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From the 10/8/2021 release of VAERS data:

Found 781,870 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 432 out of 7,819

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VAERS ID: 1645298 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-19
Onset:2021-08-16
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Ear discomfort, Eye pain, Headache, Hypoacusis, Lymphadenopathy, Myalgia, Neck pain, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pain in the Head, Neck and Shoulder (Where the neck connects to the shoulder) after the second shot; Eye balls hurt after the second shot; Left ear clogged up after the second shot; Could not hear in the left ear after the second shot; Itching Injection Site on the left arm after the second shot; Headache after the second shot, Pain in the Head; Low Grade Fever 99.7F after the second shot; Hurt all over her body after the second shot; Chills after the second shot after the second shot; Swollen gland on the left side of the neck after the second shot; Red Injection Site on the left arm after the second shot; Swollen Injection Site on the left arm after the second shot; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the Head, Neck and Shoulder (Where the neck connects to the shoulder) after the second shot), EYE PAIN (Eye balls hurt after the second shot), EAR DISCOMFORT (Left ear clogged up after the second shot), HYPOACUSIS (Could not hear in the left ear after the second shot) and VACCINATION SITE PRURITUS (Itching Injection Site on the left arm after the second shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 088C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced NECK PAIN (Pain in the Head, Neck and Shoulder (Where the neck connects to the shoulder) after the second shot), EYE PAIN (Eye balls hurt after the second shot), EAR DISCOMFORT (Left ear clogged up after the second shot), HYPOACUSIS (Could not hear in the left ear after the second shot), VACCINATION SITE PRURITUS (Itching Injection Site on the left arm after the second shot), HEADACHE (Headache after the second shot, Pain in the Head), PYREXIA (Low Grade Fever 99.7F after the second shot), MYALGIA (Hurt all over her body after the second shot), CHILLS (Chills after the second shot after the second shot), LYMPHADENOPATHY (Swollen gland on the left side of the neck after the second shot), VACCINATION SITE ERYTHEMA (Red Injection Site on the left arm after the second shot), VACCINATION SITE SWELLING (Swollen Injection Site on the left arm after the second shot) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Pain in the Head, Neck and Shoulder (Where the neck connects to the shoulder) after the second shot), EYE PAIN (Eye balls hurt after the second shot), EAR DISCOMFORT (Left ear clogged up after the second shot), HYPOACUSIS (Could not hear in the left ear after the second shot), VACCINATION SITE PRURITUS (Itching Injection Site on the left arm after the second shot), HEADACHE (Headache after the second shot, Pain in the Head), PYREXIA (Low Grade Fever 99.7F after the second shot), MYALGIA (Hurt all over her body after the second shot), CHILLS (Chills after the second shot after the second shot), LYMPHADENOPATHY (Swollen gland on the left side of the neck after the second shot), VACCINATION SITE ERYTHEMA (Red Injection Site on the left arm after the second shot), VACCINATION SITE SWELLING (Swollen Injection Site on the left arm after the second shot) and ARTHRALGIA (Shoulder pain) outcome was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-291138 (E2B Linked Report).; Sender''s Comments: US-MODERNATX, INC.-MOD-2021-291138:wife case


VAERS ID: 1645395 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-02
Onset:2021-08-16
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: biotin 10,000 mcg capsule buPROPion SR (WELLBUTRIN SR) 100 mg 12 hr tablet calcium citrate-vitamin D2 250-100 mg-unit per tablet citalopram (CeleXA) 20 mg tablet fluticasone (FLONASE) 50 mcg/actuation nasal spray multivitamin capsule
Current Illness:
Preexisting Conditions: Digestive Morbid obesity Musculoskeletal Bunionette of left foot Pes planus of left foot Pes equinus, acquired, left Other At high risk for breast cancer
Allergies: Nickel
Diagnostic Lab Data: COVID-19 PCR
CDC Split Type:

Write-up: Cough Nasal congestion Shortness of breath


VAERS ID: 1647288 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-08-16
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; ZYRTEC; CELEBREX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: test positive for covid this morning; Test Result: Positive
CDC Split Type: USPFIZER INC202101057223

Write-up: test positive for covid this morning; test positive for covid this morning; This is a spontaneous report received from a non-contactable consumer (patient) received via a sales representative. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ep7533), via intramuscular route of administration on 01Apr2021 (at the age of 48-year-old), as dose 2, single in left arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6208), via intramuscular route of administration on 11Mar2021 (at the age of 48-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient''s medical history included allergy to shellfish. Concomitant medications received within in two weeks of vaccination included atorvastatin calcium (LIPITOR), cetirizine hydrochloride (ZYRTEC) and celecoxib (CELEBREX); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 16Aug2021 at 08:00, 4 months 15 days and 8 hours after vaccination, the patient tested positive for COVID this morning. No treatment medication was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 16Aug2021. The clinical outcome of the event COVID-19 was resolving.


VAERS ID: 1647309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Covid test; Test Result: Positive ; Comments: was tested last (11Aug2021) and received the positive result 16Aug2021.
CDC Split Type: USPFIZER INC202101057989

Write-up: patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, both for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Reporter reported that, patient was in a nursing home and on 16Aug2021, patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine. The patient underwent the lab test and procedure which included tested for covid last Wednesday (11Aug2021) and received the positive result today 16Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647336 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-02-01
Onset:2021-08-16
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPROPION; ZOLOFT; TADALAFIL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other medical history: No
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: PCR test/ Nasal Swab; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101063572

Write-up: obtained a positive test for covid approx 6 months after vaccine; obtained a positive test for covid approx 6 months after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via an intramuscular route of administration, in the left arm, on an unspecified date in Feb2021 (at the age of 43-year-old), as DOSE 1, SINGLE, for COVID-19 immunization. The patient''s medical history was none. No known allergies. The patient received other medications within 2 weeks of vaccination included bupropion, sertraline hydrochloride (ZOLOFT) and tadalafil. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Aug2021, obtained a positive test for COVID approx. 6 months after vaccine. Since the vaccination, patient has been tested for COVID-19 and covid test type post vaccination was nasal swab/ PCR Covid Test and result was positive on 16Aug2021. Prior to vaccination, patient was not diagnosed with COVID-19. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test/ Nasal Swab and result was positive on 16Aug2021. No treatment for AE. Outcome of the events was recovering The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647355 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-10
Onset:2021-08-16
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: SARS-CoV-2 test
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Rapid COVID 19 test; Test Result: Positive
CDC Split Type: USPFIZER INC202101065421

Write-up: Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number: EW0162) dose 2 via unknown route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 38-years-old) as dose 2 and received first dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number: ER2613) dose 1 via unknown route of administration, administered in Arm Left on 20Mar2021 2:15 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Family medical history included daughter tested positive on 09Aug2021. The patient did not require emergency Room and physician Office for event. The patient did not received and prior vaccination within 4 weeks and list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was tested positive for COVID 19 (vaccination failure and Covid-19) on 16Aug2021. The patient relevant tests included rapid COVID 19 test was positive on 16Aug2021. Since last night, he was very much improved. Outcome of the event was recovering.


VAERS ID: 1647357 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-16
Onset:2021-08-16
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 LA / OT

Administered by: Work       Purchased by: ?
Symptoms: Cough, Headache, Oropharyngeal pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065541

Write-up: Headache; runny nose; cough; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported that a 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 2 intramuscular, administered in Arm Left on 16Apr2021 (Age 20-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 1 intramuscular, administered in Arm Left on 26Mar2021 (Age 20-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not diagnosed with COVID-19, prior to vaccination. The patient not been tested for COVID-19 Since the vaccination. There were no known allergies. Facility included a clinic the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications were not received within 2 weeks of vaccination. The patient experienced headache, runny nose, cough, and sore throat on 16Aug2021. No treatment was received for the events headache, runny nose, cough, and sore throat. The outcome of the events was reported as recovering.


VAERS ID: 1647380 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADD (ADD non medicated); COVID-19; Seasonal allergy (seasonal allergies non medicated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101070420

Write-up: Delayed Anaphalaxsis; This is a spontaneous report from a contactable consumer. A 17-year-old male patient (reporter''s son) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 15Aug2021 13:45 at the age of 17 years old, as single dose for covid-19 immunisation. Medical history included seasonal allergies (non medicated), covid-19, ADD (attention deficit hyperactivity disorder, non medicated). There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced delayed anaphalaxsis on 16Aug2021 17:45. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment Epi, IM Benadryl, IM Steroid IM anxiolytic, IV fluids was received for the event. The outcome of the event was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1647394 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Ocular hyperaemia, Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101076219

Write-up: experiencing fever; chest pains; difficulty breathing; painful red rash on body; red eyes; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (Pfizer COVID Vaccine), dose 2 via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient experienced experiencing fever, chest pains, difficulty breathing, painful red rash on body and limbs, red eyes early Monday morning on 16Aug2021. The patient was hospitalized for events from Aug2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1651220 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-02-01
Onset:2021-08-16
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Multiple medications for underlying chronic conditions of hypertension, type 2 diabetes, and depression
Current Illness:
Preexisting Conditions: As above
Allergies:
Diagnostic Lab Data: PCR COVID testing
CDC Split Type:

Write-up: Breakthrough COVID infection


VAERS ID: 1651245 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Weight decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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: uncontrolled Diabetes Type 2 PCOS Psoriasis Bipolar Disorder 1
Allergies: None that I am aware of
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Normal side effects immediately after injection. From 8/10 to 8/16 weight loss of 17 lbs with no changes to diet or activity level. On 8/16 started spotting, which lasted 7 days, then after starting, 1 day of clotty heavy flow, 2 days of abnormal light flow and still spotting as of today 8/28. I normally have EXTREMELY HEAVY periods that are painful. I normally have to wear adult diapers due to how heavy they are. It definitely changed my cycle, honestly for the better.


VAERS ID: 1651504 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-04-15
Onset:2021-08-16
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Fatigue, Tearfulness
SMQs:, Neuroleptic malignant syndrome (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, singular,plaquenil, vistaril, buspar, advair, albuterol
Current Illness: Sjogrens, asthma
Preexisting Conditions: Same as above
Allergies: Metronidazole, mobic, bactrim
Diagnostic Lab Data:
CDC Split Type:

Write-up: Temperature ranging 101-103, moderate joint pain, fatigue, tearful. Last about 12 hours and started slowly going away. I felt worse after the vaccine than I did when I had covid in December of 2020. The reason I?m reporting this is because I?ve had mild to moderate joint pain and fatigue since having the vaccine.


VAERS ID: 1651510 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2020-12-30
Onset:2021-08-16
   Days after vaccination:229
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chronic myeloid leukaemia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: 8/16/21 WBC 157,000
CDC Split Type:

Write-up: chronic phase chronic myeloid leukemia


VAERS ID: 1654127 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Pain in extremity, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Non6
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, itchiness on legs, burning and pains on legs and feet


VAERS ID: 1654129 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Grandiosity, Insomnia, Mania, Psychotic disorder, Restlessness
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: GABA, taurine, iron, fish oil supplements
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: experienced mania/mild psychosis as a result of the vaccine. He is having grandiose thoughts, not able to relax, sleeping only 2 hrs or less per night.


VAERS ID: 1655029 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-08-16
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC [CETIRIZINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Covid test; Test Result: Positive ; Comments: test positive for Covid this morning 16Aug; Test Date: 20210813; Test Name: Nasal swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101057218

Write-up: patient tested positive for COVID; patient tested positive for COVID; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on 11Mar2021 (at the age of 47-year-old), as single dose and received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on 01Apr2021 (at the age of 47-year-old), as single dose, both for COVID-19 immunization. The patient''s medical history was not reported. Patient received the other medication in two weeks included cetirizine hydrochloride (ZYRTEC). On 16Aug2021 at 08:00, patient tested positive for COVID. No treatment received for the events. No covid prior vaccination. The patient underwent the lab tests and procedure which included the Covid test result was positive on 16Aug2021 and Nasal swab result was Negative on 13Aug2021. Outcome of the event was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1655031 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness, Blood test, Electrocardiogram, Investigation, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), 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? 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: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Name: Exam; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202101057238

Write-up: Fainted; Fever; Blindness; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received second dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Aug2021 05:45 PM (Batch/Lot number was not reported) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 05:45 PM as single dose for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Aug2021, at 07:30 AM the patient experienced Fever, fainted, blindness, complete loss of vision for about 15 minutes. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events with some Examinations, EKG, blood work. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, investigation: unknown results on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1655047 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065159

Write-up: He passed out; He was convulsing on the floor; This is a spontaneous report from a contactable consumer (patient''s wife). A 36-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 16Aug2021 at 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Not even a minute after vaccination the patient passed out (medically significant) on 16Aug2021 with outcome of unknown, he was convulsing on the floor (medically significant) on 16Aug2021 with outcome of unknown. Emergency number was called. No therapeutic measures were taken. The lot number for bnt162b2 was not provided and will be requested during follow-up.


VAERS ID: 1655382 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states that area is warm to the touch & there is a knot the size of silver dollar coin in the location of injection.


VAERS ID: 1655385 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-09
Onset:2021-08-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Eye swelling, Fatigue, Headache, Hypotension, Injection site erythema, Injection site pain, Lethargy, Mouth swelling, Nausea, Pain, Swelling face, Swollen tongue, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium


VAERS ID: 1655734 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Headache
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Headache and elevated BP


VAERS ID: 1655923 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-28
Onset:2021-08-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Ageusia, Anosmia, COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Pneumonia viral, Respiratory failure, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Taste and smell disorders (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: HIV AND HYPERTENSION
Allergies: UNKNOWN
Diagnostic Lab Data: DIAGNOSED WITH ARDS ABNORMAL CXR AND POSITIVE PCR FOR COVID-19
CDC Split Type:

Write-up: PRESENTED TO ER WITH RUNNY NOSE, COUGH, SHORTNESS OF BREATH AND LOSS OF TASTE AND SMELL. HE WAS ADMITTED TO THE MEDICAL CENTER ON 8/16/2021 WITH COVID-19, VIRAL PNEUMONIA AND RESPIRATORY FAILURE. HE CLAIMS TO HAVE HAD THE J&J VACCINE ON 7/28/21, BUT THERE IS NO RECORD OF IT. HE HAD CONTACT WITH HIS CHILDREN WHO ARE ALL COVID-19 POSITIVE


VAERS ID: 1656041 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not known
Current Illness: Not known
Preexisting Conditions: not known
Allergies: Not known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received COVID Vaccine dose that was expired at the time of administration. Pfizer vaccine had been prepared on Friday 8/13/2021 at 1805 so would have expired on 8/14/2021 at 0005 and was administered to patient on 8/16/2021 at 1100.


VAERS ID: 1656047 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram, Cerebrovascular accident, Chest X-ray, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging head, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE-BENAZEPRIL 10-20 MG
Current Illness: NONE
Preexisting Conditions: NO CHRONIC HEALTH ISSUES BUT DO HAVE HIGH BLOOD PRESSURE
Allergies: CEFDINIR / SHELL FISH
Diagnostic Lab Data: NO SCARRING SHOWING STROKE WAS FOUND. CURRENTLY WEARING A HEART MONITOR FOR 30 DAYS AND FOLLOWING UP WITH CARDIOLOGIST.
CDC Split Type:

Write-up: WOKE UP EARLY AM MONDAY, AUGUST 16TH WITH NUMBNESS TO RIGHT SIDE OF FACE AND MOUTH AND SEVERE (CONSTANT) DIZZYNESS TO POINT OF VOMITTING. CALLED MY DR OFFICE AND WAS TOLD TO GO TO EMERGENCY ROOM. HAD FOLLOWING TESTS: ELECTROCARDIOGRAM, ECHOCARDIOGRAM, CHEST X RAY, BRAIN MRI, CT ANGIOGRAPH, HEAD TOMOGRAPHY, HEAD CT, CT ANGIOGRAPHY. NO SCARRING SHOWING STROKE WAS FOUND. CONSTANT DIZZYNESS SUBSIDED BUT BLURRY VISION IN RIGHT EYE. HAVE OCCASIONAL DIZZYNESS AND RIGHT SIDE OF FACE STILL SLIGHTLY NUMB. ENT DR DO NOT BELIEVE THE DIZZYNESS IS FROM VERTIGO. FOLLOWING UP WITH PRIMARY DR., NEUROLOGIST AND CURRENTLY WEARING A HEART MONITOR FOR 30 DAYS AND FOLLOWING UP WITH CARDIOLOGIST.


VAERS ID: 1656076 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Cold sweat, Dizziness, Feeling abnormal, Hypoaesthesia oral, Nervousness, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan 100mg qd Rosuvastatin 10mg qd Caltrate 600+D bid Levothyroxine 75mcg qd
Current Illness: Ear infection resolved
Preexisting Conditions: HTN Hypercholesterolemia Hyperthyroidism
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5 minutes post injection felt like a wave washed over me. Heart started pounding, felt shaky, weak and dizzy, lips felt numb, felt clammy. Removed mask to increase breathing capacity.


VAERS ID: 1656281 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3181 / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin 10mg tab 1/day
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I had gone to the Pharmacy to get a flu shot for 2021. However, by mistake they administered a Covid-19 Pfizer vaccine shot #3. Earlier on March 10, 2021 I had received second Moderna Covid-19 vaccine shot. Therefore I had two Moderna shots by March 10, 2021 and now a third Pfizer Covid-19 vaccine shot on 8/16/2021. Pharmacy called it a "Booster shot" when they realized their mistake. However, Booster shot was not approved by CDC/FDA at that time for people like me without any Immune compromise condition. What precautions and actions should I take before taking any more covid-19 shots including any future Booster shots ? Thank you......


VAERS ID: 1656539 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-08
Onset:2021-08-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Dizziness, Feeling of body temperature change, Headache, Loss of personal independence in daily activities, Neck pain, Pain
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (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? Yes
Hospitalized? No
Previous Vaccinations: Facial palsy
Other Medications: None
Current Illness: Irregular heartbeat anxiety panic attacks
Preexisting Conditions: None
Allergies: Tumeric tamerin
Diagnostic Lab Data: 8/30/21 hospital visit at 4am for extreme body pain and neck ,back and head pain
CDC Split Type:

Write-up: Extreme pain in head and neck area body hot sometimes and head cold and vise versa dizziness inability to perform everyday tasks such as care for children bin to hospital at least 4 or 5 times since second dose


VAERS ID: 1656559 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Cardiac flutter, Diarrhoea, Dizziness, Dysmenorrhoea, Fatigue, Feeling abnormal, Feeling cold, Hyperhidrosis, Hypoaesthesia, Lymphadenopathy, Malaise, Myalgia, Nausea, Sleep disorder, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse 50mg 3 times a day Loryna Drospirenone & Ethinyl Estradiol tablets (3mg/0.02mg) Vitamin D3 Zinc Magnesium-calcium-zinc Vitamin B6 Super Lysine + immune support (vitamin c, calcium, L-Lysine, garlic, echinacea, propolis, licorice r
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The hours following my vaccination, I had random heart fluttering/palpitations which subsided after the first day. 72 hours after vaccination I had a sudden and rapid onset of chills, sweatiness, achey muscles, and extreme nausea. I proceeded to vomit and was ill/fatigued the entire day. The days following I had extreme fatigue and spells of dizziness. I have also had intermittent diarrhea, bloating, nausea, and another episode of vomiting. I had additional episodes of achey muscles, sweating and feeling chills which disrupted my ability to sleep., menstrual cramps when I am not on my period, swollen lymph nodes in the neck, numbness in my arms and hands, brain fog. Symptoms seem to be persistent and becoming worse as time goes on.


VAERS ID: 1656583 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Alopecia, Balance disorder, Blood test, Dizziness, Iron deficiency
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre 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: N/A
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: Blood Work... identified Iron Deficiency
CDC Split Type:

Write-up: Dizziness, Imbalance, slight nausea, Much hair loss


VAERS ID: 1657430 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA COZF21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vaccination site swelling
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rosuvastatin 20mg Metoprolol 25mg 1/4 tablet
Current Illness:
Preexisting Conditions: clogged arteries/ has open heart surgery 4 years ago
Allergies: milk allergyarteries
Diagnostic Lab Data:
CDC Split Type:

Write-up: After a day or two, the vaccination site bubbled up. There was fluid and blood in the bubble.


VAERS ID: 1657779 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Unknown  
Location: California  
Vaccinated:2021-07-16
Onset:2021-08-16
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: A single dose of expired Moderna Covid-19 vaccine was given accidentally; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 007D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.


VAERS ID: 1657791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088O21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (Immunocompromised due to steroids). On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient felt that the pharmacy was not following best practice after the vial is punctured. She stated there was news of a pharmacist who gave saline injection instead of Moderna vaccine but said the saline injection was Moderna vaccine. Concomitant medication included unspecified steroids. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received and contains no new information.


VAERS ID: 1657861 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dreamy state, Fall, Feeling abnormal, Headache, Loss of consciousness, Malaise, Syncope, Vital signs measurement, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Passed out
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Vitals; Result Unstructured Data: Test Result:Normal; Comments: Vitals all okay
CDC Split Type: USPFIZER INC202101058371

Write-up: Faint; I passed out; I wasn''t feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I''ve passed out several times before and knew it was coming on quick. I sat down and propped myself up in a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn''t feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can''t keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.


VAERS ID: 1658126 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

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

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

Write-up: Severe Hives on face and neck. Benadryl administered. Hives continued throughout the evening. She awoke and they were gone


VAERS ID: 1658349 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-07
Onset:2021-08-16
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cycle threshold 8/16/21 = 22.7
CDC Split Type:

Write-up: Hospitalization with COVID-19 Reported per vaccine EUA


VAERS ID: 1658576 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Dizzy spells, referred to a cardiologist, short of breath, nauseous, fatigue.


VAERS ID: 1658661 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-09
Onset:2021-08-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: she is no
Preexisting Conditions: High blood pressure, Osteoporosis, Sclerosis Spine , Osteoarthritis and glaucoma.
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Pt got her Vaccine on her right arm after a week she got her left arm swelling and pain.


VAERS ID: 1658916 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO198 / 2 RA / SC

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Malaise, Muscular weakness, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall, HCTZ, D3, Magnesium, Amour Thyroid
Current Illness: None
Preexisting Conditions: CKD, Hypothyroid, ADD
Allergies: NKDA, Gluten intolerant
Diagnostic Lab Data: I have not seen the doctor yet. I am calling him today.
CDC Split Type:

Write-up: I had my 2nd vaccine over two-weeks ago. I have had significant malaise and deep muscle aches with weakness since then. I also have issues with no appetite, and getting nausea with eating more than a little bit. I have been minimizing my symptoms to my family and have not told extended family/friends because they would use it as an excuse to not be vaccinated. When should I be concerned about my symptoms?


VAERS ID: 1659084 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
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: Skyrizi, Tylenol
Current Illness:
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Joint pain right elbow still persistent opposite arm of vaccine injection sight


VAERS ID: 1659272 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-03-18
Onset:2021-08-16
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Hypophagia, Infection, Nausea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Tested positive for COVID-19 8/16/21
CDC Split Type:

Write-up: This case meets vaccine breakthrough criteria review. SxS headache, nausea, poor oral intake, SOB, cough


VAERS ID: 1659329 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-22
Onset:2021-08-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Headache, Myalgia, Night sweats, Palpitations, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Stinging Nettle, Astragalus capsules, Vitamini D3, continued: Quercitin/ bromelain capsules (whole food brand), Vitamin C/ ascorbic acid
Current Illness: common cold like symptom, frequently confused itself with allergy-like symptoms. Stuffy nose, leaking, scratchy throat, irritated throat, dry eyes.
Preexisting Conditions: allergies: seasonal, dust mites, weather changes/ non-identified sources for allergic immune reactions/ symptoms. Gastrointestinal effects (IBS) sensitive gut. Frequent voiding of bladder (3 times in a day). Frequent urination some times. Tied with stress, anxiety levels, as well as performance issues and food ingestion. (Have been doignosed with IBS in the past.)
Allergies: none known, except to those that display short tempers
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: * Night sweats for several days (very unusual, I am very slim and do not sweat normally at night). * Headache/ general muscle aches/ soreness -not limited to the injection site (like after going on a multiple-day hike) for 3 -4 days. * pain in chest - left side of body, near or affecting the heart. (location is not always specific enough/ or I am unaware of the subtleties/ nuance in that region of my body, as I have never had problems of this nature before) Specific times: Unsure. I have noticed it when I''m doing computer work and when sitting and eating. Duration: not sure when the heart palpitation/ pain/ discomfort started. It was there 3 weeks after and now, 40 days after injection still flares up some days. * Tinnitus, ringing in ears; comes and goes at various times of day. Some days no flare up. Has occurred on day 38 after injection. Very unusual for me. Have not had any specific treatments done for the above two longer-term conditions, other than average holistic care and more attention to sleep patterns.


VAERS ID: 1659722 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-08
Onset:2021-08-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vaccination complication
SMQs:

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

Write-up: Covid Arm


VAERS ID: 1660329 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-07
Onset:2021-08-16
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Haemothorax, Ultrasound Doppler
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (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, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: No medical history
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: CT 8/16/21 upper extremity, NIVL venous duplex 8/16
CDC Split Type:

Write-up: DVT to LUE, hemothorax x2


VAERS ID: 1661039 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise
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: USMODERNATX, INC.MOD20212

Write-up: haven''t felt great since first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (haven''t felt great since first vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced MALAISE (haven''t felt great since first vaccination). At the time of the report, MALAISE (haven''t felt great since first vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitent drugs were provided. No Treatment drugs were provided.


VAERS ID: 1661047 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 019B21A / 1 - / OT

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

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

Write-up: A 13 year old patient received 1st dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. the concomitant medication ware not provided the treatment medication s was not provided


VAERS ID: 1661048 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Unknown  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Vial that had been punctured 24 hours and 6 minutes before administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.


VAERS ID: 1661049 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 - / OT

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

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

Write-up: received J&J vaccine 4 days after receiving first dose of Modernna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received J&J vaccine 4 days after receiving first dose of Modernna) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received J&J vaccine 4 days after receiving first dose of Modernna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received J&J vaccine 4 days after receiving first dose of Modernna) 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. No concomitant medications were reported. No treatment medications were reported. He administered the MODERNA vaccine to a patient on 12Aug2021. He wasn''t able to enter it in the system right away


VAERS ID: 1661070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ear discomfort, Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: It kind of seems like there is water in my ear; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (It kind of seems like there is water in my ear) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 17-Aug-2021, the patient experienced EAR DISCOMFORT (It kind of seems like there is water in my ear). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, EAR DISCOMFORT (It kind of seems like there is water in my ear) had not resolved. No concomitant medication provided. No treatment information mentioned. After the second shot, the patient had 3 rounds of steroids plus 3 injections to treat the symptom. After six months the hearing started to get better, like 30% better, until the third dose was given and the problem started again. This case was linked to MOD-2021-103664.


VAERS ID: 1661119 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-03-31
Onset:2021-08-16
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Blood test; Test Result: Positive
CDC Split Type: USPFIZER INC202101063439

Write-up: Tested postitive for COVID virus; Tested postitive for COVID virus; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 31Mar2021 (Batch/Lot number was not reported) (at the age of 49-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no covid prior vaccination. It was reported that the patient tested positive for covid virus on 16Aug2021 17:00 with outcome of not recovered. No treatment received for the events. The patient was covid tested post vaccination through blood test on 16Aug2021 with positive result. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.


VAERS ID: 1661150 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101069776

Write-up: she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; she was "supposed to get the influenza shot at the local pharmacy but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-Year-old female patient received dose 3 [booster dose] of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3181; Expiration date: 31Oct2021) via an unspecified route of administration on 16Aug2021 as single dose for COVID-19 immunization. Medical history of the patient included cholesterol. Concomitant medications included Simvastatin 5mg started on an unspecified date [initially was on 10mg Simvastatin and then it was reduced to 5mg because of the muscle, according to patient it reduces strength in the muscle] and was ongoing for Cholesterol and regular vitamins without iron, she didn''t have enough strength in her legs and she has always been very active but the last couple of years, she didn''t have enough strength, so her doctor incorporated strengthening exercise and told her to take vitamins. Patient previously received first dose of Moderna (Lot number: 027L20A; Expiration date: Unknown) on 04Feb2021 in left arm for COVID-19 immunization and second dose of Moderna (Lot number: 001B21A; Expiration date: Unknown) on 04Feb2021 in left arm for COVID-19 immunization. Patient received the first dose of the Moderna vaccine last 04Feb2021 and the second dose last 10Mar2021. Caller mentioned that she was supposed to get the influenza shot at the local pharmacy, but they gave her a booster shot of the Pfizer BioNTech COVID-19 vaccine by mistake last Monday 16Aug2021. Caller wanted to know if a booster shot is the same as third dose and wanted information about it. Confirms product was the Pfizer Covid 19 and confirms she received on Monday,16Aug2021. Caller states it was supposed to be a flu shot so she doesn''t know anything about this because after it happened the technician shook up, so she called the pharmacist and the pharmacist refused to give her any information. She didn''t know any good information from the technician, but she told her that it was called the Pfizer Covid 19 booster shot, she doesn''t know what she got really, she didn''t get any information from the pharmacist.


VAERS ID: 1661170 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Communication disorder, Disability, Dizziness, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Vestibular disorders (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: Test Date: 20210816; Test Name: Blood pressure; Result Unstructured Data: Test Result:180-120; Comments: 180-120; Test Date: 20210818; Test Name: Blood pressure; Result Unstructured Data: Test Result:160-101; Comments: 160-101; Test Date: 20210818; Test Name: Pulse rate; Result Unstructured Data: Test Result:111; Comments: 111
CDC Split Type: USPFIZER INC202101075002

Write-up: Blood Pressure 160/101; Pulse 111; Blood Pressure 160/101; Pulse 111; Dizzy; Feeling Funny; Couldn''t Communicate; Feeling tired, can''t wake up; Blood Pressure 180/120; Has been out of work; cannot work in this condition; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number, Expiry Date, NDC number: Unknown) via an unspecified route of administration in Arm Left on 16Aug2021 at 10:15 (at the age of 25-years-old) as dose 1, single for covid-19 immunisation. No medical history, any medical conditions and other products were reported. No family medical history was there relevant to adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines were administered on same date of the Pfizer Suspect, the vaccination facility type was Clinic, vaccine was not administered at military facility, no prior vaccinations (within 4 weeks) the patient took, no adverse events occurred following prior vaccinations. The patient stated that she went to her Primary Care Provider to get the vaccine, they had an outside clinic to get it, soon as the shot was injected, she started feeling funny, dizzy, she couldn''t communicate, her symptoms began on the day she got the shot on Monday 16Aug2021, they tried to get her blood pressure; at first, they could not, then they did and it was 180/120 (16Aug2021). She also felt tired and cannot wake up (16Aug2021), had been out of work; cannot work in this condition (on an unspecified date in 2021), she felt really bad for the last week and doesn''t know what else to do, she further stated that not being able to communicate (16Aug2021) only lasted for a short time, her blood pressure came down it got better, she never had blood pressure issues, except when she was pregnant, she has a 3-year-old child, she went to a Urgent Care on Tuesday for her symptoms. She also went to the Emergency Room yesterday (unspecified date) because her blood pressure was 160/101 and her pulse was 111. Adverse events required a visit to Emergency Room and Physician Office. The patient mentioned that she does not have her vaccination card available at this time, it was in the car, she does not have any information readily available with the NDC, Lot Number, or Expiry Date for her vaccine, she thought the expiry date for her vaccine was 3 weeks. No treatments relevant to these events was given. Lastly the patient stated that her friend told her she should call and report her symptoms, asked what happened with the report now, she has been out of work, has bills to pay, but cannot work in this condition. The patient underwent lab tests and procedures which included Blood pressure: 180-120 on 16Aug2021, Blood pressure: 160-101 on 18Aug2021, Pulse rate: 111 on 18Aug2021. The events Blood Pressure 160/101; Pulse 111 were considered as serious (Medically Significant). The outcome of events dizzy, feeling funny, feeling tired, can''t wake up was not recovered, outcome of event Couldn''t Communicate was recovered on 16Aug2021, and outcome for remaining events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1661209 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2020-12-28
Onset:2021-08-16
   Days after vaccination:231
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Nasal swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101082550

Write-up: Contracted Covid on 16Aug2021; Contracted Covid on 16Aug2021; administration date=28Dec2020/other vaccine same date vaccine date=28Dec2020; This is a spontaneous report from a contactable Nurse(reporter). A 51-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on 28Dec2021in right arm as DOSE 1, SINGLE and also received second dose (COMIRNATY, Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 28Dec2021 in right arm as DOSE 2, SINGLE for covid-19 immunization (at the age of 51 years)at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not any known history of allergies. The patient had not diagnosed with COVID-19 prior to vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. On 16Aug2021 the patient had experienced Contracted Covid-19. The patient underwent lab tests and procedures, which included Nasal Swab and was diagnosed as having covid test Positive after vaccination on 16Aug2021. Therapeutic measures were taken as a result of adverse events. The outcome of the events were recovering; Sender''s Comments: As there is limited information in the case provided, the causal association between the event drug ineffective and Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1662139 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-06
Onset:2021-08-16
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fall, Hyperhidrosis, Hyperventilation, Mental status changes, Metabolic encephalopathy, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 325 MG tablet albuterol (VENTOLIN) (2.5 mg/3 mL) 0.083% nebulizer solution amLODIPine (NORVASC) 10 MG tablet aspirin (ECOTRIN) 81 MG EC tablet atorvastatin (LIPITOR) 80 MG tablet Blood Pressure kit clopidogrel (PLAVI
Current Illness: None known
Preexisting Conditions: Degenerative arthritis of left knee Unstable angina Contracture of knee Chest pain Need for prophylactic vaccination and inoculation against influenza Dehydration CAD (coronary artery disease) HTN (hypertension) COPD (chronic obstructive pulmonary disease) COPD with acute exacerbation Acute exacerbation of chronic obstructive pulmonary disease (COPD) Chest pain Vomiting and diarrhea Subdural hematoma Fall Left leg weakness Uncontrolled hypertension Pyogenic arthritis of left knee joint, due to unspecified organism Episode of confusion History of TIA (transient ischemic attack) Generalized weakness Physical debility Delirium
Allergies: Ativan (delirium), azithromycin (hives), codeine (nausea, vomiting)
Diagnostic Lab Data: COVID-19 test positive on 8/16/2021.
CDC Split Type:

Write-up: Patient presented to emergency department on 8/16/2021 after falling at home. Patient presented with altered mental status associated with hyperventilation and diaphoresis. She was treated for metabolic encephalopathy related to COVID-19 infection. Her daughter had tested positive for COVID-19 prior to patient''s admission. She did not requirement treatment of COVID-19 symptoms during admission with antivirals, steroids, or supplemental oxygen.


VAERS ID: 1662342 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-14
Onset:2021-08-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Adenovirus test, Angiogram pulmonary abnormal, Bordetella test negative, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills, Chlamydia test negative, Computerised tomogram thorax abnormal, Convalescent plasma transfusion, Coronavirus test negative, Cough, Dyspnoea, Enterovirus test negative, Essential hypertension, Human metapneumovirus test, Human rhinovirus test, Hyperglycaemia, Imaging procedure, Influenza A virus test negative, Influenza B virus test, Lung consolidation, Lung infiltration, Lung opacity, Malaise, Mycoplasma test negative, Pneumonia, Pyrexia, Respiratory syncytial virus test negative, Respirovirus test, SARS-CoV-2 test negative, Scan with contrast abnormal, Type 2 diabetes mellitus, Viral test
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 500 mg tablet amlodipine-valsartan (EXFORGE) 5-160 mg per tablet aspirin 81 mg tablet atorvastatin (LIPITOR) 80 mg tablet metFORMIN (GLUCOPHAGE) 500 mg tablet metoprolol succinate XL (TOPROL-XL) 50 mg 24 hr tabl
Current Illness:
Preexisting Conditions: Respiratory Respiratory insufficiency Circulatory HTN (hypertension) Endocrine/Metabolic Type 2 diabetes mellitus, without long-term current use of insulin Infectious/Inflammatory COVID-19 virus infection
Allergies: NKA
Diagnostic Lab Data: 08/25/21 1518 Respiratory virus detection panel Collected: 08/25/21 1329 | Final result | Specimen: Swab from Nasopharynx Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result DetectedCritical Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Syncytial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected Metapneumovirus Not Detected CT angiogram chest pulmonary embolism with and without contrast [3299635044] Resulted: 08/25/21 2150 Order Status: Completed Updated: 08/25/21 2150 Narrative: CTA CHEST PULMONARY EMBOLISM W WO CONTRAST IMPRESSION: No pulmonary embolus. Multifocal airspace consolidation compatible with Covid pneumonia. END OF IMPRESSION: INDICATION: sob r/o PE. Assess for pulmonary artery embolism. TECHNIQUE: Enhanced helical CTA scan of the chest was performed from the lung apices to below the diaphragm, including the pulmonary artery. 2 mm axial reconstruction with MPR coronal, oblique and sagittal images were created. 3D post processing imaging were obtained and stored. CONTRAST: 80mL of IOHEXOL 350 MG IODINE/ML INTRAVENOUS SOLUTION administered INTRAVENOUS. Quality of contrast opacification was adequate. COMPARISON: None. FINDINGS: Pulmonary arteries: No pulmonary embolus. Lungs: Extensive multifocal airspace consolidation compatible with Covid pneumonia. No pleural effusion or pneumothorax. Central airways are patent. Mediastinum: Heart normal in size. No pericardial effusion. Thoracic aorta normal in caliber. No adenopathy. Upper Abdomen: No abnormalities identified. Bones: Unremarkable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view, Portable [3299605818] Resulted: 08/25/21 1344 Order Status: Completed Updated: 08/25/21 1344 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mild-moderate multifocal pneumonia END OF IMPRESSION: INDICATION: covid, sob. TECHNIQUE: AP portable projection of the chest is acquired. COMPARISON: None available. FINDINGS: Lung volumes within normal limits. Multifocal hazy peripheral airspace disease in both lungs. Heart mixed are within normal limits. Pleural spaces clear. Bones and soft tissues normal.
CDC Split Type:

Write-up: ED to Hosp-Admission Discharged 8/25/2021 - 8/29/2021 (4 days) COVID-19 virus infection Respiratory insufficiency Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath [R06.02] COVID-19 virus infection [U07.1] Hospital Course This is a 49-year-old male with essential hypertension and type 2 diabetes on oral medications who got his first Covid vaccine (moderna)-2 days later started getting sick coughing fever chills and ultimately presented to the hospital with acute hypoxic respiratory insufficiency requiring supplemental oxygen he was admitted to the hospital and had convalescent plasma for COVID-19, CT scan showing infiltrates but negative for PE, his COVID-19 pneumonia responded to the combination of convalescent plasma, remdesivir, dexamethasone and time He had hyperglycemia secondary to steroids and was treated with insulin Blood pressure medications were adjusted for lower blood pressures however at the time of discharge his blood pressure is 130/84


VAERS ID: 1662366 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-29
Onset:2021-08-16
   Days after vaccination:199
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atorvastatin, trulicity, humulin 70/30, lispro insulin, metformin, scopalamine patch, carvedilol, glipizide, fluoxetine, amlodipine, lisinopril
Current Illness: no
Preexisting Conditions: diabetes, hypertension, obesity, coronary artery disease
Allergies: lactose and morphine
Diagnostic Lab Data: +covid testing on 8/16/2021
CDC Split Type:

Write-up: Patient had breakthrough case of covid diagnosed on 8/16/21. She had received her covid vaccines on 1/29/21 and 2/26/21. She received regencov on 8/17/21. She was not hospitalized.


VAERS ID: 1662480 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006O21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray, Cold sweat, Dyspnoea, Erythema, Hypertension, Myocardial necrosis marker, Scleral haemorrhage, Skin discolouration, Syncope, Vascular injury, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Scleral disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: HPV, patient have a very high fever after 1st dose and was hospitalize after 2nd dose. Third dose was not administered
Other Medications: None
Current Illness: None
Preexisting Conditions: Rosacea
Allergies: Shellfish, tomatoes, wheat, oranges
Diagnostic Lab Data: Chest X-ray, cardiac enzymes test, The patient was given Benadryl, Solu-Medrol and was put on oxygen at the hospital
CDC Split Type:

Write-up: Face became extremely red. High blood pressure for her. The fingers of the hand turn black and the patient complained that has trouble breathing and then fainted. Once the patient regained consciousness she started with cold sweats and 911 was called and at that point the patient started to vomit. The patient end up in the hospital. In the hospital she kept getting worse all the small vessel of the face and neck broke. The sclera of the right eye filled with blood. The patient remained 12 hours at the hospital. She was also a COVID-19 patient back on the February 17 2021 and was given monoclonal therapy.


VAERS ID: 1662887 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

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

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

Write-up: Patient received J+J vaccine at 1028am and had vomiting at 1050am


VAERS ID: 1663016 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-16
Onset:2021-08-16
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Cough, Thyroiditis
SMQs:, Anaphylactic reaction (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, probiotics, allergy shots 1x weekly
Current Illness:
Preexisting Conditions: Hoshimotos thyroiditis, alopecia, Autism
Allergies: Oral allergy syndrome to apple, carrot, hazelnut, walnut. Environmental allergies to trees, grasses, weeds, animal dander
Diagnostic Lab Data: Examination by pediatrician.
CDC Split Type:

Write-up: Dry cough, inflammation around thyroid - she has had these previously, but they have become worse - may not be related to the vaccine, but we were told to report it.


VAERS ID: 1663028 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-06
Onset:2021-08-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA MOOORNA027D21A / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: Metformin, Beet root,Fenofibrate,Losartan potassium, Vitamin B complex,81 mg of aspirin, Turmeric
Current Illness: None
Preexisting Conditions:
Allergies: Statins
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blood Sugars went very high. Then the fluctuation just continue to go on for another two weeks. I was not able to get control over it.


VAERS ID: 1663130 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-11
Onset:2021-08-16
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001B21A / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rituxan infusion, prednisone 5mg
Current Illness:
Preexisting Conditions: crest syndrome
Allergies:
Diagnostic Lab Data: covid 19 positive test
CDC Split Type:

Write-up: covid positive test and illness


VAERS ID: 1663605 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chills, Headache, Hyperaesthesia, Pain, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Renal pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Varicella Vaccine
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Varicella Vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itching all over and headache within 15 minutes of vaccination. Fever, body aches, skin sensitivity, chills, kidney pain, generalized weakness, swelling of right arm, pain in right arm within 24 hours of vaccination. Fever resolved within 48 hours of vaccination. All other symptoms lasted 5 days.


VAERS ID: 1665431 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Idaho  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: POSITIVE
CDC Split Type: USJNJFOC20210858816

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 47 year and 9 months old white male, ethnicity unknown. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: Unknown) 0.5 ml, frequency 1 total, administered on 20-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on an unspecified date the patient experienced fever, headache and diarrhea. On 16-Aug-2021, SARS-CoV-2 PCR test was performed, and result was positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649.; Sender''s Comments: V0-20210858816-Covid-19 Vaccine AD26.COV2.s-Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1665609 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-21
Onset:2021-08-16
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective, Fatigue, Nasal congestion, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: COVID-19; Loss of taste and smell; Loss of taste and smell; Congestion; Cough here and there; Sneeze here and there; Body fatigue; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough here and there) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The consumer have received first dose of Moderna COVID-19 vaccine on 21 May 2021 and second dose on 21 June 2021. The consumer had tested positive for COVID-19 on 16 Aug 2021 and her symptoms are loss of taste and smell, congestion, cough here and there, sneeze here and there and body fatigue. No concomitant product use was provided by the reporter. No treatment medications were reported.


VAERS ID: 1665688 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-03
Onset:2021-08-16
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 RA / OT

Administered by: Work       Purchased by: ?
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202101068379

Write-up: Covid test result: Positive; sore thraot; sneezing; runny nose; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 25-year-old male patient. A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 03Feb2021 (at the age of 25-year-old), as dose 2, single in right arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 13Jan2021 (at the age of 25-year-old), as dose 1, single in right arm for COVID-19 immunization at Workplace clinic. The patient''s medical history and concomitant medications were not reported. On 16Aug2021, 6 months and 13 days after vaccination, the patient experienced sore throat, sneezing and runny nose. On 17Aug2021, post vaccination, the patient''s nasal swab test or COVID test result was positive. It was reported as unknown that patient received treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): positive, on 17Aug2021. It was reported as unknown if patient had COVID prior vaccination and patient was tested COVID post vaccination. The clinical outcome of all the events was reported as resolving. No follow-up attempts possible. No further information expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event SARS-CoV-2 test positive and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1665736 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1665739 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1665759 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1665988 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-11
Onset:2021-08-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia, Sleep disorder
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: multivitamin ASA 81 mg
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Paresthesia of upper and lower limbs which is exacerbated by sitting or lying. Symptoms are worse at night causing sleeplessness.


VAERS ID: 1666004 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1666096 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1666105 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1666116 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1666137 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1666213 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Colorado  
Vaccinated:2020-12-21
Onset:2021-08-16
   Days after vaccination:238
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Immunosuppression, Organ transplant
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin, vit D, lisinopril, myophenolate sodium 360 mg po BID, pravastatin, prednisone7.5 mg daily, sirolimus 1 mg po daily, tacrolimus 3 mg qam and 2 mg qevening, casirivimab-indevimab 1200 mg IV once 8/16/21
Current Illness: None
Preexisting Conditions: Kidney and pancreas transplant on immunosuppression, HLD, HTN
Allergies: Oxycodone
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient vaccinated with Pfizer vaccine 12/21/21 and 1/11/2021. He was diagnosed with Covid on 8/8/21 and admitted to the hospital on 8/16/21. He received casirivimab-indevimab on the morning prior to his admission. Double organ transplant patient on immunosuppression.


VAERS ID: 1666267 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-21
Onset:2021-08-16
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity, Vaccine positive rechallenge
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: Starting with shot 1 - my left arm has fatigue, soreness and is weak and hurts daily leading up to now 9/2/21 even after 2nd shot. Then, since shot 2, my left leg has been sore, numb at times and constant pain, which was not the case during shot 1 and did not have these symptoms before the shot, during shot 1, however now both my left arm and left leg have soreness, fatigue and at times numbness.


VAERS ID: 1666307 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-22
Onset:2021-08-16
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Covid 19 positive 8/16/2021


VAERS ID: 1666395 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Allergy to vaccine, Aphonia, Asthenia, Decreased appetite, Diarrhoea, Dyspepsia, Fatigue, Full blood count normal, Gastritis, Headache, Hypoaesthesia, Immediate post-injection reaction, Malaise, Nausea, Pain, Paraesthesia, Retching, Sleep disorder, Speech disorder, Throat irritation, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin C; Zinc
Current Illness: No
Preexisting Conditions: Migraines
Allergies: Vicodin
Diagnostic Lab Data: CBC-normal
CDC Split Type: Vsafe

Write-up: Almost immediately after the vaccine I started feeling numbness and tingling in my bilateral hand and face. I had to lay down and was dry heaving and immediately I had to go to the restroom 3 different times in a row with severe diarrhea. That night my face was numb and loss of appetite. No appetite the next morning but went to work. Started not feeling well so I left work and around 2pm I lost my voice and couldn''t talk, began vomiting and loss all energy. I was so out of it I could not talk for about 24hrs. I was vomiting for about 8hrs straight with diarrhea close to every 30 minutes. I had a bad headache feeling like my head was going to explode and severe body pain. I was extremely nauseated. The next day my stomach felt as if it was burning, and I couldn''t keep any food down. I have had diarrhea, been fatigued and extremely nauseated with acid burning from my stomach to my throat, can''t sleep and gastritis since the day of the vaccine. On 8/18 I went to the ER because the symptoms were just so bad. I was administered Zofran and was sent home. On 8/31 I went back to the ER at and was given IV fluids and various meds to try to calm my stomach to bring down the acid. I have been referred to a GI specialist. I have a disability appointment scheduled. 9/10 appointment scheduled for an Endoscopy and have since been prescribed: Famotidine, Zofran, Pepcid, Ativan and Phenergan if the Zofran doesn''t work. And I continue to have the diarrhea, nausea, upset stomachs and I still can''t sleep without the Ativan. One provider feels I am allergic to the poly ethanol in the vaccine.


VAERS ID: 1666556 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088021A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardioversion, Fibrin D dimer increased, Supraventricular tachycardia, Troponin increased
SMQs:, Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow)

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

Write-up: SVT, requiring adenosine for cardioversion. ER visit and overnight stay.


VAERS ID: 1666775 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-08-12
Onset:2021-08-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac stress test, Chest X-ray, Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram, Laboratory test
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: COVID during December 2020.
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: EKG and chest xray 8/19 Lab work and EKG 9/2 Pending ECHO and stress test
CDC Split Type:

Write-up: 3 days later chest pain/discomfort started developing.


VAERS ID: 1666838 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Palpitations, Skin burning sensation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: shingles
Allergies: no
Diagnostic Lab Data: Went to Dr on 8/19/21 physical examine was done
CDC Split Type:

Write-up: Racing heart and burning scalp .Hives on right side of head . Feels like a headache on right side


VAERS ID: 1666842 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / UNK LA / IM

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

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

Write-up: PATIENT HAS A HISTORY OF GBS AND A FEW HOURS AFTER ADMINISTRATION SHE STARTED HAVING NUMBNESS IN THE LOWER PART OF HER FACE AND HER HANDS. OVER THE COURSE OF A FEW DAYS IT SPREAD TO HER EXTREMETIES AND HAS NOT RESOLVED AS OF 9/2/21.


VAERS ID: 1667375 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-07-15
Onset:2021-08-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0190 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Splint application, Tenosynovitis, X-ray limb normal
SMQs:, Arthritis (broad), Tendinopathies and ligament 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vestura
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: X-rays done but nothing abnormal 08/22/2021. Diagnosed 08/22/2021 as tenosynovitis.
CDC Split Type:

Write-up: Left (non-dominant) wrist pain increasing over a week. Occurred after sustaining no injury. Visited ER after not being able to use wrist because of severe pain for around 12 hours. Diagnosed as tenosynovitis with an unknown cause. Put in a splint for 1-2 weeks, following up with primary care tomorrow.


VAERS ID: 1667384 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: ibuprofen Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given Covid 19 vaccine at approximately 1730. Patient notified us that "my throat feels itchy". I went into the patients room to take vitals while contacted Rapid Response Team. They responded immediately and patient was assessed and taken to Urgent Care to be further evaluated. Patient administered Benedryl and discharged.


VAERS ID: 1667414 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-04
Onset:2021-08-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pain in extremity, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Erythromycin and Cortisone
Other Medications: High blood pressure - Maxide
Current Illness: None
Preexisting Conditions: Lupus, RA
Allergies: Naproxen, Shell fish, Erythromycin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Itching, rash, pain, unable to lay on my arm without having intermittent pain.


VAERS ID: 1667911 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-17
Onset:2021-08-16
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9264 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Productive cough, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen, albuterol, alendronate, ASA, calcium and Vit D, chlorhexidine, gabapentin, ibuprofen, isosorbide mononitrate, levothyroxine, lisinopril/HCTZ, metformin, metoprolol, multivitamin, macrobid, KCl, psyllium seed, rosuvastatin,
Current Illness:
Preexisting Conditions: COPD, DM, hyperlipidemia, HTN, hypothyroidism, MI, osteoporosis
Allergies: penicillin, lipitor
Diagnostic Lab Data:
CDC Split Type:

Write-up: 8/16/21: COVID pos presented to ED with cough, clear phlegm, fatigue, weakness 8/18/21: discharged on steroids and told to f/u with PCP as needed


VAERS ID: 1669551 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-30
Onset:2021-08-16
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029L20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: noticed that the injection site is red like a light sunburn; noticed that the injection site kind of itches; noticed a lump at the injection site; her left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (noticed a lump at the injection site), MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 029L20A) for COVID-19 vaccination. The patient''s past medical history included Pulmonary fibrosis in 2010. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (her left arm hurt). On 17-Aug-2021, the patient experienced VACCINATION SITE MASS (noticed a lump at the injection site). On 18-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches). At the time of the report, VACCINATION SITE MASS (noticed a lump at the injection site) had not resolved and MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. The reporter states that the patient took the booster dose as the patient is immunocompromised due to pulmonary fibrosis from chemotherapy in 2010.


VAERS ID: 1670544 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia, Neuralgia, Pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: Patient reports arm soreness and nerve pain (including tingling, numbness and shooting pain) in body, arms, legs, and lower back for several days post vaccination. Patient follow up with primary care provider and received a prescription for a prednisone taper as a result of this nerve pain.


VAERS ID: 1670575 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1670622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Feeling of body temperature change, Headache, Hot flush, Hyperacusis, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)

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

Write-up: Patient reports fatigue, hot and cold flashes within a day of vaccine administration. She also reports worsening of headache (light and noise sensitivity unrelieved by rest or over the counter medications) that resulted in a Primary Care Provider visit with an injection of sumatriptan and prescription for sumatriptan.


VAERS ID: 1670638 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1670661 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1670666 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error, Improper Storage temperature.


VAERS ID: 1670765 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Axillary pain, Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: 200mg Lyrica 2x daily.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A few hours after the injection, Pt started complaining of pain under her arm. Not at the injection site. The next evening, we noticed a large bruise under her arm. It spread from under her arm down to her breast.


VAERS ID: 1670778 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-02-25
Onset:2021-08-16
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Fatigue, Headache, Heart rate decreased, Immediate post-injection reaction, Musculoskeletal discomfort, Oxygen saturation decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (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: Eliquis (Apixaban); Omeprazole; Atorvastatin; Diltiazem; Alopurinol; Metoprolol Succinate; Hydrocodone; Supplements: Iron; Vitamin D3; Daily Multi-Vitamin; Chromium; Ubiquinol; Glucosamine/Chondroitin; Tart cherry extract - natural anti-inf
Current Illness: No
Preexisting Conditions: A Fib; Idiopathic Peripheral Neuropathy; Episodic Gout; Chronic low back pain
Allergies: Augmentin - ankle rash
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: Immediately after vaccine, no significant ones other than I reported on v-safe permanent a fib - my heart rate/vitals changed dramatically; usually I''m stable 115/75 BP normal to 100-110 - Pulse rate; dropped to as low as 39 pulse rates. Average heart rate was 78 and BP 124/74. The lowest being as low as 39 for heart rate. I had a little shortness of breath and my O2 saturation dropped to 90 a nd that happened over a couple of day period. Normally I can''t even force it down to 94. I had general fatigue. Persistent headache - slight pulse rate is coming back up. At the beginning of the episode periodic discomfort at my left pec and shoulder. Increased anxiety levels with this - didn''t trust me to go out to get the mail. Spoke with a doctor - did not see a doctor - the facility is two hours away; did it via message service. They decreased the Metoprolol to 50 mg, and they are monitoring it now. And then we''ll examine it again. I am free to message them at any time. I have confirmed that I am feeling better as I am compliant with the decrease, and I will be getting back to them on Tuesday of next week. So, it''s an ongoing monitoring process. The average on the Pulse rate is 64 now. Anxiety has come down - but I do still have some recognized fatigue - I''m easily fatigued. We''re still maintaining self-quarantining - over this last year and a half. Not being very social at this time.


VAERS ID: 1670839 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Gait inability, Neuralgia, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Azathioprine 75 mg Synthroid 0.05 mg Simvastatin 20 mg Fluoxetine 10mg Bupropion XL 150 mg Amlodipine besylate 5 mg Lubiprostone 24 mcg, twice daily Ozempic 0.5 mg/dose weekly Pantoprazole 40 mg FiberCon 625 tablets, twice daily Vitamin D3
Current Illness:
Preexisting Conditions: Autoimmune hepatitis Hypertension High cholesterol Chronic depression Hypothyroidism
Allergies: None
Diagnostic Lab Data: None Did not seek treatment because local facilities were overrun with Covid patients
CDC Split Type:

Write-up: Sharp nerve pain in right hip, dull pain in right thigh, sudden onset upon standing after sitting down, pain worsened over next 12 hours, became excruciating, could not sit up or walk unassisted, pain remained intense for 2 days before lessening, pain nearly gone after 5 days, still discomfort when lying on right side after 2 weeks. Treated at home with prescription pain killer for first 5 days, ibuprofen after that; used heat and elevation, bed rest. Would definitely have visited ER first night, but our local hospitals are overrun with Covid right now.


VAERS ID: 1672352 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Plaque psoriasis (MODERATE TO SEVERE)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210904763

Write-up: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 63 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 2021, and dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 16-AUG-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.


VAERS ID: 1672432 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Muscle tightness
SMQs:, Anaphylactic reaction (broad), Dystonia (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: LOSARTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Redness of the face; Tightness of the face; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LOSARTAN for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face). At the time of the report, ERYTHEMA (Redness of the face) and MUSCLE TIGHTNESS (Tightness of the face) 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 took a medication that causes angioedema (Losartan for more than a year). No treatment information was provided.


VAERS ID: 1672433 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product storage error
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: USMODERNATX, INC.MOD20212

Write-up: expired dose was given to a patient; vial was moved from the freezer to the refrigerator on 13Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non significant Follow up


VAERS ID: 1672437 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: ADDERALL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Heart Rate; Result Unstructured Data: 110 BPM
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No medical history was provided by reporter. . Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 16-Aug-2021, the patient experienced HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening). At the time of the report, HEART RATE INCREASED (heart rate has been elevated, heart rate was 110 BPM and has been over 100 most of the afternoon/evening) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: 110 bpm (High) 110 BPM. No medical history was provided by reporter. Other concomitant includes blood pressure pills. No treatment medication reported.


VAERS ID: 1672476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (got the third dose of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (got the third dose of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (got the third dose of the Moderna COVID-19 vaccine) had resolved. No treatment information was reported. The patient wanted to know if she could take an antihistamine she regularly took (claritin) and wanted to be sure it would not interfere with the vaccine.


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