Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mast cell activation syndrome, Odynophagia, Oesophageal stenosis, Oesophagogastroduodenoscopy
Clinical narrative: narrowing of esophagus; mast cell activation; fatigue; Severe Hives  swollen Ankle swollen lips; Severe Hives  swollen Ankle swollen lips; Severe Hives trouble swallowing pain in chest/upper stomach; Severe Hives swelling of lips itchy skin; Severe Hives swelling of lips itchy skin; Severe Hives swelling of lips itchy skin; Covered head to toe with rash; spots of rash around her eyes; spots of rash around her eyes; This is a spontaneous report received from contactable reporter (patient's husband) for a Pfizer sponsored program (005570).  A 62-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Apr2021 09:35 (Lot number: ER8732, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe hives" (unspecified if ongoing). Family history included: "Hashimoto's", start date: 06Jan1985 (ongoing), notes: N/A, Taking synthroid daily -112- 125 every other day. Concomitant medication(s) included: CLARITIN [LORATADINE] taken for urticaria, start date: 31May2021 (ongoing) (25 mg, 2x/day); FAMOTIDINE taken for urticaria, start date: 31May2021 (ongoing) 20 mg, 2x/day; BENADRYL taken for urticaria, start date: 31May2021 (ongoing) 50 mg, 2x/day; MEDROL ACNE, start date: 01Sep2021, stop date: 06Sep2021 UNK (taken 4x for 6 days). Vaccination history included: Bnt162b2 (Dose: 1, Date (dd-Mmm-yyyy): 13Mar2021 , Time: 12:40 PM, Anatomical site of Injection: Left arm/Sholder, Route of administration: Intramuscular, Batch/Lot number: EN6201, Exp. date :30Jun2021), administration date: 13Mar2021, when the patient was 62 years old, for COVID-19 immunization. The patient did not received any other vaccine prior to covid vaccine. The patient vaccination facility type was hospital. The following information was reported: MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown", described as "mast cell activation"; ODYNOPHAGIA (medically significant) with onset 31May2021, outcome "not recovered", described as "Severe Hives trouble swallowing pain in chest/upper stomach"; LIP SWELLING (medically significant), JOINT SWELLING (medically significant) all with onset 01Sep2021, outcome "recovering" and all described as "Severe Hives swollen Ankle swollen lips"; RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "Covered head to toe with rash"; RASH MACULAR (non-serious), EYE ALLERGY (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "spots of rash around her eyes"; OESOPHAGEAL STENOSIS (non-serious), outcome "unknown", described as "narrowing of esophagus"; URTICARIA (non-serious), LIP SWELLING (non-serious), PRURITUS (non-serious) all with onset 16Apr2021, outcome "not recovered" and all described as "Severe Hives swelling of lips itchy skin"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The events "severe hives trouble swallowing pain in chest/upper stomach", "severe hives swelling of lips itchy skin", "severe hives swelling of lips itchy skin", "severe hives swelling of lips itchy skin" were evaluated at the physician office visit and emergency room visit. The event "severe hives swollen ankle swollen lips" and "severe hives swollen ankle swollen lips" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) tsh was elevated; culture urine: (unspecified date) mast cell activation (mcas); Clinical course: My wife (patient) had a rash that developed a few weeks after receiving her second dose of your Covid-19 vaccine 03Apr2021. She was 62 without a history of rashes. Patient started developing spots of rash around her eyes mid-April she was now covered head to toe with rash. Multiple doctors have not been able to find a cause. Any help would be appreciated. oesophagogastroduodenoscopy: (04Oct2021) narrowing of esophagus, notes: Performed ablation to open VP narrowing esophagus; sars-cov-2 test: (03May2021) negative; urine analysis: (20Sep2021) mast cell activation, notes: Confirmed 28Oct2021. Therapeutic measures were taken as a result of odynophagia, lip swelling, joint swelling, urticaria, lip swelling, pruritus. It was reported that after receiving her second pfizer vaccine, she become very tired. she contacted her endocrinologist to order thyroid (TSH, Fever T3). The test came back in the normal range. she Continued to feel fatigued. On 31May2021. she broke out in hives, she had trouble swallowing and went to the ER. They ran blood test and found my TSH was elevated and recommended she made an appointment with my endocrinologist. she saw her endocrinologist on 06Jul2021 and told her TSH at the hospital was 4.99. She ordered another TSH 06Jul2021 and it was a 7.75. Increased her synthroid (1/2/125) every other day. (she had been stable for years on 112 with normal TSH . she was referred to allergist -recommended she take Claritin (25 mg, 2x/day)/ Benadryl /Famotidine for hives and lip swelling for 6-week 24 hr. Urine catch was sent to (withheld clinic). Diagnosed with mast cell activation (MCAS). Continue to take Claritin, Benadryl and Famotidine daily. still sensitive to many foods -causing hives, that never been sensitive to before. On a low histamine diet. will be seeing dictation on 18Nov2021. she still had breakouts of hives, but not as severe. PCP prescribed epipen. still taking antihistamine during breakouts.  Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.