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This is VAERS ID 1709547

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First Appeared on 9/24/2021

VAERS ID: 1709547
VAERS Form:2
Age:15.0
Sex:Female
Location:Foreign
Vaccinated:2021-08-19
Onset:2021-08-20
Submitted:0000-00-00
Entered:2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Anosmia, Cough, Headache, Nasal congestion, Nasopharyngitis, Neck pain, Pyrexia, Impaired work ability, Oropharyngeal pain, Vaccination site pain

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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:
CDC 'Split Type': FIMODERNATX, INC.MOD20213

Write-up: Neck pain; Pyrexia; Headache; Vaccination site pain; Cough; Common cold; Nasal stuffiness; Anosmia; Impaired work ability; Throat pain; This case was received via Medicines Agency (Reference number: FI-FIMEA-20214380) on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), PYREXIA (Pyrexia), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), COUGH (Cough), NASOPHARYNGITIS (Common cold), NASAL CONGESTION (Nasal stuffiness), ANOSMIA (Anosmia), IMPAIRED WORK ABILITY (Impaired work ability) and OROPHARYNGEAL PAIN (Throat pain) in a 15-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion disability), PYREXIA (Pyrexia) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion disability), COUGH (Cough) (seriousness criterion disability), NASOPHARYNGITIS (Common cold) (seriousness criterion disability), NASAL CONGESTION (Nasal stuffiness) (seriousness criterion disability), ANOSMIA (Anosmia) (seriousness criterion disability), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criterion disability) and OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion disability). At the time of the report, NECK PAIN (Neck pain), PYREXIA (Pyrexia), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), COUGH (Cough), NASOPHARYNGITIS (Common cold), NASAL CONGESTION (Nasal stuffiness), ANOSMIA (Anosmia), IMPAIRED WORK ABILITY (Impaired work ability) and OROPHARYNGEAL PAIN (Throat pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment product information was not provided. Company Comment: This case concerns a 15 year-old, female subject with no reported medical history, who experienced the unexpected events of neck pain, pyrexia, headache, vaccination site pain, cough, nasopharyngitis, nasal congestion, anosmia, impaired work ability, oropharyngeal pain. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the events occurred after the first dose. The events pyrexia, headache and vaccination site pain are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 15 year-old, female subject with no reported medical history, who experienced the unexpected events of neck pain, pyrexia, headache, vaccination site pain, cough, nasopharyngitis, nasal congestion, anosmia, impaired work ability, oropharyngeal pain. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the events occurred after the first dose. The events pyrexia, headache and vaccination site pain are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.

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