Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | SYR / LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 94CC4 | IM / LA |
could not chew/cannot eat sometimes; could not breathe; could not swallow; could not walk/could barely walk this summer; no sensation in legs/knees down to ankles he has no response; Light-headed; Anxiety; shaking so bad cannot hold utensils; quick temper; cannot tolerate heat or cold; Neuropathy/fingers feel like lightening is shooting out of them; Fainted; Headache; atypical to GBS; increased blood pressure; heart rate went down; Premature ventricular contractions; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 94CC4, expiry date 25-OCT-2025) for prophylaxis. The patient's past medical history included aortic aneurysm, ureteric cancer and solitary kidney (lost one kidney due to cancer). On 13-JAN-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 14-JAN-2025, 1 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: atypical to GBS) (serious criteria GSK medically significant) and headache (Verbatim: Headache). In JAN-2025, the patient experienced premature ventricular contractions (Verbatim: Premature ventricular contractions), increased blood pressure (Verbatim: increased blood pressure) and heart rate decreased (Verbatim: heart rate went down). On an unknown date, the patient experienced neuropathy (Verbatim: Neuropathy/fingers feel like lightening is shooting out of them) (serious criteria GSK medically significant), fainting (Verbatim: Fainted) (serious criteria GSK medically significant), chewing difficulty (Verbatim: could not chew/cannot eat sometimes), difficulty breathing (Verbatim: could not breathe), unable to swallow (Verbatim: could not swallow), unable to walk (Verbatim: could not walk/could barely walk this summer), loss of sensation (Verbatim: no sensation in legs/knees down to ankles he has no response), light headedness (Verbatim: Light-headed), anxiety (Verbatim: Anxiety), tremor (Verbatim: shaking so bad cannot hold utensils), impulsive aggression (Verbatim: quick temper) and temperature intolerance (Verbatim: cannot tolerate heat or cold). The patient was treated with sertraline hydrochloride (Zoloft). The outcome of the guillain barre syndrome, neuropathy, fainting, premature ventricular contractions, headache, increased blood pressure, heart rate decreased, chewing difficulty, difficulty breathing, unable to swallow, unable to walk, loss of sensation, light headedness, anxiety, tremor, impulsive aggression and temperature intolerance were unknown. It was unknown if the reporter considered the guillain barre syndrome, neuropathy, fainting, premature ventricular contractions, headache, increased blood pressure, heart rate decreased, chewing difficulty, difficulty breathing, unable to swallow, unable to walk, loss of sensation, light headedness, anxiety, tremor, impulsive aggression and temperature intolerance to be related to Arexvy. The company considered the guillain barre syndrome, neuropathy and fainting to be unrelated to Arexvy. It was unknown if the company considered the premature ventricular contractions, headache, increased blood pressure, heart rate decreased, chewing difficulty, difficulty breathing, unable to swallow, unable to walk, loss of sensation, light headedness, anxiety, tremor, impulsive aggression and temperature intolerance to be related to Arexvy. Additional Information: GSK Receipt Date: 15-DEC-2025 The patient was vaccinated with Arexvy in his left arm. The next day the consumer reported he had a headache and went to the emergency department on 18- Jan-2025. The reporter stated that his blood pressure was very high and he was experiencing premature ventricular contractions and his heart rate went down. The reporter stated that he was released from the emergency department with no diagnosis or treatment. The consumer stated that that at some time after this he fainted at home and was transported to the emergency department. The reporter stated that he was not provided with a diagnosis or treatment. The reporter stated that he went to the emergency department again, at another time, and did not receive a diagnosis or treatment. The reporter was under the care of a neurologist for a multitude of symptoms. The reporter states no firm diagnosis has been established. The reporter stated that he has not been diagnosed with Guillain-Barre Syndrome (GBS) but one neurologist told him that his symptoms are atypical to GSB. The reporter stated that his symptoms come and go. He reported that one day he might feel fine and the next day he could not walk. The reporter reported having the following symptoms: could not chew, could not breathe, could not swallow, no sensation in legs, cannot walk, life has turned into a nightmare, when tested with an instrument running down his legs he had no response from knees down to ankles, positive nerve conduction test, could barely walk this summer, could not eat sometimes, light-headed, anxiety (was prescribed Zoloft for the anxiety,) shaking so bad he could not hold utensils, quick temper, could not tolerate heat or cold, fingers felt like lightening was shooting out of them, neuropathy, when he has difficulty walking he cannot breathe, and was at his wits end. The reporter also reported that he had the Arexvy administered because he was going to have surgery for an aortic aneurysm. The reporter reported he was being treated by a neurologist, however, no diagnosis has been provided and no medications or other tests have been provided. No further information was provided/obtained.; Sender's Comments: A case of Syncope, Neuropathy peripheral and Guillain-Barre syndrome (BCWG Level 4), 1 day after receiving a dose of Arexvy in an 80-year-old male subject. Causal association is indeterminate. Case lacks further information on medical history, concurrent conditions and laboratory confirmation. 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.
Medical History/Concurrent Conditions: Aortic aneurysm; Solitary kidney (lost one kidney due to cancer); Ureteric cancer
Test Date: 202501; Test Name: Blood pressure; Result Unstructured Data: (Test Result:Increased,Unit:unknown,Normal Low:,Normal High:); Test Date: 202501; Test Name: Heart rate; Result Unstructured Data: (Test Result:went down,Unit:unknown,Normal Low:,Normal High:); Test Date: 2025; Test Name: Nerve conduction test; Result Unstructured Data: (Test Result:Positive,Unit:unknown,Normal Low:,Normal High:)