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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 276 out of 8,010

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VAERS ID: 1742278 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-09-04
   Days after vaccination:203
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, COVID-19, Cough, Diarrhoea, Malaise, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101199533

Write-up: Drug ineffective/PCR test for COVID-19: POSITIVE; COVID-19; Anosmia; Cough; General malaise; Diarrhoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number ES-AEMPS-996974. A 41-year-old male patient received BNT162B2 (COMIRNATY), 1st dose intramuscular on 16Jan2021 (Lot Number: EM0477, expiration date: Apr2021) as a single dose, 2nd dose intramuscular on 13Feb2021 (Lot Number: EM6950, expiration date unknown) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced drug ineffective/PCR test for covid-19: positive, COVID-19, anosmia, cough, general malaise, diarrhoea, all on 04Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 04Sep2021. The outcome of the events was not recovered. Investigation result for BNT162B2 (COMIRNATY) was as follow: COMPOUNDBNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, lot: EM6950, EM0477, expiration date: EM0477 Apr2021; EM6950: unknown. Brief complaint description: After ECLIA test no antibodies 7 days after 2nd vaccination; Reasonably Suggest Device Malfunction? NO; Severity of Harm: N/A; Complaint Class: Product Use Attributes; Complaint Sub-Class: Lack Of Effect. Root Cause: No root cause or CAPA were identified as the complaint was not confirmed. Process Related: NO; Final Confirmation Status: Not Confirmed; Vendor Related: NO; Lot-Specific Trend Identified: NO; Lot Trend Assmt. & Rationale: Blank; Lot Trend Actions Taken: blank; Other Trend Identified?: blank; Other Trend Assmt. & Rationale: blank; Site Sample Status: Not Received; Summary of Investigation from PUURS division was: blank ; Investigational report conclusion from PUURS division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5595397 (see File attachment in this investigation record)The complaint for a cardiac arrest after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1742488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Diabetes mellitus, Dyspnoea, Myocarditis, Thrombosis, Troponin
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood sugar; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood clot; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood troponin level; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101211513

Write-up: breathlessness; chest pain; Myocarditis; Building of pressure and heaviness in the chest for 2 days; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141340233490-C0RMQ. Safety Report Unique Identifier GB-MHRA-ADR 25939418. A 42-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 04Sep2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Completely healthy prior to vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19, since having the vaccine. Patient was not enrolled in clinical trial. It was reported that on 06Sep2021, the patient experienced breathlessness. On 04Sep2021, myocarditis, building of pressure and heaviness in the chest for 2 days. On 06Sep2021, chest pain. Building of pressure and heaviness in the chest for 2 days then pain and breathlessness on day 2.5. A & E visit confirmation of myocarditis but no medication given as considered mild and self-limiting. Sent home to rest with indeterminate timing. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on an unspecified date, diabetes mellitus: unknown results on an unspecified date, thrombosis: unknown results on an unspecified date, troponin: unknown results on an unspecified date. The outcome of event for event breathlessness was recovered on an unspecified date and heaviness in the chest for two days was recovered on 06Sep2021. Outcome for myocarditis was not recovered. Outcome for other event chest pain was unknown. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Blood pressure, blood sugar, ECG, blood tests for clots and troponin levels. " No follow-up attempts are needed; No further information is expected.


VAERS ID: 1742489 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Axillary pain, Confusional state, Dizziness, Feeling abnormal, Headache, Malaise, Pain in extremity, Palpitations, SARS-CoV-2 test, Syncope, Tinnitus, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hearing impairment (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211515

Write-up: Dizzy; Headaches; Ringing in my ears; Brain fog; Sudden fast heart beating; Cramps in my heart or still ongoing; Vertigo; Confusion; Feeling sick; Extrem pain in the arm and opsit armpit the next day; Extrem pain in the arm and opsit armpit the next day; Feeling faint; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141418503910-FKAOR, Safety Report Unique Identifier GB-MHRA-ADR 25939582. A 43-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 04Sep2021 (at the age of 43-years-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Have been a fit and healthy person all her life. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 04Sep2021, the patient had feeling faint, on 05Sep2021, had confusion, feeling sick, extreme pain in the arm and opsit armpit the next day on 06Sep2021, had vertigo and on an unspecified date, the patient had dizzy, headaches, ringing in her ears, brain fog, sudden fast heart beating and feeling cramps in her heart or still ongoing. Feeling faint 40 mins after having vaccination. Extreme pain in the arm and opsit armpit the next day. Feeling as she would pass out if she stand up and feeling sick and dizzy and headaches, Ringing in her ears confusion and brain fog and sudden fast heart beating feeling cramps in my heart or still ongoing. The patient underwent lab tests and procedures which included covid-19 virus test: negative (No - Negative COVID-19 test) on 30Aug2021. The reporter considered the events as serioius (disability and medically significant). The outcome of events syncope, confusion, malaise was recovering, pain in extremity, axillary pain, dizziness, headache, tinnitus, feeling abnormal, palpitations was unknown, angina pectoris and vertigo was not recovered. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Trying to get in to see a doctor but being fogged off by the call back nurse. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742573 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217914

Write-up: Vomiting; Headache; Shivering; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109152207123280-ZLKKO, Safety Report Unique Identifier GB-MHRA-ADR 25948509. A 22-year-old, non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 04Sep2021 (age at Vaccination: 22 years) as dose 2, single for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date Unsure when symptoms started and stopped. Patient was not pregnant, Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. On 04Sep2021, the patient experienced shivering. On 05Sep2021, the patient experienced vomiting, headache. The events were assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on Yes - Positive COVID-19 test on an unspecified date. The outcome of events vomiting and shivering was recovered on 06Sep2021 while headache was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Rash macular, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: Medical History/Concurrent Conditions: Depression; Pain; Removal of wisdom teeth
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217833

Write-up: Hives; first dose on 28Jun2021 and second dose on 04Sep2021; There were numerous spots on my body; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160222188580-MHII8. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25948854. A 24-year-old non-pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection, Lot Number: FE3380), via an unspecified route of administration on 04Sep2021, as dose 2, single for COVID-19 immunization. Medical history included wisdom teeth removal, pain and depression. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for wisdom teeth removal (from 31Aug2021 to 07Sep2021); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for pain (from 02Sep2021 to 06Sep2021); paracetamol (PARACETAMOL) taken for pain (from 31Aug2021 to 06Sep2021); sertraline (SERTRALINE) taken for depression (from 15Apr2020 to an unspecified stop date). The patient previously received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection) via an unspecified route of administration on 28Jun2021, as dose 1, single for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial . On 08Sep2021, the patient had hives and on an unspecified date in 2021, the patient had numerous spots on body. Both the events were reported as serious (medically significant). The patient stated that hives started in hands and feet and spread to whole body. Reaction worsened over several days before improving. There were numerous spots on her body. The patient underwent lab tests which included SARS-Cov-2 test: negative on 14Sep2021.The outcome of the event there were numerous spots on body was unknown and patient recovered from hives was on 14Sep2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1742591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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 INC202101217857

Write-up: bleeding; some small delay; Prolonged periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160648549020-PXDCL, Safety Report Unique Identifier GB-MHRA-ADR 25949507. The female patient of an unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) 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. The historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunisation. Patient did not have symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced bleeding and some small delay, on 04Sep2021 prolonged periods. Patient normally had very regular periods which were painful during first day. They were regular, with a heavy bleeding on the day 2, from day 3 the bleeding was significantly smaller and the period normally lasted up to 5 or 6 days. Patient first period after the second dose of the pfizer vaccine started with some small delay. Unlike the normal ones it was not painful at all, there was no standard heavy bleeding on day 2. Each day the bleeding was minimal and today was the day 12 since the period started and patient was still bleeding. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date No - Negative COVID-19 test. The outcome of the event bleeding was recovering, prolonged periods was not recovered, some small delay was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1742598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PF12ER / 2 - / -

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

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: GBPFIZER INC202101217693

Write-up: Period pains; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160724378140-ZLEO3, Safety Report Unique Identifier GB-MHRA-ADR 25949836. A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: PF12ER), dose 2 via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and patient''s concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. The patient had not a COVID-19 test. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. It was reported that the patient had unusually strong period pain lasting 2 days on 04Sep2021. Therapeutic measures were taken as a result of period pains. The patient has not tested positive for COVID-19 since having the vaccine. Seriousness for the event was medically significant. Outcome of the event was reported as resolved as on 06Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101209435

Write-up: left facial nerve palsy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number -MINISAL02-783722. A 13-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FG4686), dose 1 intramuscular on 01Sep2021, as DOSE 1, 0.3 ml SINGLE for covid-19 immunisation. The patient medical history not reported and concomitant medication(s) included epinephrine bitartrate, mepivacaine hydrochloride (MEPIVACAINA ADRENALINA) on 02Sep2021 for an unspecified indication. The patient experienced left facial nerve palsy on 04Sep2021. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1743070 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase increased, Blood test, Brain natriuretic peptide, Brain natriuretic peptide increased, Cerebrovascular accident, Chest X-ray, Chills, Coagulopathy, Computerised tomogram head, Echocardiogram, Electrocardiogram, Fibrin D dimer, Fibrin degradation products, Haematocrit, Haemoglobin, Headache, Magnetic resonance imaging, Malaise, Myocarditis, Platelet count, Prothrombin time, Prothrombin time ratio, Pyrexia, Red blood cell count, Smear test, Subarachnoid haemorrhage, Thrombocytopenia, Troponin, Troponin increased, Ultrasound scan, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: APTT; Test Result: 30.5 s; Test Date: 20210906; Test Name: blood test; Result Unstructured Data: Test Result:coagulation disorder accompanied by thrombocytope; Test Date: 20210907; Test Name: blood test; Result Unstructured Data: Test Result:marked increase in CK; Test Date: 20210907; Test Name: BNP; Result Unstructured Data: Test Result:100.3; Test Date: 20210906; Test Name: Chest radiography; Result Unstructured Data: Test Result:No findings of thrombus/thrombosis; Test Date: 20210906; Test Name: Computed tomography; Result Unstructured Data: Test Result:multiple subarachnoid haemorrhage; Comments: No imaging. Multiple small amounts of subarachnoid haemorrhage are observed in the bilateral frontal lobe and parietal lobe.; Test Date: 20210907; Test Name: echocardiography; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210907; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210906; Test Name: D-dimer; Result Unstructured Data: Test Result:2.4 ug/ml; Comments: highest value during the course was 2.4 ug/mL.; Test Date: 20210906; Test Name: FDP; Result Unstructured Data: Test Result:6.3 ug/ml; Test Date: 20210906; Test Name: Hematocrit; Test Result: 40.1 %; Test Date: 20210906; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20210906; Test Name: MRI scan; Result Unstructured Data: Test Result:multiple subarachnoid haemorrhage; Comments: Findings of thrombus/thrombosis was suspected.; Test Date: 20210906; Test Name: Platelet count; Result Unstructured Data: Test Result:11.8*10^4 uL; Comments: Lowest value was 11.8*10^4/ul.; Test Date: 20210906; Test Name: Platelet count; Result Unstructured Data: Test Result:22.5*10^4 uL; Comments: Platelet count under usual condition was 22.5*10^4/ul.; Test Date: 20210906; Test Name: PT; Test Result: 12.1 s; Test Date: 20210906; Test Name: PT-INR; Result Unstructured Data: Test Result:1.02; Comments: highest value during the course was 1.02.; Test Date: 20210906; Test Name: Red blood cell count; Result Unstructured Data: Test Result:460*10^4 uL; Test Date: 20210906; Test Name: smear; Result Unstructured Data: Test Result:No Aggregation findings; Test Date: 20210907; Test Name: Troponin; Result Unstructured Data: Test Result:1105.9; Test Date: 20210907; Test Name: Ultrasonography; Result Unstructured Data: Test Result:performed on Heart site; Test Date: 20210906; Test Name: White blood cell count; Test Result: 3100 uL
CDC Split Type: JPPFIZER INC202101207196

Write-up: increase in CK; Troponin 1105.9 and BNP100.3 were markedly elevated; Troponin 1105.9 and BNP100.3 were markedly elevated; Myocarditis; multiple subarachnoid haemorrhage; thrombocytopenia; Stroke; coagulation disorder; headache; chills; malaise; pyrexia; This is a spontaneous report from a contactable physician received. Regulatory authority report number is v21126711. A 62-year and 9-month-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021) via an unspecified route of administration on 04Sep2021 (the day of vaccination) (at age of 62-year and 9-month-old) as dose 2, single for COVID-19 immunization. Body temperature before vaccination was not provided. Patient medical history and concomitant medications were not reported. On 06Sep2021 (2 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 04Sep2021 (same day of vaccination) the patient received vaccination, pyrexia on the same day. Events onset reported on 06Sep2021 at 13:30 (2 days 13 hrs 30 min after vaccination), the patient had headache and chills, but no pyrexia. The patient visited hospital and performed Computerized tomogram head (head CT) and MRI (magnetic resonance imaging). Then the patient was diagnosed as multiple subarachnoid haemorrhage, blood test pointed out coagulation disorder accompanied by thrombocytopenia, hospitalized, on 07Sep2021 (3days after vaccination) blood test showed marked increase in CK (creatine phosphokinase) etc. There was no abnormality on electrocardiogram and echocardiography, but Troponin 1105.9 and BNP (Brain natriuretic peptide) 100.3 were markedly elevated, and myocarditis was suspected to be conservative treatment. Three days later, the values were almost normal, and the patient was scheduled to be discharged. Thrombosis (including thromboembolism) (with thrombocytopenia only) (TTS) Investigation Form were as follows: The patient had malaise on 04Sep2021 and headache on 06Sep2021 Onset date was as 04Sep2021.The first test date was 06Sep2021.No Aggregation findings of smear. White blood cell count was 3100/ul. Red blood cell count was 460*10^4/ul. Hemoglobin was 13.7 g/dL. Hematocrit was 40.1%. Platelet count was 11.8*10^4/ul. Lowest value was 11.8*10^4/ul. Platelet count under usual condition was 22.5*10^4/ul. PT (prothrombin time) was 12.1 second(s). PT-INR (prothrombin time - international normalized ratio) was 1.02. highest value during the course was 1.02. APTT (Activated partial thromboplastin) was 30.5 second(s). D-dimer was 2.4 ug/mL. highest value during the course was 2.4 ug/mL. FDP (Fibrin degradation products) was 6.3 ug/mL. Anti-platelet 4th factor antibody, Anti-HIT antibody, and SARS-CoV-2 test was not performed. Other test(s) that should be specially noted was that Troponin 1105.9, BNP 100.3 on 07Sep2021. On 07Sep2021, Ultrasonography was performed on Heart site. On 06Sep2021, Computed tomography was performed on Head site. And No imaging. Findings of thrombus/thrombosis was suspected. Details: Multiple small amounts of subarachnoid haemorrhage are observed in the bilateral frontal lobe and parietal lobe. On 06Sep2021, No imaging. MRI scan was performed on Head site. Findings of thrombus/thrombosis was suspected. Details: Findings similar to CT. Angiography, Lung ventilation-perfusion scintigraphy, other test(s) that should be specially noted was not performed. On 06Sep2021, Chest radiography was performed. No findings of thrombus/thrombosis. Diagnosed disease name(s) was Stroke. No Surgical treatment, No Pathological examination, No Excluded disease(s), No History of COVID-19, No Heparin administration history, No Factor(s) that become(s) the risk of thrombus. On 10Sep2021 (6 days after vaccination), the outcome of the events was recovered. The reporting physician classified the events as serious (caused hospitalization from 06Sep2021 to 10Sep2021) and did not assess that the causality between the event and bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: On 04Sep2021, the patient received the second dose vaccination. No follow up attempts are possible. No further information is expected.


VAERS ID: 1743239 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Malaise, Palpitations, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), 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? 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: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; Palpitations; Malaise; Pyrexia; This case was received via Regulatory Authority on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, reported by a physician, was received via the adverse reaction reporting site (TASK0021788), and reported to the Regulatory Authority by a physician, was received Ref, v21127231). On 07-Aug-2021, at 14:00, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 04-Sep-2021, at 10:00, the patient received the 2nd dose of this vaccine. At 10:20, difficulty of breathing and dizziness developed. At 11:00, difficulty of breathing and feeling of weakness developed. At 11:30, because the symptoms were accompanied by numbness of limbs and abdominal pain, the patient was diagnosed with anaphylaxis and was ungently transported to hospital. Anaphylaxis occurred suddenly with rapid progression of the symptoms. The patient also experienced malaise, pyrexia, and palpitations and was hospitalized for treatment. On 06-Sep-2021, the symptoms were alleviated, and the patient was discharged from the hospital. On 08-Sep-2021, pyrexia was resolving. On 13-Sep-2021, malaise and palpitations persisted. On 14-Sep-2021, malaise and palpitations were resolving. Thereafter, recovery of the symptoms was confirmed. The outcome of anaphylaxis, pyrexia, malaise, and palpitations was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the serious, expected event of Anaphylactic reaction and the serious unexpected events of Palpitation, Malaise and Pyrexia. The events occurred twenty minutes after the second dose of mRNA-1273. The rechallenge was not applicable as the events occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1743338 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-09-04
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: PHPFIZER INC202101219829

Write-up: Malaise; fever; This is a spontaneous report from a contactable healthcare professional. This is a report received from the. Regulatory authority report number PH-PHFDA-300105401. An 85-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 12Jun2021 (at the age of 84 years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced malaise and fever (body temperature: 39 centigrade) on 04Sep2021. The patient took paracetamol for the event. The patient was hospitalized due to the events. It was reported that "FHTPA - still with signs and symptoms since admitted". The patient had a COVID-19 exposure to a household member. The outcome of the events was recovering. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1743393 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-04
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Freezing phenomenon, Hyperhidrosis, Neck pain, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Arthritis (broad), Tendinopathies and ligament disorders (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101207435

Write-up: heavy sweating; freezing attacks; Severe pain in shoulders; Severe pain in neck; Severe pain in both hands; Severe pain in arms; This is a spontaneous report from a contactable consumer reporting about herself. A 34-years-old female patient received second dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/lot number UNKNOWN), via an unspecified route of administration, administered in Arm Left on 14Jul2021 15:15 as single dose for COVID-19 immunisation (Age at vaccination 34 years). Patient had allergy to Morgen. The patient medical history and dose 1 of bnt162b2 (COMIRNATY), on unknown date. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at time of vaccination. Concomitant medication included gabapentin. It was Reported that, the patient experienced severe pain in both hands, arms shoulders and neck for 24 hours with onset on 04Sep2021 at 06:30. No pain killers helped. For 48 hours, following the recovery from the pain, heavy sweating and freezing attacks (onset approx 5Sep2021) No treatment was received. The outcome of the events was recovered on an unknown date in 2021. No Follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1744900 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Injection site reaction, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: BEJNJFOC20210951399

Write-up: NAUSEA; FEVER; HEADACHE; INJECTION SITE REACTION; PAINFUL ARM; This spontaneous report received from a consumer via Regulatory Authority (BE-FAMHP-DHH-N2021-106803) on 27-SEP-2021 concerned a 41 year old female. The patient''s weight was 70 kilograms, and height was 177 centimeters. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: CNK 4314258 and expiry: unknown) dose was not reported, 1 total administered on 04-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 04-SEP-2021, the patient experienced nausea, fever, headache, injection site reaction and painful arm. The patient took antipyretic agents. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, fever, headache, injection site reaction, and painful arm on 11-SEP-2021. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: "Treatment - Yes antipyretic agent. Evolution of the ADR - Recovered: 7 days. Situations - Other: ADR description - 2 days fever, a week of pain in the arm"


VAERS ID: 1746228 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (Smoker< 15 pack-year)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic sinusitis; Oral cancer stage unspecified (Oral cancer in remission for five years); Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Ischemic stroke; This case was received via regulatory authority 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 ISCHAEMIC STROKE (Ischemic stroke) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214021) for COVID-19 vaccination. The patient''s past medical history included Oral cancer stage unspecified (Oral cancer in remission for five years), Tabaquism and Chronic sinusitis. Concurrent medical conditions included Smoker (Smoker< 15 pack-year). On 27-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria medically significant and life threatening). At the time of the report, ISCHAEMIC STROKE (Ischemic stroke) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 48 year old male patient with history of smoking, who experienced the unexpected event of Ischaemic Stroke. The event occurred approximately 8 days after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. Patient history of smoking remains a confounder. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 21-SEP-21 contains current condition added.; Sender''s Comments: This case concerns a 48 year old male patient with history of smoking, who experienced the unexpected event of Ischaemic Stroke. The event occurred approximately 8 days after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. Patient history of smoking remains a confounder. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1746477 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Influenza like illness; This case was received via the Regulatory Agency (Reference number: FR-AFSSAPS-TO20217788) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 03-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion medically significant). On 04-Sep-2021, INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 36 year old female patient with no relevant medical history, who experienced the unexpected event of influenza like illness. The event occurred approximately 1 day after an unknown dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36 year old female patient with no relevant medical history, who experienced the unexpected event of influenza like illness. The event occurred approximately 1 day after an unknown dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1746994 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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 FG6273 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Oropharyngeal pain, Overdose, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronavirus infection; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative; Comments: negative severe acute respiratory syndrome-CoV-2 test. Reaction time: 06:30 am
CDC Split Type: ITPFIZER INC202101209418

Write-up: Fainting; Sore throat; Asthenia; COVID 19 COMIRNATY VACCINE (PFIZER)*195 vial 0.45ML; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the regulatory authority IT-MINISAL02-783898. A 33-year-old female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FG6273) via an unspecified route of administration, administered in arm left (left shoulder as reported) on 04Sep2021 as DOSE 1, 0.45mL SINGLE for COVID-19 immunisation. The patient medical history included coronavirus infection and diabetes. Concomitant medication included Humalog. On 04Sep2021, the patient received COVID 19 COMIRNATY VACCINE (PFIZER)*195 vial 0.45ML. On 08Sep2021, the patient experienced sore throat and asthenia and on 09Sep2021, the patient experienced syncope access to emergency room. The patient underwent lab tests and procedures which included SARS-CoV-2 test on 04Apr2021 and the results was negative to severe acute respiratory syndrome-CoV-2 test. Adverse event resulted in emergency room visit. Therapeutic measures were taken as a result of the event which included treatment with Bentelan 4 mg intravenously, Perfalgan 100 mg/ml intravenously, sodium chloride 0.9% 500 ml and cortisone. The outcome of the event (received COVID 19 COMIRNATY VACCINE (PFIZER)*195 vial 0.45ML) was unknown and all other events was recovering. Health authority comment: Concomitant conditions: Diabetes - Previous coronavirus infection: yes - Last negative severe acute respiratory syndrome-CoV-2 test: 04Apr2021 - Reaction time: 06:30 am - Sent from VigiCovid19-form No follow-up attempts are possible. No further information was expected.


VAERS ID: 1747018 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Disease recurrence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOBIVON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101222973

Write-up: asthma attacks that it is impossible to breath (the allergy had disappeared for 20 years); the following night another less serious crisis.; asthma attacks that it is impossible to breath (the allergy had disappeared for 20 years); the following night another less serious crisis.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. Regulatory authority number IT-MINISAL02-785146. A 60-years-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 01Sep2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included hypertension arterial and allergy asthma. Concomitant medication included nebivolol hydrochloride (LOBIVON) taken for an unspecified indication, start and stop date were not reported. Almost 3 days after the administration of the first dose of BNT162B2, patient experienced around 4 hours asthma attacks that it was impossible to breath (the allergy had disappeared for 20 years), the following night another less serious crisis. Event onset date was reported as 04Sep2021. Patient received treatment self-administration of aerosol sprays, including cortisone. Outcome of the event was recovered/resolved with sequel. The event was reported as life-threatening. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1747326 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE9174 / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 immunisation, Ejection fraction, Magnetic resonance imaging heart, N-terminal prohormone brain natriuretic peptide, Pericarditis, Troponin I
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: C-reactive protein; Result Unstructured Data: 79/milligram per litre; Test Date: 20210907; Test Name: Ejection fraction; Result Unstructured Data: 49%; Test Date: 20210907; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Weak intermediary contrast uptake epicardially in parts of left ventricle. Slightly reduced systolic function of left ventricle.; Test Date: 20210904; Test Name: NT-proBNP; Result Unstructured Data: Maximum of 954 ng/L; Test Date: 20210904; Test Name: Troponin I; Result Unstructured Data: Maximum of 770
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: PERICARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00048910) 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 PERICARDITIS (PERICARDITIS) in a 35-year-old male patient who received mRNA-1273 (batch no. FE9174) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. On 01-Sep-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PERICARDITIS (PERICARDITIS) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). At the time of the report, PERICARDITIS (PERICARDITIS) and COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, C-reactive protein: 79 (abnormal) 79/milligram per litre. On 04-Sep-2021, N-terminal prohormone brain natriuretic peptide: 954 nanogram per litre (abnormal) Maximum of 954 ng/L. On 04-Sep-2021, Troponin I: 770 (abnormal) Maximum of 770. On 07-Sep-2021, Ejection fraction: 49 (abnormal) 49%. On 07-Sep-2021, Magnetic resonance imaging heart: abnormal (abnormal) Weak intermediary contrast uptake epicardially in parts of left ventricle. Slightly reduced systolic function of left ventricle.. For mRNA-1273 (Intramuscular), the reporter considered PERICARDITIS (PERICARDITIS) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). Concomitant product use was not provided by the reporter. Treatment medications included were Colchicine, Ibuprofen and Paracetamol for the pain. Patient was hospitalized with central burning chest pain, worsening when standing upright and deep inspiration. Patient was diagnosed with pericarditis, which has been uncomplicated up to point of reporting. Company comment: This case concerns a 35 year-old male patient with no reported medical history, who experienced the unexpected serious event of Pericarditis and the non-serious event of Revaccination with different COVID-19 vaccine. The event of Pericarditis occurred 4 days after the second dose of mRNA-1273 vaccine. The event of Revaccination with different COVID-19 vaccine occurred when patient was initially dosed with Comirnaty followed by the second dose with vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-Sep-2021 and contains no new information.; Reporter''s Comments: * Hospitalised with central burning chest pain, worsening when standing upright and deep inspiration. * Diagnosed with pericarditis, which has been uncomplicated up to point of reporting. * Colchicine, ibuprofen and paracetamol relieved the pain. 08/Sep/2021 regulatory authority: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2021-Ue7a5n (this report). Report NO-NOMAADVRE-FHI-2021-U98mx3 has been nullified. 09/Sep/2021 regulatory authority: additional information received. The following fields have been updated: Lab, Narratives.; Sender''s Comments: This case concerns a 35 year-old male patient with no reported medical history, who experienced the unexpected serious event of Pericarditis and the non-serious event of Revaccination with different COVID-19 vaccine. The event of Pericarditis occurred 4 days after the second dose of mRNA-1273 vaccine. The event of Revaccination with different COVID-19 vaccine occurred when patient was initially dosed with Comirnaty followed by the second dose with vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1747360 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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 FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:165/106
CDC Split Type: PHPFIZER INC202101183187

Write-up: Elevated BP/ BP 165/106; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. Regulatory authority report number is PH-PHFDA-300104278. A 42-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 04Sep2021 (Batch/Lot Number: FD0350) (at the age of 42-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04Sep2021 at 09:31, the patient experienced elevated BP. The patient underwent lab tests and procedures which included blood pressure measurement: 165/106 on 04Sep2021. Outcome of event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747401 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: positive
CDC Split Type: PTJNJFOC20210951525

Write-up: PCR POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority (PT-INFARMED-T202109-762) on 27-SEP-2021 and concerned a 21 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: XE393 expiry: UNKNOWN) .5 ml, 1 total administered on 30-JUL-2021 for covid-19 immunisation. Duration of drug administration was 0 day. No concomitant medications were reported. On 04-SEP-2021, the patient experienced pcr positive (vaccination failure). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of pcr positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194976.; Reporter''s Comments: Other info-Student. Works as athletic coach (last day in attendance) on 3-Sep. Started symptoms 3-Sep: tiredness, fever, cough, anosmia, mild discomfort in head and neck. Lives alone. Had dinner with friends thursday 2-Sep (2 friends with covid + and 4 friends with covid - ).


VAERS ID: 1749156 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Coeliac disease, Dizziness, Dyspnoea, Haemorrhage, Insomnia, Nausea, Palpitations, Thrombosis, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL; PROPOFOL; ANTI NAUSEANT; MOTRIN [IBUPROFEN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Celiac disease; Cervical intraepithelial neoplasia NOS (CIN 5); COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101256867

Write-up: worsened bleeding at the site of the surgery; passing baseball sized clots; dizziness; vertigo; severe stomach pain; triggered celiac; nausea; heart pounding; couldn''t catch her breath; 10 days of insomnia; This is a spontaneous report received via Regulatory Authority from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration, administered in arm left on 02Sep2021 (Batch/Lot number was not reported) as single dose, at the age of 41-year-old, for COVID-19 immunisation. Medical history included celiac disease, cervical intraepithelial neoplasia (CIN) (CIN 5), and Covid-19. Concomitant medications included paracetamol (TYLENOL); propofol; diphenhydramine (ANTI NAUSEANT); ibuprofen (MOTRIN). Relevant past drug history reported as a lot but unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient experienced heart pounding (disability, life threatening) on 04Sep2021 with outcome of recovered on 11Sep2021, couldn''t catch her breath (disability, life threatening) on 04Sep2021 with outcome of recovered on 11Sep2021, 10 days of insomnia (disability, life threatening) on 04Sep2021 with outcome of recovered on 14Sep2021, worsened bleeding at the site of the surgery (hospitalization, disability, life threatening) on 04Sep2021 09:00 with outcome of not recovered, passing baseball sized clots (hospitalization, disability, life threatening) on 04Sep2021 09:00 with outcome of not recovered, dizziness (disability, life threatening) on 04Sep2021 with outcome of not recovered , vertigo (disability, life threatening) on 04Sep2021 with outcome of not recovered, severe stomach pain (disability, life threatening) on 04Sep2021 with outcome of not recovered, triggered celiac (disability, life threatening) on 04Sep2021 with outcome of not recovered, nausea (disability, life threatening) on 04Sep2021 with outcome of not recovered. The patient was hospitalized from Sep2021. Therapeutic measures were taken as a result of the events (worsened bleeding at the site of the surgery, passing baseball sized clots); and no treatment received for the other remain events. Events resulted in emergency room visit and physician office visit. Clinical course: 7 days of heart pounding so hard she couldn''t catch her breath; 10 days of insomnia; worsened bleeding at the site of the surgery; emergency hospitalization requiring trans examic acid (bleeding through 2 overnight pads an hour, passing baseball sized clots); dizziness and vertigo; severe stomach pain; triggered celiac, severe stomach pain and nausea. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1750743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-09-04
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101229397

Write-up: Right facial paralysis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NC20214179. A 50-years-old female patient received a dose of bnt162b2 (COMIRNATY formulation: Solution for injection, Batch/Lot Number: FE7051), via intramuscular, administered in Arm Left on 10Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Sep2021 patient experienced right facial paralysis. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1750957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-04
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation irregular, SARS-CoV-2 test
SMQs:, 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 INC202101226566

Write-up: Irregular periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170826394710-IRZR9, Safety Report Unique Identifier GB-MHRA-ADR 25957672. A 27-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 09Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19, patient was not currently breastfeeding, patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. The patient took previously bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On 04Sep2021, The patient experienced irregular periods (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The clinical outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1751355 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Semen analysis, Testicular pain, Testicular swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Sexual dysfunction (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: LEVOPRAID [LEVOSULPIRIDE]; DIOSMIN; IBUPROFEN
Current Illness: Anxious depression; Chronic anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Piles
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Semen abnormal; Result Unstructured Data: abnormal
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via the RA (Reference number: 785595) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TESTICULAR PAIN and TESTICULAR SWELLING in a 50-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. The patient''s past medical history included Piles. Concurrent medical conditions included Chronic anxiety and Anxious depression. Concomitant products included DIOSMIN for Acute cervical pain, AMITRIPTYLINE HYDROCHLORIDE, PERPHENAZINE from 19-May-2017 to an unknown date for Anxiety depression, LEVOSULPIRIDE (LEVOPRAID [LEVOSULPIRIDE]) from 19-May-2017 to an unknown date for Chronic anxiety, DIOSMIN for Hemorrhoidal bleeding, IBUPROFEN for Sinusitis. On 27-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced TESTICULAR PAIN(seriousness criteria disability and medically significant) and TESTICULAR SWELLING (seriousness criteria disability and medically significant). On 08-Sep-2021, TESTICULAR PAIN and TESTICULAR SWELLING had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Semen analysis: abnormal (abnormal) abnormal. No treatment information was provided by the reporter. As per report during a sexual intercourse, the patient stated that he felt a stabbing pain in his left testicle that interrupted the intercourse, and had a swollen left testicle the day after. Company comment This case concerns a 50-year-old, male patient, with no medical history, who experienced the unexpected events of Testicular pain, and Testicular swelling. The events occurred approximately 9 days after an unknown dose of Spikevax. The rechallenge was unknown since no information about the dose number was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received included patient''s medical history and concurrent medical conditions. On 23-Sep-2021: Follow-up received included stop date and outcome of the events testicular pain, testicular swelling and semen analysis abnormal were updated from recovering to recovered. Seriousness criteria of medically significant was also updated along with disability for all the events. On 23-Sep-2021: Translation document received on 27-Sep-2021 included concomitant medications, their indications and updated events related information in narrative. On 23-Sep-2021: Translation document received on 28-Sep-2021 included no new information.; Reporter''s Comments: During the pre-vaccine interview on Aug 27, 2021, the concomitant drugs were reported to the physician giving the vaccination: 1 tablet in the morning of Levopraid, 1 tablet in the morning of, antidepressive, 1 tablet in the evening of, antidepressive, 2 tablets in the evening of the supplement for bleeding hemorrhoids now sporadic on Diosmin occasionally for acute neck/shoulder pain or sinusitus, 1 tablet of ibuprofen.; Sender''s Comments: This case concerns a 50-year-old, male patient, with no medical history, who experienced the unexpected events of Testicular pain, and Testicular swelling. The events occurred approximately 9 days after an unknown dose of Spikevax. The rechallenge was unknown since no information about the dose number was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1751419 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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: Alanine aminotransferase, Aphthous ulcer, Aspartate aminotransferase, Body temperature, Cytomegalovirus test, Epstein-Barr virus test, Haemoglobin, Headache, Hepatic enzyme, Hepatic enzyme increased, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Hypophagia, Influenza virus test, Liver disorder, Parvovirus B19 test, Physical examination, Platelet count, Platelet count decreased, Pyrexia, SARS-CoV-2 test, Stomatitis, White blood cell count, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Severe cutaneous adverse reactions (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: ALT; Result Unstructured Data: Test Result:31 IU/l; Test Date: 20210908; Test Name: ALT; Result Unstructured Data: Test Result:66 IU/l; Test Date: 20210910; Test Name: ALT; Result Unstructured Data: Test Result:419 IU/l; Test Date: 20210911; Test Name: ALT; Result Unstructured Data: Test Result:412 IU/l; Test Date: 20210913; Test Name: ALT; Result Unstructured Data: Test Result:246 IU/l; Test Date: 20210907; Test Name: AST; Result Unstructured Data: Test Result:49 IU/l; Test Date: 20210908; Test Name: AST; Result Unstructured Data: Test Result:104 IU/l; Test Date: 20210910; Test Name: AST; Result Unstructured Data: Test Result:539 IU/l; Test Date: 20210911; Test Name: AST; Result Unstructured Data: Test Result:400 IU/l; Test Date: 20210913; Test Name: AST; Result Unstructured Data: Test Result:119 IU/l; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0s Centigrade; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Name: cytomegalovirus; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Name: EB virus; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Date: 20210907; Test Name: Hb; Result Unstructured Data: Test Result:13.3 g/dl; Test Date: 20210908; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Date: 20210910; Test Name: Hb; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210911; Test Name: Hb; Result Unstructured Data: Test Result:12.3 g/dl; Test Date: 20210913; Test Name: Hb; Result Unstructured Data: Test Result:12.4 g/dl; Test Date: 20210907; Test Name: hepatic enzyme test; Result Unstructured Data: Test Result:increased; Test Date: 20210908; Test Name: hepatic enzyme test; Result Unstructured Data: Test Result:increased; Test Date: 20210910; Test Name: hepatic enzyme test; Result Unstructured Data: Test Result:increased markedly; Test Date: 20210911; Test Name: hepatic enzyme test; Result Unstructured Data: Test Result:turned to decrease; Test Date: 20210913; Test Name: hepatic enzyme test; Result Unstructured Data: Test Result:decreased significantly; Test Name: hepatitis A virus; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Name: hepatitis B virus; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Name: hepatitis C virus; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Date: 20210907; Test Name: Influenza test; Test Result: Negative ; Test Name: parvovirus B-19 test; Result Unstructured Data: Test Result:was not confirmed at all; Comments: findings which suggested infection was not confirmed at all; Test Date: 20210908; Test Name: physical examination; Result Unstructured Data: Test Result:no obvious abnormal findings were showed except fo; Comments: no obvious abnormal findings were showed except for aphtha on the gingival part of the lower dentition; Test Date: 20210907; Test Name: Plt; Test Result: 113000 uL; Test Date: 20210908; Test Name: Plt; Test Result: 112000 uL; Test Date: 20210910; Test Name: Plt; Test Result: 135000 uL; Test Date: 20210911; Test Name: Plt; Test Result: 163000 uL; Test Date: 20210913; Test Name: Plt; Test Result: 258000 uL; Test Date: 20210907; Test Name: COVID-19 rapid antigen test; Test Result: Negative ; Test Date: 20210907; Test Name: WBC; Test Result: 1800 uL; Test Date: 20210908; Test Name: WBC; Test Result: 1500 uL; Test Date: 20210910; Test Name: WBC; Test Result: 1800 uL; Test Date: 20210911; Test Name: WBC; Test Result: 2300 uL; Test Date: 20210913; Test Name: WBC; Test Result: 4200 uL
CDC Split Type: JPPFIZER INC202101223160

Write-up: aphtha on the gingival part of the lower dentition; liver disorder was expected to improve; decreased of white blood cell and platelets/WBC 1800/uL; decreased of white blood cell and platelets/Plt 113000/uL; mildly Hepatic enzyme increased were confirmed/hepatic enzyme increased markedly/AST 49 IU/l, ALT 31 IU/l; the amount of intake was decreased to about 30 percent of the usual; Stomatitis; pyrexia of 38.0s degrees centigrade; headache; This is a spontaneous report received from a contactable physician via medical information team. A 15-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 04Sep2021 (the day of vaccination)(at the age of 15-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was a born-healthy girl as reported. The detail of the reaction was reported as follows: On 04Sep2021, the patient received the first dose of Comirnaty. From the evening of the same day, headache appeared. From the night, since pyrexia of 38.0s degrees centigrade and stomatitis appeared, the patient was prescribed Calonal orally with further observing. The symptoms were not improved afterwards, and the amount of intake of food was decreased to about 30 percent of the usual on an unspecified date. On 07Sep2021(3 days after vaccination), the patient visited the hospital where she was vaccinated. Influenza and COVID-19 rapid antigen test were performed and turned out to be negative. In aspect of blood test, the results were as follow: WBC 1800/uL, Hb 13.3 g/dl, Plt 113000/uL, AST 49 IU/l, ALT 31 IU/l. Since decreased of white blood cell and platelets, mildly Hepatic enzyme increased were confirmed. On 08Sep2021 (4 days after vaccination), the patient was referred to visit the reporter''s hospital. When visiting the hospital, the patient was lively, but pyrexia of 37.7 degrees centigrade was confirmed. In physical examination, no obvious abnormal findings were showed except for aphtha on the gingival part of the lower dentition. Blood test were as follow: WBC 1500/uL, Hb 12.8 g/dl, Plt 112000/uL, AST 104 IU/l, ALT 66 IU/l, decreased of white blood cell and platelets, Hepatic enzyme increased were confirmed, which were considered the same as the former physician. The degree of changes was slight, rest treatment at home was suggested, the patient returned home. After that, Pyrexia and headache disappeared. On 10Sep2021(6 days after vaccination), in the subsequent visit, the results in blood test were as follow: WBC 1800/uL, Hb 12.5 g/dl, Plt 135000/uL, AST 539 IU/l, ALT 419 IU/l, although decrease of white blood cell and platelets got improved, hepatic enzyme increased markedly. For purpose of detailed examination and treatment, the patient was hospitalized in the pediatrics department. After hospitalization, follow observation was performed with the patient resting in bed. On 11Sep2021(7 days after vaccination), the results in blood test were as follow: WBC 2300/uL, Hb12.3 g/dl, Plt 163000/uL, AST 400 IU/l, ALT 412 IU/l, further increase of white blood cell and platelets, hepatic enzyme turned to decrease. On 13Sep2021(9 days after vaccination), the results in blood test were as follow: WBC 4200/uL, Hb 12.4 g/dl, Plt 258000/uL, AST 119 IU/l, ALT 246 IU/l, white blood cell and platelets turned to normal and hepatic enzyme decreased significantly. With good general condition, judging that liver disorder on 07Sep2021 was expected to improve as time went by, the patient was discharged on the same day. Besides, during hospitalization, for the cause of liver disorder, serological tests were performed for hepatitis A virus, hepatitis B virus, hepatitis C virus, EB virus, cytomegalovirus, and parvovirus B-19, findings which suggested infection was not confirmed at all. Above were the full course of the event. From the timing of the onset of the series of the events after vaccination, side reactions caused by Comirnaty was firstly suspected. When receiving the second dose, a high possibility that the same or stronger liver disorder will occur was considered, refrained from the vaccination was recommended. Would like to figure out the degree of antibody produced in this patient through the vaccination this time. Outcome of the event Hepatic enzyme increased and liver disorder was recovering; outcome of events pyrexia and headache recovered on an unspecified date while the outcome of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events White blood cell count decreased, Platelet count decreased, Hepatic enzyme increased, Aph-thous ulcer, and Liver disorder and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1751448 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Body temperature, Eye disorder, Facial paralysis, Myalgia, Oral disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101236064

Write-up: Facial palsy; difficulty in closing the left eye; bend of the corners of mouth; Localised muscle pain; Bell''s palsy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127255. A 42-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021), via an unspecified route of administration on 03Sep2021 18:00 (the day of vaccination) as DOSE 1, SINGLE for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees Centigrade on 03Sep2021. The patient had no medical history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s received unspecified concomitant medications. On 04Sep2021 (1 day after the vaccination), the patient experienced localised muscle pain. On 08Sep2021 (4 days 6 hrs after the vaccination), the patient experienced, difficulty in closing the left eye, bend of the corners of mouth. 09Sep2021 (5 days 6 hrs after the vaccination), the patient experienced facial palsy. On an unspecified date in 2021, the patient experienced Bell''s palsy. The course of the event was as follows: On 03Sep2021 (Friday), the patient received the first vaccination. On 04-05Sep2021 (Saturday and Sunday), the patient had localised muscle pain. There was no other symptom such as pyrexia. On 06Sep2021, myalgia improved. On 08Sep2021, when the patient waked up, he experienced difficulty in closing the left eye and noted the bend of the corners of mouth. The patient visited a nearby clinic on the same day and was introduced to hospital. On 09Sep2021, the patient was diagnosed as left facial palsy in the Clinic. On 11Sep2021, the patient visited our hospital and told us that he was receiving treatments from the above-mentioned clinic and the progress. The events resulted in physician office visit. The patient received treatment for the events. The outcome of the event Localised muscle pain Resolved on 06Sep2021. On 11Sep2021 (8 days after the vaccination), the outcome of the other events was recovering. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Bell''s palsy. The reporting physician commented as follows: The causality was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1751464 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: 2021TJP087796) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, reported by a vaccine recipient other than a physician, was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK0021599), and reported to the regulatory authority by a vaccine recipient other than a physician, was received via the regulatory authority (Ref, v21126306). Anaphylaxis was assessed as serious by the regulatory authority. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 04-Sep-2021, at 10:26, the patient received the 1st dose of this vaccine. At 10:40, anaphylaxis developed. Pharynx discomfort, sore throat, cough, and cold sweat developed, and the patient was raced to a hospital and received treatment. Thereafter, the symptoms resolved and stabilized; the patient returned home. The outcome of anaphylaxis was reported as resolved. Follow-up investigation will be impossible due to the reporter''s non-cooperation. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 51 year-old, female patient with no relevant medical history, who experienced the serious expected event of Anaphylactic reaction. The event occurred 14 minutes after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reporter''s Comments: Not reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 51 year-old, female patient with no relevant medical history, who experienced the serious expected event of Anaphylactic reaction. The event occurred 14 minutes after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1752960 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Marevan
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve replacement (Mechanical heart valve); Nosebleed.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00050842) 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 EPISTAXIS in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. The patient''s past medical history included Nosebleed in January 2020 and Heart valve replacement (Mechanical heart valve) in 2018. Previously administered products included for Product used for unknown indication: Albyl-E. Past adverse reactions to the above products included No adverse event with Albyl-E. Concomitant products included WARFARIN SODIUM (MAREVAN) from November 2020 to an unknown date for Heart valve operation. On 03-Sep-2021 at 9:55 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced EPISTAXIS (seriousness criterion hospitalization) and CHILLS (seriousness criterion hospitalization). On 08-Sep-2021, EPISTAXIS and CHILLS had resolved. Patient first experienced strong shivering and then nosebleed lasting a few minutes. About 5 hours later, the patient had severe nosebleed lasting for 8 hours and had lost about 1 L blood according to the hospital. Previous nosebleed was in Jan-2020 was probably caused by combination of Marevan and Albyl-E. Albyl-E was discontinued, and the patient has been healthy since. No treatment information was provided. Company Comment: This case concerns a 52-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of epistaxis, and chills. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old, male patient with no previous relevant medical history, who experienced the unexpected events of epistaxis, and chills. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1752970 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-04
   Days after vaccination:14
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: COVID-19, Cough, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: body malaise; cough; fever; critical covid pneumonia; This regulatory authority case was reported by a pharmacist and describes the occurrence of MALAISE (body malaise), COUGH (cough), PYREXIA (fever) and COVID-19 (critical covid pneumonia) in a 74-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced MALAISE (body malaise) (seriousness criterion hospitalization), COUGH (cough) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and COVID-19 (critical covid pneumonia) (seriousness criterion hospitalization). At the time of the report, MALAISE (body malaise), COUGH (cough), PYREXIA (fever) and COVID-19 (critical covid pneumonia) was resolving. Not Provided The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The treatment history was not reported. The concomitant medication was not reported. ATC code was reported J07BX. Active ingredient was reported Elasomeran. Company comment: This case concerns a 74-year-old male subject, with no relevant medical history, who experienced the unexpected serious events of COVID-19 (AESI), COUGH, PYREXIA and MALAISE. The events occurred 15 days after the administration of a dose of COVID 19 Vaccine Moderna. The rechallenge is not applicable as there is only information about one dose. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 74-year-old male subject, with no relevant medical history, who experienced the unexpected serious events of COVID-19 (AESI), COUGH, PYREXIA and MALAISE. The events occurred 15 days after the administration of a dose of COVID 19 Vaccine Moderna. The rechallenge is not applicable as there is only information about one dose. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1754666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-09-04
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oligomenorrhoea, Pelvic pain, Uterine spasm, Visual analogue scale
SMQs:, Fertility 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: VAS: visual analogue scale; Result Unstructured Data: Test Result:9
CDC Split Type: ESPFIZER INC202101229054

Write-up: Pelvic pain; Oligomenorrhoea; uterine contractions; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB with regulatory authority number ES-AEMPS-1002038. A 40-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Jul2021 (Lot Number: FC1435) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included deep bilateral endometriosis. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. The patient''s concomitant medications were not reported. On 04Sep2021, the patient experienced pelvic pain, oligomenorrhoea and uterine contractions which were considered as serious medically significant. It was further reported that the patient was attended in the emergency room with pelvic pain (VAS: visual analogue scale: 9 [2021]) and uterine contractions, first episode of acute pain since the diagnosis and menstrual cycle with less bleeding since. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754711 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-09-04
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatine, Body temperature, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage (At 3 months after a head trauma had brain bleeding.)
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Creatinine; Result Unstructured Data: Blood creatine increased, 1.31; Test Date: 20210604; Test Name: fever; Result Unstructured Data: 40.3 degree Celsius
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: ES-AEMPS-998838) 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 ACUTE KIDNEY INJURY and PYREXIA in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005790 and 214016) for COVID-19 vaccination. The patient''s past medical history included Cerebral haemorrhage (At 3 months after a head trauma had brain bleeding.). Concurrent medical conditions included Epilepsy. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced ACUTE KIDNEY INJURY (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). On 06-Sep-2021, ACUTE KIDNEY INJURY and PYREXIA had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Blood creatine: 1.31 (High) Blood creatine increased, 1.31. On 04-Jun-2021, Body temperature: 40.3 degree Celsius (High) 40.3?C. No Concomitant product use was reported. No treatment information was provided. It was reported that the patient developed high fever of 40.3? and experienced acute prerenal insufficiency/ failure. Company Comment: This case concerns a 15-year-old male patient, who experienced the unexpected, serious (medically significant) events of pyrexia and acute kidney injury. The events occurred approximately 28 days after the first dose of mRNA-1273 and 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events occurred after 2nd dose administration. Pyrexia is an expected event but considered unexpected due to seriousness assessment which has been retained as per Regulatory Authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 27-Sep-2021 contains relevant information such as medical history comment, dosage text and event verbatim reported by the primary source.; Sender''s Comments: This case concerns a 15-year-old male patient, who experienced the unexpected, serious (medically significant) events of pyrexia and acute kidney injury. The events occurred approximately 28 days after the first dose of mRNA-1273 and 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events occurred after 2nd dose administration. Pyrexia is an expected event but considered unexpected due to seriousness assessment which has been retained as per Regulatory Authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1754929 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214017 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fall, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: FRMODERNATX, INC.MOD20213

Write-up: Feeling sick; Fall; Emesis; Chills; This case was received via regulatory authority (Reference number: FR-AFSSAPS-ST20213432) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MALAISE (Feeling sick) and FALL (Fall) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant), FALL (Fall) (seriousness criterion medically significant), VOMITING (Emesis) and CHILLS (Chills). On 06-Sep-2021, MALAISE (Feeling sick), FALL (Fall), VOMITING (Emesis) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. 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 50-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Malaise and Fall.The events occurred approximately 2 days after the first dose of Spikevax.The rechallenge is unknown since there''s no information about the second dose. 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 contains non new information.; Sender''s Comments: This case concerns a 50-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Malaise and Fall.The events occurred approximately 2 days after the first dose of Spikevax.The rechallenge is unknown since there''s no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood; Heart attack; Open heart surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101266645

Write-up: Clot blood; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109241904246220-JIHMG,Safety Report Unique Identifier GB-MHRA-ADR 25991419 . A 31-years-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included myocardial infarction (Patient also has had two open heart surgeries, blood clots threatened valve repairs and caused risk of heart attack).The patient''s concomitant medications were not reported.Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient experienced clot blood (Blood tests at ICU confirmed blood clots in legs ) on 04Sep2021 with outcome of recovering. Seriousness criterion: life threatening. Additional information:Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1757789 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Asthenia, Chills, Decreased appetite, Fatigue, Headache, Muscular weakness, Myalgia, Nausea, Orthostatic intolerance, Pyrexia, SARS-CoV-2 test, Tachycardia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; DEPO-PROVERA; IVABRADINE; OMEPRAZOL [OMEPRAZOLE]; PREGABALIN
Current Illness: Ehlers-Danlos syndrome; Gastroparesis; Migraine; Mitral valve insufficiency (Mitral valve regurgitation); Postural orthostatic tachycardia syndrome; Raynauds
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Orthostatic intolerance; Tachycardia; Muscle weakness; General debility; Headache; Lower abdominal pain; Appetite lost; Nausea aggravated; Muscle pain; Fatigue; Tremor muscle; Fever; Chills; This case was received via regulatory authority on 26-Sep-2021 and was forwarded to Moderna on 26-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ORTHOSTATIC INTOLERANCE (Orthostatic intolerance), TACHYCARDIA (Tachycardia), MUSCULAR WEAKNESS (Muscle weakness), DECREASED APPETITE (Appetite lost), ABDOMINAL PAIN LOWER (Lower abdominal pain), TREMOR (Tremor muscle), ASTHENIA (General debility), NAUSEA (Nausea aggravated), MYALGIA (Muscle pain), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. Concurrent medical conditions included Postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, Raynauds, Mitral valve insufficiency (Mitral valve regurgitation), Gastroparesis and Migraine. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) from 02-Nov-2012 to an unknown date for Contraception, CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from March 2012 to an unknown date and PREGABALIN from 10-Sep-2019 to an unknown date for Ehlers-Danlos syndrome, OMEPRAZOL [OMEPRAZOLE] from 2019 to an unknown date for Gastroparesis, IVABRADINE from 03-Apr-2021 to an unknown date for Postural orthostatic tachycardia syndrome. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced TREMOR (Tremor muscle) (seriousness criteria disability and medically significant), NAUSEA (Nausea aggravated) (seriousness criteria disability and medically significant), MYALGIA (Muscle pain) (seriousness criteria disability and medically significant), FATIGUE (Fatigue) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant) and CHILLS (Chills) (seriousness criteria disability and medically significant). On 05-Sep-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criteria disability and medically significant). On 06-Sep-2021, the patient experienced ABDOMINAL PAIN LOWER (Lower abdominal pain) (seriousness criteria disability and medically significant). On 08-Sep-2021, the patient experienced ORTHOSTATIC INTOLERANCE (Orthostatic intolerance) (seriousness criteria disability and medically significant), TACHYCARDIA (Tachycardia) (seriousness criteria disability and medically significant), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criteria disability and medically significant), ASTHENIA (General debility) (seriousness criteria disability and medically significant) and HEADACHE (Headache) (seriousness criteria disability and medically significant). At the time of the report, ORTHOSTATIC INTOLERANCE (Orthostatic intolerance), TACHYCARDIA (Tachycardia), MUSCULAR WEAKNESS (Muscle weakness), DECREASED APPETITE (Appetite lost), ABDOMINAL PAIN LOWER (Lower abdominal pain), TREMOR (Tremor muscle), ASTHENIA (General debility), NAUSEA (Nausea aggravated), MYALGIA (Muscle pain), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. The patient experienced tachycardia despite being on ivabradine which usually kept the patient''s heart rate under control. The patient was completely debilitated for 3 weeks on from the second dose and was barely able to climb stairs and let alone go to work. It was also reported that the patient had their bloods checked and had lft, inflammatory markers, thyroid and blood count all in normal ranges. Company Comment : This case concerns a 25-year-old female patient with relevant medical history of Postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, Raynauds syndrome, Mitral valve insufficiency (Mitral valve regurgitation), Gastroparesis and Migraine., who experienced the unexpected serious events of Orthostatic intolerance, Tachycardia , asthenia, Tachycardia , Tremor, and Muscular weakness.The events occurred approximately 1 to 6 days after the second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. However, multiple underlying co-morbidities may remain as confounding factors. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 25-year-old female patient with relevant medical history of Postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, Raynauds syndrome, Mitral valve insufficiency (Mitral valve regurgitation), Gastroparesis and Migraine., who experienced the unexpected serious events of Orthostatic intolerance, Tachycardia , asthenia, Tachycardia , Tremor, and Muscular weakness.The events occurred approximately 1 to 6 days after the second dose of Spikevax. The rechallenge is not applicable since the events occurred after the second dose and no details were provided about the first dose. However, multiple underlying co-morbidities may remain as confounding factors. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757804 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Dyspnoea, Myocarditis, Pyrexia, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? 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: Tabaquism
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: C-reactive protein; Test Result: 4.5 mg; Result Unstructured Data: 4.5 mg; Test Date: 20210904; Test Name: C-reactive protein; Test Result: 4.8 mg; Result Unstructured Data: 4.8mg; Test Date: 20210904; Test Name: Troponin; Test Result: 6307 ng; Result Unstructured Data: 6307 ng; Test Date: 20210904; Test Name: Troponin; Test Result: 540 ng; Result Unstructured Data: 540ng
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-788144) 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 PYREXIA, CHEST PAIN, DYSPNOEA in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. The patient''s past medical history included Tabaquism. On 01-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 04-Sep-2021, the patient experienced PYREXIA (seriousness criterion hospitalization), CHEST PAIN(seriousness criterion hospitalization prolonged), DYSPNOE (seriousness criterion hospitalization prolonged) and MYOCARDITIS (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, PYREXIA, CHEST PAIN, DYSPNOEA and MYOCARDITIS had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, C-reactive protein: 4.5 milligram (High) 4.5 mg and 4.8 milligram (High) 4.8mg. On 04-Sep-2021, Troponin: 6307 nanogram (High) 6307 ng and 540 nanogram (High) 540ng. 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 medication was reported. No treatment was reported. It was reported that Cardiac MRI, White blood cells, and Echocardiogram had been performed and no results were provided. This case concerns a 30 year-old, male subject, with no relevant medical history, who experienced the unexpected events of Pyrexia, Chest pain, and Dyspnoea, and the expected and AESI event of Myocarditis. The event of Pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events occurred approximately 4 days after an unknown dose of Spikevax. The rechallenge was unknown since no information about the dose number was disclosed. 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 Contains No New Information; Sender''s Comments: This case concerns a 30 year-old, male subject, with no relevant medical history, who experienced the unexpected events of Pyrexia, Chest pain, and Dyspnoea, and the expected and AESI event of Myocarditis. The event of Pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events occurred approximately 4 days after an unknown dose of Spikevax. The rechallenge was unknown since no information about the dose number was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757991 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-09-04
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Epilepsy, Monoplegia, Speech disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101229268

Write-up: temporary paralysis of the right hand and speech disorders; This triggered an epileptic seizure; Sinus vein thrombosis in the left side of the brain.; temporary paralysis of the right hand and speech disorders; 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-CADR2021177917. Sender''s Safety Report Unique Identifier: DE-PEI-202100187770. A 48-years-old male patient (weight was 80 kg, and height was 175 cm) received bnt162b2 (COMIRNATY; mRNA TOZINAMERAN; strength: 0.3 ml), second dose via an unspecified route of administration on 04Jul2021 (Batch/Lot Number: Unknown) as DOSE 2,SINGLE for covid-19 immunisation. Medical history included pulmonary embolism from 2018 to an unknown date. The patient''s concomitant medications were not reported. Historical vaccine included 1st dose of Comirnaty (strength: 0.3 ml) administered on unknown date for covid-19 immunization. The patient experienced temporary paralysis of the right hand and speech disorders, this triggered an epileptic seizure, sinus vein thrombosis in the left side of the brain, all on 04Sep2021 with outcome of recovering. Therapeutic measures were taken as a result of events. This report is serious as hospitalization. Sender Comment: Information on risk factors or previous illnesses: Pulmonary Embolism 2018. Treatment with blood thinners / treatment with blood thinners and anti-epileptic drugs for 3 months, followed by MRI follow-up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   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 FG7387 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest pain, Echocardiogram, Electrocardiogram, Oxygen saturation, Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Arterial pressure; Result Unstructured Data: Test Result:regular; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210904; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:flaps of pericardial effusion; Comments: at the anterior margin with a thickness of 0.8 mm; Test Date: 20210904; Test Name: ECG; Test Result: Negative ; Test Date: 20210904; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: ITPFIZER INC202101232027

Write-up: Pericarditis; Pericardial effusion; Acute chest pain; This is a spontaneous report from a contactable physician from a regulatory authority, regulatory authority number IT-MINISAL02-786958. A 16-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG7387), via intramuscular route on 03Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Sep2021, the patient experienced after a few hours, at 21:55 acute chest pain access to the emergency room at the PRIVACY polyclinic for sudden acute chest pain, pericarditis, pericardial effusion. The patient underwent lab tests and procedures which included blood pressure measurement: regular, body temperature: 36.7 centigrade, echocardiogram: flaps of pericardial effusion at the anterior margin with a thickness of 0.8 mm , electrocardiogram: negative, oxygen saturation: 99 % on 04Sep2021. The patient is discharged from the emergency room after about 5 hours with the prescription of a home therapy based on Colchicine and Ibuprofen 400 mg (2 tablets per day) and cardiac control after 2 weeks. The outcome of pericarditis, pericardial effusion, acute chest pain was not recovered. Reporter comment: 13Sep2021 requested medical records from emergency room and production batch to the reporter who reports not to be in possession of them. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1758198 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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 FH0151 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Electrocardiogram, Headache, Heart rate, Heart rate increased, Nausea, Pyrexia, Sinus tachycardia, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Childhood asthma; Food allergy; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:120/60; Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:130/96; Test Date: 20210814; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: first dose; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination.; Test Date: 20210904; Test Name: ECG; Result Unstructured Data: Test Result:Sinus tachycardia; Test Date: 20210904; Test Name: heart rate; Result Unstructured Data: Test Result:130; Comments: /min; Test Date: 20210904; Test Name: heart rate; Result Unstructured Data: Test Result:118; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:120; Comments: times
CDC Split Type: JPPFIZER INC202101227970

Write-up: mild intermittent headache; queasy; tachycardia/tachycardia of 120 times; Heart rate: 130/min/heart rate was 118/min/heart rate increased by 16 /min; Blood pressure: 120/60/blood pressure was 130 / 96; Sinus tachycardia; pyrexia; anaphylaxis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21127184 and v21127183. A 22-year and 2-month-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration on 04Sep2021 at 15:30 at age of 22 years old as a single dose for COVID-19 immunization. Medical history included beef and egg allergy, pollinosis and Childhood asthma. Concomitant medications were unknown. Body temperature before vaccination was 36.5 degrees Centigrade on 04Sep2021. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included Hyperthermia, Vomiting, Diarrhoea, Feeling queasy after seeing eggs, Headache, Feeling queasy , Hypertension and elevated heart rate appear after DPT vaccine, influenza vaccine and Corona vaccine. On 14Aug2021 around 14:00, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# FF3622, Expiration date30Nov2021) for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees Centigrade on 14Aug2021. On 04Sep2021 at 15:35 (5 minutes after the vaccination), the patient experienced queasy, headache and tachycardia. On 04Sep2021 (the same day of the vaccination), the patient was admitted to the hospital (from 04Sep2021 to 05Sep2021). On 05Sep2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: At about 15:30 on 04Sep2021, the patient came to the vaccination venue of the reporting hospital and received the second dose of vaccine (first dose was received on 14Aug2021). Five minutes after the second vaccination, the patient complained of mild intermittent headache and queasy. No rash occurred. When the monitor was put on, Heart rate: 130/min, Blood pressure: 120/60. The same symptoms were observed during the first vaccination, and the heart rate was 120/min. Because the normal blood pressure is 90s and the pulse should not reach 100, there is no special tension. When the patient visited the ER, the blood pressure was 130 / 96 and the heart rate was 118 / min. ECG showed Sinus tachycardia. Because more than 2 symptoms of grade 2 or more existed such as heart rate increased by 15/min, mild headache and queasy occurred 5 minutes after vaccination, there are many specific reaction factors such as beef and egg allergy, pollinosis and Childhood asthma, as well as the possibility of anaphylaxis, the patient was intramuscularly injected with BOSMIN INJECTION 0.3ml. Although queasy had improved, headache and Tachycardia were still persistent, so it was considered that the possibility of anaphylaxis leading to symptoms was very low. At 17:50, although the symptoms tended to improve, the patient was hospitalized for the purpose of observation because food allergy and allergic symptoms caused by vaccine occurred before. Although tachycardia improved at night, tachycardia of 120 times was confirmed the next day. Because there were no skin or digestive symptoms, the possibility of anaphylaxis was very low, so the patient was discharged from the hospital. Because of the pyrexia thought to be caused by the vaccine occurred, the prescription drug of CALONAL was given. The reporting pharmacist classified the event as serious (Hospitalized) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Outcome of the events was recovering. The reporting pharmacist commented as follows: Because the same mild symptoms occurred after the first injection of Comirnaty, it was considered that it was likely to be an adverse reaction caused by the vaccine. After the first vaccination, no particular drug was administered and the patient was observed. Similar symptoms appear more strongly after the second vaccination(3 weeks after the first vaccination), so it was as mild as the second side reaction report, but the side reaction after the first vaccination should also be reported. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1758266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-04
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphonia, Pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Tracheitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s thyroiditis; Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232721

Write-up: positive molecular swab in vaccinated 20Mar and 10Apr.; Vaccination failure; tracheitis; Aphonia; fever; pain; This is a spontaneous report received from a contactable Other Health Professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-787137. A 65-year-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EW2246; Expiration Date: 31Jul2021), via intramuscular route of administration in left arm on 10Apr2021 as Dose 2, 0.3mL Single for COVID-19 immunization and first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: ET3620; Expiration Date: 30Jun2021), via intramuscular route of administration in left arm on 20Mar2021 as Dose 1, 0.3mL Single for COVID-19 immunization. The patient''s medical history included Hashimoto''s thyroiditis on 01Feb2005 and neoplasm NOS on 11Nov1998. Concomitant medication was not reported. According to the reporter, the patient had positive molecular swab in vaccinated 20Mar and 10Apr. The patient experienced tracheitis, aphonia, fever and pain on 04Sep2021. The patient underwent lab test and procedures which included COVID-19 PCR test and the results was positive on 06Sep2021. The outcome of the events was not recovered. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and 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 EW2246 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1758321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
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? 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: 20210904; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive lu international unit(s); Comments: Positive lu international unit(s)
CDC Split Type: PTJNJFOC20211001502

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via regulatory authority (PT-INFARMED-T202109-1306) on 01-OCT-2021 concerned a 27 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: 21C19-02 expiry: unknown) 0.5 ml, 01 total, administered on 16-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 04-SEP-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive lu (international unit) (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1759848 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Lymphadenopathy, Myalgia, Nausea, Skin disorder, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (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 INC202101228511

Write-up: Nausea; Fatigue; Arthralgia; Swollen glands; Skin disorder; Injection site reaction; Myalgia; Flu like symptoms; Headache; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number BE-FAMHP-DHH-N2021-106564. A 35-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FG3716) via an unspecified route of administration on 04Sep2021 (at the age of 35 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, fatigue, arthralgia, swollen glands, skin disorder, injection site reaction, myalgia, flu like symptoms, headache on 04Sep2021. Dosage text reported as, first dose administered presumably the side effects were gone, still swollen glands, muscle and joint pain upper body (neck, shoulders, back). Outcome of all the events were recovered on 08Sep2021. Health Authority Comment: Treatment - No Evolution of the ADR - Recovering ADR description - also a bit flu. swollen glands side effects increased in the first days, then decreased. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-09-04
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Cardiac discomfort, Hypoaesthesia, Insomnia, Pain in extremity, Paraesthesia, Peripheral venous disease
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Hay fever; Non-smoker.
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder abscess; Varicose veins.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101228557

Write-up: Pain in feet and especially shins; Lower legs were heavy and warm. Numbness and tingling; Pain in feet and especially shins; Joint pain; Chronic venous insufficiency; Lower legs were heavy and warm. Numbness and tingling; stinging sensations in the heart region; Pain in feet and especially shins were getting worse to the extent that I was lying awake at night.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. Regulatory Authority Number: BE-FAMHP-DHH-N2021-106331. A 54-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) dose 1 via an unspecified route of administration on 04Jun2021 as dose 1, single for COVID- 19 immunisation. Medical history included Never smoked, never used alcohol both. Varicose veins. History of removal of gall bladder on an unknown date. Hay fever (allergy to house dust and grass pollen). It was reported that on 04Sep2021 patient experienced Pain in feet and especially shins were getting worse to the extent that I was lying awake at night, Lower legs were heavy and warm, Numbness and tingling, Joint pain, Pricks around the heart have occurred 2 more times at night, Stinging sensations in the heart region, Chronic venous insufficiency. Patient stated has become worse: Pain in the lower legs. Patient visited Physician Office for the events. Examinations - Been to two different vascular surgeons as well as general practitioner. Diagnosis: chronic venous disease. Surgery on varicose veins desired + neurological examination. Haven''t had a heart exam done yet. Patient did not receive any treatment for the events. Outcome of the events was not recovered. No follow-up attempts possible. No further information expected. Batch/Lot number cannot be obtained. Reporter''s Comments: Treatment - No Evolution of the adverse drug reaction - Has become worse: Pain in the lower legs. Conditions - Other: I don''t know Examinations - Been to two different vascular surgeons as well as general practitioner. Diagnosis: chronic venous disease. Surgery on varicose veins desired + neurological examination. Haven''t had a heart exam done yet. Adverse drug reaction description - - Pain top of both feet and shins. - stinging sensations in the heart region


VAERS ID: 1760178 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   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 SCKT8 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer, Headache, Magnetic resonance imaging, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: D-Dimer; Result Unstructured Data: Test Result:5.99 ?/ml; Test Date: 2021; Test Name: cranial magnetic resonance tomogram; Result Unstructured Data: Test Result:exclusion sinus vein thrombosis
CDC Split Type: DEPFIZER INC202101239010

Write-up: Headache; Thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100192077. A 15-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: SCKT8) as dose number unknown, 0.3 ml single at the age of 15-year-old for covid-19 immunization. Medical history included obesity. The patient''s concomitant medications were not reported. On 04Sep2021, the patient experienced headache, thrombosis. Cranial magnetic resonance tomogram (CMRT) exclusion sinus vein thrombosis (SVT), D-Dimer: 5.99 ?/ml in 2021. This report is serious due to hospitalization. The outcome of event was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1760592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE 2707 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Anxiety, Asthenia, Brain natriuretic peptide, Emergency care examination, Fibrin D dimer, Loss of consciousness, Malaise, Muscle contracture, Mydriasis, Nausea, Oxygen saturation, Oxygen saturation decreased, Psychomotor retardation, Pulmonary embolism, Pulmonary hypertension, SARS-CoV-2 test, Troponin T, Vomiting
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROPRANOLOL; LEVOTHYROXINE; BROMAZEPAM; FLUOXETINE; PANTOPRAZOLE; EZETIMIBE; VALACICLOVIR
Current Illness: Hypertension arterial; Hyperthyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Cervical syndrome; Dizziness (due to cervical and otolaryngological problems); Ear, nose and throat examination abnormal; Herpes simplex; Hiatus hernia; Loss of consciousness (due to cervical and otolaryngological problems); Smoker; Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Angiography of the pulmonary arteries; Result Unstructured Data: Test Result:pulmonary embolism; Comments: in the non-proximal levels sitting at the level of the left interlobar artery associated with signs of pulmonary hypertension; Test Date: 20210904; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:64 ng/L; Test Date: 20210904; Test Name: Clinically; Result Unstructured Data: Test Result:psychomotor slowing; Comments: pupils in bilateral reactive mydriasis. No overdose on usual treatment according to the patient.; Test Date: 20210904; Test Name: D-dimer; Result Unstructured Data: Test Result:2900 ng/ml; Test Date: 20210904; Test Name: oxygen saturation; Test Result: 97 %; Comments: slight desaturation in room air; Test Date: 20210904; Test Name: COVID polymerase chain reaction test; Test Result: Negative ; Test Date: 20210904; Test Name: Troponin T; Result Unstructured Data: Test Result:less than 3
CDC Split Type: FRPFIZER INC202101239573

Write-up: Pulmonary embolism; loss of consciousness; pulmonary hypertension; asthenia; malaise; contractures in the calves; anxiety attacks; nausea; black vomit; slight desaturation in room air; psychomotor slowing; bilateral reactive mydriasis; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report downloaded from the regulatory authority number: FR-AFSSAPS-PP20211382. A 70-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 12Aug2021 (Lot Number: FE 2707) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Anxiety depression from an unknown date and unknown if ongoing, ongoing hyperthyroidism, ongoing hypertension arterial, hiatus hernia, episode of discomfort with loss of consciousness and dizziness (due to cervical and otolaryngological problems) from 10Apr2021 to an unknown date, cervical problems from 10Apr2021 to an unknown date, otolaryngological problems from 10Apr2021 to an unknown date, total thyroidectomy from 2006 to an unknown date, herpes, quit smoking from 2009 to an unknown date. The patient had no COVID history. Concomitant medication(s) included propranolol (PROPRANOLOL) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; bromazepam (BROMAZEPAM) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (EZETIMIBE) taken for an unspecified indication, start and stop date were not reported; valaciclovir (VALACICLOVIR) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose the first dose of bnt162b2 (COMIRNATY), intramuscular on 22Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation in which the patient experienced asthenia and malaise. The patient experienced pulmonary embolism, loss of consciousness, pulmonary hypertension, asthenia, malaise, contractures in the calves, anxiety attacks, nausea, black vomit, slight desaturation in room air, psychomotor slowing, bilateral reactive mydriasis on 04Sep2021. It was reported that the patient experienced a pulmonary embolism after 24 days of receiving the second vaccination with bnt162b2 on 12Aug2021, by intramuscular route. The clinical course was reported as follows: On 04Sep2021, the patient had a consultation in the emergency room for asthenia, malaise, contractures in the calves and anxiety attacks evolving since the vaccination, with loss of consciousness accompanied by nausea and black vomit on this day. Asthenia and malaise were also reportedly present following the first dose of bnt162b2. Clinically: slight desaturation in room air (97% oxygen saturation), psychomotor slowing, pupils in bilateral reactive mydriasis. No overdose on usual treatment according to the patient. Blood test (04Sep2021) revealed D-dimer 2900 ng/mL, N-terminal pro-brain natriuretic peptide 64 ng/L, troponin T less than 3. On the therapeutic level: oral anticoagulation with rivaroxaban 30 mg/day. Microbiologically (04Sep2021): COVID polymerase chain reaction test negative. Angiography of the pulmonary arteries (04Sep2021): pulmonary embolism in the non-proximal levels sitting at the level of the left interlobar artery associated with signs of pulmonary hypertension. Resolution ongoing as of 07Sep2021. Therapeutic measures were taken as a result of the adverse events. Outcome of the events was recovering. The regulatory authority assessed the events pulmonary embolism, loss of consciousness, and pulmonary hypertension as serious (medically significant). All events resulted into a visit to the emergency room. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101294844 same patient, different dose number and event


VAERS ID: 1760608 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-09-04
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19 pneumonia, Computerised tomogram, Oxygen saturation, Vaccination failure
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal failure; Dyslipidaemia; Hypertension arterial; Ischaemic cardiomyopathy; Obesity; Recovered smoker
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Name: pulmonary CT; Result Unstructured Data: Test Result:25-50 %; Comments: 25 to 50% pulmonary involvement with fibrosing evolution + superinfection; Test Name: SPO2; Test Result: 89 %; Test Name: SPO2; Test Result: 96 %; Comments: under 3L/min of O2
CDC Split Type: FRPFIZER INC202101239783

Write-up: Vaccination failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority, Regulatory authority report number is FR-AFSSAPS-ST20213454, Safety Report Unique Identifier is FR-AFSSAPS-2021128498. A 79-year-old male patient received BNT162B2 (COMIRNATY), dose 1 and dose 2; both intramuscularly on an unspecified date in May2021 (batch/lot number: unknown) as 0.3 ml, single dose for COVID-19 immunisation. Dosage time interval: 4 weeks. Medical history included atrial fibrillation, hypertension arterial, ischaemic cardiomyopathy, chronic renal failure, recovered smoker, dyslipidaemia, and obesity. Concomitant medications were not reported. The patient experienced vaccination failure and COVID-19 pneumonitis; both with onset date on 04Sep2021 and with seriousness criteria of hospitalization, and with outcome of not recovered. The clinical course was reported as follows: Occurrence of hypoxemic respiratory failure on COVID-19 with 89% desaturation in a context of infection evolving since 04Sep2021. Dyspnoea at rest since 12Sep2021 with 38? fever. The patient lives with his wife who was COVID positive as well. In the emergency department, no sign of respiratory distress, no recent PE on lung scintigraphy (96% SPO2 under 3L/min of O2). Pulmonary CT: 25 to 50% pulmonary involvement with fibrosing evolution + superinfection. On 14Sep2021 transferred to intensive care due to the increase in oxygen dependence at 15ml/min with polypnea. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-09-04
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243373

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 624808. A 30-years-old female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Sep2021, patient experienced bell''s palsy. The outcome of the event was recovered on Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Extensive swelling of vaccinated limb, Lethargy, Myalgia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (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: AUPFIZER INC202101243748

Write-up: Deep vein thrombosis; Extensive swelling of vaccinated limb; Injection site reaction; Lethargy; Myalgia; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number: 625814. A 37-year-old female patient received BNT162B2 (COMIRNATY; solution for injection, Lot Number: Unknown) via unspecified route of administration, on unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 04Sep2021, the patient experienced deep vein thrombosis, extensive swelling of vaccinated limb, injection site reaction, lethargy and myalgia. The 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: 1761163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Antiphospholipid antibodies positive, Haematochezia, Portal vein thrombosis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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 INC202101244503

Write-up: Haematochezia; Portal vein thrombosis; Abdominal pain; Antiphospholipid antibodies positive; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627355. A 44-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant were not reported. On 04Sep2021, the patient experienced haematochezia, portal vein thrombosis, abdominal pain and antiphospholipid antibodies positive. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram, Heart rate, Investigation, Magnetic resonance imaging, Myocarditis, Physical examination, Renal function test, 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nasopharyngitis; Pneumonia (at 9 months of age)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:145/87 mmHg; Test Name: Chest x-ray; Result Unstructured Data: Test Result:no focus, no effusion.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:49; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:normal, dry pericardium; Test Date: 20210902; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:no pericardial effusion; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:diffuse ST depression + PQ depression, except in V; Comments: diffuse ST depression + PQ depression, except in V1 ST depression + negative T wave. Sinus rhythm, normal corrected QT interval; Test Name: Heart rate; Result Unstructured Data: Test Result:95; Comments: unit: beats per minute; Test Name: hepatic function; Result Unstructured Data: Test Result:normal; Test Name: Myocardial Magnetic Resonance Imaging; Result Unstructured Data: Test Result:diagnosis of acute lateral myocarditis (involvemen; Comments: diagnosis of acute lateral myocarditis (involvement of 3 segments) with an inflammatory phase. Normal left ventricular systolic function; Test Name: Clinical examination; Result Unstructured Data: Test Result:unremarkable; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Name: Troponins; Result Unstructured Data: Test Result:12792 ng/L; Test Name: Troponins; Result Unstructured Data: Test Result:14000 ng/L; Comments: 2nd troponin dosage
CDC Split Type: FRPFIZER INC202101256370

Write-up: Myocarditis; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-PO20214935. A 14-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular route on 31Aug2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history included pneumonia at 9 months of age, and nasopharyngitis (last episode in Jul2021). patient had notion of asthma in the family and heart valve disease in a grandmother. The patient''s concomitant medications were not reported. Patient had no usual treatment. On 04Sep2021, the patient experienced myocarditis. Subsequently, after the second injection of the COMIRNATY vaccine, the patient presented with a flu-like syndrome with fever. On 05Sep2021, patient had occurrence of retro-sternal chest pain of a continuous burning type on waking, radiating into the jaw and into the left arm, increased on inspiration and lying down, improved by standing and walking associated with palpitations. The patient was hospitalised. Blood pressure was 145/87 mmHg, Heart rate was 95 beats per minute, and patient was afebrile. Clinical examination was unremarkable. Electrocardiogram showed diffuse ST depression + PQ depression, except in V1 ST depression + negative T wave. Sinus rhythm, normal corrected QT interval. Trans-thoracic echocardiography was normal, dry pericardium. Chest x-ray showed no focus, no effusion. Troponins was 12,792 ng/L, C-reactive protein was 49. Patient had normal hepatic and renal function. Second troponin dosage was 14,000 ng/L. On 02Sep2021, patient had normal trans-thoracic echocardiography follow-up, no pericardial effusion. Myocardial Magnetic Resonance Imaging: diagnosis of acute lateral myocarditis (involvement of 3 segments) with an inflammatory phase. Normal left ventricular systolic function. In conclusion, Acute myocarditis with preserved left ventricular ejection fraction in a young patient with no history following the injection of the COMINARTY vaccine performed on 31Aug2021. The patient had favourable evolution with decrease in pain and troponinaemia. Patient returned home with treatment: bisoprolol 5 mg per day; ramipril 2.5 mg per day; and paracetamol 1 g. Patient had contraindication to sports and was scheduled for ultrasound and Magnetic Resonance Imaging follow-ups. Outcome of event was recovering. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1763202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101256686

Write-up: appendicitis; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IS-IMA-4796. A 12-year-old female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot number: not provided, Expiration date: not provided), via an unspecified route of administration on 02Sep2021 as dose 1, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On 04Sep2021, 2 days after vaccination, patient experienced appendicitis. An adverse event resulted into hospitalization. Therapeutic measures were taken as a result of appendicitis: the appendix was surgically removed on 05Sep2021. The outcome of event was recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763300 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITPFIZER INC202101248509

Write-up: Fainting after 1 dose of Covid-19 vaccine. After 5-10 minutes of administration. Regaining consciousness in 1-2 Min and complete in 15 minutes.; Tiredness and exhaustion for the next 2..3 days.; Tiredness and exhaustion for the next 2..3 days.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IT-MINISAL02-788250. A 12-year-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FF2834) via intramuscular, administered in right shoulder on 04Sep2021 as dose 1, 0.3 mL single (at the age of 12-year-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04Sep2021, the patient stated fainting after first dose of Covid-19 vaccine, after 5-10 minutes of administration, regaining consciousness in 1 to 2 minutes and complete in 15 minutes, tiredness and exhaustion for the next 2 to 3 days. This events were considered medically significant. Action taken included control by personnel 118 present on the vaccination site. Impact of the quality of life was (4/10). At the time of reporting, outcome of the events were recovering. No follow-up attempts are possible. No further information is expected


VAERS ID: 1763416 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aphthous ulcer, Aspartate aminotransferase, Body temperature, Cytomegalovirus test, Decreased appetite, Epstein-Barr virus test, Haemoglobin, Headache, Hepatic enzyme increased, Hepatic function abnormal, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Influenza virus test, Parvovirus B19 test, Physical examination, Platelet count, Platelet count decreased, Pyrexia, SARS-CoV-2 test, Stomatitis, Viral infection, White blood cell count, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: ALT; Result Unstructured Data: Test Result:31 IU/l; Comments: mild hepatic enzyme increased; Test Date: 20210908; Test Name: ALT; Result Unstructured Data: Test Result:66 IU/l; Test Date: 20210910; Test Name: ALT; Result Unstructured Data: Test Result:419 IU/l; Test Date: 20210911; Test Name: ALT; Result Unstructured Data: Test Result:412 IU/l; Test Date: 20210913; Test Name: ALT; Result Unstructured Data: Test Result:246 IU/l; Test Date: 20210907; Test Name: AST; Result Unstructured Data: Test Result:49 IU/l; Comments: mild hepatic enzyme increased; Test Date: 20210908; Test Name: AST; Result Unstructured Data: Test Result:104 IU/l; Test Date: 20210910; Test Name: AST; Result Unstructured Data: Test Result:539 IU/l; Test Date: 20210911; Test Name: AST; Result Unstructured Data: Test Result:400 IU/l; Test Date: 20210913; Test Name: AST; Result Unstructured Data: Test Result:119 IU/l; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Name: serologic tests on cytomegalovirus; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Name: serologic tests on EV virus; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Date: 20210907; Test Name: Hb; Result Unstructured Data: Test Result:13.3 g/dl; Test Date: 20210908; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Date: 20210910; Test Name: Hb; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210911; Test Name: Hb; Result Unstructured Data: Test Result:12.3 g/dl; Test Date: 20210913; Test Name: Hb; Result Unstructured Data: Test Result:12.4 g/dl; Test Name: serologic tests on hepatitis A virus; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Name: serologic tests on hepatitis B virus; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Name: serologic tests on hepatitis C viruse; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Date: 20210907; Test Name: rapid Influenza antigen test; Test Result: Negative ; Test Name: serologic tests on parvovirus B19; Result Unstructured Data: Test Result:no findings suggestive of infections; Comments: no findings suggestive of infections; Test Date: 20210908; Test Name: physical examination; Result Unstructured Data: Test Result:no obvious abnormality except Aphtha in the gum of; Comments: no obvious abnormality except Aphtha in the gum of lower dentition; Test Date: 20210907; Test Name: Plt; Result Unstructured Data: Test Result:113000 /mm3; Comments: platelets decreased; Test Date: 20210908; Test Name: Plt; Result Unstructured Data: Test Result:112000 /mm3; Test Date: 20210910; Test Name: Plt; Result Unstructured Data: Test Result:135000 /mm3; Test Date: 20210911; Test Name: Plt; Result Unstructured Data: Test Result:163000 /mm3; Test Date: 20210913; Test Name: Plt; Result Unstructured Data: Test Result:258000 /mm3; Test Date: 20210907; Test Name: rapid COVID-19 antigen test; Test Result: Negative ; Test Date: 20210907; Test Name: WBC; Result Unstructured Data: Test Result:1800 /mm3; Comments: white blood cell decreased; Test Date: 20210908; Test Name: WBC; Result Unstructured Data: Test Result:1500 /mm3; Test Date: 20210910; Test Name: WBC; Result Unstructured Data: Test Result:1800 /mm3; Test Date: 20210911; Test Name: WBC; Result Unstructured Data: Test Result:2300 /mm3; Test Date: 20210913; Test Name: WBC; Result Unstructured Data: Test Result:4200 /mm3
CDC Split Type: JPPFIZER INC202101236102

Write-up: Aphtha in the gum of lower dentition; hepatic enzyme increased; Hepatic function disorder; White blood cell decreased; Platelets decreased; headache; slight potential of the symptoms due to some viral infection disease; meal intake volume reduced to 30% of usual.; Stomatitis; pyrexia; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21128044. A 15-year and 0-month-old female patient received BNT162B2 (COMIRNATY; Solution for injection Lot number FF2782, Expiration date 30Nov2021), via an unspecified route of administration on 04Sep2021 at 12:00 (at the age of 15-year and 0-month-old) (age at first vaccination) as dose 1, single for COVID-19 immunisation. The patient''s medical history and the concomitant medications were not reported. Body temperature before vaccination was 36.5 degree Centigrade on 04Sep2021. The patient had no family history. On 04Sep2021 at 17:00 (5 hours after the vaccination), the patient had headache and it as mentioned that there was a slight potential of the symptoms due to some viral infection disease. On 04Sep2021, the patient had stomatitis, pyrexia and meal intake volume reduced to 30% of usual. On 07Sep2021, the patient experienced hepatic function disorder, white blood cell decreased, platelets decreased, hepatic enzyme increased. On 08Sep2021, the patient had developed aphtha in the gum of lower dentition. On 10Sep2021 (6 days after the vaccination), the patient was admitted to the hospital. On 13Sep2021 (9 days after the vaccination), the patient was discharged from hospital. The course of the event was as follows: On 04Sep2021, the patient received the 1st dose of vaccination of COMIRNATY. On the same day from evening, the patient presented with headache. From night, pyrexia of 38s degrees Centigrade and Stomatitis developed and the patient received prescribed paracetamol (CALONAL) orally with following up. Then, the symptoms were not improved, and the meal intake volume reduced to 30% of usual. On 07Sep2021, the patient presented to the clinic where the patient had received vaccination and underwent rapid Influenza antigen test and rapid COVID-19 antigen test with both negative results. Blood test results showed WBC (white blood cells) 1800/ul, Hb (hemoglobin) 13.3 g/dl, Plt (platelet) 113000/ul, AST (Aspartate transaminase ) 49 IU/l, ALT (Alanine transaminase) 31 IU/I, revealing white blood cell decreased, platelets decreased, and mild hepatic enzyme increased, the patient was referred to the hospital on 08Sep2021. The patient was fine and active by the time visiting the hospital but with pyrexia of 37.7 degrees Centigrade. physical examination showed no obvious abnormality except Aphtha in the gum of lower dentition. Blood test results showed WBC of 1500/ul, Hb 12.8 g/dl, Plt 112000/ul, AST 104 IU/I, ALT 66 IU/I, revealing white blood cell decreased, platelets decreased, and hepatic enzyme increased, the similar results in the tests by the previous physician; however, the degree of the change was mild, and the patient returned home with a direction to undergo in-home therapy with rest. After that, while pyrexia and headache disappeared. Blood test on another hospital visit on 10Sep2021 showed WBC of 1800/ul, Hb 12.5 g/dl, Plt 135000/ul, AST 539 IU/I, ALT 419 U/I, despite the symptoms of white blood cell decreased and platelets decreased had improved, the hepatic enzyme showed marked increase. For further detailed examinations, the patient was admitted to the pediatrics unit of the hospital. After admission, the patient was followed up under bedrest. On 11Sep2021, blood tests showed WBC of 2300/ul, Hb 12.3 g/dl, Plt 163000/ul, AST 400 IU/I, ALT 412 U/I, suggesting further increase in both white blood cells and platelets, while hepatic enzyme level tuned to decrease. Blood tests on 13Sep2021 showed WBC of 4200/ul, Hb 12.4 g/dl, Plt 258000/ul, AST 119 IU/I, ALT 246 U/I, suggesting normalized white blood cells and platelets. marked decrease in hepatic enzyme level. The patient''s fine systemic condition led to a decision that liver disorder would improve with time, the patient discharged from the hospital on the day. Further, to identify the causal factors of the liver disorder, serologic tests on hepatitis A, B, and C viruses, EV virus, cytomegalovirus, and parvovirus B19 were performed, revealing no findings suggestive of infections at all. The outcome was reported as recovered in Sep2021 for pyrexia and headache and on 17Sep2021 for hepatic function disorder, white blood cell decreased, platelets decreased, stomatitis, hepatic enzyme increased, aphtha in the gum of lower dentition and meal intake volume reduced to 30% of usual and viral infection. The reporting physician classified the event as serious (Hospitalized)and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases that was a slight potential of the symptoms due to some viral infection disease. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1763472 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: JPPFIZER INC202101246223

Write-up: Facial palsy/ right facial palsy; This is a spontaneous report from a contactable physician received from the Regulatory authority (RA). Regulatory authority report number is v21127416. The patient was a 36-year and 3-month-old male (age at second vaccination). On 02Sep2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021) via an unspecified route of administration as dose 2, single (at the age of 36 years old) for COVID-19 immunization. On 04Sep2021 (2 days after the vaccination), the patient experienced Facial palsy. On an unspecified day, the outcome of the event was not recovered. The course of the event was as follows: On 02Sep2021, the patient received vaccine. On 04Sep2021, the patient was aware of right facial palsy. On 05Sep2021, the patient visited another clinic and was prescribed with PSL. On 06Sep2021, the patient came to reporter''s hospital. The reporting physician classified the event as serious (medically significant) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1763715 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
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: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: Comments: Concomitant elements: good
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211002524

Write-up: ASYMPTOMATIC COVID-19; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority(Vaccines, PT-INFARMED-B202109-1356) on 01-OCT-2021 and concerned a 26 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Concomitant elements: good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: unknown) 0.5 ml, 1 total, administered on 19-AUG-2021 for covid-19 immunisation. The Drug Start Period and Drug Last Period were 16 days. No concomitant medications were reported. On 04-SEP-2021, the patient Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive Iu international unit (s). The patient experienced asymptomatic covid-19 and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asymptomatic covid-19 on 15-SEP-2021, and the outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1763765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-09-04
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-10-06
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: 20210904; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive
CDC Split Type: PTPFIZER INC202101268477

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from Regulatory authority report number [PT-INFARMED-T202109-779] with Safety Report Unique Identifier [PT-INFARMED-T202109-779]. A 66-years-old female patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EX8680; Expiration Date: unknown) intramuscular on 15May2021 as DOSE 2, 0.3 ML SINGLE and patient had received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW9127; Expiration Date: unknown) intramuscular on 17Apr2021 as DOSE 1, 0.3 ML SINGLE both for COVID-19 immunization. No medical history and concomitant medications were not reported. The patient previously took penicillin and experienced hypersensitivity. Patient had no ADR to vaccine, relevant AP and no usual medications. Patient had not pre-vaccine COVID-19 infection. The patient experienced vaccination failure and COVID-19 on 04Sep2021. COVID clinical evaluation - Not serious. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on 04Sep2021 Positive. The outcome of event COVID-19 was unknown. Health authority Comment: Other information-Epidemiological COVID clinical evaluation - Not serious No pre-vaccine COVID19 infection No ADR to vaccine No relevant AP No usual medication Penicillin allergy No follow-up attempts are possible. No further information is expected.


VAERS ID: 1769935 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
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: Guillain-Barre syndrome, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20211010905

Write-up: Paresthesia distal; Guillain-Barre syndrome; This spontaneous report received from a physician by a Regulatory Authority (IT-MINISAL02-793953) on 30-SEP-2021 was received on 06-OCT-2021 and concerned a 46 year old male. The patient''s weight was 69 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21c17-03) 1 dosage forms,1 total administered on 19-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced paresthesia distal, and was hospitalized (date unspecified). On 04-SEP-2021, the patient experienced guillain-barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from paresthesia distal, and guillain-barre syndrome. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1773281 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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: 20210904; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: POSITIVE
CDC Split Type: PHJNJFOC20211012397

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; COUGH; DYSPNEA; RTPCR POSITIVE; GENERAL WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300108806] concerned a 60 year old male of unknown 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 unknown and expiry unknown) dose was not reported, administered on 04-AUG-2021 for drug used for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-SEP-2021, the patient experienced confirmed clinical vaccination failure, cough, dyspnea, RTPCR positive, general weakness. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, dyspnea, RTPCR positive, and general weakness, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20211012397-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1787041 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test, Throat irritation, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Cancer (CHEMOTHERAPY); Chemotherapy (For cancer)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20211012307

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; COVID 19 POSITIVE MILD; COLDS; ITCHY THROAT; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority, PH-PHFDA-300108658] concerned a 35 year old female. Initial information was processed with additional information received on 08-Oct-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cancer, and chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 04-SEP-2021, the patient was tested positive for covid 19 (mild), colds and itchy throat. The incubation period of 28 days has been completed (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid 19 positive mild, colds, itchy throat, and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number 90000196704.; Sender''s Comments: V0: 20211012307-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1787053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test, Throat irritation, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Cancer (FOR CHEMOTHERAPY (CANCER PATIENT)); Chemotherapy (Patient is on chemotherapy for treating cancer.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 virus test; Result Unstructured Data: POSITIVE
CDC Split Type: PHJNJFOC20211012602

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19 POSITIVE MILD; COLDS; ITCHY THROAT; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300108655] concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cancer, and chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 04-SEP-2021, the patient experienced confirmed clinical vaccination failure, covid-19 positive mild, colds and itchy throat. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 positive mild, confirmed clinical vaccination failure, colds and itchy throat was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196597.; Sender''s Comments: V0: 20211012602-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1787056 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Diarrhoea, Fatigue, Nasopharyngitis, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211025446

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19 CONFIRMED; COUGH; COLD; ANOSMIA; AGEUSIA; FATIGUE; DIARRHEA; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA:PH-PHFDA-300109169] concerned a 25 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: 213C21A, expiry: UNKNOWN) dose was not reported,1 total, administered on 29-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 04-SEP-2021, the patient started experiencing cough, cold, anosmia, ageusia fatigue diarrhea, fever and concluded as covid-19 confirmed which indicates confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, fever, cold, diarrhea, fatigue, anosmia, ageusia, and covid-19 confirmed, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender''s Comments: V0: 20211025446-ovid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination 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: 1667891 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-23
Onset:2021-09-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / SYR

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

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

Write-up: Tinnitus in my left ear


VAERS ID: 1667895 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT SURE / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, Flushing, Influenza like illness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Hypersensitivity (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: 1st dose moderna, 30 hours after test significant trouble breathing
Other Medications: Amlo Benaz
Current Illness: Na
Preexisting Conditions: Hypertension
Allergies: Penicillin, shellfish
Diagnostic Lab Data:
CDC Split Type:

Write-up: Just a few minutes after the shot became very dizzy, had severe medicine head for about 25 minutes. Face was very flushed and felt extremely tired. Symtoms subsided at around 30 min. Flu-like symptoms the rest of the day


VAERS ID: 1670082 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms
SMQs:, Dystonia (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: Employee calling to report a reaction after receiving a COVID-19 vaccine. Vaccine Name - Pfizer Vaccine Date - ? 09/02/2021 Is this your first or second dose- 2nd Date of symptom onset - ? 09/03/2021 Symptoms - ? Leg spasm in the left thigh from knee to groin Last day of work and shift - ? 09/02/2021 Home remedies- Employee stated she took ibuprofen, walked, stretched the leg, and applied a heating pad Any improvement- The employee stated the remedies she is using have helped but there is still some tightness like it wants to cramp up. Recommendation- Advised employee to keep doing everything she is doing and to follow up with PCP if this continues or worsens. Employee voiced understanding Employee of information ? Yes Employee voiced any concerns ? No Employee?s questions answered to employee?s satisfaction -Yes


VAERS ID: 1670141 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain
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:

Write-up: Employee calling to report a reaction after receiving a COVID-19 vaccine. Vaccine Name - Pfizer Vaccine Date - ? 09/02/2021 Is this your first or second dose- 2nd Date of symptom onset - ? 09/03/2021 Symptoms - ? fatigue, bodyache Last day of work and shift - ? 09/02/2021 Home remedies- none Any improvement- no Recommendation- Advised employee to take Tylenol/Ibuprofen per package instructions as needed for any pain. If symptoms continue, worsen, or new ones develop follow up with PCP. Employee voiced understanding Employee of information ? Yes Employee voiced any concerns ? No Employee?s questions answered to employees satisfaction -Yes


VAERS ID: 1670153 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RA / SYR

Administered by: Public       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I woke up in the middle of the night with a 102.9 graver, and heavy shivering.


VAERS ID: 1670185 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-01
Onset:2021-09-03
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Tremor, Urine analysis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antidepressant, cholesterol, BP vitamin D and pain medication.
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Tested for A and B flu and COVID 19 also urine test. 8/4/21 on semi annual physical in June 21 my WBCs were elevated to 13, but were normal 8/25/21
CDC Split Type:

Write-up: On 8/3/21 I got fever, 103, chill, shaking that lasted about three or four hours. Next day, went to urgent care. Tested not the flu, not a UTI. On 8/14/21 happens again fever and all the rest as stated first time. Temp 102.4. On 8/31/21. 4pm started temp 102 that went to 103.4. Again lasted three or four hours. Went to sleep okay the next day.


VAERS ID: 1670190 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Muscle tightness, Pruritus
SMQs:, Anaphylactic reaction (narrow), Dystonia (broad), Hypersensitivity (broad), Arthritis (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: Fluoxetine, Vitamin D3, Multivitamin, Probiotic, Allegra, Spironolactone
Current Illness: None
Preexisting Conditions: Asthma, GERD
Allergies: Ciprofloxacin, Penicillin, Doxycycline
Diagnostic Lab Data: None
CDC Split Type:

Write-up: With the first dose on 8/13/21 my left knee, hip, and shoulder hurt. I also had some tightness in my upper chest/neck area. These symptoms lasted for 1 to 2 hours. Took Advil to help symptoms. With the second dose 9/3/21 I have had some itching through my fingers and legs. This lasted for about 1 hour.


VAERS ID: 1670193 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None listed by patient
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: None as of reporting
CDC Split Type:

Write-up: Pt reports rash on both hands 1.5 days after receiving Pfizer Vaccine 1st dose. Pt has applied topical steroids due to itching and was advise to take benadryl. Pt will seek emergency health if rash gets worst or pt has trouble breathing, faints or dizziness.


VAERS ID: 1670202 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-02-25
Onset:2021-09-03
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012121A / 2 RA / IM

Administered by: Pharmacy       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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminphen 650mg rectal q4hrs for pain/fever apixaban 5mg BID bisacodyl 10mg Rectal daily PRN docusate-senna 8.6mg-50mg BID PRN escitalopram 5mg daily famotidine 20mg HS Lidocaine topical 4% patch daily loperamide 2mg q4hr PRN loratadine
Current Illness: 2/3/2021 hospitalization for cellulitis of lower legs
Preexisting Conditions: Hypertension Arthritis GERD Dyslipidemia Diverticulosis of colon osteoporosis Bradycardia Pulmonary embolus lymphedema neuropaty basal cell carcinoma of skin
Allergies: Ciprofloxacin - shoulder, arm and back pain
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient contracted COVID-19 after being fully vaccinated - Asymptomatic


VAERS ID: 1670211 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-09-03
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 3 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
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? 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:

Write-up: hospitalized, SARS-CoV-2 positive


VAERS ID: 1670224 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Erythema, Headache, Nausea, Peripheral swelling, Pruritus, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: none
Current Illness: none
Preexisting Conditions:
Allergies: allergic to Nasonex, Shell fish and pork.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Slight headache, flashed/red on the left side of my face, tenderness on my right arm, nauseous and every now an then a chill. Also my right arm is a little bit swollen and on my right side of my torso by my hip area it has been itching since I woke up.


VAERS ID: 1670275 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (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), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dexilant, birth control, Sertraline, nortriptyline, mvi, B, D E
Current Illness: No
Preexisting Conditions: No
Allergies: Maybe Bactrim
Diagnostic Lab Data:
CDC Split Type:

Write-up: She said she woke up 09/03/2021 0100 with severe nausea, dizziness. she stood up to go to the bathroom and passed out. She said her arms felt like pins and needles were in them


VAERS ID: 1670284 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Influenza like illness, Respiratory tract congestion, Rhinorrhoea, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: FLU LIKE SYPMTOMS ALONG WITH RUNNY NOSE AND CONGESTION. PT REPORTS MINOR SWELLING ON LEFT SIDE OF FACE.


VAERS ID: 1670322 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-27
Onset:2021-09-03
   Days after vaccination:219
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested PCR positive for COVID 9/3/21 after being fully vaccinated. Admitted to hospital 9/3/21.


VAERS ID: 1670339 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: Not need
CDC Split Type:

Write-up: Patients was suppose to receive Moderna not Pfizer. Patient was notified and an attempted was made to notify PCP.


VAERS ID: 1670344 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Syringe issue
SMQs:, Medication errors (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: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 defective syringe, body temp 97.1


VAERS ID: 1670355 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-09-03
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
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? 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: COVID PCR positive/detected 9/2/2021
CDC Split Type:

Write-up: patient hospitalized on 09/02/2021


VAERS ID: 1670360 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (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: Wheezing
Allergies: Amoxicillin-pot Clavulanate Cefpodoxime
Diagnostic Lab Data:
CDC Split Type:

Write-up: Concentrated dose administered to patient. Dilution of Pfizer COVID vaccine was done incorrectly. Patient had no adverse reaction while waiting 15 minutes in the office.


VAERS ID: 1670370 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not known
Current Illness: lukemia
Preexisting Conditions: lukemia
Allergies: penicillin
Diagnostic Lab Data: none
CDC Split Type: N/A

Write-up: Arm below shot developed a rash.


VAERS ID: 1670373 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product preparation error
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: None
Current Illness: Scabies
Preexisting Conditions:
Allergies: Watermelon
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received concentrated dose of vaccine. When mix Pfizer vaccine was diluted with 0.8 ml instead of 1.8 ml sodium chloride. Patient had no adverse event while waiting 15 minutes in the clinic after receiving vaccine.


VAERS ID: 1670374 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045B21A / 1 OT / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: tylenol
Current Illness: Negative
Preexisting Conditions: NA
Allergies: Erythromycin, Sulfa, Benadryl, Theophylline
Diagnostic Lab Data:
CDC Split Type:

Write-up: itching, redness


VAERS ID: 1670376 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Blood glucose normal, Chest pain, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (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: Hepatitis C
Preexisting Conditions: Alcohol dependence Hypertension Hepatitis C Hepatitis B
Allergies:
Diagnostic Lab Data: Blood glucose-102 O2-97 Pulse- 97 Bp-108/60
CDC Split Type:

Write-up: 10 minutes after injection patient was sitting in chair became diaphoretic and unconscious. Patient heart rate dropped to 51. After 2 minutes patient was aroused to consciousness and moved to a lying position. Patient began to shake and complain of crushing left shoulder and chest pain.


VAERS ID: 1670386 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory tract congestion, SARS-CoV-2 test
SMQs:, 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: None
Preexisting Conditions: Muscle weakness, Dementia, MDD
Allergies: None
Diagnostic Lab Data: Rapid positive PCR completed 9/3/21
CDC Split Type:

Write-up: Congestion


VAERS ID: 1670393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test positive
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Parkinson''s DM 2 Bipolar Alzheimer''s
Preexisting Conditions: Parkinson''s DM 2 Bipolar Alzheimer''s
Allergies: None
Diagnostic Lab Data: Rapid positive PCR completed 9/3/21
CDC Split Type:

Write-up: Congestion


VAERS ID: 1670395 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
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: Fluoxetine Propranolol
Current Illness: Seizure
Preexisting Conditions: Seizure PTSD Autism Anxiety
Allergies: Amoxicillin Animal Dander Cat Saliva Dog Saliva Horsetail (Equisetum)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received concentrated dose of vaccine. When mix Pfizer vaccine was diluted with 0.8 ml instead of 1.8 ml sodium chloride. Patient had no adverse event while waiting 15 minutes in the clinic after receiving vaccine.


VAERS ID: 1670420 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 14-001DK / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ732AA / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
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: Unknown
Current Illness: None
Preexisting Conditions: Unknown, not reported on VAR
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. only requested to get the flu shot. A Pfizer covid shot was given by mistake. Pt. already had received 2 moderna shots in the past. Pt. was aware of the vaccine given and did not have any ADR.


VAERS ID: 1670461 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165969 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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:
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: ROUGHLY 30SECONDS AFTER THE DOSE WAS ADMINISTERED THE PATIENT STATED HE WAS DIZZY. HE BEGAN SWEATING AND BECAME VERY PALE. I GAVE HIM SOME WATER. HE THEN PROCEEDED TO PASS OUT AND WAS STRUGGLING TO BREATH. I CAUGHT HIMM BEFORE HE FELL AND ANOTHER PERSON HELPED ME HOLD HIM THE THE CHAIR. I ADMINISTERED AN ADULT DOSE 0.3MG OF EPINEPHRINE WHICH REVIVED HIM AND ALLOWED HIM TO RESURE BREATHING. 911 WAS CALLED AND HE WAS TAKEN TO THE HOSPITAL


VAERS ID: 1670470 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 3 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The client previously received two doses of Moderna Covid vaccine. Today, I gave her a third Covid vaccine due to an immunocompromising condtion, however it was the Pfizer vaccine, not Moderna. It was given at the proper time interval.


VAERS ID: 1670473 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Pruritus, Urticaria, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nature Made Vitamin D one daily, eye drops
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Itching and hives around 24 hours after receiving vaccine. Mainly around neck area, some areas to side of stomach. States happened with the first vaccine but didn''t occur until a couple days after. Patient has been taking Benadryl. States symptoms aren''t severe, just present. Denies any other symptoms or side effects.


VAERS ID: 1670481 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong product administered
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: Patient was given the wrong vaccine . She has had two Pfizer 1/19/21 EL8982 2/9/21 EL9261 today she was given Moderna


VAERS ID: 1670491 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-08-13
Onset:2021-09-03
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Hypertension, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient experienced a headache the first night and lasted 3 to 4 days. After 3 to 4 days, he got a skin rash and high blood pressure. He still has the rash on the leg and high blood pressure.


VAERS ID: 1670493 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, Blood thyroid stimulating hormone, Culture throat, Dysphonia, Full blood count, Headache, Influenza A virus test, Metabolic function test, Oropharyngeal pain, Pain, Streptococcus test
SMQs:, Taste and smell disorders (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: 9/3/21 - throat culture, rapid strep, flu culture, CBCdiff, BMP, TSH/Free T4
CDC Split Type:

Write-up: headaches, body aches, sore throat, hoarse voice, loss of sense of taste and smell


VAERS ID: 1670522 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Her first vaccine was Moderna, incorrect vaccine given. She had now symptoms.


VAERS ID: 1670530 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered, No adverse event
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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: PCN
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Vial had expired 1 day previous on 8-31-21 and Vaccine given on 9-1-21. No adverse reactions


VAERS ID: 1670536 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-18
Onset:2021-09-03
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
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? 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: Tested NAAT positive for COVID 9/3/21 after being fully vaccinated.


VAERS ID: 1670540 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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: Paxil, Norvasc, Meloxicam, Keflex
Current Illness: Bug bite
Preexisting Conditions:
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives


VAERS ID: 1670554 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (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: unknown
Current Illness: denied
Preexisting Conditions: denied
Allergies: unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Client came to County HD requesting second moderna vaccine , stated he was due and lost his vaccine card. Clerk could not find client shots database so client was vaccinated with moderna, client was with relative who stated they recieved first vaccine on the same date 8/5/2021 and relative was due and was at HD to receive second moderna dose . Moderna dose was given to Marcos and clerk found client in fl shots after vaccine administration and noticed that client recieved Pfizer on 8/5/2021 and not moderna .


VAERS ID: 1670559 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered, 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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: vial expired on 8-31-21, dose given from vial on 9-1-21, no adverse reactions noted


VAERS ID: 1670568 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: An hour after after receiving the injection, the patient experienced numbness and tingling in his arm that later spread to his face.


VAERS ID: 1670582 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-01
Onset:2021-09-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered, 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: n/a
Current Illness: n/a
Preexisting Conditions: blood disorder
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: vial expired 8-31-21, dose given from vial on 9-1-21, no adverse reactions noted


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