Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Inflammation, Influenza like illness, Insomnia
Clinical narrative: Inflammation; Difficulty sleeping/not able to sleep; Migraine; Blood clots in her lungs; Pneumonia in one lung; flu like symptoms after covid vaccine with humira (adalimumab); COVID-19 virus test positive/COVID; Coughing; Pain was at 9.5/ Aches; This is a solicited report based on the information received by Pfizer from AbbVie (Mfr. Control No. :21K-163-4076308-00). A 54-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 1 via intramuscular route of administration on 02Sep2021 as dose 1, single (At the age of 54-years) for covid 19 immunization and adalimumab (HUMIRA, Solution for injection in pre-filled pen: Batch/Lot number was not reported), via subcutaneous route of administration from an unspecified date to an unspecified date (Citrate free) for psoriatic arthropathy. There was no reported medical history. The patient's concomitant medications were not reported. On Sep2021, the patient experienced flu like symptoms after covid vaccine with humira, COVID-19 and other drug ineffective and on an unspecified date, patient had inflammation, difficulty sleeping. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The lab test included pain scale with result 9.5 on an unspecified date of Sep 2021 and COVID-19 virus test with positive result on Sep2021. On unknown dates, the patient experienced inflammation and not able to sleep. In Sep2021, the patient experienced COVID. It was reported that, the patient got covid in Sep2021, few hours after getting the covid vaccine. She and her husband both had covid with coughing, aches and pains. They tested positive before the second dose. Her pain was at 9.5. She had inflammation and her physician add prednisone and methotrexate due to inflammation. In Feb2022, the patient experienced blood clots in lungs and pneumonia in one lung. On 10Mar2022, the patient experienced migraine. The action taken for adalimumab was unknown. The patient was treated with Prednisone and Methotrexate. The outcome of the Inflammation, flu like symptoms after covid vaccine with humira was recovering and recovered for COVID-19 and other drug ineffective. The outcome of difficulty sleeping was unknown.  The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE for event Flu like symptoms after covid vaccine with Humira (Adalimumab) was no reasonable possibility and for events COVID-19 virus test positive, Inflammation. The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE for event Pulmonary thrombosis, Inflammation, Difficulty sleeping, Migraine were not reported. The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE for event pneumonia as Not Related.  The reporter's causality of HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) for event Flu like symptoms after covid vaccine with Humira (Adalimumab), COVID-19 virus test positive, Inflammation, Difficulty sleeping, blood clots in lungs, pneumonia were Not Reported. AbbVie's opinion is that the events of blood clots in lungs, migraine and pneumonia in one lung  are not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of inflammation, not able to sleep and COVID are related to Humira (Adalimumab). The manufacturer's causality for events Pulmonary thrombosis, Pneumonia and Migraine as not assessable while Inflammation, Difficulty sleeping, COVID-19 were assessed as no reasonable possibility.  Follow up (09Dec2021): This is a follow up solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4078537-00). A contactable 54-year-old female consumer (patient) reported that: Updated information: lab data, suspect drug coding, event coding.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (26Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow up (14Mar2022): This is a follow-up solicited report from a Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from AbbVie, MFR Control No. 21K-163-4078537-00). A contactable 54-year-old female consumer (patient) reported for herself that: Updated information: New events ''Coughing/aches/pain was at 9.5/blood clots in her lungs/pneumonia in one lung migraine/ COVID/ not able to sleep.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Due to implausible temporal association, the event of  Pulmonary thrombosis, Pneumonia and Migraine  is assessed as unrelated to PFIZER BIONTECH COVID-19 VACCINE. The event of Covid 19 and its associated events of cough, pain  as assessed as unrelated  to suspected vaccine as it the patient was tested positive few hours of vaccination suggesting patient was infected with Covid 19 virus prior to vaccination. Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of   insomnia and inflammation    cannot be excluded.