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From the 11/26/2021 release of VAERS data:

This is VAERS ID 1189473

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Case Details

VAERS ID: 1189473 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Unknown  
Location: Arkansas  
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product administered to patient of inappropriate age, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210411482

Write-up: SWELLING OF TONGUE; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 12 year old of unspecified sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced off label use. On 02-APR-2021, the subject experienced product administered to subject of inappropriate age. On 03-APR-2021, the subject experienced swelling of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of tongue, and the outcome of off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.

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