. Since after getting the Pfizer Covid-19 Vaccine her symptoms for the other condition mast cell disorder were remarkably improved after getting the Pfizer Covid-19 Vaccine. Caller clarified that she has been administered 3 doses of Pfizer Covid-19 Vaccine including the primary series of 2 doses as well as the booster dose/third dose. 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; does the Pfizer Covid-19 Vaccine target mast cells, because she read somewhere that it does. She also asked if the second booster of Pfizer Covid-19 Vaccine is available. Primary/prescriber: Caller did not have anyone in particular to provide contact information for or for Pfizer to contact. She is seen through multiple organizations and multiple specialties. 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. Third dose/booster dose was administered at (facility name withheld). She didn't have a sore arm with the vaccine doses. 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. 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 has other conditions: hypermobility syndrome; Raynaud's; hypertension; Hashimotos thyroid disease; hypercholesterolemia for no good reason because her diet is good. 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. Husband works in the auto industry. They got early indication because his facility has a lot of people that came in from (Country name withheld).  They always had people coming in and out so very early on they provided information about it and started doing telecommuting so they were giving very serious warnings. 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 Italy 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. Their daughter is a Nurse Practitioner in (city name withheld) working with patient family medicine practice and their daughter would have killed them if they skipped the vaccines. Is there a product complaint to report? Yes. Description of Product Complaint: PC is not on suspect product. Description of complaint: For massive amount of GERD, laryngospasms where throat would close probably related to food intolerance; massive coughing; would expel all the air in her lungs; Coughing would resolve, and would suck in breath again-Doctor put her on Omeprazole which didn't help Omeprazole: Lot/NDC/Expiry: Unknown, caller did not have product with them.