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From the 10/15/2021 release of VAERS data:

Found 9 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'

Table

   
AgeCountPercent
12-17 Years555.56%
17-44 Years444.44%
TOTAL9100%



Case Details

VAERS ID: 1142350 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-03-23
Onset:2021-03-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / -

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


VAERS ID: 1181828 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-04-02
Onset:2021-04-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

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.


VAERS ID: 1189473 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Unknown  
Location: Arkansas  
Vaccinated:0000-00-00
Onset:2021-04-02
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
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.


VAERS ID: 1300261 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / N/A RA / IM

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.


VAERS ID: 1575637 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Northern Mariana Islands  
Vaccinated:2021-08-13
Onset:2021-08-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / IM

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.


VAERS ID: 1588558 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN EW0217 / 2 LA / IM

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


VAERS ID: 1678544 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Hypersomnia, Irritability, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Does not take medications
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: He started feeling bad around midnight 9/3-9/4/2021, he vomited, tiredness, dizzy, shortness of breath, fever, chills. His mother gave him Tylenol. He slept most of the day. Mom reports he was irritable when he was awake but he slept most of the day. Started feeling better around lunchtime on Sunday, 9/5/2021.


VAERS ID: 1671102 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Hypotension
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (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:
CDC Split Type: DEJNJFOC20210906366

Write-up: CIRCULATORY COLLAPSE; HYPOTENSION; This spontaneous report received from consumer a via Regulatory Authority (DE-PEI-202100177343) on 01-SEP-2021 and concerned a 17 year old of unspecified sex of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE395 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced circulatory collapse and hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the circulatory collapse and hypotension was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: RR: 110/70 HF: 68


VAERS ID: 1697827 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Dry eye, Dyspnoea, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210918408

Write-up: DRY EYES; ABDOMINAL CRAMPS; CHILLS; PAIN IN ARM; PYREXIA; DYSPNOEA; This spontaneous report received from a consumer by a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021154729) on 08-SEP-2021 and concerned a 17 year old male of unspecified race and ethnic origin. The patient''s weight was 108 kilograms, and height was 188 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Lot XE395 expiry: Unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced dyspnoea, abdominal cramps, chills, pain in arm and pyrexia. On 03-AUG-2021, patient experienced dry eyes. On an unspecified date, the patient was hospitalized. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dyspnoea, chills, pain in arm, abdominal cramps, and pyrexia, and had not recovered from dry eyes. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: Are you or the affected person aware of any allergies? If yes, which? Pollen, Hay Indications regarding risk factors or underlying conditions None that I am aware of / Arm was hurting, I went home all was good, a little tired I laid myself in bed I was hot getting out from under the covers ice-cold Eyes after 8 hours dry and somewhat painful cramping during respiration when in inhale deeply Fever that has subsided but all the rest is still present


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https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&SYMPTOMSSMQ=21&VAX=COVID19&VAXMAN=JANSSEN&WhichAge=range&LOWAGE=12&HIGHAGE=18

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