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From the 1/7/2022 release of VAERS data:

Found 265 cases where Age is under-19 and Vaccine is COVID19 and Manufacturer is PFIZER/BIONTECH and Patient Did Not Die and Hospitalized and Vaccination Date from '2021-07-01' to '2021-07-31'

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Case Details

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VAERS ID: 1502624 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Diagnostic procedure, Echocardiogram, Electrocardiogram, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
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: Medical History/Concurrent Conditions: Croup (Croup symptoms in 1st year of life after vaccination); Vaccination complication (Croup symptoms in 1st year of life after vaccination)
Allergies:
Diagnostic Lab Data: Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:excluded: coronary heart disease; Comments: excluded: coronary heart disease, parainfectious (mi.) myocardial infarction Croup symptoms in 1st year of life after vaccination; Test Name: ECG; Result Unstructured Data: Test Result:excluded: coronary heart disease; Comments: excluded: coronary heart disease, parainfectious (mi.) myocardial infarction Croup symptoms in 1st year of life after vaccination; Test Name: coronary angiography; Result Unstructured Data: Test Result:excluded: coronary heart disease; Comments: excluded: coronary heart disease, parainfectious (mi.) myocardial infarction; Test Name: Clinical examination; Result Unstructured Data: Test Result:excluded: coronary heart disease; Comments: excluded: coronary heart disease, parainfectious (mi.) myocardial infarction
CDC Split Type: DEPFIZER INC2021873872

Write-up: Myocarditis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number DE-PEI-202100127743. This spontaneous report was received from a Physician and concerns a 17-year-old male patient who received his second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FE6975) via an unspecified route of administration on 02Jul2021 (at the age of 17-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient medical history included vaccination complication and Croup symptoms in 1st year of life after vaccination, croup infectious from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received his first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 21May2021 as dose 1, 0.3 ml single for COVID-19 immunisation with no adverse effect. On 05Jul2021, the patient experienced myocarditis. This report is serious - hospitalization, life threatening. The patient underwent lab tests which showed angio cardiogram, diagnostic procedure, echocardiogram and electrocardiogram all with results: excluded: coronary heart disease, excluded: coronary heart disease, parainfectious (mi) myocardial infarction. Croup symptoms in 1st year of life after vaccination. Outcome of the event was not resolved. Result of assessment: Comirnaty/ event(s): Myocarditis/ Agency: D. unclassifiable. No follow-up attempts possible. No further information expected.


VAERS ID: 1503090 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874095

Write-up: Vomiting; Hypotension; nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [FR-AFSSAPS-2021088033], Safety Report Unique Identifier [FR-AFSSAPS-BX20216458]. A 17-years-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: FE2296), via an intramuscular route on 02Jul2021 (at the age of 17-years) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have COVID history. On 02Jul2021 (15 minutes after vaccination), the patient experienced nausea, vomiting, arterial hypotension. The patient had 3 hours of hospitalization. The clinical outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1506854 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac function test, Coma scale, Generalised tonic-clonic seizure, Heart rate, Neurological examination, Oxygen saturation, Presyncope, Pulmonary function test
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: blood pressure; Result Unstructured Data: Test Result:14/6; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:afebrile; Test Date: 20210703; Test Name: Cardio; Result Unstructured Data: Test Result:Regular heart sounds, absence of murmurs; Test Date: 20210703; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15; Test Date: 20210703; Test Name: heart rate; Result Unstructured Data: Test Result:90 bpm; Test Date: 20210703; Test Name: Neuro; Result Unstructured Data: Test Result:no sensory-motor disorder,; Comments: symmetrical pupils, no vertigo; Test Date: 20210703; Test Name: Saturation; Test Result: 100 %; Comments: in ambient air; Test Date: 20210703; Test Name: Pneumological; Result Unstructured Data: Test Result:bilateral vesicular murmur
CDC Split Type: FRPFIZER INC2021882957

Write-up: Vagal reaction; tonic-clonic convulsive seizure; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021088549. A 12-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FE7010), intramuscular in Right Arm on 03Jul2021 (at 12 years) as single dose for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. On 03Jul2021 the patient experienced vagal reaction. Five minutes after the injection on 03Jul2021, onset of a tonic-clonic convulsive seizure. Medical observations from the Emergency Room and the child was treated at the Emergency Room on 03July2021 at 7:54 pm. The patient was hospitalized from 03Jul2021 to 03Jul2021 due to the event. Clinical course was also described as follows: five to ten minutes after the injection of the vaccine, malaise. Fast recovery.The child was seated and lost consciousness. He started off with podrome type headaches.No chest pain, no palpitations.No tongue biting, no urine loss.No vertigo.The child was stressed before the vaccination.Lab tests done on 03Jul2021 included blood pressure 14/6, heart rate 90bpm; afebrile; saturation 100% in ambient air; cardio showed regular heart sounds, absence of murmurs; Pneumological: bilateral vesicular murmur.Neuro: Glasgow Coma Scale 15, no sensory-motor disorder, symmetrical pupils, no vertigo. On 03Jul2021 at 11 p.m spontaneous clinical improvement after having stayed at Emergency Room. Vagal discomfort occurring within 5-10 minutes after 1st dose of the vaccine in a child aged 12 years and 9 months with no medical or allergic history.Good recovery after going to Emergency Room and re-insurance. Conclusion : vagal discomfort and return home. Outcome of the event was recovered on 03Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1507616 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Cold sweat, Dizziness, Heart rate, Hypoaesthesia, Malaise, Nausea, Oxygen saturation, Pruritus, Respiratory rate, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Medical History/Concurrent Conditions: Peanut allergy (Serious allergic reaction with breathing difficulties, swelling of throat and rash.)
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: Blood pressure; Result Unstructured Data: Test Result:103/65 mmHg; Test Date: 20210707; Test Name: Blood pressure; Result Unstructured Data: Test Result:126/81 mmHg; Test Date: 20210707; Test Name: Pulse rate; Result Unstructured Data: Test Result:80-104 beats/min; Test Date: 20210707; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210707; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16-20 breaths/min
CDC Split Type: NOPFIZER INC2021883289

Write-up: cold and clammy; numbness of the right leg; itchy throat; Anaphylaxis; generalized itching; feeling unwell; dizziness; nausea; This is a spontaneous report from a contactable physician downloaded from the WEB NO-NOMAADVRE-FHI-2021-Uj7wym. An 18-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 07Jul2021 14:34 (Lot Number: FC5029, at the age of 18-year-old) as single dose for COVID-19 immunisation. Medical history included peanut allergy (Serious allergic reaction with breathing difficulties, swelling of throat and rash). Concomitant medication was not reported. Patient experienced anaphylaxis, generalized itching (starting in both arms and spreading), feeling unwell, dizziness and nausea at 10 minutes after the first dose of COVID-19 vaccine Comirnaty (on 07Jul2021 14:44). The patient was given 20 mg of prednisolone, with no sign of recovery and itchy throat, numbness of the right leg (on 08Jul2021). The patient was cold and clammy (on 08Jul2021) and was given 0.5 mg of epinephrine and hospitalized. The patient underwent lab tests and procedures which included Blood pressure: 103/65 mmhg, 126/81 mmhg; Pulse rate: 80-104 beats/min; Oxygen saturation: 98 %; Respiratory rate: 16-20 breaths/min; all on 07Jul2021. The outcome of the events was recovering. Assessed the relatedness of drug to AE was possible. Reporters comment: Generalized itching (starting in both arms and spreading), feeling unwell, dizziness and nausea 10 minutes after the first dose of COVID-19 vaccine Comirnaty. The patient was given 20 mg of prednisolone, with no sign of recovery and itchy throat, numbness of the right leg. The patient was cold and clammy and was given 0.5 mg of epinephrine and hospitalized. Peanut allergy, but no other known diseases or medicines.; Reporter''s Comments: Generalized itching (starting in both arms and spreading), feeling unwell, dizziness and nausea 10 minutes after the first dose of COVID-19 vaccine Comirnaty. The patient was given 20 mg of prednisolone, with no sign of recovery and itchy throat, numbness of the right leg. The patient was cold and clammy and was given 0.5 mg of epinephrine and hospitalized. Peanut allergy, but no other known diseases or medicines.


VAERS ID: 1517687 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100940120

Write-up: Acute myocarditis; This is a spontaneous report from a contactable consumer (patient) received via a regulatory authority. A 18-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration, administered in Arm Right on 15Jul2021 01:00 PM (Lot Number: FE6029) as DOSE 2, SINGLE for covid-19 immunisation in Hospital. Medical history included gilbert''s syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously received the first single dose of bnt162b2 (COMIRNATY) on 10Jun2021 01:00 PM administered in Arm Right (Lot Number: FD4342) for covid-19 immunisation. The patient experienced acute myocarditis (hospitalization, disability, life threatening) on 18Jul2021 09:00 with outcome of recovering. The patient was hospitalized for acute myocarditis for 5 days. The event Acute myocarditis resulted in Emergency room/department or urgent care and Diagnostics and treatment in a cardiology clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1519708 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100935041

Write-up: myocarditis; This is a spontaneous report from a contactable physician. A 17-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Jul2021, at the age of 17-years-old, (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine include dose 1 of BNT162b2, received on 01Jun2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Jul2021 10:00, the patient experienced chest pain, increased troponin, and myocarditis. The involves Emergency room care and hospitalization for 1 day. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events which includes Ibuprofen. No follow-up attempts possible. No further information expected.; Sender''s Comments: The event was considered related to suspect drug based on strong temporal association and known safety profile of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1520303 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202100916083

Write-up: blackout/fainted; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number is CZ-CZSUKL-21008107. A 14-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 02Jul2021 (Batch/Lot Number: FD6840) (at the age of 14-years-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications were reported as none. On 02Jul2021, the patient fainted (also reported as blackout). The reaction lasted approximately 2 minutes. Outcome of event was recovered on 02Jul2021. The reporter assessed the event as serious (hospitalization). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523530 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypersensitivity, Hypotension, Rash, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/45
CDC Split Type: EEPFIZER INC202100932380

Write-up: Rash; Syncope; Hypotension; Allergic reaction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-439721070610. A 13-years-old male patient received first dose of bnt162b2 (COMIRNATY), Formulation: Solution for injection, Batch/Lot Number: FE2083), via an intramuscular on 06Jul2021 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient was 13-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. It was reported that on 06Jul2021, the patient experienced rash, Syncope, hypotension and allergic reaction. On 06Jul2021, the patient underwent lab tests and procedures which included blood pressure measurement was 80/45. Therapeutic measures were taken as a result of rash, syncope, hypotension and allergic reaction. The outcome of event was rash, syncope, hypotension and allergic reaction was not recovered. Sender''s comments: Serious known side effects. The causal relationship is considered possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1525509 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202100921858

Write-up: Myocarditis; This is a spontaneous report from a contactable physician. A 16-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 17Jul2021 at 12:00 (Lot Number and Expiry date unknown) as dose number unknown, single for COVID-19 immunization. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 18Jul2021 at 15:00 the patient experienced myocarditis. The patient visited the emergency room/department or urgent care due to the event. The patient was hospitalized for 3 days due to the event. The patient received ibuprofen as treatment for the event. The patient underwent a COVID-19 PCR test nasal swab on 19Jul2021 and got a negative result. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1526408 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Lung disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100932894

Write-up: pulmonary disorder; fever; General physical health deterioration; This is a spontaneous report based on information received by Pfizer from BioNTech [manufacturer control number: 74705], license party for Comirnaty. A contactable physician reported that a 14-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 03Jul2021 (at the age of 14-year-old)(Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 03Jul2021, 2 hours later after vaccination, the patient experienced fever and general physical health deterioration. The patient got worse in 3 days with involvement of pulmonary disease on an unspecified date. She was currently away from oxygen. On 07Jul2021, the patient was admitted to the hospital seriously ill due to the event. The patient was treated by a healthcare professional. It was reported that the patient was still experiencing side effects and was not doing well and clearly ill. Outcome of events was not recovered. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of short fever, general physical health deterioration, and pulmonary disease due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


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