Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fibromyalgia, Head discomfort, Illness
Clinical narrative: fibromyalgia symptoms; unable to pick her head up; make her much more sick than the previous doses; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (fibromyalgia symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Drug allergy (Compazine), Drug allergy (mesalamine), Drug allergy (Statin drugs) and Sickness.   In April 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (fibromyalgia symptoms) (seriousness criterion medically significant), HEAD DISCOMFORT (unable to pick her head up), ILLNESS (make her much more sick than the previous doses) and DIARRHOEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (fibromyalgia symptoms), HEAD DISCOMFORT (unable to pick her head up), ILLNESS (make her much more sick than the previous doses) and DIARRHOEA (diarrhea) had resolved.            The patient had received a lot of concomitant medications for fibromyalgia. Events asthenia, lethargy, fatigue, myalgia, chills subsumed under the event fibromyalgia Following vaccination with the 1st booster of the vaccine patient experienced the following, which lasted for weeks: worse than the previous doses, unable to pick her head up, like paralysis. It was reported that a lot of the symptoms she experienced were a lot like fibromyalgia symptoms, chills fatigue muscle hurt. The patient was concerned about receiving the new booster. The health care professional told her to get the bivalent booster anyways.  The patient never had COVID-19 positive test or diagnosis. The patient had not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine The patient experienced similar symptoms in the past when she received the shingles vaccine, both times for a couple of days.  Company comment: This spontaneous case concerns unspecified age female patient, with Concurrent medical conditions included Fibromyalgia, who experienced the unexpected serious (medically significant) AESI event of fibromyalgia, which occurred unspecified days after first booster of mRNA-1273. After vaccination patient experienced which worse than previous dose, make patient much more sick than previous doses, feeling very weak, diarrhea, chills, lethargic, unable to pick her head up, like paralysis. Patient got treated with paracetamol. Concurrent medical conditions included Fibromyalgia is confounding for the event. At the time of reporting event was resolved. The benefit-risk relationship of mRNA-1273.214 vaccine is not affected by this report.   This case was linked to MOD-2022-653602, MOD-2022-653655 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns unspecified age female patient, with Concurrent medical conditions included Fibromyalgia, who experienced the unexpected serious (medically significant) AESI event of fibromyalgia, which occurred unspecified days after first booster of mRNA-1273. After vaccination patient experienced which worse than previous dose, make patient much more sick than previous doses, feeling very weak, diarrhea, chills, lethargic, unable to pick her head up, like paralysis. Patient got treated with paracetamol. Concurrent medical conditions included Fibromyalgia is confounding for the event. At the time of reporting event was resolved. The benefit-risk relationship of mRNA-1273.214 vaccine is not affected by this report.