Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Loose stools; difficulty breathing; congestion; dry cough; dark red,itchy, rash at injection site; injection site that was hard and painful; dark red,itchy, rash at injection site; shivers (chills); dark red,itchy, rash at injection site; injection site that was hard and painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough) and VACCINATION SITE RASH (dark red,itchy, rash at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (took nasal spray) since 2000, Hypertension (High Blood Pressure) since 2004, Hyperthyroidism, Arthritis, Heartburn and Obesity. Concomitant products included NAPROXEN for Arthritis, OMEPRAZOLE for Heartburn, LOSARTAN for Hypertension, LEVOTHYROXINE for Hyperthyroidism, LORATADINE (CLARITINE) for Seasonal allergy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 12-Feb-2021, DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache) to be possibly related.    Treatment medications included allergy nasal spray.   This case was linked to MOD-2021-169064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Reporter contact details updated. On 25-May-2021: No new information reported On 27-Jul-2021: Significant follow up appended. patient demography added. Medical history high blood pressure, Arthritis ,heartburn and seasonal allergy added. Concomitant medication Losartan, levothyroxine, omeprazole, naproxen, claritine added. outcome of events recovered/resolved added.