Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Unevaluable event
Clinical narrative: Feeling under the weather; Ringing in my ears; Right leg had a knot in calf muscle that restricted, blood circulation to right foot; Right leg had a knot in calf muscle that restricted blood circulation to right foot; Fever of 100.7 degrees fahrenheit; Feels warm/ skin feels hot; Not being able to sleep/ little sleepy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (Not being able to sleep/ little sleepy), FEELING HOT (Feels warm/ skin feels hot), UNEVALUABLE EVENT (Feeling under the weather), TINNITUS (Ringing in my ears) and NODULE (Right leg had a knot in calf muscle that restricted, blood circulation to right foot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gluten intolerance, Lactose intolerance, Egg allergy, Caffeine allergy, Peanut allergy and Glaucoma (Open ended glaucoma).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INSOMNIA (Not being able to sleep/ little sleepy). On 01-Apr-2021, the patient experienced FEELING HOT (Feels warm/ skin feels hot) and PYREXIA (Fever of 100.7 degrees fahrenheit). On an unknown date, the patient experienced UNEVALUABLE EVENT (Feeling under the weather), TINNITUS (Ringing in my ears), NODULE (Right leg had a knot in calf muscle that restricted, blood circulation to right foot) and POOR PERIPHERAL CIRCULATION (Right leg had a knot in calf muscle that restricted blood circulation to right foot). The patient was treated with TRAZODONE for Difficulty sleeping, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INSOMNIA (Not being able to sleep/ little sleepy) had resolved, FEELING HOT (Feels warm/ skin feels hot) was resolving and UNEVALUABLE EVENT (Feeling under the weather), TINNITUS (Ringing in my ears), NODULE (Right leg had a knot in calf muscle that restricted, blood circulation to right foot), POOR PERIPHERAL CIRCULATION (Right leg had a knot in calf muscle that restricted blood circulation to right foot) and PYREXIA (Fever of 100.7 degrees fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 100.7 (Inconclusive) Fever of 100.7 degrees fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant products included eye drops for open ended glaucoma.   This case was linked to MOD-2021-066546 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Reporter details, medical history, lab details, suspect product details, concomitant medication, treatment information and events were updated. On 18-May-2021: Additional events (Tinnitus, Nodule, poor peripheral circulation) were updated.