Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood test
Clinical narrative: Autoimmune Hemolytic Anemia, vaccines stirred up the antibodies; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia, vaccines stirred up the antibodies) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cough (3 weeks long) in January 2020, Sore throat in January 2020, Feeling abnormal in January 2020 and COVID-19 in January 2020.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia, vaccines stirred up the antibodies) (seriousness criterion medically significant). The patient was treated with FOLIC ACID for Autoimmune hemolytic anemia, at an unspecified dose and frequency and PREDNISONE for Autoimmune hemolytic anemia, at a dose of 40 milligram. At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia, vaccines stirred up the antibodies) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Blood test: abnormal (abnormal) severe anemia with hemolysis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Two weeks after the patient's 2nd shot, a routine blood test during a physical revealed severe anemia. Currently patient was monitored by a hematologist who has diagnosed the problem as Autoimmune Hemolytic Anemia. The patient getting tested every few weeks and was being treated with folic acid supplements. No transfusion or steroids were prescribed so far. The doctor though that one explanation for the event was that the patient might had had COVID before producing natural antibodies. With the vaccines they were stirred up leading to the autoimmune reaction. Patient stated on dose of 40 of prednisone and was not improving rapidly. Patient doctor believes that the vaccines kicked existing antibodies into high gear and which set about destroyed cells. Patient does not feel sick and was able to do activities.   Company Comment: This spontaneous case concerns a 66 year old female patient with suspected medical history of Covid 19 who experienced the unexpected serious event of Autoimmune haemolytic anaemia (seriousness criterion- important medical event), on the 17th day of receiving the second dose of mRNA-1273 vaccine. It was reported that during routine blood tests, severe anaemia with hemolysis were revealed following which the patient consulted a haematologist who diagnosed it as Autoimmune hemolytic anaemia. She had been put on Prednisone and folic acid since then. Her consulting physician suggested that the patient might have had COVID-19 before and the antibodies boost produced by the vaccination led to the autoimmune reaction. Her booster dose was reported to be delayed due to the event. At the time of the report, the outcome of event was resolving. Medical history of suspected COVID 19 during the pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow-up received contains HCP information, first dose and second dose details. On 09-Feb-2022: Follow-up included event, reporter address, relevant medical information and treatment medication added. Lab data and event date updated.; Sender's Comments: This spontaneous case concerns a 66 year old female patient with suspected medical history of Covid 19 who experienced the unexpected serious event of Autoimmune haemolytic anaemia (seriousness criterion- important medical event), on the 17th day of receiving the second dose of mRNA-1273 vaccine. It was reported that during routine blood tests, severe anaemia with hemolysis were revealed following which the patient consulted a haematologist who diagnosed it as Autoimmune hemolytic anaemia. She had been put on Prednisone and folic acid since then. Her consulting physician suggested that the patient might have had COVID-19 before and the antibodies boost produced by the vaccination led to the autoimmune reaction. Her booster dose was reported to be delayed due to the event. At the time of the report, the outcome of event was resolving. Medical history of suspected covid 19 during the pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.