Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: mild shortness of breath; really bad cold; diarrhea; high temp about 99.5; chills for 6 hours; severe headache immediately after the shot for 5 hours, mild headache for about 40 hours; muscle aches; nausea; soreness; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (mild shortness of breath), NASOPHARYNGITIS (really bad cold), DIARRHOEA (diarrhea), PYREXIA (high temp about 99.5) and CHILLS (chills for 6 hours) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced DYSPNOEA (mild shortness of breath), NASOPHARYNGITIS (really bad cold), DIARRHOEA (diarrhea), PYREXIA (high temp about 99.5), CHILLS (chills for 6 hours), HEADACHE (severe headache immediately after the shot for 5 hours, mild headache for about 40 hours), MYALGIA (muscle aches), NAUSEA (nausea), ARTHRALGIA (soreness) and INJECTION SITE PAIN (Pain in injection site). On 24-Dec-2020, DYSPNOEA (mild shortness of breath), NASOPHARYNGITIS (really bad cold), DIARRHOEA (diarrhea), PYREXIA (high temp about 99.5), CHILLS (chills for 6 hours), HEADACHE (severe headache immediately after the shot for 5 hours, mild headache for about 40 hours), MYALGIA (muscle aches), NAUSEA (nausea), ARTHRALGIA (soreness) and INJECTION SITE PAIN (Pain in injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Following vaccine administration, per her report, she experienced an elevated temperature of 99.5, a really bad cold and chills for six hours.  She reported a severe headache immediately following the injection that lasted for about 5 hours followed by a mild headache lasting approximately 40 hours.  Additionally, she reported experiencing muscle aches, mild shortness of breath, nausea and diarrhea, soreness and pain at the injection site.  She admitted taking paracetamol which she stated did not help very much.  Patient stated that her symptoms resolved two days after vaccine administration.   Treatment for the event included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No new information was provided.; Reporter's Comments: This case concerns a 60-year-old female who had NS unexpected events of nasopharyngitis, dyspnea, diarrhea, and NS expected events of injection site pain, pyrexia, chills, headache, myalgia, arthralgia and nausea. Event onset the same day as the first dose of mRNA-1273. Treatment with paracetamol. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.