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From the 5/7/2021 release of VAERS data:

Found 188,897 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 25 out of 1,889

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VAERS ID: 1269608 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad)

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

Write-up: Frequent facial twitching and on less frequently on the arm


VAERS ID: 1269947 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test negative, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: SARS-CoV-2 antibody test negative; Result Unstructured Data: 0.63, negative
CDC Split Type: USJNJFOC20210446599

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on left arm on15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received the Janssen COVID 19 Vaccine on 15-MAR-2021, He didn''t have any side effects after vaccination. On 19-APR-2021, he went to get tested for COVID 19 antibodies. On 21-APR-2021, The test results came back negative for SARS-COV2 antibodies (coded as confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210446599-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1270345 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-12
Onset:2021-04-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

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

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

Write-up: Rash spreading from injection site; spread for approx 3 days and then went away


VAERS ID: 1270592 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-12
Onset:2021-04-19
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Antiplatelet therapy, Aspartate aminotransferase increased, Basilar artery stenosis, Blood alkaline phosphatase increased, Blood glucose increased, Carotid artery stenosis, Cerebral infarction, Computerised tomogram head abnormal, Condition aggravated, Glomerular filtration rate increased, Hypertension, International normalised ratio normal, Laboratory test abnormal, Magnetic resonance imaging head abnormal, Platelet count decreased, SARS-CoV-2 test negative, Thrombocytopenia, Troponin I increased, Vertebral artery stenosis, Viral test negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Biliary system related investigations, signs and symptoms (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diltiazem 300 Mg ER24 hour PO daily Advil PM 200/28 2 cap PO HS Metformin 1000mg PO BID Omega3 fatty Acid Capsule 1 cap PO BID Ramipril 5 Mg PO Daily
Current Illness: None
Preexisting Conditions: Hypertension Hyperlipidemia Diabetes Mellitus type 2
Allergies: Erythromycin Shellfish Shellfish Derived
Diagnostic Lab Data: Inpatient hospitalization from 4/23/2021-4/28/2021.
CDC Split Type:

Write-up: On 4/23/21 she presented to the ED with 4 day history of left sided weakness and slurred speech. She was hypertensive on arrival 249/121. In the emergency room labs remarkable for platelet count 92, INR 1.0, glucose 170, GFR 70.7, AST 48, alkaline phosphatase 167, troponin I 0.039. COVID-19 and other viral serologies not detected. CT of the brain showed a small subacute infarct in the right body of the corpus callosum. MRI advised by radiology. Patient received aspirin, amlodipine 10 mg, enalapril 1.25 mg IV then 0.625 mg IV for uncontrolled hypertension. MRI of brain reveals small subacute infarct involving the body of the corpus callosum, and punctuate acute infarct to the posterior left frontal lobe. Angiogram of brain was performed revealing focal severe stenosis of the mid basilar artery, moderate to severe stenosis of the short segments of both intracranial internal carotid arteries and moderate to severe short-segment stenosis of the intracranial left vertebral artery, felt to be chronic and unrelated to current symptoms. She was started on dual antiplatelet therapy: clopidogrel 75 mg PO DAILY and aspirin 81 mg Tablet, Delayed Release (Dr/Ec) 81 mg PO DAILY. It should be noted that lab work reveals Thrombocytopenia chronically from 2011 forward.


VAERS ID: 1271189 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-18
Onset:2021-04-19
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Condition aggravated, Dyspnoea, Lung infiltration, Pneumonia, Respiratory failure, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 325 MG tablet acetaminophen (TYLENOL) 650 MG suppository albuterol (PROAIR HFA) 108 (90 BASE) MCG/ACT HFA inhaler amLODIPine (NORVASC) 5 MG tablet Ascorbic Acid 1000 MG tablet benzonatate (TESSALON) 100 MG capsule bi
Current Illness: None known
Preexisting Conditions: History of prostate cancer HTN (hypertension), benign Muscular dystrophy (HCC) Neuropathy PTSD (post-traumatic stress disorder) PVD (peripheral vascular disease) (HCC) Prostate cancer (HCC) Pneumonia due to organism Hypoxemia Acute respiratory failure (HCC) COVID-19 virus infection Acute respiratory failure with hypoxia (HCC) Nosocomial pneumonia Former smoker CRP elevated
Allergies: Hazelnuts (anaphylaxis)
Diagnostic Lab Data: COVID 19 test positive on 3/19/21
CDC Split Type:

Write-up: Presented to emergency department at ancillary facility on 3/19/21 with shortness of breath and was admitted at that time. He was transferred to regional medical facility on 3/23/21 for further management due to increasing oxygen requirements and worsening congestion. Patient was discharged on 4/2/21 to rehab facility. Patient presented to emergency department on 4/12/21 from rehab facility for worsening hypoxia and respiratory failure. Chest xray showed new infiltrates and he was started on antibiotics for pneumonia. He was discharged on 4/20/21 to a skilled nursing facility.


VAERS ID: 1272060 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test normal, Chest discomfort, Dyspnoea, Headache, Hypoaesthesia, Hypotonia, Injection site pain, Malaise, Nausea, Neck pain, Pain, Pain in extremity, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil and Trazadone
Current Illness: Unknown
Preexisting Conditions: Depression, Anxiety, Panic Attacks and Insomnia
Allergies: NKDA
Diagnostic Lab Data: The following was reported to me by the patient. Patient was seen at the ER on 4/19/21 and a work up ruled out a blood clot. Her blood work was normal. She was seen at the Urgent are on 4/21/21 and her blood work was normal. She was diagnosed with a UTI and was prescribed Antibiotics.
CDC Split Type:

Write-up: Patient has been feeling ill with persisting nausea, headaches, malaise, generalized abdominal pain. She has intermittent shortness of breath with chest discomfort. She is not sure if this related to panic attacks. For the last 3 days she has had left posterior neck pain with radiation of pain to her head and left upper and lower arm. Her left arm feels numb and limp at times. She received the vaccine in her left arm.


VAERS ID: 1272649 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER 8731 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Rash, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolo 100 mg 2xdaily/ escitalopram 20mg 1xdaily/furosemide 40 mg 1x daily/irbesarten 150mg 1x daily/ bupropion 100 1x daily/ zinc, vit d, vit c, multivitamin, baby aspirin and iron 1 x daily.
Current Illness: High blood pressure.
Preexisting Conditions: High blood pressure. Obesity. Anxiety
Allergies: Xarelto reaction periacardial effusion tampanade. Diltiazem immediate reaction of large blisters.
Diagnostic Lab Data: None. Searched side effects and was not worried.
CDC Split Type:

Write-up: 04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.


VAERS ID: 1273477 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-11
Onset:2021-04-19
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 UN / SYR

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chest pain, Chills, Cough, Dyspnoea, Fatigue, Headache, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes, Heart disease, hypertension
Allergies:
Diagnostic Lab Data: PCR positive for COVID-19 on 4/19/2021
CDC Split Type:

Write-up: Hospitalized with COVID-19 a month after COVID-19 vaccine. Had fever, chills, congestion, sore through, cough, shortness of breath, chest pain, fatigue, and headache.


VAERS ID: 1274213 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-07
Onset:2021-04-19
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, Deep vein thrombosis, Pulmonary embolism
SMQs:, Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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:

Write-up: DVT and saddle PE. Did have Afib but no A/c


VAERS ID: 1274416 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-11
Onset:2021-04-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient vaccinated at another location. approx 7 days post vaccination was admitted to the hospital for increasing shortness of breath and leg pain and swelling.


VAERS ID: 1276502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2U6A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had No known allergies.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210452169

Write-up: SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2U6A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced shortness of breath. On 19-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and headache was not reported. This report was non-serious.; Sender''s Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1276542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ulcerative colitis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210454247

Write-up: EXHAUSTED; This spontaneous report received from a patient concerned a 29 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included ulcerative colitis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 18-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ulcerative colitis, and crohn''s disease. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from exhausted on 19-APR-2021. This report was non-serious.


VAERS ID: 1276626 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body mass index, Body temperature, Deep vein thrombosis, Heart rate, Oxygen saturation, Physical examination, Respiratory rate, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLEGRA; PRILOSEC [OMEPRAZOLE]; XARELTO
Current Illness: Abstains from alcohol; Marijuana abuse; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Back surgery; Deep vein thrombosis postoperative (More than 30 years ago); Depression; Heart murmur; Comments: The patient had history of no known allergies. The patient''s mother had a history of aneurysm.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Ultrasound Doppler; Result Unstructured Data: subocclusive thrombus within the left common superficial femoral vein; Test Date: 20210421; Test Name: Physical examination; Result Unstructured Data: Abnormal; Test Date: 202104211625; Test Name: Respiratory rate; Result Unstructured Data: 16 /min; Test Date: 202104211625; Test Name: Body temperature; Result Unstructured Data: 98.8 F; Comments: oral temperature; Test Date: 202104211625; Test Name: Pulse rate; Result Unstructured Data: 88; Test Date: 202104211625; Test Name: Oxygen saturation; Result Unstructured Data: 100 %; Test Date: 202104211625; Test Name: Body mass index; Result Unstructured Data: 24; Test Date: 202104211625; Test Name: Blood pressure; Result Unstructured Data: 148/66 mmHg; Test Date: 202104211632; Test Name: Oxygen saturation; Result Unstructured Data: 100 %; Test Date: 202104211632; Test Name: Respiratory rate; Result Unstructured Data: 15; Test Date: 202104211632; Test Name: Body temperature; Result Unstructured Data: 97.8 F; Comments: oral temperature; Test Date: 202104211632; Test Name: Pulse rate; Result Unstructured Data: 91; Test Date: 202104211632; Test Name: Blood pressure; Result Unstructured Data: 148/66 mmHg
CDC Split Type: USJNJFOC20210457179

Write-up: DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 49 year old male. The patient''s weight was 80.3 kilograms, and height was 182.9 centimeters. The patient''s past medical history included post-operative deep vein thrombosis (more than 30 years ago), depression, heart murmur, and back surgery, and his concurrent conditions included non-smoker, no alcohol use, and marijuana abuse. The patient had no history of known allergies. The patient''s mother had a history of aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fexofenadine hydrochloride (Allegra) for allergy, rivaroxaban (Xarelto) for venous thromboembolism, and omeprazole (Prilosec) for unknown indication. About one and half weeks after vaccination, on 21-APR-2021, the patient was taken to the emergency department and was admitted with the complaints of leg pain since 2 days with suspected blood clot in leg. Over the last days, patient''s left leg looked swollen compared to the right leg. The patient also had pain, initially started in groin area and radiated down across the anterior portion of the leg, then to posterior leg, and into toes. The patient also had some intermittent tingling in toes. The patient denied of weakness, numbness or persistent paresthesia. The patient was concerned regarding the pain as it felt similar to the post-operative deep vein thrombosis he had in the past. The patient had been anxious since vaccination when hearing about the development of blood clots. The patient also denied of fevers, chills, chest pain, shortness of breath abdominal pain, nausea, vomiting, diarrhea, and difficulty walking. On 21-APR-2021 16:25, the patient''s laboratory data included: Blood pressure (148/66 mmHg), Body mass index (24), Body temperature (98.8 F), Oxygen saturation (100 %) Pulse rate (88), and Respiratory rate (16). On 21-APR-2021 16:32, laboratory data included: Blood pressure (148/66 mmHg), Body temperature (97.8 F), Oxygen saturation (100 %), Pulse rate (91), and Respiratory rate (15). Other general physical examinations included: General: Well-developed well-nourished in no acute distress. HEENT (Head, Eye, Ear, Nose, Throat) examination: normocephalic atraumatic extra ocular motions are intact. Neck examination: Supple without jugular vein distention or meningismus. Lung examination: Clear auscultation bilaterally without wheezes rales or rhonchi. Heart examination: Regular rate and rhythm without murmurs rubs or gallops. Abdomen examination: Soft no tender non-distended without rebound or guarding. Extremities: Without clubbing cyanosis edema, no lacerations or abrasions or ecchymosis noted, no appreciable size difference in the left leg compared to the right, the patient had some tenderness throughout palpation of the medial thigh on the left with radiation up into the left inguinal region, no calf tenderness or swelling, no erythema, palpable posterior tibialis pulse. Skin examination: Warm and dry and well perfused. Psych examination: Appropriate mood and affect. Neuro examination: Cranial nerves 2-12 are grossly intact, strength is 5/5 in upper and lower extremities, full distal sensation in the left lower extremity, full plantar and dorsiflexion of the left foot including the left great toe, sensation is grossly intact, awake, alert and oriented x3. On ultrasound Doppler venous lower extremity test, identified sub occlusive thrombus in the left superficial femoral veins, likely related to organizing/chronic thrombus, however no prior imaging was available at the institution for comparison, no evidence of occlusive deep vein thrombosis. The final diagnosis was made as Deep Vein Thrombosis (DVT). At no time the patient had ever endorsed any chest pain/pleuritic pain, shortness of breath or exertional dyspnea. Due to the nature of this clot, a course of anticoagulation was planned. Patient was prescribed with Xarelto at twice daily starting doses, with transition to 20 mg doses. During the initiation of treatment, the patient should be followed up by his primary care physician for further evaluation. The patient stated that he would call the primary care physician in the following morning for follow-up appointment. The patient was discharged from the hospital on APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210457179-Covid-19 vaccine ad26.cov2.s-deep vein thrombosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1276729 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-08
Onset:2021-04-19
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027A21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Product availability issue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (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: ZYRTEC ALLERGY
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Fainted after 2nd dose; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted after 2nd dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm). On 20-Apr-2021, the patient experienced SYNCOPE (Fainted after 2nd dose) (seriousness criterion medically significant). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) had resolved. On 20-Apr-2021, SYNCOPE (Fainted after 2nd dose) had resolved. No treatment information for the event was reported. Company comment:This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered. Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.; Sender''s Comments: This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered. Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.


VAERS ID: 1276734 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Ear pain, Headache, Lethargy, Meniere's disease, Migraine, Nausea, Neck pain, Pain, Pyrexia, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (narrow), Arthritis (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: RELPAX; ADVIL [IBUPROFEN]; ALLEGRA-D [FEXOFENADINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]; AIMOVIG [ERENUMAB]; VALSARTAN
Current Illness: Drug allergy (Bactrim and Augmentin)
Preexisting Conditions: Medical History/Concurrent Conditions: Meniere''s disease; Migraine (well controlled)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Meniere''s disease; Migraine; Extreme dizziness; Lethargy; Nausea; Fever; Stabbing pain in ears; stabbing pain in neck; Pain that radiated through her body like a jolt of lightning; Ringing in her right ear that will not stop; Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head; This spontaneous case was reported by an other health care professional and describes the occurrence of MENIERE''S DISEASE (Meniere''s disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Migraine (well controlled) and Meniere''s disease. Concurrent medical conditions included Drug allergy (Bactrim and Augmentin). Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX), IBUPROFEN (ADVIL [IBUPROFEN]), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]), ERENUMAB (AIMOVIG [ERENUMAB]) and VALSARTAN. On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head). On 20-Apr-2021, the patient experienced PAIN (Pain that radiated through her body like a jolt of lightning), TINNITUS (Ringing in her right ear that will not stop), EAR PAIN (Stabbing pain in ears) and NECK PAIN (stabbing pain in neck). On 22-Apr-2021, the patient experienced PYREXIA (Fever). On 23-Apr-2021, the patient experienced DIZZINESS (Extreme dizziness), LETHARGY (Lethargy) and NAUSEA (Nausea). On an unknown date, the patient experienced MENIERE''S DISEASE (Meniere''s disease) (seriousness criterion medically significant) and MIGRAINE (Migraine). At the time of the report, MENIERE''S DISEASE (Meniere''s disease) and PYREXIA (Fever) outcome was unknown, MIGRAINE (Migraine), PAIN (Pain that radiated through her body like a jolt of lightning), TINNITUS (Ringing in her right ear that will not stop), EAR PAIN (Stabbing pain in ears), NECK PAIN (stabbing pain in neck) and HEADACHE (Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head) was resolving and DIZZINESS (Extreme dizziness), LETHARGY (Lethargy) and NAUSEA (Nausea) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the event included migraine cocktail. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache, nausea and pyrexia are consistent with the product safety profile.; Sender''s Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache, nausea and pyrexia are consistent with the product safety profile


VAERS ID: 1277143 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-08
Onset:2021-04-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Herbal tea and acupuncture. nothing else
Current Illness: none
Preexisting Conditions: hypo thyroid
Allergies: none known except seem sensitive to gluten
Diagnostic Lab Data: none yet
CDC Split Type:

Write-up: I now have Tinnitus....thanks and this is so very awesome! Please someone tell me this will go away!!!!!


VAERS ID: 1278985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021432155

Write-up: vaccine was administered subcutaneously instead of intramuscular according to her; This is a spontaneous report from a contactable registered nurse (patient) via Pfizer-sponsored program via medical information team. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730, Expiration date 31Jul2021), subcutaneously administered in the Left Upper Arm on 19Apr2021 (age at the time of vaccination 31-year-old) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6200, Expiration date 30Jun2021), via unknown route administered in the Left Upper Arm on 29Mar2021 at a single dose for COVID-19 immunization. Patient got the 2nd shot of the vaccine on 19Apr2021 and, she felt that the vaccine was not administered properly as she was bigger than the usual, vaccine was administered subcutaneously instead of intramuscular according to her. She stated that she is a big girl and does not think the needle reached her muscle. Reporter would like to know the efficacy of the covid vaccine if administered subcutaneously as opposed to intramuscularly. Do I still have the same percentage of coverage if I received the covid vaccine subcutaneously, instead of muscularly? No PQC present. Upon follow up on 19Apr2021 as per the reporter the report was serious with seriousness criteria-Other medically important condition. Report is not related to a study or program. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (19Apr2021): New information received from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: reporter seriousness added, dose details lot number and expiration date added for both the doses. Amendment: This follow-up report is also being submitted to amend previously reported Information: delete the off-label use event as this is a medication error based on the description of the event and was not off label use.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Inappropriate route of vaccination,Off label use. The case will be reassessed once new information is available.


VAERS ID: 1279321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: South Carolina  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Dizziness, Feeling abnormal, Hypoaesthesia, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021449490

Write-up: felt like the left side of her body was numb; felt bad; blurred vision; dizziness; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced difficult breathing, difficult to swallow, dizziness, headache, tachycardia, low blood pressure, redness in her face, felt shortness of breath and felt bad right after received the vaccination. 30 min after administration, the patient was admitted to the emergency room to manage the condition and was in observation for 3 hours and was diagnosed as anaphylactic reaction to the vaccine. After being released from the emergency room, the patient was experiencing blurred vision, tachycardia, continuous headache, felt like the left side of her body was numb, had nausea and dizziness. The patient was treated with benadryl and ondansetron in emergency room. Outcome of the events were reported as unknown. Follow-up attempts are needed. Further information is expected.


VAERS ID: 1279696 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-03-27
Onset:2021-04-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: JnJ Covid-19 vaccine
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: unknow but patient was treated for DVT in the leg
CDC Split Type:

Write-up: patient reported to the pharmacy that they had to go to ER for blood clot on 04/19/2021


VAERS ID: 1281688 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-08
Onset:2021-04-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

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

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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ReliOn Insulin Syringe 1ML/31G Miscellaneous USE AS DIRECTED. Insulin Syringe 31G X 5/16 Miscellaneous as directed. Reglan 10 MG Tablet as directed Orally 4 times a day as needed. Diphenhydramine Cit-Aspirin 38.3-500
Current Illness:
Preexisting Conditions: COPD Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pulmonary embolism


VAERS ID: 1283369 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-08
Onset:2021-04-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Adenocarcinoma, Bladder catheterisation, Encephalomyelitis, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Monoparesis, Musculoskeletal stiffness, Night sweats, Pleocytosis, Spinal cord neoplasm, Tremor, Urinary retention, Vasogenic cerebral oedema, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (broad)

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

Write-up: 24 yo female admitted 4/21 for 2 days of acute onset urinary retention, , blurry vision, and LE paresis/stiffness/tremulousness, found to have csf pleocytosis and abnormal mri t2 signal of brain/cord. she went to the urgent care and a foley catheter was placed on 4/20. 4/21 on exam: spontaneous clonus substantial vasogenic edema that is more prominent posteriorly and longitudinal spine lesion in the thoracic cord that is likely responsible for her grossly abnormal exam. night sweats over the past several weeks has an episode of vomitting after foley catheter was placed Diagnosis ADEM (Acute disseminated encephalitis and encephalomyelitis)


VAERS ID: 1284665 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Chest pain, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210419; Test Name: EKG; Result Unstructured Data: Normal; Test Name: Stress test; Result Unstructured Data: not reported
CDC Split Type: USJNJFOC20210458883

Write-up: CHEST PAIN; CHEST PRESSURE; This spontaneous report received from a consumer concerned a 58 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced chest pressure. Laboratory data included: Blood test (NR: not provided) Normal, and EKG (NR: not provided) Normal. Laboratory data (dates unspecified) included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and chest pressure. This report was non-serious.; Sender''s Comments: MAC not required as per standard procedure as case was assessed as non-serious.


VAERS ID: 1284758 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fall, Lip injury, Loss of consciousness, Nausea
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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]; OMEPRAZOLE; D3; VIT C; FISH OIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Irritable bowel syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021432193

Write-up: passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It''s unknown if treatment was received. The outcome of events was recovering.


VAERS ID: 1284780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-04-15
Onset:2021-04-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diplegia, Muscular weakness, Myopathy
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bone marrow transplant (3 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021433124

Write-up: she developed " a myopathy, weakness, (almost like a paralysis), mostly in both lower extremities."; she developed " a myopathy, weakness, (almost like a paralysis), mostly in both lower extremities."; she developed " a myopathy, weakness, (almost like a paralysis), mostly in both lower extremities."; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Apr2021 (Lot number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history included history of a bone marrow transplant from 2018 (reported as 3 years ago) to an unknown date. The patient''s concomitant medications were not reported. She was currently not taking any immunosuppressant medications at this time. On 19Apr2021, 4 days after receiving the 1st dose, she developed a myopathy, weakness, (almost like a paralysis), mostly in both lower extremities. The Medical Director and the Neurologist are looking for any data Pfizer has on this type of adverse event, any treatment recommendations based from the post EUA AE reports received by Pfizer DSU. The outcome of the events was unknown. Information about the Lot/batch number has been requested.; Sender''s Comments: Based on temporal association a contributory role of BNT162B2 cannot be totally excluded. Case will be reassessed if additional information is received. 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 Ethics Committees and Investigators, as appropriate.


VAERS ID: 1284798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-04-19
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Gait inability, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021433942

Write-up: she did not know if the patient''s inability to walk was due to Guillain-Barre; Unable to walk; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20''s received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Apr2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The pharmacist reported that she did not have a lot of information but the incident prompted her to reach out to Pfizer. There was a situation with a young female that received her first dose of the Covid-19 vaccine last week that was unable to walk on 19Apr2021. She was unsure of where the patient received her Covid-19 vaccine. She was unsure if there were any co-factors that could have contributed to the patient''s inability to walk. She reported that she did not know if the patient''s inability to walk was due to Guillain-Barre. Her number one concern was that the patient was not walking. The pharmacist inquired if there was any help that Pfizer could provide. She reported that she did not know if IViG, intravenous immunoglobin, had a place in therapy for the patient. The patient was going to be admitted to the hospital at the time of the report on 19Apr2021. Clarified that the patient was not hospitalized yet and that she believed that the patient was en route to the caller''s facility at time of call on 19Apr2021. The event unable to walk was reported as serious due to Medically significant. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on limited information provided, a possible relation for BNT162B2 injection and serious Guillain-Barre syndrome with secondary walking inability cannot be completely excluded, only supported by plausible drug/event chronological sequence. Other evidence or argument, indicating a contributory role in development of reported events cannot be established. 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: 1284816 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: USPFIZER INC2021443829

Write-up: suffered from a TIA post covid shot; This is a spontaneous report from a contactable consumer (reporter''s family member). A male patient of an unspecified age (reported as 65 +) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient suffered from a transient ischemic attack (TIA) post COVID shot this morning on 19Apr2021 with outcome of unknown. He was doing well, but was warned her could suffer from another stroke up to 4 months after his vaccination. The outcome of the event was unknown. Information about the Lot/batch number has been requested.


VAERS ID: 1284842 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 03461 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Hypoaesthesia, Paraesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hearing impairment (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN-D; FISH OIL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021450591

Write-up: Bell''s Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell''s Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell''s Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.


VAERS ID: 1286868 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-18
Onset:2021-04-19
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / N/A LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: Unisom, vitamin d, magnesium, b vitamins
Current Illness:
Preexisting Conditions: Chronic neck/back pain
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shingles


VAERS ID: 1288102 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA K1OC / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis, Respiratory tract haemorrhage, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: blood clot coming out of the mouth when coughing; Nose bleed; pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. K1OC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm). On an unknown date, the patient experienced RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) (seriousness criterion medically significant) and EPISTAXIS (Nose bleed). At the time of the report, RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) and EPISTAXIS (Nose bleed) outcome was unknown and VACCINATION SITE PAIN (pain in her left arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. 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. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: patient''s address was updated (changed), adverse events updated; 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: 1288109 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-04
Onset:2021-04-19
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram, Gait disturbance, Headache, Inappropriate schedule of product administration, Loss of consciousness, Somnolence, X-ray
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), Dementia (broad), Parkinson-like events (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), Medication errors (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:
Current Illness: Asthma (Taking asthma medication as concomitant)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: CT Scan; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210423; Test Name: X-RAY; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: passed out; can''t walk very well without assistance; Sleepy; Very weak; headache; In appropriate doses interval, more than 35 days; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Taking asthma medication as concomitant). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days). On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), GAIT DISTURBANCE (can''t walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT DISTURBANCE (can''t walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Computerised tomogram: (Negative) negative. On 23-Apr-2021, X-ray: (Negative) negative. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient''s heart was checked but no abnormal results. Company comment: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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: 1288385 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-03-01
Onset:2021-04-19
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 1 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
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: SERTRALINE; CLOBETASOL; KETOCONAZOLE; VINEGAR APPLE CIDER PLUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Allergy to molds; Asthma; Grass allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210419; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC2021437530

Write-up: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in the left arm in Mar2021 (at 09:15AM) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization. Medical history included asthma, and allergies to grass, mold, pollen, and cat. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; clobetasol (CLOBETASOL) taken for an unspecified indication, start and stop date were not reported; ketoconazole (KETOCONAZOLE) taken for an unspecified indication, start and stop date were not reported; aloe vera, malus domestica (VINEGAR APPLE CIDER PLUS) taken for an unspecified indication, start and stop date were not reported. The patient tested positive for COVID virus on 19Apr2021 at 17:00. Treatment for the event included OTC medication. The patient had no Covid prior vaccination and had tested post vaccination. The patient underwent lab tests and procedures which included nasal swab (PCR): negative on 13Apr2021 and positive on 19Apr2021. The outcome of the events resolving.


VAERS ID: 1288401 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, Fatigue, Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Mental impairment, Repetitive speech, Seizure, Thinking abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA; CARBAMAZEPINE
Current Illness: Epilepsy (diagnosed with this when he was 15 years old.)
Preexisting Conditions: Medical History/Concurrent Conditions: Seizure (Then at 2015 he had a seizure.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021438496

Write-up: Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient''s wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn''t had a seizure in over 10 years and hasn''t missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.


VAERS ID: 1288549 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-12
Onset:2021-04-19
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Alopecia, Alopecia areata
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Cymbalta, Vitamin D, Multivitamin, xulane patch, Propanalol
Current Illness: Multiple Sclerosis
Preexisting Conditions: Multiple Sclerosis
Allergies: No
Diagnostic Lab Data: Examination by dermatologist followed by diagnosis of Alopecia Aratea and scalp injections.
CDC Split Type:

Write-up: Hair loss


VAERS ID: 1289409 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-03-09
Onset:2021-04-19
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: 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: Actos, folic acid, gabapentin, glipizide, hydrochlorthiazide, levothyroxine
Current Illness:
Preexisting Conditions:
Allergies: Penicillins
Diagnostic Lab Data: SARS-COVID-19 detected 4/19/21.
CDC Split Type:

Write-up: Covid vaccine monitoring documentation. SARS-COVID-19 detected 4/19/21. Patient received the Janssen covid vaccine 3/9/21, Lot 1802068.


VAERS ID: 1290435 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-30
Onset:2021-04-19
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Blood test normal, Full blood count normal, Metabolic function test, Oedema, Oedema peripheral, Rash, Troponin normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions:
Allergies: ibuprofen causes rash
Diagnostic Lab Data: cbc, cmp, trop, bnp were normal during ER visit 4/30 u/s LE dvt ordered 5/5 during outpatient visit
CDC Split Type:

Write-up: pt developed b/l LE edema 1+ pitting edema roughly 2-3 weeks after getting covid vaccine cbc, cmp, trop, bnp were normal during ER visit 4/30 pt complained of "red dots" like rash at first but no petichial rash noted on exam


VAERS ID: 1291093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dysarthria, Head injury, Hyperhidrosis, Pain, Pain in extremity, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLOFT
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021437198

Write-up: fainting; Extreme pain in left arm to the point of barely moving; hitting head; vomiting; Slurred speech; Chills; sweats; aches; This is a spontaneous report from a contactable consumer (the patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8731), via an unspecified route of administration in the left arm on 18Apr2021 at 12:30 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included: sertraline hydrochloride (ZOLOFT). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 06:00, the patient experienced extreme pain in the left arm to the point of barely moving, fainting and hitting head, vomiting, slurred speech, chills, sweats, and aches. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1291164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Kansas  
Vaccinated:2021-03-22
Onset:2021-04-19
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Blood test, Body temperature, Dizziness, Drug hypersensitivity, Ear pain, Feeling cold, Foreign body sensation in eyes, Full blood count, Headache, Influenza virus test, Insomnia, Malaise, Oropharyngeal pain, Palpitations, SARS-CoV-2 test, Throat irritation, Thyroid function test, Vision blurred
SMQs:, Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Graves'' disease; Hyperthyroidism; Penicillin allergy (7 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: temperature; Result Unstructured Data: Test Result:96; Test Date: 2021; Test Name: CBC; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: flu test; Test Result: Negative ; Test Date: 2021; Test Name: Covid test; Test Result: Negative ; Test Date: 2021; Test Name: Thyroid; Result Unstructured Data: Test Result:Normal
CDC Split Type: USPFIZER INC2021438499

Write-up: I had heart palpitation.; felt really chilly/I was cold; throat was sore and itchy; My throat was sore and itchy; felt so terrible; I had back pain, ear pain,; ear pain; insomnia/could not sleep; dizzy; might be allergic to amoxicillin; Headache; Cannot see clearly; I feel like there is something in my eye.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. Medical history included penicillin allergy 7 years ago, hyperthyroid, Graves diseases. The patient''s concomitant medications were not reported. Patient got the first dose of the Pfizer BioNTech covid vaccine on 22Mar2021. For the first 2 weeks she felt really chilly. Her throat was sore and itchy. She was cold and her temperature was 96. She felt so terrible. She was seen at Immediate Care and tested for the flu and for covid. Both tests were negative. They tested her blood, CBC and thyroid and they were normal. They gave her amoxicillin. She still felt terrible and went back for her symptoms and it was also because 7 years ago she found out that she was allergic to penicillin. So she thought she might be allergic to amoxicillin. She had back pain, ear pain, could not sleep, had insomnia and was dizzy. When she went back they gave her a steroid injection. Since the steroid injection patient has been feeling much better. She has a little bit of a headache. But she is not chilly and she did not have back or ear pain. Her reading has been affected since getting the vaccine. She cannot see clearly and she did not have that trouble before the vaccine. She had just gotten new glasses in February. She feels like there is something in her eye. Last night she had heart palpitation (19Apr2021). Patient questioned symptoms associated with the vaccine and if she should get the second dose. She stated that she is scheduled to receive the second dose of the Pfizer BioNTech covid vaccine tomorrow (21Apr2021) and scheduled to see her eye doctor on Thursday. Patient was told that she should wait 90 days after taking amoxicillin and was wondering if it is true. Outcome of felt so terrible was recovering, outcome of felt really chilly/was cold and back pain, ear pain was recovered in 2021, outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1291181 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021438709

Write-up: left jugular left vein thrombosis; This is a spontaneous report from a contactable consumer physician (reporting for herself). This 35- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 as a single dose for COVID-19 vaccination. No relevant medical history and concomitant medications was reported. States: no past medical history of blood clots, not on birth control pills and had two children with no issues. She received her first dose of the Pfizer BioNTech Covid 19 vaccine on 12Apr2021, she developed symptoms 5 days later, and then went to the ER and was diagnosed with a left jugular left vein thrombosis on 19Apr2021. Patient was released on Xarelto starter pack and then will be on Xarelto 20mg. The clinical outcome of the events was unknown. Information about the Lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Jugular vein thrombosis cannot be excluded. The case will be reassessed if additional information becomes available. 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: 1291184 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dehydration, Dizziness, Feeling abnormal, Hyperhidrosis, Night sweats, Peripheral swelling, Pyrexia, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: Knee pain
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: fever; Result Unstructured Data: Test Result:low-grade 99.8 degrees
CDC Split Type: USPFIZER INC2021438755

Write-up: This is a spontaneous report from a contactable consumer (patient''s fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it''s related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn''t know if it''s a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn''t know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn''t go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.


VAERS ID: 1291208 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Blood creatinine, Drug ineffective, Full blood count, Haematocrit, Haemoglobin, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETAMINOPHEN; DOCUSATE; ENOXAPARIN; GABAPENTIN; METHYLPHENIDATE; MIRALAX; SENNA [SENNA ALEXANDRINA LEAF]; TRAZODONE; ELIDEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Bowel dysfunction; Increased state of alertness; Mood disorder; Neuropathic pain; Obesity; Pain; Pneumonia due to pseudomonas; Seborrheic dermatitis; Sleep disorder; Traumatic brain injury
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Serum creatinine; Result Unstructured Data: Test Result:1.04; Comments: normal kidney functioning; Test Date: 20210419; Test Name: CBC done; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210419; Test Name: Hematocrit; Result Unstructured Data: Test Result:36.6; Test Date: 20210419; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.2; Test Date: 20210313; Test Name: Unspecified COVID19 test; Test Result: Negative ; Test Date: 20210323; Test Name: Unspecified COVID19 test; Test Result: Negative ; Test Date: 20210326; Test Name: Unspecified COVID19 test; Test Result: Negative ; Test Date: 20210419; Test Name: Unspecified COVID19 test; Test Result: Positive ; Test Date: 20210419; Test Name: White blood cells; Result Unstructured Data: Test Result:5.3
CDC Split Type: USPFIZER INC2021441368

Write-up: diagnosed with COVID19 after receiving vaccine/ patient tested positive for COVID on 19Apr2021/ was asymptomatic; diagnosed with COVID19 after receiving vaccine/ patient tested positive for COVID on 19Apr2021/ was asymptomatic; This is a spontaneous report from a contactable pharmacist. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose (first dose) (at the age of 50 years old) and via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: ER8731; Expiration Date: 31Jul2021) as single dose (second dose), for COVID-19 immunisation. Medical history included traumatic brain injury from 13Mar2021, alcohol abuse, pseudomonas pneumonia, pain, bowel dysfunction, sleep disorder and mood disorder, neuropathic pain, seborrhoeic dermatitis, obesity and increased alertness. Concomitant medications included paracetamol (ACETAMINOPHEN) taken for pain relief; docusate taken for bowel management from 05Apr2021 and ongoing; enoxaparin injection taken for DVT prophylaxis from 30Mar2021 and ongoing; gabapentin taken for neuropathic pain from 30Mar2021 and ongoing; methylphenidate taken for increased alertness (unknown dose from 30Mar2021; Patient takes 10 mg twice a day and it was started on 08Apr2021; it was initially 2.5 mg on 03Apr2021 and then increased to 5 mg on 07Apr2021. The dose was then increased to 10 mg on 08Apr2021 and the patient is currently on 10 mg. This is a normal dosing schedule and due to a typical dose increase. The increase in dose was not due to effectiveness, but because of how the medication is started.); macrogol 3350 (MIRALAX) taken for bowel management from 30Mar2021 and ongoing; senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]) taken for bowel management from 06Apr2021 and ongoing; trazodone taken for sleep and mood from 31Mar2021 and ongoing; and pimecrolimus (ELIDEL cream) taken for seborrhoeic dermatitis from 13Apr2021 and ongoing. The patient previously took cipro [ciprofloxacin] for pseudomonas pneumonia (completed cipro on 31Mar2021). The patient received Diphtheria Pertussis Tetanus (DPT) vaccine on 13Mar2021. On 19Apr2021, the patient experienced diagnosed with COVID19 after receiving vaccine. The patient tested positive for COVID on 19Apr2021. The patient was hospitalized at the time of diagnosis. The pharmacist clarified that the patient had been hospitalized prior to receiving the COVID-19 vaccines and prior to being diagnosed with COVID-19. The patient was not admitted to an Intensive Care Unit. The patient was still hospitalized. The patient did not display clinical signs at rest indicative of severe systemic illness and patient is currently asymptomatic. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The facility was assuming he had exposure but they do not know where the exposure came from or the origin. The patient is on acetaminophen but it is scheduled and he has no documented fever. No new or worsened symptoms/signs during the COVID-19 illness experienced (Multiorgan failure, Respiratory, Cardiovascular, Gastrointestinal/Hepatic, Vascular, Renal, Neurological, Hematological. Dermatological, Other: none). The patient did not receive any additional therapies (event did not require the initiation of new medication or other treatment or procedure) for COVID-19. The patient been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination: the elidel cream, which is a very small amount and applied topically. The patient received his first dose on 01Apr2021. Patient received his second dose yesterday on 19Apr2021. Between the time the patient was administered the vaccine, he also was given a COVID test for placement purposes. The patient tested positive for COVID, and was asymptomatic. The facility that the patient is being transferred to has requested that the pharmacist call to confirm that the patient does not need another dose of the vaccine. The pharmacist confirmed that the patient tested positive for COVID-19 on 19Apr2021. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient underwent lab tests and procedures on 19Apr2021 which included Serum creatinine: 1.04 (normal kidney functioning), CBC: unknown results, Hematocrit: 36.6, Hemoglobin: 12.2 and white blood cells: 5.3; and the patient had an (Unspecified, NAA ICU for the type of COVID test, as reported) COVID19 test with following results: negative on 13Mar2021, negative on 23Mar2021, negative on 26Mar2021 and positive on 19Apr2021. The outcome of the events was unknown.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded in a context of LOE.


VAERS ID: 1291209 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-04-10
Onset:2021-04-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISOLONE ACETATE; MOXIFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: LASIK eye surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: CAT scan; Result Unstructured Data: Test Result:determined it was not a stroke, its bells palsy
CDC Split Type: USPFIZER INC2021441401

Write-up: Bell''s palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient, height: 66.22 cm & weight: 175 kg, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 17:00 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in the clinical trial. Medical history included LASIK eye surgery. Concomitant medication(s) included prednisolone acetate (manufacturer unknown) and moxifloxacin (manufacturer unknown) both were taken after LASIK eye surgery. On 19Apr2021 12:30, the patient experienced Bell''s palsy. The clinical course was described as follows: On 19Apr2021 at 12:30, the patient was eating lunch and he noticed the left side of his face was a little numb. The patient states he thought originally that he might be having an allergic reaction, but he was eating the same food that he always eats so it couldn''t have been that and sort of ignored it. About 21:30, 22:00 at night (19Apr2021), he realized in the shower that he could not open his right eye, right eyelid, then his face was numb and he couldn''t form his mouth to make a whistle, and he still can''t, and he thought he was having a stroke because his face was all messed up. So that''s when he went to the emergency room and they did a CAT scan that determined it was not a stroke, it is Bell''s Palsy. The patient stated they prescribed him medications to take, and he was not hospitalized and discharged home. The patient stated his eyelids, they don''t blink at the same rate and his left eye doesn''t close all the way, he had to force it closed and it''s very annoying. The patient verified that all his symptoms began on 19Apr2021 at 12:30 and all symptoms have worsened. The patient stated that he is perfectly healthy, not overweight and he''s never had it before, and it came right out of the blue. The clinical outcome of the Bell''s palsy was not resolved.


VAERS ID: 1291256 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-07
Onset:2021-04-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EV8732 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Neck pain, Palpitations, Pericarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes)
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: body temperature; Result Unstructured Data: Test Result:low grade fever
CDC Split Type: USPFIZER INC2021442537

Write-up: Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down; Heart palpitations; left armpit with pain radiating to entire left shoulder through the middle of the neck; low grade fever; severe fatigue; slightly dry cough; This is a spontaneous report from a contactable consumer reporting for himself. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EV8732/expiration date: not provided), via an unspecified route of administration, on 07Apr2021 at 13:45 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included COVID-19 on an unspecified date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021 at 22:00, the patient experienced similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, Heart palpitations, left armpit with pain radiating to entire left shoulder through the middle of the neck, low grade fever, severe fatigue and slightly dry cough. The events required a physician''s office visit. The patient received treatment for these events. The clinical course of the events was as follows: Heart palpitations originating under left armpit with pain radiating to entire left shoulder through the middle of the neck. Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, low grade fever, severe fatigue, and slightly dry cough. Lasted about 30 hours. Discomfort relief, like pericarditis, was only felt when sitting up and propping myself up by my arms leaning forward. Onset was rapid, occurring 13 days after the first dose of the vaccine over a period of 8 hours (palpitations came first, followed by shoulder and neck pain in the morning). Treated with Aspirin at first (low effectiveness) followed by NSAID Advil 7 hours later (high effectiveness, symptom relief was about 50%). High strength Advil recommended by MD. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1291274 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Hypersensitivity, SARS-CoV-2 test
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021442629

Write-up: Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0162) via an unspecified route of administration, administered in Arm Right, at the age of 54-year-old, on 19Apr2021 11:45, as SINGLE DOSE for covid-19 immunisation. Medical history included Auto Immune Mixed Connective Tissue Disease and allergies to sesame seeds. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took codeine and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot Number ER8727) via an unspecified route of administration, administered in Arm Right, at the age of 54-year-old on 29Mar2021 11:30, as SINGLE DOSE for covid-19 immunisation. There are no other vaccines received in four weeks and no other medications in two weeks. On 19Apr2021 12:00 PM, the patient experienced severe allergic reaction requiring ambulance to er hospital and administration of epipen injection, IV steroids, antihistamines and histamine blockers. The patient was admitted in the hospital in Apr2021 for 1 day. Covid test (nasal swab) on 19Apr2021 showed negative result. Outcome was recovering.


VAERS ID: 1291280 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-05
Onset:2021-04-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       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: Renal disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Covid-19; Test Result: Positive
CDC Split Type: USPFIZER INC2021442695

Write-up: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for Covid-19 immunization. Medical history included ongoing kidney disease. Concomitant medications were not reported. The patient stated he had the first dose of the vaccine on 05Apr2021 and was supposed to go for the second dose on 26Apr2021, but on 19Apr2021, Monday, he tested positive for Covid-19 after first dose of vaccine. He asked if he should still go to his appointment on 26Apr2021 to get his second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on 19Apr2021. Outcome of the events was unknown. Information on the batch/lot number has been requested.


VAERS ID: 1291335 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Electrocardiogram, Heart rate, Heart rate increased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), 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: Food allergy
Allergies:
Diagnostic Lab Data: Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal sinus rhythm; Test Name: heart rate; Result Unstructured Data: Test Result:base line is 65-72; Test Date: 20210419; Test Name: heart rate; Result Unstructured Data: Test Result:rapidly increased, and it got up to 160; Test Date: 20210419; Test Name: heart rate; Result Unstructured Data: Test Result:95 to 100; Test Date: 20210420; Test Name: heart rate; Result Unstructured Data: Test Result:65 to 70
CDC Split Type: USPFIZER INC2021466579

Write-up: does not know if this is considered a anaphylactic reaction; her heart rate rapidly increased, and it got up to 160; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history included food allergy. Concomitant medications were not reported. On 19Apr2021, shortly after the vaccination, the patient''s heart rate rapidly increased, up to 160. Her heartbeat also increased in intensity. The patient did not have any skipped heart beats. The patient''s baseline heart rate was 65-72. The reporter did not know if it was considered an anaphylactic reaction and queried whether this was a full anaphylactic reaction. Within half an hour, the patient''s heart rate was down to 95 to 100. The rest of the day, the patient rested, drank fluids, and had no stimulants. Today (20Apr2021), the patient''s heart rate was back to her baseline at 65 to 70. The reporter preformed an electrocardiogram on the patient on an unspecified date, and it showed normal sinus rhythm. The reporter asked if the patient should get the second dose of the vaccine. The clinical outcome of anaphylactic reaction was unknown, while of "her heart rate rapidly increased, and it got up to 160" was resolved on 20Apr2021. Information about batch/lot number has been requested.; Sender''s Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylactic reaction cannot be excluded. The case will be reassessed if additional information becomes available.


VAERS ID: 1293929 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-05
Onset:2021-04-19
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test positive
SMQs:, 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: confirmed with two rapid antigen tests on 4/22 and 4/27.
CDC Split Type:

Write-up: Contracted covid-19 . Symptoms (fever, chills, body aches, headache) from 4/19 thru 4/24


VAERS ID: 1294020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210504393

Write-up: SWOLLEN LEG; CALF PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced swollen leg. On 19-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen leg and calf pain was not reported. This report was non-serious.


VAERS ID: 1294092 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Speech disorder, Walking disability
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20211

Write-up: brain hemorrhage; Can not Walk; Can not speak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not Walk) and SPEECH DISORDER (Can not speak) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain hemorrhage) (seriousness criterion hospitalization). On 30-Apr-2021, the patient experienced WALKING DISABILITY (Can not Walk) (seriousness criterion intervention required) and SPEECH DISORDER (Can not speak) (seriousness criterion intervention required). The patient was hospitalized on sometime in April 2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not Walk) and SPEECH DISORDER (Can not speak) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient ended up going to Hospital by ambulance and underwent t emergency surgery. She stayed in ICU and in at the time of report, she was still hospitalized.; 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: 1294689 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Heart rate, Heart rate increased, Paraesthesia, Paraesthesia oral
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), 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: Medical History/Concurrent Conditions: Asthma; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: bpm; Test Date: 20210419; Test Name: heart rate; Result Unstructured Data: Test Result:110; Comments: bpm
CDC Split Type: USPFIZER INC2021444303

Write-up: heart rate jumped from a normal 70 bpm to 90 then 110; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; It was hard to swallow; taking a breath felt empty; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 19Apr2021 12:30 (39-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history included psoriasis and asthma as a kid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received ustekinumab (STELARA) 90mg on 24Jan2021; previously received sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies. At the 13 minute mark of the safety wait time, his face, tongue, lips and arm went extremely tingly. It was hard to swallow, taking a breath felt empty and his heart rate jumped from a normal 70 bpm to 90 then 110 while sitting within a few seconds of the tingling starting. He sat for 10 more minutes then left the pharmacy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1294832 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-12
Onset:2021-04-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Myocardial infarction, Myocardial necrosis marker, Oxygen saturation, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Echo Cardiogram; Result Unstructured Data: normal; Test Date: 20210121; Test Name: EKG; Result Unstructured Data: results; Test Date: 20210121; Test Name: Heart Enzymes; Result Unstructured Data: Raised; Test Date: 20210121; Test Name: Blood O2 level; Result Unstructured Data: normal
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Suspected heart attack; Severe Chest and arm pain; Severe Chest and Arm pain; The injection site became hot to the touch; Itching injection site; Painful Injection Site; Hard to the touch; Raised red spot on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Raised red spot on the injection site). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE PAIN (Painful Injection Site). On 21-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Suspected heart attack) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Severe Chest and arm pain) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Severe Chest and Arm pain) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 22-Apr-2021 due to PAIN IN EXTREMITY, and then on 21-Apr-2021 due to MYOCARDIAL INFARCTION. On 27-Apr-2021, VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Raised red spot on the injection site) and VACCINATION SITE PAIN (Painful Injection Site) had resolved. On 29-Apr-2021, MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Echocardiogram: normal (normal) normal. On 21-Jan-2021, Electrocardiogram: normal (normal) results. On 21-Jan-2021, Myocardial necrosis marker: raised Raised. On 21-Jan-2021, Oxygen saturation: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 21-Apr-2021, the patient had severe chest and arm pain. She went to the emergency room. The ER doctor suspected a heart attack. She was hospitalized overnight under observation and was released the next day. No relevant concomitant medications were provided. No treatment information was provided. Company Comment: Very limited information regarding the events (Myocardial infarction) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.; Sender''s Comments: Very limited information regarding the events (Myocardial infarction) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.


VAERS ID: 1210183 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-04-07
Onset:2021-04-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan potassium 50 mg
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Charlie horse pain in left calf . Subsided 3 days later.


VAERS ID: 1225302 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-20
Onset:2021-04-18
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism, Troponin increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, venous (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: ACL tear
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: CT PE demonstrating pulmonary embolism and elevated troponins
CDC Split Type:

Write-up: Submassive pulmonary embolism leading to shortness of breaht


VAERS ID: 1225463 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tinnitus
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, Ashwanghanda, Turmeric, Trazadone, Glucosamine
Current Illness: None
Preexisting Conditions: Chronic Pain
Allergies: Contrast IVP Dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinnitus. Woke up with loud ringing in both ears, which has yet to subside. This has never happened to me in 61 years, so I''m very sure this is related to the shot. Prior to that, I had run a fever, and had my whole upper arm swollen and hot , which have both just started to subside.


VAERS ID: 1225900 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-03-21
Onset:2021-04-18
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood fibrinogen increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea decreased, Creatinine renal clearance increased, Fibrin D dimer, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, International normalised ratio normal, Lipase normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Platelet count decreased, Protein total normal, Pulmonary embolism, Red blood cell count decreased, Red cell distribution width normal, Thrombocytopenia, Troponin I normal, White blood cell count normal
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: none
Allergies: NKDA
Diagnostic Lab Data: Na:138 mmol/L K: 4.6 mmol/L Cl: 100 mmol/L Bicarb: 28 mmol/L BUN: 8 mg/dL Cr: 0.9 mg/dL eGFR: 101 * Cr. Clearance: 155 mL/min * Glucose: 179 mg/dL H Ca: 9.5 mg/dL T. Protein: 7.2 gm/dL Albumin: 4.6 gm/dL Bili: 1.0 mg/dL Alk Phos: 57 U/L AST: 16 U/L ALT: 28 U/L AGAP: 10 mmol/L Lipase: 5.0 U/L L Troponin I: <0.01 ng/mL WBC: 7.6 x10^3/mm3 RBC: 4.69 x10^6/mm3 Hgb: 15.6 gm/dL Hct: 44.7 % MCV: 95.3 fl MCH: 33.3 pg MCHC: 34.9 gm/dL RDW: 11.4 % L Plt: 129 x10^3/mm3 L d-Dimer: 2.53 mcg/mL (FEU) * H Fibrinogen: $g700 mg/dL * H INR: 1.0 * PTT: 31.3 sec All labs performed on 4/18/21
CDC Split Type:

Write-up: Patient with large pulmonary embolism. Associated thrombocytopenia. No provoking factor identified.


VAERS ID: 1226164 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Pain
SMQs:, Peripheral neuropathy (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: No
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Burning, Aching, Capsulated.


VAERS ID: 1226385 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-02
Onset:2021-04-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 0411A21A / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Postmenopause, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Spotting post menopause


VAERS ID: 1226447 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (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:

Write-up: headache, body aches, fever, brain fog, dizziness, leg pains,


VAERS ID: 1226472 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-11
Onset:2021-04-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling
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: Myo-inositol/d-chiro inositol and a women''s prebiotic. Both are from the brand Intimate Rose.
Current Illness: None.
Preexisting Conditions: PCOS.
Allergies: Shellfish.
Diagnostic Lab Data: I haven''t gone to the doctor yet. It just happened, and it''s a Sunday.
CDC Split Type:

Write-up: I don''t know if this is related or not, but it''s better to be safe than sorry, right? I''ve never had any kind of problems with my eyes before, and today while I was at work my left eye started swelling, and now I have this weird bump or bubble that looks like a blister on my eye. I have no idea what it is or where it came from.


VAERS ID: 1227024 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Malaise, Myalgia, Nausea, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (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: I have not been to the doctor?s office yet. Just spoke to him on the phone.
CDC Split Type:

Write-up: The day after my vaccine I became really sick. Severe nausea, dizziness, headache, muscle aches and weakness. None of these symptoms have improved and now I have constant ringing in my ears that started this morning and has not stopped.


VAERS ID: 1227195 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-07
Onset:2021-04-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042AZ1A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Headache, Lethargy
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: None.
Current Illness: None
Preexisting Conditions: Fibromyalgia
Allergies: Latex, and seasonal allergies.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lethargy, heaviness in chest, oncoming headache, fatigue


VAERS ID: 1227408 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EQ0162 / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Influenza like illness, Pain, Pyrexia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (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: Headache for two days after first dose - 43
Other Medications: Tylenol Extra Strength
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Intense flu like symptoms. Fever, body aches....enhancement of tinnitus.


VAERS ID: 1227413 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Write-up: Hives just below injection site. Appeared approximately 1 week after the vaccine was received


VAERS ID: 1227418 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-04-18
Onset:2021-04-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031B21A / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: alprazolam, falmina birth control, lamotrigine, ketorolac, acyclovir, fluconazole,
Current Illness: no
Preexisting Conditions: not disclosed
Allergies: nkda
Diagnostic Lab Data: Unknown, she went to ER for monitoring.
CDC Split Type:

Write-up: Patient was seated, given injection IM into right deltoid and immediately fainted and gave a jerk of the body. Immunizing pharmacist yelled out for Rapid Response from the ER. Emergency room staff was on scene within 1 minute. They measured patients pulse and BP and took her to the emergency room for monitoring. Patient was gone from immunizing area for 30 minutes. She came back to see us, looking much better and said that she faints all the time. She remarked she was glad she was seated because when she faints when she stands and hits her head she has a sore head for days. She proceeded to schedule her second vaccination utilizing the QR reader we had provided to all patients. Although she didn''t tell us beforehand, afterward she told us she faints all the time, that it isn''t unusual, and that she had deliberately eaten food and drank plenty of liquids before she came so that it wouldn''t be a problem. Patient stated that she was fine and fit to drive and unconcerned about the reaction.


VAERS ID: 1227456 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram, Aphasia
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Atorvastatin Metoprolol
Current Illness: None
Preexisting Conditions: Migraines Hypertension Anxiety Hyperlipidemia Asthma
Allergies: Ceclor Sulfa Augmentin Codeine Doxycycline Nitrofurantoin Amoxicillin Latex
Diagnostic Lab Data: CTA head: no bleed or large vessel occlusion
CDC Split Type:

Write-up: Expressive aphasia and apraxia starting at 5pm on 4/18/21. She went to Hospital and was treated with tPA.


VAERS ID: 1227457 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Syncope, headache, chills, nausea, vomiting


VAERS ID: 1227472 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Arkansas  
Vaccinated:0000-00-00
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / UNK - / -

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

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

Write-up: Toung is swelling.


VAERS ID: 1227480 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Mental status changes, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: fever and altered mental status


VAERS ID: 1227831 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-10
Onset:2021-04-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Chest X-ray, Chest pain, Dyspepsia, Headache, Metabolic function test, Rash, Reduced facial expression
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: Asthma
Allergies: N/A
Diagnostic Lab Data: I was in the Emergency room on 4/15 and they ran all metabolic functions and took chest xrays.
CDC Split Type:

Write-up: Tonight I started to develop pain in my mid-back, where my kidneys are located but only on the left side. I also have headaches that wont stop with electrical zaps in my head. I also have weird digestion noises located near my liver region. I have developed a rash on all of my neck. I also woke up with the left side of my fact frozen, it took a while for it to start working again. Might be Bells Palsy. Non-stop chest pain which has gone from terrible to manageable over the last 10 days.


VAERS ID: 1227991 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-11
Onset:2021-04-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (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: Lisiniprol, vitamins d & c, calcium, elderberry
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Localized swelling, hot to the touch , soreness - all one week out. Was initially sore the two days then disappeared. Returned this weekend.


VAERS ID: 1228249 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Fatigue, headache, nausea, body aches


VAERS ID: 1228281 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-04-10
Onset:2021-04-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 384 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site reaction, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro - 20mg daily Bupropion - 150mg daily
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: On Sunday 4/18 starting at 4:15pm, my vaccine site began to itch, developed a red rash, and became swollen. It is still itchy and swollen, however it is not as extreme as it was when symptoms abruptly began.


VAERS ID: 1228283 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Chills, body aches, pain at injection sight


VAERS ID: 1228464 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: As of 4/18 called reported breaking out in hives on her shoulders, which she''s never had before in her life, but got better after taking Benadryl. She is still itchy and knows that she has hives from her head to her toes and is feeling better today but wanted to report the effects.


VAERS ID: 1228511 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-29
Onset:2021-04-18
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Limb discomfort, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (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? Yes
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: 4/19 is following up with md today
CDC Split Type:

Write-up: Swelling in both legs and tightness in both legs. Has md appointment today 4/19


VAERS ID: 1228553 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-05
Onset:2021-04-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Fibrin D dimer increased, Mental status changes, Pain, Platelet count decreased, Portal vein thrombosis, Retching, Thrombocytopenia, Venous occlusion, Venous thrombosis limb
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CITALOPRAM, METOPROLOL TARTRATE
Current Illness:
Preexisting Conditions: HYPERTENSION
Allergies: PENICILLIN
Diagnostic Lab Data: Platelets: 4/15 12:31 92 4/16 07:00 36 4/16 15:00 32 4/17 08:52 23 4/18 07:48 19 4/19 05:20 28
CDC Split Type:

Write-up: The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.


VAERS ID: 1228656 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016B21A / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Akathisia, Dyskinesia, Restlessness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: Injection site pain, muscle and joint pain, fatigue
Other Medications: Lamotrigine er Doxepin
Current Illness: none
Preexisting Conditions: Epilepsy
Allergies: Tegretol
Diagnostic Lab Data: Akathisia muscle quivering, restlessness, and inability to sit still, stop yawning and stretching and rocking body Felt like I wanted to jump out of my skin
CDC Split Type:

Write-up: Akathesis Extreme urge to move body


VAERS ID: 1228688 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: Shellfish
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever


VAERS ID: 1228717 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-03
Onset:2021-04-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 25 mcg daily Calcium supplement Fish oil
Current Illness:
Preexisting Conditions: Alopecia areata
Allergies: Penicillin Seasonal pollen allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme hives on neck and jaw.


VAERS ID: 1228845 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-08
Onset:2021-04-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Electrocardiogram, Pulmonary pain, Urine analysis
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, Synthroid, Cymbalta, Caltrate calcium, B6, B12, Probiotic, Apple Cider vinegar gummies, zinc, elderberry, Glucosamine/Chondroitin
Current Illness: none
Preexisting Conditions: Mild Copd. Arthritis
Allergies: Penicillian
Diagnostic Lab Data: ekg, chest xray, CT scan, bloodwork and urine tests
CDC Split Type:

Write-up: pain in lower left lung under breast. hurt to breathe, prescribed steroids and pain patch. was told no sign of clot, possible pleurisy.


VAERS ID: 1228894 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-03-16
Onset:2021-04-18
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Haematoma, Pain in extremity, Pain of skin, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Dicyclomine, MVI (prn-Hydroxyzine, Ibuprofen, Acetaminophen)
Current Illness:
Preexisting Conditions: IBS, anxiety, Laparoscopic sleeve gastrectomy 05/31/2019 fistula repair of gastric sleeve anastomosis
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt is a 24 year old male with hx of IBS and anxiety with reported swelling and pain to the left shin that just popped up prior to presenting to ER. Complained of pain on Lt shin that started while he was standing at the sink. Started stinging, looked down at shin, he stated it started swelling and stinging. Does not remember any injury, but is unsure. DX - Hematoma to the left lower extremity. BP 155/72 Temp-98.0 HR 77 R- 18


VAERS ID: 1229014 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Brain scan abnormal, Magnetic resonance imaging head abnormal, Scan, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin/ blood pressure medications
Current Illness: Diabetic
Preexisting Conditions: Diabetic/ high blood pressure
Allergies: None
Diagnostic Lab Data: Scan and mri
CDC Split Type:

Write-up: 6 days after vaccination, patient had mini stroke and hospitalized


VAERS ID: 1229236 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax abnormal, Fall, Fibrin D dimer increased, Hemiparesis, Magnetic resonance imaging head normal, Pulmonary embolism, Troponin
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: aspirin 81mg daily, atorvastatin 10mg daily, diclofenac 50mg bid prn, duloxetine 20mg daily, gabapentin 300mg bid
Current Illness: no known
Preexisting Conditions: neuropathy, arthritis, non-smoker
Allergies: no known allergies
Diagnostic Lab Data: Imaging: CT head and brain MRI 4/18 no intracranial abnormality; CT chest 4/18 acute pulmonary embolism d-dimer: 4/18 = 7.6mcg/ml; troponin (highest) 4/18 = 0.114ng/ml
CDC Split Type:

Write-up: Per history, patient experienced a ground-level fall early 4/16, and was noted to have weakness on his left side. Patient was brought to the ER 4/18 with concern for CVA, found to have acute pulmonary embolism.


VAERS ID: 1229368 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia, Lacunar stroke, Platelet count normal
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Platelets: 4/18 0330: 216 4/29 0536: 169 4/30 1111: 176
CDC Split Type:

Write-up: Patient presented to ED with right sided numbness including arm, leg and body. Face not involved. Over 14 days since J&J COVID vaccine. Patient admitted with left thalamic stroke, neurologist involved, not believed to be related to vaccine. Started on aspirin 325 mg daily and Plavix. Still hospitalized.


VAERS ID: 1230166 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / N/A LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Hives all over body occurring April 18. Vaccine received April 9.


VAERS ID: 1230235 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Cerebral infarction, Computerised tomogram head abnormal, Nervous system disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Almlodipine/hydrochlorothiazide/olmesartan Atorvastatin
Current Illness:
Preexisting Conditions: Hypertension, hyperlipidemia, tobacco use
Allergies: Penicillin, seafood
Diagnostic Lab Data: Head CT scan resulted with suspected acute infarct in left parietotemporal region
CDC Split Type:

Write-up: Neurological motor deficit with suspected acute infarct found on CT scan


VAERS ID: 1230341 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-16
Onset:2021-04-18
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Blood test, Computerised tomogram abnormal, Dry mouth, Loss of consciousness, Pulmonary embolism, Scan, Thirst, Thrombosis, Visual impairment
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Meloxicam
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: According to patient, she woke up at 2:00 a.m. to use the restroom and noticed she had a very dry mouth and was thirsty. She passed out and when she came to she experienced decreased vision. She was taken to the emergency room via ambulance for tests. She was diagnosed with a blood clot to her lungs after CT scans. She also had aditional scans and blood work and stayed at Hospital in town (I am having trouble adding this to the shaded area in question 21).


VAERS ID: 1230404 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-06
Onset:2021-04-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram thorax, Dyspnoea, Full blood count, Platelet count decreased, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Alendronate, bupropion, calcium, levothyroxine, loratadine, losartan, metoprolol, omeprazole, simvastatin
Current Illness: unknown
Preexisting Conditions: HTN, hypothyroid, GERD, smoker
Allergies: NKDA
Diagnostic Lab Data: 4/18/21 - CTA Chest, CBC
CDC Split Type:

Write-up: Presented to Hospital for dyspnea. Diagnosed with large right sided pulmonary embolism; platelet count 138 T/UL at time of ER visit. Transfer to larger facility for higher level of care on 4/19/21.


VAERS ID: 1230785 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN CHADOX1 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Acute kidney injury, Acute respiratory failure, Atrial fibrillation, Blood creatinine increased, Blood urea increased, Carbon dioxide decreased, Computerised tomogram thorax, Endotracheal intubation, Intensive care, Pulmonary embolism
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown patient intubated
Current Illness: unknown patient intubated
Preexisting Conditions: none
Allergies: unknown
Diagnostic Lab Data: CT scan of the lungs Co2 21mEq/L, Creatinine 1.7, BUN 44mg/dL, PTT $g200.0 remains in ICU as of 4.19.2021
CDC Split Type:

Write-up: Acute respiratory failure- bilateral pulmonary emboli. Acute renal injury. New onset of atrial fibrillation. Patient in ICU intubation occurred on 4.18.2021


VAERS ID: 1231358 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Hyperacusis, Sleep disorder
SMQs:, Hearing impairment (narrow)

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

Write-up: Fast and constant low frequency throbbing or tapping sound in my left ear that would go on continually and briefly pause and then resume. I noticed that if I put in an earbud or there is sufficient noise, I do not notice it but otherwise it is fairly annoying and made it harder to fall asleep. I took a hot shower and it seemed to help but the sound came back not long after.


VAERS ID: 1231360 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dermatitis allergic, Injection site pruritus, Rash papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: ?delayed cutaneous hypersensitivity? or COVID arm. Raised, red bump approx. 1.5? in diameter and mild itchiness at injection site


VAERS ID: 1231361 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Sensitive skin
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: after 6 days after shot the area of injection has swelled up and is red and itchy. it is very sensitive to the touch.


VAERS ID: 1231373 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Injection site erythema, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (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: swelling in left armpit
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: large red raised patch on left arm (approximately 4" under injection site)


VAERS ID: 1231397 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037A21B / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain, Vaccination site pain, Vaccination site swelling
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol; Lisinopril-HCTZ; Lactaid Dairy Relief; Vitamins B, C, D, Zinc; supplements olive leaf extract, astragalus root,.
Current Illness: None.
Preexisting Conditions: Hypertension, benign.
Allergies: Lactose intolerance. No allergies to medications.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Beginning at approximately 11am the day after vaccination, experienced chills, headache, extreme fatigue, swollen and sore arm at vaccination site, general body aches, and significant nausea. Symptoms resolved by the following morning.


VAERS ID: 1231399 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Back pain, Chills, Fatigue, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling, Pain
SMQs:, Retroperitoneal fibrosis (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: Trisprintec, trazodone, spironolactone
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: Penicillin, sulfa
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: 4/17: 2nd dose moderna vaccine 4/17 night: chills during the night 4/18 morning and day: very achy (exacerbated previous back pain that I have on and off) and exhaustion, swelling at injection site 4/19 additional swelling and redness at injection site, hard lump under skin at injection site and circular red patch, a little itchy


VAERS ID: 1231442 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-07
Onset:2021-04-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036BZIA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril, Metformin, Zetia, Baby Aspirin, Zinc, Calcium, Vitamin D3, Vitamin B12, Multivitamins
Current Illness: None.
Preexisting Conditions: Hypertension, Type II Diabetes, dyslipidemia, hypothyroidism, allergic rhinitis, cod fish allergy
Allergies: cod fish allergy, hypersensitivities to statin drug and amoxicillin.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: On Day 11 (4/18/2021) after receiving the vaccine, mild itching skin rash first appeared around inguinal areas then covered neck and all extremities. As of Day 12 (today), the condition is still ongoing, I applied 2% Benadryl cream once daily before bedtime, the itchy seems to be under control. Therefore, I don''t need to see my doctor yet. (I may send her an FYI email after this) The related cause may be the small piece of salmon fish I had on Day 9 (4/16/2021) at dinner. In my history, I had seafood allergy before my elementary age, but it was gone for many years until my peri-menopause years, there were a couple of occasions that I had severe itching hives after eating not freshly made cod fish dishes. However, I do eat Salmon on regular bases (3-5 times/month) and have never had salmon allergy in my adulthood.


VAERS ID: 1232024 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Muscle spasms, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (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: No illnesses reported
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s mother called to report a new fever 3 weeks post-vaccination. Fever reported was 102.6. Patient also experiencing muscle spasms in his mid to upper back as well as a swollen lymph node in his leg.


VAERS ID: 1232593 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-04-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cerebrovascular accident, Pulmonary embolism
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow)

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

Write-up: pulmonary embolism and CVA suffered approximately 2 weeks post vaccination


VAERS ID: 1233047 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Coagulation test abnormal, Deep vein thrombosis, Full blood count, Metabolic function test, Pain in extremity, Pregnancy test, SARS-CoV-2 test, Ultrasound scan, X-ray
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oxycodone-apap 5mg/325mg, Ibuprofen 600mg
Current Illness: Patient fell on 4/9/2021 twisting her left ankle and falling onto right hip. C/O severe left ankle/foot pain and right hip pain.
Preexisting Conditions: PMH of DVT and CVA, approximately 2016
Allergies: metoclopramide
Diagnostic Lab Data: CBC, Coag, metabolic panel, pregnancy test, covid-19 pcr, ultrasound, xrays
CDC Split Type:

Write-up: 38 y/o F pt with a PMH of DVT, CVA, presents to the ED with complaints of left thigh and calf pain. Diagnosis of DVT in left leg.


VAERS ID: 1233184 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bone pain, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (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: Influenza - flu type symptoms
Other Medications: Amlodipine 10mg Tylenol 500mg
Current Illness: None
Preexisting Conditions: Hypertension, arthritis
Allergies: Alcohol, sulfa, azithromycin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Bone and muscular pain in legs


VAERS ID: 1233192 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-12
Onset:2021-04-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Feeling cold, Hyperhidrosis, Piloerection, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bactrim Cephalexin (4/12-4/19)
Current Illness: No
Preexisting Conditions: Positive for Covid 1-22-2021
Allergies: We think Bactrim . But I have taken these antibiotics several times (4-6 times) over the last 4 years with no allergic reaction. Wanted to consider my vaccine being a factor in this
Diagnostic Lab Data:
CDC Split Type:

Write-up: On the evening of 4-18-2021, I noticed the palms of my hands and feet were extremely itchy. Lotion did not relieve the itch I eventually put ice on them so I was able to sleep. I woke up 4-19-2021 and felt itchy all over but no noticeable rash. I took my last antibiotic pill around 9 am. By 2:00pm I started getting small ?hives? on my arms. By 4pm my arms were covered and my chest and neck had began to break out. By the time I reach the urgent care (4:45pm) my back and stomach, and upper legs had become affected also. I received a steroid shot in the muscle of my buttocks. I got home around 6pm and put cool towels on my legs and eventually the rash was almost completely gone. I woke up 4/20 around 6am with the chills and goosebumps all over feeling cold, but sweating like crazy. The rash/hives had came back and even worse/covering more of my body than before. I am now taking Prednisone 2x per day for the next 7days starting 4/20 11am


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