Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity, Spinal operation
Clinical narrative: Back pain; Pain; Back surgery; Pain in knees and hips; Pain in hands; FACILITATED COLLECT  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-163-4199947-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of administration: Intramuscular), administration date: 01Mar2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Back pain". The following information was reported: SPINAL OPERATION (medically significant) with onset 23Nov2021, outcome "recovering", described as "Back surgery"; ARTHRALGIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Pain in knees and hips"; PAIN (non-serious) with onset 06Dec2021, outcome "recovered" (08Dec2021), described as "Pain"; PAIN IN EXTREMITY (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Pain in hands"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain". The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of spinal operation, back pain.  The reporter considered "pain" related to bnt162b2.  Clinical Course: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Patient experienced pain in knees, hand and hips. She experienced a lot of pain. She had a back Surgery and procedure. She experienced pain in her back and had steroids injected into her spine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 01Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. Causality for RINVOQ(UPADACITINIB) The reporter's causality for the event(s) of BACK SURGERY with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of Pain in knees and hips and pain in hands with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of Pain and back pain was not provided.  Regulatory Authority opinion is that there is no reasonable possibility that the events of back Surgery, Pain in knees and hips, pain, pain in hands and Back pain are related to RINVOQ(UPADACITINIB).Reaction Information: Seq. No.: 1Reaction: Back surgery (Spinal operation) start Date: 23Nov2021.Seq. No.: 2 Reaction: Pain in joint (Arthralgia) start Date: 28Oct2021.Seq. No.: 3 Reaction: Pain (Pain) start Date: 06Dec2021 Start date: 08Dec2021 Duration: 2Days.Seq. No.: 4 Reaction: Pain in hand (Pain in extremity) start Date: 28Oct2021.Seq. No.: 5 Reaction: Back pain (Back pain)SUSPECT DRUG(S)INFORMATION:SUSPECTDRUG(S)(includegenericname):RINVOQ(UPADACITINIB),UNKNOWNIndications for use: Unknown Indication Therapy Dates(From/To): 1.UNK-Ongoing Route of admin: Oral. Causality:1. Back surgery (Spinal operation) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): No reasonable Possibility Causality as per Mfr. (Drug/Vaccine): No reasonable Possibility.2. Pain in joint (Arthralgia) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Reasonable possibility Causality as per Mfr. (Drug/Vaccine): No reasonable Possibility.3. Pain (Pain)Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Causality as per Mfr. (Drug/Vaccine): No reasonable Possibility.4. Pain in hand (Pain in extremity). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Reasonable possibility. Causality as per Mfr. (Drug/Vaccine): No reasonable Possibility.5. Back pain (Back pain). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable Possibility.2) PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) UNKNOWN, UNKNOWN Daily Dose:1)1st dose (1 in 1 Once)2) 2nd dose (1 in 1 Once) Causality:1. Back surgery (Spinal operation) Action(s) taken with drug: Not Applicable. Causality as per reporter (Drug/Vaccine): Not Reported.2. Pain in joint (Arthralgia). Action(s) taken with drug: Not Applicable. Causality as per reporter (Drug/Vaccine): Not Reported.3. Pain (Pain). Action(s) taken with drug: Not Applicable. Causality as per reporter (Drug/Vaccine): Probable.4. Pain in hand (Pain in extremity). Action(s) taken with drug: Not Applicable Causality as per reporter (Drug/Vaccine): Not Reported.5. Back pain (Back pain). Action(s) taken with drug: Not Applicable. Causality as per reporter (Drug/Vaccine): Not Reported.  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 available in narrative the reported event of pain, arthralgia, pain in extremity and back pain are assessed as related to suspected vaccine BNT162B2. However the reported event of spinal operation, back pain are assessed as unrelated to suspected vaccination due to impossible temporal association. 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.