Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Guillain Barre Syndrome; difficulty swallowing and eating food; not able to see out of his right eye properly; entire right side of his body was paralyzed/Paralyzed feet; back pain; calcium deposits on his muscles; pain in his shoulder; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Oct2024 as dose number unknown, single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CALCIFICATION OF MUSCLE (non-serious) with onset 2024, outcome "not recovered", described as "calcium deposits on his muscles"; ARTHRALGIA (non-serious) with onset 2024, outcome "not recovered", described as "pain in his shoulder"; BACK PAIN (non-serious) with onset 2025, outcome "recovered" (15Jul2025); HEMIPLEGIA (medically significant) with onset 15Jul2025, outcome "not recovered", described as "entire right side of his body was paralyzed/Paralyzed feet"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 20Jul2025, outcome "recovered", described as "Guillain Barre Syndrome"; DYSPHAGIA (non-serious), outcome "recovered", described as "difficulty swallowing and eating food"; VISUAL IMPAIRMENT (non-serious), outcome "recovered", described as "not able to see out of his right eye properly". The patient was hospitalized for guillain-barre syndrome (start date: 15Jul2025). The patient underwent the following laboratory tests and procedures: Blood test: (13Jul2025) Unknown Results; Computerised tomogram: (unspecified date) Unknown Results; Lumbar puncture: (unspecified date) Guillain Barre Syndrome; Magnetic resonance imaging: (unspecified date) Unknown Results. Therapeutic measures were taken as a result of guillain-barre syndrome, hemiplegia, back pain. Clinical course: Caller was a consumer calling about the Pfizer Covid-19 vaccine clarified to be Comirnaty. He got the product in Oct2024. Starting in around the end of Nov2024 or Dec2024, he started to have pain in his shoulder. Stated that he had calcium deposits on his muscles that were trying to solidify and that was what the pain was from. The doctor stated that it was unusual. Heading into the summer of 2025, he started getting back pain that no one knew what it was from. He started going to chiropractors and a specialist at Piner spine and sports physicians. He had to see a physiologist that specializes in movement. He said that the back pain progressed to where he could not sleep at night due to the back pain. It progressed to the point to where he had difficulty swallowing and eating food. On the 13Jul2025, he had to go to the hospital by ambulance. Stated that he had a bad doctor that did a blood test and sent him home. 2 days later, 15Jul2025 the entire right side of his body was paralyzed and said that he could not talk, could not use his right arm or right leg, and could not eat or swallow. Stated that he was not able to see out of his right eye properly. He was taken to a different hospital than he was the first time, and the 2nd hospital did 2 MRI's, a CT scan, followed by a spinal tap. They diagnosed him with Guillain Barre Syndrome. His doctor and the doctors at the hospital were going crazy trying to figure out how he got Guillain Barre Syndrome and the only thing that they could find that occurred around that time period was when they looked at his vaccination history and saw that he had the Comirnaty vaccine. They said that it was odd. Before this he had general back pain and thought he had just hurt his back and did not connect it to his shoulder pain or anything. He did not think it was connected to the vaccine. His doctor stated that it was odd that he was seeing the chiropractor and the back pain was not getting any better. He went to a more advanced Chiropractor that put him in a water massage machine and it did not help the pain either. Both Chiropractors told him his back was fine and there were no adjustments to be made. He said that he had symptoms from Guillain Barre Syndrome at least 3-4 months, maybe even 5 months, before he was diagnosed with the Guillain Barre Syndrome. When he went to the hospital they did a CT Scan with contrast led them to do the first MRI. The first MRI led to another MRI and they found something. He said that they needed to do the spinal tap to confirm their suspicions of him having Guillain Barre Syndrome. They had to do a treatment of IVIG, where they gave him IVIG through his IV. He currently has paralyzed feet. Stated that he was a rescuer and he is not rescuing anyone now. Back pain went away, in approximately end of Jul2025 after receiving the IVIG treatment for Guillain Barre Syndrome. He said that while he was in the hospital they spent a couple of days trying to figure out what he had. He was diagnosed with Guillain Barres Syndrome. Gave him IVIG for 5 days. A couple of days later he said that he was able to eat and the issue with his eye resolved. He was told it could take up to 2 years for the Guillain Barre Syndrome to resolve. He only had problems with his feet that he still has to this day. He now has a wheel chair, walker, and cane. On the same day he got the Comirnaty, he also got the influenza vaccine at the same time. Stated that his family was trying to recover from the fallout of him having Guillain Bare Syndrome. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Test Date: 20250713; Test Name: Blood Test; Result Unstructured Data: Test Result:Unknown Results; Test Name: CT Scan; Result Unstructured Data: Test Result:Unknown Results; Test Name: spinal tap; Result Unstructured Data: Test Result:Guillain Barre Syndrome; Test Name: MRI; Result Unstructured Data: Test Result:Unknown Results