Sex: M
Vaccine: COVID19
Symptoms: Influenza, Malaise, Mobility decreased, Pain, Paralysis
Clinical narrative: Collapsed day after vaccine first dose/Collapsed day after vaccine second dose; His left side still feels paralyzed and can't walk; legs wouldn't move, couldn't turn around; He had compression fractures L1 to L3 that were noticed on his x-ray; he collapsed and had a hard time getting up/felt bad; General malaise; His left side still feels paralyzed and can't walk; bedridden; Pain; Half of back is black from incident; Mobility got worse after first shot and then after second dose his mobility got even worse; felt like what I would call the flu; Collapsed day after vaccine first dose/Collapsed day after vaccine second dose; This is a spontaneous report received from a Pfizer sponsored program. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Batch/Lot Number: EP7533) as 1st dose, single dose and second dose via an unspecified route of administration, administered in Arm Left on 07May2021 14:00 (Batch/Lot Number: EW0182) as 2nd dose, single dose for covid-19 immunisation. Medical history included L1 to L3 compression fractures somewhere around 2008 to 2010, ongoing gout (from about 35 years ago) (pain in both hips and right shoulder, left shoulder some times), gouty arthritis (30 years constant pain), ongoing moderate emphysema (since 20 years ago), stroke (happened in 2010). States he was taking Warfarin at the time of the stroke and the stroke was permanent, cholesterol, smoker (20 years), excess uric acid, allergy in right sinus, cough uncontrollably, perirectal abscess and low blood pressure. Family medical history was none. States he is adopted. Concomitant medications included atorvastatin taken for blood cholesterol from an unspecified start date to unspecified date in 2021 (Taking for about 5 years, not sure if the dose is 30mg, 50mg, or 300mg, stopped after adverse event with covid vaccine), zolpidem tartrate (AMBIEN) taken for sleeping from an unspecified start date to unspecified date in 2021 at 10mg (taking for couple of decades, stopped after adverse event with covid vaccine, stated it may cause drowsiness) and allopurinol taken for gout at a dose of 300 mg, (taking for 6 or 7 years) and azelastine hydrochloride nasal spray taken for uncontrollable coughing via nasal route as 2 shots each nostril twice a day (uncontrollable coughing caused perirectal abscess, had scope done, diagnosed as allergy. Azelastine works for cough). The patient previously took pneumonia shot and stated that it hurt like hell for a week, flu shot and got sick and also took warfarin. The patient reported that he received his first dose on 16Apr2021, then the next day he collapsed and had a hard time getting up. He also reports general malaise, "just felt bad", and "felt like what I would call the flu" for the next 5 days. On 07May2021 he received his second dose, and the same thing happened where he collapsed the next day. This time, he was not able to get up on his own and had to call 911. He was admitted to the hospital and "had 2 X-rays and a CT scan", CT of torso he reports his CT scan showed compression fractures at L1, L2, and L3 on his x-ray. He is taking a lot of Norco to treat his pain. States the music on hold is so uplifting that he wants to go cut his throat. Caller stated he was bedridden. He reported "I can't walk, I used to be able to, and now I can't". He spent 5 years in a computer testing laboratory and he knows a little about testing. He states a lot of the rules apply to conductors and automobiles. Caller stated he wants to know what happened to him. He says if he dies as a result of this, there will be mountains of paperwork. He also said if his condition is permanent, there will also be mountains of paperwork. He can't go to the bathroom and this is an issue. He was falling down and collapsing several times with both shots. He says this is a major problem. He declined being admitted to assisted living saying "if I'm going to die I'm going to die at home". Caller would like to know if anything like this has been reported before, if they got better, and what treatment they received to get better? He also asked if there were any reported deaths after vaccination? Events paralyzed, bedridden, can't walk, legs wouldn't move, couldn't turn around was reported as worsened, half of back is black from incident. The patient was taking Pfizer Covid Vaccine as needs to show he had vaccine to travel. He hasn't measured his height since compression fractures. Lost 20% on 3 vertebrae, so he might only be 5 feet 10 inches. He figures 20% would be an inch lost with his calculation. He can't reach around 180 degrees to measure himself. When asked to provide NDC, lot number and expiration date from vaccine card, caller stated he needed to use magnifying glass. He then stated that his vision is good. He stated that he collapsed several times after his second shot. He says this happened approximately 2 to 3 days after the second shot. He called his doctor and was told to call 911. He went to the hospital. He was in the ER, but confirmed he was not admitted to the hospital. Outcome for collapsing after both doses, had worsened as mentioned by patient. Caller stated after the first vaccine, he noticed his left leg did not work very well. After first dose, he had trouble walking after 5 days. When he would try to move his left leg forward it would shake, not move and he had to slide it sideways across the floor. Right now he can get up and turn around before he pees all over himself and could not get to the bathroom before. Now he pees in a cooking pot. He asked to be excused while on call and stated he had to urinate again. Mobility got worse after first shot and then after second dose his mobility got even worse. Confirmed his compression fractures are an existing condition from 10 to 12 years ago. Reported he has gouty arthritis and it has been going on over 30 years and has constant pain for over 30 years but has always been able to walk and feed himself. The pain is not our fault. Reported that the malaise was better after 5 days, but his mobility went down. He has trouble walking. Sometimes knees would give out and he collapses. Caller states he now uses a walker, cane, and a wheelchair. If he has to go more than 10 feet, he has to have assistance. Treatment for Event: Norco 10-325: Takes up to 3 times per day. States the other day he had 45mg but was still in pain. This is discrepant but details were documented as provided. Caller states he is still in pain, but he can't get more without going to pain specialist. His doctor stopped atorvastatin and Ambien after adverse events with the covid vaccine. ER doctor wanted his primary doctor to review his medications since the ER doctor thought he was on too many medications. Caller tried to explain the reasons he was on the different medications. When talking about his gout: He has a picture after incident and half of his back is black, not blue, it is black. He was not in pain for about 2 years. Then he had the test to determine what was going on and that is when the pain got really bad. He has had bad pain for 35 years with gout in his hips especially, and in right shoulder. He cannot reach if something is in his right back pocket. Left shoulder sometimes. All the time with both hips. Also in right shoulder but if he does not use right shoulder then there is no problem. He was even thinking about getting a hip transplant due to the pain. His doctor did blood tests to find out that he had excess uric acid. He was on a medication called Uloric and it worked wonders but it is no longer made. Then it was found out that some people had bad reactions with it harming their heart and that was the end of Uloric. Then he started taking Allopurinol, states it does work but it works so little that it is almost worth not taking. When the pain is at 10 or 11 on pain scale, states what is the difference. He has an allergy in right sinus that caused to cough uncontrollably and his uncontrollable cough let to a perirectal abscess. He suggested to his doctor to stop his coughing and not worry about the abscess. He then went to ENT and stuck a scope down his nose and told him his sinus is inflamed and there is no infection, there is an allergy and cannot tell what the allergy is and will probably never find out what the allergy is, and prescribed him the Azelastine hydrochloride nasal spray. The pharmacist thinks the nasal spray is too much but states the pharmacist is not a physician and ENT doctor prescribed it. The two sprays a day works and he has not had uncontrollable coughing since then. Out of an abundance of caution he was sent to a lung doctor to get breathing test. Testing: He had two x-rays and CT scan of the torso. He does not know what x-rays showed. CT scan shows kidneys, liver, pancreas, and gall bladder are normal. Everything is normal except for the heart. It did not explain what was wrong with him. Clarifies he had the same CT scan at another facility a couple of years ago and he was told that calcium around the heart is normal. He knows that he has low blood pressure normally. Attempted to clarify if x-rays were off his chest, stated they stuck something under his back. States nothing was mentioned about his x-rays and if they looked at the x-rays they could see he has a broken back. No other vaccinations was done within four weeks prior to the first administration date of the suspect vaccine. Got sick the next day after the flu shot twice. Will never take again (unspecified flu shot). Patient reported about 4 years ago he let his doctor give him a pneumonia shot and his arm hurt like hell for a week, states he is never doing that again.  When discussing Allopurinol, caller stated it was not working very well, but it had positive effect and he will continue taking it as long as his doctor will let him. States when taking it, the gout does not get better, it gets worse. Allopurinol, states it does work but it works so little that it is almost worth not taking. When the pain is at 10 or 11 on pain scale, states what is the difference. Caller states he was on a different medication before that worked better, but he could not continue to take it. Caller stated that microprint was difficult to read. He was able to give NDC number using magnifying glass. Product strength and count size dispensed: 300mg, 90 count. Expiration Date: Dec 2021. The sample of the product was available to be returned, if requested. Packaging was sealed and intact. Treatment for event was Norco 10-325: Takes up to 3 times per day. Caller states he is still in pain, but he can't get more without going to pain specialist. Confirms he has been in chronic pain for over 30 years due to gouty arthritis. Advised caller to retain sample of product in the event he receives Mailer within 3-10 business days for the return. Swap. Caller took 1st dose of Covid vaccine 16Apr2021 and collapsed the next day and then for the next 5 days he felt general malaise and weakness. On 07May2021 he took 2nd dose, 21 days after 1st dose, and again collapsed the next day. Stated that he needed to call 911 to help him get up and they took him to hospital where they did a scan of his torso and said he was fine. Doctor also told him that he did not have stroke, blood clot or aneurysm. Caller thinks it is neurological as he is still having trouble standing and walking and his left side feels paralyzed. He is wondering if these side effects were documented during clinical trials. Therapeutic measures were taken as a result of pain. The outcome of the events experienced collapsed day after vaccine first dose/collapsed day after vaccine second dose, legs wouldn't move, couldn't turn around, he had compression fractures l1 to l3 that were noticed on his x-ray, pain, half of back is black from incident, mobility got worse after first shot and then after second dose his mobility got even worse, felt like what i would call the flu was unknown, for the events his left side still feels paralyzed and can't walk, he collapsed and had a hard time getting up/felt bad, his left side still feels paralyzed and can't walk, bedridden the outcome was not resolved, for the event general malaise the outcome was resolving.  Follow-up attempts are needed. Further information is expected.