Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Magnetic resonance imaging
Clinical narrative: Light-headed; Fell; Difficulty in walking/could not hardly walk across the floor; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control No.:20K-163-3678612-00). A 62 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at age of 62 years on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 25Dec2020 (Batch/Lot number was not reported) to 14Apr2021, at 40 mg, daily for moderate to severe adult crohn's. Medical history included inflammation from 24Nov2020 (magnetic resonance imaging). Concomitant medications included oxycodone; tramadol; ondansetron (ZOFRAN); aspirin [acetylsalicylic acid]; vitamin b complex. The patient experienced light-headed in 2021, difficulty in walking/could not hardly walk across the floor in 2021, fell in 2021. The events reported as serious for other medically important condition.  Clinical course: Solicited report by a consumer of a 61 year old female with events of total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, painful knee/excruciating shoulder pain, rotator cuff surgery and knee swollen and non-serious afraid to go anywhere due to covid, slept a lot, light headed and stumbling around like a drunk for two days, low immune system, tested positive for covid, boyfriend positive for covid, bowels movements three or four times a morning, pharmacy sent humira syringe instead of pen, miserable, knee was not 100 percent, gained weight, lost sense of smell, could not eat, total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, light headed, could not hardly walk across the floor, black and blue front back ankle to thigh and in front and back, still knee hurts from where had a knee replacement, little breakout crohn's disease due to stress, elevated white blood count, swollen, scar tissue, lost sense of taste, fell into the chair, shin aches/ pain, headache, nauseous, tender to touch, allergies, nerve pain, arm was sore and pain shoots down shin, physician said it was nerve endings with humira (adalimumab). The patient had a relevant medical history of inflammation. On unknown dates, the patient experienced total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, painful knee/excruciating shoulder pain, knee swollen, afraid to go anywhere due to covid, light headed and stumbling around like a drunk for two days, low immune system, tested positive for covid, boyfriend positive for covid, bowels movements three or four times a morning, miserable, knee was not 100 percent, gained weight, lost sense of smell, could not eat, black and blue front back ankle to thigh and in front and back, little breakout CROHN'S disease due to stress, elevated white blood count, swollen, scar tissue, lost sense of taste, shin aches/ pain, headache, tender to touch, allergies, nerve pain and pain shoots down shin, physician said it was nerve endings. in 2021, the patient experienced pharmacy sent HUMIRA syringe instead of pen, light headed, could not hardly walk across the floor, still knee hurts from where had a knee replacement, fell into the chair, nauseous and arm was sore. On 10Apr2021, the patient experienced slept a lot. In Apr2021, the slept a lot resolved. In May2021, the patient experienced rotator cuff surgery. On an unknown date, light headed and stumbling around like a drunk for two days resolved. Pfizer Biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect.   The patient had magnetic resonance imaging on the 24Nov2020 that showed inflammation but nothing torn. She had excruciating shoulder pain. She had to have her knee worked on again too. She was afraid to go anywhere due to COVID. Her knee was painful and swollen. Total knee replacement was done. Contraption did not adhere to her bone and fell out. She was in a lot of pain. The physician thought that little two pronged contractions they put in it was shifted. She had surgery to fix detached part from knee replacement. She had total knee replacement on 14Jan2021 and discontinued HUMIRA for six weeks. She was in a lot of pain. She had three CORTISONE shots in her knee and nothing touched the pain. She had a little breakout due to stress. In recovery, the patient got a call from her boyfriend that he had COVID so she was made to wear a mask. She had an emotional breakdown and cried. At 10 AM of the next morning, she was informed that she tested positive for COVID. Something was put in her IV. At 5 PM the patient was released and she was okay. At 9 PM her fever jumped from 101 to 103 and stayed that way all weekend. She woke up with headache and lost sense of smell and taste. She was nauseous as well. The patient thought that it might be from not taking her pain pills. She finally got to go in-person for physical therapy for her knee. Pharmacy sent her a syringe instead of a pen. Physician gave her a PHENERGAN and within a couple of hours she felt better and everything was gone. Her shin was just aching. She was black and blue from the front to the back of ankle to thigh. Physician advised her not to take a bath for six weeks due to possible infection. She massaged knee, so it would be flat. She took about four days' worth of OXYCODONE. She had no other side effects. Her allergies were horrible. She was miserable. She took allergy medicine. She had light headed, stumbling around like a drunk for two days. On 10Apr2021, she slept a lot. Her physician told her knee looks really good and that her pain was nerve pain. She was tender to touch and a little swollen. She had some scar tissue, pain and swelling. Her physician thought about changing her to another medicine from HUMIRA because bowel not normal had three to four times a day and it was diarrhea. Only time her bowel movements were normal when she eats refried beans. She said it was working so she did not want to change. She believes no matter what she did they were not going to be normal. She was used to HUMIRA and it makes her feel so much better. She agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   On 14Apr2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 04May2021 she received 2nd dose COVID-19 Vaccine manufacture by Pfizer. With the first shot she was so light headed, she could not hardly walk across the floor. She kept going to the right. Fell into the chair next to her. Pharmacist at Walgreens gave her Pfizer vaccine. She took covid vaccine because her immune system was low. The patient had still swollen knee and still hurts from where she had a knee replacement. Inclined kill her, going up or coming down. She did not understand it. Steps she had to take one at a time. She had pain shoots down her shin and the physician said it was nerve endings and that would be go away eventually. Physician told her to keep rubbing vitamin e cream on it. Patient agreed to have physician contacted. In May2021 she had Rotator cuff surgery. Gained weight and Knee had not 100 percent. She also had COVID-19 and her white blood count was elevated.   Causality for Humira with difficulty in walking, light-headed and fell per reporter was not reported per Mfr. was no reasonable possibility. The action taken in response to the events difficulty in walking, light-headed and fell for adalimumab was unknown. The outcome of the events difficulty in walking, light-headed and fell was unknown.  The reporter's assessment of the causal relationship of the events difficulty in walking, light-headed and fell with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the events difficulty in walking, Dizziness, fall and suspect drug BNT162B2 cannot be excluded.