Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Fall, Influenza like illness, Patella fracture
Clinical narrative: Anxiety attack; Weight gain; Broken right knee cap; Fell; Flu like symptoms; 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-163-4018094-00 (AbbVie).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Feb2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single, intramuscular, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral from Dec2019 (Batch/Lot number: unknown) to 2021 at 15 mg 1x/day and second regimen oral since 2021 (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day for rheumatoid arthritis; prednisone (PREDNISONE) (Batch/Lot number: unknown) for product used for unknown indication. Relevant medical history included: "NO TOBACCO USE" (unspecified if ongoing), notes: NO TOBACCO USE; "hip replacement surgery", start date: Sep2020 (unspecified if ongoing), notes: hip replacement surgery went wrong and had to be redone in Nov2020. Concomitant medication(s) included: GABAPENTIN taken for product used for unknown indication; MELOXICAM taken for product used for unknown indication; OMEPRAZOLE taken for product used for unknown indication. The following information was reported: PATELLA FRACTURE (medically significant) with onset 19May2021, outcome "unknown", described as "Broken right knee cap"; FALL (medically significant) with onset 19May2021, outcome "unknown", described as "Fell"; ANXIETY (hospitalization) with onset May2021, outcome "unknown", described as "Anxiety attack"; WEIGHT INCREASED (non-serious), outcome "recovering", described as "Weight gain"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; weight: (unspecified date) gain; x-ray: (2021) unknown results. The action taken for upadacitinib and prednisone was unknown. Therapeutic measures were taken as a result of patella fracture, anxiety, weight increased.  Clinical Course: Solicited report by a consumer of a 64 year old female with events of fell and broke right knee cap, right hip replacement surgery went wrong and had to be redone and anxiety attacks and non-serious right hip replacement surgery went wrong and had to be redone, weight gain and flu like symptoms with rinvoq (upadacitinib). On an unknown date, the patient experienced weight gain. in sep2020, the patient experienced right hip replacement surgery went wrong and had to be redone. in mar2021, the patient experienced flu like symptoms. in mar2021, the flu like symptoms resolved. in may2021, the patient experienced anxiety attacks. on 19may2021, the patient experienced fell and broke right knee cap. prednisone and pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect. the patient reported that in sep2020, she had right hip replacement. she stated that her surgery went wrong and had to be redone in nov2020. in mar2021, she had flu like symptoms for a day followed her second injection of covid-19 vaccine. on 19may2021, she fell and broke right knee cap and on the same day she had an outpatient knee surgery due to the broken right knee cap. in may2021, she was hospitalized due to two anxiety attacks. she could not recall the exact date when she stopped taking rinvoq. she was doing a physical therapy as of 04aug2021. she mentioned that she had excessive weight gain due to using prednisone in the past. she stated that she was now in 2021 losing very slowly. it was unknown if patient was enrolled in a covid-19 vaccine trial. the patient was treated with percocet. Causality for rinvoq( upadacitinib) the reporter's causality for the event(s) of fell and broke right knee cap onset 19may2021, fell and broke right knee cap onset 19may2021 and weight gain with rinvoq (upadacitinib) was no reasonable possibility. the reporter's causality for the event(s) of right hip replacement surgery went wrong and had to be redone onset in sep2020, anxiety attacks, right hip replacement surgery went wrong and had to be redone onset in sep2020 and flu like symptoms was not provided. withheld opinion is that there is no reasonable possibility that the events of fell and broke right knee cap onset 19may2021, fell and broke right knee cap onset 19may2021, right hip replacement surgery went wrong and had to be redone onset in sep2020, anxiety attacks, right hip replacement surgery went wrong and had to be redone onset in sep2020, weight gain and flu like symptoms are related to rinvoq (upadacitinib).   Seq.No.: 1 Drug: HUMIRA(Solution for injection in pre-filled syringe)(ADALIMUMAB) Daily Dose: 1)15 mg (15 mg,1 in 1 D) 2) 15 mg (15 mg,1 in 1 D)  Route of Admin: 1) Oral 2) Oral Therapy Dates/Duration: 1) Dec2019 - 2021 2) 2021 - Ongoing Causality 1) Broken knee cap (Patella fracture) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: Yes 2) Fall (Fall) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: Yes 3) Hip replacement (Hip replacement) 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 4) Anxiety attack (Anxiety) 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 5) Surgical failure (Surgical failure) 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 6) Weight gain (Weight increased) 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 7) Flu like symptoms (Influenza like illness) 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  Seq: 2 Drug: PREDNISONE (PREDNISONE)(PREDNISONE) 1) Broken knee cap (Patella fracture) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: Yes 2) Fall (Fall) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: Yes 3) Hip replacement (Hip replacement) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 4) Anxiety attack (Anxiety) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 5) Surgical failure (Surgical failure) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 6) Weight gain (Weight increased) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 7) Flu like symptoms (Influenza like illness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 3. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN)(TOZINAMERAN),Unknown, Unknown, Unknown Daily Dose: 1st dose (1 in Route of Administration: Intramuscular Indications for use: COVID-19 Vaccination Therapy Dates(From/To): 01Jan2021  Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN,UNKNOWN Daily Dose: 1) Pfizer/BioNTech: Dose 1 (1 in 1 Once) 2) Pfizer/BioNTech: Dose 2 (1 in 1 Once) 3) Pfizer/BioNTech: Booster dose (1 in 1 Once) Route of Admin: 1) Intramuscular 2) Intramuscular 3) Intramuscular Indication for use: 1) COVID-19 VACCINATION Therapy Dates/Duration: 1) 15Feb2021 - 15Feb2021 2) 08Mar2021 - 08Mar2021 3) 18Aug2021 - 18Aug2021 Causality 1) Broken knee cap (Patella fracture) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: Yes 2) Fall (Fall) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: Yes 3) Hip replacement (Hip replacement) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 4) Anxiety attack (Anxiety) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 5) Surgical failure (Surgical failure) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 6) Weight gain (Weight increased) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 7) Flu like symptoms (Influenza like illness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  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 Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events fall, Patella fracture cannot be established and ,the causal association between the events Weight Gain and influenza like illness and anxiety and the suspect drug BNT162B2 cannot be excluded. 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