Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Inappropriate schedule of product administration, Pyrexia, X-ray
Clinical narrative: Inappropriate schedule of vaccine administered; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Psoriatic arthritis.    The patient's past medical history included Knee replacement (ten years ago was not affected by the fracture.) in 2011. Concurrent medical conditions included Psoriatic arthritis, Neck discomfort, Non-smoker and Abstains from alcohol. Concomitant products included PREGABALIN (LYRICA) for Neck discomfort, METHOTREXATE for Psoriatic arthritis.   In 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Left distal femur fracture. On an unknown date, X-ray: Normal.         She slipped over the water in her bathroom that caused a distal femur fracture of her knee and went to the emergency room. Headache and fever were experienced by her for 24 hours after both times. 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 FALL THAT CAUSED A LEFT DISTAL FEMUR FRACTURE OF KNEE onset in July 2021, FALL THAT CAUSED A LEFT DISTAL FEMUR FRACTURE OF KNEE onset in July 2021, HEADACHE onset in March 2021, HEADACHE onset in April 2021, FEVER onset in March 2021 and FEVER onset in April 2021 with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of TIRED with RINVOQ(UPADACITINIB) was a reasonable possibility. Company opinion is that there is no reasonable possibility that the events of FALL THAT CAUSED A LEFT DISTAL FEMUR FRACTURE OF KNEE onset in July 2021, FALL THAT CAUSED A LEFT DISTAL FEMUR FRACTURE OF KNEE onset in July 2021, HEADACHE onset in March 2021, HEADACHE onset in April 2021, TIRED, FEVER onset in March 2021 and FEVER onset in April 2021 are related to RINVOQ(UPADACITINIB). She went to rehab and there was a heavy large brace on her leg. Did not need a cane. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Live follow-up added, events onset dates added. History and current condition, treatment details added. Narrative updated.