Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she got sick; she could not keep her balance; high fever; chills; her joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick), BALANCE DISORDER (she could not keep her balance), PYREXIA (high fever), CHILLS (chills) and ARTHRALGIA (her joints hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 048F21A) for COVID-19 vaccination.     Concomitant products included AMITRIPTYLINE, ATORVASTATIN, CYCLOBENZAPRINE, GABAPENTIN, HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE (KLOR-CON), LEVOTHYROXINE, LISINOPRIL, MELOXICAM, METOPROLOL, PANTOPRAZOLE, PAROXETINE and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced ILLNESS (she got sick) (seriousness criterion medically significant), BALANCE DISORDER (she could not keep her balance) (seriousness criterion medically significant), PYREXIA (high fever) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and ARTHRALGIA (her joints hurt) (seriousness criterion medically significant). At the time of the report, ILLNESS (she got sick), BALANCE DISORDER (she could not keep her balance), PYREXIA (high fever), CHILLS (chills) and ARTHRALGIA (her joints hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns a 68-year-old, female patient with no relevant medical history, who experienced the unexpected events of Illness, balance disorder and expected events of Pyrexia, Chills and Arthralgia. The events occurred 29 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events did not happened after the first dose. The events were considered related to the product per the reporter's assessment. The events of Pyrexia, Chills and Arthralgia are consistent with the current understanding of the mechanism of action of the study medication  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old, female patient with no relevant medical history, who experienced the unexpected events of Illness, balance disorder and expected events of Pyrexia, Chills and Arthralgia. The events occurred 29 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events did not happened after the first dose. The events were considered related to the product per the reporter's assessment. The events of Pyrexia, Chills and Arthralgia are consistent with the current understanding of the mechanism of action of the study medication  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.