Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site lymphadenopathy, Vaccination site pain, White blood cell count, White blood cell count decreased
Clinical narrative: her arthritis with spur, no cartilage in shoulder, bone on bone, and no cushion that was worsening progressively; LOW WHITE BLOOD CELL COUNT; HEADACHE; LYMPH NODE WERE SWOLLEN ON ARM COVID VACCINE INJECTION WAS GIVEN IN; Chills; FATIGUE; LOW GRADE FEVER; SORE ARM AFTER COVID VACCINE; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control No.: 21K-163-3958754-00). A 69-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EL3248), dose 2 intramuscular on 23Feb2021 (received at the age of 69-years-old) as DOSE 2, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, strength: 40MG/0.4ML), subcutaneous from Jun2020 to 03Jun2021 at 40 mg, 1 in 2 wk for non-infectious intermediate posterior and panuveitis. The patient medical history included heart (disorder), high blood pressure, blood flow, breast cancer (started Apr2015), arthritis on the right shoulder (started 2019), arthritis with spur (started 2019), no cartilage in shoulder/cartilage deteriorated (started 2019), bone on bone, no cushion to shoulder, non-tobacco user, alcohol user: glass of wine every now and then, range of motion/ cannot lift off arm, nerve block, and broke leg (started 2016). Social history included started drinking alcohol when she was 20 years old and clarified that she was not alcoholic. Concomitant medication(s) included acetylsalicylic acid (ASPIRINE) taken for blood flow, start and stop date were not reported; enalaprilat (ENALAPRILAT) taken for high blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number EL3248, expiration date was unknown) on 03Feb2021 for COVID-19 immunisation. Past drug history included aspirin for heart. One day after the covid vaccine, on 24Feb2021, the patient experienced headache, lymph node were swollen on arm covid vaccine injection was given in, chills, fatigue, low grade fever and sore arm after covid vaccine. On 08Jun2021, magnetic resonance imaging (MRI) showed shoulder, worsened arthritis with spur, bone on bone, no cushion, no cartilage in shoulder. On 08Jun2021, the patient experienced low white blood cell count. On 15Jun2021, the patient had a right shoulder surgery. On 15Jun2021, the low white blood cell count resolved. In 2021, the headache and low grade fever resolved. The clinical course was reported as follows: Vaccine (BNT162B2) was also considered suspect. The clinical course was reported as follows: On 08Jun2021, patient had pre clinical blood work and levels were fine and normal. On 15Jun2021, she underwent in a total right shoulder replacement surgery due to her arthritis with spur, no cartilage in shoulder, bone on bone, and no cushion that was worsening progressively, also experienced no range of motion that could not lift off arm and originally started few years ago. She was still in rehabilitation process for three to six months. The surgery was done, a catheter and stent were placed for the nerve block and removed three days after she came home. She was taking other pain medication pills. The physician told not take Humira two weeks before the surgery. She had a headache, lymph node were swollen on the arm the injection was given in, chills, sore arm, fatigue and low grade fever for one day after the covid vaccine on 24Feb2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with tramadol (indication was unspecified). Relevant Laboratory and Other Diagnostic Tests include: 08Jun2021 MRI: shoulder, worsened arthritis with spur, bone on bone, no cushion, no cartilage in shoulder; On 08Jun2021, white blood cell count: Low; 08Jun2021 X-RAY: shoulder, worsened arthritis with spur, bone on bone, no cushion, no cartilage in shoulder. The action taken for adalimumab was post therapy.  Outcome of low white blood cell count was recovered on 15Jun2021; outcome of headache and low grade fever was recovered in 2021; outcome of the other events was unknown. It was further reported that adalimumab was resumed on 06Aug2021 (and currently ongoing).   Assessment: Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of right shoulder surgery and headache with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of low white blood cell count, lymph node were swollen on arm covid vaccine injection was given in, chills, fatigue, low grade fever and sore arm after covid vaccine was not provided. Their opinion is that there is no reasonable possibility that the events of right shoulder surgery, headache, lymph node were swollen on arm covid vaccine injection was given in, chills, fatigue, low grade feve and sore arm after covid vaccine are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). AbbVie's opinion is that there is a reasonable possibility that the event of low white blood cell count is related to HUMIRA 40MG/0.4ML(ADALIMUMAB). The reporter's assessment of the causal relationship between the events shoulder operation and headache, and suspect drug adalimumab was no reasonable possibility. The reporter's assessment of the causal relationship between the event white blood cell count low and suspect drug adalimumab was not assessable. The reporter's assessment of the causal relationship between the events lymphadenopathy, fatigue, chills, low grade fever and vaccination site pain, and suspect drug adalimumab was not reported. The company's assessment of the causal relationship between the event white blood cell count low and suspect drug adalimumab was reasonable possibility. The company's assessment of the causal relationship between the events shoulder operation, lymphadenopathy, headache, fatigue, chills, low grade fever and vaccination site pain and suspect drug adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship between the events shoulder operation and white blood cell count low, and suspect vaccine bnt162b2 was not reported. The reporter's assessment of the causal relationship between the events headache, lymphadenopathy, chills, fatigue, low grade fever, vaccination site pain, and suspect vaccine bnt162b2 was possible.   The reporter's assessment of the causal relationship of the event white blood cell count low with the suspect product 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.  No follow-up attemps are needed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.