Age: 22.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Immunisation reaction, Pyrexia
Clinical narrative: Vaccination adverse reaction; Temperature above 103; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 22-year-old male 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 products included non-company products INFLUENZA VACCINE for an unknown indication and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    The patient's past medical history included COVID-19 (symptoms showed only for three days). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, PNEUMOCOCCAL VACCINE for an unknown indication.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free,Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) (seriousness criterion hospitalization) and PYREXIA (Temperature above 103). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved and PYREXIA (Temperature above 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: above 103.         In Jan 2022, patient got his COVID-19 booster, flu shot, and a pneumonia shot on same day and ended up in the hospital for three days. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No 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.   Company comment: This spontaneous case concerns a 22 year old male patient with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Immunisation reaction, unknown days after receiving the third dose (booster shot) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received influenza and pneumonia vaccines on the same day and was hospitalized for three days. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event resolved. Influenza and pneumonia vaccines could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 22 year old male patient with no relevant medical history, who experienced the unexpected serious (hospitalization) event of Immunisation reaction, unknown days after receiving the third dose (booster shot) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received influenza and pneumonia vaccines on the same day and was hospitalized for three days. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event resolved. Influenza and pneumonia vaccines could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.