Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccination site pain, Weight
Clinical narrative: Back pain; Pain; COVID-19/Lost weight; vaccination failure; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/Lost weight), BACK PAIN (Back pain), PAIN (Pain), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION FAILURE (vaccination failure) in a 72-year-old male 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.    The patient's past medical history included Back pain. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-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 an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In August 2021, the patient experienced COVID-19 (COVID-19/Lost weight) and VACCINATION FAILURE (vaccination failure). On an unknown date, the patient experienced BACK PAIN (Back pain) and PAIN (Pain). On 13-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, COVID-19 (COVID-19/Lost weight), BACK PAIN (Back pain) and PAIN (Pain) was resolving and VACCINATION FAILURE (vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: lost. In August 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Magnetic resonance imaging: not reported.         No concomitant medication was reported.  The patient experienced other things hurt, back was hurting not related to RA. Patient had an MRI the course of action would be exercise he stated 50 years going on this back had been hurting him he was a gymnist in HS. It was unknown if patient was enrolled in a COVID-19 vaccine trial. COVID-19 vaccination, 2nd dose, caused mild tenderness at the injection site the next day, until mid-day, early afternoon, it was gone. In Aug 2021, he had COVID-19, he lost weight because of COVID-19.   No treatment information was provided.  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.  CC: This spontaneous case concerns a 72-year-old, male patient with an underlying rheumatoid arthritis treated with upadacitinib and a historical condition of back pain, who experienced an unexpected, non-serious AESI COVID-19 approximately 6 months after receiving a 2nd dose of mRNA-1273 COVID-19 vaccine. Vaccination failure was noted in this case. Patient received his 2-dose primary series of mRNA-1273 COVID-19 vaccine 28 days apart. He experienced vaccination site pain on the same day of vaccination and the events of back pain and other things hurting on unknown dates after vaccination. Reportedly, patient lost weight because of COVID-19 on an unknown date. A positive SARS-CoV-2 test confirmed the diagnosis on an unknown date. A magnetic resonance imaging with no result was reported. Outcome of the event COVID-19 was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's elderly age, her underlying rheumatoid arthritis, and treatment with upadacitinib may have predisposed the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow up received medical history and events added.; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with an underlying rheumatoid arthritis treated with upadacitinib and a historical condition of back pain, who experienced an unexpected, non-serious AESI COVID-19 approximately 6 months after receiving a 2nd dose of mRNA-1273 COVID-19 vaccine. Vaccination failure was noted in this case. Patient received his 2-dose primary series of mRNA-1273 COVID-19 vaccine 28 days apart. He experienced vaccination site pain on the same day of vaccination and the events of back pain and other things hurting on unknown dates after vaccination. Reportedly, patient lost weight because of COVID-19 on an unknown date. A positive SARS-CoV-2 test confirmed the diagnosis on an unknown date. A magnetic resonance imaging with no result was reported. Outcome of the event COVID-19 was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's elderly age, her underlying rheumatoid arthritis, and treatment with upadacitinib may have predisposed the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.