Age: 16.0
Sex: F
Vaccine: HPVX, MEN, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: This case was reported by a nurse via licensee and described the occurrence of injection site swelling in a 16-year-old female patient who received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Co-suspect products included Meningitis B vaccine and HPV vaccine. On 6th November 2015, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, Meningitis B vaccine and HPV vaccine. On 6th November 2015, less than a day after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced injection site swelling and feeling unwell. On 7th November 2015, the patient experienced fever. In November 2015, the patient experienced injection site erythema, injection site warmth and injection site pain. The patient was treated with ibuprofen. On 8th November 2015, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, feeling unwell, injection site erythema, injection site warmth and injection site pain were unknown. The reporter considered the injection site swelling, feeling unwell, fever, injection site erythema, injection site warmth and injection site pain to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: On 6th November 2015, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and TRUMENBA in her left arm as well as Human Papillomavirus 9 valent vaccine in her right arm. On the same day, the patient complained that she had swelling at the base of her shoulder and she was feeling sick. Over the weekend, i.e. on 7th November 2015, 1 day after receiving the vaccines, the patient experienced fever on and off till 8th November 2015. The patient then received Ibuprofen. A day before time of reporting, on 9th November 2015, the patient visited the office. In November 2015, less than a week after receiving the vaccines, according to the nurse the patient's shoulder look red, hot to touch and continued to complain of sharp pain and tenderness from the shoulder to the upper neck. The sales representative of other manufacturer did not have any patient details like her medication history and other details. The doctor did not know but they suspect that all the adverse events were related to the vaccines. The doctor did not know if it was the combination of the vaccines or a single vaccine and they were actually calling to find out that and the sales representative told them to call to find the information. The reporter was called back to confirm the reporter of the adverse event and nurse was confirmed to be the reporter who had same address and contact as of doctor. The reporter did not had email address of the doctor. The reporter had limited information regarding the patient. It was unknown if the reporter considered the injection site swelling, feeling unwell, fever, injection site erythema, injection site warmth  and injection site pain to be related to TRUMENBA and Human Papillomavirus 9 valent vaccine. This case has been linked to case US2015GSK172249, reported by the same reporter.