Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Asthenia, Myalgia, Pain, SARS-CoV-2 antibody test
Clinical narrative: blood count test where abnormal and really low/keeps dropping every week, white blood count is now at 2.3; body ache/hurt so bad/can't work out/can't move; Body ache/Muscles really hurt; Super weak; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (blood count test where abnormal and really low/keeps dropping every week, white blood count is now at 2.3) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 05BEYA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2016, White blood cell count decreased and Radiation therapy. Concurrent medical conditions included Penicillin allergy, Drug allergy, Food allergy, Fruit allergy, Fruit allergy and Migraine. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, SUMATRIPTAN for Migraine.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (blood count test where abnormal and really low/keeps dropping every week, white blood count is now at 2.3) (seriousness criterion medically significant), PAIN (body ache/hurt so bad/can't work out/can't move), MYALGIA (Body ache/Muscles really hurt) and ASTHENIA (Super weak). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (blood count test where abnormal and really low/keeps dropping every week, white blood count is now at 2.3) outcome was unknown and PAIN (body ache/hurt so bad/can't work out/can't move), MYALGIA (Body ache/Muscles really hurt) and ASTHENIA (Super weak) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2022, Allergy test: allergic to pepper, avocado and strawberries allergic to Pepper, Avocado and Strawberries. On 30-Jun-2022, SARS-CoV-2 antibody test: really high really high. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative (7 tests done and everyone was negative). On an unknown date, White blood cell count: abnormal abnormal, very lowand keeps dropping every week very lowand keeps dropping every week and 2.3 2.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's height was reported as 5' 7".  Patient was diagnosed by her Endocrinologist with Lupus or another autoimmune disorder.  Patient got an allergy test on 28-Jun-2022 and patient was allergic to Pepper, Avocado and Strawberries. Patient was taking Sumatriptan as concomitant medication whenever had migraine (once a month) and a few drops of Flonase when had allergies.  Patient called for medical assistance because of the side effects. Patient got her primary series at the facility. Patient stated that 2 months ago her body ache, she can't move, she was "hurt so bad", she can't work out, muscles really hurt, she felt super weak, her white blood count test where abnormal and really low. Her white blood count was very low and keeps dropping every week, white blood count now was at 2.3. Patient seek medical care twice in urgent care. Patient had experienced the same in past. Patient was diagnosed by her Endocrinologist with "fibernausea" autoimmune disorder (patient did not know how to say or spell that illness) or Lupus. Symptoms were worsened. Treatment details not reported. Patient got her antibody COVID-19 tested on 30-Jun-2022 and they were really high. Patient mentioned that she received first primary series from Moderna COVI-19 vaccine 4 weeks apart but she was not sure if that was the correct interval.  Company Comment: This spontaneous case concerns a 51-year-old, female patient with relevant medical history of radiation therapy for breast cancer and occasional episodes of low white blood cell count, who reported the unexpected, serious (medically significant) event of White blood cell count decreased and experienced non-serious events of Pain with Myalgia and Asthenia. The events started on unspecified dates after completion of 2-dose primary COVID-19 vaccine series, presenting as generalized aching along with muscle pain and weakness, which significantly affected her mobility. Continued symptoms prompted emergency consults where laboratory tests revealed persistently low white blood count, with latest reported value of 2.3. She was eventually seen by an endocrinologist who provided a preliminary diagnosis of lupus vs another autoimmune disorder. Allergy testing was also done approximately 10 months post-vaccination in relation to the autoimmune disorder impression which revealed multiple allergies to food, apart from previously known drug allergies. Other diagnostic procedures conducted and treatment details were not provided in the case. The patient's prior radiation therapy remain as confounder for the events, while previous episodes of low WBC count could be a risk factor for the reported similar occurrence of abnormal WBC levels. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with relevant medical history of radiation therapy for breast cancer and occasional episodes of low white blood cell count, who reported the unexpected, serious (medically significant) event of White blood cell count decreased and experienced non-serious events of Pain with Myalgia and Asthenia. The events started on unspecified dates after completion of 2-dose primary COVID-19 vaccine series, presenting as generalized aching along with muscle pain and weakness, which significantly affected her mobility. Continued symptoms prompted emergency consults where laboratory tests revealed persistently low white blood count, with latest reported value of 2.3. She was eventually seen by an endocrinologist who provided a preliminary diagnosis of lupus vs another autoimmune disorder. Allergy testing was also done approximately 10 months post-vaccination in relation to the autoimmune disorder impression which revealed multiple allergies to food, apart from previously known drug allergies. Other diagnostic procedures conducted and treatment details were not provided in the case. The patient's prior radiation therapy remain as confounder for the events, while previous episodes of low WBC count could be a risk factor for the reported similar occurrence of abnormal WBC levels. The benefit-risk relationship of mRNA-1273 is not affected by this report.