Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Confusional state, Consciousness fluctuating, Depressed level of consciousness
Clinical narrative: thrombocytopenia; lymphopenia.; fatigue; shortness of breath; confusion; fluctuating levels of consciousness; obtunded state; anemia; leukopenia; rhabdomyolysis; acute renal failure; low platelets; This serious case was reported by a consumer via regulatory authority and described the occurrence of thrombocytopenia in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included cellulitis, peyronies disease, hyperlipidemia, allergic rhinitis and thrombosis. Concurrent medical conditions included deep vein thrombosis and drug allergy (Levofloxacin produces a diffuse rash). Concomitant products included doxycycline, cefalexin (Cephalexin), apixaban (Eliquis) and sildenafil citrate (Viagra).   On 08-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 1 days after receiving Arexvy, the patient experienced thrombocytopenia (Verbatim: thrombocytopenia) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). In OCT-2023, the patient experienced lymphopenia (Verbatim: lymphopenia.) (serious criteria hospitalization), fatigue (Verbatim: fatigue) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization), confusion (Verbatim: confusion) (serious criteria hospitalization), consciousness fluctuating (Verbatim: fluctuating levels of consciousness) (serious criteria hospitalization and GSK medically significant), lethargy (Verbatim: obtunded state) (serious criteria hospitalization), anemia (Verbatim: anemia) (serious criteria hospitalization), leukopenia (Verbatim: leukopenia) (serious criteria hospitalization and GSK medically significant), rhabdomyolysis (Verbatim: rhabdomyolysis) (serious criteria hospitalization and GSK medically significant), acute renal failure (Verbatim: acute renal failure) (serious criteria hospitalization and GSK medically significant) and platelets decreased (Verbatim: low platelets) (serious criteria hospitalization). The patient was treated with sodium chloride (Hypertonic Saline Solution). The outcome of the thrombocytopenia was unknown and the outcome of the lymphopenia, fatigue, shortness of breath, confusion, consciousness fluctuating, lethargy, anemia, leukopenia, rhabdomyolysis, acute renal failure and platelets decreased were not reported.   It was unknown if the reporter considered the thrombocytopenia, lymphopenia, fatigue, shortness of breath, confusion, consciousness fluctuating, lethargy, anemia, leukopenia, rhabdomyolysis, acute renal failure and platelets decreased to be related to Arexvy.     It was unknown if the company considered the thrombocytopenia, lymphopenia, fatigue, shortness of breath, confusion, consciousness fluctuating, lethargy, anemia, leukopenia, rhabdomyolysis, acute renal failure and platelets decreased to be related to Arexvy.   Additional Information: GSK receipt date: 12-MAR-2024 This report described the occurrence of thrombocytopenia in a patient who received Arexvy. Medical history included Peyronie's disease, hyperlipidemia treated with diet, allergic rhinitis, impaired fasting blood sugar treated with diet, acute thrombosis of the right common femoral vein extending distally through the right popliteal and saphenous vein in January 2023, and Levofloxacin produces a diffuse rash. On 8 October 2023 the patient received Arexvy (batch not reported) and experienced thrombocytopenia 1 day later. It was reported that patient came to the office for routine labs on October 9, 2023 and at that time labs were within acceptable limits aside from a minimal lymphopenia. At that time he had a normal blood cell count of 4.4, Hematocrit and Hemoglobin of 14.2/42.9 and platelets of 197,000. His baseline creatinine was 0.9 and his sodium level was 137. He coursed with fatigue, shortness of breath and confusion and was hospitalized with a sodium of 121 fluctuating levels of consciousness that progressed over the past week to an obtunded state. Upon admission to the hospital 48 hours later he had a white blood cell count of 2.32 with Hematocrit and Hemoglobin of 13/36.9 and platelets of 91,000. At the ICU, blood cultures had been within normal limits, and chest CT to screen for pulmonary embolism, as well as CT scan of the abdomen and pelvis were unremarkable. His labs had coursed with improvement of the sodium by administration of hypertonic saline solution. His hemogram had coarse with leukopenia, anemia and thrombocytopenia and his platelets were 25,000. His baseline was a normal white blood cell count, normal hemoglobin and normal platelets. Pulse therapy with 1000 mg of steroid IV once daily has been performed for 3 days and the patient was then coursing with rhabdomyolysis and acute renal failure. He was planning to be intubated at the time of reporting. MRI of the brain with and without contrast had shown no significant abnormality. Lumbar puncture had not been performed because of the patient's low platelets. The patient had cellulitis involving the posterior aspect of his right calf 3 weeks prior to vaccination that was initially treated with doxycycline and then treated with cephalexin with improvement in symptoms. Medications at time of vaccination included Cephalexin 500 mg every 6 hours for a cellulitis of the right lower extremity, Eliquis 5 mg orally twice daily for DVT of the right lower extremity, Viagra 100 mg as needed prior to sexual intercourse.