Found 6 cases where Age is 12-or-more-and-under-18 and Vaccine is COVID19 and Manufacturer is JANSSEN and Standard-MedDRA-Query broadly-matches 'Anaphylactic reaction'

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Tongue blistering, Tongue pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft hydroxizine
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadryl and 2 epi pens were used and then at the hospital steroids and IV benadryl were utilized. Benadryl was used for the next 24 hours and then steroids were prescribed outpatient

Administered by: Other       Purchased by: ?
Symptoms: Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: not know
Current Illness: not known
Preexisting Conditions: not known
Allergies: not known
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient was given vaccine at Community Outreach event on 04/2/21. Mother was contacted on 4/6/21 concerning incomplete name on her consent. She advised that her son received the covvid vaccine and had gone to the ER on 4/6/21 with a swollen tongue. She stated that he was treated with Tylenol and Benadryl and released to come home that day. Spoke with mom on 4/7/21 and she stated that the patient was stable and his entire tongue was not swollen just a small area. She denied any issues with his airway or breathing from time of vaccine to time of follow up call.

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
Allergies:
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.

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia oral, Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: C/O lips feeling big and numb after receiving Janssen vaccine.

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Painful respiration, Pyrexia, Troponin I increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: An EKG was normal. DATE TIME SPECIMEN TEST VALUE Ref ranges ------------------------------------------------------------------------------- 08/15/2021 03:03 BLOOD TROP-I: 0.098 ng/mL .04 - 1.5 08/15/2021 00:42 BLOOD TROP-I: 0.139 ng/mL .04 - 1.5
CDC Split Type:

Write-up: Patient developed sudden onset fever, feeling of pressure on the chest, worse with inspiration, worse when laying down, better when standing up. The patient was given hyocyamine, famotidine, and tylenol and the fever and pain resolved. Three days later it has not recurred.

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Rash
SMQs:, Anaphylactic reaction (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: KNDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received 2nd Covid Pfizer vaccine 14 days from the 1st vaccine. Father says patient had rash on waist/hip that resolved in around 7 days