Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth, X-ray dental
Clinical narrative: Shaking; Freezing phenomenon; Stiffness; Wearing off effect; Loss of energy; Headache; Tiredness; Vaccination site warmth; Vaccination site rash; Vaccination site pruritus; vaccination site erythema; Nausea; muscle soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (vaccination site erythema), FATIGUE (Tiredness), MYALGIA (muscle soreness), HEADACHE (Headache), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease.    The patient's past medical history included Skin cancer in 2011, Low blood pressure and Percutaneous endoscopic gastrostomy (PEG tube placement.) on 25-Aug-2017. Concurrent medical conditions included Orthostatic hypotension, Drug allergy (Sulfa allergy manifested by hives.), Epinephrine (Epinephrine allergy manifested by  tachycardiac), Allergy to antibiotic (Ciprofloxacin allergy manifested by hives), Drug allergy (Compazine allergy manifested by lock jaw) and Parkinson's disease. Concomitant products included PREDNISONE, OLANZAPINE (ZYPREXA), FLUVOXAMINE, CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET), LINACLOTIDE (LINZESS), OXYBUTYNIN HYDROCHLORIDE (OXYBUTININ ACCORD), MACROGOL 3350 (MIRALAX) and ALPRAZOLAM for an unknown indication.   On 07-Sep-2017, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 4.63 mg. On 07-Sep-2017, CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) dosage was changed to 20 mg. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and MYALGIA (muscle soreness) (seriousness criterion medically significant). On 26-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (vaccination site erythema) (seriousness criterion medically significant), VACCINATION SITE RASH (Vaccination site rash) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (Vaccination site pruritus) (seriousness criterion medically significant). On 11-Jun-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), TREMOR (Shaking), FREEZING PHENOMENON (Freezing phenomenon), MUSCULOSKELETAL STIFFNESS (Stiffness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and ASTHENIA (Loss of energy). In April 2021, NAUSEA (Nausea) and MYALGIA (muscle soreness) had resolved. In June 2021, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved, VACCINATION SITE RASH (Vaccination site rash) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved and HEADACHE (Headache), TREMOR (Shaking), FREEZING PHENOMENON (Freezing phenomenon), MUSCULOSKELETAL STIFFNESS (Stiffness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and ASTHENIA (Loss of energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, X-ray dental: shadow seen on right side of mandible (abnormal) Shadow seen on right side of mandible suggestive of tumor..     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 WARMTH (Vaccination site warmth), NAUSEA (Nausea), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) to be probably related. No further causality assessments were provided for VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (muscle soreness), HEADACHE (Headache), TREMOR (Shaking), FREEZING PHENOMENON (Freezing phenomenon), MUSCULOSKELETAL STIFFNESS (Stiffness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and ASTHENIA (Loss of energy).    Treatment information was not provided by reporter.   Based on current available information from the reporter and the temporal association between product use and the start date of the events Vaccination site rash, Vaccination site warmth, Vaccination site pruritus, myalgia, fatigue and nausea a causal relationship cannot be excluded. As per reporter other events mentioned in the report occurred prior to product use and are not valid events.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received On 30-Jun-2021: Percutaneous endoscopic gastrostomy and Gastrointestinal tube insertion added as relevant history. Events are added.; Sender's Comments: Based on current available information from the reporter and the temporal association between product use and the start date of the events Vaccination site rash, Vaccination site warmth, Vaccination site pruritus, myalgia, fatigue and nausea a causal relationship cannot be excluded. As per reporter other events mentioned in the report occurred prior to product use and are not valid events.