Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Fall, Hidradenitis, Injection site reaction, Laboratory test
Clinical narrative: Shortness of breath; Chest pain; Hidradenitis suppurativa; Hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up; Injection site stinging; Pulmonary embolism; Injection site reaction; She developed bruise on her spine after she fell.; blood clots in calves and two blood clots on each of her lower leg and one in her lung.; Pulmonary thrombosis; Thrombosis leg; Contusion of back; Fall/falling; Carotid artery occlusion; This is a solicited report from a FACILITATED COLLECT based on information received by Pfizer from Other Company.   A contactable consumer (patient) reported that a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 63-year-old), dose 2 intramuscular on an unspecified date in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA, strength: 40MG/0.8ML, 40 Milligram, Solution for injection in pre-filled pen), subcutaneous in 2019 (Batch/Lot number was not reported), at 40 mg, 1 in 1 week for moderate to severe hidradenitis suppurativa. Medical history included three time cancer survivor, non-smoker (as reported), abstains from alcohol, spinal stenosis, degenerative disc disease, chronic obstructive pulmonary disease, had chemotherapy, radiation, lung cancer in 2007, smoker started in 2007, gastroesophageal reflux disease, carotid blockage, pain, and allergies. Concomitant medications included citalopram; pantoprazole taken for gastrooesophageal reflux disease; omeprazole taken for gastrooesophageal reflux disease; atorvastatin calcium (LIPITOR) taken for carotid artery thrombosis; oxycodone (OXYCODONE) taken for pain; and fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity. The patient previously took ZITHROMAX IV and iodine and experienced allergy, near anaphylactic shock with iodine; and LEVAQUIN. Historical vaccine included PFIZER-BIONTECH COVID-19 VACCINE dose 1 on 15Mar2021 for COVID-19 immunisation. A 63-year-old female with events of  blood clots in calves and lungs, carotid artery blockage located in shoulder near common artery, shortness of breath, pain on left chest, blood clots on each of lower leg and pulmonary embolism and non-serious fell in the bath room, recurred falling, hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up, regular HUMIRA shot stung, bruise on back and injection site mark  with HUMIRA 40MG/0.8ML (ADALIMUMAB) and HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of  lung cancer, smoker, three time cancer survivor, non smoker, abstains  from alcohol, iodine allergy manifested by near anaphylactic shock, spinal stenosis, degenerative disc disease, chronic obstructive pulmonary disease, had chemotherapy, had radiation, Levaquin allergy manifested by brain fog, Levaquin and zithromax allergy. On unknown dates, the patient experienced hidradenitis suppurativa break out at original sites/hidradenitis suppurativa flare up, regular HUMIRA shot stung, pulmonary embolism and injection site mark. In 2020, the patient experienced Carotid artery blockage located in shoulder near common artery. In June2021, the patient experienced fell in the bathroom and bruise on. On 12Jun2021, the patient experienced shortness of breath, pain on left chest and blood clots on each of lower leg. On 15Jun2021, the patient experienced blood clots in calves and lungs. On 16Jun2021, the patient experienced Recurred falling. On 16Jun2021, the Recurred falling resolved. In June2021, the shortness of breath, pain in left chest and fell in the bathroom resolved. On unknown dates, Hidradenitis supprativa break out at original sites/hidradenitis suppurativa flare up and injection site mark resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was admitted in hospital on 12Jun2021 until 16Jun2021, due to shortness of breath and chest pain and said during her stay, she fell. On 15Jun2021, she was in hospital with blood clots in calves and two blood clots on each of her lower leg and one in her lung. She had pulmonary embolism. She had blood works done while in the hospital, but it was not specified. While she was in the hospital she fell in the bathroom, she thinks is was because of the strong pain medication she was receiving. She developed bruise on her spine after she fell. After went to home at night of 16Jun2021, she had an instance of falling again and could not get back up and laid on the floor for 13 hours. On 19Jun2021, she decided to go to the hospital again, as she  felt she was prematurely discharged but as this time was though, she was not admitted but was sent to a nursing facility where she was being treated until 21Jun2021. She could not recall which of the laboratory tests done determined the blood clot. She clarified the carotid artery blockage was not in her neck but located in the shoulder near the common artery, and she was not admitted in the hospital due to it. She was off medication and had breakout at original sites due to blood clot. It was slowly improving since restarting medication. She had regular shot stung. She usually had injection site mark after injecting Humira. She was on unspecified blood thinners and unknown anti-depressant. The alternative etiology for blood clot was reported as Covid 19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Mar2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On Apr2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. On Aug2021, she received third booster dose COVID-19 Vaccine manufactured by Pfizer.  Primary reporter did not have the lot number information, because the packaging was discarded.  The patient was treated with XARELTO. Relevant Laboratory & Other Diagnostic Tests: Unknown date CHEST X-RAY: Pulmonary embolism ; 12Jun2021 COMPUTED TOMOGRAPHY: Pulmonary embolism ; June2021 COMPUTED TOMOGRAPHY SCAN: done without contrast - Unknown ; June2021 ECHOCARDIOGRAM: Unknown ; 12Jun2021 LAB TEST: Blood clot ; 12Jun 2021 ULTRASOUND: Pulmonary embolism ; June2021 X-RAY: Unknown. The action taken in response to the events for adalimumab was dose not changed. The outcome of shortness of breath and chest pain was recovered in Jun2021; thrombosis leg, pulmonary thrombosis, carotid artery occlusion, injection site stinging was not recovered; while outcome of fall, hidradenitis suppurativa and condition aggravated  was recovered. The outcome of clot blood, pulmonary embolism, contusion of back, injection site reaction and she developed bruise on her spine after she fell was unknown.   Causality for HUMIRA 40MG/0.8ML(ADALIMUMAB). The reporter's causality for the event(s) of Blood clots in calves and lungs onset 15Jun2021, Shortness of breath and pain on left chest with humira 40MG/0.8ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event of  Carotid artery blockage located in shoulder near common artery , Hidradenitis suppurativa break out at original sites/Hidradenitis flare up, regular humira shot stung, blood clots on each lower leg, pulmonary embolism, bruise on back and injection site mark was not provided. The reporter's causality for the event(s) of Fell in the bath room and recurred falling with humira 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. Other Company's opinion is that there is no reasonable possibility that the events of blood clots in calves and lungs  onset 15Jun2021, Carotid artery blockage located in shoulder near common artery, Blood clots in calves and lungsonset 15Jun2021, Shortness of breath and pain on left chest, Fell in the bath room, recurred falling, Hidradenitis suppurativa break out at original sites/Hidradenitis suppurativa flare up, blood clots on each of lower, pulmonary embolism, bruise on back and injection site mark are related to humira 40MG/0.8ML(ADALIMUMAB). Other Company opinion is that there is a reasonable possibility that the event of regular humira shot is related to HUMIRA 40MG/0.8ML(ADALIMUMAB). Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB). The reporter's causality for the event(s) of Blood clots in calves and lungs onset 15Jun2021, and blood clots on each lower leg with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Carotid artery blockage located in shoulder near common artery Shortness of breath and pain on left chest, Fell in the bath room, recurred falling, pulmonary embolism, bruise on back and injection site mark was not provided. The reporter's causality for the event(s) of Hidradenitis suppurativa break out at original sites/Hidradenitis suppurativa flare up, and regular humira shot stung  with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. Other Company's opinion is that there is no reasonable possibility that the events of Blood clots in calves and lungs onset 15Jun2021, Carotid artery blockage located in shoulder near common artery ,  Blood clots in calves and lungs onset 15Jun2021, shortness of breath, pain on left chest, fell in the bath room, recurred falling, hidradentis suppurativa break out at original sites/hidradenitis suppurativa gfalre up, regular humira shot stung, blood clots on each lower leg, pulmonary embolism and bruise on back are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). Other Company's opinion is that there is a reasonable possibility that the event of injection site is related to HUMIRA 40MG/0.4ML (ADALIMUMAB). causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of Shortness of breath, chest pain, hidradenitis suppurativa break out at original sites and regular HUMIRA shot stung were added. On 09Sep2021, 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, past drug information, laboratory/diagnostic procedures and narrative description. The events of blood clots of each of lower leg, pulmonary embolism, bruise on back and injection site mark were added. The event of chest pain was amended to pain on left chest. The event of "FELL" was amended to felling bathroom. The event of Hidradenitis suppurativa break out at original sites was amended to Hidradenitis suppurativa break at original sites/Hidradenitis suppurativa flare up.  The causality for pulmonary thrombois, carotid artery occlusion and thrombosis leg was possible; while shortness of breath, chest pain, fall, Hidradenitis, injection site stinging, thrombosis leg, pulmonary embolism, contusion of back and injection site reaction was not reported with PFIZER BIONTECH COVID-19 vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.