Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Arthralgia, Dysstasia, Gait inability, Intervertebral disc displacement
Clinical narrative: couldn't walk; was standing up and going to sleep while standing; Had an ankle fused in the 70s and now it is swollen and broke out; Had an ankle fused in the 70s and now it is swollen and broke out; Having joint aches; sitting down can't get back up; foot and leg swollen; disc was dislocated; Heart racing; Taking steroids for pain; it hurts when she raised her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "broke her arm", start date: 1972 (unspecified if ongoing), notes: broke her arm 1972; "car accident", start date: 1976 (unspecified if ongoing); "ankle fused" (unspecified if ongoing), notes: Had an ankle fused in the 70s; "femur broken" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EN9581), administration date: 05Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, LOT: EN6202), administration date: 27Feb2021, for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious), outcome "not recovered", described as "couldn't walk"; SOMNOLENCE (non-serious), outcome "not recovered", described as "was standing up and going to sleep while standing"; JOINT SWELLING (non-serious), ANKLE FRACTURE (non-serious), outcome "unknown" and all described as "Had an ankle fused in the 70s and now it is swollen and broke out"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Having joint aches"; DYSSTASIA (non-serious), outcome "unknown", described as "sitting down can't get back up"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "foot and leg swollen"; INTERVERTEBRAL DISC DISPLACEMENT (non-serious), outcome "unknown", described as "disc was dislocated"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; PAIN (non-serious), outcome "unknown", described as "Taking steroids for pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it hurts when she raised her arm". The events "couldn't walk", "was standing up and going to sleep while standing", "had an ankle fused in the 70s and now it is swollen and broke out", "having joint aches", "sitting down can't get back up", "foot and leg swollen", "disc was dislocated", "heart racing", "taking steroids for pain" and "it hurts when she raised her arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Reporter mentioned that she knew that she received the Pfizer, but she did not knew the age group. Reporter could not confirm what vaccine she had received. University agent asked for any specific formulation/presentation, but the reporter kept referring to the product as booster, Reporter was a consumer and was asking if there was any way to get the booster out of her system or any way to get rid of the booster from her body. University agent mentioned that she had already filed a report about that. Reporter stated, "Because it had ruined, her whole life." (05Apr2023) Patient called because she wanted to speak to someone to find out if there was anything that she could be given to get it out of her system. Took the first two then got the booster. After the booster she couldn't walk, was standing up and going to sleep while standing. Had an ankle fused in the 70s and after booster vaccination it was swollen and broke out. had joint aches. She got the booster about a year ago. Took the first one and second one and didn't have no side effects. But now she could be wide awake and alert and fell asleep. She broke her arm back in 76 and after the booster vaccination she could not raise her arm, a disc dislocated in her back, she needed a hip replacement, had a femur broken. patient was about to write the president to tell him to not make the little children take it. She could not hardly walk and lives alone. Could not hardly walk or bend to put her shoes on. Just had to stick her foot in sneakers. Only sickness she ever had was a car accident. Aware this was discrepant as reporter provided she also had an ankle fused. Documented as provided by the reporter. Took the booster when she was told to take it in 2020 or 2021. Patient Height was about 5 foot 3 inches. Patient was taking steroids for the pain and gained about 6 pounds from the steroid shots. Was 152 pounds before and 158 pounds after. She was told one or two times the steroids wouldn't effect her but it did. Had a problem with her knee and that was the only reason she went back to the orthopedic doctor. was looking for a primary doctor because her primary doctor stopped practicing. Also went to Dr. (PRIVACY) for her ankle. First time she had problems in 50 years. Couldn't walk: Then everyone noticed it. She couldn't get up and just sat down. Now she was using the cane. Walks a while and then had to rest, makes her real tired. Right after she took the booster. Did not had a stroke or nothing, no sclerosis, no nothing. Heart racing and had no heart problems, no issues, nothing was basically healthy. Got nervous when she talks and got anxious. It had gotten worse to where she couldn't hardly sit down or got up. Had to hold onto things to get off her bed or to walk. Could not get into the bathroom and had to do a sponge bath at the sink for something to hold onto. In 1976 she had a car accident and was not having these problems. Went to her HCP and was told to see a specialist about her ankle. Never had a problem with joint and pains that hurt. Didn't have to wear a special shoe. When her ankle was fused she didn't have no problem. Sometimes the swelling gets worse and she used a compression stocking on it and sometimes props up her legs at night. Had a friend who also had a problem with standing up and going to sleep while standing. Finally found the paper she was given when taking the last booster that said a thing about side effects. Wanted to know why she had these side effects and still had them. Had sarcoidosis but that was just in her skin and makes her skin rough at times. Clarified she had sarcoidosis before taking the booster. Outcome: At times it was really bad, in the morning she had to walk looking down and would sometimes find herself falling. Had to go back to her cane and doesn't try to walk far or nothing. Now she had to get a buggy to have something to hold onto. Can't hardly walk up the hill to her mailbox up the slope and had to walk with a cane to get to her mailbox. Wasn't like that before. Used to play basketball with her grandson. Broke her arm in 1972 and could do her hair before. Then it was to where it hurts when she raised her arm and had to lift it up sometimes. Could not fix her hair like she wanted to fix it. It was just on one side, the side that was broke. Just slept on a heating pad all the time. Would not take the medicine she was given for it because she doesn't want to fall asleep or not be alert. Attempted to clarify medication and she provided she did not want to take the pain pills. Disc was dislocated: Start Date: Happened after the booster. Had no back problems before and went to the orthopedic doctor and was told the disc was dislocated and she needs a hip replacement. Could not even cross her hands in the back. Clarified her lower back and waist was hurting and her HCP said it was her hip then pressed on her back making her jump so an x-ray was taken, and her HCP showed her the disc was dislocated. 04Feb of last year she had the booster. Took it at a drug store, (Withheld). Might she was given the wrong medicine or something in the shot. Took steroids for the pain: Start Date: After the booster. Booster aggravated it. Clarified she did not take steroids anymore and was scared of them. Only took them when it was really bad. Steroids were supposed to only last for a certain time and did not last that long. She did not want all those chemicals. Attempted to clarify specific name of steroid and reporter stated she did not know anything about the product and to contact her HCP. Asked her HCP about a shot for the ankle. HCP said if it could be figured out where to give it she could get a shot in the ankle. Instead, the HCP ordered a cream to put on it. Attempted to clarify specific product name reporter provided all her stuff came from Pfizer, the first two shots and the booster. did not said nothing else on what she was given. On the first two papers she was given it says the products wouldn't bother her since it was the same medicine used in colonoscopies. Clarified she did not know the specific medication name for the booster specifically. Confirmed she did not know the specific Booster name. She just took the first two a few weeks apart and then got the booster later. Her HCP thought she was allergic to the antigen and an antigen was a type of protein. Reporter did not think it was the antigen. Thought the clinic gave her the virus instead. She was trying to go on a trip and all the people who only had two shots got a tested at once place. Was told all the people who had the booster had to go to some place else for testing since it was the only place that was giving out that type of test for those who had the third shot. Clarified she ended out not going for testing or going on the trip. The booster had to be different than the first two since other people only did two shots and she had taken 3 and had to go somewhere else. Provided the paper she was given talks about the COVID-19 is caused by the SARS virus. Her HCP said he and his wife both took two shots and ended out with the virus. Clarified she did not know what the name of the two shots her HCP and his wife took. Knows lots of people who had the shots and ended out with the virus. Clarified she had no patient information to provide or product information to provide. Clarified she might have information on her cousin she could find out about. Her cousin had taken a shot and got the virus. A lot of other people took it and had it. Clarified her HCP and his wife had it two times after getting the shots. Further clarified she did not know what product the other people, her cousin, her HCP, or the HCP's wife took. She took the booster in the early part of 2021 and had it before she went back to work. She did not have NDC/EXPIRY/Formulation/Dose information because it was not on her vaccine card. Testing: No, because it was the first time she called about it. Called Pfizer because she was about to call the president to try and not had him force it on anyone else. She located her vaccine card. First dose of Pfizer: LOT: EN9581, Date: 05Feb2021. Second dose of Pfizer: Date: 27Feb2021, LOT: EN6202. Third Dose: Unspecified Booster: Pfizer. Date: 11Oct2021. Aware this was discrepant as reporter previously provided she received it 04Feb of last year. Documented as provided and confirmed by reporter. LOT might be RF or REE71. Clarified the nurse's hand writing was hard to read. LOT Might be FREE1 or 11. Clarified the card did not have a lot number or anything. Aware this was discrepant as reporter previously was attempting to read LOT number. Documented as provided by reporter. (Name withheld) was the person who administered it. Attempted to clarify specific product name of Booster and first two shots reporter only provided Booster and First dose of Pfizer and Second dose of Pfizer. Doesn't know specific product names. Documented product names as provided by reporter.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow up (05Apr2023): This is a spontaneous follow-up report received from the same contactable Consumer. Updated information included: New reporter (HCP) added. Patient demographic details (DOB, Age, Race, Weight) added. Relevant medical history added. Historical vaccines recoded. Suspect vaccine dose number and vaccination date added. All new events added. Concomitant therapy selected as None, Clinical course captured.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147048 Same patient/reporter, different dose and event;