Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, COVID-19, General symptom
Clinical narrative: Bipolar disorder; COVID-19; General symptom; This spontaneous case was reported by a consumer and describes the occurrence of BIPOLAR DISORDER (Bipolar disorder) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Bipolar disorder.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BIPOLAR DISORDER (Bipolar disorder) (seriousness criterion medically significant), COVID-19 (COVID-19) and GENERAL SYMPTOM (General symptom). At the time of the report, BIPOLAR DISORDER (Bipolar disorder) had not resolved and COVID-19 (COVID-19) and GENERAL SYMPTOM (General symptom) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No Concomitant medication were reported.  It was reported that the patient was bipolar and the medicine Sulsacine had not been responding good. On her first covid injection, patient was fine but after the second one she felt most of the covid symptoms.  The reporter's causality for the event(s) of BIPOLAR and FELT MOST OF THE COVID SYMPTOMS with RINVOQ(UPADACITINIB) was no reasonable possibility.  The patient was treated with SULSACINE..  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.  Company comment.  This spontaneous case concerns an adult female patient, with bipolar disorder and in treatment with co - suspect product Upadacitinib for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine (unspecified schedule), and experienced the unexpected, non  serious AESI of COVID  19 and the medically significant event of bipolar disorder. Events onset date and vaccination dates were not reported; hence latency and temporal association cannot be properly assessed. The outcome of COVID  19 was recovered. No further details were provided for medical reviewing. Rheumatoid arthritis and Upadacitinib remains as risk factor for infections (COVID  19).  Patient´s medical history of bipolar disorder remains as risk factor for the event bipolar disorder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Live Follow up received containing significant information.. Event updated from Suspected Covid-19 to COVID-19. General symptom was added as an additional event, narrative updated..; Sender's Comments: This spontaneous case concerns an adult female patient, with bipolar disorder and in treatment with co - suspect product Upadacitinib for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine (unspecified schedule), and experienced the unexpected, non  serious AESI of COVID  19 and the medically significant event of bipolar disorder. Events onset date and vaccination dates were not reported; hence latency and temporal association cannot be properly assessed. The outcome of COVID  19 was recovered. No further details were provided for medical reviewing. Rheumatoid arthritis and Upadacitinib remains as risk factor for infections (COVID  19).  Patient´s medical history of bipolar disorder remains as risk factor for the event bipolar disorder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.