Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Injection site pain, Injection site rash, Lymphadenopathy, Myalgia
Clinical narrative: Redness; Circular rash with a pinpoint raised pustule; Slight pruritis at location of rash; Soreness near the vaccination site; Rash in the vaccine area; Headache; Body chills; Fever 100.4° F; Mild soreness; Nausea; Adenopathy,lymphadenopathy on L axillary and cervical lymph nodes; Moderate fatigue; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness), RASH PRURITIC (Slight pruritis at location of rash), RASH PUSTULAR (Circular rash with a pinpoint raised pustule), LYMPHADENOPATHY (Adenopathy,lymphadenopathy on L axillary and cervical lymph nodes) and INJECTION SITE PAIN (Soreness near the vaccination site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026LZ0A and 013L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endometriosis on 20-Dec-2018, Latex allergy (Painful and itchy rash on bilateral upper and lower extremities) in 2007, Hives and Hypersensitivity. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) from 25-Jan-2019 to an unknown date for Endometriosis.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced LYMPHADENOPATHY (Adenopathy,lymphadenopathy on L axillary and cervical lymph nodes), MYALGIA (Mild soreness), NAUSEA (Nausea), CHILLS (Body chills) and PYREXIA (Fever 100.4° F). On 01-Jan-2021, the patient experienced HEADACHE (Headache). On 04-Jan-2021, the patient experienced RASH PRURITIC (Slight pruritis at location of rash), INJECTION SITE PAIN (Soreness near the vaccination site) and INJECTION SITE RASH (Rash in the vaccine area). On an unknown date, the patient experienced ERYTHEMA (Redness), RASH PUSTULAR (Circular rash with a pinpoint raised pustule) and FATIGUE (Moderate fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Headache, at a dose of 500 mg once; HYDROCORTISONE (topical) from 06-Jan-2021 to 09-Jan-2021 at a dose of 1 dosage form once a day and LORATADINE (CLARITIN [LORATADINE]) (oral) 06-Jan-2021 at a dose of 1 dosage form once a day. On 29-Dec-2020, NAUSEA (Nausea) had resolved. On 02-Jan-2021, HEADACHE (Headache) had resolved. On 05-Jan-2021, LYMPHADENOPATHY (Adenopathy,lymphadenopathy on L axillary and cervical lymph nodes) had resolved. On 05-Jan-2021 at 1:50 PM, PYREXIA (Fever 100.4° F) outcome was unknown. On 09-Jan-2021, ERYTHEMA (Redness), RASH PRURITIC (Slight pruritis at location of rash), RASH PUSTULAR (Circular rash with a pinpoint raised pustule) and INJECTION SITE RASH (Rash in the vaccine area) had resolved, INJECTION SITE PAIN (Soreness near the vaccination site) had not resolved. At the time of the report, MYALGIA (Mild soreness), CHILLS (Body chills) and FATIGUE (Moderate fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Pyrexia: 100.4 f (High) 100.4 F. On 05-Jan-2021, Blood pressure measurement: 146/84 mmHg (Inconclusive) at 13:50. On 05-Jan-2021, Heart rate: 105 (Inconclusive) at 13:50. On 05-Jan-2021, Pyrexia: 97.4 f (Inconclusive) at 13:50.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (Redness), RASH PRURITIC (Slight pruritis at location of rash), RASH PUSTULAR (Circular rash with a pinpoint raised pustule), LYMPHADENOPATHY (Adenopathy,lymphadenopathy on L axillary and cervical lymph nodes), INJECTION SITE PAIN (Soreness near the vaccination site) and INJECTION SITE RASH (Rash in the vaccine area) to be probably related. No further causality assessments were provided for MYALGIA (Mild soreness), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Body chills), PYREXIA (Fever 100.4° F) and FATIGUE (Moderate fatigue).    This case was linked to MOD-2021-237259 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Added medical history, treatment medication start/stop dates, causality updated, rash event terms stop dates provided and outcomes updated.