Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Vaccination complication, Wound infection
Clinical narrative: Nausea; Abdominal distress; Vaccination complication; reduced general condition; back pain; Wound infection; Knee pain; Headache; Inappropriate schedule of vaccine administered; Fall; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ABDOMINAL DISCOMFORT (Upset stomach), NAUSEA (Nausea), ABDOMINAL DISCOMFORT (Abdominal distress) and VACCINATION COMPLICATION (Vaccination complication) in a 62-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 product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Peripheral neuropathy.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-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) (unknown route) at an unspecified dose. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and FALL (Fall). On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), ABDOMINAL DISCOMFORT (Abdominal distress), VACCINATION COMPLICATION (Vaccination complication), GENERAL PHYSICAL HEALTH DETERIORATION (reduced general condition), BACK PAIN (back pain), WOUND INFECTION (Wound infection) and ARTHRALGIA (Knee pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION COMPLICATION (Vaccination complication), FALL (Fall), GENERAL PHYSICAL HEALTH DETERIORATION (reduced general condition), BACK PAIN (back pain), WOUND INFECTION (Wound infection), ARTHRALGIA (Knee pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown, NAUSEA (Nausea) had not resolved and ABDOMINAL DISCOMFORT (Abdominal distress) had resolved.      No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of fall, fibromyalgia, other health issues, back pain, knee pain, upset stomach, headaches, abdominal distress, covid vaccine issue and wound infection was not provided. The reporter's causality for the event(s) of nausea with Rinvoq(upadacitinib) was a reasonable possibility.  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-2022-624564, MOD-2022-624635 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow-up information received includes dosage information, events added and narrative were updated.