Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9K34M | IM / LA |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
left side weakness; muscle pain; left fingers swollen compared to the right fingers; Sore throat; Swollen joints; Dizziness; Joint pain; Itchy throat; Chest tightness; Rash/patient presented the rash on the next day/a rash on her neck; Itching/itching all over her body; Headache; Nausea; Fatigue; Injection site swelling; left side of body feels heavy; left side of body feels sore; rashes that come and go (described in the neck along with a "burning" sensation); titer low (3) after previous vaccination with unknown hepatitis b vaccine; This serious case was reported by a nurse via call center representative and described the occurrence of weakness left or right side in a 49-year-old female patient who received HBV (Engerix B adult) (batch number 9K34M, expiry date 05-SEP-2027) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Concurrent medical conditions included fruit allergy (only known allergy was tomatoes). On 26-AUG-2025, the patient received Engerix B adult (intramuscular, left deltoid) 1 ml. On an unknown date, the patient received Hepatitis B vaccine. In AUG-2025, not applicable after receiving Engerix B adult and an unknown time after receiving Engerix B adult and Hepatitis B vaccine, the patient experienced therapeutic response decreased (Verbatim: titer low (3) after previous vaccination with unknown hepatitis b vaccine). On 26-AUG-2025, the patient experienced pruritus (Verbatim: Itching/itching all over her body), headache (Verbatim: Headache), nausea (Verbatim: Nausea), fatigue (Verbatim: Fatigue), injection site swelling (Verbatim: Injection site swelling), sensation of heaviness (Verbatim: left side of body feels heavy), pain (Verbatim: left side of body feels sore) and burning sensation (Verbatim: rashes that come and go (described in the neck along with a "burning" sensation)). On 27-AUG-2025, the patient experienced rash (Verbatim: Rash/patient presented the rash on the next day/a rash on her neck), itchy throat (Verbatim: Itchy throat) and chest tightness (Verbatim: Chest tightness). On 28-AUG-2025, the patient experienced dizziness (Verbatim: Dizziness) and joint pain (Verbatim: Joint pain). On 02-SEP-2025, the patient experienced swollen joints (Verbatim: Swollen joints). On an unknown date, the patient experienced weakness left or right side (Verbatim: left side weakness) (serious criteria GSK medically significant), muscle pain (Verbatim: muscle pain), swelling of fingers (Verbatim: left fingers swollen compared to the right fingers) and sore throat (Verbatim: Sore throat). The patient was treated with acrivastine (Benadryl). The outcome of the weakness left or right side, muscle pain, swelling of fingers, sore throat and burning sensation were not reported and the outcome of the rash was resolving and the outcome of the pruritus, itchy throat, dizziness, joint pain, swollen joints, sensation of heaviness and pain were not resolved and the outcome of the headache, nausea and fatigue were unknown and the outcome of the chest tightness and injection site swelling were resolved and the outcome of the therapeutic response decreased was not applicable. It was unknown if the reporter considered the weakness left or right side, rash, pruritus, headache, nausea, fatigue, itchy throat, chest tightness, dizziness, joint pain, swollen joints, injection site swelling, sensation of heaviness, pain, muscle pain, swelling of fingers, sore throat and burning sensation to be related to Engerix B adult. The company considered the weakness left or right side to be unrelated to Engerix B adult and Hepatitis B vaccine. It was unknown if the company considered the rash, pruritus, headache, nausea, fatigue, itchy throat, chest tightness, dizziness, joint pain, swollen joints, injection site swelling, sensation of heaviness, pain, muscle pain, swelling of fingers, sore throat and burning sensation to be related to Engerix B adult. Additional Information: GSK Receipt Date: 04-SEP-2025 The nurse reported that the adult patient was seen in the clinic after a needle stick. A hepatitis B titer was low. The patient received a booster dose of Engerix-B adult vaccine and in the evening, she had injection site swelling, a rash on her neck, itching all over her body, headache, nausea, fatigue and her whole left side of body felt heavy and sore. The patient was seen in the clinic the next day after vaccination, for the above effects and itchy throat and chest tightness. She started Benadryl for the rash and itching. Pulmonary function tests and electrocardiogram were normal. On 28-AUG-2025 her rash was improving with Benadryl. She developed dizziness and joint pain all over. On 02-SEP-2025 the joint pain continued, the rash comes and goes. She developed swollen joints in the fingers of her left hand. Nothing else was reported. The health care professional mentioned that the patient presented the rash on the next day. The health care professional described more reactions presented by the patient, rashes that come and go (described in the neck along with a burning sensation), dizziness, muscle pain, left side weakness, left fingers swollen compared to the right fingers and sore throat.; Sender's Comments: A case of Hemiparesis, 1 day after receiving unknown dose of Engerix B adult and Hepatitis B vaccine in a 49-year-old female subject. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Fruit allergy (only known allergy was tomatoes)
Test Date: 202508; Test Name: EKG; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 202508; Test Name: Laboratory test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Comments: Pulmonary function tests; Test Date: 202508; Test Name: serology tes; Result Unstructured Data: (Test Result:low titer,Unit:unknown,Normal Low:,Normal High:); Comments: LabComments: Laboratory test 15-AUG-25: Pulmonary function tests