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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 254 out of 8,010

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VAERS ID: 1755383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-09-07
   Days after vaccination:237
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210907; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232924

Write-up: "COVID-19 confirmed by positive COVID-19 test"; vaccination failure; This is a spontaneous report from a contactable other hcp downloaded from the WEB, regulatory authority number IT-MINISAL02-787183 and from a Product Quality Complaint Group. Complaint record received from the RA. A 88-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EK9788, Expiry: 31-MAY-2021) via intramuscularly, administered in Arm Left on 03Feb2021 as dose 2, 0.3ml single and dose 1 intramuscularly, administered in Arm Left on 13Jan2021 (Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Sep2021 the patient experienced covid-19 confirmed by positive covid-19 test. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 07Sep2021. The outcome of the events were not recovered. 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 EK9788 and EL1484. 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. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.


VAERS ID: 1755384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232945

Write-up: PRIVACY cluster. Positive molecular swab in vaccine. Asymptomatic; Vaccination failure; This is a spontaneous report from a contactable other hcp from the Regulatory Authority. The regulatory authority number IT-MINISAL02-787186. A 94-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: EK9788, Expiry date: 31May2021), intramuscular, administered in Arm Left on 03Feb2021 at 0.3 ml as dose 2, 0.3 mL, single and first dose (COMIRNATY, solution for injection, Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) intramuscularly administered in Arm Left on 13Jan2021 at 0.3 ml as dose 1, 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient experienced privacy cluster. positive molecular swab in vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 07Sep2021. The outcome of the events privacy cluster, positive molecular swab in vaccine. Asymptomatic was not recovered and rest of the events was unknown. 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 EK9788. 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. 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 causes were identified as the complaint was not confirmed.


VAERS ID: 1755416 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-09-07
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, Computerised tomogram
SMQs:

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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: CT; Result Unstructured Data: Test Result:Appendicitis
CDC Split Type: JPPFIZER INC202101191971

Write-up: Appendicitis; GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Study source for Protocol C4591006 from a contactable physician. A 58-year-old male subject received BNT162B2 (COMIRNATY, Solution for injection, Lot: EP2163, Expiration date: 31May2021), dose 2 intramuscular, administered in arm left on 15Mar2021 at the age of 58-year-old as 0.3 ml, single dose for covid-19 immunisation. The subject had no relevant medical history, no family history and no concomitant medications. The subject previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot: EP2163, Expiration date: 31May2021) via intramuscular in left arm on 22Feb2021 at the age of 58-year-old, as 0.3 ml single dose for COVID-19 immunization. The subject experienced appendicitis on 07Sep2021 12:00 (5 months 23 days 12 hrs after 2nd vaccination). The subject was hospitalized for appendicitis from 08Sep2021 to 10Sep2021. The investigator assessed the event as serious (hospitalization). Clinical course was as follows: On 07Sep2021 in the night (as reported), abdominal pain lower appeared. On 08Sep2021, the subject visited the surgical department in the reporter''s hospital for was diagnosed with appendicitis. On the same day, laparoscopic appendectomy was performed. On 10Sep2021, the subject was discharged. The subject underwent lab tests and procedures which included computerised tomogram (CT): appendicitis on 08Sep2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered on 16Sep2021 (6 months 2 days after 2nd vaccination). The investigator assessed that there was no reasonable possibility between the event and BNT162b2. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: As per available information, the causal association between reported event appendicitis and suspect drug BNT162B is unlikely.


VAERS ID: 1758063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-07
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Coma scale, Gait disturbance, Hypertrophic cardiomyopathy, Hypoacusis, Ischaemic stroke, Magnetic resonance imaging, Nausea, Paraesthesia, Renal colic
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DOMPERIDONE; FLUOXETINE; SIMVASTATIN; COVERAM; KERLONE; GAVISCON NF; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Facial paralysis; Hypertrophic cardiomyopathy; Meningioma; Neurofibromatosis; Neuroma (operated in 2000 with evolving remnant treated with CYBER KNIFE in 3 sessions from 30Nov2015 to 02Dec2015); Poliomyelitis; Renal colic; Schwannoma (treated with GAMMA KNIFE in 2001)
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Date: 202010; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:no change in the two residual neurinomas; Comments: as well as in the small left parieto-occipital parasagittal meningioma implanted on falx cerebri and in contact with the superior sagittal venous sinus. The same is true for linear contrast imaging of the left frontotemporal convexity.
CDC Split Type: FRPFIZER INC202101229272

Write-up: Ischemic stroke; Hypertrophic cardiomyopathy; Renal colic; instability when walking and nausea when lying down; nausea when lying down; tingling in his left arm; ataxic hand / discrete ataxia of the left lower limb; hypoacusis; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-RS20212877. A 60-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 17Aug2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history poliomyelitis, schwannoma (treated with GAMMA KNIFE in 2001), neurofibromatosis, hypertrophic cardiomyopathy, renal colic, meningioma, stage V neuroma (operated in 2000 with evolving remnant treated with CYBER KNIFE in 3 sessions from 30Nov2015 to 02Dec2015) and peripheral facial paralysis. Covid medical history was unknown. Concomitant medication included domperidone, fluoxetine, simvastatin, amlodipine besilate, perindopril arginine (COVERAM), betaxolol hydrochloride (KERLONE), calcium carbonate, sodium alginate, sodium bicarbonate (GAVISCON NF) and bromazepam. On 07Sep2021, approximately 3 weeks later, the patient experienced ischemic stroke, instability when walking, nausea when lying down, he had tingling in left arm, ataxic hand / discrete ataxia of the left lower limb and hypoacusis. The patient goes to the emergency room. Evidence of a recent ($g4.5 hours) complete right posterior cerebral ischaemic stroke. The patient was transferred to a care unit. Neurologically, Glasgow score of 15, well oriented in time and good execution of simple orders. The patient presents a paresis of the left upper limb with ataxic hand and fall on Barr? test with no epicritic sensory deficit, no paraesthesia. A discrete ataxia of the left lower limb is also mentioned as well as a sequential hypoacusis. The patient underwent lab tests and procedures which included coma scale: 15 on 17Aug2021, magnetic resonance imaging: no change in the two residual neurinomas in Oct2020 as well as in the small left parieto-occipital parasagittal meningioma implanted on falx cerebri and in contact with the superior sagittal venous sinus. The same is true for linear contrast imaging of the left frontotemporal convexity. Small left posterior parietal paragittal meningioma implanted on the falx cerebri. Hypertrophic cardiomyopathy followed in cardiology. Renal colic. Secondary poliomyelitis with sequellar asymmetry in the right lower limbs. The outcome of ischemic stroke was recovering. The outcome of events was unknown. No follow-up attempts are needed. No further information expected. Information about batch number cannot be obtained.


VAERS ID: 1758124 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-09-07
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Eye pain, Fatigue, Headache, Influenza like illness, Malaise, Myalgia, Pain in extremity, Photophobia, SARS-CoV-2 test, Thirst, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Moderately ill; Eyes sensitive to sunlight; Ringing in ears; Excessive thirst; Light headedness; Flu-like aching; Pain behind eyes; Pain in arm; Fatigue; Muscle ache; Headache; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 25997624) 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 TINNITUS (Ringing in ears), DIZZINESS (Light headedness), THIRST (Excessive thirst), MALAISE (Moderately ill), INFLUENZA LIKE ILLNESS (Flu-like aching), EYE PAIN (Pain behind eyes), PHOTOPHOBIA (Eyes sensitive to sunlight), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criteria disability and medically significant), EYE PAIN (Pain behind eyes) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criteria disability and medically significant), FATIGUE (Fatigue) (seriousness criteria disability and medically significant) and HEADACHE (Headache) (seriousness criteria disability and medically significant). 07-Sep-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criteria disability and medically significant). On 09-Sep-2021, the patient experienced DIZZINESS (Light headedness) (seriousness criteria disability and medically significant). On 10-Sep-2021, the patient experienced THIRST (Excessive thirst) (seriousness criteria disability and medically significant). On 22-Sep-2021, the patient experienced TINNITUS (Ringing in ears) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced MALAISE (Moderately ill) (seriousness criteria disability and medically significant) and PHOTOPHOBIA (Eyes sensitive to sunlight) (seriousness criteria disability and medically significant). On 11-Sep-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, TINNITUS (Ringing in ears), DIZZINESS (Light headedness), THIRST (Excessive thirst), FATIGUE (Fatigue) and MYALGIA (Muscle ache) had not resolved, MALAISE (Moderately ill) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu-like aching), EYE PAIN (Pain behind eyes), PHOTOPHOBIA (Eyes sensitive to sunlight) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. No treatment information was provided. Patient had COVID-19 less than 1 week after 1st vaccine in June 2021 and was moderately ill for 1 month. Patient had three appointments since second vaccine and one full blood count was done which was clear. This case concerns a 32-year-old, female patient with relevant medical history of Covid-19 infection, who experienced the unexpected events of Influenza-like illness, pain in extremity, thirst, dizziness, malaise, eye pain and photophobia approximately 1-4 days after the second dose of Moderna CoviD-19 Vaccine. The unexpected event of Tinnitus occurred 16 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information on the events of the first dose was disclosed. The patient''s recent history of Covid-19 infection remains a confounder to the occurrence of events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, citing information from the source document stating that the events resulted in a disabling/ Incapacitating outcome.; Sender''s Comments: This case concerns a 32-year-old, female patient with relevant medical history of Covid-19 infection, who experienced the unexpected events of Influenza-like illness, pain in extremity, thirst, dizziness, malaise, eye pain and photophobia approximately 1-4 days after the second dose of Moderna CoviD-19 Vaccine. The unexpected event of Tinnitus occurred 16 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information on the events of the first dose was disclosed. The patient''s recent history of Covid-19 infection remains a confounder to the occurrence of events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, citing information from the source document stating that the events resulted in a disabling/ Incapacitating outcome.


VAERS ID: 1758149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   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 FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Burning sensation, Gastritis, Illness, Loss of consciousness, Nausea, Quality of life decreased, Syncope, Vertigo
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: Medical History/Concurrent Conditions: Mite allergy
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC202101229074

Write-up: fainting; Impact on quality of life (10/10); She feel burn; sick; pain to death in the stomach; Gastritis; Nausea; Head revolving around; Blackout; This is a spontaneous report from a contactable consumer or other non HCP (Patient) downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-785931. A 27-year-old female patient received second dose of bnt162b2 (COMIRNATY Formulation: Solution for injection, Batch/Lot Number: FG6273), via intramuscular route, administered in deltoid Left (left shoulder) on 06Sep2021 as dose 2, single for COVID-19 immunisation. Medical history included Mite allergies from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had earlier received first dose of bnt162b2 ((COMIRNATY), Formulation: Solution for injection, Batch/Lot Number: unknown) on an unknown date for COVID-19 immunisation. On 07Sep2021 the patient experienced pain to death in the stomach, gastritis, nausea, head revolving around, blackout; on an unspecified date patient experienced fainting, she feel burn and was sick. The patient reported stating, "on 06Sep2021 I had the pfizer vaccine, since then I have been sick, nausea, vertigo, pain to death in the stomach, gastritis, I feel burn, fainting ..... please help me". The patient reported stating, not taken any medication because patient was afraid. Impact on quality of life (10/10). The events pain to death in the stomach, gastritis, nausea, head revolving around were reported as serious (disability); blackout (medically significant). The outcome of events fainting, she feel burn, sick, and Impact on quality of life was unknown and rest of the events outcome reported as not recovered. Reporter comment: Mite allergies. No follow-up attempts are possible. No further information expected.


VAERS ID: 1758165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-09-07
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypercholesteremia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test positive; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232967

Write-up: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable other healthcare professional from the Regulatory Authority. The regulatory authority number IT-MINISAL02-787189. A 60-year-old female patient received bnt162b2 (Comirnaty; Solution for injection, Lot Number: EK9788, expiry date: 31May2021) via intramuscularly in left arm on 01Feb2021, as DOSE 2, 0.3 ML SINGLE and patient received bnt162b2 (Comirnaty; Solution for injection, Lot Number: EL1484; Expiration Date: 30Apr2021) via intramuscularly, administered in left arm on 11Jan2021 as DOSE 1, 0.3ML SINGLE both for covid-19 immunisation. Medical history included hypercholesterolaemia from 27Jan2009 and unknown if ongoing and diabetes mellitus from 27Jan2009 and unknown if ongoing; Hypertension arterial from 18Aug2006 and unknown if ongoing. The patient''s concomitant medications were not reported. On 07Sep2021the patient had positive COVID-19 test with no symptoms (medically significant). The patient underwent lab tests included sars-cov-2 test positive positive on 07Sep2021. Outcome of the events was unknown. 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 EK9788. 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. 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 causes were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.


VAERS ID: 1758166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-09-07
   Days after vaccination:221
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 RA / 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232498

Write-up: PRIVACY. Positive molecular swab in vaccine. Asymptomatic; Vaccination failure; This is a spontaneous report from a contactable other healthcare professional from the Regulatory Authority. The regulatory authority report number is [IT-MINISAL02-787192]. A 53-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection, (Batch/Lot Number: EK9788; Expiration Date: 31May2021)), dose 2 via intramuscular, administered in arm right on 08Jan2021 as dose 2, 0.3 ml single, dose 1 via intramuscular, administered in arm right on 29Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had positive molecular swab in vaccine, asymptomatic, and vaccination failure on 07Sep2021. The patient underwent lab tests and procedures which included Sars-cov-2 test Positive on 07Sep2021. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot''s EL1484 and EK9788 of the reported lot EL1484 and EK9788. 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. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root causes were identified as the complaint was not confirmed. The outcome of the event positive molecular swab in vaccine, asymptomatic was not recovered and vaccination failure was unknown. Follow-up attempts completed. No further information expected.


VAERS ID: 1758211 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Clonic convulsion; Headache; This case was received via regulatory agency (Reference number: 2021TJP098721) on 24-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to RA by a physician, was received via Moderna''s adverse reaction reporting site (TASK0021878). The patient had no history of allergy or convulsion. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 07-Sep-2021, at 12:13, the patient received the 1st dose of this vaccine. At 12:18, 5 minutes after the vaccination, loss of consciousness developed for 5 minutes, and clonic convulsion persisted for a few tens of seconds. Headache developed. The symptoms improved after 40 minutes of oxygen administration and bed rest. It was confirmed that symptoms were resolving, and the patient returned home. The outcome of loss of consciousness, headache, and clonic convulsion was reported as resolving. 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.; Reporter''s Comments: 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 20-year-old, female patient with no known medical history, who experienced the unexpected events loss of consciousness, clonic convulsion and headache. The events occurred at the same day after the first dose of Moderna vaccine.The events were considered related to the product per the reporter''s assessment. The event headache is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1758221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Dizziness, Feeling abnormal, Neuralgia, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris unstable (unstabile Angina); Arthrosis; Atrial fibrillation; Diabetes; Multimorbidity; Neuropathy
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: high temperature; Result Unstructured Data: Test Result:not provided
CDC Split Type: ATPFIZER INC202101228724

Write-up: Neurological pain in the legs; Left chest pain; to be extremely bad; high temperature; Lightheadedness; This is a spontaneous report from a contactable consumer or other non-health care professional from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-044037. A 52-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection Batch/Lot number: not reported Expiration Date: Unknown) via an unspecified route of administration on 06Sep2021 as dose number unknown, single for covid-19 immunization. Patients medical history included Multimorbidity, Diabetes, Angina pectoris unstable, Atrial fibrillation, Neuropathy, Arthrosis. The patient''s concomitant medications were not reported. On 07Sep2021 the patient experienced Neuralgia, other, Chest pain, Pyrexia, Feeling bad, Lightheadedness. The patient underwent lab tests and procedures which included pyrexia with unknown results on 07Sep2021. Outcome of events was not recovered. Dosage text: Booster vaccination Sender Comment: The report is for one patient. No mail was sent to reporters. No follow-up attempts are possible, information on batch number cannot be obtained


VAERS ID: 1758267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-09-07
   Days after vaccination:237
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101232935

Write-up: Positive molecular swab in vaccinated patient. Mild symptomps; Vaccination failure; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority number IT-MINISAL02-787184. A 69-years-old female patient received BNT162B2 (COMIRNATY formulation: Solution for injection Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) via intramuscular, administered in Arm Left on 13Jan2021 as dose 1, 0.3 mL, single and received second dose of BNT162B2 (COMIRNATY formulation: Solution for injection Batch/Lot Number: Number: EK9788; Expiration Date: 31May2021) via intramuscular, administered in Arm Left on 03Feb2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included neoplasm from 14Oct2011 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced positive molecular swab in vaccinated patient. mild symptoms, vaccination failure on 07Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. Upon follow-up (21Sep2021); Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 EL1484. 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. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root were identified as the complaint was not confirmed. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 EL1484. 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. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root were identified as the complaint was not confirmed. The outcome of the event was not recovered. Follow-up (21Sep2021): The following information was received from Product Complaint Group: Conclusion was added Follow-up (21Sep2021): The following information was received from Product Complaint Group: Conclusion was added


VAERS ID: 1758268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-09-07
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210907; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101232484

Write-up: Cellini cluster. Positive molecular swab in vaccinated. Asymptomatic.; Cellini cluster. Positive molecular swab in vaccinated. Asymptomatic.1st dose on 26Apr2021 and 2nd dose on 17May2021; This is a spontaneous report from contactable other hcp downloaded from the regulatory authority IT-MINISAL02-787190. A 63-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection) on 17May2021(Lot Number: FA5831, Expiration date: 31Aug2021) as dose 2, 0.3ml single and on 26Apr2021 (Lot Number: EX3599, Expiration date: 31Aug2021) as 0.3ml single both via intramuscular route of administration, administered in left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that on 07Sep2021 Cellini cluster. Positive molecular swab in vaccinated. Asymptomatic. Product quality investigation included complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. 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 FA5831 and EX3599. 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. 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 were identified as the complaint was not confirmed.Patient underwent Lab test and procedures which included COVID-19 PCR test positive on 07Sep2021. Outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1758307 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FC5029 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Body temperature, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; High cholesterol; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: PLPFIZER INC202101231555

Write-up: high blood pressure/pressure jump to 215/110; fever; sweating; This is a spontaneous report from a contactable consumer (patient). The reporter reported two cases. This is the second case. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Sep2021 (Lot Number: FC5029) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included the patient has inserted stents, is taking medications for high blood pressure and high cholesterol (specific product names are not given). The patient''s concomitant medications included unspecified medications for high blood pressure and high cholesterol. The patient experienced high blood pressure/pressure jump to 215/110 (medically significant) on 08Sep2021 with outcome of recovered in Sep2021, fever (non-serious) on 07Sep2021 with outcome of unknown, sweating (non-serious) on 07Sep2021 with outcome of unknown. Clinical course reported that patient had a fever the night of his vaccination. The next day, 08Sep2021, he experienced a pressure jump to 215/110. The reporter applied a Captopril tablet under his tongue and the pressure dropped to the correct value. In addition, from the day of vaccination, the reporter sweats a lot. He did not consult a doctor about his symptoms.


VAERS ID: 1758440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-09-07
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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: 20210909; Test Name: Covid-19 PCR test; Test Result: Positive; Comments: Smear from 07Sep on 09Sep21 Coronavirus SARS-CoV-2 PCR positive.
CDC Split Type: DEPFIZER INC202101237541

Write-up: SARS-CoV-2 PCR test positive; Covid-19; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional from the Regulatory Authority. The regulatory authority number DE-PEI-202100191319. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6789, Expiry Date: Not Reported), via an unspecified route of administration on 13Feb2021 as dose 1, single and patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: ER2659, Expiry Date: Not Reported) via unspecified route of administration on 08Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Sep2021 patient experienced COVID-19 (medically significant). After taking two doses patient was sars-cov-2 pcr test positive hence vaccination failure was captured. The patient underwent lab tests and procedures which included Covid-19 PCR test (sars-cov-2 test) Smear from 07Sep on 09Sep2021 Coronavirus SARS-CoV-2 PCR positive on 09Sep2021. The Outcome of the event was unknown. Event assessment Comirnaty SARS-CoV-2 PCR test positive, indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1759967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-07
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Chest pain, Dyspnoea, Platelet count, Pulmonary embolism, Ultrasound Doppler
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEXPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (Body Mass Index at 30); Polycystic ovarian syndrome; Tobacco user
Allergies:
Diagnostic Lab Data: Test Name: Body Mass Index; Result Unstructured Data: Test Result:30; Test Date: 202109; Test Name: platelets; Result Unstructured Data: Test Result:239 g/l; Test Date: 202109; Test Name: Lower limb Doppler; Test Result: Negative
CDC Split Type: FRPFIZER INC202101239487

Write-up: chest pain; Embolism pulmonary; dyspnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY202111207. A 28-year-old female patient received 1st single dose of bnt162b2 (COMIRNATY) intramuscularly on 02Sep2021 (Batch/Lot Number: Unknown) for COVID-19 immunisation; etonogestrel (NEXPLANON) via an unspecified route of administration from Aug2021 (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for contraception (contraceptive method not known before placement of implant). Medical history included obesity (Body Mass Index at 30) from an unknown date and unknown if ongoing, polycystic ovarian syndrome from an unknown date and unknown if ongoing, tobacco user from an unknown date and unknown if ongoing. Patient had no family medical history of thrombosis. The patient''s concomitant medications were not reported. On 07Sep2021, there was appearance of dyspnea, which consulted the Emergency Department then discharged. On 08Sep2021, there was new consultation because worsening with chest pain, which was diagnosed of right proximal bilateral pulmonary embolism and treated with Eliquis. It was reported that the patient experienced embolism pulmonary on 07Sep2021 with outcome of recovering, dyspnea on 07Sep2021 with outcome of recovering, chest pain on 08Sep2021 with outcome of recovering. As of 08Sep2021, patient was clinically stable. The patient underwent lab tests and procedures which included body mass index: 30, platelet count: 239 g/l on Sep2021, ultrasound doppler (Lower limb): negative on Sep2021. The action taken in response to the events for etonogestrel was unknown. Therapeutic measures were taken as a result of the events. Seriousness criteria of the events was hospitalized. Evidence of recent and frequent car trips (more than 5 hours). No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760067 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-07
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Gout
SMQs:, Arthritis (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: CANDESARTAN HCTZ; EZETROL; XARELTO
Current Illness: Chronic lymphocytic leukaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Prothrombin mutation G20210A (thrombosis due to the prothrombin mutation G20210A); Thrombosis (thrombosis due to the prothrombin mutation G20210A)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101286231

Write-up: gout attack; gout attack; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB -AFSSAPS-MA20213647. A 69-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), intramuscular on 04Aug2021 (at 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing chronic lymphocytic leukaemia, breast cancer, thrombosis due to the prothrombin mutation G20210A. Concomitant medications included candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ), ezetimibe (EZETROL), rivaroxaban (XARELTO). The patient previously received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), intramuscular on 05Jul2021 (at 69-year-old) as dose 1, single for COVID-19 immunisation, and experienced gout attack, alopecia effluvium, flash hot, asthenia, fatigue. The patient experienced gout attack (medically significant) on 07Sep2021. Clinical details: 17Jul2021: gout attack, medical consultation and treatment with NSAIDs. 30Jul2021: new gout attack, medical consultation and start of treatment with ALLOPURINOL. The patient then presented hot flashes, with fatigue and hair loss for which she takes FORCAPIL. 04Aug2021: 2nd DOSE COMIRNATY (lot unknown). 07Sep2021: new gout attack. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101239530 same patient, differrent vaccine dose


VAERS ID: 1760542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   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 1F038A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101239626

Write-up: Embolism pulmonary; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. WEB, regulatory authority number FR-AFSSAPS-BX20218627. A 27-years-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular on 06Sep2021 (Batch/Lot Number: 1F038A) as single dose for covid-19 immunisation. Medical history included obesity. She had no medical history of Covid. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 06Aug2021 (lot Number: FE8244) as single dose for covid-19 immunisation and no information on the tolerance of dose 1. On day 1 from dose 2 on 07Sep2021, the patient experienced embolism pulmonary. The outcome of the event was recovered with sequel. The event was serious due to hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760996 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-07
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / 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: 20210908; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101231391

Write-up: vaccination failure; PRIVACY cluster. Positive molecular swab in vaccine. Symptomatic; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787205. A 88-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EK9788, expiry date: 31May2021), intramuscular, administered in Arm Left (left shoulder) on as dose 2, 0.3ML single and dose 1 via intramuscular route administered in Arm Left (left shoulder) on 14Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) as 0.3ML single for covid-19 immunization. The patient medical history was and concomitant medications were not reported. On 07Sep2021, the patient experienced privacy cluster. positive molecular swab in vaccine. symptomatic (medically significant), vaccination failure (medically significant). Follow up information included: Conclusion provided from division Agency for lot number EK9788. 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 EK9788. 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. Agency 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. Follow up information received. Follow up information included: Conclusion provided from division Agency for lot number EL1484. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 "EL1484". 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. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. Clinical Outcome of the events was reported as not recovered for both the events. Follow-up (21Sep2021): This is a follow-up report from Product Complaint Team. New information provided from division Agency includes: expiry date for lot number EK9788: 31May2021 Follow-up (21Sep2021): This is a follow-up report from Product Complaint Team. New information provided from division Agency includes: expiry date for lot number EL1484: 30Apr2021


VAERS ID: 1762442 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Deafness; This case was received via regulatory authority (Reference number: DE-PEI-202100186718) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEAFNESS (Deafness) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced DEAFNESS (Deafness) (seriousness criteria hospitalization and medically significant). At the time of the report, DEAFNESS (Deafness) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided by the reporter. On 07-SEP-2021 patient experienced Numbness in left arm (vaccination arm). This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Translation received on 30-SEP-2021 includes event description and narrative updated accordingly; Sender''s Comments: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1763272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-07
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2206 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, COVID-19, Cough, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101239685

Write-up: On 07Sep2021 due to the appearance of fever performs molecular swab with finding of positivity for Sars Cov 2; On 07Sep2021 due to the appearance of fever, cough, ageusia performs molecular swab with finding of positivity for Sars Cov 2; Vaccination failure; On 07Sep2021 due to the appearance of cough performs molecular swab with finding of positivity for Sars Cov 2; On 07Sep2021 due to the appearance of ageusia performs molecular swab with finding of positivity for Sars Cov 2; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-788005. A 30-year-old male patient received first dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FY7065, expiration date: 31Aug2021), via an intramuscular route of administration on 19May2021 as DOSE 1, 0.3 ML SINGLE and received second dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FE2206), via an intramuscular route of administration on 25Jun2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07sep2021, the patient experienced fever, cough, ageusia performs molecular swab with finding of positivity for Sars Cov 2. The lab tests included SARS-CoV-2 test: Positive on 07Sep2021.Therapeutic measures were taken as a result of events and treatment included Home therapy (Non-steroidal anti-inflammatory drugs. The outcome of events was not resolved. Health authority comments: I DOSE 19May2021 II DOSE 25Jun2021 Investigation conclusion (lot EY7065): 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 EY7065. 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 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.; Reporter''s Comments: I DOSE 19May2021 II DOSE 25Jun2021


VAERS ID: 1763566 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dry mouth, Dysphagia, Headache, Hypotension, Muscular weakness, Nausea, Speech disorder, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: BP; Result Unstructured Data: 90/60 mmHg
CDC Split Type: MDJNJFOC20211002894

Write-up: MARKED VERTIGO; SWALLOWING DYSFUNCTION; DIFFICULTY SPEAKING; MOUTH DRYNESS; BP 90/60; WEAKNESS IN ALL LIMBS; NAUSEA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority (MD-MMDA-300003962) concerned a 32 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206C21A, expiry: unknown) dose was not reported, 1 total administered on 07-SEP-2021 at 13:30 for an unknown indication. No concomitant medications were reported. On 07-SEP-2021 at 13:30, (the reaction occurred immediately after the administration of the vaccine) the patient had marked vertigo, swallowing dysfunction, difficulty speaking, mouth dryness, blood pressure (BP) 90/60 mmHg (hypotension), speech dysfunction, weakness in all limbs, nausea and headache. On an unspecified date the patient was hospitalized. The number of days hospitalized and discharge information was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness in all limbs, marked vertigo, swallowing dysfunction, difficulty speaking, mouth dryness, headache, nausea and BP 90/60 mmHg was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211000817, 20211002832 and 20211002890.; Sender''s Comments: V0: 20211002894-COVID-19 VACCINE AD26.COV2.S-Marked vertigo, Swallowing dysfunction, Difficulty speaking, Mouth dryness, BP 90/60 mmHg. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211002894-COVID-19 VACCINE AD26.COV2.S-Weakness in all limbs, Nausea, Headache. These events are labeled per RSI and is therefore considered potentially related.


VAERS ID: 1763650 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Breast enlargement, Breast pain, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Lipodystrophy (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: NOPFIZER INC202101237976

Write-up: painful breasts; Enlarged breasts; heavy bleedings; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number is NO-NOMAADVRE-PASRAPP-2021-Uxae89. A 17-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 intramuscular, administered in left arm on 07Sep2021 (Batch/Lot Number: Unknown) as dose 1, single (at the age of 17 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heavy bleedings on 07Sep2021, painful breasts and enlarged breasts 08Sep2021. The outcome of the events was not recovered. The regulatory authority did not provide a causality assessment. Reporter''s comments: The patient reported having a healthy diet. The patient reported Latency for BREAST ENLARGEMENT and BREAST PAIN as the day after vaccination. The patient reported Latency for HEAVY BLEEDINGS as late at night. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1770099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-07
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101263076

Write-up: ABORTION SPONTANEOUS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB NO-NOMAADVRE-FHI-2021-Ug9ngr. A 26-year-old female patient received the first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FE7053) intramuscularly administered in Arm Left on 04Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was pregnant at the time of vaccination. The patient experienced abortion spontaneous on 07Sep2021 at 7 weeks pregnant. No relevant laboratory findings or investigations were included in this report. Outcome of event was recovered on an unspecified date. Relatedness of drug to reaction/event Comirnaty/all events/Center/Possible No follow-up attempts are possible. No further information is expected.


VAERS ID: 1770153 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
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: 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: 20210907; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211010948

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via regulatory authority (PT-INFARMED-T202109-1615) on 06-OCT-2021 and concerned a 26 year old male with unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: unknown) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 07-SEP-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s) (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other info-Symptoms starting on 01-Sep-2021. Test performed on 07-Sep-2021


VAERS ID: 1783551 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (But CoVid-19 test was not performed)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101291345

Write-up: Miscarriage; First trimester of pregnancy; This is a spontaneous report from a contactable consumer or other non health professional downloaded from a regulatory authority-WEB FR-AFSSAPS-PC20213933. A 28-years-old pregnant female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: unknown), via intramuscularly in the right arm on 25Aug2021 (at the age of 28-years-old) as dose 2, 0.3 ml single for covid-19 immunization. Medical history included Covid-19, But CoVid-19 test was not performed. No other history was reported. Concomitant medication was reported as none. It was reporter that the patient was in first trimester of pregnancy. On 07Sep2021 the patient miscarries, leading to an emergency room. In total, miscarriage, in a patient who was in her first trimester of pregnancy, on D14 of D2 of the COMIRNATY vaccine (batch unknown). The outcome of the the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1784019 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac dysfunction, Chest pain, Dyspnoea, Echocardiogram, Hyperpyrexia, Investigation, Myocarditis, Pericardial effusion, Troponin
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Altered; Test Date: 20210910; Test Name: admission; Result Unstructured Data: Test Result:Slight Pericardial effusion; Comments: Minimal pericardial effusion, 422; Test Date: 20210910; Test Name: Troponin; Result Unstructured Data: Test Result:422
CDC Split Type: ITPFIZER INC202101285412

Write-up: unimpaired cardiac function; Slight Pericardial effusion; Hyperpyrexia; Thorax pain; Myopericarditis; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-791559. A 18-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FG6273, Expiration date: 30Nov2021), via intramuscular, administered at an unspecified anatomical location on 07Sep2021 08:49 (age at vaccination was 18 years) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were unknown. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FG4493, Expiration date: 30Nov2021) via an unspecified route of administration, administered at an unspecified anatomical location on 14Aug2021 16:20 (age at vaccination was 14 years) as dose 1, single for COVID-19 immunization. On 07Sep2021 the patient experienced unimpaired cardiac function, slight pericardial effusion, hyperpyrexia, thorax pain, myopericarditis and dyspnoea. The patient underwent lab tests and procedures which included echocardiogram which showed altered result, investigation which showed slight pericardial effusion result (Minimal pericardial effusion) and troponin which showed 422 result on 10Sep2021. The patient was hospitalized for unimpaired cardiac function, slight pericardial effusion, hyperpyrexia, thorax pain, myopericarditis and dyspnoea from 07Sep2021 to 17Sep2021. Therapeutic measures were taken as a result of unimpaired cardiac function, slight pericardial effusion, hyperpyrexia, thorax pain, myopericarditis and dyspnoea. Patient discharged from cardiology on 17sep2021 with a diagnosis of myopericarditis, unimpaired cardiac function. anti-inflammatory therapy. Measures taken (Admission to Cardiology at PRIVACY) Altered Electrocardiography. Troponin at 422, dropped during admission, reduced at discharge Slight Pericardial effusion The outcome of the events was resolved on 17Sep2021. Sender comment: 1st dose of Comirnaty vaccine 14Aug2021 at 4.20 p.m. batch: FG4493 Expiry date 30Nov2021.


VAERS ID: 1785961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Autoimmune thyroiditis; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211024418

Write-up: ATAXIA; MUSCLE WEAKNESS LOWER LIMB; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, DE-DCGMA-21193417) was received on 12-OCT-2021 and concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: autoimmune thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 1 total, start therapy date were not reported for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-SEP-2021, the patient experienced ataxia and muscle weakness lower limb and the patient was hospitalized (on unspecified date). It was unknown if patient was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ataxia and muscle weakness lower limb was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1787258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer, Headache, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: 800 (units unspecified)
CDC Split Type: ROJNJFOC20211022882

Write-up: NUMBNESS IN FINGERS; PAIN IN FINGERS; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (RO-NMA-2021-SPCOV12696) on 12-OCT-2021 concerned a 45 year old female of unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05 expiry: Unknown) dose of 1 dosage forms, 1 total administered on 06-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 07-SEP-2021, the patient experienced headache. On an unspecified date, the patient experienced numbness in fingers, and pain in fingers. Laboratory data (dates unspecified) included a Fibrin D dimer test (NR: not provided) with a result of 800 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from numbness in fingers, and pain in fingers. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1675381 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Insomnia, Vomiting
SMQs:, Acute pancreatitis (broad), 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:

Write-up: Got second dose at around 1:10pm on sept 5th, could not sleep that night. Woke up and threw up at 4:30Am on sept 6th.


VAERS ID: 1675584 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Pain in extremity
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Sore arm, upset stomach, chills


VAERS ID: 1675610 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Migraine, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin c, vitamin D
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Migraine, nauseated, fever, chills, weak, tired


VAERS ID: 1675613 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-08
Onset:2021-09-06
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 17B21A / 2 - / IM

Administered by: Pharmacy       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient did not have reaction to the vaccine but did test positive for COVID on 09/02/2021


VAERS ID: 1675636 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-05-04
Onset:2021-09-06
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging normal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 81mg aspirin daily, 200mg ibuprofen as needed
Current Illness: None
Preexisting Conditions: Supra ventricular tachycardia
Allergies: Metoprolol
Diagnostic Lab Data: MRIs of head and neck (7/15, 7/17) were clean. Blood work (5/26, 8/26) results were in normal ranges.
CDC Split Type:

Write-up: Approximately 30 days after my second shot, I started experiencing light tingling sensations in my lower left leg and foot. 30-90 days after my second shot, the tingling sensation spread to my left forearm and hand and right side of scalp. These arm and scalp sensations come and go. However, now 120 days after my second shot, the sensations in my left leg are more constant and intensified, spreading to the inner thigh of my upper left leg.


VAERS ID: 1675655 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / SYR

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

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

Write-up: Headache fever muscle aches bomiting


VAERS ID: 1675662 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dyskinesia, 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: unknown
Current Illness: Patient mother said she had a similar reaction once before after being in a lot of pain.
Preexisting Conditions: seizure disorder (undiagnosed)
Allergies: none
Diagnostic Lab Data: None performed at pharmacy.
CDC Split Type:

Write-up: Approximately 2 minutes after receiving vaccine, patient was dizzy, lost consciousness, and had uncontrolled muscle movements. Patient mom said she had a similar reaction once before when she was in pain. I called 911, patient regained consciousness, seemed really tired but was responding to questions from first responders. She was taken to the hospital to get checked out.


VAERS ID: 1675702 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Angiogram normal, Computerised tomogram head normal, Dizziness, Gait inability, Gaze palsy, Intensive care, Mobility decreased, Nausea, Nystagmus, Seizure, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No medications reported by pt or family
Current Illness: No significant past medical history
Preexisting Conditions: No significant PMH known, diverticulitis from 2015 is his most recent diagnosis
Allergies: No allergies reported by pt or family
Diagnostic Lab Data: 9/6/21 CToH: negative for bleed 9/6/21 CT angio: negative for occlusion
CDC Split Type:

Write-up: Presented to hospital with N/V and dizziness. Reported that before presentation he could not ambulate and the room was suddenly spinning. LKW was 0800 9/6/2021. He had both horizontal nystagmus as well as nystagmus with upward gaze. CT of the head was negative. Given concern for stroke and no other contraindication he was a candidate for TPA. Given TPA. Follow up CT angio negative, and at ~1200 9/6/21 patient began seizing, managed with levetiracetam & transferred to neuro ICU.


VAERS ID: 1675738 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pruritus, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None listed
Current Illness: None reported
Preexisting Conditions: Anemia, asthma, fibromyalgia
Allergies: Penicillin, Clindamycin, Vancomycin, Sulfa antibiotics, NSAIDs
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Approximately 1.5 hours after receiving the vaccine, patient returned to the pharmacy complaining of widespread hives and itching. She did not have shortness of breath. I administered 50mg of Benadryl and had her sit for 15 minutes. Benadryl reduced the hives and the patient left the store.


VAERS ID: 1675766 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-01
Onset:2021-09-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Mild adverse reaction to childhood vaccine at around age 4 or 5. According to mother Doctor discontinued next doses of that vacc
Other Medications: Lev-el Thrive shake Benadryl
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Shellfish, Sulfa drugs, Hydrocortisone, Codeine and Codeine derivatives, Cortisone
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day of injection brusing and pain at injection site and in muscle, flu like symptoms that went away after a few days. 16 days later injection sight has become swollen, red, sore, and hot to touch.


VAERS ID: 1675788 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

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

Write-up: After receiving vaccination, during 15 minute waiting period, patient felt weak and lightheaded. Father gave her a banana to eat and the pharmacy supplied her with water to drink. About 15 minutes after completion she felt much better and they headed home.


VAERS ID: 1675802 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphagia, Hyperhidrosis, Throat irritation, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: Pt had whole body sweat, followed by vomiting (1 case), throat irritation (difficulty swallowing slight)


VAERS ID: 1675812 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Flushing
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt lightheadedness and flushed when he was waiting during his 15 minute post vaccination time.


VAERS ID: 1675822 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Injection site pain, quarter sized redness and hard bump.


VAERS ID: 1675830 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: pt fainted after receiving first dose of pfizer vaccine


VAERS ID: 1675831 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure via skin contact, Syringe 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: Not known
Current Illness: Not known
Preexisting Conditions: Not known
Allergies: Not known
Diagnostic Lab Data: X
CDC Split Type:

Write-up: while giving the Modern injection the patient moved right when the needle went into her arm. The liquid came down her arm and on her shirt. I discussed with her and we gave another injection in her right arm


VAERS ID: 1675841 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: The patient had previously experienced syncope after a vaccine, but according to her mother, it never lasted as long as this inc
Other Medications: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: NKDA
Diagnostic Lab Data: The EMS were called and confirmed the patient''s vitals were stable.
CDC Split Type:

Write-up: The patient experienced syncope shortly after receiving the vaccine. She was sweaty, pale, and unresponsive for several minutes.


VAERS ID: 1675846 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

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

Write-up: Palpitations of a hard heart beat that started 5 days after the vaccine and then got less severe throughout the day.


VAERS ID: 1675848 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: 2 MINUTES AFTER VACCINE. PATIENT BECAME PALE AND FAINTED. NO INJURIES OCCURED AND PATIENT LEFT 15 MINUTES LATER AFTER OBSERVATION.


VAERS ID: 1675851 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-12
Onset:2021-09-06
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Rash erythematous
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clomiphene
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Widespread rash over back with red bumpy circles of many sizes, up to 12+ cm


VAERS ID: 1675853 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Testosterone cypionate
Current Illness:
Preexisting Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, nausea, soreness in arm


VAERS ID: 1675854 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control (chateal eq)
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The initial arm pain was gone by day 2-3. Today (day 7) I woke up with pain all down my left arm and swelling around my shoulder/collar bone area.


VAERS ID: 1675855 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: She said she has felt dizzy before after other vaccinations
Other Medications: Sertraline, lorazepam
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: Her blood pressure and pulse stayed normal. BP 117/86. Pulse 77
CDC Split Type:

Write-up: Patient felt dizzy, was sweating, and then fainted and lost consciousness a few minutes after receiving her first covid shot. She was sitting in front of the pharmacy in our post vaccination chairs. We noticed that she moved herself to the floor. I went out there to see if she was ok. She said she felt dizzy and faint. I started to fan her to cool her off. Then her eyes rolled back and she started to lose consciousness. We used the ammonia inhalant salts to try to arouse consciousness. We took her blood pressure and did call 911. After a few minutes, she regained consciousness. By the time the paramedics came, she was ok. We had her stay in the pharmacy post vaccination area for 30 minutes before she left with her husband.


VAERS ID: 1675859 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Muscle rigidity, Muscle twitching, Pallor
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), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Patient was extremely nervous to get vaccine. Vaccine was administered at 5:22pm. While sitting in the waiting area at 5:31pm patient lost consciousness and was very pale. I noticed his hands were twitching and became rigid. His father helped me put his feet up and after 2-3 minutes he regained consciousness. I took his blood pressure which was 101/81. Patient drank water and sat for another 30 minutes before saying he felt ok to go home. Father said he would follow up with pediatrician on 9/7/21. Called father an hour later and said child seemed ok, was resting and had a headache.


VAERS ID: 1675862 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Presyncope, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient developed vasovagal reaction and was unresponsive a brief moment


VAERS ID: 1675868 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall, Gait disturbance, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received COVID Moderna vaccine. Patient waited recommended 15 minutes after vaccine and on way out patient got dizzy and stumbled/fell. She did not fall hard. She then began vomitting. Her husband was with her and did not seem concerned, said this happens when she gives blood. She waited a while longer after she threw up then was ready to go. We kept asking her if she needed anything and she said no. We asked her if she wanted to stay longer and she said no that she was fine. She told us that she had eaten too much mexican food before coming to get the vaccine. She did not want us to call anyone as her husband was with her, and did not want any assistance. She did not want a manager called, we however did call one anyway over the walkie but no one ever came and she ended up leaving. I called her a couple of hours later to check on her, she insisted that she was fine and that she did not think it was due to the vaccine. She stated that this had happened when she has given blood before but that it had never happened when she had received a vaccine which is why she did not mention it to us beforehand. She apologized to me for not giving us a heads up for that. But said this is something that has happened to her before when giving blood which is why neither she or her husband was panicked over it. I advised her to remind us of this when we gave her second vaccine so that we could know what to expect for the next time. Even though she stated she did not think it was due to the vaccine, it happened directly after giving the vaccine during the 15 minute observation period, so I am reporting this just in case.


VAERS ID: 1676062 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Eye swelling, Facial pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (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
Current Illness: None
Preexisting Conditions: None
Allergies: Macrobid
Diagnostic Lab Data:
CDC Split Type:

Write-up: All typical side effects but have swelling under eyes and pain into cheek bones


VAERS ID: 1676063 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 5 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypertension, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No knowledge.
Current Illness: Asthma
Preexisting Conditions: Asthma
Allergies: Yes but patient did not specify.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: After receiving her shot within 5 minutes she was feeling dizzy and her tongue got swollen. We lay her down and gave some water and call 911. They checked her vitals and she had high BP. They took her to urgent treatment center just to make sure she is ok


VAERS ID: 1676255 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Woke up at 2 am with fever, chills, extreme body aches, and diarrhea. Took Tylenol which brought the fever down but had to be repeated at 8am, 12pm, 8pm due to fever of 101.5 and chills. Also had quick bouts of moderate pain around my left temple intermittently throughout the day. Heart rate usually staying around 100-125 even at rest.


VAERS ID: 1676464 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031B21A / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Delayed injection site reaction. Day 5. Redness, swelling and warm to touch. Mild itching at site.


VAERS ID: 1676476 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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: "immunocompromised"
Allergies: Potassium
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient came in and got her third pfizer dose for being immunocompromised. I asked her if there were any problems with vaccines, allergies, or anything that has made her throat close up. She only said potassium. I told her per recommendations she''d have to wait 30 minutes which she did not want to do with all the people in the lobby. She then called and spoke to another pharmacist here saying her throat was closing up with no problem breathing. She was instructed to take benadryl and seek medical help. I called her back around 415 to check on her and she said that the benadryl may be helping a little and she has a call out to her doctor. I told her that it is a holiday and probably wont respond today. I reminded her that if the swelling got worse minutes are precious with airways. She agreed to get her husband to take her to get examined.


VAERS ID: 1676486 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Blindness, Migraine, Presyncope, Urticaria, Vertigo
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Penicillin
Other Medications: No
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin Sulfa
Diagnostic Lab Data: Treated by paramedics
CDC Split Type:

Write-up: Vasovagal response (shortly after) Anaphylaxis (shortly after) Vertigo (evening of) Hives (evening of) Mild vision loss (next day) migraines (next day)


VAERS ID: 1676635 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Bladder pain, Blood urine present, Dysuria
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Retroperitoneal fibrosis (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: Vyvanse for my ADHD.
Current Illness: No.
Preexisting Conditions: No.
Allergies: Just seasonal allergies.
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 09/06/2021 around 2 pm I started to have sharp pains in my lower back and bladder area. I then went to the bathroom and had shooting pain while urinating. I then noticed a good amount of blood in my urine. After that I kept feeling like my bladder was going to explode minutes after using the bathroom but everytime I went there was just a little bit of urine and some blood. I can now not stop going to the bathroom every 10-15 minutes and it is extremely painful. I am about to go to the hospital.


VAERS ID: 1676636 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear discomfort, Tinnitus
SMQs:, Hearing impairment (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: allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: the next morning after the 2nd vaccine shot when i woke up at 10 am my right ear was feeling clogged and a mild ringing, the clogged and the ringing decreased and stoped, now my ears feel normal.


VAERS ID: 1678178 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Meningitis vaccine, 17, 2018, vomiting
Other Medications: Zoloft Birth control
Current Illness: No
Preexisting Conditions: Asthma
Allergies: Sulfur Amoxicillin Z-pac Gluten Lactose
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, chills, body aches, headache, vomiting all within of 4 hours of getting the vaccine. Taken Tylenol, zofran, and dicyclomine


VAERS ID: 1678307 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Incorrect dose 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: Error: Wrong Dose of Vaccine - Too Low-


VAERS ID: 1678320 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypersensitivity, Injection site pruritus, Injection site swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt seems to be fine overall . will use some benadryl to alleviate itching sensations. will instruct pt to get shot on oppostive arm on follow up appointment. classified pt as non severe allergic reaction because pt got hives within 4 hours of getting pfizer shot so cdc recommends to not get a second shot. this is clearly stated to pt. and pt understands this that this is her only shot.


VAERS ID: 1678329 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site was painful and "heavy" in the first 1-3 days similar to other immunizations. On Sept 6, day 4 after the shot my left arm felt very itchy. The site became swollen and red over the next several hours and up to the time of this report. The swollen site is about 2.5 inches in diameter from the shot site.


VAERS ID: 1678486 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: He was seen at Hospital ED and admitted to have his appendix removed today (9/7/2021).
CDC Split Type:

Write-up: Patients vaccination was routine and had no notable abnormalities. Said he had a sore arm with the first and that was it and had no other vaccinations or new treatments since first shot. He was doubled over in abdominal pain starting Monday 9/6/2021 at 9pm. According to his mother he never complains about pain and she is not sure it related to the vaccination at all but reporting in case. He was seen at Hospital ED and admitted to have his appendix removed today (9/7/2021).


VAERS ID: 1678497 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-26
Onset:2021-09-06
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (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), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (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: Omeprazole
Current Illness:
Preexisting Conditions: Adenocarcinoma Left Lung, Metastatic
Allergies: None
Diagnostic Lab Data: Rapid Covid-19 = positive, Influenza A&B = negative
CDC Split Type:

Write-up: COVID vaccines received on 4/30/21 and 5/26/21. She was admitted to the hospital on 9/6/2021 with acute hypoxic respiratory failure due to COVID pneumonia. She was started on dexamethasone and remdesivir.


VAERS ID: 1678524 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-31
Onset:2021-09-06
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Write-up: Pfizer on 3/10 and 3/31. Positive on 8/30 admitted 9/6 to current


VAERS ID: 1678529 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-05-06
Onset:2021-09-06
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Write-up: Moderna on 4/9 and 5/6. Positive on 9/5 admitted 9/6 to current


VAERS ID: 1678591 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Heart rate increased, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: baby aspirin, allegra, multi-vitamin, vitamin c, probiotic, elderberry
Current Illness: cold/sinus infection 3 weeks ago
Preexisting Conditions: season allergies
Allergies: pcn, sulfa, minocin, cipro
Diagnostic Lab Data: none done
CDC Split Type:

Write-up: rapid heart beat, palpitations, some light headedness when palpitations occur


VAERS ID: 1678673 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Chest discomfort, Chills, Dizziness, Dyspnoea, Nausea, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Chills and body aches started 3 AM on Monday. I took 600mg of IBUProfen at 6 AM. For the rest of the day, I experienced body aches, chills, and fevers. Later in the afternoon, around 12 PM, I was experiencing light-headedness, off-balanced, and the feeling like I was going to faint along with shortness of breath. Later at night, around 6 PM - just getting up and down off the couch would make me dizzy. It felt like at the blood was rushing out of my head. I was also nauseous and felt like my heart was acting weird.


VAERS ID: 1678731 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-12-18
Onset:2021-09-06
   Days after vaccination:262
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Infection, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough covid case. Confirmed by PCR testing on 9/5/2021


VAERS ID: 1678736 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-09
Onset:2021-09-06
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, COVID-19, Decreased appetite, Myalgia, Productive cough, Pyrexia, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amitriptyline 50 mg Tablet Directions: 4 tablet oral daily at bedtime (Active) amLODIPine 5 mg Tablet Directions: 1 tablet oral daily at bedtime (Active) hydrocortisone 10 mg Tablet Directions: 2 tablet oral daily every morning (Activ
Current Illness:
Preexisting Conditions: Dyslipidemia, HTN. s/p pituitary tumor resection 2007. Smoking Status Never Smoker. Alcohol Use Denies. Illicit Drug Use Denies.
Allergies: NKDA
Diagnostic Lab Data: SARS-CoV-2 Antigen testing POS 9/6/2021
CDC Split Type:

Write-up: Admitted to hospital on 9/6/2021 with fever chills . genralized wakness . He was exposed to his daughter and son in law who had fever and tested pos for covid , Poor Appettie severe weakness and muscle aches , no Shortness of breath , + productive sputum . The


VAERS ID: 1678744 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-10
Onset:2021-09-06
   Days after vaccination:208
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Hospitalization - COIVD-19 in immunocompromised patient


VAERS ID: 1678758 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-14
Onset:2021-09-06
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, Hyperglycaemia, Hypomagnesaemia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), 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), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Hospitalization - COVID-19 infection, hyperglycemia, hypomagnesemia, acute kidney injury


VAERS ID: 1678760 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-01-29
Onset:2021-09-06
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011M20A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025A21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Breakthrough case. Confirmed covid positive on 9/6/2021 with PCR testing


VAERS ID: 1678763 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-03
Onset:2021-09-06
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Cough, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hospital Anxiety Generalized Disorder Hypothyroidism Hypertensive Heart With Heart Failure And Chronic Kidney Disease, Hospital: Anxiety Generalized Disorder, Hypothyroidism, Hypertensive Heart With Heart Failure And Chronic Kidney Disease (CKD) Stage 3a Glomerular Filtration Rate (GFR) 45 To 59 (HCC), Chronic Respiratory Failure With Hypercapnia (HCC), Atherosclerosis Aortic (HCC), Rhinitis Chronic, History Of Falling, Chronic Respiratory Failure With Hypoxia (HCC), Acute Lower Respiratory Infection Due To COVID-19, Acute And Chronic Respiratory Failure With Hypoxia (HCC). Non-Hospital: Emphysema (HCC), Nodules Pulmonary Multiple Dyslipidemia, Anemia, Dysphagia Pharyngoesophageal Phase, Loss Hearing Sensorineural Bilateral, Weakness General, Pain Neck, Pain Low Back, Impairment Cognitive Mild, Panic Disorder Episodic Paroxysmal Anxiety, Osteoporosis, Chronic Diastolic (Congestive) Heart Failure (HCC), Psoriasis, Ulcer Gastric Personal History, Diverticulosis, Sleep Related Breathing Disorder Myocardial Infarction Old, Abdominal Pain, Oxygen Dependent, Diverticulosis Colon With Perforation, Other Injury Sigmoid Colon Sequela, Dementia (HCC), Depression Major Recurrent Full Remission (HCC), Fracture Pubis Other Closed Initial Right (HCC), Hypertension Essential Primary
Allergies:
Diagnostic Lab Data: Coronavirus 2 PCR Detect, V symptomatic POSITIVE
CDC Split Type:

Write-up: 83 y.o female presents to the ED with /co cough. Pt states she was seen by her PCP last week and given a prednisone taper for COPD exacerbation. She states her symptoms have never improved, and in fact, have worsened. She wears 2 L NC at home. She has not been febrile.


VAERS ID: 1678793 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Fatigue, Injection site pain, Myalgia, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: adderall xr 20mg
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain at injection site, Muscle Aches Fatigue Vaginal bleeding (previous endometrial ablation completed over 1 year ago- first time bleeding since procedure) Abdominal Cramping


VAERS ID: 1678800 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fainted when blood was drawn in the past
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 19-year-old female passed out after receiving her first Pfizer vaccination she was in 15 min observation area. She was responsive an attended to by medical staff on team. EMS was called individuals vital checked, blood pressure, VGL and oxygen all normal. Mother was present and patient declined to go to hospital for further evaluation.


VAERS ID: 1678875 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Minocycline, dairy, chocolate
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives, shortness of breath, chest tightness. Shot at 10:42am, hives and shortness of breath started around 220pm. Tylenol, benadryl, and water taken orally to help with symptoms.


VAERS ID: 1678876 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-01
Onset:2021-09-06
   Days after vaccination:248
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Malaise
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received 3 doses of Pfizer with last dose on 8/30/21 admitted to hospital for COVID symptoms. Unknown specifics to vaccine (date and lot numbers of other doses-pt retrieved else where)


VAERS ID: 1678878 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site rash, Lymphadenopathy, Pain
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash at injection site 7 days after first moderna shot along with swollen lymph nodes and soreness.


VAERS ID: 1678881 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-15
Onset:2021-09-06
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Bradycardia, COVID-19, Dyspnoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: aspirin, 81 mg, PO, Daily benzonatate 200 mg oral capsule, 200 mg= 1 CAP, PO, TID (3 times a day) carbidopa-levodopa 10 mg-100 mg oral tablet, 1 TAB, PO, BID (2 times a day) ferrous sulfate, 325 mg, PO, BID (2 times a day) Lyrica 100 mg ora
Current Illness:
Preexisting Conditions: duodenitis gastritis History of PCOS irritable bowel syndrome
Allergies: Latex (Rash) Tylenol with Codeine #2 (Vomiting) Zithromax (Hives) aspirin (Rash) ciprofloxacin (Vomiting) codeine (Hives) penicillin (Vomiting) Thorazine (hallucinations) doxycycline (rash)
Diagnostic Lab Data: POSTIVE COVID TEST
CDC Split Type:

Write-up: Bradycardia, shortness of breathing, COVID+


VAERS ID: 1678901 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ginseng, B-Complex, Multivitamin, Magnesium, Probiotic, Rhodiola, Veg Collagen, Levothyroxine
Current Illness: Hypothryoidism
Preexisting Conditions: Hypothyroidism
Allergies: Amoxicillin, Bactrim
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain and shortness of breath.


VAERS ID: 1678935 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electrocardiogram normal, Erythema, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), 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? Yes
Hospitalized? No
Previous Vaccinations: 1st dose moderna with same reaction and symptoms resolving spontaneously.
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies: None known
Diagnostic Lab Data: EKG: normal
CDC Split Type:

Write-up: 3 days after test patient notes occasional palpitations and redness at arm. She reports a similar reaction with 1st dose.


VAERS ID: 1678940 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-02
Onset:2021-09-06
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001A21A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, Blood urine present, COVID-19, COVID-19 pneumonia, Condition aggravated, SARS-CoV-2 test positive, Type 2 diabetes mellitus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Supraventricular tachyarrhythmias (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin, 81 mg, PO, Daily diclofenac 1% topical gel, 2 GM, TOP, 4 times a day, PRN donepezil 5 mg oral tablet, 5 mg= 1 TAB, PO, Daily Eliquis 5 mg oral tablet, 5 mg= 1 TAB, PO, BID (2 times a day) glimepiride 4 mg oral tablet, 4 mg= 1 TAB,
Current Illness:
Preexisting Conditions: Atrial fibrillation with RVR Hematuria Pneumonia due to COVID-19 virus Well controlled type 2 diabetes mellitus
Allergies: TIZANIDINE
Diagnostic Lab Data: POSITIVE COVID TEST
CDC Split Type:

Write-up: Type 2 diabetes mellitus well controlled, Blood in urine, Atrial fibrillation with rapid ventricular response., Pneumonia caused by SARS-CoV-2


VAERS ID: 1678973 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: Toradol, Latex
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: 1. severe pain to left side from collar bone to finger tips. 2. swollen, painful 3 cm cyst or lymph node on left collar bone.


VAERS ID: 1679040 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Pruritus, Rash macular, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: About 10 minutes in splotchy skin and all over itching with a tight throat. Urgent care doctor assessed her and treated with Benadryl. Assessed again approximately 10 minutes later then had her transferred over to urgent care for epinephrine shot and prednisone . She started having relief about 15 minutes after.


VAERS ID: 1679048 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: Telephone call - Describes bruising to right forearm and shoulder. Denies any known trauma to area. Has not sought medical attention.


VAERS ID: 1679055 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dry skin, Fatigue, Headache, Heavy menstrual bleeding, Menstruation irregular, Pain, Pyrexia, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Fertility disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Fever, fatigue, body aches, chills, headache which started approximately 5 hours after vaccine. Symptoms cleared after approximately 24 hours. 3 days after vaccine period came 2 weeks early. My period are always regular and on time. My period is extremely heavy. At the same time my skin became very dry. The skin on my face is peeling.


VAERS ID: 1679060 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Confusional state, Disorientation, Disturbance in attention, Dizziness, Dysarthria, Dyspnoea, Facial paresis, Fatigue, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (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: Bystolic and Losartan
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: None
Diagnostic Lab Data: None as of this time
CDC Split Type:

Write-up: Received shot on Sunday at 415 pm and on Monday at 10 pm felt light headed and whole body tingling felt confused and disoriented. On Tuesday September 7 from 7 am to current time of this reporting of 3 pm have been extremely tired disoriented felt week and have problems concentrating as well as slurred speech and shortness of breath along with my left side of face feeling funny and weak.


VAERS ID: 1679067 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-20
Onset:2021-09-06
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myocarditis
SMQs:, 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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Not yet.
CDC Split Type:

Write-up: Myocarditis I think, it started yesterday. I had never felt that. Pulse pain from my heart right side (middle of the chest) , not continuous , several times per minute.


VAERS ID: 1679096 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:1965-12-05
Onset:2021-09-06
   Days after vaccination:20364
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong product administered
SMQs:, Medication errors (narrow)

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

Write-up: PATIENT HAD ASKED FOR FLU SHOT, NOT COVID


VAERS ID: 1679135 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-08
Onset:2021-09-06
   Days after vaccination:241
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1686 / 2 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, COVID-19, Headache, Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 9/5 body aches, congestion, runny nose, loss of taste, headaches onset; 9/6 covid positive


VAERS ID: 1679145 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Joint stiffness, Mobility decreased, Myalgia, Nausea, Pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phentermine 37.5
Current Illness: None
Preexisting Conditions: Thyroid Disease
Allergies:
Diagnostic Lab Data: None at this time
CDC Split Type:

Write-up: Sore muscles after a few hours post vaccine. Around 10pm had a very hard time moving legs to get up. During the next day continued increased pain and stiffness in joints and numbness and tingling in face and arms nausea and mild dizziness


VAERS ID: 1679182 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: na
Current Illness: na
Preexisting Conditions: ha
Allergies: na
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: This patient received Pfizer for second dose when it should have been Moderna


VAERS ID: 1679228 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site pain, headache, fatigue and chills.


VAERS ID: 1679248 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Escitalopram
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm swollen, sore armpit and upper back near arm. Swollen and painful left armpit, lymph node.


VAERS ID: 1679297 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), 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: Omeprazole 40mg daily Aspirin 325mg daily Tramadol 50mg twice daily as needed for pain arava for rheumatoid arthritis Prednisone Folic acid Melatonin Methotrexate 2.5mg . 20mg every every 7 days. (not taking as of 9/6/21.
Current Illness: GERD Rheuatoid arthritis secondary polycytemia
Preexisting Conditions: GERD Rheuatoid arthritis secondary polycytemia Hx of positive covid 12/2020
Allergies: Naproxen sodium
Diagnostic Lab Data: Medications sodium chloride flush 0.9 % 5-20 mL (10 mL Intracatheter Given 9/6/21 1613) enoxaparin (LOVENOX) injection 90 mg (has no administration in time range) iohexol (OMNIPAQUE) 350 MG/ML injection 64 mL (64 mL Intravenous Given 9/6/21 1630)
CDC Split Type:

Write-up: Patient recived first vaccibne dose 3/16/2021 then second dose in the series on 46/2021. Bosster Pfizer dose 8/31/2021. Was treated in the ER with Enooxaprin and then transferd hospital. CT scan shows extensive bilateral pulmonary emboli including saddle embolus. Diagnosis Plan: 1. Bilateral pulmonary embolism 2. Saddle pulmonary embolus


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=254&PERPAGE=100&ESORT=ONSET-DATE&REVERSESORT=ON&VAX=COVID19&DIED=No

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