Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5KR3R | IM |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | TC47K | IM |
Passed out; significant drop in blood pressure; measles like rash/ rash; Psoriasis; Eczema; third dose of pediarix was given 9th August 2024/ Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 7-month-old female patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis. Previously administered products included Pediarix (received 1st dose 0.5 ml intramuscularly on 05-MAR-2024 with batch number 77J49 and expiry date 09-FEB-2026) and Pediarix (received 2nd dose 0.5 ml intramuscularly on 06-MAY-2024 with batch number X9EP5 and expiry date 09-MAR-2026). Additional patient notes included the reporter stated that she had ensured the patient was fever-free for at least two weeks before any of the vaccines were administered. On 30-APR-2025, the patient received Infanrix (intramuscular) .5 ml. On 09-AUG-2024, the patient received the 3rd dose of Pediarix (intramuscular) .5 ml. On 09-AUG-2024, not applicable after receiving Infanrix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: third dose of pediarix was given 9th August 2024/ Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: significant drop in blood pressure), measles-like rash (Verbatim: measles like rash/ rash), psoriasis (Verbatim: Psoriasis) and eczema (Verbatim: Eczema). The outcome of the passed out, blood pressure decreased and measles-like rash were unknown and the outcome of the psoriasis and eczema were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the passed out, blood pressure decreased, measles-like rash, psoriasis and eczema to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the passed out to be unrelated to Infanrix and Infanrix Pre-Filled Syringe Device. It was unknown if the company considered the blood pressure decreased, measles-like rash, psoriasis and eczema to be related to Infanrix and Infanrix 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-JUL-2025 This case was reported by the mother of the patient. After receiving Infanrix, the patient experienced a significant drop in blood pressure and passed out in 2025. Seven hours later, the patient developed a measles-like rash in 2025. Subsequently, the patient had developed psoriasis along with severe eczema in 2025. The patient underwent diagnostic testing for mast cell activation syndrome (MCAS) and small intestinal bacterial overgrowth (SIBO). The reporter stated that she insured the patient was fever free for a least 2 weeks before any of the vaccines were administered. The patient did not have any other condition and did not receive any other products. The third dose of Pediarix was administered when the patient was 7 months old, which led to an inappropriate schedule of vaccine administered (drug dose administration interval too long).; Sender's Comments: A case of Loss of consciousness, an unknown time after receiving Infanrix and Infanrix Pre-Filled Syringe Device, in a 7-month-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Comments: the reporter stated that she had ensured the patient was fever-free for at least two weeks before any of the vaccines were administered
Test Date: 2025; Test Name: Blood pressure; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: Mast cell activation syndrome; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: Small intestinal bacterial overgrowth; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:)