Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Autism spectrum disorder, Gait disturbance, Gait inability, Incorrect route of product administration, Pain
Clinical narrative: diagnosis of Autism; puffy eyes; a rash, and then followed with body rash, rash 3 by 3; inability to walk/ difficulty walking; After the injection she had pain and inability to walk, a rash, and then followed with body rash, and puffy eyes; patient recieved a yellow injection subcutaneously into her left thigh. The next morning experiened pain and difficulty walking, and then following day a rash 3x3". EMR Kinrix. We declined this vaccin; This serious case was reported by a consumer and described the occurrence of autism in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   Concomitant products included fluticasone furoate (Flonase Sensimist Allergy Relief).   On 21-JUN-2024, the patient received Kinrix (subcutaneous, left thigh) and MMR vaccine (left thigh). On 21-JUN-2024, an unknown time after receiving Kinrix and not applicable after receiving MMR vaccine, the patient experienced intramuscular formulation administered by other route (Verbatim: patient recieved a yellow injection subcutaneously into her left thigh. The next morning experiened pain and difficulty walking, and then following day a rash 3x3". EMR Kinrix. We declined this vaccin). On 22-JUN-2024, the patient experienced pain (Verbatim: After the injection she had pain and inability to walk, a rash, and then followed with body rash, and puffy eyes) and unable to walk (Verbatim: inability to walk/ difficulty walking). On 23-JUN-2024, the patient experienced generalized rash (Verbatim: a rash, and then followed with body rash, rash 3 by 3). On an unknown date, the patient experienced autism (Verbatim: diagnosis of Autism) (serious criteria GSK medically significant) and puffy eyes (Verbatim: puffy eyes). On 10-JUL-2024, the outcome of the pain and unable to walk were resolved (duration 18 days) and the outcome of the generalized rash was resolved (duration 17 days). The outcome of the autism and puffy eyes were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the autism, pain, generalized rash, puffy eyes and unable to walk to be related to Kinrix, Kinrix Pre-Filled Syringe Device and MMR vaccine.     The company considered the autism to be unrelated to Kinrix, Kinrix Pre-Filled Syringe Device and MMR vaccine. It was unknown if the company considered the pain, generalized rash, puffy eyes and unable to walk to be related to Kinrix, Kinrix Pre-Filled Syringe Device and MMR vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-SEP-2024 The patient received a yellow injection subcutaneously. The next morning of vaccine experienced pain and difficulty walking (inability to walk), then following day a rash 3 by 3 with body rash and puffy eyes.  The patient was diagnosed of autism. The reporter declined Kinrix and asked for DTap, this vaccine was injected without second step verifications and the medical assistant did not check the order before injecting. The clinic was refusing to provide us their written documentation or answer our questions about this error. The reporter were claiming Kinrix was a yellow injection that was administered subcutaneously, which led intramuscular formulation administered by other route. The reporter believe it was Measles, Mumps, Rubella vaccine on her left thigh with the adverse event. All on call providers told not to go to the hospital and to monitor, as again they were claiming it was from your vaccine. The patient received treatment to treat symptoms.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK vaccine Kinrix, Kinrix PRE-FILLED SYRINGE DEVICE and MMR vaccine.