Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site haematoma, Investigation
Clinical narrative: This is a spontaneous report received from a contactable female consumer reported for herself that a 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6203, Expiration date: unknown) via an intramuscular route on left arm on 08Mar2021 at 13:10 (at the age of 65-year-old) as a single dose for COVID-19 Immunization. The patient medical history included ongoing Autonomic neuropathy (Affected her digestive tract. Lost teeth, part of esophagus, gall bladder, stomach and large part of small intestine), Clostridium difficile, several anaphylactic reactions (immediate anaphylactic reaction with bee sting), malnutrition, walker, hypoglycemic, dermatitis from gloves, Hives for several medication (Reglan, compazine, levaquin, cipro, doxycylcine, zpac, arithromycin, sulfa drugs-macrodantin, chorhexadine, tropomate tramadol, msl4, codeines, hydrocodone, oxycodone, ultracept, Carries 4 epi pens in different locations), allergy: corticosteroids, on J tube 12 years, PICC line for 3 years, stomach had to be taken out (A tiny pouch was made where they connected what was left of her esophagus to small intestine. The pouch is the size of a quarter). The patient concomitant medication included teduglutide (GATTEX, Lot number: 1908G, expiration date: Apr2023) ongoing at a dose of 5ml, daily; dicyclomine (capsule, expiration date: 16Mar2022) ongoing at 10mg (2 capsules 3 minutes before meals and bedtime) from an unknown date in 2002; sucralfate (expiration date: Oct2021) ongoing at 100kg/m3, 4 times a day for help keep food down, colesevelam hydrochloride (expiration date: May2022) ongoing at 625mg, twice a day for help aide digestion, fludrocortisone (tablet, expiration date: 23Jan2022), ondansetron (ZOFRAN, Lot number: ON0820008-A, Expiration date : Jan2024) ongoing at 8mg as needed for nausea; midodrine (Expiration date: 22Oct2021) ongoing from 2018 at a dose of 5mg, thrice a day for orthostatic hypotension; alprazolam (tablet) at a dose of 1 mg; ongoing gabapentin. On 8Mar2021, with 5 minutes after vaccination had an anaphylactic reaction- Was taken by ambulance-Caller couldn't breathe or swallow- tongue was thick, couldn't breathe, Tachycardia, chest hurt and felt bruised afterwards, Nausea, Constipated, Oxygen level was down to 90, legs and arms were flapping, could not swallow, felt like she had brain fog. Nurse watched her carefully and she was sent to sit for 30 minutes. The doctor gave her a shot of Epinephrine and it backfired, so she didn't get it. The other doctor got it and the ambulance was there working on her. Oxygen level was down to 90 and was given Decadron. Her legs and arms were flapping due to her disease, because epinephrine was a vasodilator. It was reported that in ambulance patient Was being asked questions and she couldn't talk on 08Mar2021. The patient was taken to the hospital and was given more benadryl, and more epinephrine. Then she felt better over the next few days. She saw her own physician the next day and was given Solumedrol in her tush, 40 mg prednisone twice a day, for 3 days. The patient felt her cognitive skills were not working well the first few days and could not walk very well, even with her walker on an unknown date in Mar2021and dropped 5 dishes in one day. Caller provided information regarding article from British government stating people with history of anaphylaxis should not take Pfizer vaccine. Article stated FDA is still working with Pfizer on this. The patient states she should never have been given that shot and requests for compensation. The patient reported that she was never been so afraid in life. The patient had hematoma after 3 sticks for IV in ambulance on 08Mar2021 and had warm hot packs on it. The patient Oxygen level was low and was given 2liters nasal cannula, which was bumped up to 4 liters. The patient felt like a robot, did not have good control of legs or arms and flailing like baby when epinephrine was given. The patient took Fludrocortisone for Adrenal insufficiency, With all the steroids, should have felt fabulous but didn't. The patient Clarified Epinephrine junior was given in the thigh and backfired. Was given Epinephrine in her other thigh, Was given Benadryl at Vaccine facility. In emergency room patient received Famotidine IV 20mg/50ml STAT 1 dose, Sodium Chloride 0.9% 1000 ml over one hour STAT for hydration, Another sodium chloride 0.9% 1,000ml, Another sodium chloride 0.9% 1,000ml and discharged from emergency room after 6 hours. The patient stated she could not have second COvid-19 Vaccine that was scheduled for this coming Monday. The patient had undergone laboratory test on08Mar2021 potassium was 2.9, EKG was abnormal (tachycardia) and standard blood work was unknown. The outcome of the events anaphylactic reaction was recovering, tongue was swollen was recovered on an unknown date in Mar2021 while for other events was unknown.  Follow-up Information has been requested.; Sender's Comments: Based on known drug safety profile and close temporal association the event of Anaphylactic reaction is assessed as related to the suspect vaccine BNT162B2. As there is limited information in the case provided for gait disturbance, adrenal insufficiency and injection site haematoma, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.