Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Swollen tongue, Throat irritation, Throat tightness, Tongue oedema
Clinical narrative: chest pressure; mild steroid induced hyperglycemia; funny sensations leading down the left arm; throat got to the point of being so swollen and itchy; throat got to the point of being so swollen and itchy; anaphylaxis; flushing/facial flushing; hives; Felt warm; shortness of breath/couldn't breathe; wheeze; red rash to the chest which progressed to the face; respiratory distress; respiratory distress; cough; choking sensation; throat tightening; angioedema/tongue swelling; she couldn't swallow; mild tongue edema; This is a spontaneous report received by Pfizer via US FDA (Regulatory authority report number: 903400). A contactable other healthcare professional (HCP) and a consumer reported that a 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on the left arm on 17Dec2020 at a single dose for COVID-19 immunization. Medical history included allergy to fish, iodine, shellfish (anaphylaxis to fish in 2015 (although IgE testing was negative as per patient), prohance contrast in 2015), severe allergies, cat bite, respiratory (resp) distress, hypothyroidism, hyperlipidaemia (HLD), osteoporosis, gastroesophageal reflux disease (GERD), vertigo, and asthma diagnosed in 2015, previously on Brio/Rescue inhaler, currently on Montelukast and Proair. Concomitant medications included atorvastatin, levothyroxine, montelukast for asthma, salbutamol sulfate (PROAIR) for asthma. The patient previously received a rabies vaccine (GSK #) on 30Apr2018 post cat bite-she had respiratory distress with no intubation. She had an allergy with this rabies vaccine. The patient also reported prior history of (h/o) severe allergic reaction to influenza vaccine with eggs preservative. She has received vaccine without (w/o) egg w/o problem. Due to her prior history of severe reaction/anaphylaxis to another vaccine, in this case is the flu vaccine with eggs, it was noted to proceed with caution. She was told that the vaccination could be deferred until more information becomes available. She opted to proceed with receiving Pfizer-BioNTech Vaccine and be on a 30-minute observation period. She was pre-medicated prior to the vaccine with Dexamethasone Acetate 4 mg and Diphenhydramine Hydrochloride 25 mg. Prior to that, the patient only had breakfast at 4:00 AM which consisted of Cheerios, she did not have anything else additional to eat prior to receiving the vaccine. It was reported that, 5 minutes after the Pfizer Covid-19 vaccine administration on 17Dec2020, the patient experienced flushing, hives, felt warm and eventually, shortness of breath. She received Epi Pen within 1 minute of symptoms. When she started to wheeze, she was wheeled into the emergency room (ER) complaining of (c/o) 'couldn't breathe' while holding her throat and thrashing with facial flushness. The patient developed throat tightening approximately 20 minutes after the vaccination. She had taken another dose of Epi Pen IM and Diphenhydramine 50mg by mouth prior to coming. She was then admitted to the hospital for further observation. While on the floor, she started to feel short of breath again (about 9 AM on), which required a registered respiratory therapy (RRT). The patient took 2 Benadryl and had several Epi shots. The patient was evaluated in the emergency department (ED) and was hypo dynamically stable. Then 40 minutes after the injection, her throat and tongue started to feel weird and tight. The pharmacy at her work hospital gave her 25 mg Benadryl and 650 mg Tylenol. Then 1 hour and 45 minutes after the injection, her throat got to the point of being so swollen and itchy that she couldn't swallow. She went to the nearest emergency room hospital where she was given Decadron and Pepcid - both orally and Toradol via intramuscular route. The patient received another dose of Diphenhydramine IV, Methylprednisolone 125 mg IV and several doses of IM Epinephrine. She also required oxygen. It was also reported that almost immediately after having the vaccine, the patient began to have a red rash to the chest which progressed to the face, she then began to experience shortness of breath followed by respiratory distress, she self-administered Epinephrine, received additional steroids, Pepcid, Epinenephrine then was observed and sent home on Diphenhydramine Hydrochloride Q6hrly. Around 11:20 pm on that same day, she began to experience cough and wheezing, she initially thought it was asthma but noticed additional hives and started to experience respiratory distress. She self-injected her Epi Pen and went to the ED. In the ED, she was noted to be in respiratory distress and was complaining of cough, choking sensation, she received an additional dose of Epinephrine, Pepcid, Steroids and Diphenhydramine Hydrochloride and was admitted to the medicine floor for observation. While on the floor she began to experience another episode of anaphylaxis described as throat tightening, wheezing with the rash developing over chest. This progressed to angioedema/tongue swelling despite appropriate treatment with IM Epi 0.5 mg x 2 and steroids. ENT scoped at bed side with pertinent endoscopy findings showed intact septum, boggy nasal turbinates, pale middle meatal mucosa, no lesions within nasopharynx, non-obstructive base of tongue but with mild edema almost touching epiglottis, epiglottis in normal position with no lesions, no edema of false cords, true cords mobile, no edema of arytenoid and post-cricoid mucosa, no pooling in hypopharynx. The remainder of the examination was normal. Post procedure diagnosis showed mild tongue edema but with widely patent larynx. She was then discharged from the ER and later that day, started to feel short of breath again. She was initiated on an Epinephrine Drip and transferred to the ICU. The patient continued on the Epi drip and was weaned on around 18:59 on 18Dec2020, with symptoms of tongue swelling improving. The patient was fed and shortly after (pasta with a meat sauce thought to be beef and apple sauce), the dietician was contacted to confirm practices of meal preparation in the hospital kitchen for possible cross contamination with fish. After dinner, she began to feel facial flushing especially to the left side of her face with funny sensations leading down the left arm and associated chest pressure, EKG showed normal sinus rhythm, she was placed on oxygen via nasal cannula and Epi drip restarted. Predominantly all symptoms were upper airway with no signs of systemic shock, she did not experience vomiting or diarrhea. Course was also complicated by mild steroid induced hyperglycemia; endocrine was consulted to assist in management. She was transferred for continued management, continued on Epi 2 mcq/min and remained asymptomatic. In the ED on 11Jan2021, she was audibly gasping for air; however, she had no wheezing, had a normal saturation and a normal blood pressure. She was given IV Benadryl throughout observation. The outcome of the events funny sensations leading down the left arm, mild steroid induced hyperglycemia, chest pressure and 'she couldn't swallow' was unknown, the event mild tongue edema was resolving while the rest of the events had not resolved.   Follow-up (09Jan2021): New information received from a non-contactable consumer from the Pfizer-sponsored program, Corporate (Pfizer) Social Media Platforms, includes additional reporter, reaction details, medical history and clinical course details.