Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate irregular, Hypoaesthesia, Imaging procedure, Immediate post-injection reaction, Immunoglobulin therapy
Clinical narrative: I am writing on behalf of my father. I am an administrator for his estate, as he died in the care of Hospital on December 6, 2023. He received the flu vaccine (Sanofi Fluzone Quadrivalent Multidose, 5ml vial, NDC#49281-0639-15, Lot#U8153AB) on 10-31-23, which was administered by the office of his general practitioner, M.D. My father experienced pain, swelling, and bruising at the injection sight immediately following the vaccination, along with flu-like symptoms the following day, which lasted for two days. He began feeling acute back pain around 11-11-23 while visiting family, which he initially attributed to  I'm writing on behalf of my father. I am an administrator for his estate, as he died in the care of Hospital on December 6, 2023. He received the flu vaccine (Sanofi Fluzone Quadrivalent Multidose 5ml vial, NDC#49281-0639-15, Lot#U8153AB) on 10-31-23, which was administered by the office of his general practitioner, M.D. My father experienced pain, swelling, and bruising at the injection site immediately following vaccination, along with flu-like symptoms the following day, which lasted for about two days. He began feeling acute back pain around 11-11-23 while visiting family, which he initially attributed to the long car ride and helping with some yard work while there. He cut his trip short because of increasing pain in his back that extended to his legs and feet, along with pain and numbness in his hands. He drove home on 11-14-23 and saw Dr the same day. That office visit is described as follows: "Patient presents today with complaints of low back pain with pins and needles down his leg, particularly the right leg and into the feet at times. This has been going on now for about five days. He admits he was digging a hole to plant a tree for a neighbor and began developing these symptoms after doing that. He admits he believes he injured his back while digging the hole and planting the tree. Now he has pain in the low back mainly in the mid lower back and right lower back going down the right leg. The first few days he had some discomfort going down the left leg. He has no significant neck pain but he does admit that three days ago he had some right posterior lateral neck and shoulder area pain. Yesterday he noticed some pins and needles in his fingers and hands. He has minimal neck discomfort. Both feet and toes seem to get numb and tingly at times. He is otherwise without complaints, denies fever, no bowel or bladder incontinence, no giving away of his legs." He was prescribed Prednisone and advised to "follow up if not improving," which he did two days later on 11-16-23: "Patient presents today to follow up on his low back pain and pain and weakness into his legs. He reports that his legs have gotten weaker. He is very unsteady walking. He has some numbness in his feet and pins and needles sensation in his feet and legs up near the knee bilaterally. He denies fever. He has had no urinary incontinence or bowel incontinence., He has some pins and needles sensation in his thumb, index finger, and middle-finger bilaterally, that has improved." Dr. suspected a herniated disk and recommended an MRI of the lumbar spine for further evaluation. My dad was sent home with instructions to go to the ER if his condition worsened. The pain became so extreme that he called EMS around 3:00 am on 11-17-23. He sent me this text that night. "EMTs came to check me out [and] said the hospitals were full. I would just simply be waiting in the waiting room and they would not prescribe any pain medication. He suggested I call Doctor and he would prescribe something stronger until I can get in for my MRI, so [I] was never transported to the hospital." My brother drove him to the ER at Hospital that morning and he was admitted on 11-17-23. He could still walk with assistance, but his legs were growing increasingly weaker. He described it as "spasm, aching, numbness," and his hand "feels like it is being shocked." He had shooting pain and needles in his legs. Over the next week, the hospital performed numerous CT scans and MRIs, but it resulted in no clear diagnosis or explanation for his condition, which steadily worsened. On 11-20-23 he is described as having a shuffling gait, decreased pace, and could only stand by assistance. By 11-21-23 he was unable to stand and required total assistance to move from the bed to a chair. A code stroke was called because his speech was slurred, he had minor facial paralysis and arm weakness. He was transferred to the ICU and treated with Tenecteplase. He spent about two days in ICU, however, the follow up imaging did not suggest a stroke had occurred. On 11-22-23 his strength and coordination were "grossly decreased" and he displayed "extremity and truncal ataxia." Visual tracking impairment was also noted, and he needed assistance to sit upright in bed. "Mobility and sensory perceptions very limited" was noted on 11-23-23 He had a progressive, significant lack of strength and coordination, and no appetite - which he attributed to the pain. On or around 11-24-23 he began having difficulty urinating and a general loss of blader control: retention and incontinence. A Foley catheter was placed. MD noted on 11-26-23 after a lumbar MRI that "He has mild stenosis and no surgical intervention is recommended. This is not the cause of neurologic decline at this time." It was around this time doctors began to suspect Guillain-Barre Syndrome. MD and PA-C performed a lumbar puncture on 11-28-23, which was ultimately unsuccessful after multiple attempts to obtain samples to confirm the diagnosis. Notes after the procedure read as follows: "Progressive neurological decline with progressive LE weakness, paresthesias at presentation in hands and feet, and acute LBP at presentation, subsequent development of urinary retention. Suspected GBS. Unable to obtain CSF in FL LP." Still, treatment proceeded on the presumption of GBS. He received a series of five immune globulin (IVIG) treatments, which began on 11-28-23. He showed significant improvement after the second dose. His nurse, noted on 11-30-23, "patient endorses less [numbing] in hands, and increase energy and strength in extremities!!" We were encouraged by finally receiving a diagnosis and, consequently, a treatment that (for the first time since his symptoms began) resulted in improvement. We were also told, however, it could be an uphill battle towards recovery. An EMG test was also performed on 11-30-23. Notes from MD following the procedure state, "The electrodiagnostic testing is suggestive of a severe, acute to subacute, generalized, mainly axonal type of large fiber peripheral neuropathy affecting both motor and sensory fibers. Some secondary demyelinating changes were seen. Mild acute and chronic neurogenic changes were seen in the lower extremity muscles. This may be due to an axonal variant of GBS. This may have a protracted recovery period." On 12-2-23 PA-C writes, "Acute back pain spinal canal stenosis with disk extrusion with BLE radiculopathy - Presumed GBS (received the Flu vaccine 2 weeks ago)... -IVIG started 11/28 for 5 days, now improving strength in UE/LE." And on 12-4-23 APRN-NP assessed, "Likely Guillain-Barre. Did receive flu vaccine 2 weeks prior to presentation. Unable to obtain CFS." My father told me on 12-4-23 that he felt like he was struggling to catch his breath after a session with his physical therapist, which I was present for. Later that day, his oxygen level was observed to be 87%, so he was put on supplemental oxygen (nasal cannula). Dark red urine was also noted on this day. On 12-5-23 he again had dark red urine, with blood clots also noted. Also, the hospital performed a blood patch procedure. He had been complaining of a terrible headache, dizziness, and nausea since the previous day. He was speaking to a family friend over the phone in the presence of a nurse and the friend asked if his back was wet. She knew he'd had several lumbar punctures recently and was concerned that he was leaking spinal fluid. As my father was unable to check himself, the nurse checked his back and he was scheduled for the procedure. The only reason I know this is because my father told me about it and because I found the signed consent form among his records. I could not find any procedure notes. There are irregularities in his heartbeat noted throughout the hospital records. Beginning around 11-29-23, there is an increasing proliferation of instances of premature atrial and ventricular contractions, vent bigeminy, vent trigeminy, and frequent ectopic frequency. Despite this, he was scheduled to be moved to a rehabilitation facility on 12-6-23. My father, however, experienced cardiac arrest on 12-6-23. Code blue was called at 10:55am. His time of death was 11:45am. My brother, sister, and I were told he died of a pulmonary embolism. The head nurse, advised us that an autopsy could conform the diagnosis, but the doctor had seen the shadow of a clot on imaging done at his bedside during the cardiac arrest and an autopsy would not tell us how the clot had developed, so we opted to forgo it. According to her, it was mostly likely formed because of one of the following: prolonged time in bed, the spinal procedures, GBS, or it could have been pre existing. There was no way to know. I followed up on 12-18-23 with a certified letter to the hospital in an effort to clarify some of the events that led to his death. Specifically, I asked if a VQ scan was done or considered when he was observed to have low oxygen saturation and what the time period was between that and the blood patch. I did not receive any communication from them. Medications given during his hospital admission are numerous. Please reference pages in his records for a list.