Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site rash, Injection site warmth, Periorbital swelling, Product administered at inappropriate site, Product colour issue
Clinical narrative: pain at injection site; Rash at injection site; injection site warm to touch; arm rash/chest rash/shoulder rash; redness under the eye; the patient had: puffy eyes; pain on the left thigh; coughing; patient could not walk; Reporter states that Kinrix vaccine was administered, was yellow and this does not fit with the description of Kinrix, which is a white suspension; Vaccine Administered at Inappropriate Site; Vaccine administered at inappropriate site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain 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 Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for prophylaxis.   Concurrent medical conditions included autism and immunocompromised.   On 22-JUN-2024, the patient received Kinrix (subcutaneous, left thigh) and Mmr (right thigh). On 22-JUN-2024, an unknown time after receiving Kinrix, the patient experienced product with quality issue administered (Verbatim: Reporter states that Kinrix vaccine was administered, was yellow and this does not fit with the description of Kinrix, which is a white suspension), intramuscular formulation administered by other route (Verbatim: Vaccine Administered at Inappropriate Site) and vaccine administered at inappropriate site (Verbatim: Vaccine administered at inappropriate site). On 23-JUN-2024, the patient experienced unable to walk (Verbatim: patient could not walk). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site), injection site rash (Verbatim: Rash at injection site), injection site warmth (Verbatim: injection site warm to touch), rash (Verbatim: arm rash/chest rash/shoulder rash), erythema periorbital (Verbatim: redness under the eye), puffy eyes (Verbatim: the patient had: puffy eyes), pain in thigh (Verbatim: pain on the left thigh) and cough (Verbatim: coughing). The patient was treated with ibuprofen (Motrin). The outcome of the injection site pain, injection site rash, injection site warmth, rash, erythema periorbital, puffy eyes, unable to walk, pain in thigh and cough were resolving and the outcome of the product with quality issue administered, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, rash, erythema periorbital, puffy eyes, unable to walk, pain in thigh and cough to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site rash, injection site warmth, rash, erythema periorbital, puffy eyes, unable to walk, pain in thigh and cough to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 23-JUL-2024 The reporter was the mother of the patient.   Parent reported it was administered in a hospital facility.  Parent reported that patient also received an MMR vaccine (MSD manufacturer) on the same day in the right thigh.  Reporter stated that Kinrix vaccine was administered, was yellow and this does not fit with the description of Kinrix, which was a white suspension, which led to product with quality issue administered .  The PI stated that Kinrix should be administered intramuscular, and the preferred site of administration was the deltoid muscle of the upper arm. Parent was an HCP and reported that the vaccine was administered subcutaneously  in a severe angle, almost horizontal; which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. Parent reported that the next day, on June 23, 2024, the patient could not walk. Parent reported that the patient had pain on the left thigh.  Parent reports that the patient was given Motrin twice a day for pain.  The parent reported that the patient had puffy eyes, redness under the eye, coughing, injection site rash, injection site was warm to touch, had a shoulder rash, chest rash, arm rash.  The parent reported the symptoms are improving but are not resolved. Potential Legal Case. Consented to follow up.