Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 011M20A and 028L20A) for COVID-19 prophylaxis.     The patient's past medical history included Sickness, Pinkeye, Chest pain and Difficulty breathing. Concurrent medical conditions included Allergy to antibiotic (Erythromycin, throws up), Allergy to antibiotic (Tetracycline), Contrast media allergy (was rigid), Dust allergy, Type 2 diabetes mellitus, Hypertension and GERD ((Reflux)). Concomitant products included ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for GERD, METOPROLOL TARTRATE (LOPRESSOR) for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CANNABIDIOL (CBD OIL) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2022, SARS-CoV-2 antibody test: (Positive) Multiple positive tests.         It was reported that, patient who completed her primary series and thought she received 2 boosters and was inquiring about period for the 3rd booster. She informed that her doctor told her that she had to wait 3 months because she had tested positive. She also mentioned that immunity varies per person and can last 1 month in some and 6 months in others.  Patient was not hospitalized, no medications. No treatment medication was reported. Company comment: This spontaneous case concerns a 72-year-old, female patient with medical history of Hypertension and Type II Diabetes mellitus, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of fourth dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. The third dose of mRNA-1273 was administered 268 days prior to the onset of the event, the initial two doses of mRNA-1273 were given approximately 7 months prior, the interval between the two doses is 28 days. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event was unknown at the time of the report. The patient's medical history of Hypertension and Type II Diabetes mellitus could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-630468 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with medical history of Hypertension and Type II Diabetes mellitus, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of fourth dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. The third dose of mRNA-1273 was administered 268 days prior to the onset of the event, the initial two doses of mRNA-1273 were given approximately 7 months prior, the interval between the two doses is 28 days. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event was unknown at the time of the report. The patient's medical history of Hypertension and Type II Diabetes mellitus could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.