Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Dizziness, Fall, Headache, Hypoaesthesia
Clinical narrative: Disc in neck was blown out/three herniated discs; Neck pain; pain in shoulder/shoulder pain; numbness in right hand; Systemic Degenerative disc disease; headache; sore arm; dizzy spells; fell twice; This is a non-interventional study report from the marketing program received from a contactable consumer (patient) based on information received by Pfizer from via company (manufacturer control number: 21K-163-4073020-00).   A 51-year-old patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular route of administration, administered on 07Sep2021 (at the age of 52 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient also received Risankizumab rzaa (SKYRIZI Solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date for Moderate to severe chronic plaque Psoriasis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had disc in neck was blown out/three herniated discs, neck pain and systemic degenerative disc disease and since Mar2021, she had been having dizzy spells and fell twice. This had led to pain in shoulder and numbness in right hand. In Sep2021, the patient had sore arm and headache from vaccine. On 10Nov2021, she had surgery on neck for three herniated discs on and was hospitalized. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular route of administration, administered on 30Sep2021 as dose 2, single for covid-19 immunization. Events (Disc in neck was blown out/three herniated discs) was considered serious (hospitalization) and all other events were assessed non-serious. Outcome of events neck pain, vaccination site pain, shoulder pain, dizzy spells, headache, and numbness in hand was not recovered and for the outcome of the events cervical disc herniation, fall and degenerative disc disease was unknown.  Causality of events (Cervical disc herniation, Neck pain, Vaccination site pain, Shoulder pain, Dizzy spells, Headache, Numbness in hand, Fall, Degenerative disc disease) with Risankizumab rzaa (SKYRIZI) was assessed as not related by reporter and as No reasonable possibility by Manufacturer. Causality of events (Cervical disc herniation, Neck pain, Vaccination site pain, Shoulder pain, Dizzy spells, Headache, Numbness in hand, Fall, Degenerative disc disease) with bnt162b2 was assessed as not related by reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (19Nov2021): This is a Follow-up solicited report based on information received by Pfizer from a company (manufacturer control number: 21K-163-4073020-00) via contactable consumer (patient), New information included: Vaccine details (Dose 2), Event systemic degenerative disc disease upgraded to serious, causality (Reporter and company) updated and narrative 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 the description given in the narrative, there is reasonable possibility of causal association between the serious event and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.