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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 39 out of 1,889

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VAERS ID: 1269196 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Odynophagia, Swelling face, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Oropharyngeal infections (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:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Prevention; Comments: The patient has no known allergies or history of drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210452664

Write-up: SWELLING ON RIGHT SIDE OF FACE; SWOLLEN TONSIL; PAINFUL SWALLOWING; This spontaneous report received from a patient concerned a 45 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included filler on face, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient has no known allergies or history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced swelling on right side of face. On 14-APR-2021, the subject experienced swollen tonsil. On 14-APR-2021, the subject experienced painful swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling on right side of face, and the outcome of swollen tonsil and painful swallowing was not reported. This report was non-serious.


VAERS ID: 1269571 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Insulin, Vitamin D-3, Farxiga
Current Illness:
Preexisting Conditions: Diabetes
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Ringing in my ears.


VAERS ID: 1269545 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic (antidepressant allergy); COVID-19; Depression; Pre-diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021412242

Write-up: had 5 small seizures; felt very dizzy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 09:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included pre-diabetes and depression. Patient was not pregnant. The patient''s concomitant medications were not reported. There were no other vaccine in four weeks. The patient previously took antibiotics and antidepressants and experienced allergies. 5 minutes after getting the vaccine, patient felt very dizzy. She had 5 small seizures on 14Apr2021 10:45 which resulted in emergency room/ urgent care. Treatment was received for the events. Outcome was recovering. Patient had covid prior to vaccination on an unspecified date and had not been tested post vaccination.


VAERS ID: 1269551 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILINA CLAV [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eye allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Blood pressure; Result Unstructured Data: Test Result:everything was fine; Test Date: 20210414; Test Name: vitals; Result Unstructured Data: Test Result:everything was fine
CDC Split Type: USPFIZER INC2021413103

Write-up: fell out completely; passed out/fell off at the store; feeling dizzy; had terrible headache; chills; weak with shilling; i started sweating; I''m still feeling very sick; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158; Expiration Date: Jul2021), via an unspecified route of administration, administered in left arm on 14Apr2021 12:00 as single dose for COVID-19 immunisation. Medical history included eye allergy. Concomitant medication included amoxicillin sodium, clavulanate potassium (AMOXICILINA CLAV) taken for eye allergy from 12Apr2021. On 14Apr2021, he received the first dose of the vaccine about an hour ago and waited five minutes and went to the bathroom. He had a severe reaction while patient was in the bathroom, he started to feel dizzy, had a terrible headache and chills. He walked out of the bathroom at the store and fell out completely in front of the pharmacists. The patient also experienced weak with shilling (as reported) and started sweating. The pharmacists called 911 and the responders checked his vitals and blood pressure and all of that and everything was fine. Patient clarified he passed out completely for almost 5 minutes. Patient stayed there with everyone until, they were waiting to see how he was doing. He reported he was feeling much better now, still feel a bit dizzy, not 100% but not as bad as when it happened. It has improved and he definitely felt terrible at the time. He was monitoring himself at home to see if he notices something weird going on. He does not have a headache right now and was feeling much better. When he was having the effect, he was mentally sharp, and knew what was going on. He thought about letting himself walk outside the bathroom so he could be seen. He didn''t lose track of what was going on and body reacted adversely. He remembered stuff and everything and he felt good. Patient stated the chills went away; however, would not say they went away completely, he was recovering. The events did not require a visit to emergency room or physician office and the paramedic said it was not necessary right now because all the vitals and everything else seemed fine. There was no therapy received for the events. There were no additional vaccines administered on same date of the vaccine and no other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events feeling dizzy, terrible headache, chills was recovering; still feeling very sick was unknown; outcome of the rest of events was not recovered.


VAERS ID: 1269648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Asthenia, Chest discomfort, Gastric disorder, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (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 INC2021414804

Write-up: pains in her chest like a heart attack like her chest was tightening; sick to stomach; throwing up; stomach was hard as a rock; weak; chest was tightening; This is a spontaneous report from a contactable consumer (who is also the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included influenza vaccine (reported as "flu shot") on an unspecified date for immunization which made the patient sick. The patient reported that she woke up early on 14Apr2021 at 03:00 sick to her stomach, throwing up, her stomach was hard as a rock and weak. She had pains in her chest like a heart attack like her chest was tightening. She felt like she was dying. The patient wanted to know how long this sickness from the shot lasts. She stated that she will probably not take the second shot and mentioned that she should go to the emergency room. She wanted to know what they will give her in the emergency room. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1269654 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Dizziness, Loss of consciousness, Nausea, Pallor, Presyncope, Tinnitus, Vision blurred, Vital capacity
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ARMOUR THYROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Hypothyroidism; Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Bloodwork; Result Unstructured Data: Test Result:fine; Test Date: 20210413; Test Name: Vitals; Result Unstructured Data: Test Result:good
CDC Split Type: USPFIZER INC2021414927

Write-up: Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient''s bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.


VAERS ID: 1269685 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chills, Delirium, Headache, Pain, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN CALCIUM]; CIALIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Temperature; Result Unstructured Data: Test Result:Greater than 102 Fahrenheit
CDC Split Type: USPFIZER INC2021415822

Write-up: Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1269689 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Diarrhoea, Dizziness, Nausea, Syncope, Throat tightness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Meningitis
Allergies:
Diagnostic Lab Data: Test Date: 20201222; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021416769

Write-up: faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events. Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.


VAERS ID: 1269693 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Choking, Cough, Epistaxis, Musculoskeletal stiffness, Oropharyngeal pain, Productive cough, Pyrexia, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: ADDERALL; MARIJUANA; CALCIUM; ASPRIN; EXCEDRIN MIGRAINE; ACETAMINOPHEN; MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Post-traumatic stress disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021416951

Write-up: Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks. The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.


VAERS ID: 1269695 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Anaphylactic reaction, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARVEDILOL 1A PHARMA; LISINOPRIL; FENOFIBRATE; JANUVIA [SITAGLIPTIN]; HUMALOG; SYNTHROID; METFORMIN; NORVASC; VITAMIN D NOS; MAGNESIUM; PRAVASTATIN; ASA; CINNAMON; FERROUS SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hyperlipidemia; Hypertension; Hypothyroidism; Latex allergy (known allergies latex); Mitral regurgitation; Morbid obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021417032

Write-up: anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.


VAERS ID: 1269709 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-30
Onset:2021-04-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021417537

Write-up: Left side of face is paralyzed,bell''s palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell''s palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.


VAERS ID: 1269727 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021420633

Write-up: Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1269758 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Diarrhoea, Dizziness, Eye disorder, Eye pain, Headache, Loss of consciousness, Myalgia, Nausea, Presyncope, Seizure, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM 24HR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antacid therapy; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: temperature; Result Unstructured Data: Test Result:99.3
CDC Split Type: USPFIZER INC2021433515

Write-up: Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother''s eyes were open and they saw her mother''s eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.


VAERS ID: 1269771 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-11
Onset:2021-04-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Blood bilirubin, Blood bilirubin abnormal, Disorientation, Hyperhidrosis, Jaundice, Pruritus, Pulmonary pain, Skin exfoliation
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Bilirubin level; Result Unstructured Data: Test Result:12
CDC Split Type: USPFIZER INC2021458321

Write-up: Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1269967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood creatinine, Computerised tomogram thorax, Deep vein thrombosis, Electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, International normalised ratio, N-terminal prohormone brain natriuretic peptide, Pain in extremity, Peripheral swelling, Platelet count, Prothrombin time, SARS-CoV-2 test, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia; Chronic kidney disease; Hypertension; Hypoxic respiratory failure; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: DVT of legs (- not on anticoagulation since and was treated with warfarin x 3 months only)
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Diagnostic ultrasound; Result Unstructured Data: see comments; Test Date: 20210426; Test Name: Prothrombin time; Result Unstructured Data: 28.4; Test Date: 20210426; Test Name: Angiogram; Result Unstructured Data: pending; Test Date: 20210426; Test Name: Computerized tomogram thorax; Result Unstructured Data: pending; Test Date: 20210426; Test Name: ECG; Result Unstructured Data: results not provided; Test Date: 20210426; Test Name: COVID-19 virus test; Result Unstructured Data: pending; Test Date: 20210426; Test Name: Glomerular filtration rate; Result Unstructured Data: 52; Test Date: 20210426; Test Name: Fibrin D dimer; Result Unstructured Data: 3.95; Test Date: 20210426; Test Name: NT-proBNP; Result Unstructured Data: normal; Test Date: 20210426; Test Name: Hemoglobin; Result Unstructured Data: 10.4; Test Date: 20210426; Test Name: Hematocrit; Result Unstructured Data: 33.2 %; Test Date: 20210426; Test Name: Platelet count; Result Unstructured Data: 309; Test Date: 20210426; Test Name: Creatinine; Result Unstructured Data: 1.59; Test Date: 20210426; Test Name: International normalised ratio; Result Unstructured Data: 2.8
CDC Split Type: USJNJFOC20210450840

Write-up: A LEFT UPPER EXTREMITY DVT INVOLVING THE SUBCLAVIAN AND AXILLARY VEIN; LEFT UPPER ARM SWELLING; LEFT UPPER ARM PAIN; This spontaneous report received from a health care professional (nurse practitioner) and concerned a 74 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included DVT (deep vein thrombosis) of lower extremity and was not on anticoagulation since and was treated with warfarin times 3 months only. The concurrent conditions included type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension. The patient was previously treated with warfarin. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered in left deltoid on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient developed a left upper extremity DVT involving the subclavian and axillary vein, left upper arm swelling and had left upper arm pain. On 19-APR-2021, the patient called and notified the office that the left arm was sore and swollen times 4-5 days. A registered nurse did a home visit on 20-APR-2021 and recommended an ultrasound to be done. On 26-APR-2021, the ultrasound confirmed a left upper extremity DVT involving predominantly the subclavian and axillary vein. On 26-APR-2021, Laboratory data included: CT Angiogram (to rule out pulmonary embolism) pending, COVID-19 virus test (NR: not provided) pending, Computerized tomogram thorax (NR: not provided) pending, Creatinine (NR: not provided) 1.59, ECG (Electrocardiogram) results not provided, Fibrin D dimer (NR: not provided) 3.95, Glomerular filtration rate (NR: not provided) 52, Hematocrit (NR: not provided) 33.2 %, Hemoglobin (NR: not provided) 10.4, International normalised ratio (NR: not provided) 2.8, NT-proBNP (NR: not provided) normal, Platelet count (NR: not provided) 309, and Prothrombin time (NR: not provided) 28.4. The patient was treated with rivaroxaban, 15 mg, oral, twice a day. The patient was currently in the emergency room with testing pending. The patient did not have other symptoms to report or note. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left upper arm swelling, left upper arm pain, and a left upper extremity dvt involving the subclavian and axillary vein. This report was serious (Life Threatening).; Sender''s Comments: V0: This 74-year-old male patient was found to have left upper extremity deep vein thrombosis (DVT) confirmed by ultrasound 17 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient has underlying type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension; the patient had prior history of DVT of lower extremity of unspecified date and was treated with warfarin for 3 months. No concomitant medications were reported. The symptom reported left upper arm pain and swelling 5 days after vaccination; persistence prompted consult with a registered nurse the recommended ultrasound; which revealed left upper extremity DVT involving predominantly the subclavian and axillary vein. Platelet count 309, Prothrombin time 28.4, INR 2.8, NT-proBNP normal, Fibrin D-dimer 3.95, GFR 52; awaiting result of CT and CT angiogram, COVID test, and ECG. The patient was treated with rivaroxaban. No other details reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.


VAERS ID: 1270180 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

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

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: Spironolactone and birth control pill
Current Illness: None
Preexisting Conditions: Asthma Tmj
Allergies: Neomycin
Diagnostic Lab Data: I have an MRI scheduled but not til 5/18 I went to the dr 4/19 and she just ran some basic tests like making sure my eyes moved at different things
CDC Split Type:

Write-up: Exactly one week after my shot (4/14) I felt a headache in the evening. It felt like it was sinus related so I figured it was allergies. However it continued the next day so I tried Advil. It kept going. It has now been 2 weeks and a day since the headaches started and I still have them. They go away late at night and return shortly after I wake up. They feel like tension headaches in the back of my head and also sinus headaches. I was concerned about clots so I went to the dr on 4/19. She did not think it was clots because the headaches were not severe and I had no other symptoms. She had me do different tests and concluded I had no neurological issues. She gave me a prescription for butalb-apap-caf50. This did not help. She also told me not to drink alcohol so I didn?t. I started feeling better on 4/24. I had a little to drink and my head hurt really bad. My headache was practically nonexistent 4/25 so I had one glass of wine. Not even half way through that glass, the head feeling from last night came back. The next day my headaches were back and have now continued since. I stopped drinking and have not felt that bad feeling in my head at night since. The headaches aren?t severe but they really suck. They make it hard to do things and all I want to do is lie down even though that doesn?t help. Exercise and walks sometimes help. No medication has made any noticeable difference.


VAERS ID: 1270841 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A211A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Menstruation irregular, Pain
SMQs:, Fertility 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: Adderall ER, Bupropion, Nexplanon implant
Current Illness: none
Preexisting Conditions: hypermobility in joints
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was on day 5 of my period when I got the vaccine. It lasted another 15 days after the vaccine and I am still spotting. Also the normal aches and fatigue.


VAERS ID: 1271104 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Cerebral venous sinus thrombosis, Chest discomfort, Computerised tomogram abdomen normal, Computerised tomogram head normal, Facial paralysis, Head discomfort, Headache, Hypoaesthesia, Immediate post-injection reaction, Induration, Magnetic resonance imaging head normal, Platelet count normal, Transverse sinus thrombosis, Venogram abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hearing impairment (broad), Hypersensitivity (narrow)

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: Methadone 50mg daily Metrololol Tartrate 100mg daily Remeron 15mg daily
Current Illness: None
Preexisting Conditions: HTN DM controlled by diet H/O IV drug abuse 15 years ago heroin
Allergies: None
Diagnostic Lab Data: 4/28 CTH negative 4/28 MRI Brain negative 4/29 MRV Brain Venous sinus thrombosis left transverse sinus also suggested medially extending to the sigmoid sinus 4/28 Platelets 221, 4/29 177
CDC Split Type:

Write-up: Immediately after the injection patient felt a pressure like and felt a ball on the back of his head left side that resolved within a day. Within a week from vaccine patient started having a headache on and off with feeling of like his brain is swelling on the left side. Within another week patient experienced abdominal pain and chest pressure. went to a hospital CT abdomen was negative. On 4/28 patient had a severe headache followed by numbness to left face and left facial droop. 911 was called patient was code stroke in ED.


VAERS ID: 1272315 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Delaware  
Vaccinated:2021-04-11
Onset:2021-04-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Parosmia
SMQs:, Taste and smell disorders (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Since getting the vaccine all I can smell is cigarette smoke and I am a non smoker and not around smokers? It has since given me headaches due to the smell.


VAERS ID: 1272403 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-05
Onset:2021-04-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Rash papular, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ctive Medications as of 04/29/2021: QUETIAPINE 25 MG ORAL TAB, Sig: Take 3 to 5 tablets by mouth at bedtime as needed (insomnia or hallucinations) HYDROCODONE-ACETAMINOPHEN 5-325 MG ORAL TAB, Sig: Take 1-2 tablets by mouth 4 times a day
Current Illness: breast cancer survivor Schizoaffective disorder Obesity Asthma Fibromyalgia Hypertension Cardiomyopathy
Preexisting Conditions: as above
Allergies: Bupropion Hcl Diphenhydramine Hydrochloride.Shock and/or Unconsciousness MorphineRash Sulfa (Sulfonamide Antibiotics)Skin Rash and/or Hives Atorvastatin Calcium Ferrous SulfateSkin Rash and/or Hives IbuprofenSkin Rash and/or Hives LorazepamRash Lovastatin LurasidoneSkin Rash and/or Hives MeloxicamSkin Rash and/or Hives Methocarbamol Naproxen Non-steroidal Anti-inflammatory Agents Oxycodone HclSkin Rash and/or Hives Oxymorphone Hydrochloride Pravastatin Sodium Pregabalin
Diagnostic Lab Data: pending
CDC Split Type:

Write-up: diffuse papular rash, pruritic, mild


VAERS ID: 1276420 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Haemoptysis, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (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: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210444761

Write-up: PHLEGM WITH BLOOD; COUGH; SORE THROAT; This spontaneous report received from a patient concerned a 23 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced sore throat. On 17-APR-2021, the subject experienced phlegm with blood. On 17-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 15-APR-2021, and had not recovered from cough, and phlegm with blood. This report was non-serious.; Sender''s Comments: MAC Comment: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.


VAERS ID: 1276588 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808607 OR 1808 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging, X-ray
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: Alcohol use; Cigarette smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Back injury; Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Laboratory test; Result Unstructured Data: Guillain-Barre Syndrome; Test Date: 20210419; Test Name: X-ray; Result Unstructured Data: Abnormality in neck area; Test Date: 20210421; Test Name: MRI; Result Unstructured Data: No abnormality on neck, old back injury
CDC Split Type: USJNJFOC20210456333

Write-up: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient''s height and weight were not reported. The patient''s past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker''s compensation and was seen by his worker''s comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient''s neck and showed old back injury, but per patient''s doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender''s Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1276590 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Computerised tomogram, Dyspnoea, Hepatic artery thrombosis, Hyperhidrosis, Laboratory test, Splenic thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Laboratory test; Result Unstructured Data: clot in splenic and celiac artery; Test Date: 20210414; Test Name: CAT scan; Result Unstructured Data: clot in splenic and celiac artery
CDC Split Type: USJNJFOC20210456348

Write-up: CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 year old male. 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1276657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2021-04-12
Onset:2021-04-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Balance disorder, Blood test, Chest pain, Dizziness, Electrocardiogram, Fatigue, Feeling abnormal, Headache, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Healthy and not using any medications.
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Platelets and d-dimer were normal; Test Name: ECG; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210458904

Write-up: STOMACH ACHE; FEELS DISTORTED; DIZZINESS; BODY SWAYS; ACHES IN BILATERAL THIGHS AND FRONT/BACK OF CALVES; MUSCLE ACHES; HEADACHES; TIRED; CHEST PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included healthy and not using any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced chest pain. On 28-APR-2021, the subject experienced stomach ache. On 28-APR-2021, the subject experienced feels distorted. On 28-APR-2021, the subject experienced dizziness. On 28-APR-2021, the subject experienced body sways. On 28-APR-2021, the subject experienced aches in bilateral thighs and front/back of calves. On 28-APR-2021, the subject experienced muscle aches. On 28-APR-2021, the subject experienced headaches. On 28-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets and d-dimer were normal, and ECG (NR: not provided) unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 17-APR-2021, had not recovered from muscle aches, headaches, feels distorted, body sways, and stomach ache, and the outcome of tired, aches in bilateral thighs and front/back of calves and dizziness was not reported. This report was non-serious.


VAERS ID: 1276722 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness neurosensory, Ear discomfort, Headache, Suicidal ideation, Tinnitus
SMQs:, Suicide/self-injury (narrow), Hearing impairment (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: CALCIUM; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No Historical Condition reported); Comments: No medical history reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: contemplated suicide; She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss; left ear felt like I am in the plane and need to pop my ear; She had tinnitus/ringing in her ear; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) and SUICIDAL IDEATION (contemplated suicide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the reporter. The patient''s past medical history included No adverse event (No Historical Condition reported). Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Bone disorder NOS. On 13-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) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear), TINNITUS (She had tinnitus/ringing in her ear) and HEADACHE (Headache). On 15-Apr-2021, the patient experienced DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) (seriousness criterion medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (contemplated suicide) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) was resolving, SUICIDAL IDEATION (contemplated suicide), EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear) and HEADACHE (Headache) outcome was unknown and TINNITUS (She had tinnitus/ringing in her ear) had not resolved. Not Provided Treatment medications included prednisone 60 mg for 10 days. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1277264 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-08
Onset:2021-04-14
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3246 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COREG; GABAPENTIN; D3; CYMBALTA; MOTRIN [IBUPROFEN]; ZINC; QUERCITIN; CALCIUM; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLA; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; FLEXERIL [C
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic back pain; Costochondritis; Sinus tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC2021412233

Write-up: tested positive for covid 19 on 14Apr2021; tested positive for covid 19 on 14Apr2021; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received second dose of BNT162B2 (BNT162B2), intramuscular, administered in Arm Right on 08Jan2021 10:00 (Batch/Lot Number: EL3246) as single dose for covid-19 immunization. Medical history included inappropriate sinus tach (sinus tachycardia), chronic back pain and costochondritis all from unknown dates and unknown if ongoing. The patient received first dose of BNT162B2 on 18Dec2020. Concomitant medications included carvedilol (COREG), gabapentin (GABAPENTIN), colecalciferol (D3), duloxetine hydrochloride (CYMBALTA), ibuprofen (MOTRIN [IBUPROFEN]), zinc (ZINC), ascorbic acid, quercetin (QUERCITIN), calcium (CALCIUM), ascorbic acid, dexpanthenol, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]), oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), magnesium (MAGNESIUM) all taken for unspecified indications, start and stop dates were not reported. It was reported that the patient tested positive for covid 19 on 14apr2021, event was reported as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Apr2021. No treatment was received for the event. Outcome of the event was recovering.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported Vaccination failure / COVID-19 cannot be ruled out.


VAERS ID: 1277363 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021416914

Write-up: unconscious; seizure; throwing up while unconscious; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ew0169), dose 1 intramuscular, administered in Arm Right on 13Apr2021 14:45 (at the age of 23years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 14Apr2021 (10:15 PM), the patient was unconscious for about 15 seconds, having a seizure for 5 seconds, and throwing up while unconscious. The adverse events resulted in Emergency room/department or urgent care. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events loss of consciousness, seizure, vomiting and the suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1277756 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Electrocardiogram, Herpes zoster, Laboratory test, Lymphadenopathy, Pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazadone 50mg daily Omeprazole 20 mg daily Vitamin D 5000 IU daily Vitamin B12 1000 mcg daily
Current Illness: None
Preexisting Conditions: Fibromyalgia
Allergies: Blue dye in Zoloft
Diagnostic Lab Data: April20,2021 Hospital ER Labwork , EKG, Chest X-Ray
CDC Split Type:

Write-up: Shingles developed on April 14,2021- eight days after vaccination. Burning pain through left side back to left breast with rash left breast, enlarged lymph nodes left side and left neck, extreme pain which was treated with valtrex, gabapentin, two courses prednisone, Advil, capzacin cream. May 1,2021 pain continues. Seen in Hospital ER April 20,2021 for confirmation diagnosis.


VAERS ID: 1277939 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-16
Onset:2021-04-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Balance disorder, CSF cell count normal, CSF culture negative, CSF protein increased, Dysphagia, Gram stain, Headache, Immunoglobulin therapy, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin, gabapentin, warfarin, clonazepam
Current Illness:
Preexisting Conditions: HLD, BMI, prior pulmonar embli, hashimoto''s thyroiditis, C diff, herpes zoster
Allergies: tetracycline, cefazolin, cheese, chocolate, rosuvastatin, wine, naprosyn
Diagnostic Lab Data: lumbar puncture with no cells, protein of 82, CSF gram stain and cultures negative.
CDC Split Type:

Write-up: 2 weeks after vaccine had mild headache. 4 weeks after vaccine had cramping in R hamstring. 4-6 weeks after vaccine started having balance issues, difficulty swallowing, weakness. LP as below which showed albuminocytologic dissociation. Clinical picture was concerning for Guillain-Barre syndrome. Patient started on IVIG.


VAERS ID: 1278418 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-14
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: covid 19; Test Result: Positive
CDC Split Type: USPFIZER INC2021417448

Write-up: came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The pharmacist reported that a patient came in for her second dose of the Pfizer COVID vaccine, but tested positive for COVID 19 yesterday (14Apr2021) and asked if they need to start the series over. The outcome of the events was unknown. Information about the lot/batch number requested.; Sender''s Comments: Based on the limited information in the case report and known drug safety profile, A possible causal relationship between event Covid-19 and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1278513 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC2021422569

Write-up: Patient diagnosed with COVID-19, confirmed by PCR; Patient diagnosed with COVID-19, confirmed by PCR/ Vaccine Failure; This is a spontaneous report from a contactable physician. A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date as single dose, then second dose on 19Feb2021 (lot number and expiration date not provided) intramuscular, administered in right arm on as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. On 14Apr2021, the patient was diagnosed with COVID-19, confirmed by PCR. The patient was hospitalized for four days and received steroids and Remdesivir as treatment medication. The outcome of the events was not recovered.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.


VAERS ID: 1278545 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Haemorrhage, Headache, Pain in extremity, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPROPION; BENADRYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anxiety; Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021423021

Write-up: bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.


VAERS ID: 1278687 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-05
Onset:2021-04-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / -

Administered by: School       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden hearing loss
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Nasal Swab/PCR; Test Result: Negative
CDC Split Type: USPFIZER INC2021423994

Write-up: Left ear sudden hearing loss; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (Batch/Lot Number: Er8734) as a single dose for COVID-19 immunisation. Medical history included asthma. Allergies were unknown. The patient''s concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 12:00 PM. The patient experienced left ear sudden hearing loss on 14Apr2021 20:00. Event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included high dose steroids. The patient underwent PCR COVID Nasal swab test: negative on 14Apr2021. Outcome of event was recovering.; Sender''s Comments: Based on temporal association, a contributory role of BNT162B2 to the event left ear sudden hearing loss cannot be excluded completely. The case will be reassessed once more information become 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: 1278735 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 - / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Abortion, Haemorrhage, Pregnancy test, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210317; Test Name: Pregnancy test; Test Result: Positive ; Comments: I tested positive for pregnancy in 17Mar2021.; Test Date: 20210405; Test Name: ultrasound; Result Unstructured Data: Test Result:OK; Comments: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat.; Test Date: 20210414; Test Name: ultrasound; Result Unstructured Data: Test Result:Abortion; Comments: the doctor said that she did not find any heartbeat in the baby and that I was having an abortion.
CDC Split Type: USPFIZER INC2021424348

Write-up: I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor''s office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.


VAERS ID: 1278756 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; MACUHEALTH WITH LMZ3
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: Melanoma Brain Cancer
Allergies:
Diagnostic Lab Data: Test Name: Lab work; Result Unstructured Data: Test Result:Normal; Test Name: Spinal Tap; Result Unstructured Data: Test Result:normal; Test Name: MRI; Result Unstructured Data: Test Result:normal
CDC Split Type: USPFIZER INC2021425135

Write-up: unresponsive; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 12:45 (Lot Number: EW0158) as SINGLE DOSE for COVID-19 immunization. Medical history included melanoma brain cancer from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, calcium carbonate, colecalciferol and meso zeaxanthin, xantofyl, zeaxanthin (MACUHEALTH WITH LMZ3); all taken for an unspecified indication, start and stop date were not reported. The patient previously had first dose of BNT162B2 (lot number: ER2613) on 23Mar2021 12:15 PM in the right arm for COVID-19 immunisation at 66 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient as not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive on 14Apr2021 01:00 PM. The patient was admitted to the hospital and was released 2 days later. Many tests were performed including a Spinel Tap, MRI (brain - that is where my melanoma cancel was located), and a full panel of lab work on unspecified date. All tests responded normal. The patient was in the hospital for 2 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was given to the patient such as fluids, hydrocortisone and antibiotics. The outcome of the event was recovering. Information on about lot/batch number has been requested.; Sender''s Comments: Based on the information provided, this patient with a medical history relevant for melanoma brain cancer from an unknown date and ongoing. It was noted that the day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive. Although the reported event could be possibly related to intercurrent melanoma brain cancer, due to the plausible temporal association, a possible contributory role of the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1278847 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

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

Write-up: Left eye twitching.


VAERS ID: 1279065 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-14
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: covid; Test Result: Positive
CDC Split Type: USPFIZER INC2021435858

Write-up: A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid.; A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was supposed to receive the second dose of the COVID vaccine, but yesterday (14Apr2021) she tested positive for COVID.The pharmacist was asking if the patient would need to restart the COVID vaccine. If so, then pharmacist was asking when the patient could restart the COVID vaccines. Pharmacist was asking if the patient could just receive the second dose a couple of weeks later. The outcome of the event was unknown. The events were assessed as serious-medically significant. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event drug ineffective and COVID-19 and the suspect drug BNT162B2.


VAERS ID: 1279191 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 ER8731 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Feeling cold, Headache, Inappropriate schedule of product administration, Muscle twitching, Off label use, Seizure, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021439593

Write-up: my teeth was opening and closing as if I was having a seizure; My body was involuntarily twitching; I was cold; shaking; shivering; headaches; 1st dose: 28Mar2021/2nd dose: 14Apr2021; 1st dose: 28Mar2021/2nd dose: 14Apr2021; This is a spontaneous report from a contactable consumer (patient). This 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8731) on 14Apr2021 16:45 at single dose in right arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (lot number ER8733) on 28Mar2021 12:00 in right arm. The patient had no Known allergies. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient had not received other vaccine in four weeks. On 15Apr2021 04:00, his body was involuntarily twitching and his teeth was opening and closing as if he was having a seizure. He thought it was because he was cold so he put on 3 layers of clothes and 2 bundles of blankets and turned the heat up, but his body was still shaking and he was still cold. He tried to go back to sleep to see if that would fix it, but it did not until he went to work and around 7:30 a.m., the shivering stopped, but the headaches persisted and he had to ask to go home and he received an occurrence because he did not have a doctor''s note. He clocked out at 8 and he went to sleep for an hour in the car in the parking lot because he was in no condition to drive home. Treatment received for the events included Acetaminophen and rest. The outcome of teeth was opening and closing as if I was having a seizure, body was involuntarily twitching, was cold, shaking, was resolving. The outcome of shivering was resolved. The outcome of headaches was not resolved.


VAERS ID: 1279203 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-10
Onset:2021-04-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021440078

Write-up: 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Ew0158) via an unspecified route of administration, administered on the right arm on 10Apr2021 09:30 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. 72 hours after receiving the shot he had debilitating vertigo and nausea on 14Apr2021 10:00 AM which still persists at the 5th and 6th day. The events resulted in Emergency room/department or urgent care visit, Hospitalization for 2 days. Therapeutic measures were taken as a result of the events which included Meclizine 25mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test post vaccination: Nasal Swab on 14Apr2021: Negative. Outcome of the events was recovering.


VAERS ID: 1279286 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 ER8131 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Blindness, Chills, Cough, Fatigue, Pain
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021445363

Write-up: coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he has been in his bed and falling asleep in his chair for the past few days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8131), via an unspecified route of administration on 14Apr2021 at 09:20 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The first vaccine has been experiencing loss of vision, chills, body and back pain, and fatigue for the past 3 days, from 14Apr2021. He wanted to know if he should go to the ER. The patient was audibly coughing while on the call. He went to the appointment at 09:20 on 14Apr2021 and while driving back he noticed the loss of vision at about 10:15 on 14Apr2021. He said that the loss of vision comes and goes but is still persisting. On fatigue: Patient has been in his bed and falling asleep in his chair for the past few days. Chills, body and back pain and fatigue were reported as worsened. The outcome of the events loss of vision, chills, body and back pain, and fatigue was not recovered, while of coughing was unknown.


VAERS ID: 1279293 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO151 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021446730

Write-up: Pericarditis, inflammation of the pericardium around the heart; This is a spontaneous report from a contactable consumer who reported for herself, a 52-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO151), via an unspecified route of administration, administered in right arm on 01Apr2021 at 18:00 (at the age of 52 years old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. There were no medical histories nor concomitant medications. The patient previously received the first dose of BNT162B2 on 10Mar2021 at 06:00 PM (lot number: EN6206), at the age of 52 years old, administered in the right arm for COVID-19 immunization. The patient had no other vaccines in four weeks. The patient experienced pericarditis, inflammation of the pericardium around the heart on 14Apr2021 at 16:30. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if treatment was received for the event. The outcome of the event was recovering.


VAERS ID: 1280145 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Unknown       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: Vitamin d, vitamin c
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately two weeks following vaccine, constant tinnitus. Previously had occasional tinnitus but since vaccine, it is constant


VAERS ID: 1280952 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, Vision blurred
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: Head ache, blurry vision, random bruising


VAERS ID: 1282010 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-04-07
Onset:2021-04-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Confusional state, Disorientation, Dizziness, Feeling of despair, Headache, Inflammation, Lethargy, Lymphadenopathy, Nausea, Pain in jaw, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin 20mg/daily
Current Illness: Nasal polyps
Preexisting Conditions: N/a
Allergies: Keflex
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: Nauseous, vomiting, headache, light headed, disorientation, vision changes, jaw pain, lymph node inflammation, lethargy, mental confusion, sense of hopelessness, 15 days taper Prednisone, ibuprofen, acetaminophen, still currently experiencing symptoms today


VAERS ID: 1283479 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Blood test, Gait inability, Hypoaesthesia, Muscle twitching, Nerve conduction studies, Neuralgia, Pain, Pain in extremity, Peripheral coldness, Ultrasound Doppler normal, X-ray limb
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, vitamin d, vitamin c
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Penicillin Keflex Sulfa Flagyl Lanolin Formaldehyde
Diagnostic Lab Data: Three ultrasounds on my left leg: April 19 and 20th Leg x-rays on April 20 Nerve conduction study on April 21 Blood taken on April 20
CDC Split Type:

Write-up: On Day give I began having left leg pain, shooting pains starting at my knee going down my leg. As the next few days progressed my leg began to get numb and go cold as ice. I have lost my ability to walk and my leg still has shooting nerve pains, gets numb, and twitches. I have gone to the ER, the doctor twice, and a neurologist. Nobody seems to have any answers for me. It is not a blood clot but that is the only thing that has been ruled out.


VAERS ID: 1284769 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 - / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Blood pressure increased, Chills, Dyspnoea, Fatigue, Headache, Heart rate, Heart rate increased, Hyperhidrosis, Nausea, Pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE; SYEDA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: heart; Result Unstructured Data: Test Result:racing
CDC Split Type: USPFIZER INC2021432754

Write-up: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae. Information about lot/batch number has been requested.


VAERS ID: 1284822 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cataract, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (narrow), Retinal 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: AMLODIPINE BESYLATE
Current Illness: Hypertension (Verbatim: high blood pressure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021445068

Write-up: A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot# EP7533), via unspecified route of administration in left arm on 6Apr2021 at 2:40PM at single dose for COVID-19 immunization. The patient was not administered with prior vaccine within four weeks. Patient had a history of ongoing high blood pressure. The patient''s concomitant medication included ongoing Amlodipine Besylate at 5mg one tablet one time a day for high blood pressure and ongoing. On 14Apr2021, patient experienced her left eye got blurry. She doesn''t know if her eye getting blurry is coming from the Covid-19 vaccine. She hasn''t taken the second Covid-19 vaccine yet. She reports her eye might be blurry because of the Covid-19 vaccine. She reports the left eye blurriness started about 4 or 5 days ago on 14Apr2021. Her eye was getting blurry a little bit then it seemed to get worse, now it''s staying about the same. It seems like there is something in her eye, just her left eye. When she tries to read, the letters are blurry but if she puts what she''s reading up close to her face she can make the letters out. She reports her husband got his Covid 19 vaccine first and she was skeptical about getting the vaccine for herself. On 25Nov2020, when she went to the doctor on for a regular checkup, he changed one of her medications and she didn''t notice the change. She doesn''t know if she needs glasses. She doesn''t wear glasses not even to read. She tried reading glasses but they gave her a headache. She has made an appointment to see an eye doctor. She reports it seems like there is something in her left eye. She might have cataracts. She has an eye appointment in about 3 weeks on 04May2021 or 05May2021. She can see fine out of her right eye and she can see out of her left eye she just has to put what she''s reading close to her left eye to see it. No emergency Room/ Physician Office due to AE. Outcome of the events was not resolved.


VAERS ID: 1284851 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-04-13
Onset:2021-04-14
   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 EW0158 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastrointestinal haemorrhage, Nausea, Pulseless electrical activity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), COVID-19 (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN EC; LIPITOR [ATORVASTATIN]; COREG; LIDEX-E; ENTRESTO; COUMADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Coronary artery disease; Hyperlipidemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Roche cobas SARS-CoV-2 assay.; Test Result: Negative
CDC Split Type: USPFIZER INC2021464956

Write-up: nausea; vomiting; diarrhea; large GI bleed; PEA (Pulseless electrical activity); This is a spontaneous report from a contactable physician. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included coronary artery disease (CAD), cardiomyopathy, hyperlipidemia, and hypertension. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN EC); atorvastatin (LIPITOR [ATORVASTATIN]); carvedilol (COREG); fluocinonide (LIDEX-E); sacubitril valsartan sodium hydrate (ENTRESTO); and warfarin sodium (COUMADIN). The patient had nausea, vomiting and diarrhea since getting the vaccine which progressed to a large GI bleed, had PEA (Pulseless electrical activity), was resuscitated and was currently in the ICU intubated. The events occurred on 14Apr2021 and all events resulted in hospitalization, considered as life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included transfusions, resuscitation, and current intubation. The patient underwent lab test which included Roche cobas SARS-CoV-2 assay: negative on 19Apr2021. Outcome of the events was not recovered.; Sender''s Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded considering the temporal association. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1284856 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-29
Onset:2021-04-14
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood cholesterol, Blood pressure measurement, Myocardial infarction, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN]; NORVASC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; High cholesterol
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:high; Test Name: blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: USPFIZER INC2021470848

Write-up: 5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 12:00 on left arm at single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included high blood pressure, high cholesterol. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC). Historical Vaccine included first dose of BNT162B2 on 08Mar2021 12:00 on left arm for COVID-19 immunization. The patient experienced 5-6 Blood clots, had heart attack and blood clots were present on 14Apr2021 13:00. The events were resulted in Emergency Room Visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included Stent. The outcome of the events were resolving. Information on Lot/Batch number has been requested.


VAERS ID: 1285674 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-08
Onset:2021-04-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Full blood count normal, Metabolic function test, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: 04/14/2021: CBC, metabolic panel, covid test. All normal/negative.
CDC Split Type:

Write-up: Day 6 post vaccine: nausea, vomiting, diarrhea, chills, body aches, fever.


VAERS ID: 1286417 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-29
Onset:2021-04-14
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Atrophy of globe, Cerebral small vessel ischaemic disease, Computerised tomogram head abnormal, Condition aggravated, Dysarthria, Dysphagia, Fall, Hyponatraemia, Hypoxia, Immunoglobulin therapy, Laboratory test normal, Leukocytosis, Myasthenia gravis, Oxygen saturation decreased, Viral test negative, Walking aid user
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ? acetaminophen (TYLENOL) tablet 650 mg ? aspirin enteric coated tablet 81 mg ? famotidine (PEPCID) injection 20 mg ? metoprolol succinate (TOPROL-XL) extended release tablet 25 mg ? predniSONE (DELTASONE) tablet 5 mg ? white petrolat
Current Illness: none
Preexisting Conditions: ? A-fib ? Hypertension ? Myasthenia gravis ? Metastatic squamous cell carcinoma in situ Congenital Oculocutaneous Albinism
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient with history of myasthenia gravis with multiple prior myasthenic crises requiring IVIG and one requiring intubation experienced myasthenia gravis exacerbation with no apparent trigger that began two weeks after receiving J&J vaccine. Daughters noticed he was having progressive difficulty swallowing, slurred speech, and generalized weakness. O2 sats were also noted to be lower than normal with pulse oximeter at home (92% compared to baseline of 95%). On day of admission patient had a mechanical fall while carrying a tray with his walker. Hypoxic to 88% on arrival. Labs notable for leukocytosis (13.68), hyponatremia to 127 and negative infectious workup. CTH with chronic microvascular changes and global atrophy but negative for acute process. He was admitted and continued on prednisone 5mg daily (outpatient regimen). Patient was started on a three day course of IVIG on 5/3/21 due to concern for myasthenia exacerbation with subsequent improvement.


VAERS ID: 1286571 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / N/A RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Dehydration, Dizziness, Electrocardiogram normal, Fall, Fatigue, Fibrin D dimer normal, Hypotension, Impaired driving ability, Loss of consciousness, Sinus bradycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (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: Probiotic
Current Illness:
Preexisting Conditions:
Allergies: Lidocaine-Anaphylactic Peanuts and Tree Nuts-Anaphylactic
Diagnostic Lab Data: EKG Blood Work CT Scan D-Dimer-normal
CDC Split Type: vsafe

Write-up: Eight days after the vaccine, I started to feel light headed and I thought I was just fatigued. I woke up at 3am and started to pass out and I couldn''t see and falling down. I went to the ER and my pulse and blood pressure were low and I was mildly dehydrated. I had Sinus Bradycardia which they said may be transient. I have never had an unusual rhythm readings. I experienced the lightheadedness for about a week. I did not drive or ride my bike because I might need to lay down. Three weeks after the vaccine it seemed to get better a little a time and the events were less frequent. It has been four weeks and I feel fine now and I have resumed my normal activities.


VAERS ID: 1288374 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-07
Onset:2021-04-14
   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 - / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Ear discomfort, Head discomfort, Migraine, Nausea, Presyncope, Tinnitus, Tremor, Vertigo, Vestibular disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021433492

Write-up: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 1288376 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 EW0158 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Chills, Dyspnoea, Feeling cold, Hypoaesthesia, Hypoxia, Malaise, Pain in extremity, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: body temperature increase; Result Unstructured Data: Test Result:102 degree Fahrenheit
CDC Split Type: USPFIZER INC2021434210

Write-up: Fever; felt like trash and didn''t feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn''t have any oxygen; Got really winded; didn''t have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn''t get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn''t get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn''t get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn''t get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.


VAERS ID: 1288398 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-13
Onset:2021-04-14
   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: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Thrombophlebitis superficial
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: HYDROXYCHLOROQUINE; ZOLOFT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021438478

Write-up: superficial thrombophlebitis clot behind left knee; chills; headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 36-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the Left Arm on 13Apr2021 11:45 (Batch/Lot Number: Ew0162) as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient experienced superficial thrombophlebitis clot behind left knee on 14Apr2021 with outcome of recovering , chills on 14Apr2021 with outcome of recovering , headaches on 14Apr2021 with outcome of recovering. The reported events were considered serious because caused the patient to visit Emergency room/department or urgent care. Follow up information has been requested. Lot number has already been provided.


VAERS ID: 1290373 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-11
Onset:2021-04-14
   Days after vaccination:3
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: Oedema peripheral, Paraesthesia, Varicose vein
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Vitamin D3 supplement
Current Illness: None
Preexisting Conditions: Iron deficiency anemia, prediabetes, genital herpes
Allergies: NKDA
Diagnostic Lab Data: Workup pending
CDC Split Type:

Write-up: Venous dilation/varicosities in bilateral lower extremities with associated mild bilateral lower extremity edema and paresthesias.


VAERS ID: 1291126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Covid test; Test Result: Positive ; Comments: severe case of Covid
CDC Split Type: USPFIZER INC2021438248

Write-up: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported same event for two patients. This is the first of two reports. A 21-year-old female patient received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer Covid vaccine in Jan2021 (reported as "Jan2020") and recently tested positive for Covid on 14Apr2021 and has had a severe case of Covid. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : PFIZER INC-2021444196 same reporter/drug/event, different patient


VAERS ID: 1291146 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 EW0161 / 1 RA / OT

Administered by: Public       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WELLBUTRIN XL; ANASTROZOLE; CELEBREX; NP THYROID; LEXAPRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CPAP; Depression; Double heterozygous sickling disorders; Dyslipidemia; Erectile dysfunction; Hypogonadism; Low HDL; Lumbar disc disease; Obstructive sleep apnea syndrome; Pneumonia; Polyps; Sciatica; Sinusitis recurrent
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021438375

Write-up: MI, symptoms started 2 hours after immunization; This is a spontaneous report from a contactable physician. A 64-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the right arm on 14Apr2021 (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. The vaccination facility type was reported. Relevant medical history included obstructive sleep apnea on CPAP; hypogonadism on bioTE; depression; history of (h/o) pneumonia; colon polyps; recurrent sinusitis; erectile dysfunction; MTHFR Mutation C677T Heterozygous; low high density lipoprotein (HDL); dyslipidemia; lumbar disc disease; and sciatica; all from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL); anastrozole; celecoxib (CELEBREX); levothyroxine, liothyronine (NP THYROID); and escitalopram oxalate (LEXAPRO); all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), from which the patient had known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced myocardial infarction (MI), symptoms started 2 hours after immunization on 14Apr2021. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care, and hospitalization. The patient was hospitalized for the event "MI, symptoms started 2 hours after immunization" for 3 days. Therapeutic measures were taken as a result of the event, which included cardiac stent. The patient was recovering from the event.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of myocardial infarction. The reported event likely represent intercurrent medical condition in this patient with history of dyslipidemia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline, counteractive treatment measures and concomitant medications This case will be reassessed upon receipt of follow-up information. 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: 1291229 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 EW0151 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Burning sensation, Hyperaesthesia, Rash, Skin weeping, Urticaria, Vaccination site pain
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (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: WELLBUTRIN XL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021441903

Write-up: shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; hives and a rash that continues to get worse; hives and a rash that continues to get worse; When clothes touching it hurts, it is very uncomfortable; injection site soreness; This is a spontaneous report from a contactable registered nurse, the patient. This 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151; Expiration Date: 01Jul2021) via an intramuscular route of administration in the left arm on 14Apr2021 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for 15 years (2006) and ongoing for anxiety depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced some expected injection site soreness. On Friday evening 16Apr2021, the patient broke out in hives and rash that continued to get worse. The patient described the hives started on right side of neck and now is on her face on the right side and neck, on left breast and right lower abdomen which spread around the back down on the leg and on the left bikini line on the groin. She stated now it is like shingles type blistering, weeping, oozing and kind of on fire type of feeling. It is mostly on the right side and there are some spots on the left. When clothes touching it hurts, it is very uncomfortable. She had a friend/physician to call in for her for oral steroids but don''t seem to be doing much. The patient clarified the oral steroids as a MEDROL Dose pack, methylprednisolone 4mg tablets, and she only one full-day worth so far, she took all 6 tablets for yesterday (19Apr2021) and has taken one tablet so far today with doses being titrate down daily. It is not any worse than yesterday, but it has not started getting any better either. The patient stated that she has nothing on the left arm where she got the injection, no rash on left arm. Her second dose is scheduled 05May2021 and she does not know if she should get it. The clinical outcome of the event injection site soreness was resolved on 16Apr2021 while the events "hives and a rash that continues to get worse", "shingles type blistering, weeping, oozing and kind of on fire type of feeling" and "When clothes touching it hurts, it is very uncomfortable" were not resolved.; Sender''s Comments: Based on temporal association, a contributory role of BNT162b2 to the events of broke out in hives and rash, blistering, weeping, oozing and kind of on fire type of feeling cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1291322 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-14
Onset:2021-04-14
   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 - / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary mass, Blood test, Computerised tomogram, Disease recurrence, Seizure, Urine analysis, Vaccination site scar
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gout (Verbatim: Gout); Seizures
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: blood work; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210414; Test Name: CAT scan; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210414; Test Name: urine sample; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: USPFIZER INC2021456167

Write-up: Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; ''he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient''s concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don''t know if he had a one scar or what it says but he says that ''he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble'' (not clarified further). The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1291607 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-17
Onset:2021-04-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023M20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Loss of consciousness, Nausea, Pyrexia
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: METFORMIN
Current Illness: Blood pressure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Passed out in bathroom; Sweating; Fever; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in bathroom) in a 71-year-old female patient who received (batch nos. 031B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021 at 10:30 PM, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 15-Apr-2021 at 2:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in bathroom) (seriousness criteria medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in bathroom), HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Concomitant medications included blood pressure medications. The patient took Tylenol medication for the treatment. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 13 hours after the second vaccination, a causal relationship cannot be excluded. Further information has been requested


VAERS ID: 1292891 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypoaesthesia, Limb discomfort, Muscle spasms, Pain in extremity, Ultrasound scan, X-ray
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Ultrasound Blood work Xrays 3 visits to the ER
CDC Split Type:

Write-up: Pain on both legs, heaviness, numbness cramps


VAERS ID: 1293402 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-08
Onset:2021-04-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Varicose vein
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: oxycodone 10 mg: omeprazol, 20mg; salmon oil; vitamin E; glucosamine, 1500units; Tumeric, 400units
Current Illness: COPD
Preexisting Conditions: COPD; Cardiac pacemaker
Allergies: none
Diagnostic Lab Data:
CDC Split Type: Not known/patient filing

Write-up: Bulging veins in lower legs and both arms and present until approximately 05/01/2021


VAERS ID: 1294077 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Headache, Hypokinesia, Myalgia, Pain, Pain in extremity, Peripheral swelling, Somnolence, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; METOPROLOL; GABAPENTIN; FENOFIBRATE; FAMOTIDINE; GLUCOSAMINE CHONDROITIN & MSM; FOLIC ACID; TURMERIC [CURCUMA LONGA RHIZOME]; PRAVASTATIN
Current Illness: Blood pressure high; Diverticulitis; GERD; High cholesterol; Osteoarthritis; Spinal stenosis
Preexisting Conditions: Medical History/Concurrent Conditions: Laminectomy spinal (history of laminectomies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: constant swelling in her left leg all night long that wakes her up; constant pain in her left leg all night long that wakes her up; decreased energy level; sleeping more/sleeping 8 hours a night/napping; can only sit for a few minutes; taking longer to get up/change position; pain level unbearable/pain is very escalated all over/some days she can barely get out of bed; pain level increased to 9/10 in back and hip area; pain level increased to 9/10 in back and hip area; achiness; massive headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up), PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed), BACK PAIN (pain level increased to 9/10 in back and hip area), ARTHRALGIA (pain level increased to 9/10 in back and hip area) and PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Laminectomy spinal (history of laminectomies). Concurrent medical conditions included Osteoarthritis, GERD, Blood pressure high, Spinal stenosis, High cholesterol and Diverticulitis. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) and TURMERIC [CURCUMA LONGA RHIZOME] for Arthritis, METOPROLOL for Blood pressure high, FOLIC ACID for Bowel movement irregularity, FENOFIBRATE and PRAVASTATIN for Cholesterol, OMEPRAZOLE for GERD, FAMOTIDINE for GERD and Diverticulitis, GABAPENTIN for Spinal stenosis. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (massive headache). On 17-Apr-2021, the patient experienced PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed) (seriousness criterion medically significant), BACK PAIN (pain level increased to 9/10 in back and hip area) (seriousness criterion medically significant), ARTHRALGIA (pain level increased to 9/10 in back and hip area) (seriousness criterion medically significant), ASTHENIA (decreased energy level), SOMNOLENCE (sleeping more/sleeping 8 hours a night/napping), HYPOKINESIA (can only sit for a few minutes), HYPOKINESIA (taking longer to get up/change position) and MYALGIA (achiness). On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up) (seriousness criterion medically significant) and PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up) (seriousness criterion medically significant). On 15-Apr-2021, VACCINATION SITE PAIN (Sore arm) and HEADACHE (massive headache) had resolved. At the time of the report, PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up), PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed), BACK PAIN (pain level increased to 9/10 in back and hip area), ARTHRALGIA (pain level increased to 9/10 in back and hip area), PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up), ASTHENIA (decreased energy level), SOMNOLENCE (sleeping more/sleeping 8 hours a night/napping), HYPOKINESIA (can only sit for a few minutes), HYPOKINESIA (taking longer to get up/change position) and MYALGIA (achiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included extra strength acetaminophen every 6-8 hours for the pain. This case concerns a 75-year-old female with serious unexpected events of peripheral swelling, pain in extremity, back pain, pain, arthralgia, and nonserious unexpected asthenia, somnolence, hypokinesia, and expected myalgia, vaccination site pain, headache. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 75-year-old female with serious unexpected events of peripheral swelling, pain in extremity, back pain, pain, arthralgia, and nonserious unexpected asthenia, somnolence, hypokinesia, and expected myalgia, vaccination site pain, headache. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1294286 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-12
Onset:2021-04-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Amylase normal, Angina pectoris, Anion gap decreased, Blood test normal, Blood thyroid stimulating hormone normal, Chest X-ray normal, Dyspepsia, Electrocardiogram normal, Fibrin D dimer normal, Flatulence, Lipase normal, Liver function test normal, Metabolic function test, Stool analysis normal
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (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: Pertussis part of DPT vaccine, approximately 02/12/1987, seizure-like event (15-30 seconds), patient about 4 months old
Other Medications: Vitamin C 500mg Vitamin D 1000 IU
Current Illness: Dyshidrotic eczema (mild)
Preexisting Conditions: Scoliosis
Allergies: Allergic to penicillin Allergic reaction (? not sure what kind) to Pertussis part of DPT vaccine, when a child Food sensitivity to caffeine and MSG (migraine triggers)
Diagnostic Lab Data: EKG on 4/16 came back normal Chest X-ray on 4/16 came back normal, possible gas bubble in stomach Stool sample for H. Pylori came back negative D Dimer came back normal TSH came back normal Lipase came back normal Amylase came back normal Liver panel came back normal Basic metabolic panel came back with Anion Gap slightly low (6 mmol/L), everything else normal
CDC Split Type:

Write-up: Began with gassy feeling on 4/14 that progressed to stomach pain on 4/15, then heartburn evening of 4/15 through the day on 4/16. Heartburn faded (did try taking Tums, with little effect), changed back to mainly stomach pain. Stomach pain daily 4/19 - 4/29, mainly occurring (1) before & after breakfast, (2) late afternoon, (3) evening. Began taking Prilosec (omeprazole) on 4/30; stomach pain similar to previously described 4/30 - 5/1. Symptoms became more intense, heartburn and heart pain on 5/2, stomach pain 5/3, heartburn and heart pain 5/4. Stopped Prilosec 5/5, symptoms receded to mild heartburn and stomach pain 5/5 - 5/6. Currently deciding next steps for treatment. Stomach pain can be soreness, occasional twinges, all located just below left ribcage. Heartburn upper left, feels warm but also sore (kind of like someone punched me there).


VAERS ID: 1294732 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Back pain, Blood test, Body temperature, Chills, Head discomfort, Headache, Influenza, Pain, Polymerase chain reaction, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (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: ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: blood work; Result Unstructured Data: Test Result:no infection and lungs were clear; Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210420; Test Name: flu; Result Unstructured Data: Test Result:Negative; Test Date: 20210420; Test Name: COVID (pcr); Test Result: Negative ; Test Date: 20210419; Test Name: covid rapid test; Result Unstructured Data: Test Result:Negative
CDC Split Type: USPFIZER INC2021465405

Write-up: back pain upper and lower back; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Chills, fever, headache with heaviness of head; Severe body pain, joint pain; Severe body pain, joint pain; This is a spontaneous report from a contactable consumer. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 (Lot Number: EW0158) as SINGLE DOSE (at the age of 47 years old) for covid-19 immunisation. Medical history included High cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin (ROSUVASTATIN) 20 mg taken for an unspecified indication, start and stop date were not reported. The patient previously took Penicillin and experienced allergy; sulfa and experienced allergy. On 14Apr2021 16:00, the patient experienced back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. Patient had to go to emergency room (ER) on the 20Apr2021 since pain and fever was not decreasing. She tested negative for flu, COVID (rapid and pcr), blood work shows no infection and lungs were clear. On 21Apr2021 she still has headache and had to take off from work. ER physician said it is the adverse effect due to the vaccine. The patient underwent lab tests and procedures which included blood test: no infection and lungs were clear on 20Apr2021, body temperature: fever on 19Apr2021, influenza: negative on 20Apr2021 , covid rapid test: negative on 19Apr2021 , COVID (pcr): negative on 20Apr2021. Therapeutic measures were taken as a result of back pain upper and lower back, Chills, fever, headache with heaviness of head, Severe body pain, joint pain. The events were treated with IV Pain medicine. Outcome of the events was not recovered.


VAERS ID: 1173821 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

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

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

Write-up: pt was vaccinated with covid 19 vaccine with a Janssen brand given on her left arm, intramuscular at 03:44 pm. Pt sat down on the post vaccine area and after 5 mins pt stated that she is feeling light headed and dizzy. Pt was assisted to lay down on the floor safely and legs were elevated asassistedby RN. Pt is alert oriented towel, date,time, location. Pt stated that she is nauseous and hadn''t eaten anything yet. Initial vitals were taken and recorded BP 118/60 mmhg, PR55bpm, T96.0, RR 20, O2 sat 98% at room temp, BS 105. Vital signs monitoring done everything until stable, Pt refused to call 911 stated that she had history of being nauseous and lightheaded with blood draw and blood transfusion. Repeat Vsat4:10 pm BP 120/ 70, RR 20 cpm, T97.6, PR 76. Pt was placed in a sitting position and no complaints of dizziness, lightheadedness. NoSOB, no Chest pain as well. At4:20 RN discharged ptaccompanied by husband without any complaints. Pt statedsge appreciated our immediate care.Nyrse educator RN wasnotified as well..


VAERS ID: 1199694 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: N/A
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: ROS: General: No fatigue, + fevers/chills, + malaise Eyes: No eye pain, eye discharge, visual changes Ears: No ear pain, hearing changes Nose/throat: No nasal congestion, sore throat CV: No chest pain, palpitations, syncope, edema Pulm: No SOB, wheezes, cough, hemoptysis GI: No anorexia, abd pain, + nausea, no vomiting or diarrhea GU: No dysuria, hematuria, urgency, frequency MSK: No joint pain, edema, warmth, redness, deformity Neuro: No HA, seizures, weakness, numbness/tingling, vertigo, lightheadedness, AMS Skin: No rash, lesions, itching Heme: No easy bruising/bleeding, petechiae All systems reviewed and negative except as stated above. Physical Exam: Vital signs reviewed, no acute intervention necessary General: NAD, AOX3, cooperative Head: Normocephalic, atraumatic Eyes: PERRL, EOMI, no conjunctival injection, no scleral icterus Ears: No edema/erythema of otic canal, no TM edema/erythema/dullness/bulging Nose: No nasal discharge Throat: No pharyngeal edema, erythema, tonsillar exudates, uvular deviation, asymmetric swelling, trismus, drooling, or voice changes Neck: No meningismus; normal ROM Lymph: No cervical lymphadenopathy Respiratory: Unlabored breathing, normal respiratory effort, LCTAB CV: Normal peripheral circulation, RRR, no m/r/g Abd: Soft, NTND Skin: No rashes, petechiae, or purpura Neuro: Grossly intact, moves all extremities equally, gait normal MSK: No TTP, deformity, ecchymosis, or focal edema Psych: Normal mood, normal affect, appropriate responses
CDC Split Type:

Write-up: PT presents with fever/chills and fatigue x 1900 reports received JJ vaccine 0945 yesterday. Patient is a 25 year old male who presents to ED with fever, weakness, nausea and body aches 12 hours after receiving the J&J vaccine. He has not taken any OTC medications. He is able to drink however. He denies any vomiting, no rash, no productive cough.


VAERS ID: 1199695 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: N/A
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: ROS HEENT: no runny nose, no eye pain, no ear pain CV: chest pressure as above, no palpitations Resp: no shortness of breath, no cough, no pleurisy Abd: no abdominal pain, no N/V/D, no hematuria/dysuria MSK: no joint pain, no joint swelling, no back pain PE Gen: A&Ox4, NAD, speaking in full sentences HEENT: EOMI with conjugate gaze, no facial trauma, no AOM/OE/Ludwig''s, no cervical adenopathy CV: S1/S2 RRR no MRG Pulm: CTA all fields, no dyspnea, unlabored respirations GI: no focal TTP, no peritoneal signs MSK: moving all extremities equally 5/5 strength, no deformities, no joint effusions Neuro: CN 2-12 and cerebellar intact Labs: none indicated Rad: none indicated EKG (0721): SR 69, PR 129, QRS 96, QTc 427; no ST elevations, no blocks or dysrhythmias. MDM: Pt has normal VS, chest pressure with normal EKG and no risk factors for ACS or PE. Unlikely ACS, PE, pneumonia, PTX. He has HA without red flags, no subjective or objective neurologic deficits- not likely CVA, TIA, SAH. F/u and return precautions discussed.
CDC Split Type:

Write-up: PT reports HA, nausea, fatigue and chills x 1600 yesterday after receiving JJ vaccine. last 650mg tylenol 8pm. HPI: 25yo AD M presenting to ED for evaluation of above complaints that began yesterday after receiving the J&J COVID vaccine. The patient is having no dyspnea, no pleurisy, no cough or fever. The chest pressure is substernal without radiation, no palliating or provoking factors, not associated with N/V or diaphoresis. He has no family history of early MI, no ACS risk factors. No PE risk factors.


VAERS ID: 1199728 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20792LA / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Nausea
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: Emgality, Pristiq
Current Illness:
Preexisting Conditions: Chronic Migraines
Allergies: Citrus
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, cold chills


VAERS ID: 1199995 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Influenza like illness, Tinnitus
SMQs:, Hearing impairment (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: Weekly allergy shot. Over the counter allergy medications.
Current Illness: None
Preexisting Conditions: None
Allergies: Usuall, mold, pollen, etc.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Received Johnson & Johnson vaccine at pharmacy on Friday April 9, at 8 am. Injection in left arm. Mild flu like symptoms Friday night and most of day Saturday. Symptoms dissipated over the day Sunday. Monday received my weekly allergy shot and exercised for first time. Headache returned Monday evening. Took some Tylenol. Awoke at 2 am with tinnitus in both ears. Mostly in left. Never experienced before. Scheduling appointment with ENT. Very concerned.


VAERS ID: 1200304 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

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

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

Write-up: Fever, Nausea, Body ache, Head ache, Flu like Symptoms


VAERS ID: 1200318 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Chills, fever, muscle aches


VAERS ID: 1200540 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitafusion-Women''s Multi vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfus based products
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of over 101, body aches, and headache.


VAERS ID: 1200601 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

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

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

Write-up: Patient advised they do not do well with shots. Patient was waiting after administration when they began to feel faint and alerted wife. She yelled for help. I immediately joined patient and wife. He was already conscious and aware of surroundings, alert to time and place. I retrieved mat for him to lie down on. He stated he was feeling better. After about 15 minutes the patient was feeling back to normal and was upright in a chair. He remained there for another 15 minutes at which time he felt well and comfortable returning home with wife.


VAERS ID: 1200834 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-01
Onset:2021-04-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Headache, Pain in jaw
SMQs:, Osteonecrosis (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: Lo lo estrin
Current Illness: None
Preexisting Conditions: None
Allergies: Hives from Claratin
Diagnostic Lab Data: No
CDC Split Type:

Write-up: Headache and jaw pain.


VAERS ID: 1200908 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Headache, Pain, Pyrexia, Vertigo
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Arthritis (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: Duloxetine 60 mg , ibuprofen 900 mg
Current Illness: None
Preexisting Conditions:
Allergies: Bactirm - Hives
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 101 for a few hours, severe aches and pains all over and especially in joints, severe headache, mild vertigo / dizziness, severe chills, difficulty breathing.


VAERS ID: 1200998 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dysstasia, Fall, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), 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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore muscles , 3rd day being very dizzy and falling, 4 th day can?t stand without my body wanting to go back or forth like I want to fall down. Getting ready to go checked by a doctor


VAERS ID: 1201027 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Dizziness, Fatigue
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: dizziness and tiredness.


VAERS ID: 1201038 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Irbesartan, Metoprol, Amlodipine, Clonidine, Atorvastatin, Amitriptyline, Lorazepam, Alprazolam, Zolpidem
Current Illness:
Preexisting Conditions: High blood pressure, high cholesterol, Fibromyalgia
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bad Headache, bodyaches


VAERS ID: 1201201 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

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

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

Write-up: Fever, Nausea, headache, muscle ache, fatigue all occurred about 12 hours after I received the vaccine. I took Tylenol and used an ice pack on my head to help the fever subside. After about 20 minutes I began to feel better and was able to then lay down and rest a little more comfortably.


VAERS ID: 1201230 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Burning sensation, Chills, Decreased appetite, Headache, Hyperhidrosis, Pain, Pyrexia, Sleep disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: I first started developing chills and a mild fever about eleven or twelve hours after taking the vaccine. My entire body felt like burning and a headache came up not long after the fever. I could barely fall asleep at night due to body ache and excessive sweating. The headache and body pain persisted till the next morning, and as of I am writing this response now, I feel extremely weak and I have no appetite at all.


VAERS ID: 1201238 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Flushing, Injection site pain, Pain, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hepatitis A Vaccine Neurological side effects, tingling, weakness
Other Medications: Levothyroxine 75mcg Letrozole 2.5mg
Current Illness: None
Preexisting Conditions: Breast cancer 2016
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 100 12 hours after administration and flushing and warm feeling all over body similar to a bad sunburn. Soreness at injection site radiating to the shoulder.


VAERS ID: 1201316 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / IM

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

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

Write-up: Given out of manufacture recommendation for age


VAERS ID: 1201327 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

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

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

Write-up: Fever - 100.4 Headache Body ache slight nausea receiving vaccine All these occurred on the next day of


VAERS ID: 1201338 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Influenza like illness, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Chills, body aches, dizzy, light headed, feels like flu symptoms


VAERS ID: 1201343 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Shortness of breath, rapid heart rate, rapid breathing, dizziness, and weakness


VAERS ID: 1201389 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Headache, Pain in extremity, Pyrexia, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Liquid Advil gel capsules
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Believe I may have passed a blood clot through urine or vagina early this morning. It appeared to be quarter sized. Non painful, one time event. Also have intense back pain and leg aching. Still feverish and have mild headache as well.


VAERS ID: 1201425 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-07
Onset:2021-04-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / -

Administered by: School       Purchased by: ?
Symptoms: Chills, Headache, Influenza, Pain
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Men''s Multivitamin
Current Illness: None
Preexisting Conditions: Thrombocytopenia
Allergies: None
Diagnostic Lab Data:
CDC Split Type: 206A21A

Write-up: John & Johnson shot - severe headache and flu symptoms 8 hours after vaccination and lasting many days afterward. Chills, body aches, and major headache.


VAERS ID: 1201434 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Developed vocal tic after receiving tetanus shot approx. 5 years ago. Not sure if shot caused vocal tic but tic occurred within
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, headache, fever, dizzy, light headed. Feels like flu symptoms


VAERS ID: 1201481 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Meloxicam, gabapentin
Current Illness: None
Preexisting Conditions: Knee surgery 5 months ago
Allergies: Amoxicillin and doxycycline
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever 101, chills, body aches, sore arm, extreme leg pain.


VAERS ID: 1201499 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

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

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

Write-up: Chills and low grade fever lasting 4 hours.


VAERS ID: 1201658 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Woke up the following morning with severe headache and vomiting. Recommended follow-up immediately with MD.


VAERS ID: 1201673 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Diarrhoea, Erythema, Feeling abnormal, Lethargy, Pain, Pyrexia, Retching, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramadol, Ibuprofen, Baby Aspirin, Arnica, Multi-Vitamin, Hair, Nails, Skin Supplement, Probiotic
Current Illness: Rheum. Arthritis, IBS, Reynauds, Sinus trouble
Preexisting Conditions: RA, IBS, Reynauds, Migraines, Sinus trouble
Allergies: Erythromycin, Tetracyclin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Vomitting, Wretching, Dry Heaving, Diahrrea, Mild Fever, Beet Red Face, Body Aches, Cough, Lethargy starting the evening of the vaccination 4/10/21 9PM. Continued until 4/11/21 Midday.


VAERS ID: 1201800 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 0431A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: unknown
CDC Split Type:

Write-up: Patient stated after the vaccine she had a fever and was nauseous but all resolved after 24 hours. She woke up today with chest pain/ tightness and stated it is painful to breathe. She was advised to go to the ER.


VAERS ID: 1201802 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-03-09
Onset:2021-04-13
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / -

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

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

Write-up: I have experienced breakthrough vaginal bleeding for the first time in the 15 years I have been on birth control. I am aware that they are looking at links between the vaccine and menstration and I wanted to share this abnormal event.


VAERS ID: 1201805 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carvedilol, atorvastatin, Biktarvy, allopurinol, furosemide, montelukast, Vit D, indomethacin, Tylenol, albuterol
Current Illness: Seasonal allergies, oak pollen
Preexisting Conditions: HIV, hypertension, high cholesterol, gout, asthma, bipolar disorder 1, spinal stenosis, CHF
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: "COVID Arm" (itching and redness patch about 3 cm in diameter)


VAERS ID: 1201857 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dysstasia, Fatigue, Headache, Impaired work ability, N-terminal prohormone brain natriuretic peptide increased, Nausea
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lo Loestrin Fe Birth Control
Current Illness: None
Preexisting Conditions: None
Allergies: None that I''m aware of. I had a weird reaction after eating a strawberry (at least I think that''s what caused it!) two weeks ago where my lips broke out terribly and became chapped
Diagnostic Lab Data: Janssen COVID-19 Vaccine
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine Day 1: Fatigue within a couple of hours. Then within about seven hours I developed severe joint pains, chills, and headache. I took hot baths then iced my head. Day 2: Very fatigued again, some headache Day 3: Fatigue persisted. Had to take off work. Headache. Day 4: Nausea and lightheadedness. Can barely stand. No fever throughout


VAERS ID: 1201933 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-03-26
Onset:2021-04-13
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808069 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Erythema, Headache, Pruritus, Skin discolouration, Skin swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cymbalta Trazodone Tramadol Meloxicam Vitamin D Magnesium Sulfate Several migraine meds Benedryl
Current Illness: None
Preexisting Conditions: Lupus - SLE Fibromyalgia Arthritis Chronic Migraines Chronic Pain
Allergies: latex
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Several headaches and swollen, red, hot, itchy, huge bump since injection (March 26 - today). Contact physician Friday, April 9, 2021. She prescribed Medrol dose pack and antihistamine (Benedryl). Hot and redness subsided. Now black, itchy patch and severe headaches.


VAERS ID: 1201986 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Headache, Pain, Pain in extremity
SMQs:, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: headaches and right leg pain that radiates to her right hip


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