Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Heart rate increased, Injection site pain, Lethargy, Lip swelling, Lymphadenopathy
Clinical narrative: Fainted; Vaso-vagal response; Low heart rate / heart rate dropped; High heart rate / heart rate is higher in 54 range compared to usually it is in 32 range; Swollen lymph nodes / swollen lymph nodes in the neck; Coughing phlegm; Difficulty breathing; Loss of appetite; Lethargy; Voice change; Wheezing / occasional wheezing; Pain at injection site / , soreness at injection site; lip swelling; Pain / pain from left upper arm across chest to right deltoid and shoulder; pain from left upper arm across chest to right deltoid and shoulder; pain from left upper arm across chest to right deltoid and shoulder; This case was reported by a nurse via call center representative and described the occurrence of fainting in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABX794AB, expiry date 31st August 2020) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   The patient's past medical history included oral allergy syndrome. Concurrent medical conditions included allergy to plants, iodine allergy and pollen allergy.   On 29th April 2019, the patient received Bexsero (intramuscular) .5 ml and Havrix (intramuscular) 1 ml. On an unknown date, less than a month after receiving Bexsero and Havrix, the patient experienced fainting (serious criteria GSK medically significant), vasovagal reaction, heart rate low, heart rate high, enlargement of lymph nodes, productive cough, difficulty breathing, appetite lost, lethargy, voice alteration, wheezing, injection site pain, lip swelling, pain in arm, chest pain and shoulder pain. On an unknown date, the outcome of the fainting, vasovagal reaction, heart rate low, heart rate high, enlargement of lymph nodes, productive cough, difficulty breathing, appetite lost, lethargy, voice alteration, wheezing, injection site pain, lip swelling, pain in arm, chest pain and shoulder pain were unknown.   It was unknown if the reporter considered the fainting, vasovagal reaction, heart rate low, heart rate high, enlargement of lymph nodes, productive cough, difficulty breathing, appetite lost, lethargy, voice alteration, wheezing, injection site pain, lip swelling, pain in arm, chest pain and shoulder pain to be related to Bexsero and Havrix.  Additional details were provided as follows: The patient received Havrix and Bexsero on the left arm. In 2019, the patient fainted and his heart rate dropped while in the office. The paramedics arrived and they determined that, the patient had a vaso-vagal response and fainted. The patient stated that, his heart rate was higher in 54 range compared to usually it was in 32 range.  The patient also experienced swollen lymph nodes in the neck, coughing phlegm, difficulty breathing, loss of appetite, lethargy, voice change, occasional wheezing, soreness at injection site and pain from left upper arm across chest to right deltoid and shoulder. At the time of reporting, the patient's mother called to the office and stated that, the patient had lip swelling. The patient refused to go to the hospital and then the patient followed up at an urgent care. The patient visited to the physician's office twice already and most recently on 13th May 2019. The emergency room visit required. No further details were provided.