Adverse Event Reporting

VAERS ID 2558390
Gender Female
Age 43
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 3
Vaccinated 2022-01-15
Onset 2022-01-17
Condition
Symptoms
  • Pain in extremity
  • Peripheral swelling
  • Lymphadenopathy
  • Loss of personal independence in daily activities
  • Tenosynovitis
  • Application site swelling

Current Illness

Grass allergy (Allergy to grasses)

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Application site swelling; Lymph node swelling under the armpits; Pain in the left hand little finger; All fingers of the left hand swollen and painful, none left fist possible Right hand too, a little less bad; Inflammation of the arms on both sides, tendonitis little fingers, ring fingers, thumb; Significant impairment of work and sport; This regulatory authority case was reported by a consumer and describes the occurrence of APPLICATION SITE SWELLING (Application site swelling), LYMPHADENOPATHY (Lymph node swelling under the armpits), PAIN IN EXTREMITY (Pain in the left hand little finger), PERIPHERAL SWELLING (All fingers of the left hand swollen and painful, none left fist possible Right hand too, a little less bad), TENOSYNOVITIS (Inflammation of the arms on both sides, tendonitis little fingers, ring fingers, thumb) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Significant impairment of work and sport) in a 43-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis.
Concurrent medical conditions included Grass allergy (Allergy to grasses).
On 15-Jan-2022, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form.
On 17-Jan-2022, the patient experienced APPLICATION SITE SWELLING (Application site swelling) (seriousness criterion medically significant), LYMPHADENOPATHY (Lymph node swelling under the armpits) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in the left hand little finger) (seriousness criterion medically significant), PERIPHERAL SWELLING (All fingers of the left hand swollen and painful, none left fist possible Right hand too, a little less bad) (seriousness criterion medically significant), TENOSYNOVITIS (Inflammation of the arms on both sides, tendonitis little fingers, ring fingers, thumb) (seriousness criterion medically significant) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Significant impairment of work and sport) (seriousness criterion medically significant).
At the time of the report, APPLICATION SITE SWELLING (Application site swelling), LYMPHADENOPATHY (Lymph node swelling under the armpits), PAIN IN EXTREMITY (Pain in the left hand little finger), PERIPHERAL SWELLING (All fingers of the left hand swollen and painful, none left fist possible Right hand too, a little less bad), TENOSYNOVITIS (Inflammation of the arms on both sides, tendonitis little fingers, ring fingers, thumb) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Significant impairment of work and sport) had not resolved.
Concomitant medication was not provided.
Treatment information was not reported.
Due to the temporal context, Causality was considered possible/probable.
The reactions pain in fingers, swelling of fingers and tendovaginitis were not listed in the technical information and the labelling was not considered adequate.
Company comment: This regulatory authority case report concerns a 43-year-old female patient with no relevant medical history, who experienced serious (medically significant) unexpected events of Application site swelling, Lymphadenopathy, Pain in extremity, Peripheral swelling, Tenosynovitis and Loss of personal independence in daily activities.
The events occurred 2 days after the patient had received the mRNA-1273 vaccine (as booster dose).
Reportedly, the patient had swollen lymph nodes, pain in fingers, swelling of fingers, tendovaginitis, activities of daily living impaired and application site swelling.
At the time of this report, all events had resolved and no additional details regarding clinical course of the events were provided.
No further details were available for medical assessment.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Event seriousness was assessed as per Regulatory Authority reporting.