Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Menstruation irregular
Clinical narrative: Severe early menstruation / Menstruation 8 days after my last 1; Short of breath; Body ache/ muscle pain generalized; Severe headaches; Extreme debilitating fatigue; Weak; ferritin levels critical / Ferritin levels btw dropped to 9; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Severe early menstruation / Menstruation 8 days after my last 1), DYSPNOEA (Short of breath), MYALGIA (Body ache/ muscle pain generalized), HEADACHE (Severe headaches), FATIGUE (Extreme debilitating fatigue), ASTHENIA (Weak) and SERUM FERRITIN DECREASED (ferritin levels critical / Ferritin levels btw dropped to 9) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Celiac disease.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced MENSTRUATION IRREGULAR (Severe early menstruation / Menstruation 8 days after my last 1) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), MYALGIA (Body ache/ muscle pain generalized) (seriousness criterion medically significant), HEADACHE (Severe headaches) (seriousness criterion medically significant), FATIGUE (Extreme debilitating fatigue) (seriousness criterion medically significant), ASTHENIA (Weak) (seriousness criterion medically significant) and SERUM FERRITIN DECREASED (ferritin levels critical / Ferritin levels btw dropped to 9) (seriousness criterion medically significant). The patient was treated with IRON for Ferritin decreased, at an unspecified dose and frequency. At the time of the report, MENSTRUATION IRREGULAR (Severe early menstruation / Menstruation 8 days after my last 1), DYSPNOEA (Short of breath), MYALGIA (Body ache/ muscle pain generalized), HEADACHE (Severe headaches), FATIGUE (Extreme debilitating fatigue), ASTHENIA (Weak) and SERUM FERRITIN DECREASED (ferritin levels critical / Ferritin levels btw dropped to 9) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The concomitant medications were not reported.  It was reported that patient had menstruation 8 days after her last one, 5 days after the vaccine. The second menstruation intensified symptoms of patient. The patient stated that her hemoglobin was normal. At the time of reporting the patient was on Iron infusions number 3.  Company Comment : The case concerns a  42-year-old-male patient with previous relevant medical history of celiac disease , who experienced the unexpected event of mentruation irregular, dyspnoea, myalgia, headache, fatigue, asthenia and serum ferritin decreased. The event occurred the same day, after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of celiac disease remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: The case concerns a  42-year-old-male patient with previous relevant medical history of celiac disease , who experienced the unexpected event of mentruation irregular, dyspnoea, myalgia, headache, fatigue, asthenia and serum ferritin decreased. The event occurred the same day, after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of celiac disease remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.