Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Osteopenia, Parathyroidectomy, Vaccination site pain
Clinical narrative: Osteopenia; Arthritis; Parathyroid gland excision; Vaccination site pain; Fatigue; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (COVID-19 Vaccine, Dose 1, Manufacturer Unknown), administration date: Feb2021, for Covid-19 immunization; Covid-19 vaccine (COVID-19 Vaccine, Dose 2, Manufacturer Unknown), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PARATHYROIDECTOMY (medically significant) with onset 16Feb2022, outcome "recovering", described as "Parathyroid gland excision"; OSTEOPENIA (medically significant), outcome "not recovered", described as "Osteopenia"; ARTHRITIS (medically significant), outcome "not recovered", described as "Arthritis"; VACCINATION SITE PAIN (medically significant) with onset Dec2021, outcome "unknown", described as "Vaccination site pain"; FATIGUE (medically significant) with onset Dec2021, outcome "unknown", described as "Fatigue". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of parathyroid glands excision, osteopenia, arthritis were not reported; for vaccination site pain and fatigue with PFIZER BIONTECH COVID-19 was possible. Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of two parathyroid glands removed, osteopenia arthritis unknown onset and third covid vaccine caused sore arm and fatigue onset in Dec2021 with RINVOQ(UPADACITINIB) was no reasonable possibility.  Opinion is that there is no reasonable possibility that the events of two parathyroid glands removed, osteopenia arthritis unknown onset, third covid vaccine caused sore arm and fatigue onset in Dec2021 are related to RINVOQ(UPADACITINIB).  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 in the case report, a possible causal relationship between the reported events: Parathyroidectomy, Osteopenia, Arthritis, Vaccination site pain, Fatigue and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.