Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Chest pain, Fibrin D dimer increased
Clinical narrative: Chest Pain; neck spurs; Sore in the right wrist; Sharp Pain Right Arm/Sore in the right arm; Elevated D-dimer.; Elevator Troponin; muscle aches; backache; Arm was sore from third covid booster; Off balance uses a cane; Off balance uses a cane; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4154970.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 07Jan2022 (Lot number: 1164887) to Jan2022 at 40 mg (40 mg (every 2 weeks)), subcutaneous for uveitis, rheumatoid arthritis, colitis ulcerative. The patient's relevant medical history included: "Fractured left Tibia", start date: May1992 (unspecified if ongoing); "Fractured left Fibula", start date: May1992 (unspecified if ongoing); "Costochondritis" (unspecified if ongoing); "Non Alcohol User" (unspecified if ongoing); "Non-Tobacco User" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing); "Pain management" (unspecified if ongoing). Concomitant medication(s) included: TEGRETOL taken for pain management; ASPIRIN [ACETYLSALICYLIC ACID]; SULFADIAZINE taken for colitis ulcerative. Past drug history included: Darvocet for Drug use for unknown indication, reaction(s): "Drug hypersensitivity"; Darvocet for Drug use for unknown indication, reaction(s): "Abdominal discomfort"; Darvon for Drug use for unknown indication, reaction(s): "Abdominal discomfort"; Darvon for Drug use for unknown indication, reaction(s): "Drug hypersensitivity"; Aspro-regular for Drug use for unknown indication, reaction(s): "Drug hypersensitivity"; Aspro-regular for Drug use for unknown indication, reaction(s): "Tachycardia"; Tegretol for Drug use for unknown indication, reaction(s): "Drug hypersensitivity"; Tegretol for Drug use for unknown indication, reaction(s): "Inflammation". Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown, Route(s) of Administration: Intramuscular), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown, Route(s) of Administration: Intramuscular), for COVID-19 immunization. The following information was reported: WALKING AID USER (non-serious), BALANCE DISORDER (non-serious) all with onset 2022, outcome "unknown" and all described as "Off balance uses a cane"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2022, outcome "not recovered", described as "Arm was sore from third covid booster"; BACK PAIN (non-serious) with onset 12Dec2022, outcome "not recovered", described as "backache"; MYALGIA (non-serious) with onset 12Dec2022, outcome "not recovered", described as "muscle aches"; FIBRIN D DIMER INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Elevated D-dimer."; TROPONIN INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Elevator Troponin"; CHEST PAIN (prolonged hospitalization) with onset 26Feb2023, outcome "recovered" (2023); PAIN IN EXTREMITY (non-serious) with onset 06Mar2023, outcome "recovered" (06Mar2023), described as "Sharp Pain Right Arm/Sore in the right arm"; VERTEBRAL OSTEOPHYTE (medically significant), outcome "unknown", described as "neck spurs"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Sore in the right wrist". The patient prolonged hospitalization for chest pain (start date: Feb2023, discharge date: Feb2023, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: X-ray: (Oct2022) Unknown results, notes: Left hip hurts. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of chest pain, walking aid user, vaccination site pain, myalgia, back pain, troponin increased, pain in extremity, arthralgia.   Clinical course details: Pfizer BioNTech COVID-19 vaccine was also considered suspect. The patient had an automobile accident on 08Oct2022, boned a pick up that went on sixty five miles per hour. Her left knee, ribs and left hip was injured. She was in hospital from 08Oct2022 to 09Oct2022. She felt sore on Oct2022, but was thankful to be alive. Car was totaled. Her injections in hip first one done, turns out her pelvis was fractured. She was kept in the hospital for close monitoring and was prescribed with Tylenol for pain. She would not recall the diagnostics tests done while in the hospital as well as his treating doctor. She would recall that she had daily blood drawn however she was not aware of the result. It was during the hospitalization that she learned about the arthritis in her left hip had worsened. She received total of two injections on her left hip for pain.   Causalities: The reporter's causality for the event(s) of Arm was sore from third covid booster, Automobile accident/car accident, Chest Pain, Elevated D-dimer, Elevator Troponin, Felt sore, Hip pain/Worsened Arthritis in left hip, Left ankle hurt, Left hip/knee injured/Left hip hurts, Off balance uses a cane onset 01Jan2022, Pelvis fractured, Sharp Pain Right Arm/Sore in the right arm, Sore in the right wrist, Swollen below left knee, backache, muscle aches, neck spurs, ribs injured with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Agency's opinion was that the causality for the event(s) of Arm was sore from third covid booster, Automobile accident/car accident, Chest Pain, Elevated D-dimer, Elevator Troponin, Felt sore, Hip pain/Worsened Arthritis in left hip, Left ankle hurt, Left hip/knee injured/Left hip hurts, Off balance uses a cane onset 01Jan2022, Pelvis fractured, Sharp Pain Right Arm/Sore in the right arm, Sore in the right wrist, Swollen below left knee, backache, muscle aches, neck spurs, ribs injured with Pfizer   Assessment Results: Pfizer BioNTech COVID-19 vaccine:  Knee injury, Automobile accident , Rib injury, Pelvic fracture, Chest pain, Cervical spine osteophyte, Wrist pain, Hip arthritis, Pain in ankle , Vaccination site pain , Troponin increased , Local swelling , Fibrin D dimer increased , Cane user , Painful R arm , pain, muscle ache, Backache, Loss of balance Non-Health Care Professional, Global Introspection, Not Reported.  The reporter's assessment of the causal relationship of "chest pain", "neck spurs", "off balance uses a cane", "arm was sore from third covid booster", "muscle aches", "backache", "elevated d-dimer.", "elevator troponin", "sharp pain right arm/sore in the right arm" and "sore in the right wrist" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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 the information in the case report, a possible causal relationship between the events Chest pain, Vertebral osteophyte, Walking aid user, Balance disorder, Vaccination site pain, Myalgia, Back pain, Fibrin D dimer increased, Troponin increased, Pain in extremity, Arthralgia and suspect product BNT162b2 be completely excluded. 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.