Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Nausea, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; Appetite lost; Loss of energy; Weight loss; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive) 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 ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 11-Aug-2021, the patient experienced COVID-19 (COVID-19 virus test positive) (seriousness criterion hospitalization). On 21-Mar-2022, the patient experienced NAUSEA (Nauseated). On an unknown date, the patient experienced DECREASED APPETITE (Appetite lost), ASTHENIA (Loss of energy) and WEIGHT DECREASED (Weight loss). On 26-Oct-2021, COVID-19 (COVID-19 virus test positive) had resolved. In March 2022, NAUSEA (Nauseated) had resolved. At the time of the report, DECREASED APPETITE (Appetite lost), ASTHENIA (Loss of energy) and WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient was tested positive for COVID-19 and was hospitalized, having no energy for about six weeks, after 10 days receiving of Moderna COVID-19 vaccine. Antibiotics and vitamin treatment were provided during hospitalization.  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 no reported medical history, on Adalimumab for hidradenitis suppurativa (start date unknown), who experienced the unexpected serious (hospitalization) AESI COVID-19 that occurred 10 days after receiving the 1st dose of mRNA-1273 vaccine. Patient reported that ten days post vaccination, SARS-CoV-2 tested positive, was hospitalized, and treated with antibiotics and vitamins. It was reported that patient had no energy for about six weeks. The outcome of event was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with no reported medical history, on Adalimumab for hidradenitis suppurativa (start date unknown), who experienced the unexpected serious (hospitalization) AESI COVID-19 that occurred 10 days after receiving the 1st dose of mRNA-1273 vaccine. Patient reported that ten days post vaccination, SARS-CoV-2 tested positive, was hospitalized, and treated with antibiotics and vitamins. It was reported that patient had no energy for about six weeks. The outcome of event was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.