Age: 65.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: inflammation that presents as redness that moved from place to place on body; brown spots underneath the red rash; felt lifeless after covid vaccination; discomfort; rheumatoid arthritis flare up; Interchange of vaccine products; eyes bothering; mole on arm got darker; coldness; achiness/pain and attributes it to stress; arms red/tummy area got redness/Red Blotches; rash went and came/red rash on hands, arms and the back of head; rash went and came/red rash on hands, arms and the back of head; felt out of sorts/Feeling unwell; headache; tired/fatigue/fatigue after vaccinations; achiness/pain and attributes it to stress; arm/right hand swollen after covid vaccination; red rash on arm after vaccine; red rash on arm after vaccine; Vaccination Site Pain; tummy area bruising/Contusion Of Abdominal Wall; middle joint on finger was sore and swollen and it affected rest of right hand; middle joint on finger was sore and swollen and it affected rest of right hand;   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): 21K-163-4022223-00 (AbbVie).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM) (Batch/Lot number: unknown); adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1141161) at unk (citrate free), second regimen subcutaneous (Lot number: 1151783) at unk (citrate free), third regimen subcutaneous (Lot number: 1153257) at unk (citrate free) and fourth regimen subcutaneous (Lot number: 1141161) at unk (citrate free) for rheumatoid arthritis. Relevant medical history included: "feeling shoulder pain", start date: 15Nov2021 (ongoing), notes: on 15Nov2021, the Patient Experienced Feeling Shoulder Pain (Not recovered). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (First dose, Intramuscular, single), for COVID-19 VACCINATION; Moderna covid-19 vaccine (Second dose, Intramuscular, single), for COVID-19 VACCINATION, reaction(s): "arm ache after second Covid vaccine". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jan2022, outcome "unknown", described as "rheumatoid arthritis flare up"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown", described as "Interchange of vaccine products"; EYE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "eyes bothering"; MELANOCYTIC NAEVUS (non-serious) with onset 2021, outcome "not recovered", described as "mole on arm got darker"; FEELING COLD (non-serious) with onset 2021, outcome "not recovered", described as "coldness"; PAIN (non-serious) with onset 2021, outcome "not recovered", RASH MACULAR (non-serious) with onset 2021, outcome "not recovered" and all described as "arms red/tummy area got redness/Red Blotches"; RASH (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "rash went and came/red rash on hands, arms and the back of head"; SKIN DISCOLOURATION (non-serious), outcome "not recovered", described as "brown spots underneath the red rash"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 2021, outcome "not recovered" and all described as "middle joint on finger was sore and swollen and it affected rest of right hand"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "felt lifeless after covid vaccination"; DISCOMFORT (non-serious), outcome "not recovered", described as "discomfort"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "tummy area bruising/Contusion Of Abdominal Wall"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation that presents as redness that moved from place to place on body"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "felt out of sorts/Feeling unwell"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tired/fatigue/fatigue after vaccinations"; STRESS (non-serious) with onset 2021, outcome "recovered", described as "achiness/pain and attributes it to stress"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm/right hand swollen after covid vaccination"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "red rash on arm after vaccine"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination Site Pain". The action taken for adalimumab was unknown. The action taken for methotrexate sodium was dosage permanently withdrawn. It Was Unknown If Patient Was Enrolled In A Covid-19 Vaccine Trial.  The reporter considered "interchange of vaccine products", "eyes bothering", "mole on arm got darker", "coldness", "achiness/pain and attributes it to stress", "arms red/tummy area got redness/red blotches", "rash went and came/red rash on hands, arms and the back of head", "middle joint on finger was sore and swollen and it affected rest of right hand", "felt lifeless after covid vaccination", "tummy area bruising/contusion of abdominal wall ", "felt out of sorts/feeling unwell", "headache", "tired/fatigue/fatigue after vaccinations", "arm/right hand swollen after covid vaccination", "red rash on arm after vaccine" and "vaccination site pain" (possible) related to bnt162b2. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up (Rheumatoid Arthritis), Skin Discoloration, Discomfort, Stress, Inflammation Localised was not reported with bnt162b2.  The reporter's causality for the event(s) of Eye Disorder, Mole of Skin, Coldness, arms red/tummy area got redness coded as Rash Macular/ Red Blotches (Reasonable Possibility), and and Vaccination Site Pain, arm/right hand swollen after covid vaccination, Vaccination Site Rash, red rash on arm after vaccine, Headache, Feeling Lifeless with Humira was related (no reasonable possibility).  The reporter's causality for the event(s) of middle joint on finger was sore and swollen and it affected rest of right hand, tummy area bruising, Stress, Pain, Red Rash, Shoulder Pain, Pain In Joint Involving Hand, "felt out of sorts/feeling unwell", Rheumatoid Arthritis Flare Up, Skin Discoloration, Discomfort, Stress, Inflammation Localised, "tired/fatigue/fatigue after vaccinations" and Fatigue with Humira was not provided.  The reporter's causality for the event(s) of headache and felt out of sorts/feeling unwell was Probable) related to methotrexate sodium. The reporter's assessment of the causal relationship of the other events with the suspect product methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (25Jan2022): This is a follow up solicited report from a Non-Interventional Study based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4022223-00. A contactable female consumer (patient) reported updated Information includes: RA updated, Events added, Seriousness updated, Outcome of events updated, Causality and Other clinical information updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for the reported events of Rheumatoid arthritis, Interchange of vaccine products, Eye disorder, Melanocytic nevus, Feeling cold,  Pain, Rash macular, Rash, Rash erythematous, Skin discolouration, Arthralgia, Joint swelling, Feeling abnormal, discomfort, Contusion, Inflammation, Malaise, Headache, Fatigue, Stress, Vaccination site swelling, Vaccination site erythema, Vaccination site rash, Vaccination site pain. 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.