Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Respiratory rate, Vaccination site erythema, Vaccination site induration
Clinical narrative: Redness/erythema:local; Feeling hot; Low grade fever; Chills; Hard injection site; Red injection site/hot red injection site; Hot injection site/hot red injection site; Intense "fire/itching" sensation at the lower part of her scalp/Itching/pruritus; Flu-like symptoms; Gastro-intestinal upset - cramping; Diarrhoea; Tender injection site; Fatigue/extreme fatigue; Sore arm/tender injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Gastro-intestinal upset - cramping), DIARRHOEA (Diarrhoea), PRURITUS (Intense "fire/itching" sensation at the lower part of her scalp/Itching/pruritus) and VACCINATION SITE WARMTH (Hot injection site/hot red injection site) in a 66-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.     The patient's past medical history included Hypersensitivity reaction and Hives. Previously administered products included for an unreported indication: FLUZONE HIGH DOSE QUADRIVALENT (Next day fever, flu-like symptoms and injection site inflammation) on 28-Sep-2020. Concurrent medical conditions included Sedation during medical procedure (Extreme low blood pressure, slow to recover from sedation; admitted for 24 hours.) on 01-Mar-1999. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 01-Jan-1995 to an unknown date for Acid reflux (esophageal), SPIRONOLACTONE for Acne, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Gastro-intestinal upset - cramping), DIARRHOEA (Diarrhoea), VACCINATION SITE PAIN (Tender injection site), FATIGUE (Fatigue/extreme fatigue) and VACCINATION SITE PAIN (Sore arm/tender injection site). On 01-Apr-2021, the patient experienced PRURITUS (Intense "fire/itching" sensation at the lower part of her scalp/Itching/pruritus). On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site/hot red injection site), VACCINATION SITE INDURATION (Hard injection site) and VACCINATION SITE ERYTHEMA (Red injection site/hot red injection site). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema:local), FEELING HOT (Feeling hot), PYREXIA (Low grade fever) and CHILLS (Chills). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) (transdermal) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) (oral) from 31-Mar-2021 to 14-Apr-2021 for Pain, at a dose of 200 mg three times a day. On 03-Apr-2021, PRURITUS (Intense "fire/itching" sensation at the lower part of her scalp/Itching/pruritus) had resolved. On 07-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL DISCOMFORT (Gastro-intestinal upset - cramping), DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue/extreme fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot injection site/hot red injection site), VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE ERYTHEMA (Red injection site/hot red injection site) and VACCINATION SITE PAIN (Tender injection site) had not resolved and ERYTHEMA (Redness/erythema:local), FEELING HOT (Feeling hot), VACCINATION SITE PAIN (Sore arm/tender injection site), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Blood pressure measurement: 135/53 mmHg (Inconclusive) 135/53 mmHg. On 04-Jul-2021, Body temperature: 98.7 °F (normal) 98.7 °F. On 04-Jul-2021, Heart rate: 63 (normal) 63 beats per minute. On 04-Jul-2021, Respiratory rate: 14 (normal) 14 breaths per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow-up-Event added. On 04-Aug-2021: NNI FU received