Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypersensitivity, Joint stiffness
Clinical narrative: Experienced allergic reaction following her booster for the COVID vaccine; Breakouts/feet/hands had blisters and scaling; Had a stiff wrist as well; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Experienced allergic reaction following her booster for the COVID vaccine) and BLISTER (Breakouts/feet/hands had blisters and scaling) in a 55-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 Rheumatoid arthritis.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2022, the patient experienced JOINT STIFFNESS (Had a stiff wrist as well). On an unknown date, the patient experienced HYPERSENSITIVITY (Experienced allergic reaction following her booster for the COVID vaccine) (seriousness criterion hospitalization) and BLISTER (Breakouts/feet/hands had blisters and scaling) (seriousness criterion hospitalization). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Experienced allergic reaction following her booster for the COVID vaccine) outcome was unknown, BLISTER (Breakouts/feet/hands had blisters and scaling) had not resolved and JOINT STIFFNESS (Had a stiff wrist as well) was resolving.            Concomitant medications were not reported.  The patient had breakouts. Patient received the booster shot week before onset of events in Dec-2021.  Reporter's causality for all events was not reported with respect to Rinvoq drug.  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 a 55-year-old, female patient with history of co-suspect administration of Rinvoq (upadacitinib) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (hospitalization) event of hypersensitivity and the unexpected, non-serious event of joint stiffness. The event hypersensitivity occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Dec2021 and the event onset date was not provided, hence, the onset latency could not be assessed. The event joint stiffness occurred unknown number of days after taking Rinvoq and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the date of intake of Rinvoq was not reported while the event onset date was reported as unspecified date in Apr2022, hence, the onset latency could not be assessed. It was reported that the patient experienced an allergic reaction after receiving the booster dose of the mRNA-1273 vaccine. She was in the hospital with lip swelling, swelling under her right eye, and her lips were swollen and erythematous. The patient also had breakouts. Her feet and hands had blisters and scaling. The patient was treated with EpiPen (epinephrine). No further clinical information (including details about hospitalization) was available for medical review. Of note, no information was available regarding the first and second vaccine doses. On an unspecified date in Apr2022, the patient experienced wrist stiffness. No further details were provided. The medical history of Rheumatoid Arthritis remains a confounder for the event joint stiffness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with history of co-suspect administration of Rinvoq (upadacitinib) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (hospitalization) event of hypersensitivity and the unexpected, non-serious event of joint stiffness. The event hypersensitivity occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Dec2021 and the event onset date was not provided, hence, the onset latency could not be assessed. The event joint stiffness occurred unknown number of days after taking Rinvoq and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the date of intake of Rinvoq was not reported while the event onset date was reported as unspecified date in Apr2022, hence, the onset latency could not be assessed. It was reported that the patient experienced an allergic reaction after receiving the booster dose of the mRNA-1273 vaccine. She was in the hospital with lip swelling, swelling under her right eye, and her lips were swollen and erythematous. The patient also had breakouts. Her feet and hands had blisters and scaling. The patient was treated with EpiPen (epinephrine). No further clinical information (including details about hospitalization) was available for medical review. Of note, no information was available regarding the first and second vaccine doses. On an unspecified date in Apr2022, the patient experienced wrist stiffness. No further details were provided. The medical history of Rheumatoid Arthritis remains a confounder for the event joint stiffness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.