Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Abnormal behaviour, Asthenia, Erythema, Peripheral swelling, Scratch
Clinical narrative: Behavioral changes; scratch; weakness; localized redness, arm; Swelling of arm; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 6-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) and Varicella (received varicella vaccine on an unknown date in 2020). Concurrent medical conditions included neurogenic bladder.   On 23rd March 2021, the patient received the 1st dose of Kinrix (intramuscular) .5 ml, Kinrix Pre-Filled Syringe Device and the 1st dose of Hepatitis B vaccine. In March 2021, 2 days after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced erythema of extremities and swelling arm. In August 2021, the patient experienced weakness. On an unknown date, the patient experienced behavior abnormal and scratch. On an unknown date, the outcome of the erythema of extremities, swelling arm, weakness, behavior abnormal and scratch were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, weakness, behavior abnormal and scratch to be related to Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR037928, US2022AMR037929  Additional details were provided as follows: The reporter was the mother of the patient.  The patient had not received any prior vaccinations prior to this with the exception of MMR in 2019, and Varicella in 2020. She stated that her daughter received her first dose of Kinrix in right arm. The patient also received Hepatitis B vaccines (undisclosed manufacturer) at the same time as the Kinrix vaccinations.   Approximately 2 days after the first vaccination, the patient experienced localized redness and swelling of her arm.  The patient also self inflicted scratches to both arms and made herself bleed. The reporter stated that between 4 and 6 months after vaccination she had noticed that her daughter experienced weakness since August 2021 (had an MRI in November 2021). On an unknown date, less than 5 months after vaccination with 1st dose of Kinrix the patient experienced behavior abnormal and scratch. The reporter gave consent to follow-up with health care professional. Note: it was stated that the patient experinced weakness in Aug 2021 and patient received 2nd dose on 3rd Aug 2021, hence weakness was coded as event in this case conservatively. For tolerance of 2nd dose refer case US2022AMR037928 and for tolerance of 3rd dose refer case US2022AMR037929.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035983:FU1- Deleted US-GLAXOSMITHKLINE-US2022AMR037928:Same reporter, same patient, different dose US-GLAXOSMITHKLINE-US2022AMR037929:Same reporter, same patient, different dose