Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Loss of personal independence in daily activities, Memory impairment, Peripheral venous disease, Post procedural contusion
Clinical narrative: Intraoperative venous injury; Memory impaired; dental issues; Activities of daily living impaired; Back pain; Postoperative bruise; Procedural site pain; Postoperative thrombosis; Venous peripheral insufficiency; This is a solicited report based on the information received by Pfizer. Solicited report by a consumer (patient) of a 53-year-old female with events of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising and non-serious surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising, bad memory, dental issues and hard time putting on stockings because of pain in back with humira (adalimumab) and humira 40mg/0.4ml (adalimumab). The patient (262 lb 66 in) had a relevant medical history of smoker: ten sticks of cigarettes per day, leg surgery, fibromyalgia and high cholesterol. The patient has other concomitant therapy of tylocorpine and viscus.  On unknown dates, the patient experienced surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising, bad memory, dental issues and hard time putting on stockings because of pain in back. On 06Apr2021, the patient experienced surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising. In May2021, the patient experienced surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising and surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising. In 2021, the surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.  The patient had a vein inside of her leg that she had to have a surgery on. Glue was used to close it up but she was concerned that the vein moved or it was a blood clot because she could feel it. So, she was told that an ultrasound could be done on it to make sure that it was taken care of. A month ago, in may 2021, it was painful and was bruising but as of 15jun2021, it was not and was thought that it was possibly there. The patient was supposed to get a second ultrasound on it after the summer of 2021 because she did not think that the first one was right. She started to experience leg pain after she had the covid-19 vaccine shots. She stated that the pain was caused by the clot in her vein due to insufficiency. She was told that if she would have worn the stockings more, it would not have been as bad, but she was having a hard time putting them on because of the pain in her back. The patient also stated that her memory was bad and so, she had to look up the lot number.  It was unknown if the patient was enrolled in a covid-19 vaccine trial.  On 17Mar2021, the patient received first dose of covid-19 vaccine manufactured by Pfizer, lot number en6208, expiration date 30Jun2021. On 07Apr2021, the patient received second dose of covid-19 vaccine manufactured by Pfizer, lot number aw0151, expiration date 31Jul2021. The patient was treated with Cyclobenzaprine. Causality for Humira(Adalimumab)  The reporter's causality for the event(s) of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06Apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, dental issues, hard time putting on stockings because of pain in back unknown onset and hard time putting on stockings because of pain in back unknown onset was not provided. The reporter's causality for the event(s) of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset and bad memory with humira(adalimumab) was no reasonable possibility.  There is no reasonable possibility that the events of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may 2021, bad memory, dental issues, hard time putting on stockings because of pain in back unknown onset and hard time putting on stockings because of pain in back unknown onset are related to humira(adalimumab).  Causality for HUMIRA 40mg/0.4ml(adalimumab) The reporter's causality for the event(s) of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021 and surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021 with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, bad memory, dental issues, hard time putting on stockings because of pain in back unknown onset and hard time putting on stockings because of pain in back unknown onset was not provided.  There is no reasonable possibility that the events of surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset 06apr2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising unknown onset, surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising onset in may2021, bad memory, dental issues, hard time putting on stockings because of pain in back unknown onset and hard time putting on stockings because of pain in back unknown onset are related to humira 40mg/0.4ml(adalimumab).  Relevant laboratory & other diagnostic tests  May2021 ultrasound: insufficient vein  Change history  On 17Jun2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The event of "surgery on vein of leg/concerned that vein moved or was a blood clot/could feel it, was possibly there/was painful and bruising" was amended to "surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising". The event of "surgery on vein of leg/concerned that vein moved or was a blood clot/could feel it, was possibly there/was painful and bruising" was amended to "surgery on vein of leg/vein moved or was a blood clot/ leg pain caused by clot in vein due to insufficiency /was painful and bruising". Reaction information: The events were considered serious, other medically important condition. Suspect drug information:  Adalimumab (HUMIRA), solution for injection in pre-filled syringe, at an unknown daily dose from an unspecified date to an unspecified date (discontinued causality) subcutaneous for moderate to severe hidradenitis suppurativa moderate to severe rheumatoid arthritis; adalimumab (HUMIRA) 40 mg/0.4 ml (40 milligram, solution for injection in pre-filled pen) at daily dose of (40 mg, 1 in 1 wk), subcutaneous for rheumatoid arthritis hidradenitis suppurativa from 10Jul2020 to an unspecified date.  Product-reaction level: Seq.no.:1 adalimumab (HUMIRA, solution for injection in pre-filled syringe) subcutaneous, unknown to discontinued: The action taken in response to the events for adalimumab (HUMIRA, solution for injection in pre-filled syringe) was unknown. The causality by the reporter was not reported for postoperative thrombosis, venous peripheral insufficiency, procedural site pain, intraoperative venous injury, postoperative bruise, dental disorder NOS, activities of daily living impaired and back pain; while for venous operation and memory impaired was no reasonable possibility. The causality as per manufacturer was no reasonable possibility.  Seq.no.:2 HUMIRA 40mg/0.4ml (40 milligram, solution for injection in pre-filled pen) (adalimumab) at 40 mg, 1 in 1 wk, subcutaneous from 10Jul2020 to an unspecified date: The action taken in response to the events for HUMIRA 40mg/0.4ml was unknown. The causality by the reporter for the events postoperative thrombosis, venous peripheral insufficiency and procedural site pain was unrelated, while for the remaining events was not reported. The reported causality as per manufacturer for all events was no reasonable possibility. Seq. no.:3 Pfizer Biontech covid-19 vaccine(tozinameran)(injection)(tozinameran), first dose on 17Mar2021 (lot number: EN6208) and second dose on 07Apr2021 (lot number: AW0151) both at dose of 1 in 1 once, intramuscular for COVID-19 vaccination (at the age of 53-years-old). Causality as per reporter for the events postoperative thrombosis, venous peripheral insufficiency and procedural site pain was probable, while for the remaining event was not reported.  Concomitant medications included paracetamol (TYLENOL) montelukast; omeprazole; vitamin d3; loratadine; folic acid; pregabalin (LYRICA); fluticasone propionate, salmeterol xinafoate (ADVAIR); methotrexate sodium; ibuprofen (MOTRIN CHILDREN); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. Patient medical history included the patient started smoking when she was in middle school: smoker ten sticks of cigarettes per day, abstains from alcohol, leg surgery, fibromyalgia, high cholesterol, penicillin allergy manifested by hives. Lab result included an ultrasound in May2021.  The outcome of the events postoperative thrombosis, venous peripheral insufficiency, venous operation, intraoperative venous injury, memory impaired, dental disorder NOS was not recovered/not resolved; procedural site pain improved; postoperative bruise recovered/resolved in 2021; while the outcome of the remaining events was unknown.   The reporter's assessment of the causal relationship of the events intraoperative venous injury, postoperative bruise, memory impaired, dental issues, activties of daily living impaired and back pain with BNT162B2 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. No further information is expected.; Sender's Comments: Based on the information currently available (considering the patient's medical and personal history and patient demographics), the reported events postoperative thrombosis, venous peripheral insufficiency, intraoperative venous injury, postoperative bruise, memory impaired, dental issues, activities of daily living impaired and back pain are likely intercurrent conditions unrelated to suspect product BNT162B2. Case will be reassessed upon receipt of additional information.