Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | CT3Z7 | ID / LA |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Rheumatoid Arthritis also came back abnormal; the patient began to experience a rash; tingling, pins and needles, paresthesia; joint pain in the knees, ankles, wrists; redness; Swelling; Potassium level was elevated; ANA panel came back abnormal; Eosinophils were elevated; The patient has not had further doses of ENGERIX-B; The patient received ENGERIX B ID in the left forearm; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 19-year-old female patient who received HBV (Engerix B adult) (batch number CT3Z7) for prophylaxis. Co-suspect products included HBV (Engerix B adult) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 06-NOV-2024, the patient received the 1st dose of Engerix B adult (intradermal, left arm). On an unknown date, the patient received the 2nd dose of Engerix B adult. On 06-NOV-2024, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced wrong route of administration (Verbatim: The patient received ENGERIX B ID in the left forearm). On an unknown date, the patient experienced rheumatoid arthritis (Verbatim: Rheumatoid Arthritis also came back abnormal) (serious criteria GSK medically significant), rash (Verbatim: the patient began to experience a rash), tingling (Verbatim: tingling, pins and needles, paresthesia), knee pain (Verbatim: joint pain in the knees, ankles, wrists), erythema (Verbatim: redness), swelling (Verbatim: Swelling), potassium increased (Verbatim: Potassium level was elevated), antinuclear antibody (Verbatim: ANA panel came back abnormal), eosinophil count increased (Verbatim: Eosinophils were elevated) and incomplete course of vaccination (Verbatim: The patient has not had further doses of ENGERIX-B). The patient was treated with prednisone. On 06-NOV-2024, the outcome of the wrong route of administration was not applicable. The outcome of the rheumatoid arthritis was not reported and the outcome of the rash, tingling, knee pain, erythema and swelling were not resolved and the outcome of the potassium increased, antinuclear antibody and eosinophil count increased were unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the rheumatoid arthritis, rash, tingling, knee pain, erythema, swelling, potassium increased, antinuclear antibody and eosinophil count increased to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the rheumatoid arthritis to be unrelated to Engerix B adult and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the rash, tingling, knee pain, erythema, swelling, potassium increased, antinuclear antibody and eosinophil count increased to be related to Engerix B adult and Engerix B 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 : 27-MAR-2025 The reporter was the mother of the patient. The patient received the first dose of Engerix b on November 6, 2024. The patient received Engerix b intradermal (ID) in the left forearm which led to wrong route of administration. The patient began to experienced a rash (the rash was redness and was not raised) and tingling, pins and needles, paresthesia, in the fingers on both hands. The patient also experienced joint pain in the knees, ankles, wrists. The redness, swelling, and tingling in the patient's fingers comes and goes, but seems to be more persistent lately. The joint pain was primarily in the wrist at this time. The patient had been treated with prednisone and an antihistamine. The patient had an Antinuclear antibody (ANA) done in December 2024 or January 2025. The Antinuclear antibody (ANA) was negative, but the Potassium level was elevated and the Absolute Eosinophils were elevated. The patient had blood work repeated about one month ago in which the Antinuclear antibody (ANA) panel came back abnormal and lab work for Rheumatoid Arthritis also came back abnormal. The patient was scheduled to see a Rheumatologist in April. The patient had not had further doses of Engerix b. Till the time of reporting, the patient did not receive 2nd dose of engerix b, which led to incomplete course of vaccination.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Engerix B adult and Engerix B PRE-FILLED SYRINGE DEVICE .
Rheumatoid arthritis
Test Name: Antinuclear Antibody; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood potassium increased; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Name: Eosinophil count increased; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:)