Adverse Event Reporting

VAERS ID 2559216
Gender Female
Age 36
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 1
Vaccinated 2021-06-02
Onset 2021-09-21
Condition
Symptoms
  • Chronic fatigue syndrome

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

chronic fatigue syndrome; This regulatory authority case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (chronic fatigue syndrome) in a 36-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis.
No Medical History information was reported.
On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) .
5 milliliter.
On 30-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form.
On 21-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced CHRONIC FATIGUE SYNDROME (chronic fatigue syndrome) (seriousness criterion medically significant).
At the time of the report, CHRONIC FATIGUE SYNDROME (chronic fatigue syndrome) had not resolved.
No concomitant medication was reported.
The patient did not experience any side effects after the first vaccination.
On/the 30.
06.
2021, the patient received the second vaccination with Spikevax.
In the first 12 hours, the patient was asymptomatic.
In the 12-60 hours after vaccination, the patient experienced severe joint and joint headaches, sweats, headaches, and severe Dizziness.
The patient could only travel from bed to bathroom on all fours.
The patient also developed loss of appetite and comatose sleep.
The patient reported that she barely remembers the events.
After about 5 days, there came to Recovery and the patient was able to go back to work.
From 21.
09.
2021, the patient contracted whistling glandular fever with sweats, headache, severe Dizziness, loss of appetite and comatose sleep.
So far, the patient has not been able to fully recover from the EBV infection.
It remains unclear whether whistling glandular fever was a primary EBV infection or a reactivation.
Since the whistling glandular fever, the patient had a chronic state of fatigue with severe headache, occasional sore throat, pronounced tendency to sweat, difficulty concentrating and elevated body temperature, as well as thermoregulation disorders.
The patient also experienced post-exertional malaise.
The diagnosis of chronic fatigue syndrome was made.
Post-vac syndrome was also postulated if there was a time relationship between the COVID vaccination and the Occurrence of the first symptoms.
Prior to the onset of the symptoms, the patient had been a very athletic person and had done sports daily.
The patient was not known of any allergies or food intolerances.
No treatment medication was not reported.
Company Comment: This is a regulatory case concerning a 36 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Chronic fatigue syndrome, which occurred 2 months 22 days after the second dose of mRNA-1273 vaccine.
The patient reported that 12-60 hours after vaccination, she developed severe joint pain, sweats, headaches, severe Dizziness, loss of appetite and comatose sleep.
After about 5 days, she was Recovered and was able to go back to work.
Approximately 2 months and 20 days after vaccination, the patient contracted whistling glandular fever with sweats, headache, severe Dizziness, loss of appetite and comatose sleep.
So far, the patient has not been able to fully recover from the EBV infection.
It remains unclear whether whistling glandular fever was a primary EBV infection or a reactivation.
Since the whistling glandular fever, the patient had a chronic state of fatigue with severe headache, occasional sore throat, pronounced tendency to sweat, difficulty concentrating and elevated body temperature, as well as thermoregulation disorders.
The patient also experienced post-exertional malaise.
The diagnosis of chronic fatigue syndrome was made.
Post-vac syndrome was also postulated due to time relationship between the COVID vaccination and the Occurrence of the first symptoms.
The outcome was reported as not recovered.
The company causality for the event is considered as related to the vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: Company Comment: This is a regulatory case concerning a 36 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Chronic fatigue syndrome, which occurred 2 months 22 days after the second dose of mRNA-1273 vaccine.
The patient reported that 12-60 hours after vaccination, she developed severe joint pain, sweats, headaches, severe Dizziness, loss of appetite and comatose sleep.
After about 5 days, she was Recovered and was able to go back to work.
Approximately 2 months and 20 days after vaccination, the patient contracted whistling glandular fever with sweats, headache, severe Dizziness, loss of appetite and comatose sleep.
So far, the patient has not been able to fully recover from the EBV infection.
It remains unclear whether whistling glandular fever was a primary EBV infection or a reactivation.
Since the whistling glandular fever, the patient had a chronic state of fatigue with severe headache, occasional sore throat, pronounced tendency to sweat, difficulty concentrating and elevated body temperature, as well as thermoregulation disorders.
The patient also experienced post-exertional malaise.
The diagnosis of chronic fatigue syndrome was made.
Post-vac syndrome was also postulated due to time relationship between the COVID vaccination and the Occurrence of the first symptoms.
The outcome was reported as not recovered.
The company causality for the event is considered as related to the vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.