Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Haemoglobin
Clinical narrative: Hospitalize with critical anemia/ hemoglobin drop really low/ still have low blood hemoglobin; This spontaneous case was reported by a patient and describes the occurrence of ANAEMIA (Hospitalize with critical anemia/ hemoglobin drop really low/ still have low blood hemoglobin) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012F21A, 028A21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included IBD. Concurrent medical conditions included Drug allergy (Sulfa).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced ANAEMIA (Hospitalize with critical anemia/ hemoglobin drop really low/ still have low blood hemoglobin) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2022 due to ANAEMIA. At the time of the report, ANAEMIA (Hospitalize with critical anemia/ hemoglobin drop really low/ still have low blood hemoglobin) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: Hemoglobin drop really low.         Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was taking other medication. Patient still had low blood hemoglobin. Patient was looking for some helpful advice. Patient's last dose was in 15-May-2022. 3 months later patient was hospitalized with critical anemia. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 41-year-old, female patient with concurrent inflammatory bowel disease who experienced the unexpected, serious (hospitalization) event of Anemia which occurred approximately 3 months after receiving the fourth dose (second booster dose) of mRNA-1273. The patient received the first three doses of mRNA-1273 according to the recommended dosing interval with no information on post-vaccination adverse events. Hemoglobin was reported to be significantly decreased with severe anemia leading to hospital admission. The clinical manifestation, concomitant medications, risk factors, clinical course and treatment information were not reported. At the time of report, the event has not resolved. Anemia has been associated with inflammatory bowel disease and remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old, female patient with concurrent inflammatory bowel disease who experienced the unexpected, serious (hospitalization) event of Anemia which occurred approximately 3 months after receiving the fourth dose (second booster dose) of mRNA-1273. The patient received the first three doses of mRNA-1273 according to the recommended dosing interval with no information on post-vaccination adverse events. Hemoglobin was reported to be significantly decreased with severe anemia leading to hospital admission. The clinical manifestation, concomitant medications, risk factors, clinical course and treatment information were not reported. At the time of report, the event has not resolved. Anemia has been associated with inflammatory bowel disease and remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.