Age: 76.0
Sex: M
Vaccine: RSV, RSV, RSV, VARCEL
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Injection site pain, Pain
Clinical narrative: chronic fatigue; heart muscle basil spams; was diagnosed with GBS.; he had jabbing shooting pain with a pins and needles sensation in his feet that gradually went up his legs to his knees and hands; jabbing shooting pain; Fingers curled up; husband had soreness at the injection site; This serious case was reported by a consumer via call center representative and described the occurrence of coronary vasospasm in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 23-FEB-2024) for prophylaxis.   The patient's past medical history included neuropathy.   On 23-FEB-2024, the patient received Arexvy (left deltoid) .5 mg. In FEB-2024, 12 hrs after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: was diagnosed with GBS.) (serious criteria hospitalization and GSK medically significant), pins and needles (Verbatim: he had jabbing shooting pain with a pins and needles sensation in his feet that gradually went up his legs to his knees and hands) (serious criteria hospitalization), shooting pain (Verbatim: jabbing shooting pain) (serious criteria hospitalization) and finger contracture (Verbatim: Fingers curled up) (serious criteria hospitalization and GSK medically significant). On 23-FEB-2024, the patient experienced injection site muscle pain (Verbatim: husband had soreness at the injection site). On 20-APR-2024, the patient experienced coronary vasospasm (Verbatim: heart muscle basil spams) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced chronic fatigue (Verbatim: chronic fatigue) (serious criteria hospitalization). The outcome of the coronary vasospasm was unknown and the outcome of the guillain barre syndrome, pins and needles, chronic fatigue and shooting pain were not resolved and the outcome of the finger contracture was not reported and the outcome of the injection site muscle pain was resolved.   It was unknown if the reporter considered the coronary vasospasm, guillain barre syndrome, pins and needles, chronic fatigue, shooting pain, finger contracture and injection site muscle pain to be related to Arexvy.     It was unknown if the company considered the coronary vasospasm, guillain barre syndrome, pins and needles, chronic fatigue, shooting pain, finger contracture and injection site muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-MAY-2024 This case was reported by patient's wife. The patient had soreness at the injection site, left deltoid, immediately after injection.  12 hours after vaccine his fingers curled up and he had jabbing shooting pain with a pins and needles sensation in his feet that gradually went up his legs to his knees and hands.  The pain and pins and needles sensation traveled up his body over a course of a few days and has not resolved.  Reporter mentions previous neuropathy but did not elaborate.  The reporter states, he had neuropathy already but nothing like this. No further information given concerning previous neuropathy. Reporter also states patient has chronic fatigue that has not resolved.  Reporter states he went to his primary physician the next Monday on 26-FEB-2024 and was diagnosed with Guillain-Barre syndrome. Primary physician referred patient to a neurologist. Patient then went to the neurologist On 28-FEB-2024 as recommended.  Reporter states the neurologist did an Electromyography test and confirmed Guillain-Barre syndrome diagnosis.  Reporter states the patient was hospitalized due to his symptoms twice. The first hospitalization was from 31-MAR-2024 to 02-APR-2024. States during the first hospitalization patient received four infusions of (IGIV) Immunoglobulin intravenous and it did not help. The second hospitalization was from 20-APR-2024 to 24-APR-2024. Reporter states the second hospitalization was due to heart muscle basil spams as a result of Guillain-Barre syndrome. No further information given concerning hospitalizations.  Reporter states that patient's neurologist and pharmacist both reported adverse event of Guillain-Barre syndrome in a non GSK source. Reporter mentions in reporting that she has spoken to a lawyer. Potential Legal Case.  The reporter consented to follow up.