Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Pyrexia, Vertigo
Clinical narrative: Vertigo; Headache; Cyst; Carpal tunnel syndrome; Cervical disc herniation; Sickness; Fever; 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-163-3923676-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2010 (Lot number: 1151441) to Jan2016 at 40 mg (40 mg,  cf (1 in 2 wk)), second regimen subcutaneous from Jun2016 (Lot number: 1151441) to 20Feb2021 at 40 mg (40 mg, cf (1 in 2 wk)) and third regimen subcutaneous since 03Apr2021 (ongoing) (Lot number: 1151441) at 40 mg (40 mg, cf (1 in 2 wk)) for irritable bowel syndrome, diverticulitis, plantar fasciitis, ankylosing spondylitis, uveitis. Relevant medical history included: "Non-Smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Gluten Allergy" (unspecified if ongoing); "Silicon allergy" (unspecified if ongoing); "Stomach Cramps" (unspecified if ongoing); "Rash" (unspecified if ongoing); "Latex Allergy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Spinal fusion", start date: Jan2016, stop date: Jan2016; "Rupture tendon", start date: Mar2016 (unspecified if ongoing), notes: In Mar2016, the patient experienced torn patella knee.; "Trigger finger release", start date: Aug2020 (unspecified if ongoing); "Knee pain", start date: 2016 (unspecified if ongoing); "Back pain", start date: 2010 (unspecified if ongoing); "Fall", start date: 15Jan2021 (unspecified if ongoing); "Sinusitis recurrent", start date: 2010 (unspecified if ongoing); "Spondylitis ankylosing aggravated", start date: 2010 (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (1st Dose, Daily Dose: 1)First dose (1 in 1 Once), Route of Admin: 1)Intra-muscular, Lot number: Unknown), administration date: 26Feb2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Sickness", "Fever", "Swollen arm", "Rash over arms", "Vertigo", "Headache", "she had stuffy and runny nose", "she had stuffy and runny nose". The following information was reported: CYST (medically significant) with onset 21May2021, outcome "recovering", described as "Cyst"; ILLNESS (medically significant) with onset Apr2021, outcome "recovered" (Apr2021), described as "Sickness"; PYREXIA (medically significant) with onset Apr2021, outcome "recovered" (Apr2021), described as "Fever"; CARPAL TUNNEL SYNDROME (medically significant) with onset 21May2021, outcome "recovering", described as "Carpal tunnel syndrome"; INTERVERTEBRAL DISC PROTRUSION (medically significant) with onset Apr2021, outcome "recovering", described as "Cervical disc herniation"; VERTIGO (medically significant), outcome "unknown", described as "Vertigo"; HEADACHE (medically significant), outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: blood test: (05Feb2021) unknown result. The action taken for adalimumab was unknown. Clinical information: The patient diagnosed with ankylosing spondylitis due to her back surgery and got treated with humira. She got sick due to covid 19 vaccine. She had trigger finger surgery. On 26Feb2021 she had stuffy and runny nose which was recovered in Apr2021. Causality of runny nose was not related. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the event(s) of bone fusion in the lower back, torn patella knee, carpal tunnel syndrome, herniated disk in the neck c5-c6, recurring knee pain, recurring back pain, recurring flare up ankylosing spondilitis, swollen arm and rash in the arm with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of trigger finger release, cyst in the wrist, fall, recurring sinus infection, sick because of covid 19 vaccine, fever, vertigo and headache was not provided. The company opinion is that there is no reasonable possibility that the events of bone fusion in the lower back, torn patella knee, carpal tunnel syndrome, trigger finger release, cyst in the wrist, herniated disk in the neck c5-c6, recurring knee pain, recurring back pain, fall, recurring flare up ankylosing spondilitis, sick because of covid 19 vaccine, fever, swollen arm, rash in the arm, vertigo and headache are related to humira 40mg/0.4ml(adalimumab). The company opinion is that there is a reasonable possibility that the event of recurring sinus infection is related to humira 40mg/0.4ml(adalimumab). The reporter considered "carpal tunnel syndrome", "cervical disc herniation", "vertigo" and "headache" not associated to bnt162b2. 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 provided, a causal association between reported events cyst, illness, pyrexia, carpal tunnel syndrome, vertigo, headache and the suspect BNT162B2 cannot be excluded. Intervertebral disc protrusion may not be related to BNT162B2 as per medical assessment.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.