Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: migraines; brain fog; chest pain; weakness/Weak; Couldn't walk; dizzy; veritgo; severe cramps; couldn't focus; since it's impacting my everyday life, my job and health; Magnetic resonance imaging of head showed changes in my white matter, that it decreases; Severe early menstruation / Menstruation 8 days after my last 1; ferritin levels critical req infusions My hemoglobin is normal; Short of breath; Severe headaches; Extreme debilitating fatigue; Body ache/ muscle pain generalized; Chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Severe early menstruation / Menstruation 8 days after my last 1), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest tightness), MIGRAINE (migraines) and FEELING ABNORMAL (brain fog) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD and Celiac disease. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). On 05-Aug-2021, the patient experienced DYSPNOEA (Short of breath), HEADACHE (Severe headaches), FATIGUE (Extreme debilitating fatigue) and MYALGIA (Body ache/ muscle pain generalized). On 06-Aug-2021, the patient experienced POLYMENORRHOEA (Severe early menstruation / Menstruation 8 days after my last 1) and SERUM FERRITIN DECREASED (ferritin levels critical req infusions My hemoglobin is normal). On an unknown date, the patient experienced MIGRAINE (migraines), FEELING ABNORMAL (brain fog), CHEST PAIN (chest pain), ASTHENIA (weakness/Weak), PRESYNCOPE (Couldn't walk), DIZZINESS (dizzy), VERTIGO (veritgo), DYSMENORRHOEA (severe cramps), DISTURBANCE IN ATTENTION (couldn't focus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (since it's impacting my everyday life, my job and health) and WHITE MATTER LESION (Magnetic resonance imaging of head showed changes in my white matter, that it decreases). The patient was treated with IRON (iv bolus) for Ferritin decreased, at a dose of 4 INFUSIONS. At the time of the report, POLYMENORRHOEA (Severe early menstruation / Menstruation 8 days after my last 1) and SERUM FERRITIN DECREASED (ferritin levels critical req infusions My hemoglobin is normal) had resolved, DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest tightness), HEADACHE (Severe headaches), FATIGUE (Extreme debilitating fatigue) and MYALGIA (Body ache/ muscle pain generalized) had not resolved and MIGRAINE (migraines), FEELING ABNORMAL (brain fog), CHEST PAIN (chest pain), ASTHENIA (weakness/Weak), PRESYNCOPE (Couldn't walk), DIZZINESS (dizzy), VERTIGO (veritgo), DYSMENORRHOEA (severe cramps), DISTURBANCE IN ATTENTION (couldn't focus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (since it's impacting my everyday life, my job and health) and WHITE MATTER LESION (Magnetic resonance imaging of head showed changes in my white matter, that it decreases) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, Serum ferritin: dropped to 6 (Low) Ferritin levels - 6. Dropped to 9. On an unknown date, Haemoglobin: normal (normal) Normal. On an unknown date, Magnetic resonance imaging head: abnormal (abnormal) New white matter disease.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 16-Oct-2021: Follow-up information received on 16-OCT-2021 contains significant information. Patient did not receive second dose. On 16-Oct-2021: Follow-up information received on 16-OCT-2021 contains significant information. Patient race information,medical history, lab data, concomitants, Facility information and Events were updated; Sender's Comments: This case concerns a 42-year-old female patient with a previous relevant medical history of Celiac sensitivity, who experienced the unexpected non serious events of Polymenorrhoea, Serum ferritin decreased, Dyspnoea, Chest discomfort, Headache, Dizziness, Leukoaraiosis and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events Polymenohrrea, Headache and Dyspnoea occurred approximately 1 day after the first dose of Spikevax, Chest discomfort occurred 2 days later, and Dizziness at a later date. Patient consulted to the emergency room on an unknown date due to Headache, work-up showed low serum ferritin with normal haemoglobin and no other positive results. Later, Head MRI showed changes in white matter compatible. Neurologist consultation is pending. Treatment with intravenous iron was given. However, since the treatment was prescribed in the context of Celiac sensitivity without anaemia, there is no evidence to consider it as a medical significant intervention to prevent a serious outcome. The rechallenge is not applicable since the schedule of vaccination was discontinued. Underlying celiac sensitivity remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.