Sex: F
Vaccine: HEP
Symptoms: Insomnia, Lip swelling, Somnolence, Swelling face, Throat tightness
Clinical narrative: site where she got the vaccine injection showed hives; site where she got the vaccine injection showed hives and the area was warm/red for a few days; site where she got the vaccine injection showed hives and the area was warm/red for a few days; Facial swelling; Lip swelling; drowsy; exacerbations of her asthma; wheezing; fell asleep; Throat tightness; trouble breathing / gasping for air; This case was reported by a other health professional and described the occurrence of injection site hives in a 33-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing. On an unknown date, the outcome of the injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing were unknown.   It was unknown if the reporter considered the injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The reporter reported an adverse event that was brought to his/her attention. The reporter got a call from an allergy clinic customer who had a patient came in, had been given their Engerix-B for Hepatitis B vaccine, and was not sure if the reaction she had was due to their vaccine. They were referred this patient from a family practice clinic to see if they could test for it. The information reporter was given was, after being given the Hepatitis-B vaccine, she developed facial and lip swelling/throat tightness hours later. She took Benadryl and it caused her to be drowsy, so she fell asleep. She woke up later and had exacerbations of her asthma, trouble breathing, wheezing, gasping for air. She took her asthma inhaler and more Benadryl. The site where she got the vaccine injection showed hives and the area was warm/red for a few days. The patient received Engerix-B for Hepatitis-B. This was the only vaccine the patient received. The manufacturer was not reported, and the call was made on 31st October 2022. Additional supportive information: Concomitant medication BENADRYL was only retained in narrative, as the ingredient was "NOS" which leads to report failure. Follow-up would not be possible as no contact details were available.