Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
almost unable to work, and was looking at a job as well as farming; she couldn't lift anything anymore and had to practically crawl to get to the barn; she was tired all the time/had constant fatigue; Therapeutic response unexpected; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) (seriousness criterion disability), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn), FATIGUE (she was tired all the time/had constant fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected). At the time of the report, IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn) and FATIGUE (she was tired all the time/had constant fatigue) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected) outcome was unknown. No concomitant medications were reported. The patient was a farmer, and it was hard for her to do anything after that, she couldn't lift anything anymore and had to practically crawl to get to the barn, she could previously pick up a 50-pound bale of hay or 50-pound bag of grain, but now she was tired all the time and had constant fatigue. For the whole winter the patient was almost unable to work, and was looking at a job as well as farming, so it was really, really hard for her. Almost immediately she improved and was back to almost normal. No treatment medications were reported.; Reporter's Comments: The events were assessed as not related to the vaccine due to the absence of temporal relationship; they occurred before mRNA-1273 doses; only therapeutic response unexpected occurred after moderna vaccine. The benefit -risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: COVID-19