Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Cough, Dyspnoea, Echocardiogram
Clinical narrative: cough; chest hurts; clots on both legs and stomach; hemorrhage; Blood sugar decreased; Oxygen saturation low; Blood pressure low; Skin discoloration; vein on her right leg was torn; Difficulty breathing; Tiredness; Breast pain; blockage all over the heart; This is a solicited report from A contactable consumer (patient) based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3840719-00).  A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 27Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 2005 (Batch/Lot number was not reported) to Feb2021, at 40 mg/0.4 ml, then subcutaneous from 21Apr2021 (Batch/Lot number was not reported) and ongoing, at 40 mg 1 in 2 week for moderate to severe rheumatoid arthritis psoriatic arthritis. Medical history included patient consumed a pack of cigarette a day from 1967 to 2019, heart attack from 2003 to 2003, abstains from alcohol, and high blood pressure. Concomitant medication included metoprolol taken for high blood pressure.  The patient previously took metformin to manage blood sugar. On an unspecified date, the patient experienced cough, chest hurts, clots on both legs and stomach. In 2010, the patient experienced breast pain and blockage all over the heart. She first tried to do the balloon and had three stents on her heart due to blockage sometime in 2010. In Jan2021, the patient had bypass surgery as treatment heart blockage as well. On 18Feb2021, echocardiogram/ECHO showed blockage all over the heart again. In 2021, the patient had difficulty breathing and experienced tiredness easily. In Mar2021, she was told to have an outpatient diagnostic heart catheter procedure and they had to take her by ambulance to be admitted in a hospital, when she moved during the procedure, a vein on her right leg was torn and also had hemorrhage, blood sugar decreased, oxygen saturation low, blood pressure low, skin discoloration. She experienced a recurring pain in between the breast bone after the triple bypass surgery that was done last 09Mar2021 while in the hospital. She also had blood transfusions while hospitalized as treatment for hemorrhage. The patient was hospitalized for the events for 28 days (also reported as 4 weeks). The event vein on her right leg was torn was considered life threatening. The events breast pain, blockage all over the heart, difficulty breathing, tiredness, hemorrhage, blood sugar decreased, oxygen saturation low, blood pressure low, and skin discoloration were also considered medically significant. The patient underwent lab tests and procedures which included stress test and echocardiogram/ECHO with  unknown result in Jan2021; echocardiogram/ECHO showed blockage all over the heart on 18Feb2021; blood sugar: decreased, blood pressure: low, and oxygen saturation: low, all in Mar2021. The action taken in response to the events for adalimumab was dose not changed. The outcome of vein on her right leg was torn was recovered in Apr2021; hemorrhage and skin discoloration were recovered in Mar2021; clots on both legs and stomach, difficulty breathing, tiredness, blood sugar decreased, oxygen saturation low, blood pressure low was recovering; breast pain, blockage all over the heart was recovered on an unspecified date, while other events was unknown.  Causality: Drug : Humira 1.Vein on her right leg was torn Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  2.Clots on both legs and stomach Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  3.Blockage all over the heart Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  4.Difficulty breathing (Dyspnoea) Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  5.Hemorrhage Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  6.Breast pain Causality as per reporter (Drug/Vaccine) : Not Related  Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  7.Skin discoloration Causality as per reporter (Drug/ Dose Not Changed) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  8.Blood pressure low Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  9.Cough Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  10.Oxygen saturation low Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  11.Blood sugar decreased Causality as per reporter (Drug/Vaccine) : Not Related  Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  12.Chest pain Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  13.Tiredness Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility  Causality: Covid-19 Vaccine 1.Vein on her right leg was torn Causality as per reporter (Drug/Vaccine) : Not Related 2.Clots on both legs and stomach Causality as per reporter (Drug/Vaccine) : Not Reported 3.Difficulty breathing Causality as per reporter (Drug/Vaccine) : Not Related 4.Hemorrhage Causality as per reporter (Drug/Vaccine) : Not Related 5.Breast pain  Causality as per reporter (Drug/Vaccine) : Not Related  6.Skin discoloration  Causality as per reporter (Drug/Vaccine): Not Related 7.Blood pressure low Causality as per reporter (Drug/Vaccine) : Not Related 8.Cough Causality as per reporter (Drug/Vaccine) : Not Reported 9.Oxygen saturation low Causality as per reporter (Drug/Vaccine) : Not Related 10.Blood sugar decreased  Causality as per reporter (Drug/Vaccine) : Not Related  11.Chest pain Causality as per reporter (Drug/Vaccine) : Not Reported 12.Tiredness Causality as per reporter (Drug/Vaccine) : Not Related 13.Blockage all over the heart Causality as per reporter (Drug/Vaccine) : Not Related  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.