Adverse Event Reporting

VAERS ID 2295497
Gender Female
Age 47
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 1
Vaccinated
Onset
Condition Recovered
Symptoms
  • Fatigue
  • Throat tightness
  • Somnolence
  • Oedema peripheral
  • Oxygen saturation decreased

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: Animal protein allergy; Depressive syndrome; Drug allergy (Opioid Allergy); Fibromyalgia (Fibromyalgia followed by EC Rheumatology); Food allergy (Numerous food allergens (citrus, apricot, nuts, spices, sulfites...)); Vaginal neoplasm (Vaginal neoplasia (performed radiotherapy with resolution))

Other Medications

KESTINE; FURADANTINA MC; TRAZODONA [TRAZODONE HYDROCHLORIDE]; PREGABALINA; ZOLPIDEM; TRANXENE; AERIUS [DESLORATADINE]; DULOXETINA [DULOXETINE HYDROCHLORIDE]; PROPRANOLOL

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Low O2 saturations; Lower limb edema; "feeling of tightness in the throat"; Prostration; sleepiness; This case was received via Regulatory Authority (Reference number: PT-INFARMED-B202205-200) on 23-May-2022 and was forwarded to Moderna on 23-May-2022.
This regulatory authority case was reported by a physician and describes the occurrence of OXYGEN SATURATION DECREASED (Low O2 saturations), OEDEMA PERIPHERAL (Lower limb edema), THROAT TIGHTNESS ("feeling of tightness in the throat"), FATIGUE (Prostration) and SOMNOLENCE (sleepiness) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
214006) for COVID-19 vaccination.
Concurrent medical conditions included Fibromyalgia (Fibromyalgia followed by EC Rheumatology), Animal protein allergy, Food allergy (Numerous food allergens (citrus, apricot, nuts, spices, sulfites.
.
.
)), Depressive syndrome, Vaginal neoplasm (Vaginal neoplasia (performed radiotherapy with resolution)) and Drug allergy (Opioid Allergy).
Concomitant products included EBASTINE (KESTINE) for COVID-19 vaccination, NITROFURANTOIN (FURADANTINA MC), TRAZODONE HYDROCHLORIDE (TRAZODONA [TRAZODONE HYDROCHLORIDE]), PREGABALINA, ZOLPIDEM, CLORAZEPATE DIPOTASSIUM (TRANXENE), DESLORATADINE (AERIUS [DESLORATADINE]), DULOXETINE HYDROCHLORIDE (DULOXETINA [DULOXETINE HYDROCHLORIDE]) and PROPRANOLOL for an unknown indication.
In 2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .
5 milliliter.
On 12-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .
5 milliliter.
On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low O2 saturations) (seriousness criterion medically significant), OEDEMA PERIPHERAL (Lower limb edema) (seriousness criterion medically significant), THROAT TIGHTNESS ("feeling of tightness in the throat") (seriousness criterion medically significant), FATIGUE (Prostration) (seriousness criterion medically significant) and SOMNOLENCE (sleepiness) (seriousness criterion medically significant).
At the time of the report, OXYGEN SATURATION DECREASED (Low O2 saturations), OEDEMA PERIPHERAL (Lower limb edema), THROAT TIGHTNESS ("feeling of tightness in the throat"), FATIGUE (Prostration) and SOMNOLENCE (sleepiness) had resolved.
For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.
No treatment medications were reported.
Company comment: This regulatory case concerns a 47-year-old female patient, with reported concurrent medical conditions of Fibromyalgia, Animal Protein allergy, Food allergy, Depressive syndrome, and Vaginal neoplasm, who experienced unexpected, serious (medically significant) events of Oxygen saturation decreased, Oedema peripheral, Throat tightness, Fatigue, and Somnolence, unspecified days after receiving mRNA-1273 vaccine as a second dose.
Clinical course and treatment details are not available in this report.
The events had resolved.
The patient concurrent medical conditions of Animal Protein allergy and Food allergy could be confounders for the event Oxygen saturation decreased and Throat tightness while the patient's Fibromyalgia, Depressive syndrome and Vaginal neoplasm could be risk factors for the events Fatigue and Somnolence.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness was assessed as per Regulatory Authority's report; Sender's Comments: This regulatory case concerns a 47-year-old female patient, with reported concurrent medical conditions of Fibromyalgia, Animal Protein allergy, Food allergy, Depressive syndrome, and Vaginal neoplasm, who experienced unexpected, serious (medically significant) events of Oxygen saturation decreased, Oedema peripheral, Throat tightness, Fatigue, and Somnolence, unspecified days after receiving mRNA-1273 vaccine as a second dose.
Clinical course and treatment details are not available in this report.
The events had resolved.
The patient concurrent medical conditions of Animal Protein allergy and Food allergy could be confounders for the event Oxygen saturation decreased and Throat tightness while the patient's Fibromyalgia, Depressive syndrome and Vaginal neoplasm could be risk factors for the events Fatigue and Somnolence.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness was assessed as per Regulatory Authority's report