Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Tremor
Clinical narrative: Drug ineffective; patient got COVID-19; a little bit of achiness; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (patient got COVID-19), MYALGIA (a little bit of achiness) and DRUG INEFFECTIVE (Drug ineffective) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 026L20A and 030L20A) for COVID-19 vaccination.     The patient had no any allergies (medications, food and other products). The patient had no Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot,route, dose number).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (a little bit of achiness). On 09-Aug-2022, the patient experienced COVID-19 (patient got COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Drug ineffective). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Nov-2021, MYALGIA (a little bit of achiness) had resolved. At the time of the report, COVID-19 (patient got COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not under any concomitant or regular medication.  The adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) no. The patient experienced a similar event in the past sometimes with flu shot and shingles with pneumonia shot she felt really bad. Company comment: This spontaneous case concerns a 68-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 273 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 10 months prior, the interval between the two doses is 28 days. The event Drug ineffective was also noted in this case. It has been reported that the patient experienced muscle pain immediately after administration of third dose, patient took Tylenol and Advil for relief. On the same day of onset of event, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-004180 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 273 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 10 months prior, the interval between the two doses is 28 days. The event Drug ineffective was also noted in this case. It has been reported that the patient experienced muscle pain immediately after administration of third dose, patient took Tylenol and Advil for relief. On the same day of onset of event, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.