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This is VAERS ID 1736339

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First Appeared on 10/15/2021

VAERS ID: 1736339
VAERS Form:2
Age:37.0
Sex:Female
Location:Foreign
Vaccinated:2021-09-10
Onset:2021-09-10
Submitted:0000-00-00
Entered:2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Dizziness, Low density lipoprotein increased, Lymphadenopathy, Pain in extremity, Somnolence, Peripheral swelling, Type IV hypersensitivity reaction, SARS-CoV-2 test

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC 'Split Type': GBMODERNATX, INC.MOD20213

Write-up: Delayed type hypersensitivity; Large arm swelling; Swollen lymph nodes; Dizziness; LDL cholesterol increased; Pain in arm; Sleepiness; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25949925) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), SOMNOLENCE (Sleepiness), PERIPHERAL SWELLING (Large arm swelling), PAIN IN EXTREMITY (Pain in arm), LYMPHADENOPATHY (Swollen lymph nodes), LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced SOMNOLENCE (Sleepiness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity) (seriousness criterion medically significant), PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), PERIPHERAL SWELLING (Large arm swelling), PAIN IN EXTREMITY (Pain in arm), LYMPHADENOPATHY (Swollen lymph nodes), LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) and DIZZINESS (Dizziness) had not resolved and SOMNOLENCE (Sleepiness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No relevant concomitant medications were reported. Company Comment : This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected events of sleepiness, pain in arm, delayed type IV hypersensitivity reaction, pheripheral swelling, lymphadenopathy and dizziness. The events occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected events of sleepiness, pain in arm, delayed type IV hypersensitivity reaction, pheripheral swelling, lymphadenopathy and dizziness. The events occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.

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