Sex: F
Vaccine: RSV
Symptoms: Speech disorder, Tracheal injury
Clinical narrative: stuttering and Stammering; impaired speech/unable to form words/unable to speak in her normal voice; immediately suffered a seizure; lost ability to breath; Coronary Artery disease; contracted Pneumonia; trouble swallowing food; weak lungs/Sick lungs; This serious case was reported by a consumer and described the occurrence of coronary artery disease in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-NOV-2023 12:40, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: contracted Pneumonia) (serious criteria hospitalization and GSK medically significant), swallowing difficult (Verbatim: trouble swallowing food) (serious criteria hospitalization) and lung disorder (Verbatim: weak lungs/Sick lungs) (serious criteria hospitalization). On 19-NOV-2023, the patient experienced coronary artery disease (Verbatim: Coronary Artery disease) (serious criteria hospitalization), stammering (Verbatim: stuttering and Stammering) (serious criteria hospitalization), speech disorder (Verbatim: impaired speech/unable to form words/unable to speak in her normal voice) (serious criteria hospitalization), seizure (Verbatim: immediately suffered a seizure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and difficulty breathing (Verbatim: lost ability to breath) (serious criteria hospitalization and clinically significant/intervention required). The patient was treated with fentanyl citrate (Fentanyl). The outcome of the coronary artery disease, seizure, difficulty breathing and lung disorder were not reported and the outcome of the pneumonia and stammering were resolved and the outcome of the speech disorder and swallowing difficult were not resolved.   It was unknown if the reporter considered the coronary artery disease, pneumonia, stammering, speech disorder, seizure, difficulty breathing, swallowing difficult and lung disorder to be related to Arexvy.     It was unknown if the company considered the coronary artery disease, pneumonia, stammering, speech disorder, seizure, difficulty breathing, swallowing difficult and lung disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-MAR-2024 The patient was injected with the Arexvy vaccination and she was not instructed to wait the prescribed amount of time after an injection fifteen minutes. The patient contacted the reporter immediately following the injection and approached in the grocery aisle in. The patient was stuttering and stammering, unable to form words, the impaired speech lasted only a few seconds. The patient said she was ok, her speech was not slurred nor impaired and she exhibited no signs of paralysis. The patient couldn't remember receiving the injection and the reporter asked her to tell her birthdate and address but she continued saying she was, she couldn't answer questions. The reporter took her immediately to the nearest hospital on or about 12:55 p.m. arriving on or about 1:05 p.m and informed the staff that she had just received the Arexvy vaccination. The reporter said she had an allergic reaction to the RSV vaccine but the doctor dismissed immediately the hypothetical diagnosis. The reporter was a layman, not a doctor. They did two CT scan showing no signs of a stroke, She was incoherent and unable to speak. The doctor told she recommended an experimental early stroke medication to be administered immediately. The reporter asked about other options, but she didn't suggest any. She explained the side effects, and the reporter gave them permission to administer the experimental medicine. The reporter was there when they administered the medicine and the patient immediately suffered a seizure following the injection of the new anti-stroke medicine. The patient lost her ability to breathe and they put her on a ventilator. The doctor ordered another CT scan, it was negative again showing no signs of a stroke. The patient had been admitted to the (I.C.U.) intensive care unit and she was heavily sedated and struggling to breathe, even though she was on a ventilator. The staff of the hospital did not wear masks during the time of her stay at Medical Center. The patient contracted Pneumonia the week ending November 25. Upon trying to remove from the ventilator on or about the week ending November 25, the staff at damaged her trachea. The nurse said to the reporter that the patient had two options. The first option was Hospice care and the second option is to undergo a tracheostomy immediately. The reporter said as a layman, the word hospice means you're going to die shortly. The reporter waited outside her room for approximately 30-40 minutes while they performed the procedure. They were successful, but encountered problems trying to extract the ventilator tube. Prior to the procedure, the staff said they had to take her off the medication Fentanyl and another drug before attempting the procedure. The staff had to put her back on the ventilator because her vitals signs were all abnormal. The doctor suggested to let get her off the ventilator. They began reducing the pain medication gradually for approximately one to two hours. Within seven or eight minutes was off the ventilator, and her vital signs were stable. However, the patient was still unable to speak in her normal voice and has trouble swallowing most food. The reporter agreed there would be no hospice, nor tracheostomy. The patient was still on the ventilator but her vital signs seemed to be more in the normal range. While at the I C.U. the patient was examined by two neurologists, neither mentioned the necessity of a tracheostomy. On another note, the staff seemed to be obsessed with her high tolerance to the pain medication being administered. The reporter said that the patient doesn't drink alcohol, smoke cigarettes and doesn't use drugs. The medical board in the patient room clearly stated she was admitted because of a reaction to RSV vaccine. In addition, the attending neurologist prescribed 2000 mg of anti-seizure medicine. The patient's healthcare provider thought that was too high a dose for a person who had experienced only one seizure in her life time due to the administration of an experimental anti-stroke medication. After listening to her heart, the patient was asked on a couple of occasions by nurses or doctors if she had ever had a heart attack. Upon discharge on December 3rd, the discharging nurse said she had been diagnosed with Coronary Artery Disease (CAD) and weak lungs. The reporter had a conversation with a respiratory nurse regarding an lung X-ray on or about the week ending November 25. The doctor explained that the patient had sick lungs. The patient has never received any kind of adverse diagnosis pertaining to her lungs or heart prior to receiving the RSV vaccine.