Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | RA |
liver enzymes were elevated/The reporter states that she recently had her labs checked and her liver enzymes and cholesterol are still high but returning to normal; her cholesterol was high./The reporter states that she recently had her labs checked and her liver enzymes and cholesterol are still high but returning to normal; she developed hives all over both arms, both legs, and her stomach.; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 24-year-old female patient who received HBV (Engerix B adult) for prophylaxis. Previously administered products included Engerix B adult (1st and 2nd dose received on an unknown date). On 17-MAR-2025, the patient received the 3rd dose of Engerix B adult (right deltoid). In MAR-2025, 1 week after receiving Engerix B adult, the patient experienced hives (Verbatim: she developed hives all over both arms, both legs, and her stomach.). On an unknown date, the patient experienced elevated liver enzymes (Verbatim: liver enzymes were elevated/The reporter states that she recently had her labs checked and her liver enzymes and cholesterol are still high but returning to normal) and blood cholesterol increased (Verbatim: her cholesterol was high./The reporter states that she recently had her labs checked and her liver enzymes and cholesterol are still high but returning to normal). The patient was treated with antihistamines, cetirizine hydrochloride (Zyrtec), prednisone and famotidine (Pepcid). The outcome of the hives was resolved (duration 3 months) and the outcome of the elevated liver enzymes and blood cholesterol increased were resolving. It was unknown if the reporter considered the hives, elevated liver enzymes and blood cholesterol increased to be related to Engerix B adult. It was unknown if the company considered the hives, elevated liver enzymes and blood cholesterol increased to be related to Engerix B adult. Additional Information: GSK Receipt Date: 18-DEC-2025 The reporter had received her third dose of Engerix-B vaccine, administered in her right deltoid. Patient reported that she had completed the vaccine series because her Hepatitis B surface antibody had been less than 10 mIU/mL. One week after receiving the third dose, she developed hives across both arms, both legs, and her stomach. The hives became so bad that she presented to the emergency department on 29-March -2025, where she was given antihistamines; however, the hives did not resolve. She then consulted an allergist, who prescribed oral Zyrtec, Prednisone, and Pepcid. The hives had persisted for three months before they finally resolved. Patient also reported that her liver enzymes had been elevated and that her cholesterol had been high. She stated that she had recently had follow-up laboratory testing, and her liver enzymes and cholesterol remained elevated but were returning towards normal. The batch number was not provided upon follow up with the reporter.
Test Date: 2025; Test Name: cholesterol; Result Unstructured Data: (Test Result:High,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: cholesterol; Result Unstructured Data: (Test Result:till high but returning to normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: liver enzymes; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: liver enzymes; Result Unstructured Data: (Test Result:till high but returning to normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: Hepatitis B Surface Antibody; Result Unstructured Data: (Test Result:10,Unit:unknown,Normal Low:,Normal High:); Comments: mIU/mL; Test Date: 2025; Test Name: Hepatitis B Surface Antibody; Result Unstructured Data: (Test Result:13,349,Unit:unknown,Normal Low:,Normal High:); Comments: LabComments: Hepatitis B Surface Antibody 15-JUN-25: mIU/mL