Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Magnetic resonance imaging, Pain in jaw, Prostatic specific antigen
Clinical narrative: severe right hip and leg pain/Fever/swelling in the legs/Pain in the thighs/Still's disease; tires very easily; weak; some difficulty walking; some difficulty concentrating; pain in the jaws; woke up in severe pain in the lower back; severe headache; pain in the teeth; eye pain; astigmatism in both eyes; PSA level was high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), on 28Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "digestive problems" (ongoing), notes: before the covid vaccines; "type II diabetes" (unspecified if ongoing); "Swelling", start date: 2014 (unspecified if ongoing), notes: Swelling in legs: not ongoing; had always had swelling since 2014; "Cyst" (unspecified if ongoing), notes: he had a cyst in the back of his leg that had been putting out additional fluids.; "some pancreas problems" (unspecified if ongoing); "TMJ in the jaws" (unspecified if ongoing). He had digestive problems and did have some pancreas problems prior to this in 2014. On 16Mar2021 before he got sick he visited a nurse at the primary doctor's office and all was good and had no problems with (name withheld) and his mental status was good and all that and the next day on 17Mar2021, he went for an annual checkup, they ordered blood tests and indicated his numbers were low but that he did have type II diabetes and put him on Glipizide on 17Mar2021. There were no concomitant medications. He had no other vaccinations within 4 weeks prior to these events. Vaccination history included: pfizer covid vaccine (DOSE NUMBER 1, SINGLE), administration date: 06Feb2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "PSA level was high"; ASTIGMATISM (non-serious) with onset Apr2021, outcome "unknown", described as "astigmatism in both eyes"; EYE PAIN (non-serious) with onset 21Apr2021, outcome "unknown"; TEETHING (non-serious) with onset 24Apr2021, outcome "recovering", described as "pain in the teeth"; HEADACHE (non-serious) with onset 24Apr2021, outcome "unknown", described as "severe headache"; STILL'S DISEASE (hospitalization) with onset 24Apr2021, outcome "not recovered", described as "severe right hip and leg pain/Fever/swelling in the legs/Pain in the thighs/Still's disease"; BACK PAIN (non-serious) with onset 24Apr2021, outcome "unknown", described as "woke up in severe pain in the lower back"; PAIN IN JAW (non-serious), outcome "unknown", described as "pain in the jaws"; FATIGUE (non-serious), outcome "unknown", described as "tires very easily"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "some difficulty walking"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "some difficulty concentrating". The patient was hospitalized for interchange of vaccine products, still's disease (start date: 28Apr2021, discharge date: 01May2021, hospitalization duration: 4 day(s)). The event "woke up in severe pain in the lower back" required emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: Negative, notes: biopsy and that came back negative so they were still at a loss as to what might be happening with him and checked the temporal artery biopsy and it was called the giant cell arteritis and it was negative; Blood test: Unknown Results, notes: he drew 5 vials of blood for testing; adult Still's disease, notes: he had blood work drawn and it confirmed he had adult Still's disease; Body temperature: Unknown result, notes: the reason for the hospitalization was the severe right hip and leg pain and fever; High, notes: guessed that it was some type of blood disease and he was spiking a high fever every day; Electromyogram: Normal, notes: MRI brain scan and an EMG on his legs and blood work and all the blood work was all negative and everything was normal for those tests so he was still in the dark as to what happened to him; Magnetic resonance imaging: normal, notes: MRI brain scan and an EMG on his legs and blood work and all the blood work was all negative and everything was normal for those tests so he was still in the dark as to what happened to him; Prostatic specific antigen: High. Therapeutic measures were taken as a result of still's disease, back pain, eye pain.   Clinical course: He was in extremely good health and had just a little digestive problem at the time and went out and was spreading seed for the grass in his yard and felt fine, had a shower and went to bed and was in no pain or anything like that. About 2:30am he woke up in severe pain in the lower back and clarified it was the morning of 24Apr2021 when this happened and he went into the emergency room. He had severe pain in the lower back and got up and thought maybe he twisted his back and was up most of the night because it was hurting so he took some Tylenol and as the morning went on, some strange things started happening. Both legs swelled up 2-3 times their normal size, he had severe pain in his upper thighs and then had severe pain in his jaws and teeth. He has good teeth and sees the dentist twice a year and has no cavities but his teeth were hurting really bad and also the jaws were hurting. In years past he has had TMJ in the jaws but it had pretty much gotten better over the years and in those joints there the TMJ joint was hurting and along with that he had a severe headache; this all began on 24Apr2021 and the evening before on the 23rd he was just fine and had no swelling, no pain, and felt good and went to bed and was fine and all of a sudden bang it hit him. Swelling in legs was not ongoing; he had always had swelling since 2014 he thinks and had had a little swelling in the left leg and was previously checked out by doctors many times and they thought he had a cyst in the back of his leg that had been putting out additional fluids and just pulled to the leg and told him that was nothing to worry about and to keep it elevated and he had been doing that and that evening before on 23Apr he had no swelling. Pain in the thighs, teeth and jaws is ongoing and improved. For headaches it is ongoing and are just occasionally but still going on. His wife took him to the emergency room and thought maybe that he might have had a sciatica problem and he knows what that is and did not think it was that but kind of figured at the time it may be so they gave him morphine while he was there and he was in so much pain and they prescribed Oxycontin and Valium and sent him home; the morphine, Valium and Oxycontin did not help at all with the pain which was really strange. He put up with it for 4 days and was in a lot of pain and returned to the emergency room on 28Apr2021 and at that time he had severe right hip and leg pain which was a continuation from 24Apr2021 for the right hip and leg pain. When he went in he was also running a fever and that concerned the doctors and they admitted him to the hospital and he was in there for four days admitted on 28Apr2021 and discharged on 01May2021 and the reason for the hospitalization was the severe right hip and leg pain and fever. He was in the hospital and both his legs were still swollen from the previous 4 days and the doctors were quite concerned and guessed that it was some type of blood disease and he was spiking a high fever every day so they then shot him full of all kinds of different antibiotics and he was constantly on morphine all 4 days and that was the pain medicine and then right before he left on the day they released him they gave him steroids to take; has no names of the steroids or the antibiotics or further details to provide for those. They ran some cultures and they showed he did not have a blood disease and the swelling went down in his legs and so they decided to release him and has a date there that is released on 01May2021 from the hospital. The fever had subsided and the swelling had gone down in his legs. The emergency room doctor was stumped and did not know what he had going on and caller states he did not have covid and they did check that and it was not anything covid related and then on 18May2021 he went for another visit with the clinic and they checked for autoimmune rheumatology issues and would check for that and on the 18May2021 went back for follow up and on 26May2021 to the clinic, they were taking blood and he did not have lupus. They sent him to get a temporal arterial biopsy and there is a disease you can get that shows it and they checked for it. He went to see a surgeon and on 15Jun2021 was his surgery for the biopsy and that came back negative so they were still at a loss as to what might be happening with him and checked the temporal artery biopsy and it was called the giant cell arteritis and it was negative. His regular doctor saw him on 22Jun2021 and he drew 5 vials of blood for testing and his inflammation inside his body said that the numbers were sky high and dangerously high the doctor said on 22Jun2021. He was prescribed Prednisone of an unknown strength and he does not have that with him and then clarified he was on Prednisone 10mg and started it on 22Jun2021 for 11 months. He went back in a week later and it showed the inflammation was decreasing and then he suspected at the time the doctor mentioned Still's disease which is very rare in adults and sent him to see a neurologist on 27Jul2021 and ordered an MRI brain scan and an EMG on his legs and blood work and all the blood work was all negative and everything was normal for those tests so he was still in the dark as to what happened to him. On 08Sep2021 he had blood work drawn and it confirmed he had adult Still's disease and the main key to that was that at that time he was still running a fever every evening and one of the symptoms to look for in that was the type of pain he was having. The doctor took him off the Prednisone and he started experiencing more pain and the inflammation levels went back up and so he kept him on 10mg of Prednisone and added Methotrexate and folic acid at the time and then on 16Sep he went to see an eye specialist because of eye pain he was still having and it was severe eye pain and having trouble seeing and the eye pain had begun all the way back to the original day 21Apr2021; the eye pain is not ongoing has since cleared up. The doctor checked eyes and they were fine so they were stumped too and it the eye pain cleared up 28Oct2021 and he went for a checkup and he gave the caller some eye drops for the pain and it was called Ketorolac but he has no dose or manufacturer name to provide for the Ketolorac. During the meantime he had some more blood tests drawn as his numbers were going dangerously high and dropping and going high again and on 22Nov2021 the inflammation numbers went down and they started tapering him off the Prednisone and he went back for eye doctor visit and check because of all the Prednisone he was taking since Apr2021 he developed severe astigmatism in both eyes. Physician referred him to a hematologist to check the nerves in his legs and everything looked fine there and then he will not go into dates but it was a terrible time with his eyes and he thought he was going blind at one time and found out his eyes were healthy and with the astigmatism had to go in and had to get glasses were they going to do surgery but decided against that because they did not know what they were dealing with and everything was up in the air and none of the doctors had any explanation but the best guess was Still's disease. They believe that through the Pfizer vaccine after his 2nd covid shot that all this started happening about 8 weeks after the 2nd shot. On 17Mar2021, he went for an annual checkup, they ordered blood tests and indicated his PSA level was high on that visit and they would keep an eye on it and he felt pretty good too. He still has his symptoms that are better and states let him back up and he went to the doctor who took him off the Prednisone on 27Apr2022 and kept him on the Methotrexate and along with that he has to take a folic acid pill that you are supposed to take with that drug. On 18May2022 and basically since that time the Methotrexate has been keeping his inflammation numbers down but the doctor refuses to take the patient off of it because they are afraid he would go back into the hospital again. That was happening in 2022 and he is still on Methotrexate now and the dose is 6 tablets one time by mouth per week and it is 2.5mg and he does have a few side effects from that but is better and improved and it is keeping his numbers down and could be because according to his doctor they do not want to take him off of those now and it is a cancer drug but is also used for inflammation; the side effects from the Methotrexate are pretty bad the first 24-48 hours after he takes it and he has a pretty bad headache, is very weak, and has some difficulty walking and concentrating. Basically the pain is gone and he is still very wobbly on his legs and tires very easily and during the day at least one time per day hits a brick wall and has to sleep and if he can get 45minutes to an hour nap in he is good; he is not a spring chicken anymore and is not sure if it is old age but he does not know and is not blaming Pfizer for anything. He asked if the covid shot had to do with this and the doctor hesitated because too much time had elapsed as it been about 8 weeks since his covid vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.