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From the 11/19/2021 release of VAERS data:

This is VAERS ID 1716064

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Case Details

VAERS ID: 1716064 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: arm ache; rash all over; fatigue; Rash; This case was received via RA (Reference number: GB-MHRA-ADR 25928466) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm ache), RASH (Rash), RASH (rash all over) and FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm ache) (seriousness criterion medically significant), RASH (rash all over) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (arm ache), RASH (rash all over) and FATIGUE (fatigue) outcome was unknown and RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter. Patient experienced Arm ache, fatigue and painful rash all over her leg. This case concerns a 40-year-old, female subject with no relevant medical history, who experienced the unexpected events of rash (LLT: rash), rash (LLT: rash all over), pain in extremity and fatigue. The event rash (LLT: rash) occurred 1 day after the administration of the first dose. The event start dates of rash (LLT: rash all over), pain in extremity and fatigue were not provided. The rechallenge was not applicable as the events occurred after the first dose. The events rash (LLT: rash), rash (LLT: rash all over) and fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Sender''s Comments: This case concerns a 40-year-old, female subject with no relevant medical history, who experienced the unexpected events of rash (LLT: rash), rash (LLT: rash all over), pain in extremity and fatigue. The event rash (LLT: rash) occurred 1 day after the administration of the first dose. The event start dates of rash (LLT: rash all over), pain in extremity and fatigue were not provided. The rechallenge was not applicable as the events occurred after the first dose. The events rash (LLT: rash), rash (LLT: rash all over) and fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


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