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

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1699689 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperpyrexia, Paraesthesia oral
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rectocolitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-778192) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Rectocolitis. On 22-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), the first episode of PARAESTHESIA ORAL, the second episode of PARAESTHESIA ORAL and HEADACHE. At the time of the report, HYPERPYREXIA, the last episode of PARAESTHESIA ORAL and HEADACHE had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient experienced paresthesia of the palate and tongue. No treatment information was provided. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Translation received on 09-Sep-2021 and contains no new information; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1699787 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Headache, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (the treatment was ongoing.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101130053

Write-up: anaphylaxis; headache; dyspnoea; pain in thigh; feeling queasy; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21124724. A 60-year and 11-month-old male patient received bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot Number: FF3620; Expiration Date: 30Nov2021), via an unspecified route of administration on 22Aug2021 10:33 (the day of vaccination) (at the age of 60-years-old) at dose 2, single for COVID-19 immunization. Medical history included hypertension and the treatment was ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade. The course of the event was as follows: After the patient was vaccinated with Pfizer at 10:33 am, the patient experienced headache, dyspnoea and pain in thigh at about 10:40 am. The patient took by oral Acetaminophen at the patient own discretion, but the symptoms persisted. The patient had feeling queasy. The patient was diagnosed with anaphylaxis from the situation. At 11:07 am, the patient received injection of Adrenaline 0.3 mg at right thigh, but the symptom was not recovering. The patient was transferred by ambulance to another hospital. The patient had respiratory symptom(dyspnoea), digestive symptom (pain in thigh)(as reported), headache and no cutaneous symptom, mucosa symptom. The events onset date/time were reported as 22Aug2021,10:40 (7 minutes after the vaccination). On 22Aug2021 (the day of the vaccination), the patient was admitted to the hospital and discharged on 23Aug2021. The reporting physician classified the events as serious (hospitalized) and assessed that the events were related to bnt162b2. There was no other possible cause of the events such as any other diseases. On 23Aug2021 (1 day after the vaccination), the outcome of the events was recovered. The reporting physician commented as follows: No special matters.


VAERS ID: 1699916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Clonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

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:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139149

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 608819). A 39-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medication not reported. The patient experienced clonic convulsion on Aug 22, 2021 (onset time in days: 4 days); with outcome of recovered on an unspecified date. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699918 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Troponin increased
SMQs:, Myocardial infarction (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139156

Write-up: Myocarditis; Troponin increased; This is a spontaneous report from a contactable healthcare professional via the regulatory authority report number is 608892. A 20-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 27Jul2021 for COVID-19 immunization. On 22Aug2021, the patient experienced myocarditis and troponin increased. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

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: AUPFIZER INC202101139642

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 611530. This is a maternal report. A 33-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced abortion spontaneous. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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: AUPFIZER INC202101140284

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 614280. A 30-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 22Aug2021. The event was considered serious, medically significant. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Burning sensation, Chest pain, Dry mouth, Feeling abnormal, Hallucinations, mixed, Headache, Insomnia, Myalgia, Swollen tongue
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139160

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 608919). A 47-year-old male patient received unknown dose number of BNT162B2 (Comirnaty), single dose, via an unknown route, on an unknown date, for COVID-19 immunisation. Medical history and concomitant drug not provided. On Aug 22, 2021, patient experienced balance disorder, burning sensation, chest pain, dry mouth, feeling abnormal, hallucinations, mixed, headache, insomnia, myalgia and swollen tongue. It was also reported as "Medicine (Onset Time in Days): Comirnaty COVID-19 vaccine (BNT162B2 (mRNA)) - suspect (-)." The outcome of the events: not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1700999 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Fatigue, Headache, 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? Yes
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: BEPFIZER INC202101142512

Write-up: Headache; Ball under the armpit/ Lump under the armpit/ Axillary lump; Fatigue; Fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105760. A 14-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FC5029, Expiration date: not reported), via an unspecified route of administration on 20Aug2021 as a dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced fever and on 23Aug2021, the patient experienced headache, ball under the armpit/ lump under the armpit/ axillary lump and fatigue. It was reported that, high fever started 48 hours after injection, strong headache continuously. The reporter commented that, it was unknown whether patient had received treatment. There was no improvement in adverse events. The outcome of the events was not recovered. No follow up attempts needed, no further information is expected.


VAERS ID: 1701004 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiovascular disorder, Chest pain, Echocardiogram, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Biological; Result Unstructured Data: Test Result:Inflammatory syndrome; Test Date: 202108; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:no pericardial effusion
CDC Split Type: BEPFIZER INC202101142604

Write-up: Chest pain; Cardiovascular problem; Pericarditis sicca; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105783.A 60-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: FE7053),via an unspecified route of administration on 20Aug2021 (at the age of 60 years old) as Dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced chest pain, cardiovascular problem and pericarditis with hospitalization on 22Aug2021. The patient underwent lab tests and procedures which included blood test: inflammatory syndrome on Aug2021 and echocardiogram: no pericardial effusion on Aug2021. Therapeutic measures were taken as a result of chest pain, cardiovascular problem and pericarditis sicca . The patient was treated with analgesics, Aspegic and Colchicine. The outcome of the events was recovering. No follow-up attempts are possible, no further information is expected.; Reporter''s Comments: Treatment: - Aspegic - Colchicine - Analgesic (not specified) Evolution of the adverse reaction: In the process of improvement Examinations: - Cardiac ultrasound: no pericardial effusion. - Biological: Inflammatory syndrome


VAERS ID: 1701250 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101135936

Write-up: Acute myocarditis; This is a spontaneous report from a contactable physician do from the Regulatory Authority. The regulatory authority number ES-AEMPS-986606. A 23-years-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced acute myocarditis on 22Aug2021 which caused hospitalization. The outcome of the event was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1701405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis allergic, SARS-CoV-2 test
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145489

Write-up: Allergic rash; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291130137330-NVNTD. A 30-years-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date in 2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 22Aug2021, the patient developed allergic rash. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent Sars-CoV-2 infection test and results were negative on an unknown date. The event was considered as serious (prolonged hospitalization and medically significant) by health authority. The outcome of the event was reported as recovering. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1701438 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chills, Headache, Petechiae, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? No
Previous Vaccinations:
Other Medications: ACETIC ACID; HYDROXYQUINOLINE; IBUPROFEN; PARACETAMOL; UREA PEROXIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear infection; Ear wax; Headache; Lactation decreased; Period pains
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Results were fine; Test Date: 20210830; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138087

Write-up: Petechiae; headache; chills; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108311612471040-E4WN2. Safety Report Unique Identifier GB-MHRA-ADR 25875203. A 29-year-old female patient (not pregnant, not currently breastfeeding; age at vaccination: 29-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FE8087), via an unspecified route of administration on 22Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included decreased lactation, ear infection, excessive ear wax production, period pains and headache. Patient has not had symptoms associated with COVID-19. Concomitant medications included acetic acid for ear infection, start and stop date were not reported; hydroxyquinoline for excessive cerumen production, start and stop date were not reported; ibuprofen for dysmenorrhoea, start and stop date were not reported; paracetamol for headache, start and stop date were not reported; urea hydrogen peroxide for excessive cerumen production, start and stop date were not reported. On 22Aug2021 at night of the vaccine, she had headache and chills. On the evening of 30Aug2021, she discovered petechiae on her left arm. Tiny purplish/red spots were seen under the skin. The skin was not itchy and under the glass test does not disappear. She went to urgent care centre to be seen. The doctor felt this was not a concern and she was sent home. The mark persists on her arm. The patient underwent laboratory test which included Sars-cov-2 test: negative on 30Aug2021, blood test: results were fine on an unspecified date. The outcome of petechiae was not recovered; for other events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-22
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Medical History/Concurrent Conditions: COVID-19 ((always tested negative after recovery))
Allergies:
Diagnostic Lab Data: Test Date: 20201104; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20201117; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20201123; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20201202; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210810; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210824; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101135516

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; Symptomatic with cough.; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-776858. A 31-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 05Feb2021 (Lot Number: EL0725; Expiration Date: 31Mar2021) as DOSE 2, 0.3ML SINGLE; and intramuscular, administered in Arm Left on 15Jan2021 (Lot Number: EJ6797; Expiration Date: 30Apr2021) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. Medical history included covid-19 from 04Nov2020 to an unknown date (always tested negative after recovery). The patient''s concomitant medications were not reported. On 22Aug2021, the patient experienced new positive test (confirmed by positive covid-19 test) with symptomatic with cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Nov2020, sars-cov-2 test: positive on 17Nov2020, sars-cov-2 test: positive on 23Nov2020, sars-cov-2 test: negative on 02Dec2020, sars-cov-2 test: negative on 10Aug2021, and sars-cov-2 test: positive on 24Aug2021. The outcome of the events was not recovered. Investigation results received on 02Sep2021 includes: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EJ6797 and lot EL0725. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1701875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blister, Dermatitis bullous, Eye oedema, Pruritus, Rash macular
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101148136

Write-up: red spots appeared all over the body like itchy mosquito bites that arise and disappear; Sunday 22, the day after the pfizer vaccine, a blister appeared on the eye; red spots appeared all over the body like itchy mosquito bites that arise and disappear; Sunday 22, the day after the pfizer vaccine, a blister appeared on the eye; red spots appeared all over the body like itchy mosquito bites that arise and disappear; This is a spontaneous report from a contactable pharmacist downloaded from a Regulatory Authority, regulatory authority number IT-MINISAL02-777772. A 46-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via intramuscular route, administered in left arm on 21Aug2021 at 16:21 (Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included urticaria from 01Jan2018 to an unknown date. The patient''s concomitant medications were not reported. On 22Aug2021, the day after the pfizer vaccine, the patient developed red spots appeared all over the body like itchy mosquito bites that arise and disappear and a blister appeared on the eye. At the time of this report, the outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702044 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dysphoria, Heart rate, Heart rate decreased, Vagus nerve disorder
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Depression (excl suicide and self injury) (narrow)

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:
Diagnostic Lab Data: Test Date: 20210822; Test Name: BP; Result Unstructured Data: Test Result:103/63; Comments: BP103/63 ?109/73; Test Date: 20210822; Test Name: BP; Result Unstructured Data: Test Result:109/73; Comments: BP103/63 ?109/73; Test Date: 20210822; Test Name: HR; Result Unstructured Data: Test Result:59; Comments: HR59 ?P68; Test Date: 20210822; Test Name: HR; Result Unstructured Data: Test Result:68; Comments: HR59 ?P68
CDC Split Type: JPPFIZER INC202101139592

Write-up: vagus nerve reflex; Dysphoria; HR59; This is a spontaneous report from a contactable other healthcare professional (legal persons) received from the regulatory authority. Regulatory authority report number is v21125460. A 16-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Aug2021 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) at 16-years-old, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vagus nerve reflex, dysphoria, and HR 59 (heart rate decreased) on 22Aug2021 at 13:15. The course of the event was as follows: the patient received the second dose of BNT162B2 (COMIRNATY) and dysphoria appeared. Improving at rest. It was vagus nerve reflex. The patient underwent laboratory tests and procedures on 22Aug2021 which included blood pressure measurement: 103/63 and 109/73 (BP103/63 ?109/73) and heart rate: 59 and 68 (HR59 ?P68). Outcome of the events was recovered on 22Aug2021 at 13:35. The reporting other healthcare professional (legal persons) classified the event as non-serious and causality to the vaccine was non-assessable. There were no other possible cause of the event such as any other diseases. No follow up attempts are possible. No further information is expected.


VAERS ID: 1702050 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dysphoria, Heart rate, Oxygen saturation, Vagus nerve disorder
SMQs:, Depression (excl suicide and self injury) (narrow)

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:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:111/83; Test Date: 20210822; Test Name: BP; Result Unstructured Data: Test Result:100/63; Test Name: HR; Result Unstructured Data: Test Result:64; Test Date: 20210822; Test Name: HR; Result Unstructured Data: Test Result:61; Test Date: 20210822; Test Name: SAT; Result Unstructured Data: Test Result:95
CDC Split Type: JPPFIZER INC202101140185

Write-up: Vagus nerve reflex; Dysphoria; This is a spontaneous report from a contactable healthcare professional received from the Agency (A) (Regulatory Authority report number: v21125455). A 16-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: FF3620; Expiration Date: 30Nov2021) on 22Aug2021 (13:05) as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021 (13:35), the patient had vagus nerve reflex and dysphoria. The course of the event was as follows: 30 minutes after the second dose of COVID-19 vaccination, the patient had felt dysphoria. The symptoms improved after a quiet break, and it was suspected as vagus nerve reflex. The patient''s blood pressure (BP) was 111/83 on an unspecified date, and was 100/63 on 22Aug2021; heart rate (HR) was 64 on an unspecified date, and was 61 on 22Aug2021; and oxygen saturation (SAT) was 95 on 22Aug2021. On 22Aug2021 PM, the outcome of the event was recovered. The reporting healthcare professional (legal persons) classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1702060 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Body temperature, Dysphonia, Heart rate, Labile blood pressure, Oxygen saturation, Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: PREDONINE [PREDNISOLONE]; SULTANOL; TRELEGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Auscultation; Result Unstructured Data: Test Result:no wheeze; Test Date: 20210822; Test Name: Auscultation; Result Unstructured Data: Test Result:Results not provided; Comments: At 16:23.; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/105; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/68; Comments: At 16:14; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:141/92; Comments: At 16:20.; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/83; Comments: At 16:26.; Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210822; Test Name: pulse; Result Unstructured Data: Test Result:97; Test Date: 20210822; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: At 16:08.; Test Date: 20210822; Test Name: pulse; Result Unstructured Data: Test Result:61; Comments: At 16:14; Test Date: 20210822; Test Name: pulse; Result Unstructured Data: Test Result:59; Comments: At 16:20.; Test Date: 20210822; Test Name: pulse; Result Unstructured Data: Test Result:62; Comments: At 16:26.; Test Date: 20210822; Test Name: SPO2; Test Result: 95 %; Test Date: 20210822; Test Name: SPO2; Test Result: 98 %; Comments: At 16:08.; Test Date: 20210822; Test Name: SPO2; Test Result: 98 %; Comments: At 16:20.; Test Date: 20210822; Test Name: SPO2; Test Result: 99 %; Comments: At 16:26.
CDC Split Type: JPPFIZER INC202101140750

Write-up: BP 166/105, 144/68,141/92; Pharynx itchy sensation of; Rash all over the right wrist; had difficult to talk; This is a spontaneous report from a contactable nurse received from the Regulatory authority. A 54-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021), dose 2 via an unspecified route of administration on 22Aug2021 15:42 as a single dose (at the age of 54-year-old) for COVID-19 immunization. Medical history included asthma. Concomitant medications included prednisolone; salbutamol sulfate (SULTANOL); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY). The onset date was reported as 22Aug2021 at 16:00 (18 minutes after the vaccination). The course of the event was as follows: BT (Body temperature) 36.7 degrees centigrade, BP (Blood pressure) 166/105, P (pulse) 97, oxygen saturation (SPO2) 95%. At 16:05, Allegra 60mg was administered orally, the patient experienced Pharynx itchy sensation of. Rash occurred all over the right wrist, no itch occurred, no Wheezing occurred. The patient had difficult to talk. At 16:08, SPO2 98%, P 74. At 16:14, BP 144/68, P 61. Diagnosis and auscultation were performed, no wheeze. At 16:20, BP 141/92, P59, SPO2 98%. At 16:23, auscultation was performed, no itch occurred, The patient felt much better. At 16:26, (BP) 121/83, P 62, SPO2 99%, the patient called husband and drove home with the husband. On 22Aug2021 (the same day of the vaccination), the outcome of the event was recovered. The reporting nurse classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1702129 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood test, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Embolism, Headache, Hemiplegia, Laboratory test, Magnetic resonance imaging, Platelet factor 4, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
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: 20210827; Test Name: Cerbral angiography; Result Unstructured Data: Test Result:thrombosis; Test Date: 20210827; Test Name: Blood test; Result Unstructured Data: Test Result:platelets decreased; Test Name: clinical and laboratory findings; Test Result: Negative ; Comments: Other thrombosis (protein s, Protein C (PC) deficiency, antitronlipid deficiency, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, thrombosis associated with malignant tumors, etc.) were negative; Test Date: 20210827; Test Name: MRI; Result Unstructured Data: Test Result:cerebral vein sinus thrombosis; Comments: Diagnosed as Cerebral venous sinus thrombosis and Thrombosis with Thrombocytopenia Syndrome; Test Date: 20210827; Test Name: Anti-HIT antibody; Result Unstructured Data: Test Result:Negative
CDC Split Type: JPPFIZER INC202101153603

Write-up: cerebral hemorrhage; thromboembolism; Cerebral venous sinus thrombosis; thrombosis; platelets decreased/Thrombocytopenia Syndrome; hemiplegia(left); headache; This is a spontaneous report from a contactable physician, received from the regulatory authority. Regulatory authority report number is v21126513. A 40-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 (Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) at the age of 40-years-old, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 27Aug2021 at 3:00 (22 days after vaccination), the patient experienced events. On 27Aug2021 (22 days after the vaccination), the patient was admitted to the hospital. The clinical course of the events was as follows: On 22Aug2021, the patient experienced headache. On 27Aug2021, the patient experienced hemiplegia (left) and visited the doctor. The patient was diagnosed with cerebral vein sinus thrombosis and thrombosis with platelets decreased by MRI (Magnetic Resonance Imaging), cerebral angiography, and blood test. The patient was admitted to the hospital and started anticoagulant therapy. On 28Aug2021, there was onset of cerebral hemorrhage. The conservative treatment continued. The patient underwent laboratory tests and procedures which included angiogram: thrombosis on 27Aug2021, blood test: platelets decreased on 27Aug2021, laboratory test: negative on an unspecified date (Other thrombosis (protein s, Protein C (PC) deficiency, antitronlipid deficiency, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, thrombosis associated with malignant tumors, etc.) were negative), magnetic resonance imaging: cerebral vein sinus thrombosis on 27Aug2021 (diagnosed as cerebral venous sinus thrombosis and thrombosis with thrombocytopenia syndrome), and platelet factor 4: negative on 27Aug2021. On 02Sep2021 (28 days after vaccination), the outcome of the events was not recovered. The reporting physician classified the events (cerebral venous sinus thrombosis, thrombosis, thrombocytopenia, cerebral hemorrhage, thromboembolism) as serious (Disability, Hospitalized on 27Aug2021, Life-threatening) and assessed that the event was related to BNT162B2. There was no other possible cause of the events such as any other diseases. = The reporting physician further commented as follows: Cerebral vein sinus thrombosis in healthy men without a thrombotic predisposition. The patient received the first dose of Pfizer, but was considered to have thrombosis with platelets decreased to the case reported with the AstraZeneca vaccine. Although the anti-HIT antibody was negative, the only test that could be performed at this hospital was the latex fixation method, so the existence of the anti-HIT antibody cannot be denied (AstraZeneca has a significantly low detection rate other than the ELISA method; thrombosis with vaccine has been reported). Other thrombosis (protein s, Protein C (PC) deficiency, antitronlipid deficiency, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, thrombosis associated with malignant tumors, etc.) were negative from clinical and laboratory findings. The above diagnosis was reached. This report met the criteria of thrombosis (including thromboembolism) limited to those with thrombocytopenia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702578 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, Blood test, Computerised tomogram, Ultrasound scan, Urine analysis
SMQs:

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: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Not reported; Test Name: ct scan; Result Unstructured Data: Test Result:Not reported; Test Name: echo; Result Unstructured Data: Test Result:Not reported; Test Name: urine; Result Unstructured Data: Test Result:Not reported
CDC Split Type: NLPFIZER INC202101149974

Write-up: Acute appendicitis; This is a spontaneous report from a contactable consumer (patient) or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number is NL-LRB-00673002. A 36-years-old female patient received bnt162b2 (COMIRNATY Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 22Aug2021 (at the age of 36-year-old) as dose number unknown, single dose for COVID-19 immunization. Medical history included disease risk factor. The patient''s concomitant medications were not reported. The patient had no previous covid-19 infection. On 22Aug2021, (1 hour after vaccination), the patient experienced acute appendicitis. On an unspecified date, the patient underwent lab tests and procedures which included blood test, computerised tomogram, ultrasound scan, urine analysis was not reported. The patient was treated with acute surgery. Outcome of the event was recovering. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1702840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101131515

Write-up: Urticaria drug-induced; angioedema of the eyelids; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received INFARMED regulatory authority report number PT-INFARMED-B202108-2963 with Safety Report Unique Identifier PT-INFARMED-B202108-2963. A 15-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FE4721), intramuscular on 21Aug2021 as 0.3mL single for COVID-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications included ibuprofen taken for headache, start and stop date were not reported. The patient experienced urticaria drug-induced and angioedema of the eyelids, both on 22Aug2021. Therapeutic measures were taken as a result of urticaria drug-induced and angioedema of the eyelids. The outcome of the events was unknown. The regulatory authority assessed the report as serious (medically significant). The clinical course was reported as follows: The adverse drug reaction (ADR) started about 7 hours after the administration of the suspected drug, with itching on the scalp and skin; about an hour later, on clinical observation, he presented urticaria and angioedema of the eyelids. Specific treatment for ADR was performed in a hospital setting with 25 mg of hydroxyzine orally. ADR will have improved and then discharged under levocetirizine. It is not known whether the patient has had ADRs prior to other medications. Reference was made to the concomitant use of ibuprofen, orally, for the treatment of headache. Reporter Comment: Concomitant Medicine-Ibuprofen for headache Did Medication Error Occur?-No Other Information-Did 1st dose of vaccine covid-19 Comirnaty (Pfizer) batch FE4721 on 21Aug2021 at 17h, without immediate complications. at 1h (7h later) itching scalp and skin, OBS (observation) 8h after administration - urticaria and angioedema of the eyelids. The reporter''s assessment of the causal relationship of the Urticaria, Angioedema] with the suspect product was [not provided at the time of this report]. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4728 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multisystem inflammatory syndrome in children, SARS-CoV-2 antibody test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

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 Name: SARS-CoV-2; Test Result: Negative ; Comments: IgM antinucleocapside.; Test Name: SARS-CoV-2; Test Result: Negative ; Comments: IgG antispike.
CDC Split Type: PTPFIZER INC202101155678

Write-up: MIS-C; This is a Spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory authority report number PT-INFARMED-G202108-3939 with Safety Report Unique Identifier PT-INFARMED-G202108-3939. A 16-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, strength: 30 ug, Batch/Lot Number: FA4728), via intramuscular on 15Aug2021 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported and concomitant medications was none. On 22Aug2021, the patient experienced mis-c (multisystem inflammatory syndrome in children). The patient underwent lab tests and procedures which included sars-cov-2 antibody test with negative (IgM antinucleocapside) and sars-cov-2 antibody test with negative (IgG antispike) on an unspecified date. The outcome of the event was recovering. The reporter assessment of the causal relationship of the event (MIS-C) with the suspect product COMIRNATY was Possible. Health Authority comment: Concomitant medication: No. Other information: Adolescent aged 16, with no relevant personal history, hospitalized for a condition compatible with MIS-C but with no previous history of Sars-cov2 infection, negative IgG antinucleocapsid SARS-CoV2 and negative IgM SARS-CoV2 and IgG AntiSpike SARS-CoV2. (8 days post-vaccination anti-COVID19) No follow-up attempts are possible. No further information is expected.


VAERS ID: 1703043 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eyelid haematoma, Eyelid oedema, Laboratory test, Petechiae, Rash, Telangiectasia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Periorbital and eyelid disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADT; ZOELY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine with aura; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: laboratory tests; Result Unstructured Data: Test Result:results pending
CDC Split Type: PTPFIZER INC202101131924

Write-up: red dots in the upper part of the body, namely arms and trunk; generalized petechial rash with venous changes; telangiectasias in thorax, shoulders and thighs; edema in the eyes (lower eyelid); left eye spill (lower eyelid); This is a spontaneous report from a contactable consumer. A 39-years-old female patient reported that received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20Aug2021 09:30 (Batch/Lot Number: FG4442) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included migraine with aura from an unknown date and nodule in thyroid of 1 cm from an unknown date. Concomitant medications included amitriptyline hydrochloride (ADT) taken for migraine and estradiol, nomegestrol acetate (ZOELY) taken for contraception. The patient previously took omeprazole for an unknown indication and experienced skin reaction (Allergic to gastric protectors belonging to omeprazole class). On 22Aug2021 at 13:00, the patient experienced edema in the eyes (lower eyelid), left eye spill (lower eyelid) and telangiectasias in thorax, shoulders and thighs. On 23Aug2021, the patient experienced red dots in the upper part of the body, namely arms and trunk. Some of those dots stood out. As a result, the patient contacted SNS 24 national healthline and was advised to monitor the situation. On 26Aug2021, the patient was contacted by the SNS 24 national healthline, and since the red dots still maintained, she was advised to consult with a doctor to confirm if the event was in fact a generalized petechial rash with venous changes. On 27Aug2021, the patient was observed by her doctor and was prescribed with several clinical analyses (results pending). On 30Aug2021, the telangiectasias maintained in the shoulders and trunk and increased in the thighs. At the time of the report, the outcome of the events edema in the eyes (lower eyelid) and left eye spill (lower eyelid) was resolved. The outcome of the other events was not recovered.


VAERS ID: 1703118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Echocardiogram, Pleurisy, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Diffusion tensor imaging and echo; Result Unstructured Data: Test Result:confirmed fluid in left lung sac
CDC Split Type: SEPFIZER INC202101125812

Write-up: Pleuritis; chest pain which worsens with deep inhalation; Diffusion tensor imaging and echo confirmed fluid in left lung sac; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority. The regulatory authority number is SE-MPA-2021-077531 with Safety Report Unique Identifier: SE-VISMA-1629807216216. A 24-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FF3318, Expiration date: unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced pleuritis, also reported as pleurisy on the left side and chest pain which worsened with deep inhalation. It was further reported that the patient was admitted to the emergency ward with severe chest pain, which worsened with deep inhalation. Diffusion tensor imaging and echo confirmed fluid in left lung sac on an unspecified date. The case was assessed as serious due to hospital care. The patient was hospitalized for the events "pleuritis and chest pain which worsened with deep inhalation" on an unspecified date. The patient was recovering from pleuritis and chest pain which worsened with deep inhalation, while the outcome of the event "diffusion tensor imaging and echo confirmed fluid in left lung sac" was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1703125 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: SEPFIZER INC202101131536

Write-up: Blisters; Rash; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority, Regulatory authority report number SE-MPA-2021-077570. A 43-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced blisters and rash on 22Aug2021 with outcome of not recovered. Events described as follows suspected side effects were band-shaped skin rash and blisters, as in shingles. The rash was on the right side of the flank and started on 22Aug2021. Events serious due to disability. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1703598 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-22
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, Fibrin D dimer, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Troponin I
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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: CT coronary angiogram; Result Unstructured Data: No identifiable lesion on coronary angiogram; Test Date: 20210822; Test Name: D-Dimers; Result Unstructured Data: 296 microgram per millilitre; Test Date: 20210823; Test Name: Heart MRI; Result Unstructured Data: No evidence of active acute myocarditis or an ischemic lesion; Test Date: 20210822; Test Name: COVID PCR; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210822; Test Name: HS troponin I; Result Unstructured Data: 109 picogram per millilitre; Test Date: 20210822; Test Name: HS troponin I; Result Unstructured Data: 582 picogram per millilitre; Test Date: 20210824; Test Name: HS troponin I; Result Unstructured Data: 1272 picogram per millilitre
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: probable myocarditis; This case was received via regulatory Agency (Reference number: FR-AFSSAPS-NY20213949) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (probable myocarditis) in a 25-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214011) for SARS-CoV-2 immunization. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (probable myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (probable myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Fibrin D dimer (Unknown-24): 296 (High) 296 microgram per millilitre. On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. On 22-Aug-2021, Troponin I (Unknown-24): 109 (High) 109 picogram per millilitre and 582 (High) 582 picogram per millilitre. On 23-Aug-2021, Angiogram: normal (normal) No identifiable lesion on coronary angiogram. On 23-Aug-2021, Magnetic resonance imaging heart: normal (normal) No evidence of active acute myocarditis or an ischemic lesion. On 24-Aug-2021, Troponin I (Unknown-24): 1272 (High) 1272 picogram per millilitre. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment information was not provided. Laboratory test included: On 22-Aug-2021 ECG: Regular sinus rhythm with some ventricular extrasystoles, normal axis, normal QRS, no repolarization disorder. On 23-Aug-2021 ETT: Left ventricle non-dilated or hypertrophic, hyperkinetic overall Ejection fraction $g60%, no segmental kinetic disorder Good right ventricular function, no right cavity dilatation Thin, infracentimetric layer of fluid, right latero-ventricular. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Translation document received on 10-Sep-2021 included laboratory information updated and Reporter''s comments added.; Reporter''s Comments: Conclusion: 25-year-old male, no history, presenting with probable myocarditis with chest pain and raised troponin levels 16 days after the first dose of the Moderna (SPIKEVAX) COVID vaccine. Troponin peak two days after the onset of symptoms. The transthoracic echocardiogram and MRI, however, did not find any evidence of myocarditis. Patient recovering at the time of reporting; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.


VAERS ID: 1703820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101149703

Write-up: Pericarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority , regulatory authority number DE-PEI-CADR2021171912. A 22-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 22Aug2021 that caused hospitalization. The outcome of event was not recovered. Sender comment: Do you or the person concerned have any known allergies? If so, what are they? No. Details of risk factors or previous illnesses. None whatsoever. Sporty, healthy and fit/went to see doctor, followed by immediate admission to the hospital. In the hospital for 4 days + now taking tablets for 3 months. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1704864 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Lymphadenopathy
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101149827

Write-up: loose stools; Fatigue; Flu-like aching; cervical adenopathy; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-RS20212783. A 61-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE7051), via an intramuscular route, administered in arm left on 20Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no history of covid-19. On 22Aug2021, 2 days post-vaccination, the patient experienced loose stools, cervical adenopathy, fatigue, flu-like pain everywhere and was put on sick leave from 24Aug2021 to 29Aug2021. The events were serious (medically significant). It was unknown that patient received treatment for adverse events. Usual treatment not specified. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Test Date: 20210822; Test Name: Tachycardia around 190; Result Unstructured Data: Test Result:around 190
CDC Split Type: ATPFIZER INC202101142641

Write-up: Dyspnoea; as well as thoracic pressure sensation; Tachycardia around 190; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority number AT-BASGAGES-2021-042592. A 13-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 12Aug2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 22Aug2021 the patient experienced Tachycardia around 190, as well as thoracic pressure sensation (also reported as Chest pressure sensation of), Dyspnoea. The patient was hospitalized due to the events. The outcome of the events was not recovered. Relatedness: Tachycardia; Source of assessment: Health Care Professional; Method of assessment: WHO Assessment; Result of Assessment: Probable/Likely. "English summary (full translation available upon request)". No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1705446 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-08-22
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Hypoxia, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Bicuspid aortic valve; COVID-19; Morbid obesity; Obstructive sleep apnea syndrome; Trisomy 21
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Serology COVID; Test Result: Positive ; Test Date: 20210822; Test Name: PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101142919

Write-up: Hypoxemic lung disease; Drug ineffective; COVID-19; This is a spontaneous report from a physician downloaded from the regulatory authority number is FR-AFSSAPS-LL20215883. A 37-year-old female patient received BNT162B2 (COMIRNATY; solution for injection), in Apr2021 (lot number was not reported) as dose 1, single; then on 11May2021 (lot number was not reported) as dose 2, single - both intramuscularly for COVID-19 immunization. Medical history included morbid obesity, trisomy 21, bicuspid aortic disease, obstructive sleep apnea syndrome. The patient has history of COVID-19 on an unspecified date. The patient was considered a person at risk due to trisomy 21 and morbid obesity. The patient''s concomitant medications were not reported. On 22Aug2021, the patient experienced hypoxemic lung disease, drug ineffective, and COVID-19. The patient was admitted to hospital after 4 days of symptoms. Polymerase chain reaction (PCR) test was positive on 22Aug2021, while serology was performed on 23Aug2021 and came back positive. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.


VAERS ID: 1705536 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: IMBRUVICA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COVID-19; Lymphoma-like disorder (treated with ibrutinib)
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101142920

Write-up: COVID-19; Vaccination failure; three injections of BNT162B2; three injections of BNT162B2; This is a spontaneous report from a contactable physician from the Regulatory Authority FR-AFSSAPS-PB20215877. A 86-year-old female patient received BNT162B2 (COMIRNATY), third dose via intramuscular on unspecified date at single dose (lot# FA8016, expiry date 30Sep2021), second dose via intramuscular on unspecified date at single dose, first dose via intramuscular on unspecified date at single dose for COVID-19 immunisation. Medical history included Atrial fibrillation, Lymphoma-like disorder, treated with IMRUVICA, COVID-19. Concomitant medications included IMBRUVICA for Lymphoma-like disorder. The patient received three injections of BNT162B2. Patient was hospitalized on 22Aug2021 in a severe COVID-19 picture, vaccination failure. Lab data included SARS-CoV-2 test Positive on unspecified date. The outcome of event was unknown. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FA8016. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1705784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Palpitations, Pericarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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? Yes
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: Chest pain; Palpitations; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101160923

Write-up: Pericarditis; Palpitations; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority . Regulatory authority report number GB-MHRA-WEBCOVID-202109051737308840-GBZF2, Safety Report Unique Identifier GB-MHRA-ADR 25897234. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Aug2021 as a single dose for COVID-19 immunisation. Medical history included shortness of breath, palpitations and chest pain. It was unsure whether patient had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 22Aug2021, 1 day after vaccination, the patient experienced palpitations, shortness of breath, chest pain and pericarditis. The events resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events palpitations, shortness of breath and chest pain was unknown at the time of this report; while that of pericarditis was not resolved at the time of this report. The events palpitations, shortness of breath, chest pain and pericarditis were reported as serious for being medically significant and for hospitalization (be to hospital two times and doctors) on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1706037 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Blood pressure measurement, Body temperature, Choking sensation, Dyspnoea, Feeling cold, Headache, Hyperhidrosis, Hypertension, Nasal congestion, Oropharyngeal discomfort, Oxygen saturation, Oxygen saturation decreased, Productive cough, Swelling face
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NIFEDIPINE; ATORVASTATIN; BUSCOPAN; BIO-THREE; LOXONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Seafood allergy; Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:149/100 85 (as reported); Comments: At 17:52; Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: At 18:00; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:94-97 %; Comments: Usually, the patient''s SpO2 is 94 to 97% and there is no respiratory distress; Test Date: 20210822; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:96-97 %; Comments: At 17:52; Test Date: 20210822; Test Name: Oxygen saturation; Test Result: 96 %; Comments: At 18:30; Test Date: 20210822; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:92-93 %; Comments: At 19:05; Test Date: 20210825; Test Name: Oxygen saturation; Test Result: 92 %; Comments: at the time of bathing
CDC Split Type: JPPFIZER INC202101148481

Write-up: pain in the entire abdomen; SpO2 92-93%/SpO2 becomes 92% at the time of bathing; discomfort in the throat; sputum; choking sensation; Anaphylaxis; sweaty; feeling cold; Blood pressure 149/100 85; Dyspnoea; Swelling face; Nasal congestion; Mild headache; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21125662. A 38-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: unknown), via an unspecified route of administration at the age of 38-year-old on 22Aug2021 17:26 at single dose for covid-19 immunisation. Medical history included food allergies: shrimp, crab and headache. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication included nifedipine; atorvastatin; hyoscine butylbromide (BUSCOPAN); bacillus mesentericus, clostridium butyricum, enterococcus faecalis (BIO-THREE); loxoprofen sodium (LOXONIN) for headache. On 22Aug2021 at 17:52 (26 minutes after the vaccination), the patient experienced anaphylaxis. On 22Aug2021 (the day of the vaccination), the patient was admitted to the hospital. On 23Aug2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: There was information on food allergies and concomitant drugs, so the reporter listed them here. Food allergies: shrimp, crab; concomitant drugs: NIFEDIPINE CR40mg, ATORVASTATIN 10mg, BUSCOPAN 10mg, BIO-THREE, LOXONIN 60mg (when headache occurs). Symptom course: At 17:26, injection vaccination at the vaccination site (first dose). At 17:52, after 26 min, the patient had sweaty, feeling cold. No hypoxemia. SpO2 96-97%. Blood pressure 149/100 85 (as reported). After this, the condition seems to have changed, and oxygen was started according to the doctor''s instructions without confirming hypoxemia. At 18:00, securing a route according to the doctor''s instructions, starting 3L.N.C. Body temperature 37.1 degrees Centigrade. At 18:06, SOLMEDROL 125 mg, intravenously. At 18:07, the administration of BOSMIN was considered but was not performed. At 18:14, there were complaints of discomfort in the throat, sputum, and choking sensation. At 18:21, Polaramine 5 mg, intravenously. At 18:30, reduced to 1L of oxygen. SpO2 96%. The first 500 ml saline solution had already been completed, then the second one was started. At 19:05, oxygen off, SpO2 92-93%. Instructed by the doctor in charge to request emergency transportation. At 19:06, there was pain in the entire abdomen. No redness of rash, no awareness of itchy skin. The patient was taken to the hospital by emergency and was diagnosed as anaphylaxis. The next day, on 23Aug2021, the patient had swelling face, nasal congestion, and mild headache, but the patient was discharged without any other changes. On 25Aug2021, from the patient''s wife, SpO2 became 92% at the time of bathing and there was dyspnoea. Usually, SpO2 is 94 to 97% and there was no respiratory distress, there was no fever and there were no other symptoms, but there was a request for medical examination. A medical information provision form was created, and a recommendation for consultation with a respiratory internal medicine (specialist) was made. The outcome of event Anaphylaxis, SpO2 92-93%/SpO2 becomes 92% at the time of bathing, Swelling face, Nasal congestion, Mild headache and Dyspnoea was recovering and other events was unknown. The reporter classified the event as serious (Hospitalized from 22Aug2021 to 23Aug2021) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1706192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest X-ray, Chest discomfort, Echocardiogram, Electrocardiogram, Myocarditis, Nasal congestion, Oropharyngeal pain, Troponin T
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:normal; Test Date: 202108; Test Name: C-reactive protein; Result Unstructured Data: Test Result:8-4; Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: Test Result:Normal; Test Date: 202108; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 202108; Test Name: Troponin T; Result Unstructured Data: Test Result:65-60-61
CDC Split Type: NOPFIZER INC202101150160

Write-up: chest pressure/pain; I40.9 ACUTE MYOCARDITIS; sore throat; nasal congestion; This is a spontaneous report from a contactable physician from a regulatory authority, regulatory authority number NO-NOMAADVRE-FHI-2021-Un3rgz. An 18-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection) via intramuscular at right arm on 19Aug2021 (lot number: FG3716) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed initially only slight ADRs sore throat and nasal congestion. The patient had I40.9 acute myocarditis on 22Aug2021. Three days after the vaccination, the patient woke up with central chest pressure/pain which worsened by physical activity and deep inspiration. The patient was hospitalized. The patient laboratory investigations included TnT was 65-60-61, C-reactive protein was 8.4, ECG, echocardiography and chest x-ray were found to be normal on an unknown date Aug2021. The event acute myocarditis was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.; Reporter''s Comments: Notifier qualification: Physician.


VAERS ID: 1706319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Muscle twitching, Pericardial fibrosis
SMQs:, Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RSPFIZER INC202101153527

Write-up: severe chest and back pain; severe chest and back pain; muscles all over my body started to "twitch"; thickened pericardium; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 27Jul2021 at single dose for COVID-19 immunisation and four days later, she was woken up by a strong pain in her chest and back. The patient was revaccinated on August 22, and for the following two nights she was woken up again by that impossibly strong pain in her chest and back, and it lasted whole night. In the emergency medical service, they told her that she had a very thickened pericardium. The patient received medicine for the pain. Since then, muscles all over her body started to "twitch" in 2021. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1708135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Cerebral haemorrhage, Cerebral salt-wasting syndrome, Computerised tomogram, Haemorrhage intracranial, Malaise, Skull fracture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:
Allergies:
Diagnostic Lab Data: Test Name: Body scanner; Result Unstructured Data: Test Result:Left occipital bifocal fracture; Comments: for post-traumatic assessment. Left bifocal occipital fracture. Blood flooding in the interhemispheric scissure. Presence of multiple centimetric and subcentimetric hemorrhagic foci in the frontal region bilaterally and right parietotemporally.Cerebral edema with effacement of subarachnoid spaces. Hematic filling of the sphenoidal sinus. No other recent post-traumatic abnormality detected.
CDC Split Type: BEPFIZER INC202101180265

Write-up: Cerebral edema with erasure of subarachnoid spaces; Blood flooding in the interhemispheric scissure; Presence of multiple centimetric and subcentimetric hemorrhagic sites in the frontal region bilaterally and right parietotemporally; Left bifocal occipital fracture; Cerebral salt-wasting syndrome; Malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number BE-FAMHP-DHH-N2021-106127. A 36-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced cerebral oedema, bleeding intracranial, hemorrhage intracranial, fracture, malaise and cerebral salt-wasting syndrome. It was reported that the patient experienced discomfort on day 3, while cycling in a straight line, incomprehensible according to a witness, there was no car, nothing but she fell from her bike without catching up, nor getting hurt anywhere other than the head, hence the hypothesis discomfort. The patient cycled more than 50km every weekend without problem, and was in great health. The chronological link with the vaccine was striking, and yet it had not been spontaneously noted by emergency physicians (drug history) nor by intensive care physicians. The head trauma was currently complicated by a cerebral salt-wasting syndrome and the patient was still hospitalized in critical condition in intensive care at the time of reporting. The events were reported serious due to life-threatening events and hospitalization. Outcome of the events was not recovered. Reporters comment: Treatment - No. Evolution of the ADR - Aggravation. Examinations - Body scanner Reason: post-traumatic assessment. Left occipital bifocal fracture. Flood of blood in the interhemispheric fissure. Presence of multiple centimetric and infracentimetric hemorrhagic sites in the frontal region bilaterally and right parietotemporal. Cerebral edema with erasure of the subarachnoid spaces Hematic filling of the sphenoid sinus. No other anomaly of recent post-traumatic origin detected. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Aggravation Examinations - Body scanner Reason: post-traumatic assessment. Left occipital bifocal fracture. Flood of blood in the interhemispheric fissure. Presence of multiple centimetric and infracentimetric hemorrhagic sites in the frontal region bilaterally and right parietotemporal. Cerebral edema with erasure of the subarachnoid spaces Hematic filling of the sphenoid sinus. No other anomaly of recent post-traumatic origin detected.


VAERS ID: 1708162 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-08-22
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Colitis ulcerative, Colonoscopy, Diarrhoea haemorrhagic, Haematochezia, Investigation, Mucous stools, Pyrexia, Weight, Weight decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLECTRA [INFLIXIMAB]; PREDNISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis (Diagnosed 3 months ago)
Allergies:
Diagnostic Lab Data: Test Name: Colonoscopy; Result Unstructured Data: Test Result:Not reported; Test Date: 20210822; Test Name: CRP; Result Unstructured Data: Test Result:51; Test Name: bowel movements; Result Unstructured Data: Test Result:20 a day; Test Name: Partial Mayo Index Score; Result Unstructured Data: Test Result:9; Comments: Prior to prednisone/hospitalization; Test Name: Partial Mayo Index Score; Result Unstructured Data: Test Result:3; Test Name: weight; Result Unstructured Data: Test Result:lost 20 lbs
CDC Split Type: CAPFIZER INC202101162158

Write-up: Patient then went to the ER, underwent a colonoscopy and had a fever.; Patient had lost 20 lbs by then; her symptoms have been getting more and more severe since.; For 3 weeks then began having blood in her diarrhea; patient was evacuating 20BMs a day, with often only blood and mucus in stool.; patient was evacuating 20BMs a day, with often only blood and mucus in stool.; CRP of 51 on 22Aug2021; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Lot number was not reported), via an unspecified route of administration on May2021 at the age of 54-year-old as dose unknown, single for covid-19 immunisation. Medical history included ulcerative colitis (Diagnosed 3 months ago) and allergy to ciprofloxacin. Concomitant medications included infliximab (Infliximab 100Mg) taken 10mg/kg for ulcerative colitis from 01Sep2021 and ongoing prednisone taken 40mg, with weaning doses for 8 weeks for an unspecified indication from 18Aug2021. On May2021, patient received COVID-19 vaccine and starting her ulcerative colitis related reaction, states her symptoms have been getting more and more severe since. Patient started diarrhea 12 days after vaccine, for 3 weeks then began having blood in her diarrhea. Patient then went to the emergency room (ER), underwent a colonoscopy and had a fever. Patient was hospitalized on 18Aug2021, where she started prednisone. Patient had lost 20 lbs by then. C- Reactive Protein (CRP) of 51 on 22AUG2021. Prior to hospitalization, patient was evacuating 20 bowel movements (BMs) a day, with often only blood and mucus in stool. Partial Mayo prior to prednisone/hospitalization at 9. Patient reports having 5 stools a day that are partially formed since receiving first dose of infliximab on 02Sep2021, with no blood in stool. On 03Sep2021, Partial Mayo at 3. The outcome of events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pyrexia, weight decreased, C-reactive protein increased, Colitis ulcerative, Diarrhoea haemor-rhagic, and Haematochezia, and BNT162B2. 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: 1708199 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Hyperhidrosis, Pallor, Presyncope, Tinnitus, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: 97/60 mmHg
CDC Split Type: CZJNJFOC20210930740

Write-up: Tinnitus; Pre-syncope; Fog in front of eyes; Felt faint; Sweating; Pallor; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, CZ-CZSUKL-21010311) on 15-SEP-2021 concerned a 46 year old male with an unspecified race and ethnic origin. The patient''s weight was 83 kilograms and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) 1 dosage forms, with frequency 1 total administered on 22-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 22-AUG-2021, the patient experienced tinnitus, pre-syncope, fog in front of eyes, felt faint, sweating and pallor. On the same day, the patient went for laboratory tests included Blood pressure (NR: not provided) 97/60 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tinnitus, pre-syncope, fog in front of eyes, felt faint, sweating, and pallor on 22-AUG-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1709259 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCPT7 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Myocarditis, Troponin
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:
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: Test Result:Rised; Test Name: Troponin; Result Unstructured Data: Test Result:Rised
CDC Split Type: DEPFIZER INC202101180617

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100184105. A 21-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 11Aug2021 (at the age of 21 years old) (Lot Number: SCPT7) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced Myocarditis. Lab test showed troponin and CK (creatine phosphokinase) rise. Therapy with Ramipril/Eplerenone/Bisoprolol was initiated. The event was reported as serious - hospitalization, life threatening. The patient''s outcome was: not recovered/not resolved for Myocarditis. Relatedness Assessment: Myocarditis: DB. Indeterminate. Source of assessment: PEI. Sender Comment: Initials: PRIVACY troponin and CK rise. Therapy with Ramipril/Eplerenone/Bisoprolol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0884 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute leukaemia (As 2 years old patient was diagnosed with Acute Leukemia); Bone marrow transplant (It is considered that the immune response can therefore be threatened by infections.); Myelodysplastic syndrome (As 6 years old patient was diagnosed with MDS)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101155698

Write-up: Vomiting; Nausea; Appendicitis; Subfebrile; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is DK-DKMA-WBS-0086984. A 14-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Aug2021 (Lot Number: FF0884; Expiration Date: 30Nov2021) as dose 2, single for COVID-19 immunization. Historical Vaccine (COMIRNATY) was given via an unspecified route of administration on 26Jul2021 (Lot Number: FD4555; Expiration Date: 30Sep2021) for COVID-19 immunization. Medical history included myelodysplastic syndrome (As 6 years old patient was diagnosed with MDS), bone marrow transplant (it is considered that the immune response can therefore be threatened by infections), acute leukaemia (2 years old patient was diagnosed with Acute Leukemia); all were not ongoing. The patient''s concomitant medications were not reported. The patient previously took primcillin on 29Jun2020 for infection. On 22Aug2021, the patient experienced vomiting, nausea, appendicitis and subfebrile. The outcome of the events was recovered with sequelae on 24Aug2021. The events were assessed as serious (hospitalization). Therapeutic measures were taken as a result of appendicitis that included appendectomy on an unknown date in Aug2021. The patient was discharged with an uncomplicated course. No follow-up attempts possible. No further information expected.


VAERS ID: 1709739 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153105

Write-up: Eye haemorrhage; This is a This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210903181811, Safety Report Unique Identifier GB-MHRA-ADR 25893835. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on 21Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history included ongoing suspected COVID-19 (unsure when symptoms started). Concomitant medications were not reported. The patient was not enrolled in clinical trial. On 22Aug2021, the patient experienced eye haemorrhage. GP advised all ok and should go within a week but still there. The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on 03Jul2021. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1709776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153331

Write-up: Sleepy; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109031012058630-MCRJB. Safety Report Unique Identifier GB-MHRA-ADR 25891836. A 27-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: FE3380) dose 2 via an unspecified route of administration on 21Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. The patient previously took BNT162B2, dose 1 for COVID-19 immunization on an unspecified date. The patient''s medical history and concomitant medications were not reported. On 22Aug2021 the patient experienced sleepy and headache. The patient underwent lab tests and procedures which included SARS-CoV-2 test was negative on 03Sep2021, No-Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of event (sleepy) was recovering and event of (Headache) was recovered on 27Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709835 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Heart rate, Investigation, Oxygen saturation, Pallor, Syncope, Vaccination site haemorrhage, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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:
Diagnostic Lab Data: Test Date: 20210822; Test Name: pulse rate; Result Unstructured Data: Test Result:normal; Comments: pulse rate, breathing rate, O2 sat level) - all were normal; Test Date: 20210822; Test Name: breathing rate; Result Unstructured Data: Test Result:normal; Comments: pulse rate, breathing rate, O2 sat level) - all were normal; Test Date: 20210822; Test Name: O2 sat level; Result Unstructured Data: Test Result:normal; Comments: pulse rate, breathing rate, O2 sat level) - all were normal
CDC Split Type: GBPFIZER INC202101153269

Write-up: Syncope; Pale; Disorientated; bleeding at injection site; mild pain in the arm after injection; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109032211336100-UTLWD, Safety Report Unique Identifier GB-MHRA-ADR 25895222. A 23-years-old non-pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number: FE3380, Expiration date was not reported), via an unspecified route of administration on 22Aug2021 (at the age of 23-years-old) as dose 2, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient medical history and concomitant medications were not reported. On 22Aug2021the patient experienced syncope. on an unspecified date in 2021, patient experienced pale, disorientated, bleeding at injection site and mild pain in the arm after injection. Patient experienced 2 episodes of syncope during vaccination. Patient said there was excessive bleeding at injection site during the second vaccination. Clinical lead could not ascertain the amount of blood as it was cleaned before lead could made a judgment. Syncope lasted for approximately a few seconds on each occasion and patient vital signs were extensively monitored. Patient recovered very quickly. Patient syncope could be anxiety related witnessing bleeding arm as expressed by patient or other factors such as a lack of fluids /food prior to vaccine which was declared by the patient. This could have contributed to the syncope. Clinical lead made determination that injection technique of vaccinator required improvement so vaccinator was placed under supervision and subsequently given a non-vaccinator role. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included heart rate: normal, pulse rate normal, breathing rate, (O2 sat level: normal) all on 22Aug2021. The outcome of the event syncope was recovered on 22Aug2021, outcome of event pale, disorientation was recovered on unspecified date in 2021 and outcome of event bleeding at injection site, mild pain in the arm after injection was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1710012 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain menstrual; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101217289

Write-up: Ache; second dose bnt162b2 on 22Aug2021, first dose of bnt162b2 on 13Jun2021; This is a solicited report from the RA program received from a contactable consumer. This is the second of two reports. The first report is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106092214476280-OX1HI, Safety Report Unique Identifier GB-MHRA-ADR 25506667. A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose via an unspecified route of administration on 22Aug2021 at the age of 30-year-old (Lot Number: FE3380) for COVID-19 immunization. Medical history included suspected covid-19 from 25Dec2020 and unsure when symptoms stopped and pain menstrual. Concomitant medication included naproxen taken for pain menstrual. Last menstrual period date of the patient was 03Aug2021. The patient was not pregnant, was not currently breastfeeding. The historical vaccine included the first dose of bnt162b2 (Lot Number: FC8289) on 13Jun2021 for COVID-19 immunisation and experienced tenderness. The patient experienced ache on 23Aug2021 with outcome of recovered on 24Aug2021. The patient had positive COVID-19 test on 27Dec2020, had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The case was reported as serious, the seriousness criteria was other medically important condition. The reporter''s assessment of the causal relationship of the event ache with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Pain and BNT162B2. 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.,Linked Report(s) : GB-PFIZER INC-2021747180 same patient,different dose/different event


VAERS ID: 1710485 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004952 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Trigeminal neuralgia
SMQs:, Demyelination (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: AERIUS [DESLORATADINE]; VENTOLINE [SALBUTAMOL]; BUFOMIX EASYHALER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Trigeminusnevralgi; This case was received via Agency (Reference number: NO-NOMAADVRE-E2B_00046190) on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminusnevralgi) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004952) for Vaccination. Concomitant products included DESLORATADINE (AERIUS [DESLORATADINE]), SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and BUDESONIDE, FORMOTEROL FUMARATE (BUFOMIX EASYHALER) for an unknown indication. On 12-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminusnevralgi) (seriousness criterion hospitalization). At the time of the report, TRIGEMINAL NEURALGIA (Trigeminusnevralgi) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered TRIGEMINAL NEURALGIA (Trigeminusnevralgi) to be possibly related. Treatment information was not provided. Company Comment: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Trigeminal neuralgia. The event Trigeminal neuralgia occurred 10 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Translation received on 14-sep-2021 added no new information.; Sender''s Comments: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Trigeminal neuralgia. The event Trigeminal neuralgia occurred 10 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1710557 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-22
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Malaise, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: PHMODERNATX, INC.MOD20213

Write-up: Chest pain, Colds, Body Malaise, Difficulty breathing; Chest pain, Colds, Body Malaise, Difficulty breathing; Chest pain, Colds, Body Malaise, Difficulty breathing; Chest pain, Colds, Body Malaise, Difficulty breathing; This regulatory authority case was reported by an other health care professional and describes the occurrence of MALAISE (Chest pain, Colds, Body Malaise, Difficulty breathing), DYSPNOEA (Chest pain, Colds, Body Malaise, Difficulty breathing), CHEST PAIN (Chest pain, Colds, Body Malaise, Difficulty breathing) and RHINITIS (Chest pain, Colds, Body Malaise, Difficulty breathing) in a 34-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced MALAISE (Chest pain, Colds, Body Malaise, Difficulty breathing) (seriousness criterion hospitalization prolonged), DYSPNOEA (Chest pain, Colds, Body Malaise, Difficulty breathing) (seriousness criterion hospitalization prolonged), CHEST PAIN (Chest pain, Colds, Body Malaise, Difficulty breathing) (seriousness criterion hospitalization prolonged) and RHINITIS (Chest pain, Colds, Body Malaise, Difficulty breathing) (seriousness criterion hospitalization prolonged). At the time of the report, MALAISE (Chest pain, Colds, Body Malaise, Difficulty breathing) and DYSPNOEA (Chest pain, Colds, Body Malaise, Difficulty breathing) was resolving and CHEST PAIN (Chest pain, Colds, Body Malaise, Difficulty breathing) and RHINITIS (Chest pain, Colds, Body Malaise, Difficulty breathing) had resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. This case concerns a 34-year-old, female subject with no relevant medical history, who experienced unexpected events of Malaise, Dyspnea, Rhinitis, and Chest pain. The event occurred 25 days from the last dose of mRNA-1273 vaccine. The rechallenge is not applicable since the dose number is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 34-year-old, female subject with no relevant medical history, who experienced unexpected events of Malaise, Dyspnea, Rhinitis, and Chest pain. The event occurred 25 days from the last dose of mRNA-1273 vaccine. The rechallenge is not applicable since the dose number is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1710632 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Illness, Loss of personal independence in daily activities, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness: Asthma; Diabetes; Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101150020

Write-up: ill; could not get out of bed, eat and drink.; Vomiting; Breathing difficult; throat felt tighter; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-077562. A 58-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, at age 58 years, on 22Aug2021 (Batch/Lot Number: FE8235) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing diabetes, ongoing epilepsy, and ongoing asthma. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The reporter described the patient having breathing difficult/difficulty breathing immediately after the vaccination on 22Aug2021, and when she got home her throat felt tighter and became even more difficult to breathe and she needed to take her nebulizer with asthma medication (although not specified which asthma medication she uses). The reporter stated that it came quickly, and she became very ill and could not get out of bed, eat and drink from an unspecified date. The patient also experienced vomiting the day after vaccination on 23Aug2021. The outcome of the event/course was still not recovered. The case was assessed as a serious, permanent physical impairment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1714589 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-22
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Breath shortness; Chest pain; Throat tightness; This case was received via the RA (Reference number: GB-MHRA-ADR 25928694) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breath shortness), CHEST PAIN (Chest pain) and THROAT TIGHTNESS (Throat tightness) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DYSPNOEA (Breath shortness) (seriousness criterion disability), CHEST PAIN (Chest pain) (seriousness criterion disability) and THROAT TIGHTNESS (Throat tightness) (seriousness criterion disability). At the time of the report, DYSPNOEA (Breath shortness), CHEST PAIN (Chest pain) and THROAT TIGHTNESS (Throat tightness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. Company comment: This case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected events of dyspnoea, chest pain and throat tightness. The events occurred approximately 1 month after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected events of dyspnoea, chest pain and throat tightness. The events occurred approximately 1 month after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1714794 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Serology test
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: echocardiography; Result Unstructured Data: Test Result: excluded: viral myocarditis; Test Name: ECG; Result Unstructured Data: Test Result: excluded: viral myocarditis; Test Name: serology; Result Unstructured Data: Test Result: excluded: viral myocarditis
CDC Split Type: DEPFIZER INC202101155579

Write-up: Myocarditis; This is a spontaneous report from a non-contactable other-healthcare professional downloaded from the Medicines Agency (MA) EudraVigilance-WEB DE-PEI-202100180599. A 15-year-old male patient was treated with BNT162B2 (Pfizer. Solution for injection, Lot number SCRM8 and Expiry date was not reported) via an unspecified route of administration on 19Aug2021 (at the age of 15-years-old) as dose number unknown, 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 (Comirnaty. Solution for injection, Lot number and Expiry date was unknown) via an unspecified route of administration on 15Jul2021 as dose number unknown, 0.3 ml, single for COVID-19 immunisation. On 22Aug2021, the patient experienced Myocarditis. The event was serious hospitalization. The patient underwent lab tests and procedures which included echocardiogram: excluded: On an unspecified date viral myocarditis, electrocardiogram: excluded: viral myocarditis, serology test: excluded: viral myocarditis. Outcome of event was not recovered. Regulatory authority comment: ECG, serology, echocardiography excluded: viral myocarditis Event assessment: PEI/D. Unclassifiable No follow-up attempts possible. No further information expected.


VAERS ID: 1715943 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

Administered by: Unknown       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? 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: Drug allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Myopericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via a Regulatory Authority (Reference number: FR-AFSSAPS-BR20213299) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included Myopericarditis in 2016. Concurrent medical conditions included Drug allergy. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality is confounded with patient''s reported medical history.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality is confounded with patient''s reported medical history.


VAERS ID: 1715995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site urticaria
SMQs:, Hypersensitivity (narrow)

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: FRPFIZER INC202101155400

Write-up: Administration site urticaria; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212677. A 72-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FF0688), via an intramuscular route of administration on 21Aug2021 in Arm Right as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient''s medical history of COVID-19 and tested for COVID-19 reported as no. On 22Aug2021 the patient experienced administration site urticaria. The clinical outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKT3 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (narrow), 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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

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: MUNALEA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155113

Write-up: Lung embolism; Circulatory collapse; Dyspnoea; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021172778. A 17-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Lot number: SCKT3) via an unspecified route of administration on 18Aug2021, as dose number unknown, 0.3ml single for COVID-19 immunization. Medical history was not reported. Concomitant medications included desogestrel, ethinylestradiol (Munalea). On 22Aug2021, the patient experienced dyspnoea (hospitalization). On 30Aug2021, the patient experienced lung embolism (hospitalization) and circulatory collapse (hospitalization). The outcome of the event dyspnoea was recovered with sequelae on 31Aug2021 while for the other events was recovered with sequelae on an unspecified date. Sender comment: Do you or the person concerned have any known allergies If so, which ones? Details of risk factors or previous illnesses. Taking Munalea 30 (the pill). Latent circulatory collapse on 30Aug2021 and hospitalisation via ambulance service, currently being treated as an inpatient. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1716544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-08-22
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chest pain, Chills, Cough, Diarrhoea, Dyspnoea, Fatigue, Headache, Myalgia, Nasal congestion, Odynophagia, Oropharyngeal discomfort, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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: Test Date: 20210827; Test Name: COVID-19 antibody test; Test Result: Positive ; Comments: IgG Serology for SARS-CoV-2 (Acs for Protein N and Protein S): IgG positive for anti-spicule antibodies (UA/mL) that can be generated in response to infection or post-vaccination. Anti-nucleocapsid Ac, which occurs only in response to infection, is negative. It is advisable to send a new sample in a week to see evolution. SARS-CoV-2 IgG (anti-spicule) 266.00 AU/mL Positive 37.77 BAU/mL Technique: CMIA SARS-CoV-2 IgG vs. spicule protein Absence of immunity .50 AU/mL Acquired immunity . 50 AU/mL SARS-CoV-2 IgG (anti-nucleocapsid) 0.050 Negative Index Technique: CMIA SARS-CoV-2 IgG vs. nucleocapsid protein; Test Date: 20210823; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210821; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101156445

Write-up: throat clawing; Myalgia; Fever; COVID-19/Vaccination failure; COVID-19/Vaccination failure; Odynophagia; Congestion nasal; Rhinorrhea; Chills; Cough; Dyspnea; Diarrhea; Headache; Chest pain; Anosmia; Ageusia; Tiredness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-989648. A 38-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 12Feb2021 (lot number: EM6950) as dose 2, single and intramuscularly on 15Jan2021 (lot number: EM0477) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19/vaccination failure, odynophagia, congestion nasal, rhinorrhea, chills, cough, dyspnea, diarrhea, headache, chest pain, anosmia, ageusia, tiredness on 22Aug2021, myalgia, fever on 25Aug2021, throat clawing on 26Aug2021. It was reported that on 22Aug2021, the symptoms began: odynophagia, nasal congestion and rhinorrhea, chills. No other symptoms (as reported; pending clarification): fever, cough, dyspnea, diarrhea, headache, chest pain, anosmia, ageusia, myalgia/arthralgia, asthenia. On 23Aug2021, antibody Trst (PDAg) negative. Clinic: It is better than yesterday, without chills, maintains odynophagia, congestion and rhinorrhea. On 25Aug2021, Polymerase chain reaction (PCR) positive. On 26Aug2021, it was reported that yesterday afternoon, he had a bad time, with great fatigue, fever of 38?C and generalized myalgias. Today, these symptoms have disappeared, but nasal congestion, rhinorrhea and throat clawing persist, odynophagia has disappeared. It was reported that on 27Aug2021: IgG serology for SARS-CoV-2 (Acs for protein N and protein S): IgG positive for anti-spicule antibodies (UA/mL) that can be generated in response to infection or post-vaccination. Anti-nucleocapsid Ac, which occurs only in response to infection, is negative. It is advisable to send a new sample in a week to see evolution. SARS-CoV-2 IgG (anti-spicule) 266.00 UA/mL Positive 37.77 BAU/mL. Technique: CMIA SARS-CoV-2 IgG vs. spicule protein. Absence of immunity 50 AU/mL. Acquired immunity = 50 AU/mL. SARS-CoV-2 IgG (anti-nucleocapsid) 0.050 Negative Index. Technique: CMIA SARS-CoV-2 IgG vs. nucleocapsid protein. The patient underwent lab tests and procedures which included COVID-19 antibody test positive, COVID-19 antigen test: negative on 23Aug2021, COVID-19 PCR test: negative on 21Aug2021 and positive on 25Aug2021. The outcome of the events COVID-19/vaccination failure, congestion nasal, rhinorrhea was recovering, the events odynophagia, chills, tiredness, myalgia, fever was recovered on 26Aug2021, while the outcome of all other events was unknown. On 08Sep2021, the Quality Complaints group reported the following investigational results. Conclusion of previously completed investigation: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. Conclusion of Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM6950. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. On 09Sep2021, the Quality Complaints group reported the following investigational results. Brief complaint description: After ECLIA test no antibodies 7 days after 2nd vaccination; Reasonably Suggest Device Malfunction? No; Severity of Harm: Not Applicable. Site Sample Status: Not Received; Summary of Investigation from Regulatory Authority was: blank; Investigational report conclusion from Regulatory Authority was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the Lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for a cardiac arrest after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No additional information is expected.


VAERS ID: 1716655 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Erythema, Fatigue, Hypersensitivity, Pain of skin, Pericarditis, Tinnitus
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LUDEAL; L THYROXIN HENNING
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s thyroiditis (chronic); Thyroidectomy (partial thyroidectomy 3 years ago.)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:inflammatory syndrome; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:acute pericarditis; Test Name: electrocardiogram; Result Unstructured Data: Test Result:acute pericarditis
CDC Split Type: FRPFIZER INC202101160464

Write-up: Pericarditis; Stethalgia; difficulty breathing; very tired very quickly; allergic reaction; Ear buzzing; redness and pain in the scalp; redness and pain in the scalp; This is a spontaneous report from a contactable consumer (patient herself), downloaded from the Agency. The regulatory authority number is FR-AFSSAPS-MP20216992. A 40-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly on 21Aug2021 (Batch/Lot Number: FE8244, Expiration date: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included partial thyroidectomy 3 years ago (in 2018) and Hashimoto''s thyroiditis, chronic from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, levonorgestrel (LUDEAL, Coated tablet, strength: levonorgestrel 150 ug, ethinylestradiol 30 ug) taken for an unspecified indication, start and stop date were not reported and levothyroxine sodium (L THYROXIN HENNING, scored tablet, strength: 50 ug) taken for an unspecified indication, start and stop date were not reported. On 22Aug2021, the patient experienced pericarditis, stethalgia (chest pain), and difficulty breathing. On 24Aug2021, the patient experienced ear buzzing, also reported as ringing in the ears; redness and pain in the scalp; and allergic reaction. On an unspecified, the patient experienced and was very tired very quickly. It was further reported that the patient had chest pain and difficulty breathing due to pain in the heart the day after the vaccine was injected. They called 15 and there was an intervention of the firefighters, who transported the patient to the hospital. After an electrocardiogram and cardiac ultrasound on an unspecified date, the physician diagnosed acute pericarditis. Aspegic introduction was initiated; inflammatory syndrome was noted on blood test on an unspecified date. The patient was discharged from the hospital with a prescription for ASPEGIC 1g 3x/day for 1 week then 2x/day for 1 week then 1x/day for 1 week; COLCHIMAX 0.5 tab for 1 month; and INEXIUM 20 mg for 1 month. Cardiologist appointment was scheduled for 09Sep2021 and a 3-week leave. After 7 days of treatment, the patient still had pain in the heart; she became out of breath and very tired very quickly. Two days after the diagnosis of pericarditis, the patient saw her doctor because she had ringing in the ears as well as redness and pain in the scalp; the physician prescribed EBASTINE 10 mg for 8 days because the doctor diagnosed that as an allergic reaction. This report was considered serious, as the patient was hospitalized for the events pericarditis, stethalgia, and difficulty breathing on an unspecified. Therapeutic measures were taken as a result of pericarditis, stethalgia, difficulty breathing, ear buzzing, redness and pain in the scalp, and allergic reaction. The patient was not recovered from the events pericarditis, stethalgia, difficulty breathing, ear buzzing, redness and pain in the scalp, and allergic reaction; while the outcome of very tired very quickly was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Blood test, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Inappropriate schedule of product administration, Inflammation, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow)

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: Medical History/Concurrent Conditions: Blood test; Chest pain; Creatine kinase; ECG; Inflammation; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:raised levels of cardiac enzymes; Comments: (troponin, creatine kinase), which later dissipated.; Test Name: ECHO; Result Unstructured Data: Test Result:no damage; Test Name: ECG; Result Unstructured Data: Test Result:no damage
CDC Split Type: GBPFIZER INC202101168481

Write-up: inflammation; Raised levels of cardiac enzymes (troponin, creatine kinase); Raised levels of cardiac enzymes (troponin, creatine kinase); Chest pain; Shortness of breath; Dose 1 on 27Jun2021 and dose 2 on 22Aug2021; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109061039143090-JZRSH, Safety Report Unique Identifier GB-MHRA-ADR 25899475. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 22Aug2021, as dose 2, single for COVID-19 immunization. Medical history included dyspnoea, Blood creatine phosphokinase, inflammation, chest pain, blood test, electrocardiogram. The patient''s concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number was not reported) on 27Jun2021 for COVID-19 immunization. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Reporter stated that he was admitted to the Medical Assessment Unit (at the hospital) on Wednesday 01Sep2021 following reports of chest pain and shortness of breath. A blood test revealed that he had raised levels of cardiac enzymes (troponin, creatine kinase), which later dissipated. After an ECG and ECHO, her heart did reveal no damage, however the Cardiologist does suspect that there was an adverse reaction of mild inflammation because of the second Pfizer vaccination. He was now at home and able to work but have a follow up appointment with Cardiology. He was still experiencing chest pains and shortness of breath. On 01Sep2021, the patient experienced chest pain, Shortness of breath and on an unspecified date, the patient also had inflammation. The patient underwent lab tests and procedures which included blood test: cardiac enzymes elevated on an unspecified date, (troponin, creatine kinase), which later dissipated; ECG: no damage on an unspecified date; ECHO: no damage on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event inflammation was recovering, for events Chest pain and Shortness of breath was not recovered and for Raised levels of cardiac enzymes (troponin, creatine kinase) was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1717265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-22
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus test, Blood immunoglobulin G, Blood immunoglobulin M, Borrelia test, C-reactive protein, Chest pain, Dyspnoea, Echocardiogram, Enterovirus test, Heart rate, Influenza A virus test, Influenza B virus test, Malaise, Myocardial necrosis marker, Prohormone brain natriuretic peptide, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin I, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Adenovirus test; Result Unstructured Data: Test Result:unknown results; Test Name: IgG; Result Unstructured Data: Test Result:Negative; Test Name: IgM; Result Unstructured Data: Test Result:Negative; Test Date: 20210825; Test Name: Borrelia test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210824; Test Name: C-reactive protein; Result Unstructured Data: Test Result:unknown results; Test Name: Ecocardiography; Result Unstructured Data: Test Result:unknown results; Test Date: 20210823; Test Name: Enterovirus test; Result Unstructured Data: Test Result:unknown results; Test Name: evaluation of rhythm/heart rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20210823; Test Name: Influenza A; Result Unstructured Data: Test Result:Negative; Test Date: 20210823; Test Name: Influenza B; Result Unstructured Data: Test Result:Negative; Test Name: evaluation of cardiac enzymes; Result Unstructured Data: Test Result:unknown results; Test Date: 20210823; Test Name: Prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:unknown results; Test Date: 20210823; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210822; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210822; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210822; Test Name: Troponin I; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101157977

Write-up: Acute dyspnea; Tachycardia ventricular; Pain retrosternal; General malaise; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-778413. A 20-year-old male patient received bnt162b2 (COMIRNATY) intramuscular, administered in left deltoid on 04Aug2021 (Batch/Lot Number: FF0680; Expiration Date: 04Aug2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced acute dyspnea, tachycardia ventricular, pain retrosternal, and general malaise. Clinical course was reported as follows. Acute onset of dyspnoea, retrosternal pain and general malaise 18 days after vaccination with the first dose of Comirnaty, a self-limited episode of ventricular tachycardia on 22Aug2021. Measures taken included observation in Intensive Unit Care (ICU) for 5 days. Ecocardiography, evaluation of rhythm/heart rate, evaluation of cardiac enzymes. On 01Sep2021 the patient is still hospitalised but no longer in ICU, his conditions were improving. Influence A / B negative; 7.14mg/dl; negative (performed to rule out post-Covid myocarditis); negative (IgG and IgM); negative; negative; 70956ng/l; 290pg/ml; negative; negative. The patient underwent lab tests and procedures which included IgG and IgM on an unspecified date with negative results; Ecocardiography, evaluation of rhythm/heart rate, evaluation of cardiac enzymes on unspecified dates with unknown results; Troponin I, COVID-19 antigen test and SARS-CoV-2 PCR test all on 22Aug2021 with unknown results; adenovirus test, enterovirus test, prohormone brain natriuretic peptide, SARS-CoV-2 IgG antibody test all on 23Aug2021 with unknown results; influenza A, influenza B on 23Aug2021 with negative result; c-reactive protein on 24Aug2021 with unknown results; borrelia test with unknown results on 25Aug2021; The patient was recovering from the events. Sender comment: Local Pharmacovigilance Manager: on 01Sep2021 reporting the additional information provided by the reporter on request (Update result, SARS-Cov2 tests details, result Borrelia test). At the request of Agency, I request the following additional information from the reporter on 06Sep2021: clinical course, further investigations, updated outcome, pending.


VAERS ID: 1717428 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Interstitial lung disease, Pyrexia, SARS-CoV-2 test
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XELJANZ 5MG
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: PCR test; Test Result: Positive.
CDC Split Type: JPPFIZER INC202101165118

Write-up: Interstitial pneumonia; COVID-19 Infection; Pyrexia; This is a spontaneous report from a contactable physician via a Representative. An adult female patient around 40s or 50s received bnt162b2 (COVID-19 vaccine) dose 1 via an unspecified route of administration on 21Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation, XELJANZ 5MG, tablet, oral from an unspecified date (Lot Number: not reported) to 26Aug2021, at 10 mg daily for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. The patient experienced COVID-19 infection on 22Aug2021 and interstitial pneumonia on 26Aug2021. The action taken in response to the events for XELJANZ was temporarily withdrawn on 26Aug2021. The reporter classified the events COVID-19 infection and interstitial pneumonia as serious (Hospitalization) and assessed the events as related to XELJANZ. Clinical course was on 21Aug2021 (day of the vaccination), the patient received the first dose of coronavirus vaccine. On 22Aug2021 (1 day after the vaccination), the pyrexia was noted. Pyrexia persisted for about 3 to 4 days. The patient visited hospital and underwent PCR test which showed positive in Aug2021. Since the Interstitial pneumonia was also confirmed, the patient admitted to the hospital just in case. Events were recovering at the time of report, and the patient is scheduled to be discharged on 07Sep2021. Pyrexia resulted in physician office visit. The outcome of events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Reported events are assessed as related to the suspect drug based temporal association and drug safety profile. Case to be re-assessed upon receipt of new information. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


VAERS ID: 1717615 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Borrelia test, Electrocardiogram, Facial paresis, Magnetic resonance imaging head
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Normal findings; Test Date: 202108; Test Name: Borrelia test; Result Unstructured Data: Test Result:Negative; Test Date: 202108; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm, normal frequency and registration.; Test Date: 202108; Test Name: MRI brain; Result Unstructured Data: Test Result:Normal findings.; Comments: No signs of infarction, inflammation or tumor.
CDC Split Type: NOPFIZER INC202101155746

Write-up: FACIAL PARESIS; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority-WEB, Regulatory authority number: NO-NOMAADVRE-FHI-2021-Urqmge. A 38-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in the left arm on 12Aug2021 at 11:00 (Batch/Lot Number: FG3716) as dose 2, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient developed facial paresis described as right central paresis and left peripheral paresis. The patient was hospitalized. The patient underwent lab tests and procedures which included blood test: normal findings in Aug2021, borrelia test: negative in Aug2021, electrocardiogram (ECG): sinus rhythm, normal frequency and registration in Aug2021, and Magnetic Resonance Imaging (MRI) brain: normal findings in Aug2021 with no signs of infarction, inflammation or tumor. The outcome of the event was not resolved. The case was assessed as serious. The source of assessment was reported as Agency and result of assessment was reported as Possible. Sender''s comment: translated text - no quotes needed.


VAERS ID: 1717617 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis, Pain, Pyrexia, Troponin T, Troponin T increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: C-reactive protein; Result Unstructured Data: Test Result:56 mg/l; Comments: increased; Test Date: 20210822; Test Name: Echocardiography; Result Unstructured Data: Test Result:Without definite signs of perimyocarditis; Comments: good left ventricular function.; Test Date: 20210822; Test Name: ECG; Result Unstructured Data: Test Result:Without ischemia changes or ST elevations; Test Date: 20210822; Test Name: Troponin T; Result Unstructured Data: Test Result:800 ng/L; Comments: Increased troponin T
CDC Split Type: NOPFIZER INC202101155737

Write-up: Perimyocarditis; C-reactive protein 56 mg/L; Troponin T 800 ng/L; position-dependent retrosternal chest pain; Vomiting; Fever; episodic pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uz8j9g. A 25-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FG3716), intramuscular on 18Aug2021 19:44 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021 19:44, the patient experienced perimyocarditis. On 22Aug2021, the patient had c-reactive protein 56 mg/l (c-reactive protein increased) and troponin t 800 ng/l (troponin t increased). In addition, the patient had position-dependent retrosternal chest pain on 22Aug2021. Furthermore, the patient experienced vomiting, fever and episodic pain on an unspecified date in 2021. The patient underwent lab tests and procedures which included c-reactive protein: 56 mg/l on 22Aug2021, echocardiogram: without definite signs of perimyocarditis on 22Aug2021 good left ventricular function, electrocardiogram: without ischemia changes or ST elevations on 22Aug2021 and troponin T: 800 ng/l on 22Aug2021 (increased troponin T). Clinical course details: A 25 years old man hospitalized with perimyocarditis four days after vaccination with covid-19 vaccine (Comirnaty), first dose (18Aug2021). Debut of position-dependent retrosternal chest pain on the evening of 22Aug2021. Subsequent vomiting and fever. Persistent episodic pain. Electrocardiogram (ECG) without ischemia changes or ST elevations. Echocardiography without definite signs of perimyocarditis, good left ventricular function. Increased troponin T and C-reactive protein. Waiting for Magnetic resonance imaging (MRI) cor. The outcome of perimyocarditis was recovering; outcome of the other events was unknown. Relatedness of drug to reactions/events: Source of assessment: Regional Pharmacovigilance Center. Result of Assessment: Possible. Reporter comment: Debut of position-dependent retrosternal chest pain on the evening of 22Aug2021. Subsequent vomiting and fever. Persistent episodic pain. Waiting for MRI cor. Sender''s comment: translated text - no quotes needed.


VAERS ID: 1717656 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Atopic eczema
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:maximum of 38.5? Centigrade; Comments: Fever
CDC Split Type: PTPFIZER INC202101155908

Write-up: Headache; Fever (maximum of 38.5?C); This is a spontaneous report from a contactable physician downloaded from the RA0. This is a report received from INFARMED Regulatory authority report number [PT-INFARMED-B202108-3083] with Safety Report Unique Identifier [PT-INFARMED-B202108-3083]. ~ A 14-year-old male patient received the first dose of BNT162B2 (COMIRNATY solution for injection; strength: 0.3 ml; lot number: FD9309), via intramuscular on 21Aug2021 (at an unspecified age) at dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included allergic rhinitis and atopic eczema; both from an unspecified date and unknown if ongoing. The patient''s concomitant medications were reported as none. On 22Aug2021, 1 day after the vaccination, the patient experienced headache and fever (maximum of 38.5?C). The events caused absence from work for two days on the part of the patient''s mother in order to ensure surveillance and assistance. The patient was given paracetamol which was administered orally as treatment for the events. No medication error occurred. The events were reported as serious, medically significant. As of date of report, the events persisted without recovery. The evolution was unknown. The patient''s body temperature on 22Aug2021 was maximum of 38.5? Centigrade (fever). Outcome of the events was not recovered. Relatedness of BNT162B2 (COMIRNATY) to the events was probable (source of assessment: reporter, method of assessment: unknown). Reporter''s comment: No concomitant medications and no medication error occurred. The patient experienced maximum fever of 38.5?C. Personal history of the patient includes allergic rhinitis and atopic eczema. The suspected adverse reactions caused the patient''s mother to be absent from work for two days in order to ensure surveillance and assistance to the adolescent patient. No other information reported. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No concomitant medications and no medication error occurred. The patient experienced maximum fever of 38.5?C. Personal history of the patient includes allergic rhinitis and atopic eczema. The suspected adverse reactions caused the patient''s mother to be absent from work for two days in order to ensure surveillance and assistance to the adolescent patient. No other information reported.


VAERS ID: 1718586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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: AUPFIZER INC202101169963

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable other health professional via the Administration (A). Regulatory authority report number is 614280. A 30-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Pulmonary embolism on 22Aug2021. The outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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: AUPFIZER INC202101170304

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable other health professional via Regulatory Authority, Regulatory authority report number is 616013. A 30-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Pulmonary embolism on 22Aug2021. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101172741

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority, Regulatory Authority report number is 616788. A 55-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 22Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hepatitis acute
SMQs:, Hepatitis, non-infectious (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101172905

Write-up: Hepatitis acute; This is a spontaneous report from a contactable other health professional via the Administration (A). Regulatory authority report number is 617302. A 47-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hepatitis acute on 22Aug2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718612 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-08-22
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK8788 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Asthma puffer
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (asthma puffer used within 2 weeks of vaccination); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: ALLERGY MEDICATION, Comment: house dustmites
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Nasal Swab; Test Result: Positive ; Comments: nasal swab
CDC Split Type: BEPFIZER INC202101167847

Write-up: Covid infection; Covid infection; This is a spontaneous report from a contactable consumer via COVAES. A 56-year-old male patient received bnt162b2 (COMIRNATY), dose number unknown via an unspecified route of administration, administered in arm left on 16Feb2021 at 55 years (Batch/Lot Number: EK8788) as single dose for COVID-19 immunisation. Medical history included asthma (asthma puffer used within 2 weeks of vaccination), allergy medication (house dustmites). The patient''s concomitant medications included asthma puffer. The patient experienced COVID infection on 22Aug2021 with outcome of recovering. The patient underwent lab tests and procedures which included: Sars-cov-2 test: positive on 23Aug2021 (nasal swab). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720589 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Benign paroxysmal postural vertigo; Intestinal functional disorder NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Lipoma (Cervical lipoma excision)
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Diarrhea; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BR20213314) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005242) for COVID-19 vaccination. The patient''s past medical history included Lipoma (Cervical lipoma excision). Concurrent medical conditions included Benign paroxysmal postural vertigo and Intestinal functional disorder NOS. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. Company comment : This case concerns a 34 year old female patient with medical history of intestinal functional disorder NOS who experienced an unexpected serious event of diarrhea. The event occurred 2 days after vaccination with mRNA-1273. Based on the available information, the patient''s medical history of intestinal functional disorder NOS remains a confounder for the event. The re-challenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Translation received on 14-SEP-2021 and patient medical history added.; Sender''s Comments: This case concerns a 34 year old female patient with medical history of intestinal functional disorder NOS who experienced an unexpected serious event of diarrhea. The event occurred 2 days after vaccination with mRNA-1273. Based on the available information, the patient''s medical history of intestinal functional disorder NOS remains a confounder for the event. The re-challenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1721084 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, C-reactive protein, Chest pain, Electrocardiogram ST segment elevation, Myocarditis, Pyrexia, Troponin I
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Creatine kinase; Result Unstructured Data: 340 dosage form; Test Date: 20210822; Test Name: Creatine kinase MB; Result Unstructured Data: 35,4 NANOGRAM(S); Test Date: 20210822; Test Name: C-reactive protein; Test Result: 1.25 mg; Result Unstructured Data: 1,25 MILLIGRAM(S); Test Date: 20210822; Test Name: Troponin I; Result Unstructured Data: 3841 nanogram; Test Date: 20210822; Test Name: Troponin I; Result Unstructured Data: 8307 nanogram; Test Date: 20210822; Test Name: Troponin I; Result Unstructured Data: 5528 nanogram; Test Date: 20210827; Test Name: Troponin I; Result Unstructured Data: 45 nanogram
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-780085) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 immunisation. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 22-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Blood creatine phosphokinase (24-190): 340 (High) 340 dosage form. On 22-Aug-2021, Blood creatine phosphokinase MB: 35.4 35,4 NANOGRAM(S). On 22-Aug-2021, C-reactive protein: 1.25 milligram 1,25 MILLIGRAM(S). On 22-Aug-2021, Troponin I: 3841 3841 nanogram, 8307 8307 nanogram and 5528 5528 nanogram. On 27-Aug-2021, Troponin I: 45 45 nanogram. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Patient experienced Febrile episode (38?C) and persistence of fever, precordial chest pain exacerbated by breathing, radiating to the right arm, large depression of the ST Segment: Discovery of myocarditis. No concomitant drug details were reported. No treatment details were reported. On 22-Aug-2021 patient had undergone following tests- Troponin I, Creatine kinase MB, Troponin I, Troponin I, C-reactive protein, Creatine kinase and the results were not reported. On 27-Aug-2021 patient had undergone following tests- Troponin I, Cardiac MRI the results were not reported. Company Comment: This case concerns a 33-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis and unexpected events of chest pain, fever, electrocardiogram ST segment elevation. The events myocarditis, chest pain, fever, electrocardiogram ST segment elevation occurred 3 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Translation document received on 15-Sep-2021. Translated event description is updated in I-narrative. On 17-Sep-2021: All laboratory data added.; Sender''s Comments: This case concerns a 33-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis and unexpected events of chest pain, fever, electrocardiogram ST segment elevation. The events myocarditis, chest pain, fever, electrocardiogram ST segment elevation occurred 3 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1721098 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Rheumatoid arthritis
SMQs:, Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

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: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101171445

Write-up: Rheumatoid arthritis exacerbated again after vaccine; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority. WEB, regulatory authority number IT-MINISAL02-780230. A 44-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) intramuscular in deltoid right on 22Aug2021 at 08:50 (at the age of 44-years-old) as dose 1, 0.3 mL single for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient experienced rheumatoid arthritis exacerbated again after vaccine (medically significant) on 22Aug2021. The outcome of event was not recovered. Sender''s comments: First dose of Comirnaty on 22Aug2021 08:50 am, batch FG4686 exp. 30Nov2021; site of administration: right deltoid. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1722375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-22
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: AUPFIZER INC202101170315

Write-up: Deep vein thrombosis; Pulmonary embolism; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 615915. A 52-year-old female patient received bnt162b2 (COMIRNATY) on 22Jul2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Aug2021, patient experienced Deep vein thrombosis; Pulmonary embolism. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722411 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Legionella infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (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: AUPFIZER INC202101173058

Write-up: Legionella infection; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 617334. A 46-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (at the age of 46 years old, Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced legionella infection on 22Aug2021 (the same as vaccination date) with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1723464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Ear pain
SMQs:, Hearing impairment (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: AUPFIZER INC202101170391

Write-up: Bell''s palsy; Ear pain; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The Regulatory authority report number is 616048. A 58-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bell''s palsy and ear pain, both on 22Aug2021 with outcome of not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1723656 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-22
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH IDO20A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

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 INC202101180284

Write-up: Lung embolism; Leg vein thrombosis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from The Regulatory Authority DE-PEI-202100181788. A 63-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: IDO20A, expiry date: unknown), via an unspecified route of administration on 30Jul2021 as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of Comirnaty, via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation and experienced dyspnoea. The patient medical history and concomitant medications were not reported. The patient experienced lung embolism on and leg vein thrombosis on 22Aug2021. The outcome of event was not recovered. The reporter (health authority) considered the event as serious (hospitalization). Health Authority comment: Diagnostics at the PRIVACY Clinic, according to the patient, noticed an episode of dyspnoea after the first vaccination Assessment: Comirnaty/ Lung embolism / PEI:. Unclassifiable Assessment: Comirnaty/ Venous thrombosis / PEI: Unclassifiable No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101233416 The same patient, first dose, different events


VAERS ID: 1724363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (allergy to the Antibiotics, Augmentin and Orelox.); Hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101187266

Write-up: a very swollen upper lip; This is a spontaneous report from a contactable consumer (patient), downloaded from the Regulatory Authority-WEB FR-AFSSAPS-GR20213729. A 15-year-old male patient received unknown dose of bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number was unknown), via intramuscular route of administration on 20Aug2021 (reported as Friday; at the end of the morning) as dose number unknown, 0.3 ml single for COVID-19 immunization. Medical history included hypersensitivity and allergy to the Antibiotics, Augmentin and Orelox. The patient previously took Augmentin and Orelox and experienced giant urticaria as a baby. Concomitant medications were not reported. On 22Aug2021, Sunday, in the evening, the patient found himself with a very swollen upper lip. Monday morning (on an unspecified date) the lip was still very swollen. Patient had consultation with the doctor who thinks of an allergy may be to the vaccine. She prescribes Aerius morning and evening and Solupred if the reaction worsens. Monday evening, the lip is less swollen but still swollen. Therapeutic measures were taken as a result of event with Aerius morning and evening and Solupred if the reaction worsens. The outcome of the event was recovering at the time of report. Health Authority Comment: Vaccine made on Friday 20Aug2021 at the end of the morning. On Sunday 22Aug2021 in the evening, I found myself with a very swollen upper lip. Monday morning the lip is still very swollen. Consultation with the doctor who thinks of an allergy may be to the vaccine. She prescribes Aerius morning and evening and Solupred if the reaction worsens. Monday evening, the lip is less swollen but still swollen. Text for Relevant Medical History and Concurrent Conditions: allergy to the antibiotics augmentin and orelox (giant urticaria as a baby). No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724420 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chest pain, Headache, Pain, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; NASOBEC AQUEOUS; SYMBICORT; SPIRIVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Fibromyalgia
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101166632

Write-up: itchy; pain; Itching but short term; 3 day headache; Shoulder chest pain; Shoulder chest pain; Slightly tighter feeling when breathing/chest felt slightly tighter when breathing; This is a spontaneous from a contactable consumer (patient) downloaded from a Regulatory Authority received a Health Authority. Regulatory authority report number is GB-MHRA-APPCOVID-20210901120051 with Safety Report Unique Identifier is GB-MHRA-ADR 25879619. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Fe8087, Expiry date not reported), via an unspecified route of administration on 22Aug2021 (age at vaccination was 45 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included fibromyalgia and asthma. Patient had not had symptoms associated with COVID-19. Concomitant medications included acetylsalicylic acid taken from 13Oct2016 for aneurysm (prevent blood clot); beclometasone dipropionate (NASOBEC AQUEOUS) taken from 12Jun2021 for nasal drip and phlegm; budesonide, formoterol fumarate (SYMBICORT) taken for asthma from 20Sep2018; tiotropium bromide monohydrate (SPIRIVA) taken for asthma from 20Oct2017. The patient experienced itching but short term on 22Aug2021 with outcome of recovered on an unspecified date, 3 day headache on 22Aug2021 with outcome of recovered on an unspecified date, shoulder chest pain on 22Aug2021 with outcome of not recovered, slightly tighter feeling when breathing/chest felt slightly tighter when breathing on 22Aug2021 with outcome of not recovered, itchy on an unspecified date with outcome of recovering, and pain on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 14May2021. The events were reported as serious, medically significant by the health authority. Case narrative: Patient did take a really itchy left shoulder 5 minutes after jab it did stop later that night but notice her chest felt slightly tighter when breathing, she took pain through her left shoulder though the really bad pain eased after a few days its still there just below shoulder through left side of chest right through to her back 10 days later, now she''s wondering if she should chance the second jab when she''s due it. Also had bad headache for the first 3 days. She phoned doctors today but was told she had to report, she didn''t know if she should have her left side of chest checked out as its strange feeling with the pain being there. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information expected.


VAERS ID: 1724815 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Fear, Palpitations, Sleep disorder
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result: Normal; Comments: Normal; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result: Normal; Comments: Normal
CDC Split Type: IEPFIZER INC202101180426

Write-up: Palpitation; Chest Pain; I was afraid to fall asleep; it was very scary and frightening; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number IE-HPRA-2021-083192, Safety Report Unique Identifier IE-HPRA-2021-083192. A 15-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FE7053; Expiration Date: Nov2021) via an unspecified route of administration on 22Aug2021 as DOSE 1, SINGLE (Age at vaccination: 15-year-old) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 22Aug2021, The patient experienced it was very scary and frightening, palpitation, chest pain and I was afraid to fall asleep. Initial report received by the RA on 23Aug2021 from a member of the public reporting on behalf of herself. This report concerned a 15 year old female who experienced palpitations, chest pain, fear and sleep disorder following vaccination with Comirnaty for Covid-19 immunisation. The patient was not taking any concomitant medication. The patient did not have any relevant medical history/concurrent conditions. The patient noted in the report that she was a very healthy and active 15 year old. At 18:00 on 22Aug2021, the patient experienced palpitations and chest pain, persisting for a few seconds, then there was a break and it happened again. The patient outlined that it then started to occur more frequently. The patient rang the doctors (KDOC) at 9.15pm who rang her back by 10.52pm and sent her to the hospital. The patient described feeling as if she was going to have a heart attack. The patient was in the hospital for 3 hours and was sent home after Electrocardiogram (EKG) and blood test results came back normal. They patient outlined that it was very scary and frightening. She was told to take paracetamol and see how she was in 24 hours. The patient stated that she was afraid to fall asleep. At the time of reporting the patient''s symptoms of palpitations and chest pain were continuing. The patient underwent lab tests and procedures which included blood test: normal on Aug2021 Normal, electrocardiogram: normal on Aug2021 Normal. The outcome of the events (it was very scary and frightening, palpitation, chest pain and I was afraid to fall asleep) was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1725067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-08-22
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Thrombosis, Ultrasound scan, X-ray
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Medical History/Concurrent Conditions: Hay fever (occasional hay fever medication); Ringworm of body; Skin rash (ointment for skin rashes (ringworm)); Varicose veins (My mother suffers very much from varicose veins; I don''t know if that matters.)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:results unknown; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no abnormalities; Test Name: ultrasound; Result Unstructured Data: Test Result:Blood clot in the vein of my arm; Test Name: X-ray; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: NLPFIZER INC202101166724

Write-up: thrombosis; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB NL-LRB-00672429, Safety Report Unique Identifier: NL-LRB-00676969. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included occasional hay fever medication, skin rashes, ringworm, varicose vein (mother). The patient did not have COVID-19 prior the vaccination. Historical vaccine includes dose 1 of Comirnaty received on 14May2021. The patient''s concomitant medications were not reported. On 22Aug2021, the patient experienced thrombosis in his right arm. The patient underwent lab tests and procedures which included blood test: results unknown, electrocardiogram: no abnormalities, ultrasound scan: blood clot in the vein of my arm, and x-ray: no abnormalities. The outcome of the event was not recovered. Therapeutic measures include Thrombosis arm is treated with anticoagulation and compression stocking.


VAERS ID: 1729644 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic steatosis
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: PCR; Test Result: Positive
CDC Split Type: JPPFIZER INC202101189750

Write-up: the patient was infected with COVID-19/Sputum; the patient was infected with COVID-19/Sputum; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A female patient of an unknown age received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on 08Aug2021, as dose 1, single for COVID-19 immunization. The patient''s medical history included hepatic steatosis. Concomitant medications were not reported. The patient was a high school student. On 22Aug2021, the patient was infected with COVID-19 by her family and the test result was positive. The patient failed to receive the second dose of vaccination on 29Aug2021. At that time, the patient had sputum, so the patient received a prescription of oral expectorant and antipyretic from hospital, and then took it. The reporter inquired can the patient with Hepatic steatosis still received vaccinated. The patient underwent laboratory tests that included PCR on 22Aug2021 resulted positive. The events resulted in physician office visit. The patient received treatment for the events. The outcome for the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729865 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Hyperpyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Medical History/Concurrent Conditions: Asymptomatic COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: body temperature; Result Unstructured Data: Test Result:40.5 - 42 Centigrade; Test Date: 20210302; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101185918

Write-up: Fever 40.5 to 42 C; Chills; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [Regulatory Authority number NL-LRB-00674008]. A 49-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Aug2021 at 49 years (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asymptomatic COVID-19 from 02Mar2021 to an unknown date (not ongoing). The patient''s concomitant medications were not reported. The patient experienced fever 40.5 to 42 C (medically significant) on 22Aug2021 6 hours after vaccination with outcome of recovered on 22Aug2021 after 2 hours, chills (non-serious) on 22Aug2021 3 hours after vaccination with outcome of recovered on 23Aug2021. The patient underwent lab tests and procedures which included body temperature: 40.5 - 42 C on 22Aug2021, COVID-19 virus test: positive on 02Mar2021. Regulatory Authority comment: BioNTech/Pfizer vaccine (Comirnaty) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Obesity (BMI 32.1)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210940250

Write-up: THROMBOSIS LEG; This spontaneous report received from a consumer via a Regulatory Authority (NL-LRB-00681465) on 21-SEP-2021 and concerned a 64 year old male. Initial information was processed with the additional information received on 22-SEP-2021. The patient''s weight was 110 kilograms, and height was 185 centimeters. The patient''s concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985 expiry: UNKNOWN) 0.5ml,1 dosage forms,1total, administered on 29-JUN-2021 for covid-19 immunisation. Drug start period (latency) 7 Weeks. No concomitant medications were reported. On 22-AUG-2021, the patient experienced thrombosis leg (Thrombosis, after approximately 7 weeks a swollen and painful right leg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombosis leg. This report was serious (Other Medically Important Condition).


VAERS ID: 1730663 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: ITMODERNATX, INC.MOD20213

Write-up: a; This case was received (Reference number: IT-MINISAL02-781701) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA, DECREASED APPETITE and CHEST PAIN in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form in total. On 22-Aug-2021, the patient experienced DYSPNOEA (seriousness criterion disability), DECREASED APPETITE (seriousness criterion disability) and CHEST PAIN (seriousness criterion disability). At the time of the report, DYSPNOEA, DECREASED APPETITE and CHEST PAIN had not resolved. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the same vaccination day the unexpected and serious (Incapacity) events of DYSPNOEA, DECREASED APPETITE and CHEST PAIN 21 days after 1st dose vaccinationn. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received included no new information On 17-Sep-2021: Translation was received on 21-SEP-2021. Sender''s comment updated; Reporter''s Comments: Sep 09, 2021 batch no. 3005294; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the same vaccination day the unexpected and serious (Incapacity) events of DYSPNOEA, DECREASED APPETITE and CHEST PAIN 21 days after 1st dose vaccinationn. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1730858 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pruritus, Tachycardia, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to bee sting ; Latex allergy ; Polycystic ovary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-780393) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA, PAIN IN EXTREMITY, PRURITUS and VACCINATION SITE REACTION in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Allergic reaction to bee sting, Polycystic ovary and Latex allergy. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced TACHYCARDIA (seriousness criterion life threatening), PAIN IN EXTREMITY (seriousness criterion life threatening), PRURITUS (seriousness criterion life threatening) and VACCINATION SITE REACTION (seriousness criterion life threatening). On 03-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 03-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, TACHYCARDIA, PAIN IN EXTREMITY, PRURITUS and VACCINATION SITE REACTION had not resolved. Past medical history included Allergic to bee sting ,Allergic to latex contact,Polycystic ovary syndrome. On an unknown date patient had swelling,radiation of the patch Allergic reaction and Overheating of the vaccinated area. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of Tachycardia, pain in extremity, Vaccination site reaction, and expected event of pruritus. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Translation for initial document was received on 17-Sep-2021, included reporters comments translated medical history information updated. On 17-Sep-2021: Significant follow up received on 17-SEP-2021 contains new event.; Reporter''s Comments: Allergic to bee sting Allergic to latex contact Polycystic ovary syndrome; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of Tachycardia, pain in extremity, Vaccination site reaction, and expected event of pruritus. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1732443 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiocardiogram, Aspartate aminotransferase, Asthenia, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood pressure measurement, Body temperature, C-reactive protein, Chest X-ray, Chest discomfort, Chest pain, Disease recurrence, Echocardiogram, Ejection fraction, Electrocardiogram, Haemoglobin, Heart rate, Hyperhidrosis, Hypertension, Magnetic resonance imaging heart, Myocarditis, Nausea, Oxygen saturation, Troponin T, Vertigo, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (alcohol occasionally); Meningitis; Viral myocarditis (in patient?s 20 years)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SGPT; Result Unstructured Data: Test Result:0.6 ukat/L; Comments: equal 36 iU/L; Test Date: 202108; Test Name: SGPT; Result Unstructured Data: Test Result:1.13 ukat/L; Comments: equal 67.8 iU/L; Test Date: 20210823; Test Name: Coronary angiograph; Result Unstructured Data: Test Result:normal finding; Comments: left ventricle and ascending aorta; Test Date: 202108; Test Name: Aspartate transferase; Result Unstructured Data: Test Result:1.01; 1.13 ukat/L; Comments: equal to 60.6 iU/l; Test Date: 202108; Test Name: Creatine kinase; Result Unstructured Data: Test Result:8.21 ukat/L; Comments: equal 492.6 iU/L; Test Date: 202108; Test Name: Creatine kinase MB; Result Unstructured Data: Test Result:0.91 ukat/L; Comments: equal 54.6 iU/L; Test Date: 20210823; Test Name: Blood pressure; Result Unstructured Data: Test Result:143/92 mmHg; Test Date: 20210823; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20210824; Test Name: Chest X-ray; Result Unstructured Data: Test Result:normal wide of the cardiac silhouette; Comments: normal wide of the cardiac silhouette, normal wide and shape of the aorta, no signs of distinct congestion, no signs of fluidothorax; Test Date: 202108; Test Name: C-reactive protein; Result Unstructured Data: Test Result:36.3 mg/l; Test Date: 20210824; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:normal size of the heart chambers; Comments: normal size of the heart chambers, there is no left ventricle hypertrophy, abnormal movement of the ventricular septum, otherwise normal kinetic function of the left ventricle, ejection fraction 55 %, 1st-degree diastolic dysfunction of the left ventricle, a systolic function of the right ventricle preserved, slight mitral valve insufficiency, traces of tricuspid valve insufficiency, no ultrasound signs of pulmonary hypertension, no signs of pericardial effusion; Test Date: 20210824; Test Name: Ejection fraction; Test Result: 56 %; Comments: right ventricle; Test Date: 20210824; Test Name: Left ventricular ejection fraction; Test Result: 55 %; Test Date: 20210824; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm, 58 bpm, PQ 160 ms, QRS 80 ms; Comments: sinus rhythm, 58 bpm, PQ 160 ms, QRS 80 ms, QT 380 ms, ST isoelectric, negative T in aVL, flat T in V1; Test Date: 202108; Test Name: Hemoglobin; Result Unstructured Data: Test Result:150 g/l; Test Date: 20210823; Test Name: Heart rate; Result Unstructured Data: Test Result:73 /min; Test Date: 20210824; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:non-dilated left ventricle; Comments: non-dilated left ventricle, ejection fraction 60 %, no kinetic disorder, late gadolinium enhancement with multiple small lesions in the apical half of the anterior, inferior, and lateral wall, which correspond to small edematic lesions in T2, the finding has a character of subacute myocarditis, right ventricle without dilatation, ejection fraction 56 % of the right ventricle; Test Date: 20210823; Test Name: Oxygen saturation; Test Result: 100 %; Test Date: 202108; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:718 ng/L; Test Date: 202108; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:923 ng/L; Test Date: 202108; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:1033 ng/L; Test Date: 202108; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:244 ng/L; Test Date: 202108; Test Name: White blood cell count; Result Unstructured Data: Test Result:11.39 x10 9/l
CDC Split Type: CZPFIZER INC202101215792

Write-up: Chest pain with radiation to left arm; Chest pressure; Acute myocarditis; Acute myocarditis; blood pressure measurement: 143/92 mmhg; Sweating; Head spinning; Weakness; Nausea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21010427. A 46-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 19Aug2021 (Batch/Lot Number: FF3318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included viral myocarditis from 1994 to 1994 in patient''s 20 years, condition after meningitis in Jul2012, non-smoker, alcohol occasionally. The patient did not use any concomitant medication. Historical vaccine included bnt162b2 (COMIRNATY, batch/lot number: FE8244), via intramuscular administered on 29Jul2021 for COVID-19 immunization. The patient experienced acute myocarditis on 22Aug2021. On 22Aug2021 at 16:00 p.m., while sitting, the patient experienced sudden chest pressure with mild radiation to the left upper limb (pain on the chest similar to stenocardia), sweating, nausea, spinning of the head, weakness. It lasted for 1 hour and a half. On 23Aug2021 patient woke up with the same problems. The pain receded after the administration of nitroglycerine. On the same day, the patient was hospitalized at the cardiology department. At the time of admission, the patient rejected any breathing difficulties, swelling, palpitations, spinning of the head, chills, rigoring, fever, smell or taste disorders, cough, diarrhea, vomiting, dysuria, or defecation problems. Objective examination showed blood pressure 143/92 mmHg, heart rate 73 bpm, saturation 100 % (without O2), body temperature 36.1 ?C. Normal coronarography findings, mild C-reactive protein elevation in blood tests, creatine kinase, creatine kinase MB + Troponin T elevation (with a dynamic). On heart ultrasound, just an abnormal ventricular sept movement was found. Ejection fraction 55 %, without any valve disorder. Magnetic resonance imagining was done with the finding of subacute myocarditis. On 26Aug2021 patient was dismissed. Examinations performed: 23Aug2021 coronarography and angiography of the left ventricle and ascending aorta - normal finding. On 24Aug2021 anteroposterior chest X-ray - normal wide of the cardiac silhouette, normal wide and shape of the aorta, no signs of distinct congestion, no signs of fluidothorax. On 24Aug2021 transthoracic echocardiography, conclusion: normal size of the heart chambers, there is no left ventricle hypertrophy, abnormal movement of the ventricular septum, otherwise normal kinetics of the left ventricle, ejection fraction 55 %, 1st-degree diastolic dysfunction of the left ventricle, a systolic function of the right ventricle preserved, slight mitral valve insufficiency, traces of tricuspid valve insufficiency, no ultrasound signs of pulmonary hypertension, no signs of pericardial effusion. On 24Aug2021 magnetic resonance imaging of the heart with using of a contrast agent, conclusion: non-dilated left ventricle, ejection fraction 60 %, no kinetic disorder, late gadolinium enhancement with multiple small lesions in the apical half of the anterior, inferior, and lateral wall, which correspond to small edematic lesions in T2, the finding has a character of subacute myocarditis, right ventricle without dilatation, ejection fraction of the right ventricle 56 %. On 24Aug2021 electrocardiography - sinus rhythm, 58 bpm, PQ 160 ms, QRS 80 ms, QT 380 ms, ST isoelectric, negative T in aVL, flat T in V1. The patient underwent lab tests and procedures which included alanine aminotransferase: 0.6 ukat/l in Aug2021 equal 36 iU/L, alanine aminotransferase: 1.13 ukat/l in Aug2021 equal 67.8 iU/L, angiocardiogram: normal finding on 23Aug2021 left ventricle and ascending aorta, aspartate aminotransferase: 1.01; 1.13 ukat/l in Aug2021 equal to 60.6 iU/l, blood creatine phosphokinase: 8.21 ukat/l in Aug2021 equal 492.6 iU/L, blood creatine phosphokinase mb: 0.91 ukat/l in Aug2021 equal 54.6 iU/L, blood pressure measurement: 143/92 mmhg on 23Aug2021, body temperature: 36.1 centigrade on 23Aug2021, chest x-ray: normal wide of the cardiac silhouette on 24Aug2021 normal wide of the cardiac silhouette, normal wide and shape of the aorta, no signs of distinct congestion, no signs of fluidothorax, c-reactive protein: 36.3 mg/l in Aug2021, echocardiogram: normal size of the heart chambers on 24Aug2021 normal size of the heart chambers, there is no left ventricle hypertrophy, abnormal movement of the ventricular septum, otherwise normal kinetic function of the left ventricle, ejection fraction 55 %, 1st-degree diastolic dysfunction of the left ventricle, a systolic function of the right ventricle preserved, slight mitral valve insufficiency, traces of tricuspid valve insufficiency, no ultrasound signs of pulmonary hypertension, no signs of pericardial effusion, ejection fraction: 56 % on 24Aug2021 right ventricle, ejection fraction: 55 % on 24Aug2021, electrocardiogram: sinus rhythm, 58 bpm, pq 160 ms, qrs 80 ms on 24Aug2021 sinus rhythm, 58 bpm, PQ 160 ms, QRS 80 ms, QT 380 ms, ST isoelectric, negative T in aVL, flat T in V1, haemoglobin: 150 g/l in Aug2021. The patient was hospitalized for chest pain with radiation to left arm, acute myocarditis and chest pressure from 23Aug2021 to 26Aug2021. The events chest pain with radiation to left arm, acute myocarditis and chest pressure were classified as serious for life-threatening and hospitalization. Therapeutic measures were taken as a result of chest pain with radiation to left arm, acute myocarditis, chest pressure, sweating, head spinning, weakness and nausea. The outcome of event acute myocarditis was recovering, chest pain with radiation to left arm, chest pressure, sweating, head spinning, weakness and nausea was recovered on 22Aug2021 at 17:30, of blood pressure measurement: 143/92 mmhg was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1732460 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-22
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via European Medicines Agency (Reference number: DE-PEI-202100184758) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 27-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. Concomitant medications were not reported . Treatment information was not provided. Lab data included Cardiac MRI, labs, echo, ECG,Ruled out: Heart attack. Treatment at the hospital was required. Company Comment: This case concerns a 27 year-old male patient with no medical history provided, who experienced the expected event of Myocarditis. The event occurred approximately 9 days after the second dose of Spikevax.The event was considered related to the study drug per the reporter''s assessment.). The event is 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. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21-SEP-2021 as narrative updated.; Reporter''s Comments: Cardiac MRI, labs, echo, ECG. Ruled out: Heart attack. Treatment at the hospital was required.; Sender''s Comments: This case concerns a 27 year-old male patient with no medical history provided, who experienced the expected event of Myocarditis. The event occurred approximately 9 days after the second dose of Spikevax.The event was considered related to the study drug per the reporter''s assessment.). The event is 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.


VAERS ID: 1732638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PANODIL; BETMIGA; COLECALCIFEROL; BAKLOFEN 2CARE4
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Incontinence; Muscle cramps; Pain; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101193361

Write-up: Dead fetus; Maternal exposure during pregnancy; This is a spontaneous report from contactable physicians downloaded from a regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0087096 and DK-DKMA-WBS-0087095. A 37-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Aug2021 (Lot Number: FE9174; Expiration Date: 30Oct2021) as DOSE 2, SINGLE; and via an unspecified route of administration on 23Jul2021 (Lot Number: FD4555) as DOSE 1, SINGLE for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, via an unspecified route of administration from 09Aug2021 (Lot Number: KB0044D) to 09Aug2021, at Dose number unknown, single for immunisation. Medical history included muscle cramps, incontinence, constipation, pain, and vitamin D deficiency. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride dose 1 DF, 1x/day oral, taken for constipation from 20May2019; paracetamol Strength 500mg, dose 3000 mg, 1x/day, oral taken for pain from 02Sep2020; mirabegron Strength 50mg, dose 50 mg, 1x/day, taken for incontinence from 15Aug2017; colecalciferol (COLECALCIFEROL)Strength 35ug, dose 70 ug, 1x/day, oral taken for vitamin d deficiency from 20May2019; baclofen (BAKLOFEN 2CARE4) Strength 10mg, 20 mg, 1x/day, oral taken for muscle spasms from 06Oct2020. On 22Aug2021, the patient experienced dead fetus. The mother reported she became pregnant while taking bnt162b2, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid. The events resulted in hospitalization. The outcome of the event dead fetus was not recovered. No follow-up attempts are possible. Information about batch number was obtained.


VAERS ID: 1733037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pregnancy (Patient no longer pregnant at the time of reporting)
Allergies:
Diagnostic Lab Data: Test Date: 20210302; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101205408

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109130920247110-HYYBE with Safety Report Unique Identifier GB-MHRA-ADR 25930795. A 32-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD5613) via an unspecified route of administration on 15Aug2021 as a single dose for COVID-19 immunisation. Medical history included pregnancy (patient no longer pregnant at the time of reporting) and suspect COVID-19 from 01Mar2021 to 05Mar2021. On 02Mar2021, the patient underwent a COVID-19 virus test and the result was positive and COVID-19 was stopped on 05Mar2021. The patient was not currently breastfeeding at the time of this report. The patient was not enrolled in a clinical trial. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) taken for folic acid supplementation from an unknown date and unknown if ongoing. Patient was exposed to the medicine first-trimester (1-12 weeks). On 22Aug2021, 7 days after vaccination, the patient experienced miscarriage of pregnancy; all events reported as serious for being medically significant. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event miscarriage of pregnancy was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733325 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IS-IMA-4652) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN, BACK PAIN and PERICARDITIS in a 42-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced CHEST PAIN (seriousness criterion hospitalization), BACK PAIN (seriousness criterion hospitalization) and PERICARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, CHEST PAIN, BACK PAIN and PERICARDITIS was resolving. mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date. No concomitant medication details was provided. No treatment medication details was provided. Company comment: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of Chest pain and Back pain and expected event of Pericarditis. The events occurred five days after the administration of mRNA-1273. (Dose sequence not provided). The event of Pericarditis is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. A discrepancy was noted in the country in which event of Chest pain occurred as India instead of Iceland. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-SEP-2021 contains no new information; Sender''s Comments: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of Chest pain and Back pain and expected event of Pericarditis. The events occurred five days after the administration of mRNA-1273. (Dose sequence not provided). The event of Pericarditis is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. A discrepancy was noted in the country in which event of Chest pain occurred as India instead of Iceland. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1733676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210941681

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (EVHUMAN Vaccines, PT-INFARMED-T202109-80) on 22-SEP-2021 and concerned a 31-year-old male of unspecified race and ethnic origin. 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, intramuscular, batch number: XE393 expiry: unknown) 0.5 ml, 1 total administered on 19-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 22-AUG-2021, the patient had vaccination failure (Covid-19 vaccine - vaccine failure - user with complete vaccination schedule more than 2 weeks ago had Covid-19). Laboratory data included: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information: Symptoms starting on 19-SEP-2021 Test performed on 22-AUG-2021


VAERS ID: 1733701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Headache, Investigation, Magnetic resonance imaging, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data: Test Name: Samples were taken; Result Unstructured Data: Test Result:unknown results; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:unknown results
CDC Split Type: SEPFIZER INC202101239817

Write-up: Cardiac arrest; headache; fainted; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number SE-MPA-2021-083056. An 18-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 10Aug2021 (Lot Number: FF0680) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced cardiac arrest. On 22Aug2021, 12 days after the vaccination, the woman got a headache and fainted afterwards. She went to the hospital where she fainted again. According to the reporter, they saw in the hospital that the patient heart had paused for 15 seconds. Samples were taken and magnetic resonance imaging was performed; both with unknown results. According to the reporter, all the results were without remark, they found no reason for what happened. Sequence: Unknown. The case was assessed as serious, life-threatening, Hospitalized. All events received treatment, hospital care. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1736089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (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: DEJNJFOC20210945251

Write-up: Tachycardia; Dyspnoea; Paresthesia; Dizziness; This spontaneous report received from a consumer Via a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021177201) on 23-SEP-2021 concerned a 38 year old female of an unspecified race and ethnic origin. The patient''s weight was 59 kilograms, and height was 163 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: XE395, expiry: unknown) dose was not reported, frequency time 1 total administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced tachycardia, dyspnoea, paresthesia and dizziness and was hospitalized on an unspecified date. Discharge date was not provided. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, dyspnoea, paresthesia and dizziness. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736095 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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: FRJNJFOC20210945963

Write-up: EMBOLISM PULMONARY; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-PO20214949) on 23-SEP-2021 and concerned a 45 year old female. The patient''s weight was 78 kilograms, and height was 157 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-02 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 02-AUG-2021 for covid-19 vaccination. The drug start period (latency) was 21 days and drug last period (latency) was 21 days. Duration of drug administration was 1 days. No concomitant medications were reported. On 22-AUG-2021, the patient experienced Embolism pulmonary. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from embolism pulmonary. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hallucination, Headache, Hyperventilation, Nausea, Restlessness, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypoglycaemia (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: DEJNJFOC20210945920

Write-up: Nausea; Vomiting; Restlessness; Headache; Tachycardia; Chills; Hyperventilation; Hallucination; This spontaneous report received from a consumer Via a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021167346) on 23-SEP-2021 concerned a 20 year old male of an unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 178 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, batch number and expiry were not reported) dose was not reported, frequency time 1 total administered on 21-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 22-AUG-2021, the patient experienced nausea, vomiting, restlessness, headache, tachycardia, chills, hyperventilation and hallucination and was hospitalized on an unspecified date. Discharge date was not provided. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, headache, tachycardia, hyperventilation and hallucination, and the outcome of nausea, restlessness and chills was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736318 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Dyslipidaemia; Hypertension arterial; Obesity; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: myocardite; This case was received via regulatory authority (Reference number: FR-AFSSAPS-LL20216126) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (myocardite) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Type II diabetes mellitus, Hypertension arterial, Dyslipidaemia and Obesity. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced MYOCARDITIS (myocardite) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocardite) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter. Company Comment: This case concerns a 71-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event myocarditis occurrence unknown with respect to first dose of mRNA-1273 vaccine administration. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document was received on 22 sep 2021 and contains no new information.; Sender''s Comments: This case concerns a 71-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event myocarditis occurrence unknown with respect to first dose of mRNA-1273 vaccine administration. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1736319 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-22
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: Nystagmus
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Ear operation NOS (surgery on right ear)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Facial palsy; This case was received via Regulatory Authority (Reference number: -AFSSAPS-2021124289) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of FACIAL PARALYSIS (Facial palsy) in a 35-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Cataract operation and Ear operation NOS (surgery on right ear). Concurrent medical conditions included Nystagmus. On 26-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial palsy) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 26-Jul-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. Company Comment : This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the expected event of Facial paralysis. The event occurred around 28 days after the dose of Spikevax. The rechallenge was unknown since information about one dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 23-Sep-2021: Relevant medical history was updated.; Sender''s Comments: This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the expected event of Facial paralysis. The event occurred around 28 days after the dose of Spikevax. The rechallenge was unknown since information about one dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1736403 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-22
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Premature baby
SMQs:, Neonatal disorders (narrow)

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: NLMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PREMATURE BABY in a neonate of an unknown age and gender exposed to mRNA-1273 (Spikevax) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 26). Concurrent medical conditions included Maternal exposure during pregnancy. No Medical History information was reported. On 09-Jul-2021, the mother received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Aug-2021, after exposure to mRNA-1273 (Spikevax), the neonate was diagnosed with PREMATURE BABY (seriousness criterion hospitalization). The Neonate was exposed to mRNA-1273 (Spikevax) beginning around the twenty-sixth week of the pregnancy. The delivery occurred, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, PREMATURE BABY outcome was unknown. Concomitant drug was not reported. Treatment medication was not reported. This case concerns a neonate born prematurely to a mother, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at during 26 weeks of gestation. The premature delivery occurred days after the second dose of Spikevax. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness for the reported event assessed as per Regulatory Authority reporting as event involved a hospitalization. This case was linked to MOD-2021-324798 (Parent-Child Link). See case MOD-2021-324798 for details regarding the Parent case. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received on 17-SEP-2021 contains no new information.; Sender''s Comments: This case concerns a neonate born prematurely to a mother, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at during 26 weeks of gestation. The premature delivery occurred 8 days after the second dose of Spikevax. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness for the reported event assessed as per Regulatory Authority reporting as event involved a hospitalization.


VAERS ID: 1736559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Facial paresis, Haemoglobin, Nervous system disorder, Peripheral nerve paresis, Platelet count
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Test Name: creatinine; Result Unstructured Data: Test Result:0.90; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.9; Test Name: platelets; Result Unstructured Data: Test Result:228
CDC Split Type: BEPFIZER INC202101194804

Write-up: Peripheral and Facial paresis; Neurological problem; Peripheral and Facial paresis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-106432. A 24-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced peripheral and facial paresis, and neurological problem; the events were reported as serious - disability. The patient underwent lab tests and procedures which included creatinine: 0.90, hemoglobin: 14.9, and platelets: 228; all on an unspecified date. The outcome of the events was not recovered. Reporter''s Comment : Treatment - Yes Oral prednisone 48 mg per day for 10 days; Evolution of the adverse drug reaction - No Improvement; Examinations - lab: Hemoglobin 14.9 platelets 228 creatinine 0.90; Adverse drug reaction description - Peripheral and Facial paresis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - Yes Oral prednisone 48 mg per day for 10 days; Evolution of the adverse drug reaction - No Improvement; Examinations - lab: Hemoglobin 14.9 platelets 228 creatinine 0.90; Adverse drug reaction description - Peripheral and Facial paresis.


VAERS ID: 1737754 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-08-22
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden hearing loss
SMQs:, Hearing impairment (narrow)

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: PAI-1 4G/5G polymorphism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101201324

Write-up: Sudden hearing loss; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100184762. An adult female patient of unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. Medical history included 4G/5G heterozygote from 23Mar2010 and ongoing. The patient''s concomitant medications were not reported. The patient experienced sudden hearing loss on 22Aug2021. The patient has not yet recovered from the event. Sender''s comments: I was vaccinated with BioNTech for the second time on 27Jun2021. I have had a hearing loss since 22Aug2021. I have also had a 4G/5G heterozygote since 23Mar2010, which I also told the doctor at the. I do not take any blood clotting medication. The relatedness of COMIRNATY to event sudden hearing loss is assessed as "B. Indeterminate". No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1737759 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, 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? 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: Test Name: Blood test; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: ecg; Result Unstructured Data: Test Result:UNKNOWN RESULTS
CDC Split Type: DEPFIZER INC202101194329

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100184900. A 16-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis on 22Aug2021. The event was reported as serious due to hospitalization. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, electrocardiogram: unknown results on an unspecified date. The outcome of the event was resolved on an unspecified date in 2021. Sender''s comment: ECG, Blood draw Assessment: Comirnaty/ Myocarditis/ Regulatory Authority: B. Indeterminate No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8236 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Seizure
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195072

Write-up: Paraesthesia; Duration: 15 min. (seizure); This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number is DE-PEI-202100186397. A 13-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 15Aug2021 (Batch/Lot Number: FE8236) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced paraesthesia and duration: 15 min. (seizure) The outcome of the event paraesthesia was recovered on 25Aug2021, while for seizure was recovered on 22Aug2021. Sender''s comment: Patient was hospitalized. Relatedness of BNT162b2 to Paraesthesia by PEI was indeterminate, while for Seizure was unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Myalgia, Pericarditis
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (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? Yes
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: AUPFIZER INC202101212441

Write-up: Pericarditis; Headache; Myalgia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 618157. A 27-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date in 2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Aug2021, the patient experienced pericarditis, headache, and myalgia. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737960 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Pulmonary embolism, Vaccination site pain
SMQs:, Embolic and thrombotic events, venous (narrow)

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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195415

Write-up: Pulmonary embolism with weakening of the right ventricle!; Pain at the injection site; Pulmonary embolism with weakening of the right ventricle!; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021176071. Safety Report Unique Identifier: DE-PEI-202100185431. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: 1E028A) as dose number unknown, 0.3mL single for COVID-19 immunization. The patient''s weight was 92 kg, and height was 193 cm. Medical history was none. The patient had no known allergies. The patient''s concomitant medications were not reported. On 22Aug2021 the patient experienced pain at the injection site, pulmonary embolism with weakening of the right ventricle! This report is serious for hospitalization. The outcome of the events was not resolved. The RA assessment for bnt162b2 with events heart disorder, injection site pain, pulmonary embolism headache was unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses: None. I have been an athlete for 40 years and have never experienced anything like this. Pressure pain at injection site that extended down the arm into the chest area. Then on 22Aug2021 pain in rib area with difficulty breathing. On 25Aug2021 diagnosis of pulmonary embolism. No follow-up attempts are needed. No further information expected.


VAERS ID: 1738127 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood culture, Blood fibrinogen, Myocarditis, Troponin T
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EBASTEL FORTE FLAS; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]
Current Illness: Allergic rhinitis; Asthma extrinsic; Cannabis use; Dermatitis atopic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Serum creatinine; Result Unstructured Data: Test Result:982 IU/l; Test Date: 20210823; Test Name: Serum creatinine; Result Unstructured Data: Test Result:412 IU/l; Test Date: 20210905; Test Name: Blood culture; Test Result: Negative ; Test Date: 20210822; Test Name: Fibrinogen; Test Result: 537 mg/dl; Test Date: 20210822; Test Name: Troponin T; Result Unstructured Data: Test Result:524 ng/L; Test Date: 20210822; Test Name: Troponin T; Result Unstructured Data: Test Result:523 ng/L; Test Date: 20210823; Test Name: Troponin T; Result Unstructured Data: Test Result:491 ng/L; Test Date: 20210823; Test Name: Troponin T; Result Unstructured Data: Test Result:531 ng/L; Test Date: 20210824; Test Name: Troponin T; Result Unstructured Data: Test Result:718 ng/L; Test Date: 20210825; Test Name: Troponin T; Result Unstructured Data: Test Result:309 ng/L
CDC Split Type: ESPFIZER INC202101193918

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-995069. A 17-year-old male patient received bnt162b2 (COMIRNATY), via unknown route on 19Aug2021 (Batch/Lot Number: FF2832) as dose 2, single for COVID-19 immunisation. Medical history included allergic rhinitis from 2006 and ongoing, Cannabis use from 2019 and ongoing, Asthma extrinsic from 2006 and ongoing and dermatitis atopic from 2018 and ongoing. Concomitant medications included ebastine (EBASTEL FORTE FLAS) taken for dermatitis atopic from Jun2021 to an unspecified stop date; and beclometasone dipropionate, formoterol fumarate (FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]) taken for Asthma extrinsic from 2019 to an unspecified stop date. The patient took the first dose of Comirnaty via unknown route on 29Jul2021 (Lot number: FE8405) for COVID-19 immunisation. The patient experienced myocarditis on 22Aug2021. Second dose treatment during admission: enantym enantyum 50 mg iv / 8h + paracetamol 1g packet / 8h + colchicine 0.5 mg / 24h. The patient underwent lab tests and procedures which included Serum creatinine: 982 iu/l on 22Aug2021 and 412 iu/l on 23Aug2021; blood culture: negative on 05Sep2021; fibrinogen: 537 mg/dl on 22Aug2021; and troponin t: 524 ng/l on 22Aug2021, 523 ng/l on 22Aug2021, 491 ng/l on 23Aug2021, 531 ng/l on 23Aug2021, 718 ng/l on 24Aug2021 and 309 ng/l on 25Aug2021. The report is serious - hospitalization. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


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