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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)

This is page 402 out of 8,010

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VAERS ID: 1746803 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea, Menstruation delayed, SARS-CoV-2 test, Young's syndrome
SMQs:, Congenital, familial and genetic disorders (narrow), Fertility 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101224752

Write-up: Young''s syndrome; had some small spotting; Late period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109162126472080-OKUQ4, Safety Report Unique Identifier GB-MHRA-ADR 25955550. A 29-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 25Aug2021 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 on unspecified date (Lot number was not reported) for COVID-19 immunisation. The patient experienced Young''s syndrome, also reported as I am a young, on an unspecified date with outcome of recovering, late period on 25Aug2021 with outcome of not recovered and had some small spotting on an unspecified date with outcome of unknown. The patient underwent lab test which included Covid19 virus test: Yes - Positive COVID-19 test on 20Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant. Additional information: I am a young, healthy woman with a regular cycle. I am taking no contraception and since my 2nd vaccine, I have not had a period. I am currently nearly 2 weeks late. I have had some small spotting. I am not pregnant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1747089 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Arthritis, Body temperature, C-reactive protein, C-reactive protein increased, Dizziness, Feeling hot, Lip swelling, Matrix metalloproteinase-3, Matrix metalloproteinase-3 increased, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Rheumatoid factor, Rheumatoid factor increased
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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: Rheumatoid arthritis (Rheumatoid arthritis was being inactive, but arthritis of the left 3rd finger occurred.)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210825; Test Name: CRP; Result Unstructured Data: Test Result:marked increase; Test Date: 20210825; Test Name: MMP3; Result Unstructured Data: Test Result:marked increase; Test Date: 20210825; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:marked increase; Test Date: 20210825; Test Name: rheumatoid factor; Result Unstructured Data: Test Result:marked increase
CDC Split Type: JPPFIZER INC202101192813

Write-up: Lip swelling; feeling hot; Felt faint; Arthritis / Arthropathy; CRP showed marked increase; erythrocyte sedimentation rate showed marked increase; MMP3 showed marked increase; rheumatoid factor showed marked increase; anaphylaxis; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21127786. A 65-year and 2-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 25Aug2021 (Lot Number: Unknown) at the age of 65-year-old as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Rheumatoid arthritis was being inactive, but arthritis of the left 3rd finger occurred. Body temperature before vaccination was 36.0 degrees Centigrade. Concomitant medication was not reported. On 25Aug2021 (the same day of the vaccination), the patient experienced anaphylaxis and arthritis. The clinical course was as follows: Lip swelling, feeling hot, and felt faint occured 15 minutes after the vaccination. CRP, erythrocyte sedimentation rate, MMP3, and rheumatoid factor showed marked increase. The reporting physician classified the event as serious (Medically Significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Rheumatoid arthritis underactive and quiescent for 9 years abruptly frequently activated. Arthropathy and immunostimulation due to vaccination were considered. On 06Sep2021 (12 days after the vaccination), the outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1747359 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Decreased appetite, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101183175

Write-up: Abdominal pain; Appetite lost; Malaise; fever; vomiting; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300103919. A 20-year-old female patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) intramuscular on 03Aug2021 (at the age of 20-year-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever and vomiting on 25Aug2021, abdominal pain, appetite lost and malaise on 27Aug2021. The patient was hospitalized due to the events. 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: 1747397 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-08-25
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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? 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: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive
CDC Split Type: PTPFIZER INC202101237384

Write-up: COVID-19 vaccine - Vaccine failure - User with complete vaccination schedule for $g2 weeks had COVID-19; COVID-19 vaccine - Vaccine failure - User with complete vaccination schedule for $g2 weeks had COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202109-109. A 66-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EX8680) via intramuscular route on 16May2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunization and first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW9127) via intramuscular route 17Apr2021 DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced covid-19 vaccine - vaccine failure - user with complete vaccination schedule for $g2 weeks had covid-19 on 25Aug2021. Adverse drug reaction (ADR) after 2nd dose. Case is reported as non-serious. Additional data: Onset of symptomatology associated with SARS-CoV-2 infection on the same day of the test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021 Positive. The outcome of the events was unknown. The reporter''s assessment of the causal relationship of the (vaccination failure, covid-19) with the suspect product was: This part was not received in the source document. Since no determination has been received, the case is managed based on the company causality assessment. Reporter comment: Other Information-Symptoms beginning on 25Aug2021 Test performed on 25Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747418 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / UNK - / 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: SE-MPA-2021-079997) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Company Comment: This case concerns a 18-year-old male patient with no relevant medical history, who experienced the serious expected event of Myocarditis. The event occurred approximately 2 days after unknown dose of Spikevax . The rechallenge was unknown as there''s no information available about the dose number. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 18-year-old male patient with no relevant medical history,who experienced the serious expected event of Myocarditis.The event occurred approximately 2 days after unknown dose of Spikevax . The rechallenge was unknown as there''s no information available about the dose number.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1749162 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004219 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Concussion, Fall, Fatigue, Inappropriate schedule of product administration, Loss of consciousness, Lymphadenopathy, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Fall; Concussion; Enlarged lymph nodes; Persistent fatigue; Loss of consciousness; Fainting with loss of consciousness the next day; Malaise; Second dose was given 21 days after the first one. Off-label use; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness), SYNCOPE (Fainting with loss of consciousness the next day), MALAISE (Malaise), FALL (Fall), CONCUSSION (Concussion), LYMPHADENOPATHY (Enlarged lymph nodes) and FATIGUE (Persistent fatigue) in a 39-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 21 days after the first one. Off-label use). On 16-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria hospitalization and medically significant), SYNCOPE (Fainting with loss of consciousness the next day) (seriousness criteria hospitalization and medically significant), MALAISE (Malaise) (seriousness criterion hospitalization), LYMPHADENOPATHY (Enlarged lymph nodes) (seriousness criterion hospitalization) and FATIGUE (Persistent fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced FALL (Fall) (seriousness criterion hospitalization) and CONCUSSION (Concussion) (seriousness criterion hospitalization). On 15-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 21 days after the first one. Off-label use) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), SYNCOPE (Fainting with loss of consciousness the next day), MALAISE (Malaise), LYMPHADENOPATHY (Enlarged lymph nodes) and FATIGUE (Persistent fatigue) had not resolved and FALL (Fall) and CONCUSSION (Concussion) outcome was unknown. The patient had no allergies,no pre-existent medical conditions. The concomitant medications on use were not provided. No treatment information was provided. Second dose was given 21 days after the first one. Off-label use. The patient selected AEs as not serious but then she added that she needed hospitalization and exams following her fall indicated concussion.


VAERS ID: 1749299 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-25
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003660 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (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: ESMODERNATX, INC.MOD20213

Write-up: This case was received via Agency (Reference number: ES-AEMPS-995997) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 214016 and 3003660) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced ARTHRALGIA (seriousness criterion medically significant). At the time of the report, ARTHRALGIA had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 15-Jul-2021. No concomitant medications reported by reporter No treatment medications provided by the reporter. Company Comment: This case concerns a 56-year-old male patient with no relevant medical history, who experienced the unexpected serious event of Arthralgia. The event occurred approximately 10 days after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and not expecting more doses . The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 27-Sep-2021, added anatomical location of 2nd dose of Moderna.; Sender''s Comments: This case concerns a 56-year-old male patient with no relevant medical history, who experienced the unexpected serious event of Arthralgia. The event occurred approximately 10 days after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and not expecting more doses . The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1750755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bouveret-Hoffmann syndrome (bouveret disease); Gastric ulcer; Hernia hiatal; Major depressive disorder NOS; Salpingitis
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Chest x-ray; Result Unstructured Data: Test Result:No systematic focus. No pleural effusion. No disor; Comments: No systematic focus. No pleural effusion. No disorder of the cardio-mediastinal silhouette. No overload.; Test Date: 20210825; Test Name: Echocardiography; Result Unstructured Data: Test Result:Probable post-vaccination myocarditis; Comments: Probable post-vaccination myocarditis with retained LVEF; Test Date: 20210825; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm at 912 bpm, normal QRS axis,; Comments: Regular sinus rhythm at 912 bpm, normal QRS axis, no significant conduction or repolarization disorder, no cavity hypertrophy, normal QT.; Test Date: 20210825; Test Name: NT-proBNP; Result Unstructured Data: Test Result:406.6 pg/mL; Test Date: 20210825; Test Name: Troponin; Result Unstructured Data: Test Result:225 ng/L
CDC Split Type: FRPFIZER INC202101215896

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the REGULATORY AUTHORITY-WEB, regulatory authority number FR-AFSSAPS-NY20214015. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 18Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included salpingitis, major depressive disorder NOS, hernia hiatal, Bouveret-Hoffmann syndrome (bouveret disease), gastric ulcer, and arterial hypertension. Concomitant medications included verapamil HCl taken for arterial hypertension, start and stop date were not reported; desogestrel (OPTIMIZETTE, 75 ug film-coated tablet) taken for oral contraception, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, solution for injection) on 28Jul2021 for COVID-19 immunisation. On 25Aug2021, the patient experienced myocarditis (hospitalization). The patient underwent lab tests and procedures which included chest x-ray: No systematic focus. No pleural effusion. No disorder of the cardio-mediastinal silhouette. No overload; Echocardiography: Probable post-vaccination myocarditis with retained LVEF; ECG: Regular sinus rhythm at 912 bpm, normal QRS axis, no significant conduction or repolarization disorder, no cavity hypertrophy, normal QT; NT-proBNP: 406.6 pg/ml; troponin: 225 ng/l; all on 25Aug2021. Therapeutic measures were taken as a result of myocarditis. The patient had not yet recovered from myocarditis. NB: Imputability without prejudice to the elements of investigation that could be carried out in the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. Report''s comment: A 30-year-old woman presenting to the emergency room with chest pain is diagnosed with acute post-vaccination myocarditis which occurred 8 days after the second injection of the COMIRNATY vaccine against COVID-19. Patient not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: A 30-year-old woman presenting to the emergency room with chest pain is diagnosed with acute post-vaccination myocarditis which occurred 8 days after the second injection of the COMIRNATY vaccine against COVID-19. Patient not recovered.


VAERS ID: 1750950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product use issue, SARS-CoV-2 test, Uterine haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (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: Breast feeding (for the last 15 months)
Preexisting Conditions: Medical History/Concurrent Conditions: Absence of menstruation (in the last 2 years, do not have periods at all whilst breast feeding); Pregnancy (for 9 months); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225509

Write-up: very heavy uterine bleeding; ongoing breastfeeding; ongoing breastfeeding; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory authority report number GB-MHRA-WEBCOVID-202109162245082620-3CUGD, Safety Report Unique Identifier GB-MHRA-ADR 25956549. This consumer reported information for both mother and baby. This is the maternal report. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 09Jul2021 to 23Jul2021 and was not ongoing, have not had a menstrual period in the last 2 years (do not have periods at all whilst breast feeding), ongoing breast feeding for the last 15 months, pregnancy (for 9 months). The patient''s concomitant medications were not reported. The patient experienced very heavy uterine bleeding on 08Sep2021. The patient reported that this was completely unexpected and the patient can only attribute it to the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the uterine bleeding was recovered on 14Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-08-25
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Blood pressure measurement, Chest pain, Dizziness, Dyspnoea, Investigation, Muscle tightness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Vestibular 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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperhomocysteinemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:stable; Test Date: 2021; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC202101223169

Write-up: Chest pain. 7 days in cardiology and discharged without diagnosis; loss of vision. 7 days in cardiology and discharged without diagnosis; shortness of breath. 7 days in cardiology and discharged without diagnosis; tightness in the neck. 7 days in cardiology and discharged without diagnosis; dizziness. 7 days in cardiology and discharged without diagnosis; This is a spontaneous report from a contactable consumer downloaded from the -WEB, regulatory authority number IT-MINISAL02-785152. A 53-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number FE2625, expiry date not provided), intramuscular, administered in right arm (also reported as right shoulder) on 27Jun2021 as dose 2, single for covid-19 immunisation. Medical history included hyperhomocysteinaemia and hypertension, both from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (tablet), orally at 20 mg, daily; oral ramipril (tablet), at 5 mg, daily; and oral bisoprolol fumarate (tablet), taken for hypertension at 1.25 mg, daily. On 25Aug2021, the patient experienced chest pain, loss of vision, shortness of breath, tightness in the neck and dizziness; and patient was 7 days (unspecified dates in 2021) in cardiology due to the events and discharged without diagnosis. On 13Sep2021, patient reported improvement of the symptomatology (reported as "sitnomatology") including chest pain (even if he was not making any effort). Impact on quality of life in 2021 was 10/10. Patient had stable blood pressure on an unknown date. The outcome of the events was recovering.; Reporter''s Comments: I suffer from hyperhomocysteinemia and hypertension


VAERS ID: 1751581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Myocarditis, Troponin
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: Myalgia; Precordial pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:without changes in segmental kinetics and good fun; Comments: without changes in segmental kinetics and good function.; Test Name: troponin; Result Unstructured Data: Test Result:0.249; Comments: Myocarditis with maximum troponin 0.249.
CDC Split Type: PTPFIZER INC202101272986

Write-up: Post-second vaccination myocarditis/ Myocarditis with maximum troponin 0.249; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from INFARMED Regulatory authority report number PT-INFARMED-M202109-1259 with Safety Report Unique Identifier PT-INFARMED-M202109-1259. A 17-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4442, Expiration date not reported), via intramuscular route on 21Aug2021 as dose 2, 0.3 ml (30mcg) single for active immunization to prevent covid-19 caused by the SARSCoV-2 virus. Medical history included myalgias and precordialgia, both from an unknown date and ongoing. There were no concomitant medications reported. On 25Aug2021, after 4 days of drug administration, the patient experienced post-second vaccination myocarditis/myocarditis with maximum troponin 0.249. It was reported that, the event was for approximate duration of 9 days. ADR involved the myocardium and motivated the use of hospital observation. There was no suspicion of drug interactions. The same drug was not reintroduced, as the vaccine schedule was complete. No previous reactions to the same drug or to other drugs were known. There was no reference to the usual taking of medications. Therapeutic measures were taken as a result of event and patient received treatment with unspecified beta-blocker. The patient underwent lab tests and procedures which included echocardiogram: without changes in segmental kinetics and good function, and troponin: 0.249, both on an unknown date. The event was recovered on 03Sep2021. Health Authority Comments: Other information-Myocarditis with maximum troponin 0.249. Echo without changes in segmental kinetics and good function. The reporter assessment of the causal relationship of the Myocarditis with the suspect product was: Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable. No follow-up attempts are possible. No further information expected.


VAERS ID: 1753066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sars-cov-2 test; Test Result: Positive ; Comments: Variant PCR-based: n.a. Variant Sequenced: n.a. n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101238887

Write-up: inappropriate schedule of vaccine administered; SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. This is a report received from the regulatory authority, Regulatory authority report number is AT-BASGAGES-2021-044521. A 42-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Batch/Lot FD6840), via Intramuscular route of administration, administered anatomical location not reported, on 25Jun2021 as dose 1, single for COVID-19 immunization. The patient received second dose of bnt162b2 (Formulation: Solution for injection, Batch/Lot FF3318), via Intramuscular route of administration, administered anatomical location not reported, on 06Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 25Aug2021, the patient experienced SARS-CoV-2 infection, Vaccination failure. On unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: N.A, Variant Sequenced: N.A, n501y-positive: Unknown). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1753073 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-08-25
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 antibody test, 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? 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: n501y; Test Result: Positive
CDC Split Type: ATPFIZER INC202101238936

Write-up: vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the regulatory authority number AT-2021-044539. A 57-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, batch/lot number: EJ6134, expiry date: unknown) via intramuscular route on 29Jan2021, as dose 1, single and second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, batch/lot number: EP2163, expiry date: unknown) via intramuscular route on 26Feb2021 as dose 2, single for covid-19 immunisation. The patient had no relevant medical history reported. The concomitant medications and concurrent conditions were not reported. The patient weight and height were not reported. On 25Aug2021, the patient experienced SARS-CoV-2 infection, vaccination failure. The patient underwent lab which included SARS-CoV-2 antibody test (n501y), with positive results on an unspecified date. The reporter (health authority) considered the event as serious and medically significant. The outcome of all events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1754776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Axillary pain, Chills, Headache, Malaise, Nausea, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: FIMODERNATX, INC.MOD20213

Write-up: Malaise; Nausea; Pain in arm; Syncope; Axillary pain; Chills; Abdominal discomfort; Headache; This case was received via regulatory authority (Reference number: FI-FIMEA-20214762) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Malaise), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), SYNCOPE (Syncope), AXILLARY PAIN (Axillary pain), CHILLS (Chills), ABDOMINAL DISCOMFORT (Abdominal discomfort) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MALAISE (Malaise) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), AXILLARY PAIN (Axillary pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Abdominal discomfort) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MALAISE (Malaise), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), SYNCOPE (Syncope), AXILLARY PAIN (Axillary pain), CHILLS (Chills), ABDOMINAL DISCOMFORT (Abdominal discomfort) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. The events are assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious. This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of Malaise, Nausea, Pain in extremity, Syncope, Axillary pain, Chills, Abdominal discomfort, and Headache. The events occurred around 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of Malaise, Nausea, Pain in extremity, Syncope, Axillary pain, Chills, Abdominal discomfort, and Headache. The events occurred around 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1754911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Menopause
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis of ovary (right); Generalised anxiety disorder; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101141965

Write-up: Menopausal menorrhagia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PV20212558. A 48-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FE8235) via intramuscular route of administration on 23Aug2021 as dose number unknown, 0.3 ml single for COVID-19 immunization. The medical history of the patient included endometriosis of ovary (right), obesity, generalized anxiety disorder from an unknown date and unknown if ongoing and ongoing menopause. The concomitant medications of the patient were not reported. The patient experienced menopausal menorrhagia on 25Aug2021. The clinical outcome for the event was not resolved. No FU attempts are possible. No further information is expected.


VAERS ID: 1754932 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonitis; Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: IgA vasculitis; This case was received via regulatory authority (Reference number: FR-AFSSAPS-TO20217893) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HENOCH-SCHONLEIN PURPURA (IgA vasculitis) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Tobacco user and COVID-19 pneumonitis in March 2020. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced HENOCH-SCHONLEIN PURPURA (IgA vasculitis) (seriousness criterion hospitalization). On 27-Aug-2021, HENOCH-SCHONLEIN PURPURA (IgA vasculitis) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 56 year old female patient with no relevant medical history, who experienced the unexpected event of Henoch-Schonlein Purpura. The event occurred approximately 2 days after a dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-2021 and does not contain any new information.; Sender''s Comments: This case concerns a 56 year old female patient with no relevant medical history, who experienced the unexpected event of Henoch-Schonlein Purpura. The event occurred approximately 2 days after a dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-25
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coronavirus pneumonia, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), 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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101228868

Write-up: positive COVID-19 test with symptoms; Coronavirus pneumonia; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-786110. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FD7959), dose 1 intramuscular on 22Jul2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included insulin; glibenclamide, metformin hydrochloride (GLIBOMET); atorvastatin calcium (TORVAST); and fenofibrate (FULCRO). On 25Aug2021, the patient experienced positive COVID-19 test with symptoms and coronavirus pneumonia. The patient''s symptoms included fever and dyspnea on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. The patient was hospitalized for positive COVID-19 test with symptoms and coronavirus pneumonia from 27Aug2021 to an unknown date. The patient was hospitalized on 27Aug2021 and transferred to Intensive care unit on 03Sep2021 for severe COVID pneumonia with severe respiratory organ insufficiency. The patient had not recovered from the events. Sender comment: The choice was made to report this case, even if the patient had done only one dose because of the gravity of his condition. Follow-up (24Sep2021): New information received from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number IT-MINISAL02-786110 includes: No new information provided.


VAERS ID: 1755578 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: NT-proBNP; Result Unstructured Data: Test Result:Were verified up to control on the fifth day; Test Date: 20210830; Test Name: Troponin; Result Unstructured Data: Test Result:Were verified up to control on the fifth day
CDC Split Type: PTPFIZER INC202101233393

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority report number PT-INFARMED-B202109-212. A 13-year-old male patient received bnt162b2 (COMIRNATY) (Strength: 30 ug), intramuscular on 25Aug2021 (Batch/Lot Number: Unknown) (at age of 13-year-old) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient experienced myocarditis (hospitalization) on 25Aug2021. The patient''s hospitalization was prolonged as a result of myocarditis. The patient felt pain for a day. Analytical changes (troponin and NT-proBNP (N-terminal prohormone brain natriuretic peptide)) were verified up to control on the 5th day on 30Aug2021. The specific treatment for ADR was ibuprofen. The patient also rested. The adverse reaction lasted approximately 5 days. The patient was under surveillance at the Pediatric Cardiology Consultation. The outcome of the event was recovered on 30Aug2021. Reporter comment: Concomitant Medication: No. Medication Error Occurred: No. Other Information: Pain for 24 hours. Analytical changes (troponin and NT-proBNP) up to 5 day control. Maintain surveillance in Pediatric Cardiology Appointments. The reporter''s assessment of the causal relationship of the Myocarditis with the suspect product was not provided at the time of this report. No follow-up attempts are possible, Information about batch number cannot be obtained.; Reporter''s Comments: Concomitant Medication: No. Medication Error Occurred: No. Other Information: Pain for 24 hours. Analytical changes (troponin and NT-proBNP) up to 5 day control. Maintain surveillance in Pediatric Cardiology Appointments.


VAERS ID: 1755599 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Product administration error, Vaccination site pain, Vaccination site swelling, Vaccination site vesicles
SMQs:, Hypersensitivity (narrow), Medication errors (narrow)

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: PTMODERNATX, INC.MOD20213

Write-up: blister 10 cm2 + swelling of 40 cm on the left side of the arm; blister 10 cm2 + swelling of 40 cm on the left side of the arm; This case was received via Regulatory Agency (Reference number: PT-INFARMED-T202109-287) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN, VACCINATION SITE VESICLES (blister 10 cm2 + swelling of 40 cm on the left side of the arm), VACCINATION SITE SWELLING (blister 10 cm2 + swelling of 40 cm on the left side of the arm) and PRODUCT ADMINISTRATION ERROR in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intravenous) .5 milliliter. On 25-Aug-2021, the patient experienced VACCINATION SITE PAIN (seriousness criterion disability). On an unknown date, the patient experienced VACCINATION SITE VESICLES (blister 10 cm2 + swelling of 40 cm on the left side of the arm) (seriousness criterion disability), VACCINATION SITE SWELLING (blister 10 cm2 + swelling of 40 cm on the left side of the arm) (seriousness criterion disability) and PRODUCT ADMINISTRATION ERROR (seriousness criterion disability). At the time of the report, VACCINATION SITE PAIN, VACCINATION SITE VESICLES (blister 10 cm2 + swelling of 40 cm on the left side of the arm), VACCINATION SITE SWELLING (blister 10 cm2 + swelling of 40 cm on the left side of the arm) and PRODUCT ADMINISTRATION ERROR outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intravenous) was unknown. For mRNA-1273 (Spikevax) (Intravenous), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. As per Reporters comments patient provide other information are blister 10 cm2 with swelling of 40 cm on the left side of the arm as it is shown in the attachments. Company Comment: This is a case of Product administration error for this 43-year-old female patient with no medical history provided. Reportedly, the patient received an unknown dose of Spikevax intravenously, which is considered to be product administration error. Furthermore, the patient experienced serious unexpected event of vaccination site pain that occurred two days following the administration of the Spikevax. In addition, the patient also developed unexpected events of Vaccination site vesicles and Vaccination site swelling (reported as "blister 10 cm2 with swelling of 40 cm on the left side of the arm" as per source document), but the exact start date of these events was not specified. The outcome of the events was unknown at the time of the report. Having in mind that it was unknown whether the patient received the first or the second dose of the product, rechallenge is considered unknown at the moment. 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 disability. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 28-Sep-2021 as live follow up. Reporter''s comments, Dosage text and event verbatim translated.; Sender''s Comments: This is a case of Product administration error for this 43-year-old female patient with no medical history provided. Reportedly, the patient received an unknown dose of Spikevax intravenously, which is considered to be product administration error. Furthermore, the patient experienced serious unexpected event of vaccination site pain that occurred two days following the administration of the Spikevax. In addition, the patient also developed unexpected events of Vaccination site vesicles and Vaccination site swelling (reported as "blister 10 cm2 with swelling of 40 cm on the left side of the arm" as per source document), but the exact start date of these events was not specified. The outcome of the events was unknown at the time of the report. Having in mind that it was unknown whether the patient received the first or the second dose of the product, rechallenge is considered unknown at the moment. 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 disability.


VAERS ID: 1757886 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-25
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Contusion, Inflammation, Laboratory test normal, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Saw doctor a couple of days after symptoms first appeared. Doctor referred me to emergency at the hospital. Hospital did some initial blood tests which came back normal, then referred me to a specialist for more testing. Specialist ordered additional tests but all came back normal. Prescribed cortisone cream to assist with the inflammation. Also antihistamines. Symptoms started to reduce and then cleared up (~4-5 weeks after first starting).
CDC Split Type:

Write-up: Extensive skin rash causing significant itching. Itched areas quickly bruised (first time I have ever encountered this). Legs, arms, back all affected, with thighs bruising most visibly. This started about 3-4 weeks after my second dose and lasted for about 4-5 weeks.


VAERS ID: 1757951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211002548

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-046876) on 01-OCT-2021 and concerned a 57 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: XD985 expiry: UNKNOWN) dose was not reported, administered 1 total on 07-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure, and sars-cov-2 infection.. He was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint.


VAERS ID: 1757996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-08-25
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Left ventricular dysfunction, Magnetic resonance imaging heart, Mitral valve incompetence, Myocarditis
SMQs:, Cardiac failure (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 Name: Heart-magnetic resonance imaging; Result Unstructured Data: Test Result:Perimyocarditis; Comments: Consequences high-grade mitral valve regurgitation
CDC Split Type: DEPFIZER INC202101228952

Write-up: Perimyocarditis; Perimyocarditis with severely reduced left ventricle (LV) function; heart failure symptoms; high-grade mitral valve regurgitation; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021179108. A 37-years-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Jun2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced perimyocarditis (hospitalization) on 25Aug2021 with outcome of recovering, perimyocarditis with severely reduced left ventricle (lv) function (hospitalization) on 25Aug2021 with outcome of recovering, heart failure symptoms (medically significant) in 2021 with outcome of unknown, high-grade mitral valve regurgitation (medically significant) in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included magnetic resonance imaging heart: perimyocarditis on an unspecified date Consequences high-grade mitral valve regurgitation. Sender comment: Information on risk factors or previous illnesses None known / heart failure symptoms. 11 days stay. In Heart-magnetic resonance imaging Perimyocarditis. Consequences high-grade mitral valve regurgitation. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1758017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood bilirubin, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Blood thromboplastin, Blood urea, Brain natriuretic peptide, C-reactive protein, Cardiac murmur functional, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, Heart rate, Investigation, Lymphocyte count, Magnetic resonance imaging, Myocarditis, Neutrophil count, Oxygen saturation, Paraesthesia, Platelet count, Prothrombin time, Pyrexia, Sinus rhythm, Troponin I, White blood cell count
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Irritable bowel; Migraine; Palpitations (with echocardiogram, Holter, P. normal exertion (does not provide reports))
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:8; Test Date: 20210827; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:35; Test Date: 20210827; Test Name: Total bilirubin; Result Unstructured Data: Test Result:0.4; Test Date: 20210830; Test Name: Chloride; Result Unstructured Data: Test Result:102; Test Date: 20210827; Test Name: Creatine kinase; Result Unstructured Data: Test Result:218; Test Date: 20210827; Test Name: Creatine kinase; Result Unstructured Data: Test Result:285; Test Date: 20210830; Test Name: Creatine kinase; Result Unstructured Data: Test Result:37; Test Date: 20210827; Test Name: Creatinine; Result Unstructured Data: Test Result:0.7; Test Date: 20210830; Test Name: Creatinine; Result Unstructured Data: Test Result:0.7; Test Date: 20210827; Test Name: Fibrinogen; Result Unstructured Data: Test Result:590; Test Date: 20210827; Test Name: Fibrinogen; Result Unstructured Data: Test Result:559; Test Date: 20210830; Test Name: Fibrinogen; Result Unstructured Data: Test Result:458; Test Date: 20210830; Test Name: Glucose; Result Unstructured Data: Test Result:110; Test Date: 20210827; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:335; Test Date: 20210827; Test Name: Potassium; Result Unstructured Data: Test Result:4.3; Test Date: 20210830; Test Name: Potassium; Result Unstructured Data: Test Result:4.3; Test Name: Blood pressure; Result Unstructured Data: Test Result:107/98; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/76; Test Date: 20210827; Test Name: Sodium; Result Unstructured Data: Test Result:135; Test Date: 20210830; Test Name: Sodium; Result Unstructured Data: Test Result:137; Test Date: 20210827; Test Name: Phosphatase alkaline; Result Unstructured Data: Test Result:42; Test Date: 20210827; Test Name: thromboplastin time; Result Unstructured Data: Test Result:0.97; Test Date: 20210830; Test Name: urea; Result Unstructured Data: Test Result:31; Test Date: 20210827; Test Name: Natriuretic peptide; Result Unstructured Data: Test Result:153; Test Name: murmur; Result Unstructured Data: Test Result:No murmurs or extra tones; Test Name: murmur; Result Unstructured Data: Test Result:not murmur or rub; Test Name: Chest x-ray; Result Unstructured Data: Test Result:no cardiomegaly or effusion; Test Date: 20210827; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:5.8; Test Date: 20210830; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:1.1; Test Name: echocardiogram; Result Unstructured Data: Test Result:good biventricular function; Comments: without apparent segmental alterations, no effusion or congenital defects; Test Name: EKG; Result Unstructured Data: Test Result:pericarditis; Test Date: 20210827; Test Name: D-dimer; Result Unstructured Data: Test Result:438; Test Date: 20210830; Test Name: D-dimer; Result Unstructured Data: Test Result:508; Test Date: 20210827; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:11; Test Date: 20210827; Test Name: Glomerular filtration; Result Unstructured Data: Test Result:90; Comments: (CKD-EPI,2011); Test Date: 20210830; Test Name: Glomerular filtration; Result Unstructured Data: Test Result:90; Test Date: 20210827; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.5; Test Name: pulse; Result Unstructured Data: Test Result:78; Comments: beats per minute; Test Name: pulse; Result Unstructured Data: Test Result:70; Comments: beats per minute; Test Name: pathological anatomy; Result Unstructured Data: Test Result:without crackles, no edema; Test Date: 20210827; Test Name: Lymphocytes; Result Unstructured Data: Test Result:15.7; Test Name: MRI; Result Unstructured Data: Test Result:Requested; Test Date: 20210827; Test Name: Neutrophils; Result Unstructured Data: Test Result:76.6; Test Name: oxygen saturation; Result Unstructured Data: Test Result:100; Comments: %; Test Name: oxygen saturation; Result Unstructured Data: Test Result:98; Comments: %; Test Date: 20210827; Test Name: Platelets; Result Unstructured Data: Test Result:223; Test Date: 20210827; Test Name: prothrombin time; Result Unstructured Data: Test Result:1.02; Test Name: sinus rhythm; Result Unstructured Data: Test Result:maintained; Comments: does not do any arrhythmia and not even EV or ESV (extra systole) is observed; Test Name: sinus rhythm; Result Unstructured Data: Test Result:72; Comments: beats per minute subjectively T somewhat flattened in V2-V3, normal rest. In the high trace the T is normal in all leads, narrow QRS and U wave; Test Name: troponin I; Result Unstructured Data: Test Result:marked elevation; Test Name: troponin I; Result Unstructured Data: Test Result:4050; Comments: peak in the first 24hrs of 4050 in subsequent descent; Test Date: 20210827; Test Name: troponin I; Result Unstructured Data: Test Result:2304; Test Date: 20210827; Test Name: troponin I; Result Unstructured Data: Test Result:4050; Test Date: 20210830; Test Name: troponin I; Result Unstructured Data: Test Result:459; Test Date: 20210827; Test Name: Leukocytes; Result Unstructured Data: Test Result:10.640
CDC Split Type: ESPFIZER INC202101228844

Write-up: chest pain; paresthesias; Myopericarditis; fever at 24hrs; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-999049. A 27-years-old female (no pregnant) patient received bnt162b2 (COMIRNATY), dose 2, via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: FG4686) as DOSE 2, SINGLE for covid-19 immunisation. Historical Vaccine was Comirnaty on 03Aug2021 (batch/lot number FG4442) for covid-19 immunisation. Medical history included anxiety, irritable bowel syndrome, migraine, palpitations with echocardiogram, Holter, P. normal exertion (does not provide reports). The patient''s concomitant medications were not reported. The patient experienced myopericarditis (hospitalization) on 27Aug2021 with outcome of recovering, chest pain (hospitalization) on 27Aug2021 with outcome of recovering, paresthesias (hospitalization) on 27Aug2021 with outcome of recovering, fever at 24hrs (non-serious) on 25Aug2021 with outcome unknown. The patient underwent lab tests and procedures which included alanine aminotransferase: 8 on 27Aug2021, aspartate aminotransferase: 35 on 27Aug2021, blood bilirubin: 0.4 on 27Aug2021, blood chloride: 102 on 30Aug2021, blood creatine phosphokinase: 218 on 27Aug2021, blood creatine phosphokinase: 285 on 27Aug2021, blood creatine phosphokinase: 37 on 30Aug2021, blood creatinine: 0.7 on 27Aug2021, blood creatinine: 0.7 on 30Aug2021, blood fibrinogen: 590 on 27Aug2021, blood fibrinogen: 559 on 27Aug2021, blood fibrinogen: 458 on 30Aug2021, blood glucose: 110 on 30Aug2021, blood lactate dehydrogenase: 335 on 27Aug2021, blood potassium: 4.3 on 27Aug2021. Therapeutic measures were taken as a result of myopericarditis. Emergency due to suspicion of myopericarditis. The clinical course was reported as follows: Episode of intense chest pain on the day of admission around 9AM, clearly defines it oppressive, radiated to the left arm and associating paresthesia. It lasts almost 3 hours. Initially it is interpreted as anxiety. He is referred to (PRIVACY), where marked elevation of troponin I stands out and therefore they request the assessment. As a background second dose of COVID vaccine Pfizer on 24Aug, he had a fever at 24hrs and a subsequent fever. There is no apparent infectious clinic in systems anamnesis. Troponin I makes a peak in the first 24hrs of 4050, in subsequent descent, being In RS (sinus rhythm) maintained all the income, does not do any arrhythmia and not even extra systole (EV or ESV) is observed. In the echocardiogram performed at 24hrs there is good biventricular function, without apparent segmental alterations, no effusion or congenital defects. As it did not occur with clinical, ECG or imaging data compatible with pericarditis, colchicine was not prescribed. It is managed with prednisone doses of 1mg/kg in a descending regimen and conventional analgesia, with good response. Ambulatory cardiac MRI and early review is left requested. As the only antecedent and probable trigger of the picture, which at the moment impresses acute myocarditis, is the COVID Pfizer vaccination (described as a side effect). Physical state (PS) TA 107/98, FC 78lpm, SpO2 100%. No murmurs or extra tones, pathological anatomy (PA) without crackles, no edema. PS at discharge: TA 112/76, FC 70lpm in RS, SpO2 98%. Do not murmur or rub. EKG (electrocardiogram) admission: RS at 72lpm, subjectively T somewhat flattened in V2-V3, normal rest. In the high trace the T is normal in all leads, narrow QRS and U wave. Chest Rx: no cardiomegaly or effusion, also not consolidated. 27/08/2021 14:12*: Creatinine 0.7, Glomerular filtration (CKD-EPI,2011) 90, Total bilirubin 0.4, Sodium Ion 135, Potassium Ion 4.3, Creatine kinase (CK) 218, Natriuretic peptide cerebral (NT-proBNP) 153, Troponin I (ultra-sensitive) 2304, Aspartate aminotransferase (ASAT/GOT) 35, Alanine aminotransferase (ALAT/GPT) 8, Gamma-glutamyltransferase (GGT) 11, Phosphatase alkaline 42, Lactate dehydrogenase (Corrected) 335, C-Reactive Protein 5.8, Leukocytes 10.640, Neutrophils 76.6, Lymphocytes 15.7, Hemoglobin 12.5, Platelets 223, Prothrombin time (TP - INR) 1.02, thromboplastin time (TTPA) - Ratio 0.97, Fibrinogen derivative 590. 27/08/2021 17:53: Creatine Kinase (CK) 285, Troponin I (ultra-sensitive) 4050, Fibrinogen derivative 559, D-dimer 438. 30/08/2021 09:48: Glucose 110, Urea 31, Creatinine 0.7, Glomerular filtration (CKD-EPI,2011) 90, Sodium Ion 137, Potassium Ion 4.3, Chloride 102, Creatine Kinase (CK) 37, Troponin I (ultra-sensitive) 459, C-Reactive Protein 1.1, Fibrinogen derivative 458, D-dimer 508. DIAGNOSTICS was chest pain with elevation of troponin i. suspected acute non-severe myocarditis, post vaccine (Pfizer covid vaccination completed on 24Aug21). TREATMENT was Normal diet. Relative rest until the next check-up in consultations- You can go for a daily walk and do daily activities, which do not involve physical exertion. Medication was PREDNISONE 10MG; in the following guideline: 3 for breakfast and one for dinner for 3 more days, 3 in breakfast for 5 days, 2 in breakfast for 7 days, 1 in breakfast for 7 days and suspend. OMEPRAZOLE 40MG one at breakfast, while on PREDNISONE. BISOPROLOL COR 1,25MG one at dinner, until the next review. If you have pain, you can take IBUPROFEN 400MG or better PARACETAMOL 1GR but if intense pain such as the one that motivated the admission, going back to the emergency room. REVIEWS: You will be called for preferred Nuclear magnetic resonance (NMR). In cardiology consultation on 28Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1758251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Oedema peripheral, Rash, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (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: DEXAMETHASONE; ZOMETA
Current Illness: Monoclonal gammopathy (treated with the triplet VRD regimen (Velcade, Revlimid, dexamethasone) since 04Jun2021)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101228596

Write-up: Erythema diffuse/ upper limb erythema/ granular skin appearance on the back, simple macules on the abdomen and a map-like pattern on the forearms; rash; Moderate left upper limb edema; urticaria-like erythema on the back and abdomen.; This is a spontaneous report from a contactable physician downloaded from the REGULATORY AUTHORITY-WEB, regulatory authority number FR-AFSSAPS-TS20214232. A 69-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection), intramuscularly on 18Aug2021 (Batch/Lot Number was not reported) as SINGLE for covid-19 immunization, lenalidomide (REVLIMID), oral (Batch/Lot Number: Unknown) from 03Aug2021 to 23Aug2021 for monoclonal gammopathy, bortezomib (VELCADE), subcutaneous (Batch/Lot Number: Unknown) from 06Aug2021 to 17Aug2021, at 1.3 mg, 4x/day, from 06Aug2021 (Batch/Lot number was not reported) to an unspecified date, at Course 3 Day 1 2.13mg, from 10Aug2021 (Batch/Lot number was not reported) to an unspecified date, at Course 3 Day 4, from 13Aug2021 (Batch/Lot number was not reported) to an unspecified date, at Course 3 Day 8, from 17Aug2021 (Batch/Lot number was not reported) to an unspecified date, at Course 3 Day 11 via an unspecified route of administration for monoclonal gammopathy, ofloxacin (OFLOXACINE), oral (Batch/Lot Number: Unknown) from 18Aug2021 to 26Aug2021 for urinary tract infection, ondansetron (ZOPHREN [ONDANSETRON] (Batch/Lot number was not reported), via an unspecified route of administration from 06Aug2021 to an unspecified date, at 8 mg 4 days/week for an unspecified indication. The patient medical history included monoclonal gammopathy (treated with the triplet VRD regimen (Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone) since 04Jun2021). Concomitant medications included dexamethasone (DEXAMETHASONE), zoledronic acid monohydrate (ZOMETA) taken for an unspecified indication, start and stop date were not reported. On 25Aug2021, the patient experienced erythema diffuse/ upper limb erythema/ granular skin appearance on the back, simple macules on the abdomen and a map-like pattern on the forearms, rash, moderate left upper limb edema, urticaria-like erythema on the back and abdomenon occurred on Day 22 of Lenalidomide, Day 8 of Bortezomib, Day 7 of Comirnaty and Day 7 of Ofloxacin. No regression of rash despite discontinuation of all drugs. On 31Aug2021, the patient presented for the start of course 4 of his treatment. The erythema was still present with a granular skin appearance on the back, simple macules on the abdomen and a map-like pattern on the forearms. Moderate left upper limb edema. No axillary lymphadenopathy, Apyrexia, no loss of appetite, no pruritus. Introduction of Prednisone 40mg/day and cancellation of the VRD regimen 4 which was to start on this day. The action taken in response to the events for lenalidomide was permanently withdrawn on 23Aug2021, for bortezomib was permanently withdrawn on an unspecified date , for ofloxacin was permanently withdrawn on 26Aug2021. The patient received treatment for the events and event rash with citrizine and the rash worsened in the following days, despite stopping the medication. Outcome of the event erythema diffuse/ upper limb erythema/ granular skin appearance on the back, simple macules on the abdomen and a map-like pattern on the forearms was not recovered. Outcome of the events rash, Moderate left upper limb edema and urticaria-like erythema on the back and abdomen were unknown. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1758260 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Investigation, Loss of consciousness, Neurological examination, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Memory disturbance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: cardiological investigation; Result Unstructured Data: Test Result: unknown results; Test Date: 202108; Test Name: neurological investigations; Result Unstructured Data: Test Result: unknown results.
CDC Split Type: ITPFIZER INC202101229602

Write-up: A few hours after the vaccine dose, headache appeared, she went to the bathroom where she lost consciousness and was taken to the emergency room; A few hours after the vaccine dose, headache appeared, she went to the bathroom where she lost consciousness and was taken to the emergency room; episodes of tachycardia and sweating; episodes of tachycardia and sweating; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-785768. A 39-year-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection; Lot Number: FG4686, expiration date: 30Nov2021), via intramuscular route administered in Arm Right on 25Aug2021 at 10:47 (at the age of 39-years-old) as dose 1, 0.3 mL single for COVID-19 immunization. The patient''s medical history included ongoing Recent memory disturbances and concomitant medications were not reported. On 25Aug2021, the patient experienced a few hours after the vaccine dose, headache appeared, she went to the bathroom where she lost consciousness and was taken to the emergency room. Patient was taken to emergency room and resigned, is undergoing cardiological and neurological investigations. Recent memory disturbances persisted with episodes of tachycardia and sweating. The patient underwent lab tests and procedures which included cardiological investigation: unknown results and neurological examination: unknown results on an unknown date in Aug2021. The outcome of events was not recovered. Reporter''s comments: Investigations are being carried out to be able to make both an exact correlation and to be able to make a possible second dose. The symptoms are still persistent. No follow-up attempts possible. No further information expected.


VAERS ID: 1758319 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-04
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Behavior disorder; Fibrodysplasia ossificans progressiva; Mitral valve disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210960267

Write-up: Vaccination failure; This spontaneous report received from a health care professional via Regulatory Authority (PT-INFARMED-T202109-1229) on 30-SEP-2021 and concerned a 19 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: mitral valve disease, fibrodysplasia ossificans progressiva, and behavior disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-04 expiry: UNKNOWN) 0.5 ml, frequency time 1 total administered on 09-AUG-2021 for covid-19 immunisation. The drug start period was 16 days. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure. Laboratory data included: 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 patient recovered from vaccination failure on 04-SEP-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information - CONGENITAL CARDIOVASCULAR MALFORMATION 19-Nov-2015 CARDIAC VALVULAR DISEASE NE Minimal Mitral Dysplasia 10-Nov-2015 P22 CHILD''S SYMPTOM / BEHAVIOR COMPLAINT


VAERS ID: 1760068 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram ambulatory, Hypertension, Influenza like illness, Psoriasis
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Psoriasis
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive episode
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: holter; Result Unstructured Data: Test Result:an average systolic blood pressure of 165 and 98
CDC Split Type: FRPFIZER INC202101286309

Write-up: Psoriasis flare-up; Hypertension arterial; Influenza like illness; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Agency Regulatory Authority-WEB with regulatory authority number: FR-AFSSAPS-MA20213599. A 42-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 24Aug2021 (Lot Number: FF4213), at the age of 42-years-old, as dose 2, single for COVID-19 immunisation. Medical history included ongoing psoriasis and Hypertensive episode from 2017 to an unknown date. The patient previously took first dose of bnt162b2 (COMIRNATY) on 03Aug2021 (Batch/Lot Number: FE8244) for COVID-19 immunisation and experienced Influenza like illness and psoriasis flare-up. The patient''s concomitant medications were not reported. The patient experienced hypertension arterial on 27Aug2021 with outcome of recovering, psoriasis flare-up on an unspecified date with outcome of unknown and influenza like illness on 25Aug2021 with outcome of recovered on 27Aug2021. The clinical course was reported as follows: Patient who presented an influenza-like illness 2 hours after the first dose of COMIRNATY batch FE8244 with recurrence at the second dose, unknown batch, accompanied by an outbreak of arterial hypertension. The patient also describes an outbreak of psoriasis between the 2 doses. The flu syndrome lasted until 15Aug2021, PCR Covid negative on 16Aug2021. The flu syndrome recurred the day after the second dose and lasted 48 hours. The patient received a holter on 31Aug2021 which showed an average systolic blood pressure of 165 and 98 for the diastolic. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101239575 same patient, different events after 1st and 2nd dose of vaccine (Comirnaty)


VAERS ID: 1760111 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site reaction, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: BEPFIZER INC202101239075

Write-up: Injection site reaction; Fever; Fatigue; Nausea (can hardly eat anything for 2 days); Vomiting; Flu-like symptoms; Myalgia; Headache; Feeling unwell; Shivering; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number BE-FAMHP-DHH-N2021-106601. A 13-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FG3716), via an unspecified route of administration on 25Aug2021 (at the age of 13-years-old) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced injection site reaction, fever, fatigue, nausea, vomiting, flu-like symptoms, myalgia, headache, feeling unwell and shivering. Clinical course details: flu-like feeling, nausea, severe headache, fatigue, muscle pain, vomiting, nausea (can hardly eat anything for 2 days). First days a lot of problems with the above-mentioned side effects, then a few more days tired and muscle pain. Therapeutic measures were taken as a result of events as the patient received Motilium and Dafalgan. The outcome of the events was recovered on 27Aug2021. This report is serious - disabling. No follow-up attempts possible. No further information expected.


VAERS ID: 1760487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-08-25
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic ischemic heart disease, unspecified; Pulmonary sarcoidosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101239752

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number EE-SAM-502821090625. A 65-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 17Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as dose 2, 0.3 ml, single and dose 1 intramuscular on 27Dec2020 (Batch/Lot Number: EJ6796; Expiration Date: 30Apr2021) as dose 1, 0.3 ml, single for covid-19 immunisation. Medical history included ongoing pulmonary sarcoidosis and ongoing chronic ischemic heart disease, unspecified. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced vaccination failure and Covid-19. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test positive on 26Aug2021. The outcome of the events was recovering. As of 22Sep2021, investigation result received for complaint of lack of effect. 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(s) of the reported lot EJ6796 and EL1491. 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 evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1760504 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Skin reaction
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Medical History/Concurrent Conditions: Multiple sclerosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101239561

Write-up: Skin reaction; Herpes zoster; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-1004335. A 49-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: FC1439) as dose number unknown, single for covid-19 immunisation at age of 49-year-old. Medical history included multiple sclerosis. The patient''s concomitant medications were not reported. The patient experienced skin reaction (medically significant) on 25Aug2021, and herpes zoster (medically significant) on 25Aug2021. Outcome of the events was recovering No follow-up attempts are possible. No further information expected.


VAERS ID: 1760601 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Cardiac telemetry, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haemoglobin, Heart rate, Influenza like illness, Myocarditis, Oxygen saturation, Pain, Physical examination, Pyrexia, Troponin, White blood cell count
SMQs:, Neuroleptic malignant syndrome (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: creatinine; Result Unstructured Data: Test Result:78 umol/l; Test Date: 20210829; Test Name: Kalium; Result Unstructured Data: Test Result:4.1; Test Date: 20210829; Test Name: Blood pressure; Result Unstructured Data: Test Result:12/7; Test Date: 20210829; Test Name: Sodium ion; Result Unstructured Data: Test Result:138; Test Date: 20210829; Test Name: Temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: no fever; Test Date: 20210829; Test Name: Telemetric monitoring; Result Unstructured Data: Test Result:did not reveal any rhythm or conduction disorders; Comments: during the hospital stay; Test Date: 20210829; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210829; Test Name: C-reactive protein; Result Unstructured Data: Test Result:59 mg/l; Test Date: 20210829; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Normal; Comments: Non-dilated left ventricle with normal segmental and global kinetics. Left ventricular ejection fraction estimated at 60% by modified Simpson method, global longitudinal strain=-18.4, dry pericardium. No right ventricle dysfunction.; Test Date: 20210829; Test Name: Electrocardiography; Result Unstructured Data: Test Result:discrete concave ST depression; Comments: Regular sinus rhythm 90 bpm; PR interval 150 ms; incomplete right bundle branch block (QRS=109 ms), discrete concave ST depression in Augmented Vector Left (AVL), no PQ interval depression, heart rate-corrected QT interval=427 ms.; Test Date: 20210829; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:$g120; Test Date: 20210829; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.7 g/dl; Test Date: 20210829; Test Name: heart rate; Result Unstructured Data: Test Result:88; Comments: bpm (beats per minute); Test Date: 20210829; Test Name: oxygen saturation; Test Result: 100 %; Comments: Eupnoeic in room air with 100% oxygen saturation; Test Date: 20210829; Test Name: clinical examination; Result Unstructured Data: Test Result:no thoracic pain, no fever (temperature 36.3?C); Comments: blood pressure 12/7, heart rate 88 bpm (beats per minute). No audible murmur and no pericardial rub. No signs of right or left heart failure. Eupnoeic in room air with 100% oxygen saturation. Bilateral symmetrical vesicular murmur without superimposed noises. Soft, yielding abdomen, painless on palpitation. No urinary symptoms.; Test Date: 20210829; Test Name: troponin; Result Unstructured Data: Test Result:200; Test Date: 20210829; Test Name: Leukocytes; Result Unstructured Data: Test Result:11.9 g/l
CDC Split Type: FRPFIZER INC202101239565

Write-up: pain; Myocarditis; constrictive thoracic pain; Mild fever; influenza-like syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RS20212899. A 19-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), at the age of 19 years old, via intramuscular on 25Aug2021 at single dose for COVID-19 immunisation. Medical history included acute pericarditis from Oct2020. There were no concomitant medications. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and experienced rash as a newborn. The patient experienced mild fever and influenza-like syndrome thereafter. 4 days after the injection, on 29Aug2021, around 10:00, sudden onset of constrictive thoracic pain (probable myocarditis), without irradiation and without any other associated symptom at rest and lasting about 2-3 hours before resolving spontaneously. The patient experienced pain on an unspecified date. Spontaneous regression of pain; no recurrence. The patient was hospitalized from 29Aug2021 to 01Sep2021 for thoracic pain (probable myocarditis) and pain. Clinical examination on arrival (29Aug2021): no thoracic pain, no fever (temperature 36.3?C), blood pressure 12/7, heart rate 88 bpm (beats per minute). No audible murmur and no pericardial rub. No signs of right or left heart failure. Eupnoeic in room air with 100% oxygen saturation. Bilateral symmetrical vesicular murmur without superimposed noises. Soft, yielding abdomen, painless on palpitation. No urinary symptoms. Electrocardiography: Regular sinus rhythm 90 bpm; PR interval 150 ms; incomplete right bundle branch block (QRS=109 ms), discrete concave ST depression in Augmented Vector Left (AVL), no PQ interval depression, heart rate-corrected QT interval=427 ms. Blood test: troponin 200, C-reactive protein 59 mg/L, Leukocytes 11.9 G/L, Haemoglobin 14.7 g/dL, creatinine 78 ?mol/L, glomerular filtration rate $g120, Kalium 4.1; Sodium ion 138. Chest X-ray: Nothing to report. Trans-thoracic echocardiography: normal. Non-dilated left ventricle with normal segmental and global kinetics. Left ventricular ejection fraction estimated at 60% by modified Simpson method, global longitudinal strain=-18.4, dry pericardium. No right ventricle dysfunction. Telemetric monitoring did not reveal any rhythm or conduction disorders during the hospital stay. Cardiac magnetic resonance imaging scheduled for 06Sep2021. Therapeutic measures were taken as a result of myocarditis, thoracic pain, pain and included treatment with initiation of beta-blocker therapy: bisoprolol 1.25 mg morning and evening, with good tolerance. Continuation of this treatment planned for 6 months. Contraindication to sport for 3 months. Patient was discharged on 01Sep2021 given the improvement in general condition and complete disappearance of pain. The outcome of events myocarditis and thoracic pain was recovering. The outcome of event pain was recovered. The outcome of other events was unknown. In summary, probable myocarditis 4 days after a second injection of BNT162B2 in a 19-year-old male patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
SMQs:

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: Food allergy; Gordon syndrome; Irritable bowel syndrome; Joint disorder; Type 2 diabetes mellitus (Suspected type 2 diabetes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101243182

Write-up: Persistent headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109200921043760-KBYWK, Safety Report Unique Identifier is GB-MHRA-ADR 25967368. A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 (Batch/Lot number was not reported) as Dose 1, single for COVID-19 immunization. Medical history included food allergy, irritable bowel syndrome, arthropathy (hyperjoint mobility), type 2 diabetes mellitus (suspected type 2 diabetes), and congenital multiplex arthrogryposis (Gordon syndrome). Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Concomitant medications were not reported. The patient experienced persistent headache on 25Aug2021 with outcome of not recovered. The event was reported as serious, medically significant by the health authority. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1761085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211005715

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046681) on 04-OCT-2021 concerned a 23 year old male. 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: XD974, expiry: Unknown) dose was not reported, 1 total, administered on 30-JUN-2021 for unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced SARS-COV-2 infection, hence vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-COV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.


VAERS ID: 1761113 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein, C-reactive protein increased, Gait inability, Polymyalgia rheumatica, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vasculitis (narrow), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased; Test Date: 20210825; Test Name: Red blood cell sedimentation rate; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101243045

Write-up: Polymyalgia rheumatica; Arthralgia; C-reactive protein increased; Gait inability; Red blood cell sedimentation rate increased; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number 624162. A 55-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced polymyalgia rheumatica, arthralgia, C-reactive protein increased, gait inability and red blood cell sedimentation rate increased. On 25Aug2021, the patient underwent lab tests and procedures which included C-reactive protein: increased and red blood cell sedimentation rate: 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: 1761122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Myocarditis, Off label use, 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 INC202101243403

Write-up: booster; off label use; Myocarditis; Troponin increased; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 624822. As per source. A 45-years-old female patient received BNT162B2 (COMIRNATY Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of (COMIRNATY Formulation: Solution for injection Batch/Lot number was not reported ) via an unspecified route of administration on an unspecified date as single and received third dose of (COMIRNATY Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as (BOOSTER) single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving booster dose of vaccine the patient experienced myocarditis, troponin increased on 25Aug2021. The outcome of 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: 1762462 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F036A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebral venous thrombosis, Chromatopsia, Diarrhoea, Fibrin D dimer increased, Headache, Heart rate, Heart rate increased, Magnetic resonance imaging, Migraine with aura, Nasopharyngitis, Ultrasound scan, Vaccination site pain
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), 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: L-THYROXINE [LEVOTHYROXINE SODIUM]
Current Illness: Hashimoto''s thyroiditis (L-thyroxine 100)
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Name: d dimer; Result Unstructured Data: Test Result:0.900 mg/l; Test Name: Resting pulse; Result Unstructured Data: Test Result:110-120; Test Name: Resting pulse; Result Unstructured Data: Test Result:permanently pulse rises to 150; Comments: permanently pulse rises to 150; Test Name: MRI; Result Unstructured Data: Test Result:without findings; Test Name: ultrasound scan; Result Unstructured Data: Test Result:without findings
CDC Split Type: DEPFIZER INC202101249251

Write-up: suspicion of Cerebral venous thrombosis; one-sided right headache changed to migraine with aura; Pain at injection site; diarrhoea; D-dimer rises every time when colour vision; Vision color tinged; pulse is high; cold symptoms; generally very weak; headache; This is a spontaneous report from a contactable consumer (parent). This is a report based on information received by Pfizer from Biontech, license party for Comirnaty. This case is about 2nd dose. A 17-years-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: 1F036A), via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 17-years-old). Medical history included ongoing Hashimoto and obesity from an unknown date and unknown if it is ongoing. Concomitant medications included levothyroxine sodium (L-THYROXINE 100) taken for hashimoto, start and stop date were not reported. The patient previously took first dose of COMIRNATY (solution for injection; Batch/Lot Number: FE 6975), via an unspecified route of administration on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced pain at injection site. The patient experienced suspicion of cerebral venous thrombosis on 03Sep2021, one-sided right headache changed to migraine with aura on 25Aug2021, also unilateral headache 5-6 times since 03Sep2021, pain at injection site, diarrhoea, d-dimer rises every time when colour vision, vision colour tinged, pulse is high, cold, generally very weak on an unspecified date. The patient underwent lab tests and procedures which included fibrin d dimer increased: 0.900 mg/L Ref 0-0.500, heart rate: 110-120, heart rate: permanently pulse rises to 150, magnetic resonance imaging: without findings, ultrasound scan: without findings on unspecified date. Treatment received included Novalgin, Ibuprofen, Paracetamol electrolytes. The clinical outcome of the event Migraine with aura, Fibrin D dimer increased, headache and asthenia were not recovered and unknown for other events. No follow up attempts needed. No further information expected.


VAERS ID: 1764438 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211007657

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046568) on 05-OCT-2021 and concerned a 28 year old male. 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: 21C11-01 expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1764451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211007618

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046749) on 05-OCT-2021 and concerned a 49 year old female. 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1765768 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 7680682250011 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pityriasis rosea
SMQs:

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: CHPFIZER INC202101262690

Write-up: Pityriasis rosea; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is CH-SM-2021-24118. A 13-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Aug2021 (Batch/Lot Number: 7680682250011) (at the age of 13-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced pityriasis rosea. The event was assessed as serious medically significant. The patient had not yet recovered from the event. Relatedness of Comirnaty to event Pityriasis rosebay SM was possible (Method of assessment: Regulatory aurhority Assessment). Health Authority Comment: Due to the temporal relationship, causality is considered possible. Pytiriasis rosae is not listed in the (country) information for healthcare professionals.


VAERS ID: 1765840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Fibrin D dimer increased, Hyperfibrinogenaemia
SMQs:, Haemorrhage laboratory terms (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: Hyperlipidemia; Hypertension arterial; Perennial rhinitis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Plasma fibrinogen; Result Unstructured Data: 654 mg/dL; Test Date: 20210825; Test Name: Fibrin D dimer increased; Result Unstructured Data: 624 ng/mL
CDC Split Type: ESJNJFOC20211007506

Write-up: HYPERFIBRINOGENAEMIA; FIBRIN D DIMER INCREASED; This spontaneous report received from a physician by Regulatory Authority (regulatory authority, ES-AEMPS-1017166) on 05-OCT-2021 concerned a 39 year old female. The patient''s weight was 77.5 kilograms, and height was 152 centimeters. The patient''s concurrent conditions included: hypertension arterial, perennial rhinitis, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-04 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 10-JUL-2021 for covid-19 vaccination. Drug start period and drug last period was 47 days. No concomitant medications were reported. On 25-AUG-2021, the patient experienced hyperfibrinogenaemia and fibrin d dimer increased. Laboratory data included: Fibrin D dimer increased (NR: 0 - 500) 624 ng/mL and Plasma fibrinogen (NR:180 - 500) 654 mg/dL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hyperfibrinogenaemia and fibrin d dimer increased was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1767231 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Anxiety; COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Syncope vasovagale; perte de connaissance; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-LL20215942) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope vasovagale) and LOSS OF CONSCIOUSNESS (perte de connaissance) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included Anxiety and COVID-19. On 25-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Syncope vasovagale) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (perte de connaissance) (seriousness criterion medically significant). On 25-Aug-2021, SYNCOPE (Syncope vasovagale) and LOSS OF CONSCIOUSNESS (perte de connaissance) was resolving. 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 were reported. No treatment medications were reported. Company Comment: This case concerns a 18 year old female patient with relevant past medical history of Anxiety and COVID-19, who experienced the serious unexpected events of Syncope and Loss of consciousness. The events occurred on same day after administration of unknown dose of Spikevax . The rechallenge was unknown as there''s no information available about the dose number.The medical history of Anxiety and COVID-19 remains as confounders. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation document received on 01-Oct-2021 included no new information; Sender''s Comments: This case concerns a 18 year old female patient with relevant past medical history of Anxiety and COVID-19, who experienced the serious unexpected events of Syncope and Loss of consciousness. The events occurred on same day after administration of unknown dose of Spikevax . The rechallenge was unknown as there''s no information available about the dose number.The medical history of Anxiety and COVID-19 remains as confounders. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1767863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211008070

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046719) on 05-OCT-2021 concerned a 18 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 and expiry: unknown) dose was not reported, 1 total administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection, and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1771327 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211013458

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046974) on 07-OCT-2021 and concerned a 34 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-01 expiry: UNKNOWN) dose was not reported,1 total administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1771329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211012634

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046995) on 07-OCT-2021 concerned an 18 year old female. The patient''s height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 and expiry: unknown) dose was not reported, 1 total administered on 15-JUN-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint


VAERS ID: 1776196 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211013311

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046983) on 07-OCT-2021 concerned a 60 year old male. 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: 21C17-05 expiry: unknown) dose was not reported, 1 total administered on 17-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196804.


VAERS ID: 1776197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016424

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047014) on 08-OCT-2021 and concerned a 24 year old male. 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: 21C11-01 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAY-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1776198 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016391

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047015) on 08-OCT-2021 concerned a 47 year old male. 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: 21C11-01 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated to product quality complaint.


VAERS ID: 1776199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211015910

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (regulatory authority, AT-BASGAGES-2021-047017) on 08-OCT-2021 and concerned a 23 year old male. 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: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1776200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016166

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory authority (regulatory authority, AT-BASGAGES-2021-047019) was received on 08-OCT-2021 and concerned a 47 year old female. 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: XD955 expiry: unknown) dose was not reported, 1 total administered on 12-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1776201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016419

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-047029) was received on 08-OCT-2021 and concerned a 27 year old female. 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: XD985, expiry: unknown) dose was not reported, administered on 07-JUL-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection (vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-COV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1776202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016280

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047030) on 08-OCT-2021 and concerned a 24 year old male. 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: XD975 expiry: unknown) dose was not reported,1 total, administered on 19-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1776203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211016246

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047034) on 08-OCT-2021 concerned a 23 year old male. 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: XD974 expiry: UNKNOWN) dose was not reported,1 total administered on 07-JUN-2021 for drug use for unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1777225 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electroencephalogram, Magnetic resonance imaging, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Electroencephalogram; Result Unstructured Data: Test Result:increased susceptibility to seizures; Comments: increased susceptibility to seizures of focal origin from the right frontal precentral temporal region; Test Name: MRI; Result Unstructured Data: Test Result:inconspicuous
CDC Split Type: DEPFIZER INC202101273343

Write-up: Focal cerebral seizure; This is a spontaneous report from a non-contactable consumer downloaded from the , regulatory authority number is DE-PEI-202100195833. A 13-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: SCRW2) as dose 1, single (at the age of 13 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized from 25Aug2021 to 27Aug2021 due to seizure cerebral (focal cerebral seizure). Electroencephalogram: increased susceptibility to seizures of focal origin from the right frontal precentral temporal region and MRI: inconspicuous, both on a unspecified date. The outcome of the event was recovered on 27Aug2021. Relatedness of drug to reaction(s)/event(s): for Seizure cerebral, Source of assessment , Result of Assessment: D. Unclassifiable. Sender Comment: Inpatient stay from 25Aug2021 to 27Aug2021, medical report is available. Focal cerebral seizure, duration 5 min. No pre-existing conditions. Physical examination: unremarkable. Laboratory values: unremarkable. Electroencephalogram: increased susceptibility to seizures of focal origin from the right frontal precentral temporal region. Sleep deprivation electroencephalogram: Normal findings. Magnetic resonance imaging: inconspicuous. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1777768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 1 LA / OT

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? 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: Early miscarriage (7 weeks of gestation); Normal birth
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101273384

Write-up: spontaneous miscarriage (early miscarriage) at 4 weeks gestation; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority number is FR-AFSSAPS-RN20212785. A 30-year-old pregnant female patient received the first dose of BNT162B2 (COMIRNATY solution for injection; lot number: UNK), via intramuscular on 03Aug2021 (at an unspecified age) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included early miscarriage (7 weeks of gestation) on Dec2018, early miscarriage (7 weeks of gestation) on Apr2019, and full term pregnancy and labour on Jan2020. The patient was pregnant at the time of vaccination. The patient has no long-term treatment. The patient''s history of allergy was not specified. The patient has no history of COVID-19 infection and was not tested for COVID-19. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced spontaneous miscarriage (early miscarriage) at 4 weeks gestation. Outcome of the event was reported as recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1777992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211015309

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via Regulatory authority (AT-BASGAGES-2021-047038) on 08-OCT-2021 concerned a 19 year old female 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) dose was not reported, 1 total administered on 16-JUL-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1778084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Hormone level abnormal, Maternal exposure timing unspecified, Menstruation delayed, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101280609

Write-up: feeling bloated; Hormones are everywhere; Adverse reaction did not occur as a result of an exposure during pregnancy; Late period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109272104503610-BJ2EY. Safety Report Unique Identifier GB-MHRA-ADR 26002697. A 33-year-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and was not enrolled in clinical trial. The patient experienced late period on 25Aug2021 and feeling bloated, adverse reaction did not occur as a result of an exposure during pregnancy on an unspecified date. The clinical course was as follows: Since the jab patient has been feeling bloated/hormones are everywhere. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date (No - Negative COVID-19 test). The outcome of the event late period was not resolved, and other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1778229 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chest pain, Fatigue, Feeling abnormal, Headache, Myalgia, Nervousness, Pain, Pain in extremity, Palpitations, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: high temperature (39.4C)
CDC Split Type: IEPFIZER INC202101279055

Write-up: PAIN IN THE ARM THAT RADIATED TO HIS CHEST; PALPITATIONS; FATIGUE; JOINT PAIN; MUSCLE PAIN; WOKE WITH HEADACHE; PAIN IN THE ARM THAT RADIATED TO HIS CHEST; feeling fuzzy; HIGH TEMPERATURE (39.4C); FAINT; NERVOUS; GOT SICK IMMEDIATELY AFTER THE VACCINE; ARM PAIN; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority number IE-HPRA-2021-084267, Safety Report Unique Identifier IE-HPRA-2021-084267. Initial report received by the HPRA on 10Sep2021 from a member of the public (patient''s relative). A 15-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot number: not reported), via an unspecified route of administration on 25Aug2021 (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient was not taking any concomitant medications. It was reported that on 25Aug2021, the patient was vaccinated with his first dose of Comirnaty. Immediately after receiving the vaccine on 25Aug2021, the patient fainted and got sick. The reporter noted that the patient was nervous. Later, the patient experienced a high temperature of 39.4 degrees Celsius (which took 3 days to come down) and arm pain, persisting for a duration of a week and a half. On 26Aug2021, the patient woke with a headache, which was ongoing at the time of reporting. The patient also experienced muscle and joint pain, fatigue, pain in the arm that radiated to his chest, palpitations and described feeling fuzzy. It was reported that the patient''s neighbour, who is a nurse, checked him and advised that there was nothing to be concerned about. The reporter noted in the report that the patient loved sports and he was playing football and was not complaining of muscle and joint pains anymore. The patient was treated with Calpol. At the time of reporting the patient''s symptoms of arm pain, muscle and joint pain and high temperature had resolved. According to the reporter symptoms of fatigue and headache were ongoing however it was unknown to the reporter if the patient still felt fuzzy. The patient underwent lab tests and procedures which included body temperature: 39.4 Centigrade (high temperature (39.4C)) on 25Aug2021. The outcome of the events fatigue and woke with headache was not recovered, arm pain, joint pain, and muscle pain was recovered on an unspecified date in 2021, high temperature (39.4c) recovered on an unspecified date in Aug2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1778398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211015599

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via Regulatory authority (AT-BASGAGES-2021-047020) on 08-OCT-2021 concerned a 50 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: 21C10-03 expiry: unknown) dose was not reported, 1 total administered on 28-MAY-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1782044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211022683

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046900) on 12-OCT-2021 and concerned a 33 year old male. 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: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total, administered on 21-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product Quality Complaint


VAERS ID: 1782046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211021986

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-047087) was received on 12-OCT-2021 and concerned a 36 year old male. 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: XD975 expiry: unknown) dose was not reported, administered on 28-MAY-2021 for an unknown indication. No concomitant medications were reported. On 25-AUG-2021,the patient had severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection (vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-COV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1784204 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase MB, C-reactive protein, Chest pain, Electrocardiogram, Headache, Malaise, Myocarditis, Pyrexia, X-ray
SMQs:, Neuroleptic malignant syndrome (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: CK-MB; Result Unstructured Data: Test Result:under 0.7 ng/ml; Test Date: 20210826; Test Name: CRP; Test Result: 0.76 mg/dl; Test Date: 20210826; Test Name: Electrocardiography; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210826; Test Name: chest Xp; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101191349

Write-up: suspected myocarditis; Chest pain; Pyrexia; Malaise; Headache; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 07Oct2021, this case now contains serious adverse reactions. Information processed together. A 15-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular, administered in the left arm on 24Aug2021 16:00 (Lot Number: FF3622; Expiration Date: 30Nov2021) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in the left arm on 03Aug2021 16:00 (Lot Number: FF3622; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event onset date/time were reported as 25Aug2021 (1 day after the vaccination). The course of the event was as follows: On 25Aug2021, the patient had pyrexia, malaise, and headache. On 25Aug2021 at 21:00, the patient experienced chest pain (suspected myocarditis). Chest pain was ongoing for about 10 days and then recovering. No treatment was received for the events. The patient had tests on 26Aug2021: chest Xp, the result was no abnormality; electrocardiography (ECG), the result was no abnormality; CK-MB, the result was under 0.7 ng/ml; CRP, the result was 0.76 mg/dl. The outcome of the event chest pain (suspected myocarditis) was recovered about 04Sep2021. The outcome of other events was recovered on an unspecified date. The reporter classified the event chest pain (suspected myocarditis) as serious (medically significant); the event required a physician office visit. The causal relation between the vaccine and event chest pain (suspected myocarditis) was unassessable. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal association and known safety profile, a causal association between BNT162B2 and the reported myocarditis cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1784486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211021233

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-046874) on 12-OCT-2021 concerned a 47 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) dose was not reported,1 total administered on 30-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1784487 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211024416

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-046914) on 12-OCT-2021 and concerned a 23 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product Quality Complaint.


VAERS ID: 1784545 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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? 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: 20210825; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: NLJNJFOC20210856137

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, 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, route of administration not reported, batch number: XD985 expiry: UNKNWON) with frequency as 1 total, dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient tested positive on 25-Aug-2021. He did not contact a physician, but went into the prescribed self-isolation. His symptoms were fever (woke up sweating 2 times) and coughing when talking. He fully recovered within the self-isolation period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This report was associated with a product quality complaint. Additional information was received from the patient on 11-OCT-2021. The following information was updated and incorporated into the case narrative: Patient sex, Events (confirmed clinical vaccination failure) and Event dates (25-Aug-2021), Therapy start date (04-Jun-2021) and Batch number.; Sender''s Comments: V2:This version is created to update the information regarding: Patient sex, Events (confirmed clinical vaccination failure), event dates, therapy date and batch number. Case upgraded to serious. 20210856137-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1785813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211024453

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046861) on 12-OCT-2021 and concerned a 20 year old female. 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: XD974 and expiry: unknown) dose was not reported, frequency time 1 total administered on 17-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1785814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211024423

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046879) on 12-OCT-2021 concerned a 52 year old female. 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: XD974 expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 17-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced SARS-COV-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-COV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1785817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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? 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: ATJNJFOC20211024512

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047085) on 12-OCT-2021 and concerned a 49 year old female. 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: XD974 expiry:unknown) dose was not reported, 1 total, administered on 22-JUL-2021 for product use for unknown indication. No concomitant medications were reported. On 25-AUG-2021, the patient experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection, and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint.


VAERS ID: 1625064 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 16yM received Moderna instead of Pfizer, no complications


VAERS ID: 1625456 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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: None
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Tinnitus


VAERS ID: 1627709 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CVS16241 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Hypoaesthesia, Immediate post-injection reaction, Myalgia, Nausea, Pain in extremity, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: CVA in 2015
Allergies: Reglan, Detrol
Diagnostic Lab Data: Have not had any tests/labs done yet. I am reporting this immediately. will call my PCP today first thing. I am an acute care NP myself
CDC Split Type:

Write-up: Moderna COVID-19 Vaccine EUA Immediate side effects were left hand numbness for about few minutes, Nausea, then throughout the day I had headache, weakness/fatigue, severe joint/muscle aches. today on 8/24/21 I woke up with left arm swelling and pain


VAERS ID: 1627738 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Pain, 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: Rosa trip tan for migraines, taz generic birth control
Current Illness: None
Preexisting Conditions: Migraines
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme body aches, bad headache, high grade fever, chills


VAERS ID: 1627933 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chills, 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: na
Current Illness:
Preexisting Conditions:
Allergies: amoxicillian
Diagnostic Lab Data: na
CDC Split Type:

Write-up: fever 100,chills on going


VAERS ID: 1627959 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 7+ LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Epistaxis, Headache, Malaise, Pain, Thirst
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Guillain-Barre 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:

Write-up: Nose bleed. Body aches. Headache. Malaise. Thirst. Weakness


VAERS ID: 1627976 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F08448 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Oropharyngeal pain, Pain in extremity
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament 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: Tylenol
Current Illness: At time of vaccine sore throat, arm soreness and a little bit of chills.
Preexisting Conditions: BP take medicine amlodipine 5mg
Allergies: Lisinopril
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm soreness, sore throat, little bit of chills.


VAERS ID: 1628048 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Prozac, Wellbutrin
Current Illness: No
Preexisting Conditions: Asthma
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, vomiting, headache


VAERS ID: 1628059 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-12
Onset:2021-08-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Feeling cold, Gait inability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), 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? 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: NA
CDC Split Type:

Write-up: SEVERE CHILLS , FEVER, , BACK PAIN, UNABLE TO WALK FOR FEW MINUTES


VAERS ID: 1628063 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site reaction, Pain in extremity, Rash papular
SMQs:, Tendinopathies and ligament disorders (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: Ibuprofen
Current Illness:
Preexisting Conditions: Graves Disease, Hypothyroidism, surgical menopause
Allergies: Morphine, methimazole
Diagnostic Lab Data:
CDC Split Type:

Write-up: I woke up the morning of 8/24/21 with a raised rash on my left arm right where my vaccine was given. My left arm is still very sore as well. This is occurring 5 days after I received my Moderna vaccine.


VAERS ID: 1628087 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Headache, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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:

Write-up: Pt feeling very week. Headache. Blacked out


VAERS ID: 1628094 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood lactic acid, Computerised tomogram head, Culture urine, Dizziness, Dyskinesia, Extraocular muscle paresis, Full blood count, Metabolic function test, Tremor, Urine analysis, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (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: Influenza- pt had gullian barre
Other Medications: Metoprolol Tartrate XL 25mg daily, Tadalafil 10mg as needed, Aspirin 81 mg daily, Vitamin E 400U
Current Illness: None. Pt states he has felt fine for past few months.
Preexisting Conditions: gullian barre, hypertension, hyperlipidemia
Allergies: Influenza vaccine-gullian barre
Diagnostic Lab Data: CT head, CBC, CMP, UA with auto diff, urine culture, whole blood lactic acid
CDC Split Type:

Write-up: Pt given 3rd vaccine booster on 8/23/21 in right arm. Pt states he was woke up around 0400 today 8/24/2021 and started having involuntary right arm, hand, and right leg jerking/tremors. Pt started having dizziness where he said he felt like he was spinning at 0600. Pt states it felt like his right eye is spinning and very weak. Vitals 101.3F, 92% on room air, 72-pulse, BP- 176/123.


VAERS ID: 1628125 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (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: cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pfizer was given as a third dose, Previous 2 doses were Moderna


VAERS ID: 1628137 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: topiramate 50mg
Current Illness: n/a
Preexisting Conditions: Epilepsy
Allergies: NKDA
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Patient received 1st Moderna dose at 9:11am and was alert, talking, and felt fine after dose and 15 min wait time. Patient proceeded to go shopping in the store. At 9:38am front end notified me that a girl I gave a vaccine to passed out in check out line and they already called 911. She was sitting in chair and talking to front end personnel when I reached patient and they had placed her in a chair. Patient said she was still feeling dizzy so I helped her lay prone on the floor so she didn''t pass out and fall down again. Ambulance arrived and took patient to ER to be checked out.


VAERS ID: 1628139 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (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: cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 st and 2nd dose were Moderna, Pfizer was given as a 3rd dose


VAERS ID: 1628158 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye movement disorder, Loss of consciousness, Nausea, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Water at visit. Took Lexapro 10 mg this morning after missing prior two days of doses.
Current Illness: Nothing reported
Preexisting Conditions: Asthma and Fibromyalgia!
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was unresponsive and eyes rolled to the back of the head for a couple of seconds. Upon waking up the patient was nauseous.


VAERS ID: 1628166 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aggression, Condition aggravated, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown other than seizure medications
Current Illness: seizure disorder
Preexisting Conditions: seizure disorder
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had seizure 5 minutes post vaccination and became very combative. Seizure lasted 10 minutes


VAERS ID: 1628193 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Hypoglycaemia (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: Metformin, Lisinopril, Amlodipine, furosemide, vitamin c, vitamin D3, centrum, zinc, low dose aspirin, cranberry, Omeprazole, iron, flovent hfa, proventil hfa, acetaminophen
Current Illness:
Preexisting Conditions: CKD, diabetes, post-covid long term effects, high blood pressure
Allergies: Morphine, vicadin, oxycodone, oxycotin, any narcotic pain med, tomatoes
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain in injection site, shakes, joint pain, chills, headache


VAERS ID: 1628194 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Sexual dysfunction (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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: DUST
Diagnostic Lab Data: Blood pressure 122/72 HR 63
CDC Split Type:

Write-up: Once patient received the COVID-19 vaccine (Pfizer) he said his arm immediately went numb and he could not feel it. The patient sat in the immunization room for a few moments until he said the feeling had passed. The patient was instructed to sit outside the immunization room for 15 minutes to be monitored. The patient said his eyes went dark, meaning he felt like he was going to pass out. After a few moments he said that feeling passed and was feeling better. We asked the patient if he wanted us to call an ambulance or his PCP and his guardian said no. Told us the patient was feeling better and was just nervous to be receiving the vaccine. The patient did not have a PCP in because he is from .


VAERS ID: 1628199 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia
SMQs:, Guillain-Barre 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: As per pt, pt took tylenol tab po prior to vaccination and vasotec day after for HBP
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT STATES FEELING WEEK WITH BP OF 169/89; PULSE 118; TEMP 39.7C.


VAERS ID: 1628227 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Head injury, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient fainted, banged head on wall behind her, began to shake, and fell to ground. Became alert a few seconds after. Was taken by ambulance.


VAERS ID: 1628229 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-02-03
Onset:2021-08-24
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9261 / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (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:

Write-up: Dehydration


VAERS ID: 1628234 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incomplete course of vaccination, No adverse event
SMQs:, Medication errors (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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: NO ADVERSE EVENT-THIS CLIENT HAS PREVIOUSLY BEEN VACCINATED IN MEXICO WITH THE ASTRA ZENECA AS THE FIRST DOSE BUT RETURNS TO THE USA FOR SECOND DOSE IN WHICH THIS VACCINE IS UNAVAILABLE TO ADMINISTER THE SECOND DOSE; THEREFORE, THIS CLIENT CHOSE TO COMPLETE A VACCINATION SERIES (2 DOSES) OF PFIZER TO COMPLETE FULL VACCINATION FOR THE COVID-19 VIRUS.


VAERS ID: 1628237 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (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: Atrovastatin, escitalopram, lantus, metformin, omeprazol
Current Illness: None
Preexisting Conditions: Diabetes Type 2
Allergies: Codeine
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Left sided facial numbness


VAERS ID: 1628239 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular 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:

Write-up: After vaccine patient felt dizziness, stated he had not had anything to eat this morning, this usually happens with all vaccines. BP was checked; 136/84. Patient monitored additional 15 minutes and BP was 126/78. Patient stated he was feeling better. He was cleared and advised to eat and drink fluids electrolytes''. Stated he understood.


VAERS ID: 1628248 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular 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:

Write-up: Patient had pre-medicated with about 75 mg of benadryl because of a prior reaction with her first vaccine (generalized rash). After about 2 minutes after receiving the vaccine patient complained of lightheadedness and chest tighness, also difficulty breathing. Her difficulty breathing and chest tightness worsened over the next 2 minutes. Patient''s pulse was assessed, she had a 2/2 radial pulse. An epi-pen was administered to the patient (0.3 mg) Im in the right thigh, patient felt significantly better over the next 2 minutes. Patient refused medical treatment and left the pharmacy against my advice, citing that she had to take her mother to a doctor''s appointment.


VAERS ID: 1628250 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Nurse diluted with 0.8cc diluent instead of 1.8cc


VAERS ID: 1628252 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Pain, 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: Fluoxetine 20mg, birth control-generic for yaz
Current Illness: No
Preexisting Conditions: No
Allergies: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever and chills for 5 hours over night, subsided on own. Concurrent with body aches and headache that has not subsided. 400 mg ibuprofen has little effect on headache.


VAERS ID: 1628257 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary mass
SMQs:

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: fenofibrate and metformin
Current Illness: no acute illnesses
Preexisting Conditions: type 2 diabetes and hypertriglyceridemia
Allergies: no known allergies
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Lump in armpit of arm that received immunization


VAERS ID: 1628275 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Nurse diluted vaccine with 0.8cc diluent instead of 1.8cc


VAERS ID: 1628296 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Pruritus, Rash, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Flu shot per patient report
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Whole body itching and burning. Red rash to upper chest, R arm, abdomen. Small bumps on bilat arms, abdomen. Shaking (that could be due to anxiety). Pt was given Benadryl injection with improvement in itching and rash.


VAERS ID: 1628300 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-06
Onset:2021-08-24
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037A21B / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt hospitalized for COVID post vaccination


VAERS ID: 1628301 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Product preparation issue, Underdose
SMQs:, Medication errors (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: None per patient
Current Illness: None per patient
Preexisting Conditions: None per patient
Allergies: None per patient
Diagnostic Lab Data:
CDC Split Type:

Write-up: Due to reconstitution error patient was given less than half of required dosage. Patient was notified and scheduled to receive appropriate dose.


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