Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Unspecified illness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. Previously administered products included for Prophylactic vaccination: Flu vaccine. Past adverse reactions to the above products included Illness with Flu vaccine. Concurrent medical conditions included Asthma, Penicillin allergy, Drug allergy (Tetracycline allergy), Shellfish allergy and Drug allergy (Sulfa allergy). On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Unspecified illness) (seriousness criterion medically significant). At the time of the report, ILLNESS (Unspecified illness) outcome was unknown. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient was healthy and had no past history of similar events. The patient had no illness at the time of vaccination. The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no hospitalizations and interventions other than medication, The patient had no family history of autoimmune disorders. The patient had no concomitant medications or vaccine or any immunomodulatory drugs steroids, no vaccine administration errors needle disconnect, syringe leak, no complaint with vaccine storage, transport or usage deviations. The patient was not breast feeding. The patient had no medical history of autoimmune disorders, immunodeficiency or transplant, malignancy, asthma, COPD, any chronic lung or other comorbid ailment. The patient had no CBC, X-ray, CT, chest oximetry, COVID antibody test, respiratory viral panel, other blood work, microbiology culture tests. No treatment information was provided. Company comment: This is a spontaneous case concerning a 60-year-old female with a medical history of 2 doses of mRNA-1273 in April and May 2021, 28 days apart, with a booster on 15 Dec 2021 of the Jansen vaccine who experienced the serious (medically significant), unexpected event of COVID-19 infection and the non-serious events of drug ineffective (LOE and reportable), asthma and blood pressure increased 9 months after the second dose of RNA-1273. Testing was reported as 3 positive COVID-19 PCR tests and symptoms fever and asthma like illness. Treatment was with prednisone and azithromycin. The outcome is recovered for the COVID-19 infection and ongoing for the others. A confounder is the use of the Jansen VOVID-19 vaccine 53 days before the events as that could have been the cause or contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-509060 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 60-year-old female with a medical history of 2 doses of mRNA-1273 in April and May 2021, 28 days apart, with a booster on 15 Dec 2021 of the Jansen vaccine who experienced the serious (medically significant), unexpected event of COVID-19 infection and the non-serious events of drug ineffective (LOE and reportable), asthma and blood pressure increased 9 months after the second dose of RNA-1273. Testing was reported as 3 positive COVID-19 PCR tests and symptoms fever and asthma like illness. Treatment was with prednisone and azithromycin. The outcome is recovered for the COVID-19 infection and ongoing for the others. A confounder is the use of the Jansen VOVID-19 vaccine 53 days before the events as that could have been the cause or contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.