Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Swollen tongue
Clinical narrative: redness at the site of injection (left arm); pain at the site of injection (left arm); patient was talking funny and speaking different; Headache; fever; decrease  in appetite; tongue swollen; Entire face swelling; swelling from shoulder to finger tips; swelling from shoulder to finger tips; adverse allergic reaction; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included DTaP vaccine (received on an unknown date), Polio vaccine (received on an unknown date), Infanrix (received on an unknown date) and Pediarix (received on an unknown date).   On 03-APR-2024, the patient received the 1st dose of Kinrix (left arm). In APR-2024, 6 hrs after receiving Kinrix, the patient experienced injection site erythema (Verbatim: redness at the site of injection (left arm)), injection site pain (Verbatim: pain at the site of injection (left arm)), speech disorder (Verbatim: patient was talking funny and speaking different), headache (Verbatim: Headache), fever (Verbatim: fever), decreased appetite (Verbatim: decrease  in appetite), swollen tongue (Verbatim: tongue swollen), facial swelling (Verbatim: Entire face swelling), swollen joints (Verbatim: swelling from shoulder to finger tips), peripheral swelling (Verbatim: swelling from shoulder to finger tips) and allergic reaction (Verbatim: adverse allergic reaction). The outcome of the injection site erythema, injection site pain, speech disorder, headache, fever, decreased appetite, swollen tongue, facial swelling, swollen joints and peripheral swelling were unknown and the outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the injection site erythema, injection site pain, speech disorder, headache, fever, decreased appetite, swollen tongue, facial swelling, swollen joints, peripheral swelling and allergic reaction to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site pain, speech disorder, headache, fever, decreased appetite, swollen tongue, facial swelling, swollen joints, peripheral swelling and allergic reaction 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: 09-APR-2024 The health care professional reported that the patient received the only dose of Kinrix. The parent reported that six hours later patient started with swelling from shoulder to finger tips,  entire face swelling and tongue swollen, pain and redness at the site of injection (left arm), decrease in appetite, fever and headache.  The patient was talking funny and speaking different.  The patient in the past received DTap and Polio, Infanrix and Pediarix but only had this reaction with Kinrix. The HCP inquired had there been any report of known allergens. Any information on a reaction of speaking different and talking funny. The nurse stated that speaking differently talking funny, she suspected this was for swelling but she did not saw the patient herself. This was the first time with a reaction like this.