Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Genital abscess, Influenza, Joint swelling, Muscular weakness
Clinical narrative: bad flu, bad flu like reaction; small boils genital area; hand weakness; small boil under breast; swelling in ankle; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL ABSCESS (small boils genital area) 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.    The patient's past medical history included Ankle swelling and Rheumatoid arthritis. Concurrent medical conditions included Blood pressure abnormal (Concomitant therapy of diuretic orally for blood pressure.).   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 15-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2022, the patient experienced GENITAL ABSCESS (small boils genital area) (seriousness criterion medically significant), MUSCULAR WEAKNESS (hand weakness), FURUNCLE (small boil under breast) and JOINT SWELLING (swelling in ankle). On an unknown date, the patient experienced INFLUENZA (bad flu, bad flu like reaction). At the time of the report, GENITAL ABSCESS (small boils genital area), MUSCULAR WEAKNESS (hand weakness), FURUNCLE (small boil under breast) and JOINT SWELLING (swelling in ankle) had not resolved and INFLUENZA (bad flu, bad flu like reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event Grip strength decreased subsume under the event Muscular weakness  Patient reported daily dose of the vaccine as first dose.  On an unknown date in 2022, patient took 4th moderna vaccine.  Patient reported that in 2022 the patient experienced Bad flu. On 15 Apr 2022, the patient experienced Hands weak, Small boils under breasts, Trouble opening jars, Small boils in genital area and swelling in ankle MODERNA COVID-19 vaccine was also considered suspect.  The patient hands became weak and she had trouble opening jars. She had a bad flu like reaction to fourth COVID vaccine, no reaction with first three.  It was unknown if patient was enrolled in clinical trial.  The reporters causality for Hands weak, Small boils under breasts, Trouble opening jars, Small boils in genital area was a reasonable possibility, causality for swelling in ankles was no reasonable possibility and for bad flu was not provided.  Company comment: This spontaneous case concerns a 62-year-old female patient, on Upadacitinib due to severe rheumatoid arthritis, who experienced, unexpected, serious (medically significant) event of Genital Abscess, unspecified days after receiving mRNA-1273 vaccine as a fourth dose.  Temporal association cannot be assessed due to lack of information regarding the date of vaccination.  Clinical course and treatment details are not available in this report.  The outcome of the event is unknown.  Concomitant intake of Upadacitinib, an immunosuppressant could be considered as a risk factor for the event.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, on Upadacitinib due to severe rheumatoid arthritis, who experienced, unexpected, serious (medically significant) event of Genital Abscess, unspecified days after receiving mRNA-1273 vaccine as a fourth dose.  Temporal association cannot be assessed due to lack of information regarding the date of vaccination.  Clinical course and treatment details are not available in this report.  The outcome of the event is unknown.  Concomitant intake of Upadacitinib, an immunosuppressant could be considered as a risk factor for the event.  The benefit-risk relationship of mRNA-1273 is not affected by this report.