Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Fibromyalgia, Flushing, Hypoaesthesia, Hypotension, Injection site bruising
Clinical narrative: legs would turn red from her knees down and her feet would be so red they looked almost purple; asthma; small fiber neuropathy; fibromyalgia; low blood pressure; medium nerve damage; numbness; bluish in color; feet where very painful; left arm is swollen from mid-lower arm down to her knuckles; cognitive problems; trouble talking; Her fingers are ice cold; vertigo/dizzy; tingling; red on her upper arm where she received the injection; rash; whole body felt like it was bruised all over; full anaphylactic reaction; flushing; Feeling dizzy; trouble breathing; became unresponsive; troubble keeping consiousness; hot to touch; Skin warm; hives; This case was reported by a consumer via call center representative and described the occurrence of asthma in a 44-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 25th January 2019, the patient received the 1st dose of Engerix B (intramuscular). On 25th January 2019, 30 min after receiving Engerix B and an unknown time after starting Zyrtec, the patient experienced anaphylaxis (serious criteria disability, GSK medically significant, life threatening and clinically significant/intervention required), flushing (serious criteria disability, life threatening and clinically significant/intervention required), dizziness (serious criteria life threatening), difficulty breathing (serious criteria disability, life threatening and clinically significant/intervention required), unresponsive to stimuli (serious criteria disability, GSK medically significant, life threatening and clinically significant/intervention required), consciousness disturbed (serious criteria GSK medically significant and life threatening), feeling hot (serious criteria disability, life threatening and clinically significant/intervention required), skin warm (serious criteria disability, life threatening and clinically significant/intervention required) and hives (serious criteria disability, life threatening and clinically significant/intervention required). In July 2019, the patient experienced asthma (serious criteria disability, life threatening and clinically significant/intervention required), small fiber neuropathy (serious criteria disability, life threatening and clinically significant/intervention required), fibromyalgia (serious criteria disability, life threatening and clinically significant/intervention required), low blood pressure (serious criteria disability, life threatening and clinically significant/intervention required), nerve damage (serious criteria disability, life threatening and clinically significant/intervention required), numbness (serious criteria disability, life threatening and clinically significant/intervention required), injection site discoloration (serious criteria disability, life threatening and clinically significant/intervention required), foot pain (serious criteria disability, life threatening and clinically significant/intervention required), extensive swelling of vaccinated limb (serious criteria disability, life threatening and clinically significant/intervention required), cognitive disturbance (serious criteria disability, life threatening and clinically significant/intervention required), speech disorder (serious criteria disability, life threatening and clinically significant/intervention required), fingers cold feeling of (serious criteria disability, life threatening and clinically significant/intervention required), vertigo (serious criteria disability, life threatening and clinically significant/intervention required), tingling (serious criteria disability, life threatening and clinically significant/intervention required), injection site erythema, rash and contusion. On an unknown date, the patient experienced redness of legs. The patient was treated with ranitidine hydrochloride (Zantac), cetirizine hydrochloride (Zyrtec), epinephrine, benadryl (nos) (Benadryl), steroids nos (Steroids), fexofenadine hydrochloride (Allegra), cromoglicate sodium (Cromolyn Sodium) and steroids nos (Steroid Inhaler). Engerix B was discontinued. On an unknown date, the outcome of the asthma, anaphylaxis, flushing, dizziness, difficulty breathing, unresponsive to stimuli, consciousness disturbed, feeling hot, skin warm, hives, low blood pressure, injection site discoloration, foot pain, extensive swelling of vaccinated limb, cognitive disturbance, speech disorder, fingers cold feeling of, vertigo, injection site erythema, rash, contusion and redness of legs were unknown and the outcome of the small fiber neuropathy, fibromyalgia, nerve damage, numbness and tingling were not recovered/not resolved.   It was unknown if the reporter considered the asthma, small fiber neuropathy, fibromyalgia, anaphylaxis, flushing, dizziness, difficulty breathing, unresponsive to stimuli, consciousness disturbed, feeling hot, skin warm, hives, low blood pressure, nerve damage, numbness, injection site discoloration, foot pain, extensive swelling of vaccinated limb, cognitive disturbance, speech disorder, fingers cold feeling of, vertigo, tingling, injection site erythema, rash, contusion and redness of legs to be related to Engerix B.  Additional details were provided as follows: The patient received the Engerix-B and about 30 min after the injection her face started feeling hot, and the nurse noted that she was flushed. She started feeling dizzy and was instructed to lay down on her right side. She had trouble keeping consciousness and breathing and eventually became unresponsive. Her respiration was 10 and her heart rate 114. She was administered epinephrine and taken to the emergency room (ER) by ambulance. She went home later that day, but the next day, the symptoms returned and she had to go to the emergency room (ER) again. The patient was started on steroids and Benadryl. The steroids and Benadryl helped, but she kept having small reactions during the night when the medications wore off. Later she had a full anaphylactic reaction again. She saw an allergist and was started on a Zantac, Zyrtec and Allegra regimen. She did better on that regimen, but still had episodes of hives and flushing. She also experienced several anaphylactic reactions. She was referred to another allergist and started on Cromolyn sodium, a mast cell stabilizer.  She has been on that for about 1 month and has not had an anaphylactic reaction since July 2019. Her last anaphylactic reaction in July 2019, had her blood pressure at 80-48 with a rash. She was administered epinephrine, but the reaction rebounded at the emergency room (ER) where she was given Benadryl and steroids. The 2nd allergist also diagnosed her with asthma and she started taking a steroid inhaler. A few weeks after getting the vaccine she started experiencing numbness and tingling (paresthesia) in her lower legs, feet hands and arms. When standing her legs would turn red from her knees down and her feet would be so red they looked almost purple. Her feet where very painful and her whole body felt like it was bruised all over. She saw a rheumatologist, who did a biopsy and was diagnosed with fibromyalgia and small fiber neuropathy. A nerve conduction study was performed and showed medium nerve damage. She has to use a walker and wheelchair due to the nerve damage in her legs. Her left arm, where she received the injection, still turns red on her upper arm where she received the injection. Her left arm is swollen from mid-lower arm down to her knuckles, is hot to the touch and bluish in color. Her fingers were ice cold. Her arm will also randomly go numb. She has also been experiencing severe vertigo such that she had to lay down and cover her head. She was also having cognitive problems where she was having trouble talking. She tested positive on a test done by her rheumatologist showing she was at high risk of developing an autoimmune disease. The reporter did not consent to follow-up.