Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Scratch, Swelling face, Tongue movement disturbance, Vaccine positive rechallenge
Clinical narrative: injection site swelling; injection site redness; splotchy rash, both legs; moved tongue across roof of mouth; behavior episodes; self inflicts scratches on  arm; fits of rage; Second dose of Kinrix; HEP B vaccines on March 23, 2021 and August 3 , 2021; weakness; redness under eye; swelling on left side of face; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included MMR (received MMR vaccine on an unknown date in 2019), Varicella (received varicella vaccine on an unknown date in 2020) and Kinrix with an associated reaction of erythema (on 23rd March 2021 received 1st dose, refer case US2022035982). Concurrent medical conditions included neurogenic bladder.   On 3rd August 2021, the patient received the 2nd dose of Kinrix (intramuscular) .5 ml, Kinrix Pre-Filled Syringe Device and the 2nd dose of Hepatitis B vaccine. On 3rd August 2021, less than a day after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced erythema periorbital, facial swelling, extra dose administered and drug dose administration interval too long. In August 2021, the patient experienced weakness. In October 2021, the patient experienced behavior abnormal, scratch and rage. On an unknown date, the patient experienced injection site swelling, injection site erythema, blotchy rash and tongue movement disturbance. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Kinrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, blotchy rash, tongue movement disturbance, behavior abnormal, scratch, rage, weakness, extra dose administered and drug dose administration interval too long were unknown and the outcome of the erythema periorbital and facial swelling were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, erythema periorbital, facial swelling, blotchy rash, tongue movement disturbance, behavior abnormal, scratch, rage and weakness to be related to Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: This case was reported by the patient's mother. The patient had spinal surgery in April 2021. The patient received 2nd dose of Kinrix in the left arm, which led to extra dose administered. The patient also received Hepatitis B vaccine as the same time as Kinrix vaccination but she undisclosed manufacturer. Within hours after the second vaccination, the patient experienced swelling on the left side of her face, and redness under her eye. Within 2 days these symptoms resolved.   Less than nine months after vaccination, the patient also experienced injection site redness and swelling, a splotchy rash on both legs, and tongue movement like moved the tongue across of the roof of her mouth.  The patient was referred to an allergist.  Benadryl was given to treat symptoms. Less than a month after vaccination, the patient experienced weakness since August 2021. The patient had an MRI in November 2021 but result not provided. Between 1 and 3 months after vaccination, the patient had more behavior episodes in October through December 2021 in which she self inflicted scratches on her arm and had fits of rage. The consent to follow up was given. For tolerance of 3rd dose refer case US2022AMR037929.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035983:FU1- Deleted US-GLAXOSMITHKLINE-US2022035982:Same reporter, same patient, different dose US-GLAXOSMITHKLINE-US2022AMR037929:Same reporter, same patient, different dose