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FDA Warning on Shingrix Shingles Vaccine Mirrors My Experience

Two years after I experienced muscle paralysis I attributed to receiving the first dose of the Shingrix Shingles vaccine, the Food and Drug Administration has issued a warning about such side effects. While my doctor at the time dismissed my concerns, I have little doubt that the shoulder paralysis I experienced for months was a direct result of the Shingrix vaccine. Now I have a fancy name associated with the side effect: Guillain-Barre’ Syndrome (GBS.)

The risk of GBS following vaccination with Shingrix was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination. The primary analysis (claims-based, all doses) found an increased risk of GBS during the 42 days following vaccination with Shingrix, with an estimated 3 excess cases of GBS per million doses administered to adults aged 65 years or older.

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix
I experienced shoulder paralysis and weakness because of the Shingrix vaccine.

My experience with GBS was within the window noted in the FDA warning. What is GBS?

Guillain–Barré syndrome (GBS) is a rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system.[2] Typically, both sides of the body are involved, and the initial symptoms are changes in sensation or pain often in the back along with muscle weakness, beginning in the feet and hands, often spreading to the arms and upper body.[2] The symptoms may develop over hours to a few weeks.[2] During the acute phase, the disorder can be life-threatening, with about 15 percent of people developing weakness of the breathing muscles and, therefore, requiring mechanical ventilation.

https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_syndrome

The above description of GBS is pretty much what I experienced. Fortunately, it did not affect my breathing. Because my doctor looked for other causes of my sudden paralysis, I kept a journal to document the progression once I knew something serious was happening. The following is an edited version of my notes.

Journal of Shingrix Side Effects of Paralysis

April 9, 2019: received Shingrix vaccine first dose. Felt mild flu symptoms over the weekend: headache, lethargy, pain at the injection site.

April 27, 2019: onset of intense headaches, lethargy. By April 29th, started running a low-grade fever.

April 30, 2019: Appointment with Dr., diagnosis Sinus infection, prescribe Amoxicillin and Flonase.

May 2, 2019: Correspondence with physician –

Subject: Sinus Condition Continuation *No Response Required*

Just an update. There are been little change in my symptoms surrounding the sinus infection diagnosis. I still have headaches, most noticeable pain is associated with eye movement, either looking up or down. I am still tired and sluggish. Wednesday evening, I started experiencing chills, and the thermometer indicated a fever between 99 and 100.

I have been taking the Amoxil faithfully as directed. Flonase every morning. I have not noticed any positive or negative reactions to the Flonase. I will stay the course of the prescribed anti-biotics and nasal spray. Fingers crossed that they will kick in by this weekend to eliminate the current illness.

May 7, 2019: noticeable weakness, numbness in shoulders. Still have a foggy brain, perhaps fever, chills in the evening. Finally make appointment with Dr.

May 9, 2019: Correspondence with Physician – Lots of shoulder pain during the night. I went to the gym this morning but could only do leg exercises. Arms feel very heavy and I have difficulty raising them over my head. I must be careful when lifting things like a coffee cup as the shoulder/arm, especially the left arm, is unexpectedly weak. Fortunately, the full coffee cup landed on the keyboard of the iPad and did not spill 🙂

May 10, 2019: Dr. diagnosis of issue with neck. I can feel or sense nerve irritation from my neck over to each shoulder. I could virtually draw a line with a sharpie pen. Lots of pain at night, after I loosen up in the morning, just left with mild pain but numbness and weakness. I can’t lift arms above head and they won’t perform certain functions. Dr. prescribes 800 mg of ibuprofen twice a day (to reduce neck vertebrae swelling and promote healing), a muscle relaxant to help sleep, and an x-ray of neck.

May 13, 2019: I have not started the high dose of ibuprofen, only small doses for pain. Have not started muscle relaxant. At 1 AM I developed intense itching throughout my body: palms of my hands, base of my feet, chest, legs, groin, back, top of head. Hydrocortisone cream stops some of the itching. The weakness in my shoulders seems to have improve.

May 14, 2019: Itching all over my body continues, less during the day. I took some cold medicine with an anti-histamine and it seemed to help through the night. Tuesday morning itching still present and I had to speak in front of a group. I took a loratadine Claritin tablet anti-histamine and that really helped reduce the itching sensation.

May 15, 2019: Tuesday night, Wednesday morning experiencing horrible pain in left shoulder, the worst in days, could not sleep. Left arm shoulder very weak in terms of raising it above my chest, usually need the right hand to help it. Turning my neck does not increase the pain. Moving my arm in different positions is what really hurts. Just resting at night, the shoulder throbs and I get some sharp pains when I try to move it into another position. Sitting upright seems to help the most. Spent hours sleeping in a chair for relief. Finally took more ibuprofen to deaden the pain. The only thing I did Tuesday was move computer stuff at the place where I spoke, no real pain. I did get x-rays at Sutter and had to have my left arm above my head for a few minutes. Once I get moving in the morning the shoulder pain subsides. I have some small pain in the right shoulder, but nothing compared to the left shoulder, which is where I received the Shingrix shot. 

May 16, 2019: Shoulder pain moved from back of left shoulder to front portion deltoid region, but there is still some remaining pain on the back side. I’ve been sleeping better with a pillow under my left arm to keep it chest level, usually taking two to three 200mg ibuprofen to get through the night. However, the paralysis of the deltoid, infraspinatus and supraspinatus muscles is the worse to date. I cannot lift my arm off of a table. I need to use my right arm to position my left arm on the keyboard to type. I have no pain in my neck, even though the x-ray impression noted degenerative neck disease and narrowing of the openings in which the nerves to the arms, especially on the left side, exit.

May 18, 2019: No real change, the pain is not as bad, but the paralysis remains. I still have episodic itching on my palms, chest, and other regions, but it subsides quickly or I treat it with hydrocortisone cream.

July 10, 2019: Weakness in my left shoulder persists preventing full use. I have problems bringing my left arm across my body to the right. To raise the arm, I need to lead with my elbow upwards. There is still minor aching pain around the muscles of the left shoulder on the front that attach to breast.

I have limited range of motion in my right shoulder. Most notably is I can’t fully reach over my left shoulder to either scratch an itch or wash the left shoulder when I am showering. I need to pull the right elbow with my left hand to reach areas that before were no problem.

Then on July 6, I noticed my right shoulder blade hitting the back of a chair. The chair was a metal outdoor patio chair in Davis. I went to raise my right arm and felt the shoulder blade hitting the hard surface of the chair. This is called scapular winging since the shoulder blade is the scapula and winging for its flaring out like a wing. It’s possible that this winging may have been occurring earlier, but I had never sat in a hard-back chair like that before.

However, since that day, I can tell the winging even when working on the computer with no chair back for the scapula to hit. My back is also getting mildly sore because of this odd strain. Research says that the winging can occur because of damage to three different nerves that control muscles that keep the scapula in place during different range of motion activities.

I have no problems with my left shoulder blade. I test other people for the winging when lifting their arms, and there was none. But everyone saw my shoulder blade protrude when I lifted my arm.

Sent Dr. a message, have an appointment with the neurologist Dr. on July 29


Paralysis Improves

My shoulder paralysis began to improve in July. I received a call from the medical group saying they had to reschedule my appointment which was for a nerve test. They stick needles in your skin and test for impulses to make sure they are working correctly. The medical group never rescheduled. They dropped the ball, then the covid pandemic hit in March of 2020.

I did get the nerve test done in the Summer of 2020, and even though I have spinal stenosis in one of my neck vertebrae, everything was functioning properly. Two years after my bout with GBS and shoulder paralysis, my shoulders are still not 100 percent and my right scapula still sticks out.

I will not be getting the second dose of Shingrix. I’ll take my chances with Shingles. (Shingle’s Rash, Back Pain, Sensitivity…my experience having Shingles.) The covid-19 vaccine caused me some reticence because, like Shingrix, it is designer vaccine, messenger RNA. I did get the two doses of the Pfizer vaccine with no complications to date.

When it comes to the medical profession, my view has been dimmed. As I mentioned in another blog post, if something serious happens to me, they can take me in an ambulance to the emergency room. The GBS cleared up by itself, as did the Shingles rash, and a problem with my prostate. There is nothing the doctor could have done for me if she would have believed my shoulder paralysis was a function of the Shingrix vaccine and GBS. But it would have been nice to have been believed that all the pain, itching, and paralysis was linked to the vaccine. Crazy as it sounds, at least the federal government believes me.


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