Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Pain
Clinical narrative: tiredness; Body pain; MARKETING PROGRAM NAME NOT AVALAIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 20K-163-3296255-00 (AbbVie).  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date 2015 (Batch/Lot number: unknown) as 40 mg (40 mg, 1 in 2wk)(40mg/0.8ml ) and subcutaneous, administration date 2018 (ongoing) (Batch/Lot number: unknown) as 40 mg (40 mg, 1 in 2wk) for rheumatoid arthritis. Relevant medical history included: "Lupus", start date: 2016 (unspecified if ongoing); "Non tobacco user" (unspecified if ongoing); "Penicillin drug allergy manifested by hives" (unspecified if ongoing); "Penicillin drug allergy manifested by hives" (unspecified if ongoing); "Partial hysterectomy" (unspecified if ongoing); "Swelling face" (unspecified if ongoing); "Eye bleeding" (unspecified if ongoing); "Eye infected" (unspecified if ongoing); "Blurry vision" (unspecified if ongoing); "Menstrual problems" (unspecified if ongoing); "body ache" (unspecified if ongoing); "gallbladder surgery", start date: Sep2018 (unspecified if ongoing); "acid reflux", start date: 2018 (unspecified if ongoing); "gall stones", start date: Sep2018, stop date: 2018; "Stomach pain", start date: 2018 (unspecified if ongoing); "Cramps", start date: 2018 (unspecified if ongoing); "enlarged liver", start date: 2018 (unspecified if ongoing); "Gastric disorder" (unspecified if ongoing); "Hepatomegaly", start date: Sep2018, stop date: 2021; "Skin red", start date: Jul2020 (unspecified if ongoing); "Tiredness", start date: Jun2020 (unspecified if ongoing); "Numbness of limbs" (unspecified if ongoing); "Inflammation localised" (unspecified if ongoing); "asthma", start date: Apr2020 (unspecified if ongoing); "Injection site urticaria", start date: 31Aug2020, stop date: 31Aug2020; "Injection site stinging", start date: 31Aug2020, stop date: 31Aug2020; "Digital ulcer", start date: 2020 (unspecified if ongoing); "Swelling of fingers", start date: 2020 (unspecified if ongoing); "Pain of lower extremities", start date: Jan2020 (unspecified if ongoing); "Headache" (unspecified if ongoing); "Joint pain" (unspecified if ongoing); "Generalized aching", start date: 2018 (unspecified if ongoing); "Choking sensation" (unspecified if ongoing); "Salivary gland swelling", start date: Mar2021 (unspecified if ongoing); "Spasm tongue", start date: Mar2021 (unspecified if ongoing); "Swallowing difficult", start date: Mar2021 (unspecified if ongoing); "Speech disorder", start date: Mar2021 (unspecified if ongoing); "Back pain", start date: Jan2021 (unspecified if ongoing); "Mobility decreased", start date: Jan2021 (unspecified if ongoing); "Skin disorder", start date: 2020 (unspecified if ongoing); "Pre-existing condition improved" (unspecified if ongoing); "Unexpected therapeutic benefit" (unspecified if ongoing); "Sinus pressure" (unspecified if ongoing); "Sleep excessive" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for systemic lupus erythematosus; FOLIC ACID taken for abdominal discomfort; HYDROXYCHLOROQUINE taken for systemic lupus erythematosus. Vaccination history included: Bnt162b2 (First dose, Tired after first covid shot/slept two days), for COVID-19 Immunization, reaction(s): "Tired"; Bnt162b2 (First dose, Tired after first covid shot/slept two days), for COVID-19 immunization, reaction(s): "slept two days". The following information was reported: FATIGUE (hospitalization, medically significant), outcome "recovered", described as "tiredness"; PAIN (hospitalization, medically significant), outcome "recovered", described as "Body pain". The patient underwent the following laboratory tests and procedures: blood test: (Mar2021) liver was doing fine. The action taken for adalimumab was dosage not changed.  Clinical course reported as: Patient had injection site welt. Patient had tiredness after second covid shot and body pain with humira 40mg/0.8ml (adalimumab). On unknown dates, the patient experienced stomach issues, numbness in limb, sinus issues/pressure hurts in face  and eyes, inflammation in fingers, headache, joint pains, feelings of choking or suffocating, had  lupus/swelling of the face/infected eye/bleeding eye and blurry vision prior to start of humira which got  better after the start of humira. The patient had lupus before she started on HUMIRA. She still had lupus. She took Prednisone and Hydrocortisone for the issue. In Sep2018 she had her gall bladder surgery as an outpatient. She was off HUMIRA two to three  weeks after the gallbladder surgery. She had circle spots or bumps on the back of her leg. They were a little  puffy but did not release any liquid of puss. They were not painful until she pressed on them. In Mar2021 un-specified blood work that was done showed that her liver was doing fine and no abnormal findings was revealed. On 21Jul2020, received updates to patient demographics, event information, reporter opinion of causality,  company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "lupus", "numbness in limb", "spots or bumps on back of leg" and "red/bumpy patches like little  balls on left and right fingers" were added. the event of "swollen hands" was amended to "swollen  hands/fingers". On 19Aug2020, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information, treatment drug information and narrative  description. the events of "enlarged liver", "sinus issues/pressure hurts in face and eyes", "headache" and  "joint pains" were added. On 02Sep2020, received updates to patient demographics, medical history, event information, reporter opinion  of causality, company opinion of causality, company alternative etiology, suspect drug information, treatment drug information, past drug information and narrative description. The events of "GALL STONES", "difficulty of breathing", "cough", "asthma", "injection site sting", "body aches" and "injection site welt" were added. the  events of "lupus" and "gallbladder surgery" were removed. On 22Oct2020, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology and narrative description. The events of "TIRED" and "BUMPS ON HANDS" were added. On 19Nov2020, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. the events of "stomach  issues" and "inflammation in fingers" were added. the events of "cough" and "difficulty of breathing" were  removed. On 15Mar2021, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information and narrative description. The events of  "PARTIAL HYSTERECTOMY" and "FEELINGS OF CHOKING OR SUFFOCATING" were added. On 30Mar2021, received updates to 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 events of "SWOLLEN salivary gland", "cramping underneath tongue", "difficulty swallowing", "difficulty speaking", "pain in back",  "lying on bed and had difficulty turning around", "spots/bumpy patches like little balls on left and right  fingers and back of leg/hands" and "had lupus/swelling of the face/infected eye/bleeding eye and blurry vision  prior to start of humira which got better after the start of humira" were added. the event of "stomach  pain/cramps/thought it was due to gallbladder surgery" was amended to "recurrent stomach pain/cramps/thought it was due to gallbladder surgery". the event of "sores or red swollen patches on fingers/red, bumpy patches like little balls on left and right fingers/swollen fingers" was amended to "sores/red swollen patches on fingers".  the event of "tired" was amended to "easily gets tired". the event of "body aches" was amended to "recurrent  body aches". the events of "partial hysterectomy", "bumps on hands" and "spots or bumps on back of leg" were  removed. On 14Jun2021, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information and narrative description. The events of  "tired after first covid shot/slept two days", "body pain" and "tiredness after second covid shot" were added.  The event of "EASILY GETS TIRED" was amended to "WAS EASILY GETTING TIRED". On 06Jan2022, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information and narrative description. The events of  "tiredness after covid 19 vaccination booster" and "sore arm for covid-19 vaccination booster" were added. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received first and second dose COVID-19 Vaccine manufactured by Pfizer. Other Relevant History: Patient had a history of menstrual problem and underwent hysterectomy when she was 24 years old. The menstrual problem resolved and did not recur after the surgery. She mentioned that she was diagnosed with lupus around 2015 or 2016 same time when she was diagnosed with rheumatoid arthritis. Her lupus was accompanied by swelling of the face, infected and bleeding eye, blurry vision. She was given unspecified infusion shot but had allergic reaction to it and was shifted to Humira. She mentioned that after she started with Humira her lupus, swelling of the face, infected and bleeding eye and blurry vision got better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.   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.