Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aortic arteriosclerosis, Blood cholesterol increased, Cerebral disorder, Fall, Feeling cold
Clinical narrative: Wound infection; Atherosclerosis of aorta; FALL; Pain; Injury; Delayed healing of wound; Swelling of feet; HIGH CHOLESTEROL; FEELING HOT; FELLING COLD; Cerebral disorder; This is a Solicited report based on information received by a regulatory authority from a contactable consumer (patient) .  A 60-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to Dec2020, at 40 mg, 1 in 2 wk, subcutaneous from Jul2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg, 1 in 1 wk, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 1 wk for rheumatoid arthritis  .  Medical history included depression from an unknown date and unknown if ongoing she was very depressed , tobacco user from 1975 to 1995 TOBACCO USE: ABOUT A PACK PER DAY OF CIGARETTE (1975 - 1995) , hysterectomy from 1979 to an unknown date HYSTERECTOMY (Started 1979) , TUMOR IN OVARY (Started 1979) , ELECTRO SHOTS IN BRAIN (Started 2010) , NO ALCOHOL USE , rheumatoid arthritis (family history), bipolar disorder (FAMILY HISTORY OF BIPOLAR DISORDER/BROTHER HAD BIPOLAR) DEGENERATIVE SPINE DISEASE , osteoarthritis , SHORT TERM MEMORY LOSS, SUICIDAL, surgery done in Oct2020 to fix the torn tendon in right wrist, surgery to scrape the bone in Nov2020. In 2021, two more surgeries for the fracture right wrist, fourth surgery was done in Jun2021, INFECTION IN OVARIAN TUBES (Started 1979), SEVERE ANXIETY, PANIC ATTACKS, POST TRAUMATIC STRESS DISORDER, MOOD SWINGS, HELP SLEEP, SUPPLEMENT, IMMUNE HEALTH SYSTEM BOOST, MANIC DISORDER. The patient previously took morphine and experienced ALLERGY MANIFESTED BY SEVERE HEADACHE.The patient received the first dose of bnt162b2 for covid-19 immunisation via IM in May2021 at age of 60 years.Concomitant medication(s) included aripiprazole (ABILIFY) taken for bipolar disorder, psychotic disorder, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for depression, start and stop date were not reported; lamotrigine (LAMICTAL) taken for bipolar disorder, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for anxiety, panic attack, post-traumatic stress disorder, bipolar disorder, start and stop date were not reported; quetiapine fumarate (SEROQUEL) taken for bipolar disorder, mood swings, sleep disorder, depression, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis, start and stop date were not reported; methylprednisolone (METHYLPREDNISOLONE) taken for rheumatoid arthritis, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for supplementation therapy, immune system disorder, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy, start and stop date were not reported; folic acid (FOLIC ACID) taken for supplementation therapy, start and stop date were not reported; quetiapine (QUETIAPINE) taken for mania, bipolar disorder, depression, start and stop date were not reported; lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; mecobalamin (METHYL B12) taken for vitamin supplementation, start and stop date were not reported.  The patient experienced feeling hot (feeling hot) (hospitalization, medically significant) on Jul2021 with outcome of unknown , felling cold (feeling cold) (hospitalization, medically significant) on Jul2021 with outcome of unknown , cerebral disorder (cerebral disorder) (hospitalization, medically significant) on Jul2021 with outcome of unknown , wound infection (wound infection) (hospitalization, medically significant) on an unspecified date with outcome of recovered , atherosclerosis of aorta (aortic arteriosclerosis) (hospitalization, medically significant) on an unspecified date with outcome of unknown , fall (fall) (hospitalization, medically significant) on an unspecified date with outcome of unknown , pain (pain) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , injury (injury) (hospitalization, medically significant) on an unspecified date with outcome of unknown , delayed healing of wound (impaired healing) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , swelling of feet (peripheral swelling) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , high cholesterol (blood cholesterol increased) (hospitalization, medically significant) on an unspecified date with outcome of unknown.The clinical course was reported as follows: solicited report from a patient with events of torn tendon of right wrist, right wrist became inflamed, recurrent falls, fractured/ broke right wrist, infection after surgery and infection on the wound site and non-serious sprained right ankle which was described as foot turned out and turned blue, bone scrapping due to rheumatoid arthritis, swelling in right wrist, feeling hot, felling cold, brain not functioning, right wrist feels hot, bruised legs, plaques build in carotid artery, inflammed legs, rheumatoid arthritis flare up, wound that would not heal, fall, broke wrist, had another fall that hurt left side, painful, swollen feet, pain in right wrist, high cholesterol and pain in ankle with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use: about a pack per day of cigarette, rheumatoid arthritis, degenerative spine disease and osteoarthritis. There is also a family history of rheumatoid arthritis.On unknown dates, the patient experienced infection on the wound site, plaques build in carotid artery, wound that would not heal, had another fall that hurt left side, painful, swollen feet and high cholesterol. In 2020, the patient experienced right wrist became inflamed, infection after surgery, swelling in right wrist, right wrist feels hot, rheumatoid arthritis flare up and pain in right wrist. In Feb2020, the patient experienced recurrent falls and fractured/ broke right wrist. In Aug2020, the patient experienced sprained right ankle which was described as foot turned out and turned blue, inflammed legs, inflammed legs, fall and pain in ankle. In Aug2020, the fall resolved. In Sep2020, the patient experienced sprained right ankle which was described as foot turned out and turned blue and broke wrist. In Oct2020, the patient experienced torn tendon of right wrist and bone scrapping due to rheumatoid arthritis. In Jul2021, the patient experienced feeling hot, felling cold and brain not functioning. In 2021, the infection after surgery and sprained right ankle which was described as foot turned out and turned blue resolved. On unknown dates, recurrent falls and infection on the wound site resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.The patient suffered from plaques build in carotid artery and high cholesterol. In feb2020, she had a fall which resulted in a broken right wrist. She had two surgeries for the fractured right wrist. she had infection after her surgery and her physician advised her to stop humira until she was healed. While she was off humira her rheumatoid arthritis symptoms returned. She had pain from her wrist and was taking unspecified steroids for it. she also described her broken wrist as being misshapen and permanently damaged. In Aug2020 she had another fall and she sprained her ankle. Her legs were bruised in turned into black and blue. She went to emergency room and was informed that there's no surgery needed for her wrist and bondage was put on it and it recovered on its own. She suffered from pain on right wrist when she visited a specialist. Her physician informed her that there was a tear on the tendon and it was too late to perform surgery for the bones. She had a surgery done in oct2020 to fix the torn tendon in right wrist. She had a follow up in 2020 and her physician told her that the right wrist had become inflamed, which caused another surgery to scrape the bone in Nov2020. In 2021, she had two more surgeries for the fracture right wrist and was hoping to regain use of her hand. She had a total of four outpatient surgeries and every surgery was six weeks apart. Her fourth surgery was done in Jun2021 to remove the infection from previous fall and surgery. In Jul2021, she suffered from cerebral disorder like brain not working. She felt cold and hot. She had another fall that hurt her left side as well. Her physician had cut one of her medication that helped with her pain due to inflammation. But as of 10Aug2021, she had pain. The reporter alternative etiology for the event of feeling hot, felling cold and brain not functioning was reported as covid-19 vaccine second dose.It was unknown if patient was enrolled in a covid-19 vaccine trial. On May2021, she received 1st dose covid-19 vaccine manufactured by pfizer. On Jul2021, she received 2nd dose covid-19 vaccine manufactured by pfizer.The patient was treated with naproxen, prednisone and tylenol.The patient's past medications include: morphine for unknown indication.The patient underwent lab tests and procedures which included blood test: high cholesterol on Unknown date :High cholesterol , magnetic resonance imaging: plaques building in carotid artery  on Unknown date  , magnetic resonance imaging: fractured right wrist, torn tendon   on Oct2020, x-ray: fracture in right wrist, tear in right tendon on Unknown date  , x-ray limb: no breaks   on Jan2020, x-ray limb: fractured right wrist   on Oct2020 The action taken in response to the event(s) for adalimumab was unknown.  Therapeutic measures were taken as a result of the events.  Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of torn tendon of right wrist, right wrist became inflamed, recurrent falls, fractured/ broke right wrist, infection on the wound site, sprained right ankle which was described as foot turned out and turned blue onset in Aug2020, bone scrapping due to rheumatoid arthritis, swelling in right wrist, right wrist feels hot, wound that would not heal unknown onset, broke wrist, wound that would not heal unknown onset and pain in right wrist with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of infection after surgery, sprained right ankle which was described as foot turned out and turned blue onset in Sep2020, feeling hot, felling cold, brain not functioning, bruised legs, plaques build in carotid artery, inflammed legs, rheumatoid arthritis flare up, fall, had another fall that hurt left side unknown onset, had another fall that hurt left side unknown onset, swollen feet, high cholesterol and pain in ankle was not provided. the reporter's causality for the event(s) of painful with humira 40mg/0.4ml(adalimumab) was a reasonable possibility.  Abbvie's opinion is that there is no reasonable possibility that the events of torn tendon of right wrist, right wrist became inflamed, recurrent falls, fractured/ broke right wrist, sprained right ankle which was described as foot turned out and turned blue onset in Aug2020, sprained right ankle which was described as foot turned out and turned blue onset in Sep2020, bone scrapping due to rheumatoid arthritis, swelling in right wrist, feeling hot, felling cold, brain not functioning, right wrist feels hot, bruised legs, plaques build in carotid artery, inflammed legs, rheumatoid arthritis flare up, wound that would not heal unknown onset, fall, broke wrist, had another fall that hurt left side unknown onset, had another fall that hurt left side unknown onset, painful, swollen feet, pain in right wrist, high cholesterol and pain in ankle are related to humira 40mg/0.4ml(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of infection after surgery, infection on the wound site and wound that would not heal unknown onset are related to humira 40mg/0.4ml(adalimumab).  The reporter's assessment of the causal relationship of the events with the Pfizer 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events feeling hot, feeling cold, cerebral disorder, wound infection, pain, fall, injury, high cholesterol, aortic arteriosclerosis, delayed healing of the wound, peripheral swelling  and the suspect drug BNT162B2 cannot be excluded.  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.