Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: He also developed this covid toe after the booster shot; Very worn down for about three days after each shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He also developed this covid toe after the booster shot) and FATIGUE (Very worn down for about three days after each shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Lyme's disease (Since was a  child) and Crohn's disease.   In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (He also developed this covid toe after the booster shot) (seriousness criterion medically significant) and FATIGUE (Very worn down for about three days after each shot) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (He also developed this covid toe after the booster shot) and FATIGUE (Very worn down for about three days after each shot) outcome was unknown.            Concomitant medications were not reported. Patient had a COVID Toe after the booster shot but that was not as severe. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Company comment-This spontaneous case concerns an adult male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Immunisation reaction (He also developed this covid toe after the booster shot) and Fatigue (Very worn down for about three days after each shot) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient's  wife reported that after second shot he developed covid toe where he had a rash and swelling on his feet. He developed Covid toe again after the booster shot but it was not severe. Patient also was very worn down for 3 days after each Moderna covid vaccines. Outcome of the events was not known at the time of report. No further details were available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-616769, MOD-2022-616833 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Immunisation reaction (He also developed this covid toe after the booster shot) and Fatigue (Very worn down for about three days after each shot) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient's  wife reported that after second shot he developed covid toe where he had a rash and swelling on his feet. He developed Covid toe again after the booster shot but it was not severe. Patient also was very worn down for 3 days after each Moderna covid vaccines. Outcome of the events was not known at the time of report. No further details were available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.