Age: 87.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Joint swelling, Therapeutic response unexpected, Ultrasound scan
Clinical narrative: Swelling in ankle; She had improvement in her arthritis; First dose received on 28-Mar-2021 and second dose on 15-Apr-2021; bad reaction to covid shot / covid vaccine made her symptom really bad; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in ankle), IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad), THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021) in an 87-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021). In 2021, the patient experienced IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad). On an unknown date, the patient experienced JOINT SWELLING (Swelling in ankle) and THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis). At the time of the report, JOINT SWELLING (Swelling in ankle) and IMMUNISATION REACTION (bad reaction to covid shot / covid vaccine made her symptom really bad) was resolving and THERAPEUTIC RESPONSE UNEXPECTED (She had improvement in her arthritis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 28-Mar-2021 and second dose on 15-Apr-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: All ok.         It was unknown if patient was enrolled in a COVID-19 Vaccine.  No concomitant product reported by reporter.  The patient had ankle swelling and she did ultrasound scan and all was ok. She had bad reaction to covid shot which was very bad three weeks after. She had improvement in her arthritis. It was reported that, covid vaccine made her symptoms really bad.  The reporter's causality for the event(s) of SWELLING IN ANKLE and COVID SHOT REACTION with  RINVOQ(UPADACITINIB) was no reasonable possibility.  No treatment medication reported by reporter.  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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Live Significant Follow up received. Vaccination dates updated. New events added and reported causality updated.