Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Blood glucose increased, Exeresis, Spinal operation, Vaccination site pain
Clinical narrative: Left arm sore from flu vaccine and covid vaccine; high blood sugar; Back eblasion; Back eblasion; 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-4134168.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; adalimumab (HUMIRA), (Lot number: 1164842) at single (unknown, single), subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Moderate to Severe Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXERESIS (medically significant), SPINAL OPERATION (medically significant) all with onset 14Sep2022, outcome "not recovered" and all described as "Back eblasion"; BLOOD GLUCOSE INCREASED (non-serious) with onset 26Sep2022, outcome "recovered" (2022), described as "high blood sugar"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Left arm sore from flu vaccine and covid vaccine". The patient underwent the following laboratory tests and procedures: Blood glucose increased: (26Sep2022) high 195. The action taken for adalimumab was unknown. Additional information: Solicited report from the PRIVATE by a consumer of an elderly male with events of Back eblasion, and non-serious high blood sugar, and Left arm sore from Flu vaccine and COVID vaccine with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On 14Sep2022, the patient experienced Back eblasion. On unknown date(s), the patient experienced Left arm sore from Flu vaccine and Covid vaccine, high blood sugar. On unknown date, high blood sugar recovered/resolved. Pfizer/BioNTech was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient had back eblasion on 14Sep2022 and three shots. Causalities:  The reporter's causality for the event(s) of Back eblasion, Left arm sore from Flu vaccine and COVID vaccine and high blood sugar with Adalimumab Solution for Injection was Not Provided.  The reporter's causality for the event(s) of Back eblasion and high blood sugar with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Left arm sore from Flu vaccine and COVID vaccine with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Regulatory Authority opinion was that the causality for the event(s) of Back eblasion, Left arm sore from Flu vaccine and COVID vaccine and high blood sugar with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Regulatory Authority opinion was that the causality for the event(s) of high blood sugar with Adalimumab Solution for Injection was Not Assessable. Regulatory Authority opinion was that the causality for the event(s) of Back eblasion and Left arm sore from Flu vaccine and COVID vaccine with Adalimumab Solution for Injection was No Reasonable Possibility. Regulatory Authority Alternative Etiology for Back eblasion with Adalimumab Solution for Injection: Surgical procedure performed, more likely related to back disorder in this elderly age patient. Regulatory Authority Alternative Etiology for Left arm sore from Flu vaccine and COVID vaccine with Adalimumab Solution for Injection: More likely related to concomitant use of vaccine. Assessment Results: Humira 40 mg/0.4 ml- Vaccination site pain, Non-Health Care Professional, Global Introspection, Not Reported. Humira 40 mg/0.4 ml- Blood sugar increased, Non-Health Care Professional, Global Introspection, Not Reported. Humira 40 mg/0.4 ml- Back surgery, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech- Back surgery, Market Authorization Holder (MAH) Pfizer/BioNTech- Back surgery, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech- Blood sugar increased, Market Authorization Holder (MAH). Pfizer/BioNTech- Blood sugar increased, Non-Health Care Professional, Global Introspection, Not Reported. Humira 40 mg/0.4 ml- Blood sugar increased, Market Authorization Holder (MAH), Global Introspection, not assessable. Pfizer/BioNTech- Vaccination site pain, Market Authorization Holder (MAH). Pfizer/BioNTech- Vaccination site pain, Non-Health Care Professional, Global Introspection, Possible. Humira 40 mg/0.4 ml- Back surgery, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility. Humira 40 mg/0.4 ml- Vaccination site pain, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility.  The reporter's assessment of the causal relationship of "back eblasion" and "high blood sugar" 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. The reporter's assessment of the causal relationship of "back eblasion", "high blood sugar" and "left arm sore from flu vaccine and covid vaccine" with the suspect product(s) BNT162b2 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. The reporter considered "left arm sore from flu vaccine and covid vaccine" related to BNT162b2, BNT162b2 omi ba.4-5.  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 in the case, a possible causal association between  the reported events Spinal operation, Exeresis , Blood glucose increased , Vaccination site pain  and the suspect drug cannot be excluded. The case will be reassessed after follow up information about events received. 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 RAs, Ethics Committees, and Investigators, as appropriate.