Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling size of ball was measured to be 3 to 4 inches; pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On 25-APR-2024, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine (right arm), dTpa vaccine (right arm) and HPV vaccine (left arm). On 25-APR-2024, less than a day after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, dTpa vaccine and HPV vaccine, the patient experienced extensive swelling of vaccinated limb (Verbatim: swelling size of ball was measured to be 3 to 4 inches) and injection site pain (Verbatim: pain). (Dechallenge was negative). The outcome of the extensive swelling of vaccinated limb and injection site pain were not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site pain to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, dTpa vaccine and HPV vaccine.     It was unknown if the company considered the extensive swelling of vaccinated limb and injection site pain to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, dTpa vaccine and HPV vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2024 The reporter was the parent of a male patient who reported on June 12th, 2024, that an 11 year old male had a reaction to Menveo and Boostrix vaccines administered on April 25th, 2024.  Reporter did not have lot or expiry date of Menveo or of Boostrix. Parent reported that Menveo vaccine and Boostrix vaccine were administered in the right arm.  Parent also reported that the child was administered the Human Papilloma vaccine in the left arm on the same day.  Parent reported that the area of the injection of Menveo and Boostrix developed a ball shape reaction that was painful and had increased the circumference of the left arm. Parent reported the child was taken to the doctor and ice was applied. Several days later the ball increased in size and patient return to the doctor. Reporter states that the child was recommended to apply warm compresses on the affected arm.  Parent reported that still until this day the swelling and pain had not resolved.  Reporter stated that the pain had increased as well. Parent reported the left arm was normal and had an 8 inches circumference. Parent reported that the right arm has a 9.5 inches circumference. Parent reported that the size of the ball was measured and it measures 3 to 4 inches. Parent reports that he was not given a brand name for neither of the vaccines. Parent states that he was given GlaxoSmithKline phone number to call and ask questions about the side effects.  It is unknown the manufacturing company because the lot number was not provided to confirm if they were both GlaxoSmithKline. The report will use the brand name for documentation only.