Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Drug ineffective, Inflammation, Spinal operation, Suspected COVID-19
Clinical narrative: had surgery for back; Back pain; Inflammation localized; covid; covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4435290-00.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "covid"; SPINAL OPERATION (non-serious), outcome "unknown", described as "had surgery for back"; BACK PAIN (non-serious), outcome "recovering"; INFLAMMATION (non-serious), outcome "unknown", described as "Inflammation localized". The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "covid" and "had surgery for back" 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 reporter considered "covid", "back pain" and "inflammation localized" related to BNT162b2.  Clinical course: Solicited report from a consumer of a female patient with events of pain in back and non-serious Covid and inflammation in hands with Rinvoq (UPADACITINIB). On unknown dates , the patients experienced pain in back and inflammation in hands. In 2022, the patient experienced Covid. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was considered as Suspect. The Patient had inflammation in hands but had pain her back. In Apr 2022 she had Surgery for back. Husband and Wife both had Covid. It was Unknown if Patient was enrolled in a covid vaccine trial.  Causality for RINVAQ (UPADACITINIB): The reporter's Causality for the event of pain in the back and inflammation in hands was not provided. The reporter causality for the event of covid with RINVAQ (UPADACITINIB) was no reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of pain is back, covid and inflammation in hands are related to RINVAQ (UPADACITINIB). Drug: RINVOQ (UPADACITINIB): Causality: Back pain : Causality as per reporter: Not Reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. COVID-19: Causality as per reporter: Not Related, Causality as per Mfr.: No reasonable possibility. Inflammation localized: Causality as per reporter: Not Reported, Causality as per Mfr.: No reasonable possibility.  Drug:Pfizer Biontech COVID-19 Vaccine: Causality: Back pain, COVID-19 and Inflammation localized : Causality as per reporter: Possible     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 the information available, the causal relationship between the reported events  (except Spinal operation) and suspect drug BNT162B2 cannot be excluded. Event Spinal operation is considered Unrelated to suspect drug BNT162B2.