Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Peripheral swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of choking in a adult female patient who received HAVRIX adult (batch number 53D2R, expiry date 19th December 2019). The patient's past medical history included eye pruritus, itchy throat and watering eyes. Concurrent medical conditions included seasonal allergy. On 20th March 2018, the patient received the 1st dose of HAVRIX adult 1 ml. In March 2018, less than a week after receiving HAVRIX adult, the patient experienced erythematous rash, itchy rash, scratch and infected rash. On 20th March 2018, the patient experienced allergic reaction and skin eruption. On 23rd March 2018, the patient experienced hives. On 26th March 2018, the patient experienced cough and influenza-like symptoms. On 6th May 2018, the patient experienced choking (serious criteria GSK medically significant). On 7th May 2018, the patient experienced eye swelling, shortness of breath and swelling of limb. The patient was treated with KENALOG, hydrocortisone, ZYRTEC, ATARAX, antihistamine, MEDROL, Bactrian and PEPCID. On an unknown date, the outcome of the choking and cough were recovered/resolved and the outcome of the hives, allergic reaction, erythematous rash and itchy rash were not recovered/not resolved and the outcome of the skin eruption, shortness of breath, influenza-like symptoms, scratch and infected rash were unknown and the outcome of the eye swelling and swelling of limb were recovering/resolving. The reporter considered the choking, hives, allergic reaction, skin eruption, erythematous rash, eye swelling, shortness of breath, swelling of limb, scratch and infected rash to be related to HAVRIX adult. It was unknown if the reporter considered the itchy rash, cough and influenza-like symptoms to be related to HAVRIX adult. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient claimed that she suffered only from seasonal allergies where she had itchy eyes, throat and watery eyes. Concomitant medications included birth control pills. The patient received HAVRIX adult in the right arm. Less than a days after vaccination, the patient experienced a severe allergic reaction and break out. In the noon on Tuesday, 20th March 2018, the patient started to break out and on Friday, 23rd March 2018, the rash appeared on her ankle and up the inside of her right leg. The patient experienced a big round, larger than a quarter, very red rash with rough edges that itched on both legs. The rash became infected from scratching. Three days after vaccination, the patient experienced hives. The patient changed doctors because they thought it was a bite on her legs and after a biopsy, it came back as hives. Initially they could not diagnose her as having hives and they thought it was infected skin. Six days after vaccination, the patient experienced cough and flu like symptoms. Forty seven days after vaccination, the patient experienced choking. Forty eight days after vaccination, the patient experienced swollen eyes, dyspnea, swelling from left and right arm and left and right leg. On 7th May 2018, the patient awoke with a swollen eye and her eye completely shut down from swelling. She had been on an antihistamine for 6 weeks and the dose was three times the normal dose per day and she felt drunk from the antihistamine but it had no effect. They gave her a KENALOG 40 mg injection to bring down the swelling from her left and right arm and left and right leg and her eye. The patient's eye swelling had gone down after the injection but she still had the itching sensation from the rash or hives. The patient had been staying away from seafood and her arm was full of hives on 7th May 2018. The patient was also prescribed a Hydrocortisone prescription with a MEDROL PAC 4 mg for 5 days and a Bactrian antibiotic, ZYRTEC, PEPCID Acid and ATARAX at night. Before the course was finished, the rash appeared on other parts of her body including her neck. The patient's healthcare professional (HCP) suspected it was hives and referred her to her dermatologist and she went to the dermatologist and they did a biopsy and blood work. The biopsy came back that it was hives but she was waiting for the blood work which should come on 8th May 2018 or on 9th May 2018. The patient believed that all of her symptoms were related to the HAVRIX vaccine except she was uncertain about the flu like symptoms she experienced. The patient's HCP believed it was a food allergy or the HAVRIX vaccine.