Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Hepatitis A; This serious case was reported by a physician via other manufacturer and described the occurrence of hepatitis a in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included COVID-19 vaccine (received on 04-MAR-2021) and Covid-19 vaccine (received on 25-MAR-2021). Concurrent medical conditions included attention deficit disorder, vitamin d deficiency, erectile dysfunction, glucose intolerance, increased blood pressure, fatigue, abdominal discomfort, dark urine and jaundice. Additional patient notes included Ethnicity: On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 463.5 mg, QD, Subcutaneous use route of administration for treatment of hiv prep. ,On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 2 dosage form, QD, Oral use route of administration for treatment of hiv prep. ,On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 1 dosage form, QD, Oral use route of administration for treatment of HIV PREP. ,On 08-MAR-2022, the patient received EMTRICITABINE/TENOFOVIR ALAFENAMIDE 1 dosage form, QD, Oral use route of administration for treatment of HIV PREP.. Concomitant products included sildenafil, amlodipine besilate (Amlodipine Besylate), ciprofloxacin hydrochloride (Cipro 1a Pharma), hyoscine (Scopolamine), lisdexamfetamine mesilate and HEPATITIS B VACCINE. On an unknown date, the patient received Pediarix. On 16-SEP-2025, an unknown time after receiving Pediarix, the patient experienced hepatitis a (Verbatim: Hepatitis A) (serious criteria hospitalization). The patient was treated with ibuprofen. The outcome of the hepatitis a was resolved. It was unknown if the reporter considered the hepatitis a to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The company considered the hepatitis a to be unrelated to Pediarix and Pediarix 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 25-MAR-2026 This male participant experienced hepatitis a while receiving study therapy for hiv preparation. He presented with fever, fatigue, dark urine, and jaundice. The reported event was considered likely to be an intercurrent illness and was resolved. The other hcp assessed the event of hepatitis a as serious (hospitalized), with a hospitalization start date of 25-SEP-2025 and a hospitalization end date of 27-SEP-2025, and assessed the causality as not related to blinded treatment (len vs f/tdf) or open-label len with or without f/tdf or f/taf. The outcome of the event was resolved, with a stop date of 27-SEP-2025. The other hcp also assessed the event of hepatitis a as serious (hospitalized), with a hospitalization start date of 25-SEP-2025 and a hospitalization end date of 27-SEP-2025, and assessed the causality as not related to emtricitabine/tenofovir alafenamide. The outcome of the event was resolved, with a stop date of 27-SEP-2025. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Hepatitis A, unknown time after receiving Pediarix and Pediarix Pre-Filled Syringe Device, in a male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Abdominal discomfort; Attention deficit disorder; Dark urine; Erectile dysfunction; Fatigue; Glucose intolerance; Increased blood pressure; Jaundice; Vitamin D deficiency
Comments: Ethnicity: On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 463.5 mg, QD, Subcutaneous use route of administration for treatment of hiv prep. ,On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 2 dosage form, QD, Oral use route of administration for treatment of hiv prep. ,On 31-AUG-2021, the patient received Blinded (LEN vs F/TDF); Open-label LEN +/- F/TDF or F/TAF 1 dosage form, QD, Oral use route of administration for treatment of HIV PREP. ,On 08-MAR-2022, the patient received EMTRICITABINE/TENOFOVIR ALAFENAMIDE 1 dosage form, QD, Oral use route of administration for treatment of HIV PREP.
SILDENAFIL; AMLODIPINE BESYLATE; CIPRO 1A PHARMA; SCOPOLAMINE; LISDEXAMFETAMINE MESILATE; HEPATITIS B VACCINE
Test Date: 20250925; Test Name: ALT; Result Unstructured Data: (Test Result:2214,Unit:unknown,Normal Low:10,Normal High:49) U/L; Test Date: 20250926; Test Name: ALT; Result Unstructured Data: (Test Result:1935,Unit:unknown,Normal Low:10,Normal High:49) U/L; Test Date: 20250927; Test Name: ALT; Result Unstructured Data: (Test Result:1509,Unit:unknown,Normal Low:10,Normal High:49) U/L; Test Date: 20250925; Test Name: AST; Result Unstructured Data: (Test Result:747,Unit:unknown,Normal Low:0,Normal High:3.8) U/L; Test Date: 20250926; Test Name: AST; Result Unstructured Data: (Test Result:626,Unit:unknown,Normal Low:0,Normal High:3.8) U/L; Test Date: 20250927; Test Name: AST; Result Unstructured Data: (Test Result:421,Unit:unknown,Normal Low:0,Normal High:3.8) U/L; Test Date: 20250927; Test Name: Bilirubin conjugated; Result Unstructured Data: (Test Result:1.63,Unit:unknown,Normal Low:0,Normal High:0.3) mg/dL; Test Date: 20250927; Test Name: Blood bilirubin; Result Unstructured Data: (Test Result:2.5,Unit:unknown,Normal Low:0.3,Normal High:1.2) mg/dL; Test Date: 20250926; Test Name: HEP A IGM INTRP; Result Unstructured Data: (Test Result:Reactive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180801; Test Name: blood pressure; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:)