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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 347 out of 6,867

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VAERS ID: 1541214 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Breath sounds abnormal, Dizziness, Eructation, Erythema, Hypertensive crisis, Malaise, Nausea, Parosmia, Rash, Taste disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (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: COVERAM; AERIUS [DESLORATADINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypersensitivity
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: hypertensive crisis; Result Unstructured Data: Test Result:170/100 mmHg
CDC Split Type: FRPFIZER INC202100965806

Write-up: Crisis hypertensive/ a hypertensive crisis at 170/100; Taste changed/ Modified taste and smell; Feeling sick; Burping/ Belching; Altered smell sensation/ Modified taste and smell; Nausea; Skin breakout/ Redness and rashes in the sinuses and cheeks; Faintness; A slight hissing sound in the chest; Redness and rashes in the sinuses and cheeks; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20215722. A 63-years-old female patient received bnt162b2 (COMIRNATY), via intramuscular, administered in arm left on 17Jul2021 (Lot Number: FE2296), at the age of 63-years-old, as dose 1, single for COVID-19 immunisation. Medical history included hypersensitivity (Allergy, unspecified) and arterial hypertension. Concomitant medications included amlodipine besilate, perindopril arginine (COVERAM) and desloratadine (AERIUS), both taken for an unspecified indication, start and stop date were not reported. The patient experienced crisis hypertensive/ a hypertensive crisis at 170/100, taste changed, feeling sick, burping/ belching over several days, altered smell sensation, nausea, skin breakout, faintness, a slight hissing sound in the chest, modified taste and smell, redness and rashes in the sinuses and cheeks on 17Jul2021 with outcome of recovering. Taking Aerius as the treatment of the events. Make an appointment with his attending physician. Evolution: Healing on the date of declaration (21Jul2021). No COVID test. No follow-up attempts possible. No further information expected.


VAERS ID: 1541307 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abdominal tenderness, Arthralgia, Back pain, COVID-19, Contusion, Fatigue, Limb discomfort, Myalgia, Neck pain, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE; SYMBICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lactation decreased; Pollen allergy; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:Patient has not tested positive
CDC Split Type: GBPFIZER INC202100962228

Write-up: tummy just felt a little tender/bruised type feeling; tummy just felt a little tender/bruised type feeling; achey neck; achey neck, shoulders and back; achey neck, shoulders and back; Stomach cramps; Generalised muscle aches; Injection site pain; legs felt heavy; Tiredness; This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107270844015780-YXSEW, Safety Report Unique Identifier GB-MHRA-ADR 25712457 . A 32-years-old female patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunization, at the age at vaccination of 32 years old. Medical history included suppressed lactation, asthma, Pollen allergy, all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medications included loratadine taken for Pollen allergy; budesonide, formoterol fumarate (SYMBICORT) taken for asthma. The patient experienced stomach cramps on 18Jul2021 with outcome of recovered on 19Jul2021, tiredness on 17Jul2021 with outcome of recovered on 20Jul2021, generalised muscle aches on 18Jul2021 with outcome of recovered on 19Jul2021, injection site pain on 17Jul2021 with outcome of recovered on 19Jul2021, legs felt heavy on 17Jul2021 with outcome of recovered on 19Jul2021, achey neck, shoulders and back on 18Jul2021 with outcome of recovered on 19Jul2021, tummy just felt a little tender/bruised type feeling on an unspecified date with outcome of recovered on unknown date. The events serious as medically significant. Additional information: "Had the vaccine in the morning. That evening my legs felt heavy and I felt more tired than usual. The next day I had really bad stomach cramps and felt more tired than usual. I also had an achey neck, shoulders and back. I felt unable to carry out my normal routine looking after my young children. As a consequence of the cramps I hadn''t been able to eat and drink as normal so the following day I think I was recovering from that. My tummy just felt a little tender/bruised type feeling and I felt the need to lie down a few times throughout a busy day looking after my 3 young children. Then the following day I felt completely fine again." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment received was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100961907

Write-up: Hives; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107271256228280-MGK2P, Safety Report Unique Identifier GB-MHRA-ADR 25714041. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. The patient experienced hives on 17Jul2021 with outcome of not recovered. Event was reported as medically significant by health authority. Case narrative: Whole body covered in hives. Antihistamines taken. He has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1541602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease aggravated; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: GBPFIZER INC202101005057

Write-up: COVID after vaccination; COVID after vaccination; This is a spontaneous report from a contactable consumer. An elderly male patient of an unspecified age received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single and received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization for COVID-19 immunization. Patient was vaccinated in January/February. Medical history included former smoker, heart disease. Concomitant medications were not reported. It was unknown, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Jul2021, patient experienced COVID after vaccination. Facility where the most recent COVID-19 vaccine was administered was unknown. Start of adverse event an estimate. Patient received unknown treatment. Since the vaccination, the patient had been SARS-CoV-2 tested for COVID-19 and resulted positive on17Jul2021. The outcome of the events was recovering.


VAERS ID: 1541607 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Bradycardia, Dizziness, Dyspnoea, Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no
Allergies:
Diagnostic Lab Data:
CDC Split Type: GEPFIZER INC202100961253

Write-up: 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds, angioneurotic edema; This is a spontaneous report from a non-contactable other hcp from vaccination center.This is a report received from the Regulatory Authority. This case was received via COVAES, reference number GE-COVAES-85a8c0b8-68c5-4f71-9684-cc285f6fb958. A 28-year-old female patient received first dose of BNT162B2 (BNT162B2) intramuscular on 17Jul2021 at 15:00 (Batch/Lot Number: FD8813) as DOSE 1, SINGLE for covid-19 immunization. Medical history was reported as none. The patient''s concomitant medications were not reported. The patient experienced 5 minutes after vaccination-low blood pressure, bradycardia, dizziness, difficulty breathing, loss of consciousness for a few seconds and angioneurotic edema on 17Jul2021. The events bradycardia, difficulty breathing, loss of consciousness for a few seconds and angioneurotic edema were reported as medically significant. Therapeutic measures were taken as a result of all the events which includes Adrenaline and dexamethasone. Outcome of all the events was recovered on unspecified date. No follow up attempts are possible. No further information is expected.


VAERS ID: 1541774 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: corona; Test Result: Positive
CDC Split Type: JPPFIZER INC202100966780

Write-up: corona was positive. It hasn''t been two weeks yet; This is a spontaneous report received from a contactable physician via medical information team. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient tested corona positive on 17Jul2021. Reaction was reported as follows: There was a patient infected with corona after the first vaccination. It was July 17th that the corona was positive. It hasn''t been two weeks yet. Patient accepted the first vaccination on July 1st, no, I don''t know when patient got the vaccine, but patient was infected between the first and second vaccinations of Pfizer''s vaccine, and patient came to outpatient to get the second vaccination today. The patient underwent lab tests and procedures which included on 17Jul2021 corona positive. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Covid-19 and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1541961 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Incontinence, Loss of consciousness, Musculoskeletal stiffness, Nausea, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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: PTJNJFOC20210813331

Write-up: LOSS OF CONSCIOUSNESS; TONIC-CLONIC MOVEMENTS, WITH RECOVERY OF CONSCIOUSNESS; MUSCLE STIFFNESS; SPHINCTER INCONTINENCE; NAUSEA; This spontaneous report received from a physician via a Regulatory Authority [Regulatory Authority, PT-INFARMED-F202107-3362] concerned a 33 year old of unspecified sex. 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 date was unknown) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced loss of consciousness, tonic-clonic movements, with recovery of consciousness, muscle stiffness, sphincter incontinence and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, tonic-clonic movements, with recovery of consciousness, muscle stiffness, sphincter incontinence, and nausea on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred-No Other information-he was fasting, reaction occurred around 11:00 a.m., and the air was warm and stuffy inside the center. Denies relevant AP. Denies usual medication or known allergies; Sender''s Comments: V0: 20210813331-covid-19 vaccine ad26.cov2.s -Loss of consciousness, Tonic-Clonic movements with recovery of consciousness, Muscle stiffness, Sphincter incontinence. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210813331-covid-19 vaccine ad26.cov2.s -Nausea. This event(s) is labeled per institute and is therefore considered potentially related.


VAERS ID: 1541979 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope, Tonic clonic movements, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210812987

Write-up: SYNCOPE; WITH TONIC-CLONIC REACTION; URINE INCONTINENCE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3377] concerned a 26 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. Cumulative Dose was reported as 0.5 ml No concomitant medications were reported. On 17-JUL-2021, the patient experienced syncope, tonic-clonic reaction and urine incontinence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, with tonic-clonic reaction, and urine incontinence on 17-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-Healthy patient, no known diseases, no known drug allergies, and no usual medication.; Sender''s Comments: V0-20210812987-Covid-19 vaccine ad26.cov2.s-Syncope, with tonic-clonic reaction and urine incontinence.This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1544704 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004218 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: Chills; Myalgia; geschwollene Lymphknoten; Fieber; Kopfschmerzen; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Myalgia) in a 53-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), MYALGIA (Myalgia) (seriousness criterion medically significant), LYMPHADENOPATHY (geschwollene Lymphknoten), PYREXIA (Fieber) and HEADACHE (Kopfschmerzen). At the time of the report, CHILLS (Chills), MYALGIA (Myalgia), LYMPHADENOPATHY (geschwollene Lymphknoten), PYREXIA (Fieber) and HEADACHE (Kopfschmerzen) had not resolved. No concomitant medications were provided. No treatment was reported for the events. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Translated document received on 09-Aug-2021- updated dosage text; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1544778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Haemolytic anaemia, Microangiopathy, Oedema, Pancreatitis acute, Plasmapheresis, Red blood cell abnormality, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No allergy, no medical history Tobacco use 30 cigarettes/w Alcohol approx 10U/week, sometimes more as a result of peak happenings in the past has (not recently) experimented with drugs
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210808783

Write-up: THROMBOCYTOPENIA; HEMOLYTIC ANEMIA; ACUTE KIDNEY (PRERENAL AT UNDERFILLING, DD/ STILL ALSO A FACTOR TMA COMPARED TO INFRA); ACUTE PANCREATITIS MOST LIKELY ETHYL BASED; NEED FOR PLASMAPHERESIS; EDEMATOUS; ABNORMAL RBC MORPHOLOGY AND FRAGMENTS; SECONDARY THROMBOCYTOPENIC MICROANGIOPATHY; This spontaneous report received from a physician via a Regulatory Authority (BE-FAMHP-DHH-N2021-102357) concerned a 20 year old male. The patient''s weight was 86 kilograms, and height was 176 centimeters. The patient''s pre-existing medical conditions included: No allergy, no medical history Tobacco use 30 cigarettes/w Alcohol approx 10U/week, sometimes more as a result of peak happenings in the past has (not recently) experimented with drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4314258, expiry: UNKNOWN) dose was not reported, 1 total administered on 23-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced thrombocytopenia, hemolytic anemia, acute kidney (prerenal at underfilling, dd/ still also a factor tma compared to infra), acute pancreatitis most likely ethyl based, need for plasmapheresis, edematous, abnormal rbc morphology and fragments, secondary thrombocytopenic microangiopathy and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from need for plasmapheresis, edematous, abnormal rbc morphology and fragments, acute kidney (prerenal at underfilling, dd/ still also a factor tma compared to infra), acute pancreatitis most likely ethyl based, thrombocytopenia, secondary thrombocytopenic microangiopathy, and hemolytic anemia. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; REPORTER COMMENTS: Treatment - Yes Plasmapheresis started on 20-Jul Evolution of the ADR - Recovering Examinations - See lab outcomes in appendix ADR description - Acute pancreatitis on 17-Jul, most likely ethyl based. Edema, severe with development of acute renal (prerenal at underfilling, dd still also a factor TMA compare to infra). Progressive decrease in thrombocytes up to lowest point 9*10e9/L on 20-Jul, a lot of abnormal RBC morphology and fragments, ADAMTS13 still normal. Symptoms for hematologist suspect for secondary thrombocytopenic microangiopathy, either secondary to acute pancreatitis, or (although relatively late) from the vaccine. Also a symptom of limited hemolytic anemia. Considering that case reports of acute pancreatitis and TMA at the COVID vaccination have been described we are doing this report for the sake of completeness. Working diagnosis however is for the time being that it deals with a rare secondary TMA due to acute pancreatitis.; Sender''s Comments: V0: 20210808783-covid-19 vaccine ad26.cov2.s- Acute pancreatitis most likely ethyl based, edematous. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210808783-covid-19 vaccine ad26.cov2.s-thrombocytopenia, hemolytic anemia, acute kidney, need for plasmapheresis, abnormal rbc morphology and fragments, secondary thrombocytopenic microangiopathy. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1544804 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9094 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemic; Food allergy; Gastric bypass; Kidney stones
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100963129

Write-up: SEIZURE; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Jul2021 15:15 (Lot Number: FA9094) at the age of 40 years, as dose 1, single for covid-19 immunisation. Medical history included gastric bypass, patient. kidney stones, anemic, allergy to coconut and codein, all from an unknown date and unknown if ongoing. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient''s concomitant medications were not reported. The patient experienced seizure on 17Jul2021 13:00. The patient was hospitalized for seizure for 1 days. The outcome of the event was not recovered.


VAERS ID: 1545797 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fibrin D dimer, Jugular vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon metastatic (an adenocarcinoma of the sigmoid colon is known, which is now questionably metastasizing in lungs); Metastasis in lung (an adenocarcinoma of the sigmoid colon is known, which is now questionably metastasizing in lungs)
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: CT chest + cervical vessels; Result Unstructured Data: Test Result:Thrombus detection; Test Date: 20210717; Test Name: D-Dimer; Result Unstructured Data: Test Result:612 ug/L; Comments: Fibrin D dimer increased
CDC Split Type: DEPFIZER INC202100989599

Write-up: Left external jugular vein thrombosis; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100140728. A 66-year-old female patient received COMIRNATY (mRNA TOZINAMERAN, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 14Jul2021 at the age of 66-years-old as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included adenocarcinoma of the sigmoid colon is known, which was questionably metastasizing in the lungs from an unspecified date. The patient''s weight and height were not reported. No concomitant medications were reported. The patient previously took first dose of historical vaccine, COMIRNATY on an unspecified date in 2021 as single dose for covid-19 immunisation. On 17Jul2021, the patient experienced Jugular vein thrombosis which resulted in hospitalization. The patient underwent lab tests and procedures which included CT chest + cervical vessels (computerised tomogram): thrombus detection on 18Jul2021, D-Dimer (fibrin d dimer): 612 ug/l, Fibrin D dimer increased on 17Jul2021. This case was reported as serious with hospitalization. Relatedness of drug to reactions/events was reported as Unclassifiable. The patient''s outcome was not recovered/not resolved for Jugular vein thrombosis. Sender Comment: In addition, an adenocarcinoma of the sigmoid colon is known, which is now questionably metastasizing in the lungs. If necessary, a connection can also be seen here. However, it is questionable whether these are really metastases. Did the symptoms of the above-mentioned suspected vaccination complication occur again in the patient without a temporal connection to the mentioned vaccination ?: No Was outpatient treatment required ?: No. Relatedness of drug to reactions/events Source of assessment: ADR Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained


VAERS ID: 1546044 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: Levothyroxine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100960217

Write-up: Lymphadenopathy cervical; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-948180. A 35-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left on 15Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism. Patient has not had COVID-19. Concomitant medication included levothyroxine sodium taken for hypothyroidism from 01Apr2021 to an unspecified stop date. The patient experienced lymphadenopathy cervical, reported as medically significant, on 17Jul2021. She discovered that she had an infarcted node in the left cervical area above her clavicle 24 hours ago. Today she had another node more affected in the left cervical area more cranial to the previous one. The inoculation point was in her left arm and apparently there was no infarction of the axillary ganglia on the left side or any other explorable ganglion except those already indicated. According to the vaccine leaflet this can occur in 1/100 patients but she does not know if this is serious or not. Although if it persisted, she would go to the doctor, she believed it was her obligation to report it. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1546053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Generalised oedema, Pain in extremity, Vaccination site lymphadenopathy, Vaccination site oedema, Vaccination site pain
SMQs:, Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100955072

Write-up: Vaccination site lymphadenopathy; Vaccination site oedema; Vaccination site pain; diffuse edema, prolonged by the side of the left chest, and by the inner side of the left arm; painful, indurated swelling appeared in the left armpit; painful which reached the forearm; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authrity-WEB, regulatory authority number ES-AEMPS-951516. A 33-year-old female patient received first dose of BNT162B2 (COMIRNATY) (Lot Number: FD9309) intramuscular in left arm single dose for COVID-19 immunisation on 16Jul2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced vaccination site lymphadenopathy, vaccination site oedema and vaccination site pain all on 17Jul2021 (medically significant) with outcome of recovering. At 24h of the puncture (17Jul2021), a painful, indurated swelling appeared in the left armpit, the size of a tennis ball. Since then, the swelling had become diffuse edema, had been prolonged by the side of the left chest, and by the inner side of the left arm; also painful which reached the forearm. Treatment included: Anti-inflammatories (ENANTYUM 25mg every 6h) for pain control. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-07-17
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Eosinophil count, Fibrin D dimer, Gamma-glutamyltransferase, General physical health deterioration, Haemoglobin, Heart rate, International normalised ratio, Investigation, Lymphocyte count, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin level, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COLCHICINA; AMLODIPINE; LOSARTAN; PARACETAMOL; OMEPRAZOLE; OPTOVITE B12; TAMSULOSINA [TAMSULOSIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Bone decalcification; Chondrocalcinosis; Crutch user; Deep vein thrombosis (Probable event of TVD Right upper limb); Dyspepsia; Haematuria (Repetitive episodes); Hearing loss (Severe, with hearing aid); Hypertension (Cardiovascular risk factor); Hyperuricemia; Non-smoker; Radius fracture (Distal end of the right radius(chronic radial insufficiency)); Surgical intervention (right clavicle); Syncope; Tremor; Vitiligo
Allergies:
Diagnostic Lab Data: Test Name: Activated partial thromboplastin time; Test Result: 30 s; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:1.02; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:33.00 IU/l; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:58.0 IU/l; Test Name: Basophils; Result Unstructured Data: Test Result:0.0; Comments: 10E3/microL; Test Name: Arterial bicarbonate; Result Unstructured Data: Test Result:24.100 mmol/L; Test Name: Total bilirubin; Test Result: 0.80 mg/dl; Test Name: Chloride; Result Unstructured Data: Test Result:106.00 mmol/L; Test Name: Creatinine; Test Result: 1.26 mg/dl; Test Name: fIBRINOGEN; Test Result: 736.0 mg/dl; Test Name: Glucose; Test Result: 110.00 mg/dl; Test Name: Lactatodehydrogenase; Result Unstructured Data: Test Result:406 IU/l; Test Name: Calculated osmolality; Result Unstructured Data: Test Result:298; Comments: mOsm/kg; Test Name: Potasium; Result Unstructured Data: Test Result:4.30 mmol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:129/79 mmHg; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Name: Urea; Test Result: 59.00 mg/dl; Test Name: Chest x ray; Result Unstructured Data: Test Result:bilateral infiltrators; Comments: Costophrenic angles free. Preserved cardiothoracic index. Compared to previous.; Test Name: C-reactive protein; Test Result: 250 mg/dl; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.1; Comments: 10E3/microL; Test Name: D-dimer; Result Unstructured Data: Test Result:1525.0 ng/ml; Comments: immunotrubidimetry; Test Name: gamma-Glutamyltransferase; Result Unstructured Data: Test Result:60 IU/l; Test Name: Hemoglobin; Result Unstructured Data: Test Result:16.5 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:85; Comments: BPM; Test Name: International normalized ratio; Result Unstructured Data: Test Result:1.03; Comments: R.N; Test Name: Abdominal; Result Unstructured Data: Test Result:Positive hydro-aircraft noises; Comments: Soft, discomfort to palpation on the left flank, no masses or megalias, no signs of permanent disability; Test Name: Cardiac investigation; Result Unstructured Data: Test Result:very muted heart tones; Comments: it hinders the auscultation respiratory noises. Rhythmic radial pulse.; Test Name: Lower limb; Result Unstructured Data: Test Result:no edema or signs of Deep Vein Thrombosis.; Test Name: Pulmonary investigation; Result Unstructured Data: Test Result:Preserved vesicular murmur; Comments: scattered roncus, bilateral crackles at bases.; Test Name: SEIMC-SCORE; Result Unstructured Data: Test Result:High risk; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.4; Comments: 10E3/microL; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:96.2; Comments: FL; Test Name: Monocytes; Result Unstructured Data: Test Result:0.1; Comments: 10E3/microL; Test Name: Neutrophils; Result Unstructured Data: Test Result:4.0; Comments: 10E3/microL; Test Name: Saturation; Test Result: 93 %; Test Name: Arterial CO2 partial pressure; Result Unstructured Data: Test Result:32.600 mmHg; Test Name: pH arterial; Result Unstructured Data: Test Result:7.477; Test Name: Platelet; Result Unstructured Data: Test Result:79; Comments: 10E3/microL; Test Name: Arterial O2 partial pressure; Result Unstructured Data: Test Result:58.600 mmHg; Test Name: Prothrombin activity; Test Result: 94 %; Test Name: Prothrombin time; Test Result: 12.0 s; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30; Comments: BPM; Test Date: 20210727; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: ct-20; Test Name: Leukocytes; Result Unstructured Data: Test Result:4.68; Comments: 4.68 x10E3/microL
CDC Split Type: ESPFIZER INC202100987815

Write-up: COVID-19 pneumonia; vaccination failure; deteriorating general condition; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number is ES-AEMPS-958345. A 93-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: ET3620), intramuscular on 23Mar2021 as dose 2, single for covid-19 immunization and received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EP2166) intramuscular on 26Feb2021 as dose 1, single for covid-19 immunisation. Medical history included syncope from 2014 to an unknown date (Syncope of repetition, 7 years ago) , deep vein thrombosis from 2016 to an unknown date- Probable event of TVD Right upper limb, benign prostatic hyperplasia, hypertension(Cardiovascular risk factor), haematuria - repetitive episodes, hyperuricaemia, hearing loss-Severe, with hearing aid , tremor, dyspepsia, vitiligo, Chondrocalcinosis, Surgical intervention- right clavicle, Calcification in shoulder and Fracture of radius- Distal end of the right radius(chronic radial insufficiency). Patient had no known drug reaction, Non-smoker, Hypertension, No Diabetes mellitus type 2, No Dyslipidemias. Baseline: Partially dependent basic activities of daily living. He lived with a caregiver at home. Walked with the help of a crutch. Concomitant medications included colchicine (COLCHICINA) 0.5mg 2 dosage forms daily; amlodipine (AMLODIPINE) 5mg once daily ; losartan (LOSARTAN) 50mg once daily ; paracetamol (PARACETAMOL)1g, thrice daily; omeprazole (OMEPRAZOLE) 20mg once daily; cyanocobalamin (OPTOVITE B12) 1 monthly; tamsulosina [tamsulosin] (TAMSULOSINA [TAMSULOSIN]) 0.4 mg once daily. The patient experienced Covid-19 pneumonia and vaccination failure on 17Jul2021; dyspnea, fever and cough with expectoration on an unspecified date. A 93-year-old COVID+ male attending the emergency room for dyspnea and deteriorating general condition. Anamnesis complicated by hearing loss. His caregiver reported that he started symptoms on day 17Jul2021 with a positive antigenic test at home on day 18Jul2021. He commented cough with expectoration (he did not know how to specify color), dyspnea of minimal efforts. Fever up to 38C. No diarrhea. It denied chest pain or palpitations. No headache. No nausea or vomiting. Non-clinical urination. Last deposition 2 days ago without pathological features. No other accompanying symptomatology. Good general condition. Conscious, partially oriented. Mild mucocutaneous dehydration, normocoloracion and normoperfundido. Tachypneic at 30 rpm.Pulmonary auscultation: Preserved vesicular murmur, dispersed roncus, bilateral crackles in bases. Abdomen: Positive hydro-aircraft noises. Soft, discomfort to palpation on the left flank, no masses or megalias, no signs of permanent disability. Lower limbs: no edema or signs of Deep Vein Thrombosis. Diagnostic impression was respiratory infection covid19+. CLINICAL TRIAL: Moderate bilateral COVID19+ pneumonia. Brescia 1. SEIMC-SCORE 25 (very high risk). Acute respiratory failure with secondary respiratory alkalosis. Watered-down renal failure of probable pre-renal origin with data on dehydration in the context of the above. Thrombocytopenia and moderate lymphopenias in this context. COVID treatment: dexamethasone 6 mg/24h + enoxaparin 40 mg/24h + Omeprazole 20 mg/24h. REASON FOR ADMISSION: Dyspnea.SARS-COV-2 PCR: Positive (Ct - 20). EVOLUTION 27Jul2021. A 93-year-old male without cognitive impairment, with anatomy pathology of hypertension, benign prostatic hyperplasia; chondrocalcinosis, v?tiligo. Admitted to Internal Medicine for: Bilateral pneumonia COVID19. Brescia 1. SEIMC-SCORE 25. Partial acute respiratory insufficiency. Acute renal failure, of probable pre-renal origin. Thrombocytopenia and moderate lymphopenias.Vaccinated with double doses of Pfizer (last dose on 21Mar2021). Treatment received with Dexamethasone 4 mg from 26Jul2021. Medical evolution: Stable from the respiratory point of view. To the eupneic pass, it denied dyspnea or chest pain, although if it was presented recurrent cough without expectoration. Afebrile. No gastrointestinal clinic. Significant mucocutaneous dryness. The scan features dry crackles in baess and right midfield. plan- Before data of dehydration, antihypertensive withdrawal (it had already been given today) and initiation of serum therapy since the patient did not have easy access to water intake. - Analytical control tomorrow. - Withdrawal colchicine (no indication). UNCHANGED COVID treatment. ITC PHARMACOLOGY: The system was collected and notified of the vaccine failure. On an unspecified date, the patient underwent lab tests and procedures which included activated partial thromboplastin time: 30 seconds(Range 23 to 36) , activated partial thromboplastin time ratio: 1.02 (range 0.8 -1.25), alanine aminotransferase: 33.00 IU/l(range 6-40 IU/I), aspartate transaminase: 58.0 IU/l(range 6-40 IU/I), basophil count: 0.0 10E3/microL(range 0-0.2) , arterial bicarbonate: 24.100 mmol/l (range 22-28 mmol/L), Total bilirubin: 0.80 mg/dl (range 0.3-1.1mg/dl), chloride: 106.00 mmol/l (101-111mmol/L), Creatinine: 1.26 mg/dl (0.6-1.2 mg/dl), fibrinogen: 736.0 mg/dl (200-400 mg/dl), glucose: 110.00 mg/dl(60-100 mg/dl), Lactatodehydrogenase: 406 IU/I (120-246 IU/I), Calculated osmolality: 298mOsm/kg , potassium: 4.30 mmol/L (3.5-5 mmol/L), blood pressure measurement: 129/79 mmhg, Sodium 141 mmol/L (135-145 mmol/L), Urea 59mg/dl (21-50mg/dl), Chest X-ray: bilateral infiltrators- Costophrenic angles free. Preserved cardiothoracic index. Compared to previous, C-reactive protein: 250 mg/dl( 0.1-10mg/dl), Eosinophils: 0.1 10E3/microL (0-0.4), D-dimer: 1525 ng/ml (0-500 ng/ml)-immunotrubidimetry, gamma-Glutamyltransferase: 60 IU/l (8-61 IU/l), Hemoglobin: 16.5g/dl (12-17 g/dl), heart rate: 85 BPM, International normalized ratio: 1.03 RN(0.8-1.2), Abdominal Investigation: Positive hydro-aircraft noises- Soft, discomfort to palpation on the left flank, no masses or megalias, no signs of permanent disability; Cardiac investigation: very muted heart tones- it hinders the auscultation respiratory noises. Rhythmic radial pulse, Lower limb Investigation: no edema or signs of Deep Vein Thrombosis, Pulmonary investigation: Preserved vesicular murmur: scattered roncus, bilateral crackles at bases, SEIMC-SCORE Investigation: High risk, Lymphocytes :0.4 10E3/microL(1.2-4.0), Mean corpuscular volume 96.2 FL (82-97), Monocytes 0.110E3/microL(0.2-1.0), Neutrophils 410E3/microL(1.5-7.5), Saturation 93%, Arterial CO2 partial pressure 32.600mmHg (35-45mmHg), pH arterial 7.477(7.35-7.45), Platelet 7910E3/microL(150-400), Arterial O2 partial pressure 58.600mmHg(90-100mmHg), Prothrombin activity 94%(70-120%), Prothrombin time 12sec(9.5-14sec), Respiratory rate 30BPM, Leukocytes: 4.68 x10E3/microL(4-11.5) and Covid-19 PCR test: Positive ct-20 on 27Jul2021. Therapeutic measures were taken as a result of covid-19 pneumonia, dyspnea, fever, cough with expectoration (Dexamethasone 4 mg since 26Jul2021). Events Covid-19 pneumonia and vaccination failure were considered as Serious (hospitalization, life threatening) with outcome of not resolved and event deteriorating general condition was not recovered. Follow-up attempt are not possible. No expected further information


VAERS ID: 1546080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-07-17
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 antigen test positive; Test Result: Positive
CDC Split Type: ESPFIZER INC202100994722

Write-up: COVID-19 antigen test positive; vaccination failure; Headache; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number ES-AEMPS-960685. A 82-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EW6326), dose 2 intramuscularly on 30Apr2021 as, 0.3 ml, single, dose 1 (Batch/Lot Number: EW2239) intramuscularly on 09Apr2021 as 0.3 ml, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Jul2021 the patient experienced Covid-19, vaccination failure, febricula and headache. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 17Jul2021. The outcome of the events febricula and headache recovered on 18Jul2021 while for Covid-19 and vaccination failure it was unknown. No follow-up attempts possible. No further information expected. Lot/batch number was provided.


VAERS ID: 1546195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypercholesterolaemia; Hypertension arterial
Preexisting Conditions: Comments: Diabetes Hypercholesteromia Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: SARS-CoV-2 test; Result Unstructured Data: Negative
CDC Split Type: FRJNJFOC20210816021

Write-up: PULMONARY EMBOLISM; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-LL20215230] concerned a 66 year old female. The patient''s weight was 98 kilograms, and height was not reported. The patient''s concurrent conditions included Hypercholesterolaemia, diabetes, and hypertension arterial. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 21C 13-02 expiry: unknown) 1 dosage forms, 1 total administered on 23-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced pulmonary embolism, and was hospitalized on an unspecified date for unspecified days. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210816021-Covid-19 vaccine -Pulmonary embolism. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE


VAERS ID: 1546270 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus test, Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Bartonellosis, Blood alkaline phosphatase, Blood creatinine, Brucellosis, C-reactive protein, Cytomegalovirus test, Echocardiogram, Electrocardiogram, Enterovirus test negative, Eosinophil count, Epstein-Barr virus test, Exercise electrocardiogram, Gamma-glutamyltransferase, HIV test negative, Haemoglobin, Hepatitis B virus test, Hypogammaglobulinaemia, Interferon gamma release assay, Investigation, Lyme disease, Mumps, Mycoplasma test, Myocarditis, Neutrophil count, Parvovirus B19 test, Platelet count, Q fever, Rubella, SARS-CoV-2 test negative, Toxoplasmosis, Troponin T, Tumour marker test, Urine analysis normal, Varicella virus test negative, White blood cell count
SMQs:, Oropharyngeal infections (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL]
Current Illness: Tabaquism (10 cigarettes/day)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Asthma; Fracture multiple; Operation NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: adenovirus; Test Result: Negative ; Test Date: 20210718; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: Coronary computed tomographic angiography; Result Unstructured Data: Test Result:healthy coronary arteries; Test Date: 20210718; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:1.7N; Test Date: 20210718; Test Name: bartonellosis; Result Unstructured Data: Test Result:in progress; Test Date: 20210718; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: creatinine; Result Unstructured Data: Test Result:85 umol/l; Comments: i.e. Glomerular filtration rate at 111 ml/min/1.73m2; Test Date: 20210718; Test Name: brucellosis; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: C-reactive protein; Result Unstructured Data: Test Result:84.2 mg/l; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:71.8 mg/l; Test Date: 20210720; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210721; Test Name: C-reactive protein; Result Unstructured Data: Test Result:10.9 mg/l; Test Date: 20210718; Test Name: Cytomegalovirus; Test Result: Negative ; Test Date: 20210718; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:no pericardial effusion, left ventricle; Comments: non-dilated, not hypertrophied, with lateral hypokinesia, left ventricular ejection fraction 55 percent trivial mitral insufficiency; no aortic valvular heart disease; normal straight cavities, systolic pulmonary artery pressure at 23 mmHg; Test Date: 20210722; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:left ventricular ejection fraction; Comments: 55-60 percent with very slight lateral hypokinesia, velocity time interval ssAo 18cm, cardiac output unchanged; Test Date: 20210718; Test Name: Electrocardiography; Result Unstructured Data: Test Result:sinus rhythm, normal QRS complexes; Comments: diffuse infero-lateral concave ST-segment elevation, normal positive T waves; Test Date: 20210719; Test Name: Electrocardiography; Result Unstructured Data: Test Result:regular sinus rhythm, normal QRS complexes; Comments: N axis, sus-ST persistence in V5V6 and below, negative T wave in augmented Vector Left, QTc at 412 ms; Test Date: 20210720; Test Name: Electrocardiography; Result Unstructured Data: Test Result:70 bpm, regular sinus rhythm; Comments: normal QRS complexes, N axis, ST-elevation 1 mm in V6 and below, negative T wave in augmented Vector Left, QTc at 412 ms.; Test Date: 20210721; Test Name: Electrocardiography; Result Unstructured Data: Test Result:63 bpm, regular sinus rhythm; Comments: normal QRS complexes, N axis, ST-segment elevation 1mm from V3 to V4 and below, negative T wave augmented Vector Left and V6, QTc 408ms; Test Date: 20210722; Test Name: Electrocardiography; Result Unstructured Data: Test Result:60 bpm, regular sinus rhythm; Comments: normal QRS complexes, N axis, light persistence ST-elevation 1mm V3, QTc 387ms; Test Date: 20210718; Test Name: Enterovirus; Test Result: Negative ; Test Date: 20210718; Test Name: eosinophil polynuclear; Result Unstructured Data: Test Result:0.2 g/l; Test Date: 20210718; Test Name: Epstein-Barr virus; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: Treadmill test; Result Unstructured Data: Test Result:2 isolated ventricular extrasystoles; Test Date: 20210720; Test Name: Treadmill test; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210721; Test Name: Treadmill test; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210722; Test Name: Treadmill test; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210718; Test Name: gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: haemoglobin; Result Unstructured Data: Test Result:15.3 g/dl; Test Date: 20210718; Test Name: Hepatitis B virus; Test Result: Negative ; Test Date: 20210718; Test Name: Human Immunodeficiency Virus; Test Result: Negative ; Test Date: 20210719; Test Name: Hypogammaglobulinemia; Result Unstructured Data: Test Result:moderate on protein; Comments: electrophoresis; Test Date: 20210718; Test Name: QUANTIFERON test; Test Result: Negative ; Test Date: 20210719; Test Name: Auto-immune assessment; Result Unstructured Data: Test Result:cartilage-specific proteoglycan; Comments: core protein negative; Test Date: 20210718; Test Name: Clinical examination; Result Unstructured Data: Test Result:normo-cardial, normotensive and afebrile; Comments: patient, absence of murmurs or signs of cardiac insufficiency, rest of the exam unremarkable; Test Date: 20210719; Test Name: clinically; Result Unstructured Data: Test Result:no chest pain but persistent sensation; Comments: of chest discomfort, regular heart sounds without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right ventricular failure; Test Date: 20210720; Test Name: clinically; Result Unstructured Data: Test Result:no chest pain, no particular complaint; Comments: regular heart sounds without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right ventricular failure; Test Date: 20210721; Test Name: clinically; Result Unstructured Data: Test Result:no chest pain, no particular complaint; Comments: unremarkable cardiopulmonary auscultation, no sign of right ventricular failure or left ventricular failure; Test Date: 20210722; Test Name: clinically; Result Unstructured Data: Test Result:no particular complaint, regular; Comments: heart sounds without breath, peripheral pulses +/+, soft calves, no right ventricular failure or left ventricular failure, vesicular murmur +/+, clear and symmetrical pulmonary auscultation; Test Date: 20210718; Test Name: Lyme; Test Result: Negative ; Test Date: 20210718; Test Name: mumps; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: Mycoplasma pneumoniae; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: neutrophils; Result Unstructured Data: Test Result:5.15 g/l; Test Date: 20210718; Test Name: Parvovirus B19; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: Parvovirus B19; Test Result: Negative ; Test Date: 20210718; Test Name: platelets; Result Unstructured Data: Test Result:244 g/l; Test Date: 20210718; Test Name: coxiellosis; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: rubella; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 20210718; Test Name: toxoplasmosis; Test Result: Negative ; Test Date: 20210718; Test Name: Troponin T; Result Unstructured Data: Test Result:516 ng/L; Test Date: 20210719; Test Name: Troponin T; Result Unstructured Data: Test Result:678 ng/L; Test Date: 20210720; Test Name: Troponin T; Result Unstructured Data: Test Result:699 ng/L; Test Date: 20210721; Test Name: Troponin T; Result Unstructured Data: Test Result:820 ng/L; Test Date: 20210722; Test Name: Troponin T; Result Unstructured Data: Test Result:312 ng/L; Test Date: 20210719; Test Name: Tumour markers; Result Unstructured Data: Test Result:angiotensin-converting enzyme; Comments: alpha-fetoprotein, Cancer Antigen19-9 and total Prostate-specific antigen were all normal; Test Date: 20210718; Test Name: Cytobacteriological urine examination; Result Unstructured Data: Test Result:no leukocyturia; Comments: but 10 4 Serratia marcescens (asymptomatic patient); Test Date: 20210718; Test Name: varicella zoster virus; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: white blood cells; Result Unstructured Data: Test Result:9.66 g/l
CDC Split Type: FRPFIZER INC202100966883

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority report number FR-AFSSAPS-SE20211863. A 24-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number FE7010), intramuscularly administered in arm left on 15Jul2021 (day 0) as dose 2, single for covid-19 immunisation. Medical history included asthma, allergic rhinitis, fracture multiple, multi-operated fractures of the left thumb and left foot and, ongoing tabaquism (10 cigarettes/day). Concomitant medication included salbutamol (VENTOLIN) taken for an unspecified indication, start and stop date were not reported. The patient was not at risk of developing a severe form of covid-19. The patient has no history of COVID-19. The patient experienced myocarditis on 17Jul2021. Description: Day 2 (17Jul2021): Onset of symptoms in the evening with a sensation of hyperalgic retrosternal burning, tightness of the chest with irradiation until the left elbow. Call to telemedicine doctors and patient was advised to take paracetamol and go to the Emergency Room if the pain persists. Day 3 (18Jul2021): Patient comforted by taking paracetamol, not having been to Emergency Room and having gone to work. Far more intense recurrence of the retrosternal chest pain with irradiation in the arm in the evening, this time leading the patient to seek a consultation at the Emergency Room. Clinical examination upon admission (18Jul2021): normo-cardial, normotensive and afebrile patient, absence of murmurs or signs of cardiac insufficiency, rest of the exam unremarkable. Constrictive chest pain unrelated to exertion rated at 5/10 (taking paracetamol 1 hour 30 minutes before the examination). Electrocardiography (18Jul2021): sinus rhythm, normal QRS complexes, diffuse infero-lateral concave ST-segment elevation, normal positive T waves. Blood tests (18Jul2021) included: creatinine at 85 umol/l i.e. Glomerular filtration rate at 111 ml/min/1.73m2; haemoglobin at 15.3 g/dl; white blood cells at 9.66 G/l with neutrophils at 5.15 G/l and eosinophil polynuclear at 0.2 G/l; platelets at 244 G/l; troponin T at 516 ng/l, C-reactive protein at 84.2 mg/l; aspartate aminotransferase at 1.7N; alanine aminotransferase: unknown results, alkaline phosphatase: unknown results and gamma-glutamyltranspeptidase: unknown results. N trans-thoracic echocardiography (18Jul2021): no pericardial effusion, left ventricle non-dilated, not hypertrophied, with lateral hypokinesia, left ventricular ejection fraction 55 percent trivial mitral insufficiency; no aortic valvular heart disease; normal straight cavities, systolic pulmonary artery pressure at 23 mmHg. Cardiac Magnetic Resonance Imaging: pending, scheduled for 18Aug2021. No myocardial biopsy. Diagnosis of myocarditis. Administration of ASPEGIC 1g. The patient was sent to Cardiac Intensive Care Unit. DIFFERENTIAL DIAGNOSIS: Septic workup (18Jul2021): Polymerase Chain Reaction Covid-19, Cytomegalovirus, adenovirus, Parvovirus B19 and Enterovirus were all negative. Human Immunodeficiency Virus, Hepatitis B virus, Lyme and toxoplasmosis serologies were all negative on 18Jul2021. Serologies varicella zoster virus, cytomegalovirus, rubella, Epstein-Barr virus, mumps, Parvovirus B19, Mycoplasma pneumoniae, bartonellosis, coxiellosis and brucellosis were in progress on 18Jul2021 (unknown results). Sterile blood cultures in 24 hours. Cytobacteriological urine examination (18Jul2021): no leukocyturia but 10 4 Serratia marcescens (asymptomatic patient). Negative QUANTIFERON test on 18Jul2021. Coronary computed tomographic angiography (19Jul2021): healthy coronary arteries. Auto-immune assessment (19Jul2021): cartilage-specific proteoglycan core protein negative. Tumour markers (19Jul2021): angiotensin-converting enzyme, alpha-fetoprotein, Cancer Antigen19-9 and total Prostate-specific antigen were all normal. Moderate Hypogammaglobulinemia on protein electrophoresis on 19Jul2021. OUTCOME: Day 4 (19Jul2021): Troponin T rises to 678 ng/l, C-reactive protein lowering to 71.8 mg/l. Treadmill test (19Jul2021): 2 isolated ventricular extrasystoles. Electrocardiography (19Jul2021): regular sinus rhythm, normal QRS complexes, N axis, sus-ST persistence in V5V6 and below, negative T wave in augmented Vector Left, QTc at 412 ms. Clinically (19Jul2021): no chest pain but persistent sensation of chest discomfort, regular heart sounds without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right ventricular failure. Day 5 (20Jul2021): troponin T at 699 ng/l, C-reactive protein reduced to 30 mg/l. Treadmill test (20Jul2021): Nothing to report. Electrocardiography (20Jul2021): 70 bpm, regular sinus rhythm, normal QRS complexes, N axis, ST-elevation 1 mm in V6 and below, negative T wave in augmented Vector Left, QTc at 412 ms. Clinically (20Jul2021): no chest pain, no particular complaint, regular heart sounds without breath, peripheral pulses +/+, soft and painless calves, no lower limb oedema, no sign of right ventricular failure or right ventricular failure. Day 6 (21Jul2021): Troponin T rises to 820 ng/l, C-reactive protein still lowering to 10.9 mg/l. Treadmill test (21Jul2021): Nothing to report. Electrocardiography (21Jul2021): 63 bpm, regular sinus rhythm, normal QRS complexes, N axis, ST-segment elevation 1mm from V3 to V4 and below, negative T wave augmented Vector Left and V6, QTc 408ms. Clinically (21Jul2021): no chest pain, no particular complaint, unremarkable cardiopulmonary auscultation, no sign of right ventricular failure or left ventricular failure. Day 7 (22Jul2021): troponin T lowering to 312 ng/l. Treadmill test (22Jul2021): Nothing to report. Electrocardiography (22Jul2021): 60 bpm, regular sinus rhythm, normal QRS complexes, N axis, light persistence ST-elevation 1mm V3, QTc 387ms. Clinically (22Jul2021): no particular complaint, regular heart sounds without breath, peripheral pulses +/+, soft calves, no right ventricular failure or left ventricular failure, vesicular murmur +/+, clear and symmetrical pulmonary auscultation. Trans-thoracic echocardiography check-up (22Jul2021): left ventricular ejection fraction 55-60 percent with very slight lateral hypokinesia, velocity time interval ssAo 18cm, cardiac output unchanged. Day 8 (23Jul2021): Discharge from hospital. CONCLUSION: Myocarditis on Day 2 of Dose 2 of COMIRNATY in a 24-year-old asthmatic male patient who smokes with no cardiac history, with elevation of troponin T and C-reactive protein, ST segment elevation on electrocardiography, 55 percent left ventricular ejection fraction with lateral hypokinesia on trans-thoracic echocardiography and pending cardiac Magnetic Resonance Imaging. Hospitalisation from Day 3 (18Jul2021) to Day 8 (23Jul2021). Complete file. The patient was recovering from myocarditis. Note Accountability without prejudice to the elements of investigation which could be carried out as part of legal or amicable compensation procedures. Therapie 1985, 40: 111-8. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Dizziness, Influenza like illness, Malaise, Myalgia, Oxygen saturation, Pain in extremity, Pyrexia, Tremor, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPEGIC; DESOGESTREL BIOGARAN; MIGPRIV
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Functional bowel syndrome; Malaise; Migraine headache
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: FRPFIZER INC202100966871

Write-up: vertigo; tremors of the limbs; pain in the legs; asthenia; fever of 39?C; muscle ache +++; Influenza like illness/flu-like syndrome/influenza syndrome; Malaise; Giddiness/feeling of dizziness; This is a spontaneous report received from a contactable consumer downloaded from the Medicine Agency (MA) regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-ST20212940. A 32-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC1439), intramuscular on 16Jul2021 as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included malaise, functional bowel syndrome and migraine headache from an unknown date. Concomitant medications included acetylsalicylate lysine (ASPEGIC), desogestrel (DESOGESTREL BIOGARAN) and acetylsalicylate lysine, metoclopramide hydrochloride (MIGPRIV), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced influenza like illness/flu-like syndrome/influenza syndrome, malaise and giddiness/feeling of dizziness on 17Jul2021. The clinical course was as follows: At 7 hours post-injection, fever at 39 for 48 hours, vertigo, tremors of the limbs, inability to stand because of pain in the legs, asthenia. Called the general practitioner on 23Jul2021. Put the patient on Doliprane and Ibuprofen 400. The patient presented with a feeling of malaise, fever of 39?C, muscle ache +++. Oxygen saturation = 99%; blood pressure Normal. For her, typical flu-like syndrome. She was given a sick leave from work. The patient underwent lab tests and procedures which included blood pressure measurement: normal, body temperature: 39 centigrade and oxygen saturation: 99 %, all on an unspecified date. The events were assessed as serious and medically significant by the regulatory authority. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.


VAERS ID: 1546424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Contusion, Hypoaesthesia, Paraesthesia, Rash erythematous, Swelling, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE [FEXOFENADINE HYDROCHLORIDE]
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure monitor; Result Unstructured Data: Test Result:Unknown results; Comments: Blood pressure monitor with 24 hour cardiac device to follow
CDC Split Type: GBPFIZER INC202100969107

Write-up: bruising; numbness in arm; Red blotchy surface rash around vaccination; Red blotchy surface rash around vaccination; pins and needles which then spread all over body; Swelling; This is a spontaneous report from a contactable consumer. This is the first of two reports. This first report is a report received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202107281010038230-MCBYQ, Safety Report Unique Identifier GB-MHRA-ADR 25718975. A 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: fd5613) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing, suspected covid-19 from 10Mar2020 and ongoing, immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response and i.. (as reported)). The patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) on unspecified date for COVID-19 immunisation and experienced very lightheaded and tired. Patient did not have a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Concomitant medication included fexofenadine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient experienced bruising and numbness in arm on an unspecified date and swelling on 17Jul2021. The events were reported as serious (other medically important condition). The clinical course was reported as follows: red blotchy surface rash around vaccination. Painful swelling below vaccination and slight bruising in area for 1 day (as reported). Painful swelling under arm pit for several days. Numbness in arm and hand plus pins and needles which then spread all over body for a few days. Very light headed since first vaccination and constantly tired. Still have long lasting numbness and tingling in arm if slept that side. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent blood pressure monitor with 24-hour cardiac device to follow. The outcome of bruising and numbness in arm was recovering, for swelling was recovered with sequela and unknown for the events of red blotchy surface rash around vaccination and pins and needles. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100975971 Same patient/product,different dose & events


VAERS ID: 1546480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F08813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, Purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: GBPFIZER INC202100969217

Write-up: less/Purpura; Heart pounding; This is a spontaneous report from a contactable consumer or other non hcp received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107281446169700-MYZTO. Safety Report Unique Identifier GB-MHRA-ADR 25720825. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (also reported as "13Jul2001") (Batch/Lot Number: F08813) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 17Jul2021, the patient experienced heart pounding not more than a second or less, happens maximum 3 times a day or less, happens more when working, better when resting. The patient also experienced purpura on an unspecified date. The events were assessed as serious (medically significant). The outcome of the event purpura was recovered on an unspecified date and heart pounding was not recovered. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1547064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Asthenia, Cerebral infarction, Cold sweat, Computerised tomogram head, Dizziness, Eye disorder, Hemianopia homonymous, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Head CT angiography; Result Unstructured Data: Test Result:Impaired perfusion focus in right side. Penumbra.; Test Date: 20210717; Test Name: Head computed tomography; Result Unstructured Data: Test Result:Cerebral infarction. Left homonymous hemianopsia.
CDC Split Type: LTPFIZER INC202100973435

Write-up: Cerebral infarction; Left homonymous hemianopsia; Dizziness; Visual impairment: saw a white light; Cold sweat; Weakness; Field of vision defect; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-4219. A 29-year-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 intramuscular on 13Jul2021 as dose 1, 30 ug, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced cerebral infarction, left homonymous hemianopsia, dizziness, visual impairment: saw a white light, cold sweat, weakness, field of vision defect. The patient underwent lab tests and procedures which included angiogram: impaired perfusion focus in right side. Penumbra on 17Jul2021, computerized tomogram head: cerebral infarction. left homonymous hemianopsia on 17Jul2021. The events cerebral infarction and hemianopia homonymous resulted in hospitalization. The other events were non-serious. Therapeutic measures were taken as a result of cerebral infarction and left homonymous hemianopsia: Intravenous thrombolysis with Actilyse was done. The clinical outcome of the event''s Cerebral infarction left homonymous hemianopsia, visual impairment: saw a white light, field of vision defect was not resolved; dizziness, cold sweat, weakness was resolved on 17Jun2021. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.


VAERS ID: 1547239 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970556

Write-up: Fever; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300093036. A 19-year-old male patient received the dose of BNT162B2 (COMIRNATY; lot number: FD5996), intramuscular on 15Jul2021 (at the age of 19-years-old) at dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Jul2021 06:35 the patient experienced fever. The patient was hospitalized on Jul2021 due to the event. Outcome of the event was recovered on Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1554895 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210818889

Write-up: INTENSE FATIGUE WITH WORK INCAPACITY; MYALGIAS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-3996] concerned a 25 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced intense fatigue with work incapacity and myalgias. All these symptoms lasted for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense fatigue with work incapacity, and myalgias on 20-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0; 20210818889 -covid-19 vaccine ad26.cov2. Fatigue with work incapacity, and Myalgia. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1555680 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (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? 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: Body temperature; Result Unstructured Data: 36.7 before vaccination
CDC Split Type: JPTAKEDA2021TJP069657

Write-up: Syncope; Vasovagal reflex (cold sweat, weakness); This case was received via regulatory authority (Reference number: 2021TJP069657) on 28-Jul-2021 and was forwarded to Moderna on 05-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncope) in a 19-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reflex (cold sweat, weakness)). At the time of the report, SYNCOPE (Syncope) and PRESYNCOPE (Vasovagal reflex (cold sweat, weakness)) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.7 (normal) 36.7 before vaccination. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SYNCOPE (Syncope) and PRESYNCOPE (Vasovagal reflex (cold sweat, weakness)) to be possibly related. Concomitant medications was not reported. Treatment history was not reported On 17-Jul-2021, at 16:57, the patient received the 1st dose of this vaccination. At 17:17, vasovagal reflex, cold sweat, and weakness appeared, and the patient experienced transient syncope. The patient recovered on bed rest in the first-aid room. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1558030 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: degree Celsius
CDC Split Type: JPTAKEDA2021TJP069669AA

Write-up: Loss of consciousness; Fall (collapsed out of the chair); Vasovagal reflex; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in an 18-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), FALL (Fall (collapsed out of the chair)) and PRESYNCOPE (Vasovagal reflex). On 17-Jul-2021, LOSS OF CONSCIOUSNESS (Loss of consciousness), FALL (Fall (collapsed out of the chair)) and PRESYNCOPE (Vasovagal reflex) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.2 (normal) degree Celsius. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness), FALL (Fall (collapsed out of the chair)) and PRESYNCOPE (Vasovagal reflex) to be possibly related. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Takeda reporting. Events seriousness per assessment by Takeda; Reporter''s Comments: The event was considered as vasovagal reflex caused by intramuscular injection.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Takeda reporting. Events seriousness per assessment by Takeda


VAERS ID: 1575861 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Decreased appetite, Depression, Diarrhoea, Inappropriate schedule of product administration, Maternal exposure timing unspecified, Panic disorder, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977286

Write-up: loss of appetite; panic; Inappropriate schedule of vaccine administered; exposure during pregnancy; anxiety; diarrhea; Depression; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311446507440-MVCQZ, Safety Report Unique Identifier GB-MHRA-ADR 25737187. A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), single dose on 17Jul2021 (at the age of 35-year-old) as dose 2, single for COVID-19 immunisation. Medical history included depression, anxiety. Patient has not had symptoms associated with COVID-19. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Concomitant medication included venlafaxine taken for anxiety, start and stop date were not reported. The patient experienced anxiety (medically significant) on an unspecified date with outcome of unknown, diarrhea (medically significant) on an unspecified date with outcome of unknown, depression (medically significant) on 17Jul2021 with outcome of not recovered, loss of appetite (medically significant) on an unspecified date with outcome of unknown, panic (medically significant) on an unspecified date with outcome of unknown, inappropriate schedule of vaccine administered and exposure during pregnancy (non-serious) on an unspecified date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The patient underwent lab tests which included sars-cov-2 test: negative (No - Negative COVID-19 test) on unknown date. Additional information: Severe anxiety, panic and depression, loss of appetite, diarrhoea. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576633 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Malaise, Oropharyngeal pain, Panic attack
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic skin reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210822317

Write-up: ANAPHYLAXIS; FELT AIRWAY WAS CLOSING AND THAT BREATHING WAS COMPROMISED / DIFFICULTY BREATHING / BREATHING WAS AFFECTED; COULD NOT SWALLOW SALIVA; THOUGHT INITIALLY THAT PATIENT MIGHT BE JUST HAVING A PANIC ATTACK; THROAT VERY PAINFUL; FELT TERRIBLE; This spontaneous report received from a pharmacist via a Regulatory Authority [IE-HPRA-2021-080019] concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: allergic skin reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C18-05) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced anaphylaxis, felt airway was closing and that breathing was compromised / difficulty breathing / breathing was affected, could not swallow saliva, thought initially that patient might be just having a panic attack, throat very painful, felt terrible and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylaxis, felt airway was closing and that breathing was compromised / difficulty breathing / breathing was affected, could not swallow saliva, thought initially that patient might be just having a panic attack, throat very painful, and felt terrible. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210822317-Covid-Anaphylaxis. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210822317-Covid-19 vaccine ad26.cov2.s-Difficulty breathing, Unable to swallow, Panic attack, Feeling unwell, Throat pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1585682 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Blood pressure decreased, Blood pressure diastolic, Blood pressure systolic, Body temperature, Loss of consciousness, Malaise, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery (Thyroid cancer operated in 2015 year); Carcinoma papillary thyroid
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:50 mmHg; Test Date: 20210618; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:45 mmHg; Test Date: 20210618; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210618; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:75 mmHg; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210617; Test Name: Body temperature; Result Unstructured Data: Test Result: No fever
CDC Split Type: HRPFIZER INC202100997904

Write-up: Loss of consciousness; Blood pressure decreased (90/50; 75/45); Body temperature increased 38 degrees celsius; Malaise; Weakness; Strong pain in lumbosacral back area; This is a spontaneous report from a contactable consumer (patient), downloaded from the Medicines Agency (MA) EudraVigilance-WEB regulatory authority number HR-HALMED-300049995. An 18-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, on 17Jul2021 at 10:00, as 0.3 mL single dose (unspecified if dose 1 or 2), at the age of 18 years old, for COVID-19 immunisation. Medical history included papillary thyroid cancer until 2015 (surgery done in 2015). The patient''s concomitant medications were not reported. On 17Jul2021, at around 21:00, the patient felt strong pain in the lumbosacral part of her back, with weakness and malaise, without fever. She took a paracetamol (LUPOCET) tablet because of the pain. On 18Jul2021, around 4 o''clock at night, the patient experienced loss of consciousness while going to the toilet. On 18Jul2021, at 09:00 o''clock she loss of consciousness again, blood pressure was decreased to 90/50 mmHg, later in oxygenation at high pressure 75/45 mmHg (as reported), she had weakness. Half an hour later, body temperature increased to 38 degrees Celsius. The patient recovered from the 2 episodes of loss of consciousness, weakness, strong pain in the lumbosacral back area, pyrexia, malaise, and blood pressure decreased all on 18Jul2021. Loss of consciousness was reported as serious important medical event by the regulatory authority, while the other events were reported as non-serious. According to the regulatory authority HALMED, as per Causality method of assessment, events Weakness, Pyrexia, Malaise and Pain lumbosacral were probably/likely related to BNT162b2, while events Loss of consciousness and Blood pressure decreased were possibly related to BNT162b2.


VAERS ID: 1633864 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: non
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101038864

Write-up: Generalised urticaria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PC20212973. A 13-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 14Jul2021 (Lot Number: FE7010) as single dose (at the age of 13 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced generalised urticaria on 17Jul2021 with outcome of recovering. Seriousness criteria of the event was reported as medically significant.


VAERS ID: 1475178 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821281 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Dyspnoea, Headache, Hypoaesthesia, Influenza like illness, Muscle tightness, Throat irritation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt fine day of shot. Next day started to experience muscle tightening, flulike symptoms, scratchy throat, leg numbness, dizziness, cold sweats, shortness of breath and headaches. She was seeking care today, 7/15. I advised patient to go to hospital.


VAERS ID: 1476562 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Painful respiration
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Chest pain on the left side of sternum above nipple line, when inhaling.


VAERS ID: 1478005 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Feeling cold, Headache, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (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:
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, vomiting, muscular aches, headache, cold chills,


VAERS ID: 1478030 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 RA / SYR

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

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

Write-up: Golf ball sized lump appeared under right arm approximately 36 hours after injection. Very painful.


VAERS ID: 1478188 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

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

Write-up: Patient received first dose Pfizer on 7/14/21 with signed consent form indicating no previous COVID-19 vaccinations and/or treatment. Upon documentation of Pfizer dose, report of Janssen vaccine on 4/5/21 was found in the ImmTrac Reporting System. Patient was called and did not admit to receiving Janssen vaccine. Called Pfizer medical line (interaction #00336730) and no guidance given to administer second dose Pfizer.


VAERS ID: 1478197 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Patient reported numbness in the left side of head and neck within one hour following COVID-19 vaccination. Patient reported this to clinic via telephone and was advised to go to a local urgent care facility. No other information available at this time.


VAERS ID: 1478205 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Injection site paraesthesia, Loss of consciousness, Photopsia, 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), Retinal disorders (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec 10mg every day
Current Illness: None
Preexisting Conditions: Lyme Disease
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 12:00 Client received Pfizer #1 12:01 Client felt tingling in his injection arm 12:02 Client felt lightheaded, black flashes in his vision, and then had full syncope 12:02 Client came to in the chair in observation and felt sweaty but improving. 12:03 Client moved to a cot where he recovered fully over the next 20 minutes.


VAERS ID: 1478232 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Feeling hot, 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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: allergic to pork
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports feeling hot and warm all over body. Reported itching on palms of hands, nurse noticed sizable welts. Patient contacted his PCP and PCP recommended giving patient 2 doses of Benadryl. Patient was given 2 doses of Benadryl per PCP request and reported feeling better.


VAERS ID: 1478285 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Muscle tightness, Muscle twitching, Pallor, Presyncope, Sneezing, Torticollis, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: No more than 60 seconds or so after vaccine was administered, patient stopped responding verbally then his head tilted backwards (seemed to be vasovagal response). Held patient''s head upright so that he did not hit his head on wall and applied ice pack to the back of his neck. Patient twitched, sneezed, then muscles tensed and then relaxed. He came to not 45 seconds after initially losing consciousness. Patient was very pale and sweaty. He asked for water and sat for 5 minutes or so. Patient said he was then feeling a bit lightheaded so we gave some orange juice. 5 more minutes passed and he said he was feeling much better. Patient described feeling very dizzy and not being able to hear clearly before losing consciousness


VAERS ID: 1478291 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Polydipsia, Polyuria
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Tubulointerstitial diseases (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Polydipsia and subsequent polyuria


VAERS ID: 1478292 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T032315 / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin and Melatonin 2.5mg to sleep, Ibuprofen PRN
Current Illness: None
Preexisting Conditions: None
Allergies: NONE
Diagnostic Lab Data: NOne
CDC Split Type:

Write-up: NO adverse event at the time of this report filing. Patient got 1/6th dose of the Varicella (Varivax)


VAERS ID: 1478299 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: PATIENT BECAME LIGHTHEADED, DIZZY, SWEATY, AND SLIGHTLY NAUSEATED WITHIN 1 MINUTE OF RECEIVING COVID PFIZER VACCINE. VITALS TAKEN: BP = 98/62, PULSE = 92, O2 SAT = 100%. PATIENT WAS LAID DOWN ON BENCH WITH FEET ELEVATED AND DRANK GLASS OF APPLE JUICE AND WATER. PATIENT REPORTED RELIEF OF SYMPTOMS AFTER 5-10 MINUTES OF LYING DOWN. PATIENT SAT UP IN CHAIR FOR 5 MINUTES BEFORE ALLOWED TO STAND UP AND WALK ABOUT. PATIENT APPEARRED AND REPORTED STABLE ENOUGH TO RIDE IN CAR BACK HOME.


VAERS ID: 1478312 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye movement disorder, Heart rate increased, Pallor, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Patient was sitting in chair and head tilted back with eyes rolling back in head. Head started to tilt forward and shaking of arms and legs happened. Shaking lasted for around 3 seconds and stopped. Once done shaking, the patient became highly alert with wide eyes )as if she was unconscious). Lost color in face and lips. Took pulse of patient and was slightly elevated around 70bpm (however, could be normal for her). Placed cold pack on back of neck. Patient was able to talk and was responsive. I had water available for her if she needed.


VAERS ID: 1478320 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T032315 / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, 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: Multivitamin, Melatonin 2.5mg for sleep, Ibuprofen PRN
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: No adverse event. How this happened: I removed the smaller vial from the Covid-19 basket in refrigerator (not freezer) that has one Pfizer Covid-19 Vaccine and one Moderna Covid-19 vaccine and proceeded to dilute it with 1.8ml 0.9% sodium chloride, removed 0.3ml from the vial and attached expiration sticker to said vial. around 5:50PM I retrieved the vial from the refrigerator to waste it and discovered that I have used a vial of viravax. I called the mother and she stated that is doing OK. I will call PCP on Friday and inform them of the error.on 7-16-2021 I called PCP and Mother, She stated that is doing OK had few questions that I answered. Informed mother to contact us if has any adverse reactions.


VAERS ID: 1478338 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong patient
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: Error: Wrong Patient (documentation in EMR)-


VAERS ID: 1478342 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Feeling abnormal, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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: mother denies any other medications used
Current Illness: None reported by mother
Preexisting Conditions: None reported by mother
Allergies: NKDA
Diagnostic Lab Data: None reported
CDC Split Type: COVID-19

Write-up: Mother called to report that her child had been running a fever of 99.3 since having the 2nd COVID vaccine. Today she was feeling bad and she was called by school to come and get her because she had vomitted. This according to the mother is unusual for her in that she does not vomit and generally has no problems with vaccines.


VAERS ID: 1478348 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong route
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: Error: Wrong Route (SC, IM, etc.)-


VAERS ID: 1478352 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong route
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: Error: Wrong Route (SC, IM, etc.)-


VAERS ID: 1478354 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Urinary incontinence
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: Not a vaccine, but a steroid injection she passed out after as well.
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient lost consciousness while sitting in chair after vaccine. She also urinated on herself while passed out. Duration of unconsciousness not known for sure. She came to and was noticed to be sweating and pale. We gave her water, a snack, and a fan. Patient felt better within 15 minutes.


VAERS ID: 1478373 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Nausea, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Within 5 minutes after receiving the vaccination, the patient fainted. He was probably unconscious for 10-15 seconds per patient. He then presented as very pale and sweating. He also complained of being nauseous. The paramedics were called and he was taken to the hospital for evaluation.


VAERS ID: 1478377 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-25
Onset:2021-07-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 UN / IM

Administered by: Public       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given to early at age 11 without incident.


VAERS ID: 1478386 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphasia, Dizziness, Gaze palsy, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: Heard emergency personnel report BP 114/70, HR 98, blood glucose 124
CDC Split Type:

Write-up: Four minutes after vaccination with 2nd dose of Pfizer Covid vaccine, mom and sister reported patient''s eyes rolled back, closed eyes, "shook for a moment", and slid down chair. Family yelled for help and I called 911. Patient''s eyes reopened and was feeling dizzy; seemed to understand questions but unable to speak immediately after. Wet paper towel was provided to put on forehead and patient was monitored for anaphylactic, seizure, and other symptoms until emergency personnel arrived. Patient was evaluated and fireman stated that patient likely had "syncopal reaction".


VAERS ID: 1478391 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, 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: After vaccination, client stated he already received 1 dose of Moderna vaccine in April 2021 at a different jail.


VAERS ID: 1478396 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Chest pain, Condition aggravated, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Asthma medications, blood pressure medications
Current Illness: Trouble breathing
Preexisting Conditions: Asthma, high b/p
Allergies: Aspirin
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Complained of chest pain 7/10. Contacted nurse. Nurse questioned and stated that she had not taken b/p meds this morning and was experiencing total body weakness. B/p elevated pulse elevated volunteer MD on site. 911 contacted for further evaluation. Patient taken to hospital.


VAERS ID: 1478400 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-17
Onset:2021-07-16
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: covid test
CDC Split Type:

Write-up: tested positive for covid-19 July 16 2021 after completing covid vaccine series


VAERS ID: 1478404 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Presyncope
SMQs:, Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: client had just received 1st dose of vaccine @ 1042am, was in observation area@ 1055am. Client disclosed to Observation lead that she was about to "pass out." Nurse assisted client to the floor, NP assessed client as well. EMT on site monitored clients vitals: at 10:55am HR 61 02sat 98%, 10:58am HR 52 o2sat 98%, 11:00am HR 60 O2sat 98% BP 140/83, @ 11:05 HR 58 O2sat 99% BP 125/73. Client alert and oriented during incident, talking to NP the whole time. client approx 28weeks pregnant. Last vitals taken at 11:29am HR 63 O2sat 99%. Client was advised to by NP to report to her OB/GYN. Client left site with boyfriend at her side.


VAERS ID: 1478406 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Epistaxis, Facial pain, Nasal cavity packing, Oral pain, Rhinalgia, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (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: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: PATIENT STATES HE WAS PLAYING VIDEO GAMES WITH HIS FRIENDS YESTERDAY WHEN HIS NOSE STARTED TO BLEED. HIS GRANDMOTHER TRIED MULTIPLE METHODS TO STOP THE BLEEDING. PATIENT''S NOSE CONTINUED TO BLEED FOR 2 HOURS WHEN HIS GRANDMOTHER CALLED EMS. PATIENT WAS TAKEN TO SCH ER WHERE A BALLOON WAS PLACED. 7/15/2021 THEY REPORT THEY WERE TOLD THE BALLOON WAS TO REMAIN IN PLACE UNTIL FRIDAY. PATIENT STATES HE HAS HAD PREVIOUS EPISODES OF EPISTAXIS, BUT NOTHING TO THIS DEGREE. PATIENT REPORTS INTENSE PAIN IN HIS NOSE, FACE AND PALATE. HE HAS HAD CLEAR NASAL DISCHARGE FROM AROUND THE BALLOON, BUT NO ACTIVE BLEEDING. PATIENT WAS PRESCRIBED ANTIBIOTIC, BUT HAS NOT FILLED THAT PRESCRIPTION YET. HE IS ASKING FOR THE BALLOON TO BE REMOVED DUE TO THE PAIN.


VAERS ID: 1478408 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 3 RA / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong patient
SMQs:, Medication errors (narrow)

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

Write-up: While administering second doses of Moderna at nursing home, facility LPN brought client and paperwork filled out for vaccine. Client verbalized her name. Moderna dose given and then RN discovered through conversation with client/vaccine card that last name was incorrect. Since there was a question about client identity, facility staff reviewed their information and realized the wrong client had been brought for vaccination. She had previously received Pfizer.


VAERS ID: 1478433 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypotension, Loss of consciousness, Nausea, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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 symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: Patient received J&J COVID 19 vaccine and proceeded to waiting area for required 15 minutes with his family. After a couple minutes, he starting getting dizzy, pale, nauseated and lost consciousness briefly. 911 was called and patient was transported to a hospital due to low blood pressure.


VAERS ID: 1478436 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Circumstance or information capable of leading to medication error, Interchange of vaccine products
SMQs:, Medication errors (narrow)

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

Write-up: Patient came to get her second dose of Moderna vaccine. I logged everything in the ipad as Moderna. I then walked her back to lab 2 and drew 0.3 mL of Pfizer and gave her the vaccine in the L arm. I did not realize my mistake until I was documenting on the vial log. I spoke with nursing supervisor who consulted with for guidance. I also spoke with the our medical director about the incident. We informed patient of occurrence, gave her the chance to ask questions and let her know that she would not need an additional dose of the vaccine at this time. After waiting 15 minutes that patient said she felt fine and left.


VAERS ID: 1478438 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia oral
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: no meds
Current Illness: none
Preexisting Conditions: none
Allergies: penicillin
Diagnostic Lab Data: V/S at 11:30 on 7/16/21 116/72 b/p, 72 hr, 98% o2 16 rr
CDC Split Type:

Write-up: At 11:30am patient complained of "feeling dizzy" and a "numb tongue". We advised staying another 15 minutes after the initial 15 minutes. Patient agreed. Pt was able to stand without issue after 30 minutes. Denied numbness before she left. She didn''t drive here, but walked from home. She refused to go to hospital and said she was fine to walk home.


VAERS ID: 1478452 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect product formulation 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: medroxyprogestrone IM, cholecalciferol
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: None
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Incorrect vaccine given. Recipient stated she had received Pfizer for dose #1 at another location. Dose #2 of Pfizer was administered and then the RN realized the first vaccine was likely Moderna (dose of 0.5 mL had been pulled in from the state registry for dose #1). Confirmed in the state registry that the patient had received Moderna for dose #1. No harm.


VAERS ID: 1478455 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Dizziness, Feeling abnormal, Flushing, Hyperventilation, Immediate post-injection reaction, Nausea, Visual impairment
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Immediately upon administration of covid19 vaccination, patient became flushed (face and arms), dizzy and nauseous. Patient also reported vision changes (seeing spots) Flushing resolved in about 5 minutes and nausea/dizziness in about 10-15 minutes while patient was monitored by pharmacy staff. Patient reported heavy breathing at this time believed due to anxiety but was continued to be monitored by staff. After about 20 minutes patient was able to stand briefly and moved to another chair to relax and to continue monitoring. At this time most symptoms had resolved but patient still reported feeling uneasy and a little disoriented. Water was provided and pharmacy staff continued to sit with patient until patient felt that she had calmed down and reported no further adverse conditions. After sitting for another 10 minutes patient stood on her own, was stable and felt comfortable returning to work.


VAERS ID: 1478457 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Blood glucose normal, Generalised tonic-clonic seizure, Hyperhidrosis, Loss of consciousness, Muscle rigidity, Mydriasis, Posture abnormal, Snoring
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), 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 (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: Celexa, Vistaril
Current Illness: No recent illnesses
Preexisting Conditions: no reported chronic health conditions.
Allergies: Bactrim DS
Diagnostic Lab Data:
CDC Split Type:

Write-up: Immunization was administered at 2:41pm, aprox 2:45pm patient slumped over in clinic room chair- with snoring respirations, bilateral pupils dilated 5mm, became rigid, diaphoretic, and started having tonic clonic seizure activity lasting for approximately 4 mins, patient was lowered to ground for safety- 911 was activated- patient slowly regained consciousness post event- patients blood glucose = 100. HR 110 SPO@ 98%RA; patient denies previous seizure activity or history of seizures, denies drug abuse. Patient is transported to local hospital.


VAERS ID: 1478460 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atravance, advair, famotidine, gas x, naproxen, azithromycin, floniaze, albuterol, ipratropium bromide, hidentra
Current Illness: no
Preexisting Conditions: 24 week preemie, bronchopulmonary dysplasia, sleep apnea, hypogammaglobulinemia goblin
Allergies: symbicort
Diagnostic Lab Data: no
CDC Split Type:

Write-up: Rcvd the wrong vaccine for his age.


VAERS ID: 1478467 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Dizziness, Fear of injection, Hyperhidrosis, 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), Dementia (broad), 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), Dehydration (broad)

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

Write-up: APPROXIMATELY 10 MINUTES AFTER RECEIVING VACCINATION THE PATIENT FELT LIGHT HEADED AND PASSED OUT-HE WAS OUT ABOUT 5-6 SECONDS--WE RESPONDED AS HE CAME TO--HE WAS DISORIENTED --WE CALLED AN AMBULANCE--IN ABOUT 10-15 SECONDS HE WAS FULLY ALERT AND DID NOT WANT THE AMBULANCE WHICH WE CANCELED--HE STARTED SWEATING PROFUSELY AND WE HAD HIM REST ON THE FLOOR--WE GAVE HIM A BOTTLE OF WATER WHICH HE DRANK AND IN ABOUT 5 MINUTES HE FELT COMPLETELY BETTER--WE HAD HIM SIT IN A CHAIR FOR A FEW MINUTES THEN HE GOT UP WALKED AND SAID HE WAS COMPLETELY FINE. IT SHOULD BE NOTED THAT HE HAD A DREAD FEAR OF NEEDLES. WE ARE NOT SURE IF THIS PLAYED ANY ROLE IN THIS REACTION


VAERS ID: 1478474 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Heart pain, sharp pain


VAERS ID: 1478489 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Loss of consciousness, Malaise, 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), 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: Vasovagal syncope experienced with all vaccines, fingersticks and blood draws
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported history of vasovagal syncope after fingersticks, vaccines & blood draws. The patient stated that he felt comfortable receiving the vaccine in this particular retail pharmacy setting. Shortly after vaccination, patient became very pale and stated he did not feel well. I had the patient sit on the floor with his back against the wall, and shortly after he passed out. I remained at the patient''s side and made sure his head and upper body remained supported. Patient regained consciousness after about 45 seconds and was able to report where he was, what the date was and what had happened shortly upon awakening. Patient had a lollipop, 2 bottles of water and one granola bar and was able to get back into a chair where he sat for additional observation with me for approximately 30 minutes. Patient had someone in the car waiting for him that was able to drive him home.


VAERS ID: 1478495 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / SYR

Administered by: Military       Purchased by: ?
Symptoms: Aspartate aminotransferase increased, Blood calcium decreased, Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Laboratory test, Pyrexia, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: The patient presented with EKG abnormalities and an elevated troponin on 7/16/2021. Notable labs are presented below. afebrile, HR 110, respirations 19, BP 115/75 mmHg. calcium 8.3, AST 80, CPK 1,121, and troponin 32.30. EKG noted normal sinus rhythm with ST elevations
CDC Split Type:

Write-up: Patient presented to the ED for evaluation of chest pain. About 24-48 hours after receiving vaccination he started having left sided chest pain that worsened over the next 3-4 days. The pain intensified and he also reports having low grade fevers.


VAERS ID: 1478505 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, Spiriva, famotidine, collagen, Vit C, magnesium, mapap, gabapentin
Current Illness: No prior illnesses
Preexisting Conditions: cervical stenosis, headache, joint pain
Allergies: bee stings, eggs, mouse urine, Keflex, rum
Diagnostic Lab Data:
CDC Split Type:

Write-up: peri orbital itching that traveled to right ear, itching and redness traveled to left ear, per client trachea began to constrict, patient administered her Spiriva inhaler, followed with her albuterol inhaler at 2:20, patient had some improvement at 2:40 patient administered DOH epi injection to left thigh . EMS called per DOH policy. Per patient itching stopped, trachea felt better. Patient refused EMS care when they arrived. Patient doing better, no s/s of difficulty breathing. Patient left at 3:15. Patient called call center at 3:30 to thank everyone and let us know she felt good and was home.


VAERS ID: 1478513 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incomplete course of vaccination
SMQs:, Medication errors (narrow)

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

Write-up: Pt received Pfizer 05/25/21 unable to receive second dose of Pfizer due to transportation issues. Pt verbalized he is willing to receive moderna vaccination


VAERS ID: 1478518 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-10
Onset:2021-07-16
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abnormal uterine bleeding, Anaemia, Blood test, Contusion, Heavy menstrual bleeding, Immune thrombocytopenia, Immunoglobulin therapy, Infusion, Laboratory test abnormal, Mineral supplementation, Platelet count decreased, Platelet transfusion, Skin reaction
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Fertility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: from April 24 2021 trhu today July 16 2021 I have all kind of medical result and blood test
CDC Split Type:

Write-up: On April 13 2021, my right arm started to bruise close to the shoulder; On April 17 2021 I started with my period, with an extremely heavy flow, by April 22 2021 I got another bruise for no reason on my fore arm and red dots started to appear on my arms, left ear bulb and chest, by April 23 2021 I still had a heavy period, (my period lasts only 3 days and only first two days is extremely heavy)On Friday, April 23 2021, I went to see the doctor to verify what was happening to me, they took blood tests and they told me that on Saturday (April 24 2021) they would tell the result. On Saturday April 24 2021 they call me earlier morning from my doctor''s office to let me know that I had to run to the emergency room because I was bleeding to death. In emergencies they tell me that my platelets were very low, the Hematology, Oncology. Asked me a series of questions to verify the reason for the loss of my platelets. He treat me with platelet infusion and iron infusion because I had anemia (Caused by the low platelets). I was hospitalized from April 24 2021 to April 26 2021, they managed to stabilize my platelets. On May 6 2021 I had another appointment with Hematology, Oncology, they did laboratory studies and in the afternoon of that same day he spoke to me to tell me that I had to go back to the emergency room because my platelets had dropped again. At the emergency room They gave me an infusion of immunoglobulin (IVIG, two bags of 1g/kg ) and more iron IV, I had to stay in the hospital from May 6 2021 to May 8 2021, they sent me steroids and they have been treating me as ITP (Immune thrombocytopenic purpura) ever since. Since that day I have to go every Friday to have my blood drawn to check the platelet count, this has all happened after I received the first dose of pfizer vaccine of covid 19, during the time of the pandemic I have not caught COVID to date, Before this vaccine I was healthy.


VAERS ID: 1478529 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra, amitriptyline and Xarelto
Current Illness: Allergies
Preexisting Conditions: Allergies
Allergies: Shellfish and cat dander
Diagnostic Lab Data:
CDC Split Type:

Write-up: At around 26 minutes after the second vaccine was administered, patient started to have signs of an allergic reaction including dizziness, throat itchiness, and trouble breathing. Pharmacist and physician was notified immediately. Physician and MA took pulse Ox and looked into throat. Determined that patient needed Epinephrine. Patient was moved to a room where epi was administered within 3 minutes. EMS was called and patient was transported to hospital within 15 minutes of epinephrine administration.


VAERS ID: 1478531 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Haemorrhage, Head injury, Hypertension, Nasal injury, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: EMT was summoned and blood pressure was taken and it was found to be 170/125 mmHg. He was taken by the EMT to ER as this is an Emergency Hypertension.
CDC Split Type:

Write-up: Patient was sitting in the chair and then fell onto the floor head first causing him to bump his head and also hit his nose. He appeared to have a bump on his forehead and his was bleeding.


VAERS ID: 1478532 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incorrect product formulation 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient had received Pfizer as the initial vaccine product for their 1st dose. Due to unavailability of the Pfizer vaccine at the current clinic and patients refusal to transport themselves to a clinic offering Pfizer, patient was administered Moderna as the 2nd dose of the series.


VAERS ID: 1478536 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-02-19
Onset:2021-07-16
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016M20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Jul 16, 2021@09:45:26 FLU A (CEPHEID) NEGATIVE, FLU B (CEPHEID) NEGATIVE , RSV (CEPHEID) NEGATIVE COVID-19 (CEPHEID) POSITIVEA*
CDC Split Type:

Write-up: Covid-19 screening


VAERS ID: 1478547 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydroxyzing, methylphenidate, sertraline, trazodone
Current Illness: none
Preexisting Conditions: ADHD, anxiety, depression, insomnia
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Given when patient is too young per recommendations


VAERS ID: 1478559 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Loss of consciousness, 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), 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? 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 dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for about 30 seconds in the vaccination chair. Vitals were taken. BP was 90/55. EMS was called


VAERS ID: 1478560 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-05-05
Onset:2021-07-16
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Nucleic acid test, 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: Influenza/COVID-19 Nucleic Acid Amplification Test performed on 7/16/21 at 07:45. Result came back positive. Case investigation interview with patient has not been conducted as of the time of this written note.


VAERS ID: 1478566 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Head injury, Hyperhidrosis, Loss of consciousness, Palpitations, Paraesthesia, Syncope, Unresponsive to stimuli, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: About 2 minutes after receiving vaccine patient was seated on bench outside pharmacy, fainted and fell forward onto cement floor hitting his jaw. Patient was unresponsive for about 20 seconds while being attended to. Once he regained consciousness, he was helped to sit back on bench. He was diaphoretic and claimed to have a racing heart and right hand tingling. He lost consciousness on the bench again and lost bladder control. EMS was summoned and was on scene in 5 minutes. Patient did not claim to have difficulty breathing. Pharmacist called patient about 3 hours after the event and he was still in hospital with apparent problems keeping his blood pressure adequate.


VAERS ID: 1478577 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027C21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Eye pruritus, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient in for covid vaccine dose #1 today. Injection was given left deltoid @ 1044. At 1105 patient stated that she was itching. Advised HCP about this, she went in with patient and I gave her 25mg of diphenhydramine @ 1107. At 1120 patient stated that her eyes were itching feeling like seasonal allergy. I went to HCP and she advised me to give patient another dose of 25mg diphenhydramine. This was given at 1121. At 1138 patient had no new problems. HCP went in and spoke with patient. Patient was allowed to leave at 1142.


VAERS ID: 1478582 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / UNK LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: After giving the vaccine, this resident informed me that he has already completed his covid vaccine series in January. He did not report any immediate side effects


VAERS ID: 1478590 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Anxiety, Dizziness, Headache, Muscle twitching, Tearfulness
SMQs:, Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Depression (excl suicide and self injury) (broad), Vestibular 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None
Preexisting Conditions: None
Allergies: Allergic to penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The Chief Complaint is: 17 y/o F with history of PCN allergy (reports "anaphylactic shock" as a child) presents for first COVID vaccine. Discussed risk of remote PCN allergy and merits additional observation here after vaccination. Patient agreed to vaccination. During observation period the patient became tearful and stated she was feeling dizzy. This was about 15 minutes after the injection. She was taken to the treatment area for assessment. Endorsed dizziness, headache, twitching, anxiety. Denied dyspnea, itching, globus, chest pain (or pain of any type), abd pain or swelling. 17 y/o F with dizziness, anxiety but does not appear to be having a vasovagal or anaphylactic reaction. Recommend further observation - called EMS for evaluation and transport to medical facility No treatment given as BP normal, no rash or symptoms of anaphylaxis. Will file VAERS follow up but most likely cause for symptoms currently is anxiety.


VAERS ID: 1478592 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: c/o "itching fingers and arm" when 1st dose Pfizer/Ew6101 administered.
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt injected at 10:22. 10:30 Pt c/o "itching all over", no redness/raised area noted. 25mg Benadryl p.o. administered. 11:00 pt stated "I don''t feel itchy anymore". Pt dismissed and given emergency management information.


VAERS ID: 1478600 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-08
Onset:2021-07-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA MODERNA 009D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), 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: Hyaluronic Acid supplements, Collagen supplements, Probiotic, Centrum Multivitamin,Turmeric Curcumin supplements.
Current Illness: None known
Preexisting Conditions: asthma
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness, pain, and swelling subsided 2-3 days after 1st dose, but on day #8, redness itching and swelling of injection site returned along with tingling in left arm, pain in left armpit area.


VAERS ID: 1478601 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA 6780 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: Asthma
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swollen lymph node in my left armpit


VAERS ID: 1478608 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Chills, Headache, Pain
SMQs:

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

Write-up: Cold chills, headache, soreness


VAERS ID: 1478612 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Discomfort, Ear pain, Nausea, Pain, Pain in extremity, Skin tightness
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (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: Light-headedness, slight dizziness
Other Medications: Bio-Complete 3
Current Illness: None
Preexisting Conditions: None
Allergies: Keflex, amoxicillin
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: Sore arm, pain discomfort, pain around heart, pain and tightness behind left ear, nausea,


VAERS ID: 1478620 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: Difficulty breathing. Evaluated by EMS-Cleared


VAERS ID: 1478630 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: no adverse event but discovered when billing a rejection by insurance. Checked impactsis and discovered patient had already received J and J vaccine on 6-8-21 and Moderna on 4-15-21 and 5-28-21 and then received a moderna series from us on 6-18 and today 7-16-21.


VAERS ID: 1478640 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 1st dose with Pfizer vaccine 6-25-2021 at 48 years old, was nauseous and dizzy
Other Medications: ascorbic Acid (VITAMIN C) 500 mg Capsule, Sustained Release cholecalciferol (VITAMIN D3) 1,000 unit tablet cyanocobalamin (vitamin B-12) (VITAMIN B-12) 50 mcg tablet EPINEPHrine (EPIPEN) 0.3 mg/0.3 mL (1:1,000) injection fluticasone (FLOVEN
Current Illness: Endocrine, Nutritional and Metabolic Acquired hypothyroidism Respiratory Allergic rhinitis - tree, grass, weed, mold, dust mite Laryngeal spasm Vocal cord dysfunction Moderate persistent asthma without complication Gastrointestinal Food intolerance Gallstone pancreatitis Irritable bowel syndrome Neurology Migraine with intractable migraine Reflex sympathetic dystrophy right hand Oncology Intraductal papilloma right breast Genitourinary Left breast mass Dermatology Acne vulgaris Musculoskeletal and Connective Cervicalgia Temporomandibular joint disorder Temporomandibular joint disorder (TMJ) Facet arthropathy, lumbar Calcific tendinitis Dysfunction of right rotator cuff Psychological and Developmental Anxiety Depression Otorhinolaryngology Sudden left hearing loss Hearing loss of left ear Sensorineural hearing loss, unilateral Sensorineural hearing loss (SNHL) of left ear with unrestricted hearing of right ear Other Sinus tachycardia Inappropriate sinus tachycardia History of insect sting allergy Right groin pain Atypical chest pain
Preexisting Conditions: Endocrine, Nutritional and Metabolic Acquired hypothyroidism Respiratory Allergic rhinitis - tree, grass, weed, mold, dust mite Laryngeal spasm Vocal cord dysfunction Moderate persistent asthma without complication Gastrointestinal Food intolerance Gallstone pancreatitis Irritable bowel syndrome Neurology Migraine with intractable migraine Reflex sympathetic dystrophy right hand Oncology Intraductal papilloma right breast Genitourinary Left breast mass Dermatology Acne vulgaris Musculoskeletal and Connective Cervicalgia Temporomandibular joint disorder Temporomandibular joint disorder (TMJ) Facet arthropathy, lumbar Calcific tendinitis Dysfunction of right rotator cuff Psychological and Developmental Anxiety Depression Otorhinolaryngology Sudden left hearing loss Hearing loss of left ear Sensorineural hearing loss, unilateral Sensorineural hearing loss (SNHL) of left ear with unrestricted hearing of right ear Other Sinus tachycardia Inappropriate sinus tachycardia History of insect sting allergy Right groin pain Atypical chest pain
Allergies: Iodine And Iodide Containing ProductsRespiratory Difficulty Norco [Hydrocodone-acetaminophen]Respiratory Difficulty Sea Salt-citr-cit Ac-bicarb-avAnaphylaxis Albuterol SulfateOther (See Comments) CodeineRespiratory Difficulty IndomethacinOther (See Comments) Insect VenomRespiratory Difficulty, Other (See Comments) Nortriptyline HclHeadache, Itching, Nausea Only, Palpitations, Respiratory Difficulty OmeprazoleFever, GI Distress TramadolDizziness, Respiratory Difficulty Zoloft [Sertraline]Rash-Mild
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient began to feel dizzy and nauseous around 5:04pm, nurse walked her to the restroom where patient had emesis. Patient stated that she was fine and able to breathe during and after vomiting. Patient still felt dizzy once done vomiting, 5:11pm Patient had water to drink and was sat down in a chair with emesis basin and encouraged to take off mask to get deep breaths. Patient was checked on 4 times by staff between 5:11pm-5:25pm. Patient was encouraged to lay down due to still feeling dizzy and nauseous. 5:30pm patient BP taken 122/80. Patient remained in quiet room on stretcher and rested, patient''s sister came to room to wait with patient 5:32pm. When checking on patient at 5:48pm nurse was told that patient had taken 25 mg of their own Benadryl. Patient reported feeling better after having laid down on stretcher for duration of time. Patient encouraged to slowly sit up and sit on edge of stretcher for 5 minutes before standing. Patient left with sister at 6:02pm reporting feeling better than previously, sister expressed that they would be driving patient home. Patient reported feeling nauseous and dizzy the first time but felt more dizzy and nauseous this time with second dose.


VAERS ID: 1478648 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-06-22
Onset:2021-07-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Facial pain, Hypoaesthesia, Paraesthesia oral, Thyroid cyst
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Sexual dysfunction (broad)

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

Write-up: PT CALLED PHARMACY TODAY AND DESCRIBES FEELING NUMBNESS IN THE SIDE OF HER FACE THE EVENING AFTER HER COVID DOSE. IT EXTENDED FROM HER CHIN UP THE LEFT SIDE OF HER FACE. SHE VISITED THE EMERGENCY ROOM AROUND 1030PM THAT EVENING, CONCERNED OVER POSSIBLE STROKE(?) ER DIAGNOSED AS ACUTE FACIAL PAIN BECAUSE SHE DIDN''T TELL ER THAT SHE HAD A COVID DOSE EARLIER THAT DAY. SENT HOME WITH REST, TAKE ADVIL, ICE ON FACE. PT EXPERIENCED NUMBNESS FOR 3 WEEKS, HER BOTTOM LIP IS STILL "TINGLY" TODAY. A FAMILY MEMBER SUGGESTED TO HER THAT COVID SHOT MAY BE CAUSE OF HER SYMPTOMS AND SHE SPOKE TO THE PHYSICIANS OFFICE ABOUT HER SYMPTOMS. (SHE ALSO HAS THYROID CYCSTS, AND HAD A BIOPSY IN JUNE)


VAERS ID: 1478652 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: Vaccine was inadvertently given to 17 year old


VAERS ID: 1478655 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: CHF, Atrial Fibrillation, History of Angioplasty, Asthma COPD, Dementia, DM2,
Allergies: Lovastatin, Promethazine, Triameterene-hydrochlorothiazide
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Incorrect second dose. No immediate reaction. Observed for 30 minutes. Evaluated by doctor. 1st dos


VAERS ID: 1478661 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: Vaccine inadvertently given to 15 year old


VAERS ID: 1478673 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dry mouth, Paraesthesia oral, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Dehydration (broad)

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

Write-up: Tightness in throat, dry mouth and tongue. Evaluated be EMS- Refusal to transport.


VAERS ID: 1478675 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: The first dose given at age less than 12 years. No adverse events reported.


VAERS ID: 1478676 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient verbally confirmed to pharmacist that she had not received any previous COVID vaccines during pre-administration screening. Moderna vaccine was given. After the fact, it was discovered in the registry that patient had previously received 2 doses of Pfizer vaccine 2/19/21 and 3/10/21 at a Hospital. Upon further questioning, patient confirmed both previous doses. She did not experience any adverse effects as of time of reporting but incident entered per company policy.


VAERS ID: 1478679 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fear of injection, Feeling cold, Hyperhidrosis, Hypotension, Loss of consciousness, Refusal of treatment by patient, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: mesalamine
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Pt 20year old male- came to the pharmacy for a walk in covid vaccine. He filled out the vaccine consent form. I asked him if he was feeling ok today - he said yes. he presented as looking in healthy condition. I then asked him if he has ever had a bad reaction to a vaccine and he said not that he knew of but that he did not like needles. I told him that was normal, explained the shot was a quick pinch no stinging and would be over before he knew it. I encouraged him to relax his arm muscle and as soon as he did I gave the vaccine. I started to tell him he could take Tylenol or ibuprofen if he should get a sore arm and to make sure he is drinking plenty of water as hydration helps our bodies- he then asked if he could have some water and then tilted his head back and was passed out for i''d say 4 seconds. I massaged his arm and neck as he became kinda ridged and talked him back. he was out for about 4 seconds. I yelled for our store co manager who happened to be close by to come to the pharmacy and call 911. When he regained consciousness he started to sweat. he said he felt cold and thirsty. I gave him some water to drink. I explained to him what had happened and told him that we had called 911 out of precaution. I discussed with him calling parents and he wanted to call himself - he made the call to his mom on his cell phone to have her come pick him up. EMS arrived in about 10 minutes. they said his blood pressure was really low 100/60 and wanted to take him in but the patient refused. he also refused getting his blood sugar tested as he now told us he was deathly afraid of any medical procedure. ems left. I offered him some more water and chips. he drank 2 full bottles of water and ate a small bag of chips. his mom showed up a few minutes later to drive him home- we explained to her what had happened.. I told her to monitor his blood pressure at home (she said she had a machine)she said she should have known better than to let him come alone as she knew he reacted bad to medical situations. He left about 30 minutes after he got his vaccine. walked out on his own needed no assistance.


VAERS ID: 1478681 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Patient lied on consent form and in person and said she''d never received a dose of a COVID-19 vaccine. Pfizer was administered and when logging it into System it was discovered that the patient had received Janssen already.


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