Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Laboratory test, Lumbar puncture, Magnetic resonance imaging, Multiple sclerosis
Clinical narrative: spinal cord swelling/ transverse myelitis; multiple sclerosis; lesions in the brain; It was hard for him to walk. He has to hold on to walls to walk.; Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness.; patient cannot walk; Severe back pain; both feet have numbness and tingling; This is a spontaneous report from Pfizer. A contactable nurse (patient's mother) reported that a 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 13Apr2021 13:30 (Batch/Lot Number: EW0153) (at the age of 33 years old) as 1st dose, single for COVID-19 immunisation. Medical history included surgery on his leg (when he was 17) and cold. There were no concomitant medications. Patient had a severe reaction to the covid vaccine. On 17Apr2021 at 08:00, the patient had severe back pain. On Sunday morning (25Apr2021), patient had severe back pain. Patient was a former college athlete. Patient was mentally healthy and physically fit. Patient did not remember getting hurt while playing golf. Patient iced his back and did some stretches. Patient called his friend who is a doctor, and his friend told him he did the right thing by icing and stretching.  A few days later, either Tuesday evening, 27Apr2021 or Wednesday, 28Apr2021, patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient was able to get down a flight of stairs and then called an uber. Patient was taken to the hospital. It was his left foot and left leg initially. Now both feet have numbness and tingling. It was hard for him to walk. He has to hold on to walls to walk (also reported as Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall).  He went to the emergency department on 29Apr2021 and got an MRI of back and lower legs, "all was negative for slip disc or spinal cord swelling.  Patient had an MRI of his lower back, and legs. The MRI results were that patient had no spinal cord compression that would cause his left lower leg numbness. Patient was admitted to the hospital, to the neurology department, with a consult for a neurosurgeon to see him. The doctors agreed that he had something going on since he had left lower leg numbness. In the course of four days, Thursday through Sunday, patient was admitted to hospital in the neurology unit. Patient was in an overflow area. Several hospitals around that area have closed, so now the hospital is seeing so many more patients, and the hospital is over capacity. Patient was admitted by a hospitalist, and then was referred to a neurology team. The doctors said that that does not explain patient's symptoms, so the doctors ordered a head to toe MRI with contrast.  He was admitted to the hospital and continued to have severe back pain then, the doctors did another head to toe MRI with contrast and then they said he has "MS due to brain lesions and spinal cord swelling the length of his spinal cord." They also did a spinal tap. The family kept telling the MDs that he had just received his Pfizer vaccine. The patient denies any weakness or numbness in past 6 months. He continues to have numbness in both feet and now the left leg is always numb. The doctors gave him an outpatient appt at the end of June. It felt like whenever he sits on his foot while watching TV, and it starts going numb. By the time that patient was getting testing done, the nurses covered patient's eyes, and told patient to tell them whenever he could feel it. The doctors and nurses were sticking pens in patient's feet, and patient could not feel it at all. Patient could only feel pressure. On Friday, 30Apr2021, patient had a head to toe MRI with contrast. Reporter thinks that patient got back to his room after the total body MRI about 22:15. The head to toe MRI with contrast revealed that patient had spinal cord swelling, and lesions in the brain. Doctors diagnosed patient with multiple sclerosis. Patient has never had any symptoms of multiple sclerosis. Reporter's husband feels like patient could have transverse myelitis, because some vaccines can cause that. Reporter's husband asked patient's doctor to contact Pfizer to see if there was anything in place about how to treat this. On Thursday, patient's doctor told reporter's husband that there had been no reported adverse effects of spinal cord swelling from the covid vaccine. On Sunday, whenever patient was discharged, patient's doctor told reporter's husband that he was not going to call and report about patient to Pfizer, and that there had already been 45 documented cases. This was a really big red flag to reporter. Patient cannot walk. Patient can now only stand if he is holding a wall. Before this, he was totally healthy. Patient was discharged from the hospital on Sunday. The hospital sent his MRI results, lab work, and spinal tap fluid after his MRI to Clinic. The doctors did the spinal tap on patient to make sure he did not have an infection. Patient did not have an infection. The doctor started patient on Lyrica and some other drug. The hospital told patient to call back in two weeks, because by then they would have stuff back from Clinic, and then he could make a follow up appointment. Upon discharge, patient was told that maybe he could get a follow up appointment in Jun2021. Everything that reporter has read, says that patient's condition needs to be followed up on as soon as possible. Patient cannot walk. This is going to financially cripple patient. Reporter is sure that after this, patient will meet his deductible and is going to have to pay out all of this money to cover his hospital stay and testing. Before the COVID vaccine, patient did not have any problems at all. Patient had to have surgery on his leg when he was 17. Patient has no history of back pain. By the time the doctors and nurses did testing, that was late Friday evening, 30Apr2021 or Saturday morning, 01May2021. By the time that the testing was done, both of patient's feet and left leg were totally numb. The hospital said that patient's symptoms were terrible, and that he had something acute going on. The hospital ran tests on patient. Patient told the doctors at the hospital that he had recently received the COVID vaccine. Patient was never sick he might get a cold every once in a while. Other than that, patient only sees the doctor once a year for a physical. The hospital did preliminary lab work on patient. Patient's vital signs were stable, and he had no fever.  After patient received three doses of IV Solu-Medrol, his back pain went away. Patient's doctors felt like patient's spinal cord swelling had diminished. Patient's doctors felt like patient's spinal cord swelling is what cause patient's numbness and tingling. The first dose of IV Solu-Medrol was given sometime on 30Apr2021. Patient received IV Solu-Medrol 1 gram, three days in a row.The doctors said that was all they were going to do at this time. The doctors wanted to wait to see what the lumbar puncture shows (unknown results). Patient was given IV Solu-Medrol while in the hospital. Patient was put on Lyrica and gabapentin. The doctors are hoping that those two medications will make his symptoms go away. Patient used to take a multivitamin for years, but reporter does not know if patient still takes that. Patient is super healthy. Patient was admitted to the hospital on 29Apr2021, and discharged on 02May2021 after receiving his last dose of IV Solu-Medrol. The patient had no COVID prior vaccination. The patient had Nasal Swab (COVID test) on 28Apr2021 and was negative.  Event relatedness to Pfizer COVID vaccine: Severe back pain and Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall was related. Reporter stated that she thinks his symptoms are medically significant, but they could be disabling. If the COVID vaccine gave patient multiple sclerosis or transverse myelitis, this could be disabling. The outcome of the event back pain was recovered in May2021; event spinal cord swelling was recovering; events "terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness and It was hard for him to walk. He has to hold on to walls to walk" were not recovered; and unknown outcome for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the multiple sclerosis,  transverse myelitis and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including spinal MRI at baseline, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.