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From the 7/16/2021 release of VAERS data:

Found 479,813 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 216 out of 4,799

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VAERS ID: 1430175 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow)

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

Write-up: Over the course of the day I felt numbness in my arm and by the evening I felt excruciating heart pain


VAERS ID: 1430666 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Dysphagia, Dysphonia, Feeling abnormal, Gait disturbance, Heart rate increased, Oral discomfort, Peripheral coldness, Pharyngeal swelling, Presyncope, Rash macular, Swelling, Throat irritation, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (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), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hives, Asthma, Red blotches, fast heart beat / 58yrs old / 11-05-2020 / Fluzone PFS 2020-21 INJ 0.5ML
Other Medications: None during that day. Benadryl was taken for two weeks until the day before the vaccine appointment.
Current Illness: None.
Preexisting Conditions: Asthma, Ankylosing Spondylitis.
Allergies: FluzonePFS, Aspirin, Imitrex, Prilosec, Chemicals, Mold, Pineapple, Kiwi.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: After 7 minutes of the shot, the following events/symptoms started and gradually developed within 25 minutes: Fast heart beat, change in eyesight and then a feeling of neck disappearing-non existent. Episodes similar to Vasovagal (3) Involuntary movement of arms and legs Extremely cold hands, but I did not feel cold Burning sensation inside the mouth Numbness of mouth and lips, similar as when the dentist applies anesthesia Mild Swelling of the mouth and tongue Tightness and feeling of swollen throat and neck Difficult to speak-speaking as in slow motion Trouble swallowing Trouble walking, legs weakness (continue in next paragraph) For approximately 45 minutes Healthcare personnel at the facility provided lots of fluids and assistance until there were neither episodes similar to Vasovagal nor involuntary movement of arms and legs, the hands had a normal temperature, some strength was regained, the symptoms remain mild (did not increase) and there were no new symptoms. Hives in forehead, and red blotches in right cheek, neck, chest Hoarseness and feather sensation in throat After 2 hours of the shot, the hives and red blotches in the right cheek, neck, chest and the hoarseness and feather sensation in the throat developed. The mouth, tongue and neck were still swollen and numb. At that time, 50mg of Benadryl were ingested, again at bedtime, and for the next 2 weeks.


VAERS ID: 1431456 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: rosuvastatin 40 mg, synthroid 0.125, sertraline 100mg . metformin 500 mg, topiramate,50mg, Irvesarten 75mg, vitamin D 125 mcg, vepropion 150 mg,
Current Illness: no
Preexisting Conditions: pre diabetes high blood pressure one kidney
Allergies: penicillin, codeine, antibiotic with cillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: severely started with feet itching, base of wrist . Then Center scape and nap of the neck . Rash between breast . Thighs, neck ,most itching on left side .Welps up after itching. sometimes eyelids.


VAERS ID: 1431759 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-03
Onset:2021-06-02
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Cardiomyopathy (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Too many to list
Current Illness: none
Preexisting Conditions: diabetes, High blood pressure, and hyperlipidemia all well controlled
Allergies: Tetracycline and Brylinta
Diagnostic Lab Data: Diagnosed with chest car scan on6/2/21
CDC Split Type:

Write-up: Bilateral extensive pulmonary embolism


VAERS ID: 1432790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Pain, SARS-CoV-2 test, Tinnitus
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Hashimoto''s disease; Iodine contrast media allergy (Tightness in chest and throat and hives); Non-smoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20200301; Test Name: COVID-19 PCR test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210650238

Write-up: BODY ACHES; LETHARGY; TINNITUS ON THE LEFT EAR (LOW PITCH AND HIGH PITCH); This spontaneous report received from a patient concerned a 51 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hashimoto''s disease, abstains from alcohol, non smoker, and orange peel (has epi pen for) iodinated contrast. The patient experienced extreme bloating when treated with clarithromycin, and neurological side effects when treated with levofloxacin, and lips swelled up, rash and throat tightened up when treated with cortisone, high blood pressure when treated with prednisone, and rash when treated with methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced lethargy. On 02-JUN-2021, the subject experienced tinnitus on the left ear (low pitch and high pitch). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and lethargy on 04-JUN-2021, and had not recovered from tinnitus on the left ear (low pitch and high pitch). This report was non-serious.


VAERS ID: 1433184 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain, Orthostatic hypertension, Parosmia, Rhinitis, Taste disorder, Vision blurred, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: escitalopram, aspirin, gabapentin, insulin determir, insulin aspart, ondansetron, rosuvastatin
Current Illness: None
Preexisting Conditions: uncontrolled type 2 diabetes, hypertension, charcot foot, obesity
Allergies: Demerol, morphine, Lyrica
Diagnostic Lab Data: Nothing in office, patient was sent to ER, no records received yet.
CDC Split Type:

Write-up: Fatigue, decreased sense of taste and smell, headache, rhinitis, sore thoraot, cough, dyspnea, diarrhea, nausea, vomiting, myalgia, blurry vision since 2nd Moderna dose, not tested for COVID, was sent to ER when presented to office w/ symptoms and orthostatic hypotension.


VAERS ID: 1433202 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-01
Onset:2021-06-02
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: Acute kidney injury


VAERS ID: 1433258 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023C21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Rash on arm and chest. It was itching. Started 1-2 days after vaccine. Lasted 1 week after vaccine. Tried cortisone 10 and took plenty of showers to help with itching


VAERS ID: 1433405 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-27
Onset:2021-06-02
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9810 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Facial paralysis, Hyponatraemia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hearing impairment (broad), Chronic kidney disease (broad)

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

Write-up: FACIAL DROOP E87.1 - Hyponatremia


VAERS ID: 1433434 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Visual disturbance


VAERS ID: 1434692 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 LA / SC

Administered by: Senior Living       Purchased by: ?
Symptoms: Mobility decreased, Pain in extremity, Periarthritis
SMQs:, Parkinson-like events (broad), Arthritis (narrow), 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: Lisonpril Cymbalta levothyroxin ozempic
Current Illness: None
Preexisting Conditions: Thyroid and pre diabetes controlled blood pressure and diabetes
Allergies: Demerol
Diagnostic Lab Data: Waiting on Dr visit
CDC Split Type:

Write-up: My left arm feels frozen hurts can''t use lift it above my head. I can''t stretch out my arm.


VAERS ID: 1435918 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-27
Onset:2021-06-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Chills, Headache, Loss of consciousness, Nausea, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? 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:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: headache; nausea; chills; Hemorrhage brain; stroke; subarachnoid hemorrhage; was asleep and not aware of anything for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBRAL HAEMORRHAGE (Hemorrhage brain) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization, medically significant, life threatening and intervention required) and SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criteria hospitalization, life threatening and intervention required), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), NAUSEA (nausea) (seriousness criteria hospitalization and life threatening) and CHILLS (chills) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 02-Jun-2021 due to CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT, HEADACHE and SUBARACHNOID HAEMORRHAGE. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had brain hemorrhage and stroke. The patient was airlifted to nearby hospital from local hospital spent 8 days in the ICU. It was called subarachnoid hemorrhage. They took patient in ambulance and then they found blood in her brain so they flew her to nearby hospital for neurological ICU did EKG, MRIs and ultrasounds of brain (results were not provided). The patient had no underlying health conditions. After getting the vaccine, patient had the worse headache was screaming. The headaches very soon after the vaccine and it kept on getting worse and worse. The patient was taking Tylenol but it was not taking the pain away. The patient was asleep and not aware of anything for 3 days and then patient called an ambulance. The patient had nausea and chills was scared to get the second shot. No concomitant medication were provided. Company Comment: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1437361 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO182 / UNK RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram, Electrocardiogram, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Developed Myocarditis that lasted 12 hours. Went to hospital in for treatment.


VAERS ID: 1437471 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-25
Onset:2021-06-02
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3246/PFIZER / 2 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Breast swelling, Breast tenderness, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular, Nausea
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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: Vitamin C
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Irregular period starting at the end of May 2021. Heavy bleeding, severe cramping, and nausea lasting 1-2 days. Late start to period. Consistent breast tenderness and growth.


VAERS ID: 1437494 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-05-27
Onset:2021-06-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: Yes
Current Illness: No
Preexisting Conditions: Diabetes, COPD
Allergies: Penicillin
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: Increased tiredness, dizziness, body aches


VAERS ID: 1437495 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-17
Onset:2021-06-02
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH G00177 / 1 UN / IM

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

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

Write-up: Numbness of the pinkie toe of the right foot. First noticed 2-3 weeks after first dose, still present 6 weeks after vaccination. Exacerbated after a hot shower and while walking.


VAERS ID: 1437529 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Chills, Gait inability, Hyperhidrosis, Impaired work ability, Injection site nodule, Mobility decreased, Pain, Peripheral swelling, Pyrexia, Scan normal, Ultrasound scan normal, Urine analysis normal, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: PCOS, Trigeminal Neuroglia, Obesity, A-Fib, Migraines, Back Injury, and Diabetes
Allergies: No
Diagnostic Lab Data: Scan of my arm, urine test, blood test, and ordered an Ultrasound to see if there were any other issues (hematoma or other issues). All the tests came back negative.
CDC Split Type: vsafe

Write-up: I started sweating and aching plus there was a knot in my left arm where the vaccine was administered. I contacted my doctor and he said that it injured the tissue in my arm (caused the swelling). I had two weeks of fever and chills, not being able to walk, vomiting, and my arm was so swollen until I had to go to urgent care because I could not wear my shirts (looked like a bee sting reaction). I couldn''t bend my arm and was not able to work during that time. I ended up going to the ER for my arm and the fever. The doctors said that I would eventually recover from the adverse event in time. It lasted for 8 days or 9 days (arm gradually went down approximately a week afterwards).


VAERS ID: 1437557 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling of lymph nodes, swelling under armpit on left side of body


VAERS ID: 1437680 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphagia, Inflammation, Throat irritation, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (broad)

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

Write-up: Irritation in my throat, getting hard to swollen, muscles in my throat felt tight. Which lead me to visit the doctor. Diagnosed with inflammation in the throat. Prescribed over the counter medication.


VAERS ID: 1437788 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: patient said she had swelling in the left arm for two weeks. patient put on the ice pack and swelling went away


VAERS ID: 1437932 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN O42A21A / 1 RA / SYR

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

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

Write-up: 5 days after my shot, I began to bleed. I continued to bleed vaginally for 5 days. have been post menopausal for about 2 years.


VAERS ID: 1437994 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-15
Onset:2021-06-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Haemorrhage, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Ultrasound
CDC Split Type: vsafe

Write-up: I learned I was pregnant the day after the first dose of my vaccine. Two and a half weeks after the second dose I experienced bleeding when my pregnancy was at seven weeks. I had spotting for two days. Two weeks after that I had heavier bleeding. I thought my pregnancy was progressing but it was confirmed that the baby stopped growing at seven weeks. I should have been eleven and a half weeks pregnant at that time. Due Date: 01/08/2022 Pregnancy: fourth


VAERS ID: 1438281 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-05-12
Onset:2021-06-02
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 8735? / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Brain natriuretic peptide increased, Cardiac imaging procedure abnormal, Chest pain, Computerised tomogram normal, Computerised tomogram thorax, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Headache, Immunoglobulin therapy, Intensive care, Myocarditis, Neck pain, Oedema, Pallor, Troponin increased, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: no
Allergies: NKDA
Diagnostic Lab Data: 6/2/21 (Chest CT scan): Medical Center - no pulmonary embolus Transferred to Hospital with chest pain with elevated troponin to 7.8, BNP of 175; presumed myocarditis post COVID Vaccine from 05/12/2021. 06/03/2021 (echo: Myocardial dysfunction with an LV ejection fraction of 35% 06/04/2021 (CMR: Epicardial and mid myocardial delayed enhancement of the inferior and inferolateral walls of the mid and basilar left ventricle consistent with myocarditis 06/05/2021 (echo: Myocardial dysfunction with an LV ejection fraction b/w 37-45% 06/07/2021 (echo: Myocardial improvement with an LV ejection fraction of 62%
CDC Split Type:

Write-up: On 06/02/2021, (23 days after vaccine) the patient and his identical twin brother were at dinner when patient had shortness of breath and chest pain. They brought the patient to Medical Center where a CT of the chest was performed to rule out a pulmonary embolus. No pulmonary embolus was identified and patient was transferred the patient via ambulance to Hospital to the intensive care unit. He was noted to have an elevated troponin, an elevated BNP and a left ventricular ejection fraction of 35%. He underwent a cardiac MRI on 06/04/2021 documenting delayed enhancement in the inferior and inferolateral walls of the left ventricle consistent with myocarditis. The patient''s chest pain was quite severe and was only relieved once he was in the intensive care unit at Hospital. He did well for 2-3 days and did not require inotropes but his troponin vacillated and his ejection fraction remain low. He was given IVIG non 06/05/2021 after his echo showed an ejection fraction between 37 in 45%. He subsequently developed headache emesis and neck pain. On hospital day 5, the father was quite concerned for his son and thought ?he was going to die?. The father shared pictures of the edematous, pale son that he took with his phone. He improved over the next 1-2 days and was discharged from the hospital with an ejection fraction on 06/07/21 of 62%.


VAERS ID: 1438444 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None reported
Preexisting Conditions: COPD
Allergies: None reported
Diagnostic Lab Data: none
CDC Split Type:

Write-up: After receiving his second dose, the patient reported having a seizure about 2 hours after his first dose. He said the episode lasted about 4-5 minutes, and he was covered in sweat afterwards. He did not follow up with a physician because he does not have insurance. He also did not inform the pharmacy until later because he was afraid we would refuse to administer the second dose.


VAERS ID: 1439841 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; COLLAGEN HYDROLYSATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021709501

Write-up: My period started two days early on 02Jun (which by itself is not an issue) but I have not stopped bleeding since then and am still passing actual tissue/clots almost daily.; I have not stopped bleeding/ am still passing actual tissue/clots almost daily; This a spontaneous report from consumer (Patient). A 47-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration on 29May2021 (at the age of 47)(at 11:30 AM), as dose 2, single in left arm for covid-19 immunization at vaccine clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported and ha d no allergies to medications, food, or other products. Device Date was reported as 15Jun2021. The patient''s concomitant medications included lexapro (escitalopram oxalate) and collagen powder(collagen hydrolysate). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route on left arm on 01May2021 01:30 PM for COVID-19 Immunization. On 02Jun2021 (at 12:00PM), patient experienced her period started two days early on 02Jun (which by itself is not an issue) but she has not stopped bleeding since then and still passing actual tissue/clots almost daily. The outcome of the events was not recovered.


VAERS ID: 1439867 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021716279

Write-up: Tinnitus after the second dose; This is a spontaneous report from a contactable consumer (reporting himself). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration in left arm on 29May2021 at 10:00 (age at the time of vaccination was 72-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient had no relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on 29Apr2021 at 09:00 as a single dose for COVID-19 immunization. On 02Jun2021, the patient experienced tinnitus after the second dose and resulted in disability or permanent damage. The patient did not receive any treatment medication for the event. The outcome of the event was not resolved. Information on Lot/Batch number is available; Further information has been requested.


VAERS ID: 1440243 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033B21A / 1 LA / IM

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

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

Write-up: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Lymph Node Swelling-Mild


VAERS ID: 1440514 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-16
Onset:2021-06-02
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Laboratory test, Rheumatoid arthritis, X-ray
SMQs:, Arthritis (narrow), Immune-mediated/autoimmune 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: Mild flu-like symptoms
Other Medications: One a Day Prenatal Vitamin with Choline, Lamotrigine 100mg, cyclobenzaprine 5mg, ibuprofen 800mg, Gabapentin 400mg, Vitamin b-12, vitamin D, Benadryl 4/day, percoset 7.5/325
Current Illness: None
Preexisting Conditions: Bipolar disorder, anxiety disorder, nerve damage from neck fusion at C1, osteoarthritis
Allergies: Adhesives, cats, grass, oak
Diagnostic Lab Data: X-ray on June 30, 2021. Blood test on July 1, 2021.
CDC Split Type:

Write-up: All joints hurt when I wake in the morning. The doctor suspects Rheumatoid Arthritis, but tests have not been completed and final diagnosis has not been made.


VAERS ID: 1440678 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 02C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood culture, Cardiac telemetry, Dizziness, Palpitations, Scan, Urine analysis abnormal
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: venlafaxine xr 225 mg daily(increased from 150 mg on 05/24/2021), astelazine nasal spray
Current Illness:
Preexisting Conditions: Depression, seasonal allergies
Allergies: penicillin, sulfa
Diagnostic Lab Data: Inpatient workup, including telemetry, blood cultures, scans, and urinalysis performed. urinalysis suggested possible UTI(but was contaminated by culture results) and this was treated. There was no dysuria or flank/suprapubic discomfort to suggest UTI prior or after. Orthostasis persisted even with fluid resuscitation. Midodrine 2.5 mg improved symptoms and patient was able to be discharged to home. Venlafaxine XR was decreased from 225 mg to 150 mg daily. At follow up on 7/1/2021 patient was still orthostatic/lightheaded. pulse 90 seated, bp 120/74; standing pulse 137, bp 90/60
CDC Split Type:

Write-up: symptoms of lightheadedness and racing pulse started about two hours after second shot. these symptoms persisted. seen in clinic and admitted on 06/24/2021 for severe orthostasis.


VAERS ID: 1440775 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Condition aggravated, Pleuritic pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Medical marijuana; Plaquenil; Lexapro; Ativan; Losartan; aspirin; Vyvanse
Current Illness: none
Preexisting Conditions: Lupus; PTSD; ADHD; hypertension; Antiphospholipids syndrome
Allergies: Sulfa drugs; Cipro; Wellbutrin; Levaquin; Terbutaline
Diagnostic Lab Data: none
CDC Split Type: vsafe

Write-up: About 3 days after the vaccine 2nd dose, I noticed I was getting pleurisy chest pains. This time, the pain was on the left side (when normally is on the right side). I went to the doctor and was prescribed colchicine 0.6mg and prednisone 10mg. I am still having chest pains which has not resolved.


VAERS ID: 1441810 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Aphasia, Brain oedema, Cerebral haemorrhage, Cerebral infarction, Cerebral microhaemorrhage, Cerebral small vessel ischaemic disease, Computerised tomogram head normal, Dizziness, Dysarthria, Haemorrhagic transformation stroke, Headache, Intraventricular haemorrhage, Magnetic resonance imaging head abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: N/A
Preexisting Conditions: Dyslipidemia Prediabetes Sensorineural hearing loss, bilateral
Allergies: None
Diagnostic Lab Data: 6/4/2021 MRI BRAIN: multiple small acute infarcts to left posterior frontal, left parietal and left posterior periventricular regions, mild chronic white matter ischemic changes. 6/26/2021: MRI/MRA brain-- several small acute infarcts in L MCA territory, watershed distribution. There has been interval development of an acute L frontal ICH w/ mild surrounding edema and mass effect w/ a thin adjacent DH and trace IVH. Chronic small vessel ischemic disease, several cortical microbleeds.
CDC Split Type:

Write-up: He then felt dizzines and a headache the following day. On 6/2/2021(4 days after vaccination) he had slurred speech which prompted his family to bring him to ER. CT brain negative for acute CVA. Pt was placed on DAPT (Plavix and ASA). On 6/25/2021-- pt was hospitalized again for severe mixed aphasia and dysarthria--- second stroke with hemorrhagic conversion.


VAERS ID: 1441906 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 UN / IM

Administered by: Public       Purchased by: ?
Symptoms: Hypertension, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad)

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

Write-up: Client reported an onset of "feeling lightheaded" while ambulating from vaccination area to observation area. The client subsequently developed nausea and dizziness following the receiving the 1st COVID vaccine Pfizer. The client notified personnel in the observation area of symptoms and laid down. She states she also developed mild chest tightness which resolved a few hours later. The client was provided a juice in the observation area. The client stated she tried to drink the juice, but spit it up immediately after. No medications were provided at the vaccination site. The client states she sought care at an urgent care immediately following departure from the vaccination site. The client states they obtained "vitals and checked my lungs" at the urgent care. The client also stated "my blood pressure was a little high." The client did not take any medication following the initial episode of feeling lightheaded and dizziness. She states her symptoms resolved about 24 hours after onset. The client stated she reported her initial reaction to her PCP and her PCP gave approval to receive the 2nd COVID Pfizer dose. Vitals obtained by RN Barberan were obtained by RN Barberan at 7:56PM were as follows HR 78 and BP 115/90. A medical consult was submitted via text message. Approval to proceed with 2nd COVID vaccine Pfizer was obtained by Summer Leal, Vaccine Operations via telephone. Client received the 2nd COVID vaccine Pfizer Lot# EW0191 at 8:24PM in the anti-gravity chair. RN Withers educated the client on s/s of anaphylaxis, when to seek EMS, 30 minute observation recommendation, and V-safe. The client voiced understanding of this. At 8:32PM the client reported nausea to EMT Bustamonte. RN Withers responded. Vitals obtained at 8:36PM were as follows: HR 78 and BP 144/100. The client denied SOB or dizziness at the time. The client removed their mask and RN Withers noted pallor on the client''s face. At 8:39PM the client denied any dizziness or feeling lightheaded. Vitals obtained at 08:44PM were as follows: BP 140/98 and HR 74. The client noted mild improvement of her nausea at that time. Repeat vitals obtained at 08:54PM were as follows 142/92 and HR 78. The client reported her nausea was "a little better." At 08:59 PM RN Withers offered to call EMS to evaluate the patient. The client denied EMS. RN Withers let the client know she could seek care at an urgent care, emergency department, or monitor her symptoms at home. The client elected to monitor her symptoms at home. RN Withers reiterated when to seek EMS and s/s of anaphylaxis. The client voiced understanding of this. The client stood up from the anti gravity chair without assistance, ambulated with a steady gait unassisted, and was visualized getting into a person vehicle driven by her husband at 9:03PM.


VAERS ID: 1443035 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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

Write-up: Multiple ED visits/hospitalizations within 6 weeks of COVID vaccination. 6/2/2021 ED, 6/4/2021 ED to Hosp Admission, 6/12/2021 ED, 6/23/2021 hospital admission,


VAERS ID: 1443282 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Gait disturbance, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Patient called on 7/2 stating that 5 days after receiving vaccination started to have trouble walking and has had numb fingers. Patient states this has continued until now. Patient is going to follow up with doctor.


VAERS ID: 1445712 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Blood test, COVID-19, Hyperhidrosis, SARS-CoV-2 test, Sinus disorder, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions: Comments: Patient had no medical history. He had no known allergies and no current illness at the time of vaccination.
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood test; Result Unstructured Data: Unknown; Test Date: 20210602; Test Name: SARS-CoV-2 rapid diagnostic test; Result Unstructured Data: Positive; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210701758

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS; SWEATING; This spontaneous report received from a Pfizer on 25-JUN-2021 and concerned a 42 year old male. The patient''s weight was 99.79 kilograms, and height was 191 centimeters. The patient''s concurrent conditions included non smoker and patient had no medical history. He had no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 to right arm at 08:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in May 2021, patient underwent blood work a week before he knew he had COVID. On 02-JUN-2021, the patient experienced sinus, fever, body aches, diarrhea, congestion, nausea, headache, mild cough and sweating. On the same day, patient underwent SARS-CoV-2 rapid diagnostic test and the results came out to be positive. On an unspecified date the patient underwent SARS-COV-2 PCR TEST and the results came out to be positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus, and sweating on JUN-2021, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210701758 -COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1446107 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-13
Onset:2021-06-02
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphonia, Paraesthesia, Paraesthesia oral, Slow speech
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)

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

Write-up: Tingling feeling in fingers and lip on one side and minimally in one leg, slowed speech, using words that didn''t fit (ie said "brushtooth" instead of "toothbrush"), voice sounded different to himself. No treatment. Happened late in the evening so he went to sleep under supervision and woke up completely back to normal. He remembers everything about the event. These symptoms repeated 22 days after the second dose. He is scheduled with a neurologist for Aug 9. 2021 for follow up.


VAERS ID: 1446236 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-18
Onset:2021-06-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Migraine, Oligomenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: Rizitriptan
Current Illness: None
Preexisting Conditions: Migraines
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: After the first vaccination shot (late April 2021), my menstrual cycle was fourteen days early. After the second vaccination shot, my menstrual cycle was later than usual, arriving at about Day 31 of my cycle. My cycle is typically 26 days long. The menstruation after my second shot was exceedingly heavy and painful - I had terrible cramps, worse than normal fatigue, and very heavy bleeding. The menstruation lasted longer than normal for me (about eight days), and it was followed by a few days of spotting, which is also unusual for me. In addition to these changes in my cycle, I experienced worse than normal migraines throughout the month of June, both during menstruation and during ovulation. I typically get migraines about once or twice a month, and I was getting migraines about 3-4 times a week throughout June.


VAERS ID: 1446367 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Appointment for an MRI on July 12
CDC Split Type:

Write-up: 05/28 Second dose of vaccine 06/01 Knee cramps and pain. 06/02 Acupuncture was performed, and the pain was no longer felt after acupuncture. But two hours later the knee continued to ache. He will recover in about two weeks. 06/16 I started to have a headache in the morning, and then my dizziness continued until now. The headaches had previously only occurred on the day of the second dose and the next day. Chiropractic, acupuncture, and massage have not worked. I''m waiting for an MRI.


VAERS ID: 1446395 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Parosmia, Taste disorder
SMQs:, Taste and smell disorders (narrow)

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

Write-up: I can not taste or smell the same. Toothpaste, rice, onions, coffee and many other things do not smell and taste quite right.


VAERS ID: 1446762 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-02
Onset:2021-06-02
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW019 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi vitamin, calcium, vitamin C
Current Illness: none
Preexisting Conditions: seasonal allergies
Allergies: some antibiotics-penicillin, sulfa, a few others.
Diagnostic Lab Data:
CDC Split Type:

Write-up: tingling, pins and needles, itching all over body intermittently for 4 weeks. took Benadryl as recommended by doctor. Symptoms were very intense for 2 weeks, slowly got less frequent. It seemed to be completely gone about a week ago but then came back strongly for 2 days. Now about 80% better.


VAERS ID: 1446822 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Occasional mild tingling in fingers. Never before experienced. Lasting symptom still continues.


VAERS ID: 1447053 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Hematoma


VAERS ID: 1447130 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Hypersomnia, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: Centrum Silver, Vitamin D3 5000 units daily, Acidophilus Probiotic
Current Illness: None
Preexisting Conditions: None
Allergies: Ibuprofen, Bactrim, Cipro, Penicillin, Toradol, Acetaminophen, Zofran
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Malaise at 21.5 hours after vaccination. Fever, shaking chills, nausea and vomiting, fatigue started 25 hours after vaccination. Slept for 24 hours.


VAERS ID: 1449490 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-11
Onset:2021-06-02
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Heart rate decreased, Herpes zoster, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: heart rate; Result Unstructured Data: Test Result:low
CDC Split Type: USPFIZER INC2021739951

Write-up: Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; Shingles requiring medical emergency. Fainting and low heart rate.; This is a spontaneous report from a contactable nurse (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206) via an unspecified route of administration, in the left arm on 11May2021 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included IBS (irritable bowel syndrome). Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies were not reported. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, in the left arm on 16Apr2021 as dose 1, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any vaccines within four weeks prior to the vaccination. On 02Jun2021, the patient experienced shingles requiring medical emergency. Fainting and low heart rate. Patient received treatment for event were medications. Adverse events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 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: 1449506 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstruation irregular, Muscle spasms, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility 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: ALBUTEROL [SALBUTAMOL]; TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021748857

Write-up: Bleeding excessively; It was 4 days early and was the worse period she has experienced in 3 years; Extreme cramps; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female (non-pregnant) patient received 1st dose of BNT162B2 (lot#EW0196) on 30May2021 11:00 AM, vaccine location=Left arm at single dose for COVID-19 immunization. Relevant medical history was Asthma. No any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination included salbutamol (ALBUTEROL), paracetamol (TYLENOL) as needed. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps on 02Jun2021. We thought maybe it was a coincidence. She is only 15 yrs old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun2021 and I pray it was not as bad as last month after the shot. Outcome of reaction/event at the time of last observation was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts needed. No further information is expected.


VAERS ID: 1449729 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Upper respiratory tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown. Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. 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: 1450022 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Exposure during pregnancy, Live birth, Pain in extremity, Tenderness, Thrombosis, Ultrasound scan abnormal
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (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: Prenatal Vitamins
Current Illness: N/A
Preexisting Conditions:
Allergies: Penicillin, Cephalosporins, Sulfamethoxazole - TMP, Latex
Diagnostic Lab Data: I was sent for an ultrasound also on June 3rd where they determined I had a superficial blood clot.
CDC Split Type:

Write-up: I contacted my primary care office after experiencing a tender knot on my calf for a couple of days that also became reddened on the skin surface. It was determined by ultrasound that I had a small, superficial blood clot in my lower right calf on June 3rd. We treated the blood clot at home with a compression stocking, elevation and heat, and I had a follow-up ultrasound on June 10th that indicated no change in clot location or size. I continued with home treatment and did not have any further complications. The pain and redness have resolved since that time. Prior to this pregnancy I have had two healthy pregnancies and one miscarriage at 8 weeks between those two. I delivered my third child on June 14, 2021 via C-section without complications. Baby weight was 6 lbs 15.5 oz.


VAERS ID: 1450213 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Injection site discolouration
SMQs:

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

Write-up: Upon visiting with the patient for the 2nd dose of Moderna about 4 weeks later, the patient''s arm around where they received their 1st dose of Moderna was still discolored. The patient did not seem to be too concerned as they were present to receive 2nd dose of Moderna. The 2nd dose was given in the opposite arm.


VAERS ID: 1450221 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / UNK LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (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: Upon visiting with the patient for the 2nd dose of Moderna about 4 weeks later, the patient''s skin on the arm around where they received their 1st dose of Moderna was still discolored. The patient did not seem to be too concerned as they were present to receive 2nd dose of Moderna. The 2nd dose was given in the opposite arm.


VAERS ID: 1450700 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-30
Onset:2021-06-02
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Angioplasty, Antiplatelet therapy, Blood test, Chest X-ray, Computerised tomogram, Coronary arterial stent insertion, Coronary artery occlusion, Echocardiogram, Electrocardiogram, Metabolic function test, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yes, I was taking Levothyrox, Lisinopril, and Rosuvastatin.
Current Illness: No
Preexisting Conditions: I only have high blood pressure, high cholesterol, and low Thyroid.
Allergies: I am allergic to Darvon.
Diagnostic Lab Data: I had the following: Blood test, EKG, CT Scan, Chest X-ray, Echo-Cardiogram, and a comprehensive test.
CDC Split Type: vsafe

Write-up: My wife drove me to the hospital because I had a heart attack after receiving the 2nd dosage (suffered mild cardio inflection) which meant that there was a blockage in the left circumplex artery and I had to have an angioplasty (surgical stint). I was placed on Plavix for one year along with baby aspirin indefinitely. I spent one night in the hospital as a result of the adverse event and will be starting Cardiac rehab on June 12, 2021.


VAERS ID: 1452598 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-01
Onset:2021-06-02
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye pruritus, Eye swelling, Feeling hot, Pain in extremity, Pruritus, Sleep disorder, Somnolence, Ultrasound scan, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Ultrasound
CDC Split Type:

Write-up: May 10th 1st shot - sleepy & a little itchiness on my skin May 31st 2nd shot- sleepy June 2nd - itchiness at 1:45am in the morning which woke me up. I went to the bathroom and my entire body was broken out in hives. I immediately drove to the ER and was given benadryl, prednisone, and famotidine. 30 mins afterwards the allergic reaction went away. June 30th - woke up to itchy eyes and went to the mirror both eyes swollen like a plum. Went to the clinic and was given the same medications. July 4- right leg pain and warm to touch July 6th - went back to ER to have my right leg checked, no blood clots. Dr gave me muscle relaxers July 7th- itchy all over and hives all on my body


VAERS ID: 1453766 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphonia, Cough, Dyspnoea, Fatigue, Lacrimation increased, Migraine, Nasal congestion, Pain, Rhinorrhoea, Vaccination site swelling, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Lacrimal disorders (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: VOLTAREN [DICLOFENAC]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (other medical history: Arthritis, Depression, Anxiety, PTSD); Arthritis (other medical history: Arthritis, Depression, Anxiety, PTSD); COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Depression (other medical history: Arthritis, Depression, Anxiety, PTSD); Post-traumatic stress disorder (other medical history: Arthritis, Depression, Anxiety, PTSD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021758789

Write-up: Constant migraines ?4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional. A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.


VAERS ID: 1454439 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Contusion, Electrocardiogram normal, Panic attack, Paralysis, Tachycardia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Event 1: Severe Tachycardia (hr 133), elevated BP (130 over 110) with temporary paralysis. Drove to Hospital ER where BP was measured, and EKG performed. EKG was normal and I was sat in the waiting room with a "panic attack". I left the ER 2 hours later as there was no hope of a Dr seeing me within 12. Event 2: Noted today, 7/7/2021, spontaneous bruising on the right big toe. I also have a series of unexplained bruises down my left leg.


VAERS ID: 1454520 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028A21A / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear pain, Oropharyngeal pain, Upper respiratory tract infection
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glimepiride 2mg Januvia 100mg Levemir 100 unit daily Metformin 500mg Rosuvastatin 10mg Vitamin C 1000mg
Current Illness: none
Preexisting Conditions: diabetic
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Had upper respiratory infection with sore throat and ear ache. Took over the counter cough syrup and doctor prescribed azithromycin.


VAERS ID: 1454766 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Pruritus, Pyrexia, Rash, Thermal burn, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Small fever following a flu vaccine in 2017, only lasted a day or two
Other Medications: 25 mg metoprolol tartrate 2x a day 2 fish oil pills a day
Current Illness: Developed a fever (due to vaccine) the day after second dosage but nothing else
Preexisting Conditions: Rapid heart rate due to unknown reason (have seen 3 cardiologists, have had 2 echocardiograms - normal healthy heart and electric pulses)
Allergies: None
Diagnostic Lab Data: On June 19th, I saw the doctor listed above for my urticaria. She did not have an answer obviously, but thought we should try a dosage of Prednisone, as well as taking Benadryl at night still. The next day (June 20) I began taking the dosage of Prednisone, and within an hour, I saw almost no flare up of the urticaria. For the next 4-5 days, there was nothing as I was taking a high dosage. Finally, as I was down to my last two days where I was only taking 1 pill a day (June 30th and July 1st) I saw a few small flareups of hives creeping back on my body, mostly on my hands and forearms. On July 5th, I had the biggest flare up since stopping my dosage of Prednisone. It was all over my neck, back, torso, upper arm, and leg. The next day (July 6th) I went back to the same doctor and we thought the best bet was to try the same dosage of Prednisone one more time. Today is my second day taking it and I''ve had no flareups so far. I''m just concerned what will happen once I finish my dosage once again.
CDC Split Type:

Write-up: The morning after vaccination, I came down with a fever of 100-101 F. This fever stayed with me for approx. the next 3 days. On June 2nd, while I was still somewhat having my fever, I began to break out in hives/welts all over my body. They would appear on a few areas of my body at a time, and then would go away and appear elsewhere. I presumed this was just a temporary auto-immune response, however, for the next 2-3 weeks, they would persist, all day, at varying points of the day. They itched and burned. Some were just red patches on my skin, while some had little bumps as well, and some even appeared as long thick white welts. I could scratch myself first as well, and then it would immediately appear. However, usually I did not even touch myself and they would appear. I began taking Benadryl at night to help me sleep, and although it gave a little relief, the results were always very temporary and the next morning they would be back.


VAERS ID: 1454879 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Ear discomfort, Ear infection, Hypoacusis, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test negative, Sinusitis, Tinnitus
SMQs:, Hearing impairment (narrow), 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: Fever/body aches for period of 36 hours following Shingrix vaccines for prevention of shingles. Patient was 58 for first dose (
Other Medications: levothyroxine
Current Illness:
Preexisting Conditions: hypothyroidism
Allergies:
Diagnostic Lab Data: COVID test performed to rule out COVID, test result was negative
CDC Split Type:

Write-up: inner ear (left) and sinus infection requiring 10-day course of antibiotics to clear infection. Symptoms included diminished ability to hear clearly and feeling of "fullness" in ear; increased ringing in ear, runny/stuffy nose. After course of antibiotics, all symptoms cleared up.


VAERS ID: 1458776 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Generalized osteoarthritis; High cholesterol; Hypertension; Non-smoker; Osteopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract extraction; Gallbladder operation; Comments: The patient had no known allergies and no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210709043

Write-up: ON AND OFF TINNITUS; This spontaneous report received from a patient concerned a 79 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included gall bladder surgery, and cataract extraction, and concurrent conditions included hypertension, general osteoarthritis, high cholesterol, osteopenia, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced on and off tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off tinnitus. This report was non-serious.


VAERS ID: 1459931 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-05
Onset:2021-06-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 1 RA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Headache, Herpes zoster, Magnetic resonance imaging, Oropharyngeal pain, Rash, Rash pruritic, Streptococcal infection, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Buproprion; Atenolol; Hydroclorothiazide; Celecoxib; L-Thyroxine; Fenofibrate; Lovostatin; Xyzal; Restasis; Estradiol Vaginal Inserts; Clotrimazole and bethamethasone dipriopionate
Current Illness: n/a
Preexisting Conditions: obesity; high blood pressure; high cholesterol;
Allergies: ibuprofren;
Diagnostic Lab Data: strep test (6/7/2021) MRI (at ER on 6/10/2021)
CDC Split Type:

Write-up: (may be unrelated) Began having headaches on June 2, 2021, could feel but not see bumps on left back side of head...headache continued sore throat beginning 6/5/2021; diagnosed with strep on 6/7/2021; headache (radiating downward from bumps on head and upward from neck lymph nodes. Became severe, went to ER at 3:30 am on 6/10/2021; diagnosed with shingles at doctors office on 6/10/2021. Head continued until about June 15. Bumps still itchy today (July 9)


VAERS ID: 1460024 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014C21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Contacted parent today, no adverse reaction has been experienced.


VAERS ID: 1460348 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018B21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: Vaccination Error/Vaccine Misadministered Patient was registered for Pfizer vaccination on MyTurn however in the clinic was given Moderna. Vaccine was administered by an MA here in the clinic. No symptoms during the time of the administration, during the wait period for 15 minutes and currently. I verified by calling mother of patient today 7/9/21 whom denies any symptoms or concerns currently.


VAERS ID: 1461732 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Arthritis, Blood test, Cold sweat, Gait disturbance, Gait inability, Headache, Hypoaesthesia, Myalgia, Pain, Paraesthesia, Posture abnormal, Pyrexia, Sleep disorder, Surgery, Vitamin D decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, advil ,cortisone 10 volteren cream,benadryl amlodipine besalate, crestor hydrochloraxide, zoloft,hydromorphone carbamazepine
Current Illness: Sinus infection
Preexisting Conditions: No
Allergies: Percocet Lossrtan Zoloft
Diagnostic Lab Data: Full blood panel. All normal.
CDC Split Type:

Write-up: Git 1 injection June 1. No side effects at all. June 29, got 2nd injection and everything went to hell! I''ve never had so much pain in my life, and I e had 3 major surgeries! Woke up July 1,the next morning with low grade fever,cold sweats, aching hamstrings, aching guads,all joints feel inflamed, headache,stomach, Feet and hand were tingling very very bad! Could not sleep because pain excruciating! By Thursday morning, I could not walk. Walking caused more pain. I was able to walt in pain by Saturday afternoon. Sunday morning I wet to the Dr. He put me on prednisone. Did not help. Pain was so intense could barely walk. Went to dr on Wednesday. Prescribed higher doses of prednisone and gabapentin. Still have numbness in feet and hands. All joints are still inflamed. Just now being able to walk, but I have to walk in an awkward position. Dr did a full blood panel test. Everything came back normal except for low vitamin d.how long will this last??????.?


VAERS ID: 1461911 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Asthenia, Blood cholesterol increased, Blood creatine, Blood potassium, Fatigue, Full blood count, Haemoglobin, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Lipodystrophy (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: Prescriptions: buspirone, bupropion, fluticasone OTC: cetirizine hydrochloride Dietary supplements: one a day vitamin, 4000 IU vitamin D, 400 mg chelated magnesium, 1400 mg fish oil, 1000 mg berberine, 316 mg turmeric, 500 mg maca, 200 mc
Current Illness: None.
Preexisting Conditions: Depression, allergies, high cholesterol
Allergies: None known.
Diagnostic Lab Data: All tests performed came back with within normal range, except for total cholesterol, which was high. Tests performed included complete blood count, non-fasting lipid panel, hemoglobin A1c, thyroid stimulating hormone, potassium, creatinine and calculated glomerrular filtration rate, erythrocyte sedimentation rate, and alanine aminotransferase.
CDC Split Type:

Write-up: Approximately 10 hours after injection, a sore throat and fever occurred. The sore throat persists 5 weeks later, although lessened in severity. Fatigue occurred around day 11 after the vaccine. Debilitating fatigue and weakness occurred around day 22 and persisted for 4 days, lessening to general fatigue and weakness thereafter and persisting as of date of report. Sore throat, fatigue, and weakness persist with no end date as of this report.


VAERS ID: 1462060 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site induration, Injection site nodule, Pyrexia, Rash erythematous, Rash pruritic, Scab
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: Keppra, Vimpat, clonazepam, topamax, Vitamin B 100 complex, stool softner, aspirin, clarion, magnesium
Current Illness: None
Preexisting Conditions: Osteoarthritis, brain tumor, migraine, seizures, aneurysm, stroke, Tias
Allergies: Red dye, fire ants, reglan, Lamictal, depakote
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever around 101 for 3 days, hard/swollen knot at injection site, rash that broke out on right side of neck going down straight line to into my breast that was red/ itchy and eventually scabbed over and still have scars in placed


VAERS ID: 1463733 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

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

Write-up: Caused rectal bleeding no pain for averaged 4 hours a day


VAERS ID: 1464109 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-02-26
Onset:2021-06-02
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Biopsy skin, Dermatitis, Lichenoid keratosis, Pathology test, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxin 125 mg , Asacol 800 mg, Ursodiol 250mg 2/day .,
Current Illness: None
Preexisting Conditions: Osteoporosis
Allergies: Allergy to latex
Diagnostic Lab Data: Pathology report , skin biopsy
CDC Split Type:

Write-up: Rash , Lichenoid or interface dermatitis .


VAERS ID: 1464734 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0P11 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Rash, Rash erythematous, Rash pruritic, Skin irritation
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Spreading rash that started in left groin. it spread rapidly down leg, up the side of the abdomen and into the armpit. Rash was very itch and very red/irritated. It also started to looking like it was bruising as it healed. Rash was unaffected by Benadryl or antibiotics. Was prescribed steroids and it cleared up after about 2.5 weeks.


VAERS ID: 1464789 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: This patient received his first Covid dose on 04/28/2021 Moderna Lot #047B21A. He received his second dose on 6/2/2021 which was Pfizer Lot #EW0179. The CDC was contacted and they told him to return in 6 weeks and to receive another dose of either Moderna or Pfizer to complete his series. There was no apparent adverse outcome.


VAERS ID: 1465132 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Neck pain, Pain, Vaccination site pain
SMQs:, 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: Lyrica
Current Illness: n/a
Preexisting Conditions: nerve pain
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient is complaint about a sharp pain in the vaccinated arm. She claims she feel shocks from the vaccine site to all the way to the patient''s neck. Patient is planning to see a doctor.


VAERS ID: 1465999 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Epistaxis, Fatigue, Headache, Intensive care, Laboratory test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: venlafaxine 1.875 mg daily Advil 400 mg as needed Marajuana user
Current Illness: Depression Anxiety
Preexisting Conditions: Bulging Disks in neck Nerve damage Depression Anxiety
Allergies:
Diagnostic Lab Data: 6/2/2021. In ICU for 12 days. Many Test done
CDC Split Type:

Write-up: Tired headache bloody nose Brain Bleed Stroke 6/2/2021


VAERS ID: 1466696 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-03-29
Onset:2021-06-02
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratidine 10mg, Omeprazole 20mg, Emergen C
Current Illness:
Preexisting Conditions:
Allergies: Shellfish, Amoxicillin, Penicillin, Phenergan
Diagnostic Lab Data: Labs 6/6/21, MRI''s 7/10/21
CDC Split Type:

Write-up: Muscle weakness in Legs, numbness and tingling. Dizziness, difficulty walking. Numbness and tingling in arms. Neurology referral, MRI''s. Still being evaluated.


VAERS ID: 1467015 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-05-13
Onset:2021-06-02
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Band neutrophil percentage, Blood creatine phosphokinase MM normal, Blood creatine phosphokinase normal, Blood pressure increased, Borrelia test, Borrelia test negative, Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray normal, Chest pain, Chlamydia test negative, Coronavirus test negative, Cytomegalovirus test negative, Decreased appetite, Diarrhoea, Echocardiogram normal, Electrocardiogram ST segment abnormal, Enterovirus test negative, Epstein-Barr virus antibody negative, Feeling hot, Fibrin D dimer increased, Heart sounds abnormal, Human metapneumovirus test, Human rhinovirus test, Hypophagia, Influenza A virus test negative, Influenza B virus test, Lymphocyte percentage, MERS-CoV test negative, Monocyte percentage increased, Mycoplasma test negative, N-terminal prohormone brain natriuretic peptide increased, Neutrophil percentage, Pyrexia, Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative, Respiratory viral panel, Respirovirus test, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Tachycardia, Troponin I increased, Troponin increased, White blood cell count normal
SMQs:, Cardiac failure (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Rhinorrhea and nasal congestions (seasonal allergies) treated with Cetirizine 10 mg by mouth once a day. Not taking at the time of vaccination.
Preexisting Conditions: Autism Spectrum Disorder, obesity, anaphylaxis (peanuts, tree nuts, shellfish), and seasonal allergies
Allergies: Anaphylaxis to peanuts, tree nuts, and shellfish. No known drug allergies.
Diagnostic Lab Data: Initial labs in the local ER showed a Troponin I High Sensitivity of 2,508.1 ng/L, B Type Natriuretic Peptide of 196.0 pm/mL, CRP of 7.2 mg/dL, and D-Dimer of 660 ng/mL. WBCs were normal (8.08 k/mcL) with 50% segs, 10% bands, 26% lymphs, and 12% monos. Chest X-ray was read as normal, and an EKG showed nonspecific ST wave abnormalities. Labs at the hospital showed elevated Troponin I (repeated every 6 hours) of 3.13, 1.43, 0.94, and 0.68 ng/mL (discharged after the 0.68 ng/mL). Repeat N-Terminal BNP was 557 pg/mL, CK was 150 U/L, with 100% CK-MM fraction. ESR was 33 mm/hr, and repeat CRP was 5.99 mg/dL. NP PCR for SARS-CoV-2 through the county on June 3, 2021 was negative, and a respiratory panel (influenza A H1/H1-2009, H3, B, parainfluenza virus 1/2/3/4, multiplex coronavirus nCoV/MERS/SARS, RSV A & B, chlamydia pneumonia, mycoplasma pneumonia, human meapneumovirus & human rhinovirus/enterovirus PCR all negative. SARS-CoV-2 NP PCR negative x 2 (repeated after 24 hours in the hospital). CMV (IgM & PCR) negative; EBV (VCA IgM/IgG & EGNA IgG, & PCR of blood) negative; Lyme Antibodies (IgM/IgG) negative; Parechovirus and Enterovirus PCR of blood/plasma negative; SARS-CoV-2 IgM positive and IgG negative; SARS-CoV-2 IgG was positive. Told me that they ordered SARS-CoV-2 nucleocapsid and spike protein antibodies, but this was not done. EKGs were normal, and ECHO normal.
CDC Split Type:

Write-up: On June 2, 2021, he awoke and complained of feeling hot, tired, and not hungry. His mother had been sick with acute gastroenteritis symptoms 2 days earlier. Over the course of the day, he had a fever to 101.6 F, and began to have loose stools (twice). He received Ibuprofen 400 mg by mouth every 6 hours for the fever, and drank plenty of fluids. On June 3, 2021, he continued to have fevers to 101.5 F, loose stools (twice again), and poor oral intake of food. I canceled his scheduled 2nd Pfizer-BioNTech vaccine, and got him a NP swab test for SARS-CoV-2 through the health department. On June 4, 2021, he had no fever but now complained of a rubbing left parasternal chest pain. On physical examination, his BP was elevated (130s/90s), he had a slight tachycardia (90s), and was afebrile. On auscultation, I heard a S4 gallop and took him immediately to the local ER.


VAERS ID: 1467115 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-21
Onset:2021-06-02
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood cholesterol increased, Heavy menstrual bleeding, Hyperlipidaemia, Hypertension, Menstrual disorder
SMQs:, Dyslipidaemia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Lipodystrophy (broad)

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

Write-up: hypertension, hyperlipidemia, high cholesterol, mennhorrhagia, abnormal menstrual cycles


VAERS ID: 1467302 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-05-12
Onset:2021-06-02
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril, Gemfibrozil
Current Illness: None
Preexisting Conditions: HTN, HLD
Allergies: None
Diagnostic Lab Data: MRI lumbar spine showing intrathecal enhancement surrounding the cord and extending to the L5-S1 level CSF protein 828
CDC Split Type:

Write-up: The patient developed paresthesias and weakness in the legs approximately 2 weeks after the vaccine. After the thorough work-up he was diagnosed with Guillain-Barr? syndrome. He was treated with IVIG and has had some improvement.


VAERS ID: 1470254 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-22
Onset:2021-06-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

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

Write-up: Pt c/o feeling tired/fatigue, usually feeling exhausted during evening time on/off since she got her 2nd dose covid vaccine Pfizer on 05/22/2021. Also stated she got low grade fever this morning but did not check temperature. She stated she is checking her O2 sat and PR regularly at home,O2 sat remains $g95% and HR between 70s-90s. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. urgent care provider visit scheduled for consultation.


VAERS ID: 1470261 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Pain, Respiratory tract congestion
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

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

Write-up: Pt c/o severe body aches, congested, diarrhea 3-4 times since morning, headache. Reports dizziness and weakness in emergency screening. Pt was advised to call 911 or go to nearest ED for further treatment and evaluation,


VAERS ID: 1470321 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-04
Onset:2021-06-02
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Caffeine consumption, Dizziness, Electrocardiogram normal, Feeling abnormal, Headache, Hypertension, Migraine, Palpitations, Panic attack, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular 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? No
Previous Vaccinations:
Other Medications: Albuterol, Symbicort, Testosterone, Bupropion
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Aspirin
Diagnostic Lab Data: EKG at urgent care facility resulted in no abnormalities at the time (Heart issues are random and not happening at that time).
CDC Split Type:

Write-up: 1. Extreme panic attacks currently persisting 24/7 after second Moderna Covid shot. Xanax helps some but extremeness returns when it wears off. 2. Extreme migraine headaches started two weeks after first Moderna Covid shot. Tapered down to low/moderate headache until second shot a month later when extremeness returned. Has tapered down to chronic (24/7) mild headache. 3. Moderate vertigo/dizziness persisting 24/7. Body feels like it''s moving on it''s own. 4. Random heart palpitations, random high blood pressure. Typically have low blood pressure due to genetics (so low at times I pass out, Cardiogenic Syncope). 5. Caffeine intake exasperates all the above in extreme manner.


VAERS ID: 1470814 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-08
Onset:2021-06-02
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Computerised tomogram head, Confusional state, Dizziness, Echocardiogram, Electroencephalogram, Magnetic resonance imaging head, Nausea, Repetitive speech, Transient global amnesia, Transient ischaemic attack, Ultrasound Doppler, Urine analysis
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: lupus flare with blistering on rib cage, 64 yrs old December 28th, 2020, shingrex !st dose
Other Medications: synthroid 0.2mg dly bupropion SR 450mg dly prempro 4.25/1.5mg dly iron 27mg dly vit D3 25mg x3 dly calcium citrate w D3 630mg x2 dly multi vit dly cevimeline 30mg dly srarted March2021 Started April 2021 Breo 200mg inhaler dly and combivent
Current Illness: none
Preexisting Conditions: sjorgrens since 2017 lupus since 2011 asthma-newly dx in April 2021
Allergies: plaquinel-decreased WBC''s and retinal scaring phenylephrine-extreme facial swelling contrast dye-hives arms,face and torso shingrex vac-lupus flare with 1/2 dollar size blistering to rib cage.
Diagnostic Lab Data: CT, MRI of the head Carotid dopplers Heart echo EEG Blood work, UA
CDC Split Type:

Write-up: June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.


VAERS ID: 1471653 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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: NO INFO AVAILABLE
Current Illness: NO KNOWN
Preexisting Conditions: NO KNOWN
Allergies: NO KNOWN DRUG AND FOOD ALLERGY
Diagnostic Lab Data: NONE AVAILABLE
CDC Split Type:

Write-up: PATIENT NOTIFIED PHARMACY OF SORE ARM EVEN AFTER A MONTH OF VACCINATION. PATIENT STATED PAIN IN GETTING BETTER BUT NOT COMPLETELY GONE. NO REDNESS OR RASH IN THE INJECTION SITE.


VAERS ID: 1475424 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Fatigue, Gait disturbance, Influenza like illness, Mobility decreased, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: The patient began having flu-like symptoms the following day after the vaccine. Felt achy, fatigue and not wanting to get out of bed even on vacation. That lasted for 2 weeks and still not great even now. The patient''s spouse reported trouble walking, stumbling, falling and gait. The patient developed a cough a few weeks ago and is currently being treated with antibiotics called in from the physician. The patient has not see a physician for diagnosis. I encouraged the patient to be evaluated as soon as possible


VAERS ID: 1475426 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-27
Onset:2021-06-02
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / SYR

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

Write-up: I got Bell?s Palsy, 2 weeks after I received the shot.


VAERS ID: 1477782 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-23
Onset:2021-06-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin, Dermatitis bullous
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Skin biopsy (6/14/2021): H&E consistent with linear IgA or neutrophilic dermatosis but DIF negative
CDC Split Type:

Write-up: Bullous skin disease (clinically consistent with Linear IgA, however DIF negative), began 10 days after vaccination (no new medications or recent illness otherwise). Stabilized with prednisone but has not resolved as of 7/16/2021


VAERS ID: 1371001 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002333 / 2 RA / IM

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

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

Write-up: Fever at 39 Celsius degress, right arm deltoid muscle pain


VAERS ID: 1371145 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002545 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: iatrogenic pulmonary embolism (2001)
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: swelling hardening itching redness on the left arm


VAERS ID: 1373146 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypertension, Sciatic nerve neuropathy, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Co- codamol
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left Sciatic nerve Vaccine induced neuropathy, hypertension


VAERS ID: 1373150 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-06-02
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxazosin Hydrocortisone, Propranolol, Omeprazole, Amlodipine
Current Illness: Covid post Covid vaccination
Preexisting Conditions: Adrenalectomy, Bilateral Renal Calculi
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Abdominal pain,


VAERS ID: 1404542 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: IEPFIZER INC2021646421

Write-up: Fainted after vaccination; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 18 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 02Jun2021 (Lot Number: EW6126) at 17:30 as single dose for COVID-19 immunisation. Age at vaccination was 18 years old. The patient was not pregnant. There were no medical history and no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within 2 weeks of vaccination. The patient fainted after vaccination on 02Jun2021 at 17:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was given O2 therapy and recovered from the event on an unspecified date in Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408820 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Limb discomfort, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20210730)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649324

Write-up: Maternal exposure during pregnancy; Arm discomfort; YELLOW CARD VACCINE MONITOR This is a solicited report from a regulatory authority program from a contactable consumer or other non hcp received from a regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202106021131389970-CFPPL. Safety Report Unique Identifier is GB-MHRA-ADR 25409638. A 32-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: not known) at single dose at the age of 32 years old for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 20210730). Patient last menstrual period date reported as 23Oct2020. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for folic acid supplementation at 400 ug, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 02Jun2021, arm discomfort on 02Jun2021. The events were serious as medically significant. The outcome of the event arm discomfort was not recovered, of the other event was unknown. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine Third-trimester (29-40 weeks). The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the description given in the narrative there is reasonable possibility of causal association between the events Maternal Exposure during pregnancy, Limb Discomfort and the suspect 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: 1408830 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 LA / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021648134

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 (at age of 34-year-old) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 02Jun2021 12:00 (14 days after receiving first dose of BNT162B2 ), the patient experienced early miscarriage around 8 weeks (as reported). The mother reported she became pregnant while taking bnt162b2. Patient last menstrual period date 31Mar2021. The outcome of the event was unknown. This consumer reported information for both mother and fetus/baby. This is a enter maternal report. A 34-year-old female patient received the first dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced early miscarriage around 8 weeks, 14 days after receiving 1st. affine dose (abortion spontaneous) (congenital anomaly) on 02Jun2021 12:00 with outcome of recovering. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 07Jan2022. Additional Information: Start Date/Time: [Pfizer bioNTec] 19May2021 10:15 AM Facility where the most recent COVID-19 vaccine was administered: Doctor''s office/urgent care Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No List of any other medications the patient received within 2 weeks of vaccination: No Reported Event: Early miscarriage around 8 weeks, 14 days after receiving 1st. Affine dose Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following: Emergency room/department or urgent care Prior to vaccination, was the patient diagnosed with COVID-19: No Since the vaccination, has the patient been tested for COVID-19: No Device Date: 03Jun2021


VAERS ID: 1411556 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Disorientation, Hyperhidrosis, Maternal exposure timing unspecified, Nausea, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655704

Write-up: nausea; Feeling faint; sweating; Disorientated; tingling; Maternal exposure during pregnancy; Anxiety; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031819432390-8NMN7. Safety Report Unique Identifier GB-MHRA-ADR 25415402. A 32-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA5843), dose 1 via an unspecified route of administration on 02Jun2021 (at the age of 32 years old, pregnant) at single dose for COVID-19 immunisation. Medical history included pregnancy from an unknown date and not ongoing: Patient no longer pregnant at the time of reporting. The patient''s concomitant medications were not reported. The patient experienced nausea, feeling faint, Sweating, disorientated and tingling on an unspecified date; maternal exposure during pregnancy and Severe anxiety on 02Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The medicine didn''t have an adverse effect on any aspect of the pregnancy. The outcome of the event anxiety was not recovered, of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1424995 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperpyrexia, Nausea, Paraesthesia, Presyncope, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210642780

Write-up: HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-742556] concerned a 23 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) frequency 1 total, 1 dosage forms, administered on 02-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-JUN-2021, the patient experienced Hyperpyrexia up to 39?C, pain at site of inoculation and paresthesias at left arto superiore upper Limb). In the morning of 05/06/2021: presyncopal episode associated with nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Hyperpyrexia up to 39?C, pain at site of inoculation and paresthesias at left upper Limb). In the morning of 05/06/2021: presyncopal episode associated with nausea on 05-JUN-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments:20210642780-COVID-19 VACCINE AD26.COV2.S- Hyperpyrexia up to 39?C, presyncopal episode, paresthesias at left arto superiore upper Limb. 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). 20210642780-COVID-19 VACCINE AD26.COV2.S- pain at site of inoculation, Nausea. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1428368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-06-02
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021683492

Write-up: Patient was exposed to the medicine first-trimester (1-12 weeks); Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202106091052235290-HJ5UO], Safety Report Unique Identifier [GB-MHRA-ADR 25443293]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Lot number: EE8492) as dose 2, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy and folic acid supplementation, all from an unknown date and unknown if ongoing. Concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced early miscarriage and patient was exposed to the medicine first-trimester (1-12 weeks) on an unspecified date; and early miscarriage on 02Jun2021. The events were assessed as serious (medically significant). The outcome of the event ''early miscarriage'' was recovering and event ''Patient was exposed to the medicine first-trimester (1-12 weeks)'' was unknown. The clinical course was reported as follows: Conceived around the 28Mar2021, 2nd COVID vaccine on 31Mar2021, pregnancy didn''t progress beyond yolk scan forming (around 5 weeks) and expectant miscarriage started on the 02Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Child was exposed to the medicine: first-trimester (1-12 weeks). Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1435135 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 10Feb2022)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021700511

Write-up: Maternal exposure during pregnancy; Painful arm; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202106132220483030-OI3Z4, Safety Report Unique Identifier GB-MHRA-ADR 25467898. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 at the age of 31-year-old (Lot Number: EW3143) as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 10Feb2022). Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient last menstrual period date: 08May2021. Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 02Jun2021 with outcome of unknown, painful arm on 02Jun2021 with outcome of recovered on 04Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Feb2022. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. This is a serious medically significant case provided by Health Authority assessed by reporter. The reporter''s assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported event painful arm is considered related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1468712 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 25Jul2021)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC2021683563

Write-up: Vaginal bleeding; Maternal exposure during pregnancy; This is a solicited report. Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106022038353110-RC3BD. Safety Report Unique Identifier GB-MHRA-ADR 25448295. A 34-year-old female pregnant patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) (Lot Number: EY5456) via an unspecified route of administration on 02Jun2021, at the age of 34-year-old, at a single dose for COVID-19 vaccination. Medical history included ongoing pregnancy. Estimated due date: 25Jul2021. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient was admitted to hospital 48 hours after vaccine with pre-term vaginal/membrane bleeding and early waters breaking (pregnancy). Monitored in hospital for 3 days. No proven link between this and the vaccine, but no other cause identified. Patient has not tested positive for COVID-19 since having the vaccine. Patient is unsure if vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine third-trimester (29-40 weeks). The reported events were: maternal exposure during pregnancy on 02Jun2021 with outcome of unknown, vaginal bleeding on 04Jun2021 with outcome of recovered on 04Jun2021. The patient was treated with erythromycin for vaginal bleeding from 05Jun2021 to 13Jun2021. The case was reported as serious due to hospitalization required. The patient hospitalized from 2021. The mother reported she became pregnant while taking bnt162b2. The patient underwent lab tests and procedures which included scan: normal on unknown date. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Follow-up (20Jun2021): New information received from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106022038353110-RC3BD. Safety Report Unique Identifier GB-MHRA-ADR 25448295, included: clinical data (event "painful arm" was deleted, treatment information updated, outcome detail information updated). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Due to the known drug safety profile, the company cannot completely exclude a drug-event causal association between the reported painful arm and BNT162B2 administration. Conversely, based on the information currently provided, the company deems there is not a reasonable possibility that the vaginal bleeding in the setting of maternal exposure during pregnancy is related to BNT162B2. The impacts 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: 1473655 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Ectopic pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:all in right place; Comments: at 5 weeks, 2 days after vaccine. Scan was done because of bleeding/spotting
CDC Split Type: GBPFIZER INC2021773580

Write-up: Maternal exposure during pregnancy/exposed to the vaccine first-trimester; Vaginal bleeding; This is a solicited report from the HA from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202106021355120810-GUECJ, Safety Report Unique Identifier GB-MHRA-ADR 25510731. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (Lot Number: Et8885, at age of 38 years old) as single dose for COVID-19 vaccination. Medical history included asthma and previous ectopic pregnancy. Estimated due date: 04Feb2022 (reported as 03Jan2022). Patient last menstrual period date: 30Apr2021. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy on an unspecified date, vaginal bleeding on 02Jun2021. Patient was exposed to the vaccine first-trimester (1-12 weeks). Events were reported as medical significant. Patient was unsure if vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on unknown date. Scan at 5 weeks, 2 days after vaccine, all in right place. Scan was done because of bleeding/spotting. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event vaginal bleeding was recovered on 14Jun2021, the outcome of maternal exposure during pregnancy was unknown. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the temporal association, a causal relationship between the events and BNT162B2 cannot be completely 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: 1364287 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

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

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

Write-up: Chest pain, tightness


VAERS ID: 1364491 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

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

Write-up: I have a painful almost baseball size know that feels like there is a rash at injection site. Didn?t really notice it until this morning it is sore to the touch and movement is uncomfortable. Sister in law told me to report it.


VAERS ID: 1364499 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Vermont  
Vaccinated:2021-05-26
Onset:2021-06-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal faeces, Faeces discoloured, Fatigue, Haematochezia, Injected limb mobility decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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: 2 x 200mg Ibuprofen tablets 5/27 in the AM.
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs. No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.


VAERS ID: 1364521 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 6 days after vaccine, I noticed a red small circle at the injection site. I pressed on it slightly and noticed it hurt to the touch. The next day I woke up with a red rash at the injection site. It hurts to the touch still.


VAERS ID: 1364523 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-01
Onset:2021-06-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: armour thyroid 90 mg levothyroxin 25mg vitamin D 5m
Current Illness:
Preexisting Conditions: hypothyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough period bleeding. Longer period than ever


VAERS ID: 1364524 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

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

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

Write-up: pulsatile tinnitus - constant - whooshing sound in ear correlating to the beat of my heart - hard time hearing


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