Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Hidradenitis, Myalgia, Sinusitis
Clinical narrative: COVID-19; Hidradenitis suppurativa; Sinus infection; Generalized aching; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 52-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) injection for Hidradenitis suppurativa.    The patient's past medical history included COVID-19 in 2020 and COVID-19 pneumonia in 2020. Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2020, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). In January 2021, the patient experienced MYALGIA (Generalized aching) and CHILLS (Chills). On 08-Dec-2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). The patient was hospitalized from 08-Jun-2021 to 19-Jun-2021 due to COVID-19. In 2021, MYALGIA (Generalized aching) and CHILLS (Chills) had resolved. At the time of the report, COVID-19 (COVID-19) had resolved, SINUSITIS (Sinus infection) had not resolved and HIDRADENITIS (Hidradenitis suppurativa) was resolving.            No concomitant and treatment medications were reported.  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  Patient experienced symptoms like coughing up large amount of blood, high fever, blistering rash, could not breath and no taste or smell. In February 2021, the patient experienced chills and body aches and it was resolved.  Company comment: This spontaneous case concerns a 52-year-old female patient with medical history of COVID-19 pneumonia, who experienced the unexpected, serious (hospitalization) event of COVID-19 (AESI). The event occurred before the first dose of mRNA-1273 with outcome recovered. However, the report mentions that the patient was hospitalized 5 months after the second dose of mRNA-1273 due to COVID-19 with symptoms such as haemoptysis, pyrexia, blistering rash, dyspnoea, ageusia, and anosmia. Hospitalization lasted for 11 days. No further details were provided. COVID-19 pneumonia could be a confounder for the case. Outcome was reported as recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up received by safety on 20-APR-2022 has Email and contains no new information. Delete the event COVID-19 pneumonia and Foggy Feeling in Head , Current condition and Historical condition added.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with medical history of COVID-19 pneumonia, who experienced the unexpected, serious (hospitalization) event of COVID-19 (AESI). The event occurred before the first dose of mRNA-1273 with outcome recovered. However, the report mentions that the patient was hospitalized 5 months after the second dose of mRNA-1273 due to COVID-19 with symptoms such as haemoptysis, pyrexia, blistering rash, dyspnoea, ageusia, and anosmia. Hospitalization lasted for 11 days. No further details were provided. COVID-19 pneumonia could be a confounder for the case. Outcome was reported as recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.