Reporte zur Charge 025A21A/80777-0

Symptomtext

no energy; reaction to second covid shot; extremely fatigued; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A/80777-0273-99 and 025A21A/80777-0273-99) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus since 30-Mar-2019 and Hypercholesterolaemia (much lower LDL and higher HDL) since 11-Jan-2018. Concomitant products included METFORMIN from 30-Mar-2019 to an unknown date and INSULIN from 16-May-2021 to an unknown date for Diabetes, ATORVASTATIN from 11-Jan-2018 to an unknown date for High cholesterol, CALCIUM for an unknown indication. On 05-Mar-2021 at 3:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. On 04-Apr-2021, HYPERSENSITIVITY (reaction to second covid shot), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ASTHENIA (no energy) and FATIGUE (extremely fatigued) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Added the reporter address, patient demographics (Concurrent medical conditions), concomitant medication (Insulin). Added the start date and stop date of the events and updated the outcome of the events (Fatigue, Asthenia) from unknown to recovering and (Pyrexia, Chills) from unknown to recovered. Added one more event Hypersensitivity (Reaction to second covid shot).