Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Complication associated with device, Contusion, Crohn's disease, Device physical property issue, Dizziness
Clinical narrative: Immunodeficiency; COVID-19; Crohn's disease aggravated; Detachment of device; Painful joints; Complications due to internal joint prosthesis; Knee swelling; Fear of disease; Stumbling; Light-headed; Frequent bowel movements; Feeling miserable; Knee arthropathy; Weight gain; Loss of smell; Oral intake reduced; Mobility decreased; Stress; White blood cell count increased; Swelling; Scar; Loss of taste; Pain legs; Nauseous; Tenderness; Allergy; Nerve pain; Contusion of lower leg; Peripheral neuropathic pain; Rotator cuff repair; Sleep excessive; Difficulty in walking; Wrong dosage form dispensed; Medical device site joint pain; Pain in arm; Fall; This is a solicited report from the marketing program facilitated collect received from a contactable consumer (patient) based on information received by Pfizer from AbbVie, manufacturer control number: 20K-163-3678612-00.  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 14Apr2021 (Batch/Lot number was not reported) (at the age of 62-year-old) as DOSE 1, SINGLE and then intramuscular on 04May2021 (Batch/Lot number was not reported) (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation; and adalimumab (HUMIRA), subcutaneous from 25Dec2020 (Batch/Lot number was not reported) to an unspecified date at 40 mg at unknown frequency for moderate to severe adult Crohn's disease. Medical history included inflammation from 24Nov2020 and exposure to sars-cov-2 from an unknown date and recovering. Concomitant medications included oxycodone; tramadol; vitamin b complex; ondansetron (ZOFRAN [ONDANSETRON]); and aspirin [acetylsalicylic acid]. The patient experienced immunodeficiency, covid-19, Crohn's disease aggravated, detachment of device, painful joints, complications due to internal joint prosthesis, knee swelling, fear of disease, stumbling, light-headed, frequent bowel movements, feeling miserable, knee arthropathy, weight gain, loss of smell, oral intake reduced, mobility decreased, contusion of lower leg, stress, white blood cell count increased, swelling, scar, loss of taste, pain legs, nauseous, tenderness, allergy, nerve pain, and peripheral neuropathic pain on unspecified date; rotator cuff repair in May2021; sleep excessive on 10Apr2021; difficulty in walking on unspecified date, medical device site joint pain, fall, and pain in arm and wrong dosage form dispensed on unspecified date in 2021. It was further reported that 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 (Privacy) 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. The patient was treated with Phenergan, Cortisone and Tylenol. The patient underwent lab tests and procedures which included body temperature: 101 and 103 on unspecified date, magnetic resonance imaging: inflammation but nothing torn on 24Nov2020, COVID test: positive on unspecified date, and white blood count: elevated on unspecified date. The action taken in response to the events for adalimumab was temporarily withdrawn on an unspecified date. Therapeutic measures were taken as a result of rotator cuff repair, light-headed, loss of smell, loss of taste, nauseous, allergy, and nerve pain. On unspecified date in Apr2021, the patient recovered from sleep excessive; recovered from light-headed on unspecified date. The patient was recovering from immunodeficiency, detachment of device, painful joints, complications due to internal joint prosthesis, knee swelling, stumbling, loss of smell, oral intake reduced, mobility decreased, contusion of lower leg, swelling, scar, loss of taste, pain legs, nauseous, tenderness, and nerve pain; had not yet recovered from Crohn's disease aggravated, fear of disease, frequent bowel movements, stress, and allergy; while outcome of the rest of the events was unknown. Causality as per reporter for Humira and events rotator cuff repair, sleep excessive, covid-19, knee arthropathy, weight gain, stress, white blood cell count increased, allergy, and nerve pain was no reasonable possibility while for events painful joints, knee swelling, fear of disease, light-headed, frequent bowel movement, swelling, crohn's disease aggravated, and tenderness were reasonable possibility. Causality as per Abbvie for Humira and event of immunodeficiency was reasonable possibility, for event contusion of lower leg was not assessable, while rest of the events was assessed as no reasonable possibility. Causality as per reporter for bnt162b2 and events rotator cuff repair, covid-19, knee arthropathy, weight gain, and white blood cell count increased was possible.  The reporter's assessment of the causal relationship of the events detachment of device, painful joints, complications due to internal joint prosthesis, knee swelling, fear of disease, sleep excessive, stumbling, immunodeficiency, light-headed, frequent bowel movements, feeling miserable, loss of smell, oral intake, mobility decreased, difficulty in walking, contusion of lower leg, medical device site joint pain, stress, swelling, scar, loss of taste, fall, Crohn's disease aggravated, pain in legs, nauseous, tenderness, allergy, nerve pain, pain in arm, and peripheral neuropathic pain with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: Assuming a plausible temporal association, a causative role of BNT162B2 vaccine for aggravation of Crohn's disease, pain in extremity, neuralgia, hypersensitivity, nausea, swelling, gait disturbance, mobility decreased, weight increased, arthropathy, dizziness, and arthralgia cannot be excluded. All other events are deemed to be intercurrent occurrences likely related to preexisting medical conditions and unrelated to BNT162B2.  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.