Age: 59.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity, Pyrexia, Ultrasound kidney
Clinical narrative: Diarrhea; Swollen lymph node; Fever; Nausea; Chills; Blisters; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of BLISTER (Blisters), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen lymph node), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) in a 59-year-old 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 products included non-company products UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis and HYDROCODONE BITARTRATE;PARACETAMOL for an unknown indication.    The patient's past medical history included Cholecystectomy on 29-Mar-2021. Previously administered products included for Supplementation therapy: Codeine. Past adverse reactions to the above products included Rash with Codeine. Concurrent medical conditions included Alcohol use (Two to three glasses of wine or champagne), Drug allergy (Breakout with rash on the palm and hand), Blood pressure high, Cholesterol blood excessive and Gallbladder stone. Concomitant products included LISINOPRIL for Blood pressure, SIMVASTATIN for High cholesterol, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and KRILL OIL (MEGARED OMEGA 3 KRILL OIL) for Supplementation therapy.   In June 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HYDROCODONE BITARTRATE;PARACETAMOL (unknown route) at an unspecified dose. In March 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 29-Mar-2021, the patient experienced BLISTER (Blisters). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, BLISTER (Blisters) had not resolved, DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound kidney: gall bladder stone (abnormal) Gall bladder stone.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had gall bladder stone found unintentionally during a visit with nephrologist. On 29 Mar 2021, cholecystectomy was done and was sent home the same day. On an unspecified date of 2021, patient had chills, diarrhea, swollen lymph nodes, fever and nausea. No treatment information was provided.  Causality for rinvoq (upadacitinib): the reporter's causality for the event(s) of gall bladder stone and sore arms with rinvoq (upadacitinib) was no reasonable possibility. the reporter's causality for the event(s) of broke out with blisters, chills, diarrhea, swollen lymph nodes, fever and nausea was not provided. abbvie's opinion is that there is no reasonable possibility that the events of gall bladder stone, broke out with blisters, sore arms, chills, diarrhea, swollen lymph nodes, fever and nausea are related to rinvoq (upadacitinib).  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.