Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Asthenia, Contusion, Extra dose administered, Inappropriate schedule of product administration, Induration
Clinical narrative: weakness; arm hurts; arm fels hard; arm, bruising; fever; arm mottled; injection site redness, splotchy pocket underneath skin; Injection site swollen; injection site hot to touch; injection site looks like bugbite; redness is described/spread up towards the shoulder and is painful and itchy; redness is described/spread up towards the shoulder and is painful and itchy; third dose of Kinrix; Hep B vaccine, second on 03AUG2022, third 22FEB2022; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema 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.   The patient's past medical history included spinal operation (had in April 2021), erythema of extremities (after 1st dose), swelling arm (after 1st dose), behavior abnormal (after 1st and 2nd dose), scratch (after 1st and 2nd dose), erythema periorbital (after 2nd dose), facial swelling (after 2nd dose), blotchy rash (after 2nd dose), tongue movement disturbance (after 2nd dose) and rage (after 2nd dose). Previously administered products included MMR vaccine (received a dose on an unknown date in 2019), Varicella vaccine (received a dose on an unknown date in 2020), Kinrix with an associated reaction of erythema (received 1st dose on 23rd March 2021, for the tolerance of 1st dose refer linked case US2022035982), Kinrix with an associated reaction of injection site erythema (received 2nd dose on 03rd August 2021, for the tolerance of 2nd dose, refer linked case US2022AMR037928), Hepatitis B vaccine with an associated reaction of erythema (received 1st dose on 23rd March 2021, for the tolerance of 1st dose refer linked case US2022035982) and Hepatitis B vaccine with an associated reaction of injection site erythema (received 2nd dose on 03rd August 2021, for the tolerance of 2nd dose, refer linked case US2022AMR037928). Concurrent medical conditions included neurogenic bladder.   On 22nd February 2022, the patient received the 3rd dose of Kinrix (intramuscular) .5 ml, Kinrix Pre-Filled Syringe Device and the 3rd dose of Hepatitis B vaccine. On 22nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Hepatitis B vaccine, the patient experienced extra dose administered and drug dose administration interval too long. On 23rd February 2022, the patient experienced injection site erythema, injection site swelling, injection site warmth, injection site induration, injection site pain, injection site itching and mottled skin. On 24th February 2022, the patient experienced fever. On 25th February 2022, the patient experienced pain in arm, induration and bruising of arm. On an unknown date, the patient experienced weakness. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Kinrix was positive. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site induration, injection site pain, injection site itching, fever, pain in arm, induration, mottled skin, bruising of arm, weakness, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site induration, injection site pain, injection site itching, fever, pain in arm, induration, mottled skin, bruising of arm 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: The case was reported by the patient's mother which was registered nurse.   The patient received 3rd dose of Kinrix, which led to extra dose administered in left arm.    The patient also received 3rd dose of Hepatitis B vaccines on the same date of Kinrix, later than the recommended schedule which led to lengthening of vaccination schedule. The following day after receiving 3rd dose of Kinrix and Hepatitis B vaccine, the patient experienced injection site redness.   The redness was described as splotchy pockets underneath her skin, which was swollen and hot to the touch.   It had spread up towards the shoulder and was painful and itchy.   The patient had a low-grade fever. The body temperature was recorded as 100.6 Degree F.  The reporter also took a topical temperature of the arm which read 102 degree F.   The patient was taken to an urgent care center.   Benadryl was given to alleviate symptoms.   On the date of reporting, the patient's arm hurt and felt hard.   The reporter described the arm as red, mottled, and with some bruising.   The injection site looked like a bug bite.   The reporter stated that, less than a week after receiving Kinrix and Hepatitis B vaccine, she had noticed that, the patient experienced weakness. 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. Medical Advice disclaimer was given.   The patient was referred to healthcare professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035983:FU1- Deleted US-GLAXOSMITHKLINE-US2022AMR037928:Same reporter, same patient, different dose US-GLAXOSMITHKLINE-US2022035982:Same reporter, same patient, different dose