Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gingival pruritus, Throat tightness, Troponin normal
Clinical narrative: anaphylactic reaction to the vaccine; inflammation; Swelling of throat and face/her face, lips, and nose were puffy and edematous.; Swelling of throat and face/her face, lips, and nose were puffy and edematous.; Swelling of throat and face/her face, lips, and nose were puffy and edematous.; Noted soreness/irritation of gums prior to going to bed at 10 AM. Dismissed it as irritation from diet. Woke up at 6:00 PM and noted angioedema affecting my lips, nose and eyes.; Swelling of throat and face; Noted soreness gums/noticed some soreness on her gums; Noted soreness/irritation of gums prior to going to bed at 10 AM. Dismissed it as irritation from diet. Woke up at 6:00 PM and noted angioedema affecting my lips, nose and eyes.; tightness in my airway/tightness in my throat again; she felt her throat and chest were tight.; This is a spontaneous report from a contactable registered Nurse (Patient). A 23-year-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: 31Mar2021, solution for injection), via an unspecified route of administration on right arm on 20Dec2020 08:45 at single dose for COVID-19 immunization in hospital. Medical history included hypothyroidism r/t total thyroidectomy due to papillary carcinoma, total thyroidectomy 03Sep2020 for papillary carcinoma. Mentions she has struggled with maintaining normal calcium level and getting TSH level up since the surgery but has completely recovered from the surgery, anxiety, lack of thyroid, hypocalcemia, acne, seasonal allergy, Vitamin D deficiency. Allergies to medications, food, or other products was no. There was no current illness. Family Medical History relevant to events was none. Concomitant medication included calcitriol from 03Sep2020 and ongoing for hypocalcemia, levothyroxine from 03Sep2020 and ongoing for lack of thyroid, sertraline from 2009 and ongoing for anxiety, sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR) from 2018 and ongoing for seasonal allergy, ethinylestradiol, norgestimate (SPRINTEC) from 2016 and ongoing for acne, buspirone hydrochloride (BUSPAR) from Jul2020 and ongoing for anxiety, cetirizine hydrochloride (ZIRTEC) from 2016 and ongoing for seasonal allergy, ergocalciferol (VIT D) from 2014 and ongoing for Vitamin D deficiency, calcium carbonate (TUMS) from 03Sep2020 and ongoing for hypocalcemia, adapalene (DIFFERIN) from Oct2020 and ongoing for acne. There was no other vaccine in four weeks, Silagen from Oct2020 and ongoing topical grain of rice amount twice daily to her neck for  reduce appearance of thyroidectomy scar. The patient noted soreness/irritation of gums prior to going to bed at 10 AM on 22Dec2020. Dismissed it as irritation from diet. The patient woke up at 6:00 PM on 22Dec2020 and noted angioedema affecting her face, lips, nose and eyes. She took 2 diphenhydramine hydrochloride (BENADRYL) before driving to urgent care. That urgent care did not have a provider in. She drove to a second urgent care that did not have any epinephrine. At this point she was beginning to note some tightness in her airway. She arrived at (Institute name) emergency department (ED) and was given epinephrine and methylprednisolone at 7:20 PM. Swelling of throat and face decreased. She was discharged from the ED at 11 PM and made it to her vehicle when she began to feel tightness in her throat again. She received a second dose of IM epinephrine at 11:58 PM. Tightness improved with second dose as well. At time of the report the patient was under observation in ED for any changes in status. The event resulted in emergency room/department or urgent care. The treatment for the events included two doses of epinephrine, one dose of methylpred. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient hadn't been tested for COVID-19. The events 'soreness on her gums', 'face, lips, nose puffy and edematous' were serious for being medically significant. The event throat and chest tight was serious for being life threatening. The reporter causality for 'Soreness on her gums', 'face, lips, nose puffy and edematous', and 'throat and chest titght' were related. The registered nurse calling regarding the COVID 19 vaccine. She thought she had an anaphylactic reaction to the vaccine. She started to experience symptoms on 22Dec2020 at 6:00PM. She had gone to bed at 10:00AM after night shift on 22Dec2020. Stated she noticed some soreness on her gums at that time. She woke up at 6:00PM; and her face, lips, and nose were puffy and edematous. She didn't have any trouble breathing at that time so she drove herself to an urgent care. The first urgent care didn't have a doctor on site so she drove on to a second urgent care. The second one didn't have any epinephrine so she drove on the emergency room at (institute name)  where she was treated with Epinephrine at 7:30pm. By the time she got to the ER, she felt her throat and chest were tight. She improved with the epinephrine and she was discharging at 11:00PM but she felt her throat was tight again so at 11:30PM she was given another dose of Epinephrine and had some improvement but not as fast as the first time. It took about an hour for the inflammation to go down and her throat felt better and she was discharged. She was also treated with Methylprednisolone by IV. She has no product information to provide NDC, lot or expiration date for the epinephrine or the methylprednisolone she was given in the ER at the hospital. The soreness in her gums has completely resolved; the edema in the face, lips and nose has improved; but she does feel some feels some residual tightness in her throat. Her provided advised the tightness may remain due to the inflammation. Her provider did not recommend she take the second dose of COVID 19 vaccine. Relevant tests was none. The patient was resolved from soreness on her gums on 23Dec2020, and recovering from the rest events.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of anaphylactic reactions presented as soreness/ irritation of gums / angioedema et al resolving under antiallergic therapies including epinephrine and methylpred cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.