Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Intervertebral disc injury, Intervertebral disc protrusion, Magnetic resonance imaging neck
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4512552-00. A 34-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160069), oral for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19"; PAIN (non-serious), outcome "unknown", described as "Feeling pain"; INTERVERTEBRAL DISC PROTRUSION (non-serious), INTERVERTEBRAL DISC INJURY (non-serious), outcome "unknown" and all described as "Had two bulging discs in her neck and cervical spine". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging neck: (Mar2022) Disc damage. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of pain, intervertebral disc protrusion, intervertebral disc injury. Clinical course: On unknown dates, the patient experienced pain, two bulging discs in neck/cervical spine and magnetic resonance imaging showed disc damage. On 16Nov2021, the patient experienced COVID. In Jul2022, the patient experienced COVID. On an unknown date, COVID resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. On 16Nov2021 and in Jul2022 patient had COVID twice. She was feeling pain. She had two bulging discs in her neck and cervical spine. In Jan2022 she had started physical therapy. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality For Rinvoq (Upadacitinib): The reporter's causality for the event(s) of pain, two bulging discs in neck/cervical spine, COVID onset 16Nov2021, COVID onset in Jul2022 and magnetic resonance imaging showed disc damage was not provided. Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the event Pain (pain), Cervical disc herniation (Intervertebral disc protrusion), COVID-19 (COVID-19), Causality as per reporter (drug/vaccine): Possible. The reporter considered "covid-19", "feeling pain" and "had two bulging discs in her neck and cervical spine" related to BNT162b2. The reporter's assessment of the causal relationship of "had two bulging discs in her neck and cervical spine" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported events "Drug ineffective" "covid-19", "feeling pain" and "had two bulging discs in her neck and cervical spine" are assessed as related to suspect drug .