Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pre-existing condition improved
Clinical narrative: Headache; PRe-existing condition improved; Speech disorder; salivary gland was swollen; cramping underneath her tongue; difficulty swallowing; Pain of lower extremities; Back pain; INJECTION SITE STING; INJECTION SITE WELT; Skin red; tiredness; Asthma; Swelling of fingers; 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 1, single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2015 (Batch/Lot number: unknown) to Sep2018 at 40 mg (40 mg [40 mg,1 in 2 wk]) and second regimen subcutaneous since 2018 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg [40 mg,1 in 2 wk]) for rheumatoid arthritis. Relevant medical history included: "BLURRY VISION" (unspecified if ongoing); "MENSTRUAL PROBLEMS" (unspecified if ongoing); "EYE INFECTED" (unspecified if ongoing); "EYE BLEEDING" (unspecified if ongoing); "SWELLING FACE" (unspecified if ongoing); "PARTIAL HYSTERECTOMY" (unspecified if ongoing); "LUPUS" (unspecified if ongoing); "NON TOBACCO USER" (unspecified if ongoing); "NON ALCOHOL USER" (unspecified if ongoing); "Penicillin drug allergy manifested by hives" (unspecified if ongoing); "Stomach Upset" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; FOLIC ACID taken for abdominal discomfort; HYDROXYCHLOROQUINE taken for systemic lupus erythematosus. The following information was reported: FATIGUE (hospitalization, medically significant) with onset Jun2020, outcome "recovered", described as "tiredness"; PAIN (hospitalization, medically significant) with onset 2018, outcome "recovered", described as "pain on her legs, thighs and back"; DYSPNOEA (hospitalization, medically significant) with onset 2018, outcome "unknown", described as "shortness of breath"; SALIVARY GLAND ENLARGEMENT (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "salivary gland was swollen"; TONGUE SPASM (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "cramping underneath her tongue"; DYSPHAGIA (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "difficulty swallowing"; GASTROOESOPHAGEAL REFLUX DISEASE (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "acid reflux"; PERIPHERAL SWELLING (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "SORES/RED SWOLLEN PATCHES ON FINGERS"; PARANASAL SINUS DISCOMFORT (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "SINUS ISSUES/PRESSURE HURTS IN FACE AND EYES"; VACCINATION SITE PAIN (hospitalization, medically significant) with onset 31Aug2020, outcome "recovered" (31Aug2020), described as "INJECTION SITE STING"; VACCINATION SITE URTICARIA (hospitalization, medically significant) with onset 31Aug2020, outcome "recovered" (31Aug2020), described as "INJECTION SITE WELT"; PAIN (hospitalization, medically significant) with onset 2018, outcome "recovered", described as "body aches"; HEPATOMEGALY (hospitalization, medically significant) with onset Sep2018, outcome "recovered" (2021), described as "ENLARGED LIVER"; CHOLELITHIASIS (hospitalization, medically significant) with onset Sep2018, outcome "recovered", described as "Gallbladder stones"; ABDOMINAL PAIN UPPER (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Stomach cramps"; GASTRIC DISORDER (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Gastric disorder"; ERYTHEMA (hospitalization, medically significant) with onset Jul2020, outcome "not recovered", described as "Skin red"; HYPOAESTHESIA (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Numbness of limbs"; INFLAMMATION (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Inflammation localised"; PERIPHERAL SWELLING (hospitalization, medically significant) with onset 2020, outcome "not recovered", described as "Swelling of fingers"; PAIN IN EXTREMITY (hospitalization, medically significant) with onset Jan2021, outcome "not recovered", described as "Pain of lower extremities"; HEADACHE (hospitalization, medically significant), outcome "recovered", described as "Headache"; ARTHRALGIA (hospitalization, medically significant) with onset 2018, outcome "recovered", described as "Joint pain"; SKIN ULCER (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Digital ulcer"; GALLBLADDER OPERATION (hospitalization, medically significant) with onset Sep2018, outcome "recovered", described as "Gallbladder operation"; ASTHMA (hospitalization, medically significant) with onset Apr2020, outcome "not recovered", described as "Asthma"; DYSPHAGIA (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "Swallowing difficult"; SPEECH DISORDER (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "Speech disorder"; BACK PAIN (hospitalization, medically significant) with onset Jan2021, outcome "not recovered", described as "Back pain"; SKIN DISORDER (hospitalization, medically significant) with onset 2018, outcome "not recovered", described as "Skin disorder"; PRE-EXISTING CONDITION IMPROVED (hospitalization, medically significant), outcome "unknown", described as "PRe-existing condition improved"; HYPERSOMNIA (hospitalization, medically significant) with onset 2018, outcome "recovered", described as "Sleep excessive". The patient underwent the following laboratory tests and procedures: blood test: (Mar2021) unknown result. The action taken for adalimumab was unknown.  Additional Information: 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", "numbnes 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 19Aug 2020, 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 15 Mar 2021, 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 30 Mar2021, 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  Causality for HUMIRA 40MG/0.8ML(ADALIMUMAB):The reporter's causality for the event(s) of gall stones, recurrent stomach pain/cramps/thought it was due to  gallbladder surgery onset in 2018, stomach issues, enlarged liver, sores/red swollen patches on fingers onset in Jul2020, was easily getting tired, numbnes in limb, sinus issues/pressure hurts in face and eyes unknown  onset, acid reflux, sores/red swollen patches on fingers onset in 2020, headache unknown onset, joint pains, sores/red swollen patches on fingers onset in 2020, recurrent stomach pain/cramps/thought it was due to gallbladder surgery onset in 2018, sinus issues/pressure hurts in face and eyes unknown onset, asthma, injection site sting, recurrent body aches, injection site welt, feelings of choking or suffocating, 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, tired after first covid shot/slept two days unknown onset, tired after first covid shot/slept two DAYS unknown onset, tiredness after second covid shot, tiredness after covid 19 vaccination booster, sore arm  For covid-19 vaccination booster, body pain and headache unknown onset with humira 40mg/0.8ml(adalimumab) was  no reasonable possibility. The reporter's causality for the event(s) of inflammation in fingers, 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 unknown onset 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 unknown onset was not provided. the reporter's causality for the event(s) of pains in leg/thigh with humira 40mg/0.8ml(adalimumab) was a reasonable possibility. Abbvie&ampampampampampampampampaposs opinion is that there is no reasonable possibility that the events of gall stones, recurrent stomach  pain/cramps/thought it was due to gallbladder surgery onset in 2018, stomach issues, enlarged liver, sores/red  swollen patches on fingers onset in july2020, was easily getting tired, numbnes in limb, acid reflux, inflammation in fingers, sores/red swollen patches on fingers onset in 2020, pains in leg/thigh, joint pains,  sores/red swollen patches on fingers onset in 2020, recurrent stomach pain/cramps/thought it was due to  gallbladder surgery onset in 2018, recurrent body aches, 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, tired after first covid  shot/slept two days unknown onset, tired after first covid shot/slept two days unknown onset, tiredness after second covid shot, tiredness after covid 19 vaccination booster, sore arm for covid-19 vaccination booster,  body pain and headache unknown onset are related to humira 40mg/0.8ml(adalimumab). abbvie's opinion is that the events of sinus issues/pressure hurts in face and eyes unknown onset, headache unknown onset, sinus  issues/pressure hurts in face and eyes unknown onset, asthma and feelings of choking or suffocating are not assessable. abbvie's opinion is that there is a reasonable possibility that the events of injection site sting, injection site welt, 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 unknown onset 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 unknown onset are related to humira 40mg/0.8ml(adalimumab).   The reporter's assessment of the causal relationship of the event with the suspect product 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; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on Limited Information, there is a possibility of causal association between the events Fatigue, Salivary gland enlargement, Tongue spasm, Dysphagia, Vaccination site pain, Vaccination site urticaria, Erythema, Peripheral Swelling, Pain in extremity, Headache, Asthma, Speech disorder, Back Pain, Pre-existing condition improved 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.