Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Spinal operation
Clinical narrative: Back surgery; pain on left side of back; COVID-19;   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): 22K-163-4231234-00.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 16Aug2021, outcome "recovered" and all described as "COVID-19"; SPINAL OPERATION (medically significant), outcome "not recovered", described as "Back surgery"; BACK PAIN (non-serious), outcome "not recovered", described as "pain on left side of back". The action taken for adalimumab was unknown.  Additional information : A 68 year old male with events of Back Surgery but had Pain on Left side of Back and non-serious Back Surgery but had Pain on Left side of Back, Arm hurt after second COVID Vaccine, Felt Hot after second COVID Vaccine and COVID with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Back Surgery but had Pain on Left side of Back. In 2021, the patient experienced A Arm hurt after second COVID Vaccine and Felt Hot after second COVID Vaccine. On 16Aug2021, the patient experienced COVID. In 2021, the Arm hurt after second COVID Vaccine and Felt Hot after second COVID Vaccine resolved. On an unknown date, COVID resolved. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had back surgery a few times but still experienced pain on left side of his back. On 16Aug2021, two days after first dose of covid-19 vaccination he was diagnosed with covid. In 2021, he experienced his arm hurt and felt hot for about a week after second dose of covid-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 14Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNtech. On 28Nov2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNtech.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of Back Surgery but had Pain on Left side of Back unknown onset, Back Surgery but had Pain on Left side of Back unknown onset, Arm hurt after second COVID Vaccine, Felt Hot after second COVID Vaccine and COVID was not provided. opinion is that there is no reasonable possibility that the events of Back Surgery but had Pain on Left side of Back unknown onset, Back Surgery but had Pain on Left side of Back unknown onset, Arm hurt after second COVID Vaccine, Felt Hot after second COVID Vaccine and COVID are related to Humira (Adalimumab).  Suspect drug (information):  Suspect Drug(s) (include generic name): Humira (Solution for injection in pre-filled pen) (Adalimumab)  Route of Administration: Subcutaneous  Indications for Use: Ankylosing Spondylitis  Therapy Dates (From/to): Unknown  Product-Reaction level:  Seq No: 1  Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab)  Causality:  Back surgery (Spinal operation)  Action(s) taken with drug: Unknown  Causality as per reporter (Drug/Vaccine): Not Reported  Causality as per Mfr. (Drug/Vaccine): No reasonable possibility  Dechallenge: N/A  Postoperative pain (Procedural pain)  Action(s) taken with drug: Unknown  Causality as per reporter (Drug/Vaccine): Not Reported  Causality as per Mfr. (Drug/Vaccine): No reasonable possibility  Dechallenge: N/A  COVID-19 (COVID-19)  Action(s) taken with drug: Unknown  Causality as per reporter (Drug/Vaccine): Not Reported  Causality as per Mfr. (Drug/Vaccine): No reasonable possibility  Dechallenge: N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Spinal operation, Back pain and the suspect drug BNT162B2 cannot be excludedCovid-19 was considered unrelated as it was co-incidental occurrence.  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.