Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: shortness of breath; headache; Tested positive after first vaccination; Cough/ dry cough; Flu like symptoms; diarrhea; body aches; Low grade Fever after first vaccination; fatigue; chills; Sore arm  after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough/ dry cough), COVID-19 (Tested positive after first vaccination), DIARRHOEA (diarrhea) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Asthma since 2000, Latex allergy and Sulfonamide allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma, LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD.    On 03-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (diarrhea), MYALGIA (body aches), PYREXIA (Low grade Fever after first vaccination), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm  after first vaccination). On 04-Jan-2021, the patient experienced COUGH (Cough/ dry cough). On 05-Jan-2021, the patient experienced COVID-19 (Tested positive after first vaccination). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). On 15-Jan-2021, COUGH (Cough/ dry cough) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (Tested positive after first vaccination), DIARRHOEA (diarrhea), MYALGIA (body aches), PYREXIA (Low grade Fever after first vaccination), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PAIN (Sore arm  after first vaccination), DYSPNOEA (shortness of breath) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: Positive.         Treatment medications included tylenol and zithromax 500 mg/1st day and 250 mg Day 2-5 orally for COVID-19 infection from 05-JAN-2021 to 08-JAN-2021. It was reported that patient isolated for 10 days.   This case was linked to MOD-2021-065029 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: adverse events have been added, treatment drug for Covid-19 infection updated, dose 2 information provided, allergies updated; Sender's Comments: Covid-19 in this patient is unlikely to be due to Moderna's mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.