Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, Chills, Feeling cold, Haemoglobin, Platelet count
Clinical narrative: Resurge in aplastic anemia; Been cold; Swollen arm; Chills; Running Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant), FEELING COLD (Been cold), VACCINATION SITE SWELLING (Swollen arm), CHILLS (Chills) and PYREXIA (Running Fever). On 08-Mar-2021, FEELING COLD (Been cold), VACCINATION SITE SWELLING (Swollen arm), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (High) Platelet was 60. On 18-Dec-2020, Red blood cell count: 14 (High) Red blood cell count was 14.. On 23-Feb-2021, Haemoglobin: 10.8 (Low) hemoglobin 10.8. On 23-Feb-2021, Platelet count: 21 (Low) platelets 21. On 14-May-2021, Haemoglobin: 8.8 (Low) hemoglobin was 8.8. On 14-May-2021, Platelet count: 13 (Low) platelets 13. On 14-May-2021, White blood cell count: 2.2 (Low) white blood cell count 2.2..         Treatment included platelet transfusion, blood transfusion, cyclosporine 100mg, eltrombopag 150mg, and acetaminophen.  Per report, her aplastic anemia had gotten worse and her hemoglobin, platelet and white blood count all dropped after receiving the vaccine.Her symptoms started same day and lasted for two days after receiving the first and the second vaccine. She said she has been under a lot of stress because her husband was sick, and she is not sure if that is also a contributing factor.  Based on the current available information and temporal association between the use of the product and the start date of the events Vaccination site swelling, feeling cold, chills and pyrexia, a causal relationship cannot be excluded. Very limited information on Aplastic anaemia has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-141615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-MAY-2021 has patients date of birth updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Vaccination site swelling, feeling cold, chills and pyrexia, a causal relationship cannot be excluded. Very limited information on Aplastic anaemia has been provided at this time. Further information has been requested.