Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: COVID-19 virus test positive; Headache; Myalgia; Vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19), MYALGIA (body ache, aching), HEADACHE (headache) and VACCINATION SITE PAIN (arm hurt at the time of the injection/ right arm was very sore, tender over deltoid, felt heavy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02J20A) for COVID-19 vaccination.  No medical history was provided by the reporter. The patient's past medical history included Hypertension in 1997, Hypothyroidism in 1995, Hyperlipidemia in 1995, GERD in 2015 and Depression in 2002. Concomitant products included LORATADINE for Allergy, SERTRALINE for Depression, OMEPRAZOLE for GERD, ACYCLOVIR [ACICLOVIR] for HSV infection, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CELECOXIB (CELEBREX) for Osteoarthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (BABY ASPIRIN), FOLIC ACID, SIMVASTATIN, ESTROGENS CONJUGATED (PREMARIN), EZETIMIBE (ZETIA), VITAMINS NOS, ASCORBIC ACID (VIT C) and TOCOPHEROL (VIT E [TOCOPHEROL]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (arm hurt at the time of the injection/ right arm was very sore, tender over deltoid, felt heavy). On 01-Jan-2021, the patient experienced MYALGIA (body ache, aching) and HEADACHE (headache). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; TETANUS VACCINE at an unspecified dose and frequency; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (CORICIDIN HBP CHEST CONGESTION & COUGH) at an unspecified dose and frequency. On 04-Jan-2021, HEADACHE (headache) had resolved. On 08-Jan-2021, MYALGIA (body ache, aching) had resolved. On 30-Jan-2021, VACCINATION SITE PAIN (arm hurt at the time of the injection/ right arm was very sore, tender over deltoid, felt heavy) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (arm hurt at the time of the injection/ right arm was very sore, tender over deltoid, felt heavy) to be related. No further causality assessments were provided for SARS-COV-2 TEST POSITIVE (covid-19), MYALGIA (body ache, aching) and HEADACHE (headache).  This case was linked to MOD-2021-085204 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Additional information received On 11-Jun-2021: Follow-up received contains NNI  Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19 test positive. The event of COVID-19 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.