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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 330 out of 7,116

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VAERS ID: 1582540 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Injection site hypoaesthesia, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: None that I am aware of
Preexisting Conditions: None that I am aware of
Allergies: No
Diagnostic Lab Data: Referred to Ortho 8/17/21 to rule out SIRVA
CDC Split Type:

Write-up: First time I became aware of symptoms was at visit for 2nd COVID vaccine on 8/17/21, at this visit patient reported significant numbness and pain in right deltoid area around area of injection starting 4 days post vaccine, no redness or swelling of area noted, denies fevers, numbness persists and has pain in right shoulder when she lays on it at night so now cannot lay on right shoulder. No past shoulder pain reported. States that right arm suddenly loses strength off and on since vaccination. No numbness or tingling in lower arm. Denis any immediate tingling or pain or burning sensation after vaccine.


VAERS ID: 1582612 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood test, Chest X-ray, Dysphagia, Electrocardiogram, Feeling abnormal, Heart rate increased, Hypoaesthesia, Paraesthesia, Speech disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Auto-immune issues
Allergies: No
Diagnostic Lab Data: 7/30/21 - Blood tests, EKG, chest X-ray done at the Emergency Room
CDC Split Type:

Write-up: Severe neurological reaction including face, arms and legs tingling and numbness, fast heartrate, difficulty speaking/swallowing, elevated blood pressure, feeling of needing to jump out of skin. This occurred on 7/30 (date of vaccine) within hours and multiple times following.


VAERS ID: 1582622 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-01
Onset:2021-07-30
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Vertigo
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (narrow)

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

Write-up: Dizzyness, clouded mind, vertigo


VAERS ID: 1582632 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-03-03
Onset:2021-07-30
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, COVID-19, Cough, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETAMINOPHEN/DIPHENHYDRAMINE (TYLENOL PM EXTRA STRENGTH ORAL) blood sugar diagnostic (glucose blood) strip blood-glucose meter misc calcium carb and citrate-vitD3 600 mg calcium- 500 unit tablet extended release cyanocobalamin (vitamin B-1
Current Illness:
Preexisting Conditions: Nervous Controlled type 2 diabetes mellitus with neuropathy (CMS/HCC) Diabetic neuropathy (CMS/HCC) Diabetic polyneuropathy associated with diabetes mellitus due to underlying condition (CMS/HCC) Circulatory Essential hypertension Digestive Diverticulosis of intestine Musculoskeletal Primary osteoarthritis of right knee Endocrine/Metabolic Hyperlipidemia Hypothyroidism
Allergies: Ace InhibitorsCoughing, Paranoia AmlodipineParanoia Amlodipine BesylateParanoia OtherParanoia Valsartan Verapamil HclParanoia
Diagnostic Lab Data: 08/03/21 1944 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 08/03/21 1158 | Final result | Specimen: Swab from Nasopharynx COVID-19 SARS-CoV-2 Overall Result DetectedCritical 08/03/21 1944 COVID-19 PCR Collected: 08/03/21 1158 | Final result | Specimen: Swab from Nasopharynx
CDC Split Type:

Write-up: cough, congestion, sore throat and loss of taste


VAERS ID: 1583024 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-09
Onset:2021-07-30
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test positive
SMQs:, Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sulphasalazine,1000mg, Methotrrexate, 2.5mg 4 tablets i per week;Combigan eye drops;Latanaprost eye drops;Rheumate capsules; BNB bone support;Multivitamin; Alendronate, 70 mg once a weeek;Rosuvastatin, 5mg,3 times per week
Current Illness: none
Preexisting Conditions: rheumatoid arthritis, glaucoma
Allergies: none
Diagnostic Lab Data: COVID Test August 3 2021 positive
CDC Split Type:

Write-up: Sore arm, a little tired


VAERS ID: 1583044 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028D21A / UNK - / -

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

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

Write-up: Rash all over body


VAERS ID: 1583124 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Pain
SMQs:, 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 taking the day of the vaccination however I am on prenatal vitamins because I had a baby in early July.
Current Illness: None
Preexisting Conditions: None
Allergies: None. I am sensitive to gluten and dairy at times.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Two days after my initial shot, I noticed I had a sore spot on my right collar bone. I felt it and it was a swollen lymph node. Over the next few days it got smaller and was eventually gone within that next week. During this time I also felt soreness under both my armpits as if I had swollen lymph nodes there as we. All was gone about a week after these all appeared.


VAERS ID: 1583187 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-26
Onset:2021-07-30
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Ear pain, Exposure during pregnancy, Exposure to SARS-CoV-2, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: clobetasoL 0.05 % lotion cyanocobalamin, vitamin B-12, (vitamin B-12) 1,000 mcg tablet escitalopram (LEXAPRO) 10 mg tablet HALOG 0.1 % external solution prenatal 25/iron fum/folic/dha (PRENATAL-1 ORAL
Current Illness:
Preexisting Conditions: Nervous Arm paresthesia, left Other Anxiety 30 weeks gestation of pregnancy
Allergies:
Diagnostic Lab Data: 08/03/21 1623 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 08/02/21 1335 | Final result | Specimen: Swab from Nasopharynx COVID-19 SARS-CoV-2 Overall Result DetectedCritical 08/03/21 1623 COVID-19 PCR Collected: 08/02/21 1335 | Final result | Specimen: Swab from Nasopharynx
CDC Split Type:

Write-up: COUGH,CONGESTION OR RUNNY NOSE, S/T AND EAR PAIN Diagnoses Codes Comments Cough - Primary ICD-9-CM: 786.2 ICD-10-CM: R05 30 weeks gestation of pregnancy ICD-9-CM: V22.2 ICD-10-CM: Z3A.30 Exposure to COVID-19 virus ICD-9-CM: V01.79 ICD-10-CM: Z20.822


VAERS ID: 1586985 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19
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? No
Previous Vaccinations:
Other Medications: Labetal 00 MG 2 per day Omeperazole dr 40 MG 1 per day Calcium,magnesium,zinc, with d3 vitamin 1per day. Nature Made.
Current Illness: No illness
Preexisting Conditions: Gal bladder removed years ago. No issue, except for open hernia surgery resulted from gal bladder surgery.
Allergies: Very mild allergy to strawberries, blue berries, lettuce. Hives. Stomach sick when take prescription Codine.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Family got covid 9 to 10 months prior on same day. 19 yr old had for 1 day, I had for almost 2 was, husband 3 was. Did not need hospital. All 3 of us got the 1st round of vaccine to potentially minimize symptoms of new strain only. Or we would not have taken it. However, I was only one with after effects next 2 day. Mild case of covid again.


VAERS ID: 1587036 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587038 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587041 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, HCF, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587044 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: No adverse event, 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: The COVID-19 vaccine administered through the vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587046 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, HCF, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587049 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       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: The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587055 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587059 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587065 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Expired product administered, No adverse event, 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: The COVID-19 vaccine administered through vaccine administrator, , between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone''s health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.


VAERS ID: 1587279 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Eye irritation, Eye pain, Facial pain, Headache
SMQs:, Glaucoma (broad), Corneal disorders (broad)

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

Write-up: Patient experienced burning sensation to eyes bilateral 5 min after administration. After 25 min had passed, patient began to experience a sharp/stabbing pain to the right side of her head that traveled down to her Rt eye and Rt side of her face.


VAERS ID: 1591143 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-10
Onset:2021-07-30
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Increased tendency to bruise, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: obesity
Allergies: Penicillin
Diagnostic Lab Data: 7/30/2021-- 26 8/3/2021-- 16 8/6/2021--29
CDC Split Type:

Write-up: Patient had a very heavy menstrual , bruising very easily & platelet count dropped significantly


VAERS ID: 1591394 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Erythema, Head discomfort, Induration, Injection site pain, Monoplegia, Pain, Pyrexia, Skin warm, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil Coq10 Centrum multi vitamin
Current Illness:
Preexisting Conditions:
Allergies: Statins
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 day after shot ran a fever, weak, and achy. Left arm red, hot, very hard and very painful . Could not touch my arm where I was vaccinated. 2nd day after shot no fever but weak. Arm still hot, hard, and sore. 3rd day after shot a lot of pressure in my head, no energy and then vomiting. Arm continued to be red and sore.


VAERS ID: 1591461 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acne, Affect lability, Anxiety, Arthralgia, Back pain, Dizziness, Feeling hot, Flushing, Irritability, Muscle spasms, Muscle tightness, Myalgia, Pain, Pain in extremity, Paraesthesia, Rash, Rash pruritic, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Within minutes felt flush,dizzy,tingling warmth from face down. Withun hours my back muscle began to draw up tight in muscle spasms/pain. Arm pain but not comparable to the back pain. Tight,drew up back muscle. Hurt to touch my back with a hand. Hurt to lay on my back for bed and later woke from sleep due to pain. This severe back pain lasted 5 days then moderate pain went on throygh day 14. After that back pain eased to mild and shoulder pain was more present and lasting as of day 20 past vaccine. Shoulder pain when arm lifts or rotates. Around day 15 an itchy rash emerged on legs mostly. Unsure if its related. Within a day of the vaccine I broke out in severe acne as a fine all over face bumps, very tiny fine bumps all over. Along with this, I felt emotionally very anxious and irritable, emotionally liable. This is out of character and has remained since the shot 20 days ago. This emotional instability sincethe vaccine led to an anxiety attacks on day 3 and 17. I feel it has personally affected me hormonally with the break outs and anxiety. I am currently still awaiting resolution to all health effects the shot has caused


VAERS ID: 1591592 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-11
Onset:2021-07-30
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Anticoagulant therapy, Asthenia, COVID-19, Chest X-ray abnormal, Cough, Dizziness, Hyperhidrosis, Hypotension, Lung opacity, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: arthritis, atherosclerosis, CAD, CHF, CLL, esophageal reflux, HTN, MI 2012, Raynaud''s, s/p CABGx3
Allergies: ace inhibitors, atorvastatin, celebrex, metoprolol, rosuvastatin, zetia
Diagnostic Lab Data: 7/30/2021 SARS CoV2 Detected 7/30/2021 CXR - lower lobe opacities
CDC Split Type:

Write-up: 7/28/2021 Started to feel weak, diaphoretic, sore throat, lightheaded. 7/30/2021 presented to ED with continued cough, sore throat and R leg pain. Had been out of town on trip two weeks prior. Tested Covid-19 positive 7/30/2021. Due to immunocompromised status, did not qualify for remdesivir, decadron or tocilizumb. Placed on prophylactic heparin and given fluids and placed on O2. Was hypotensive and Benicar and HCTZ were held. Discharged 8/1/2021 in improved condition, without supplemental oxygen, with the following dx: hypotension, AKI, Covid-19. Submitter does not have access to any further hospitalization information. If further follow up information is required, please contact the hospital.


VAERS ID: 1591678 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-23
Onset:2021-07-30
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, Diarrhoea, Feeling abnormal, Nausea, Occupational exposure to SARS-CoV-2, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: n/a
Current Illness:
Preexisting Conditions: prostate cancer on chemotherapy
Allergies: NKDA
Diagnostic Lab Data: SARS CoV 2 PCR COVID-19 Positive on 7/30/2021 according to patient Repeat SARS CoV 2 PCR COVID-19 Positive on 8/8/2021 upon admission
CDC Split Type:

Write-up: 8/8/21: Patient states he decided to go get tested for COVID19 due to being exposed to a co-worker that was feeling poorly. He reports he had a positive COVID test on 07/30/2021 and states he was not really having symptoms at that time but eventually started having persistent diarrhea, occasional nausea and decreased appetite as well as having a nonproductive cough, that was exacerbated with deep breathing. He reports he came to the ED due to not feeling any better. Repeat COVID testing on 8/8/21 in ED was positive again and patient was admitted for further eval. He reports being fully vaccinated with Johnson & Johnson vaccine in May 2021. 8/9/21: Patient discharged home He states he has been using over-the-counter Robitussin at home but has not been on any other prescription medications. In the ED, patient had O2 saturations 91% on room air and was placed on 2 L nasal cannula. Repeat COVID testing positive again. He received a normal saline bolus, Decadron, and Zofran in the ED and reports feeling better.


VAERS ID: 1591691 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Headache, Parosmia
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine Clonazepam Fexofenadine Vitamin d2 50,000 Womens 1 a day multivitamin
Current Illness:
Preexisting Conditions:
Allergies: Naprosyn Keflex Clyndomycin Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: I got the 1st dose of the pfizer vaccine on 7/29/21 and the next day I had a taste in my mouth that was like a metallic taste but I could smell ink from a pen.It was like I had pen ink in my mouth.It lasted about a week and I started getting headaches that I am still having to this day.I have to go for an mri related to the headaches next week.


VAERS ID: 1591874 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / IM

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

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

Write-up: PATIENT RECEIVED TWO MODERNA DOSES 3/4 AND 4/1 ALSO RECEIVED PFIZER 7/30


VAERS ID: 1592119 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Flexeril, Ibuprofen, Minocycline
Current Illness:
Preexisting Conditions: GERD, Depression, Thoracic Radiculopathy
Allergies: Oxycodone, Wellbutrin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Report of 3 weeks of muscle cramping, intermittent chest tightness


VAERS ID: 1592535 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: C-Naltrexone Cannabis Vitamin D Zinc
Current Illness: None
Preexisting Conditions: Scoliosis Fibromyalgia Depression
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fatigue 5 days Shoulder across back 1 day Headache dizziness nausea 21!!! Days


VAERS ID: 1595980 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-09
Onset:2021-07-30
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

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

Write-up: Bell?s palsy


VAERS ID: 1602585 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-05-13
Onset:2021-07-30
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 2 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Malaise
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was taking levothyroxine and hydroxyzine.
Current Illness: I did not have any illness at the time of vaccination.
Preexisting Conditions: I have thyroid disease and I recently had a stroke.
Allergies: I am allergic to Wellbutrin and methimazole.
Diagnostic Lab Data: I had a MRI and blood work drawn.
CDC Split Type: vsafe

Write-up: The day after I received the vaccine, I felt pretty ill. It only lasted for about a day and a half. I experienced a stroke about three weeks ago. I was admitted to Wytheville County Hospital for a week and a half. I had a MRI and had blood drawn to determine that I experienced a stroke.


VAERS ID: 1602664 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Metabolic function test normal, Neuralgia, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Magnesium
Current Illness: No
Preexisting Conditions: Lichen schlerosis
Allergies: No
Diagnostic Lab Data: Metabolic panel and office visit. Normal lab results.
CDC Split Type:

Write-up: All over nerve pain and itchy rash. Has gotten better but not gone completely .


VAERS ID: 1602672 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dizziness, Pain in extremity, Throat tightness, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Ovarian insufficiency
Allergies: Band-Aids- rash Lupron- rash, injection site swelling
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 5 minutes dizziness, lightheadedness, throat stiffening, chest pain, vision difficulty lasting several hours. Took aspirin and later an antihistamine. Extreme arm pain lasting several days.


VAERS ID: 1617414 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Hypomenorrhoea, Throat irritation
SMQs:, Anaphylactic reaction (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Montelukast Zyrtec Aimovig
Current Illness:
Preexisting Conditions: Migraines Asthma
Allergies: Nuts, Contrast, Cephlex
Diagnostic Lab Data: Went to ER because breathing was getting more and more difficult. Still has cough almost a month later
CDC Split Type:

Write-up: Trouble breathing, itchy throat, upset stomach all within 15 min Very light period a month later usually only heavy


VAERS ID: 1617427 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Bronchitis, Chest discomfort, Cough, Middle ear effusion, Sinusitis, Throat irritation
SMQs:, Anaphylactic reaction (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine, cytomel, estradiol, Zyrtec, Celebrex, senna, Cosentyx, methotrexate, oxybutynin , welchol, Folic acid, vit d
Current Illness:
Preexisting Conditions: Non-radiographic axial spondyloarthritis IC Migraines Thyroid cancer
Allergies: Penicillins, morphine, hydrocodone, chlomythromycin, tramadol, tizanidine, cefazolin, amoxicillin, hydromophone, Remicade, bamlanlivimab, etesvimab
Diagnostic Lab Data: Saw dr on video visit and then dr this past week because cough progressively got worse. Turned into bronchitis, sinus infection, and fluid in ears
CDC Split Type:

Write-up: Itch in throat, upset stomach, tightness in chest all started within 5 min Cough after 45 min


VAERS ID: 1617558 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH RW0181 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness, Erythema, Fatigue, Headache, Incomplete course of vaccination, Influenza like illness, Injection site pruritus, Nausea, Nodule, Oropharyngeal pain, Pain, Pruritus, Pyrexia, Rash pruritic, Tremor, Urinary incontinence
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu shot vaccine
Other Medications: Wellbutrin XL 300 mg daily Cymbalta 40 mg daily Protonix 40 mg daily Probiotic Elderberry/ Zinc supplement magnesium supplement Pepcid 40 mg over the counter all daily
Current Illness: None
Preexisting Conditions: Fibromyalgia Depression
Allergies: Codeine Morphine and all narcotic prescriptions
Diagnostic Lab Data: Urine sample check blood sugar
CDC Split Type:

Write-up: Red lump warm to touch day of shot 3 days later shot injection site itchy and itchy rash all over the body rash hurt to itch day 6 after shot having flu like symptoms headache body aches fever chills nauseated dizzy light headed and very fatigued day 10 contacted my Family doctor to see him but instead they called in a prednisone pack to pharmacy day 13 Husband called Doctors Office asked for Doctor to see me , the Office called back and said go to urgent care went to Urgent Care Facility they checked blood sugar and urine gave me a prescription for scabies wash hydrocortisone cream and told me to get over the counter Zyrtec only got Zyrtec and itchy rash stopped itching and started to gradually disappear on 8/20/2021 I was supposed to get Pfizer Covid 19 second dose and I refused I figured if I took it it could be life threatening with the reaction I have had from first dose I have developed new symptoms on 8/20/2021 body tremors loosing bladder easily sore throat tightness in chest


VAERS ID: 1618497 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C1A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac flutter
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (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: Lisinopril
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: None. I didn''t go to a doctor or a hospital.
CDC Split Type:

Write-up: Moderna COVID-19 Vaccine EUA Four days after receiving the vaccine I had a fluttering heart for one day.


VAERS ID: 1623640 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-29
Onset:2021-07-30
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Autonomic nervous system imbalance, COVID-19, Cough, Diaphragm muscle weakness, Diarrhoea, Dyspnoea, Guillain-Barre syndrome, Hypertensive urgency, Intensive care, Nausea, Neurological symptom, Paraesthesia, Pneumonia, Pyrexia, Respiratory disorder, Respiratory muscle weakness, SARS-CoV-2 test positive, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown- at time of illness, taking cephalexin and omeprazole
Current Illness: unknown- Starting 7/21 respiratory illness, fever, diarrhea, nausea, neurological symptoms. Diagnosed with AIDP/Guillain-Barre Syndrome 8/3/21. Also, COVID positive, pneumonia, hypertensive urgency and dysautonomia.
Preexisting Conditions: obesity, borderline hypertension, OSA not on CPAP, and GERD
Allergies: tramadol- dizziness, HA and nausea Vit B complex- edema
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Starting about 7/30/21 fever, emesis and diarrhea. Then developed dyspnea and cough. Then developed neurological symptoms including weakness, parasthesias, diaphragmatic and respiratory muscle involvement, hypertensive urgency and dysautonomia. Hospitalized at Neuro ICU.


VAERS ID: 1623742 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Depression, Facial pain, Fatigue, Influenza, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Mild flu symptoms, including fever, chills, fatigue, then severe depression lasting a few days. Shooting, sharp pains in my arms and face for several days afterwards.


VAERS ID: 1623788 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Breast swelling, Fatigue, Headache, Pharyngeal swelling, Pruritus, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothroxine 20mg
Current Illness: none
Preexisting Conditions: CFIDS = Chronic Fatique Immune Disorder Syndrome (since 1990)
Allergies: Erthromiacin, Polyetheylene, Polysorbate, Latex, Methacylate
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 1ST Vaccine: 25 minutes after: Rash and Itching rib cage, ithching ears, headache. Swelling of the throat. within 2 day - 2 weeks: , swelling of breasts and fingernails strength & headache 2ND Vaccine: 20 minutes: Rash on both inner part of arms. 2days: swelling of breasts, headache, fatique. Please note: I took cetirizne oral after 20 minutes of both vaccines. Due to itching, rash and throat swelling QUESTION 23 will NOT let me fill: Has the patient ever had an adverse event following any previous vaccine?: (If yes, describe adverse event, patient age at vaccination, vaccination dates, vaccine type, and brand name) ? Yes. Prefinar13 - Pfizer 2017 Allergic reaction


VAERS ID: 1623862 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atenolol 50 mg-chlorthalidone 25 mg tablet Lipitor 40 mg tablet Advil 200 mg Tab Multivitamin Cap
Current Illness: none
Preexisting Conditions: hypertension
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: tinnitus - unrelenting


VAERS ID: 1623886 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / N/A LA / IM

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

Write-up: The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date. The provider may have given the dose outside of the 6 hour window after the vial was opened. No symptoms or signs. Pt will be contacted and offered to be re-vaccinated to offer full protection, per our Medical Group.


VAERS ID: 1624331 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Heart rate increased, Skin warm, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Humalog, Levothyroxine
Current Illness: none
Preexisting Conditions: Type One Diabetes, Hashimoto''s Hypothyroid
Allergies: none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Swelling of face and neck, hotness of face and neck, rapid heartbeat, extreme dizziness and lightheaded. Symptoms started 15 minutes after injection. Dizziness and lightheaded lasted duration of the day. Rapid heartbeat lasted approximately 3 minutes. Swelling of face lasted approximately 6 hours. Hotness of face and neck lasted approximately 3 hours.


VAERS ID: 1625035 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Injection site 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: Vitamin C 1000mg, vitamin D 1000, Nasacort, Loratadine 10mg
Current Illness: 2 weeks prior: cold/sinus
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: On August 10, 2021, discussed with my cardiologist during a routine annual visit. He suggested it was a side effect of the vaccine. No treatment. Recommended that I take an anti inflammatory on the second day after the second dose. Also recommended that if the effects don''t stop some time after the second dose, I should see a neurologist.
CDC Split Type:

Write-up: Numbness (tingling) in started in left arm, but now both legs below the knee. Not constant. sometimes skips a day, and re occurs the next day.


VAERS ID: 1625281 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi vitamin, Gelatin, Ambien
Current Illness: None
Preexisting Conditions: None
Allergies: No Known allergies
Diagnostic Lab Data: None yet.
CDC Split Type:

Write-up: Fluttering, twitching muscle spasm in both calves. They do not hurt, they''re not constant, but felt all day long whether I''m sitting or standing. First noticed them a few days after the first dose.


VAERS ID: 1627934 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Hot flush, Injection site pain, Lymphadenopathy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: glucosamine with chondrotin
Current Illness:
Preexisting Conditions: MVP, asthma, hypothyroidism
Allergies: Codeine, hydrocodone, valium, versed, sulfa, cardizem
Diagnostic Lab Data: none
CDC Split Type:

Write-up: pain at vaccine site, fever, muscle pain, hot flashes, swollen lymph nodes


VAERS ID: 1628264 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness, Nausea, Palpitations, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 10 mg Junel birth control
Current Illness: None
Preexisting Conditions: Super ventricular trachicardia corrected in 2001
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The next morning, passed out, vomiting, heart palpitations, nausea, shortness of breath


VAERS ID: 1628566 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acoustic stimulation tests, Sinusitis, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole,Benazepril,Xyzal
Current Illness: Had a cold couple weeks prior
Preexisting Conditions: Slightly elevated blood pressure
Allergies: None
Diagnostic Lab Data: Hearing test
CDC Split Type:

Write-up: Two days after vaccine developed bad tinnitus in left ear. I went to ENT and they treated me for sinus infection with Amoxicillin. Has been 4 weeks and not any better. Have never had tinnitus before this vaccine.


VAERS ID: 1628728 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-20
Onset:2021-07-30
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site reaction, Menstruation irregular, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Fertility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pt said she developed a red rash at injection site and it was down her arm about half way. she noted the rash lasted about 3-4 days. Pt also stated that after the first injection that she missed her menstrual cycle for the month.


VAERS ID: 1632190 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033B21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Pruritus, Vertigo
SMQs:, Anaphylactic reaction (broad), Vestibular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: vertigo and itching per staff seek md care


VAERS ID: 1632401 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-02-09
Onset:2021-07-30
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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:
Current Illness:
Preexisting Conditions: Marginal High Blood Pressure; Deep Vein Thrombosis is the same leg 3 years earlier
Allergies:
Diagnostic Lab Data: Deep Vein Doppler
CDC Split Type: vsafe

Write-up: In the evening of Friday July 30th and I looked down at my ankle, which it has happened to before and has happened with an overseas flight. I sent a picture to my doctors. They scheduled a deep vein doppler and they concluded I had a deep vein thrombosis about a foot long clot in my lower leg. They put me on XARELTO to treat it. I have another ultrasound for it next week to see what it has done. I had only flown a domestic flight. They only have concerns when you make a longer flight.


VAERS ID: 1632505 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0631214 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Feeling abnormal, Injection site discomfort, Nervousness, Skin discolouration, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: past 6 months, have been having random problems swallowing food, cause has not been determined yet, appointment with GI Specialist has been made.
Preexisting Conditions: Lymphedma, from lymph node removal, due to breast cancer. For years it was just in my left arm, over the past two years it has been affecting my entire left side, including my stomach. Manageable with diet restrictions (eliminating salty foods and avoiding foods that cause inflammation), lymph massage, exercise and lymphedema sleeves.
Allergies: Shellfish, iodine, rocephine, sulphur, thimerisal, latex, something in the Covid 19 vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Waited a half hour in waiting area, no one came to check on me (after I had indicated my allergy concerns and history), left pharmacy and went directly home (less than 5 minutes from pharmacy), upon arrival at home, felt weird, looked in mirror and face was swollen, red patch across cheeks/nose area, chin and red patchy look to forehead, tiny hives appearing just below cheeks and on upper chest, just below neck. Took some Tylenol, sat in a chair with fan blowing on me and slowly drank 2 large glasses of iced water. After about 2 hours (this includes the 1/2 hour in the waiting room) of monitoring myself, swelling started to go down and redness had turned pinkish. Went to bed and took a nap for 3 hours, woke up and felt fine. On Sunday, right arm where shot had been given felt like a wide elastic band was wrapped around my arm. Feeling slowly diminished over the next two days. No other symptoms since. Very concerned about having the next shot because of inflammation concerns. I had breast cancer in my left breast and have inflammation issues due to lymphedema on that side. Know that radiation can cause inflammation issues with lung and heart. Know concerned about inflammation issues with heart from vaccine. Very nervous to get second shot, contacted PCP and breast surgeon, both said to contact pharmacy with my concerns and one said to contact CDC to find out where I could go to have the vaccine administered at a facility that had a Physician or Nurse present to monitor me. Can anyone give me feedback on my concerns and inform me where I can get a supervised shot, if I should get the shot at all?


VAERS ID: 1632760 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Antinuclear antibody, Arthralgia, Blood immunoglobulin G, Blood immunoglobulin M, C-reactive protein, Differential white blood cell count, Full blood count, Injection site joint movement impairment, Injection site pain, Pain in extremity, Periorbital swelling, Red blood cell sedimentation rate, Rheumatoid factor, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent, Ventolin
Current Illness:
Preexisting Conditions: Insomnia, asthma, neural crest disorder
Allergies: None
Diagnostic Lab Data: 8/12/21- CBC + Diff, ESR, CRP, IgM, IgG, Rheumatoid factor, ANA screen, C4
CDC Split Type:

Write-up: Per patient''s most recent visit note: Patient and her mom have similar sx. it started 3 days after a recent covid (pfizer) shot, the 2nd one. Patient has intense pain at the site of the shot (right arm0, but also pain in the left arm. the right arm pain shoots down her arm and she can''t straighten her elbow because of it. She has a tremor of the hand especially the little finger. She has swelling around the eyes and generalized joint pain This all began 3 days after the shot, and she and her mom attribute it to the vaccine. Patient was diagnosed in infancy as having a neural crest disorder. i am not clear from the history whether the vaccine is reportedly exascerbating this neural crest disorder. She is otherwise a normal teen.


VAERS ID: 1632778 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052C21A / 1 RA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Seroquel 300mg 1 before bedtime Carbamazepine 200mg 2 pills 2x a day Benztropine 2mg 2pills a day hydrozoan 50mg 4 a day Benlasaxine er 37.5 mg 1 pill a day
Current Illness:
Preexisting Conditions: Scoliosis
Allergies: Tramadol Cayenne Pepper
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received full body aches the day after the vaccine. The pain is more intense in her neck and her shoulders. The pain is all over her body. Patient is taking over the counter medication to ease pain but that did not help her. Pain in her neck and shoulder pain level is an 8. in the rest of the body is a low 6 high 7.


VAERS ID: 1633607 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

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

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

Write-up: Rash on abdomen and back, noted approximately 1900 on day of injection. No changes to laundry soap, body soap, or diet in last greater than a year. Took Benadryl, rash resolved in the morning.


VAERS ID: 1634850 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal faeces, Antiphospholipid antibodies, Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Computerised tomogram, Decreased appetite, Deep vein thrombosis, Fatigue, Haemorrhage, Headache, Intestinal ischaemia, Lethargy, Magnetic resonance imaging, Malaise, Mesenteric vein thrombosis, Platelet count, Platelet count decreased, Portal vein thrombosis, Post thrombotic syndrome, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Splenic vein thrombosis, Ultrasound scan, Vomiting, Weight decreased, X-ray
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypertension (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 99.2 F; Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 170/110 mmHg; Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 202108; Test Name: Antiphospholipid antibodies; Result Unstructured Data: Positive; Test Date: 20210803; Test Name: Platelet count; Result Unstructured Data: 37,000; Test Date: 20210813; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: The bowel lining was compromised by the blood clot and was sloughing.; Test Date: 20210816; Test Name: CT scan; Result Unstructured Data: Various locations of clots as per report; Comments: major clots in portal vein.; Test Date: 20210819; Test Name: Platelet count; Result Unstructured Data: 230,000; Test Name: X-ray; Result Unstructured Data: unspecified; Test Name: Diagnostic ultrasound; Result Unstructured Data: not reported.
CDC Split Type: USJNJFOC20210840439

Write-up: BILATERAL CLOTS IN THE LEFT AND PROXIMAL MAIN PORTAL VEIN/ MULTIPLE BILATERAL CLOTS IN THE LUNGS; CLOTS IN SPLENIC VEIN; BOWEL LINING COMPROMISED BY THE BLOOD CLOT; BLEEDING (SLOUGHING OFF); MULTIPLE DVTS RIGHT LEG; MULTIPLE BILATERAL CLOTS IN LUNGS/ BILATERAL PULMONARY EMBOLISM; SMALL CLOTS WITHIN THE SMV (SUPERIOR MESENTERIC VEIN); ABDOMINAL MESENTERIC ISCHEMIA; PLATELET COUNT DECREASED 37 000; POST THROMBOTIC SYNDROME; BLOOD PRESSURE INCREASED; WEIGHT LOSS (15 LBS); CHILLS/ SHAKING; VOMITING/THREW UP; LETHARGIC; FELT SICK; FEVER OF 99.2; SEVERE HEADACHE; EXTREMELY TIRED; APPETITE IMPAIRED (NEVER ATE, COULD NOT KEEP ANYTHING DOWN); This spontaneous report received from a consumer concerned a 54 year old, not Hispanic or Latino, white male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension. The patient was previously treated with lisinopril for hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 around 05:30 a:m, the patient experienced severe shaking/chills, felt terrible and sick, vomiting/threw up, lower back pain, fever of 99.2 F, blood pressure increased, lethargic, severe headache, appetite impaired (never ate, could not keep anything down), extremely tired, felt sick. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg. On 31-JUL-2021, the patient felt horrible and saw a teledoc. Teledoc said to get the antibodies done, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, Antiphospholipid antibodies (NR: not provided) Positive. On 03-AUG-2021, the patient experienced platelet count decreased 37000 unspecified units. On AUG-2021, the patient experienced post thrombotic syndrome. On 09-AUG-2021, the patient experienced abdominal mesenteric ischemia, multiple bilateral clots in lungs/ bilateral pulmonary embolism, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and for that visited emergency department, flank pain, dry heaves in ICU (Intensive Care Units). The patient was hospitalized. On 10-AUG-2021, the patient experienced multiple deep vein thrombosis right leg and bleeding (sloughing off). On 13-AUG-2021, the patient experienced bowel lining compromised by the blood clot. Would take 2-3 weeks to heal. Laboratory data included: Nuclear magnetic resonance imaging (NR: not provided) The bowel lining was compromised by the blood clot and was sloughing. On 16-AUG-2021, Laboratory data included: Computed tomography (CT) scan (NR: not provided) Various locations of clots as per report. His clots were still there but some had improved. On 17-AUG-2021, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On 19-AUG-2021, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count (NR: not provided) 230, 000 unspecified units. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) not reported, and X-ray (NR: not provided) unspecified. Other diagnostic data included PT and PTT. On 20-AUG-2021, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life. He was being followed by hematology. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from dry heaves in ICU, and chills/ shaking, and fever of 99.2 on 30-JUL-2021, was recovering from vomiting/threw up, feels terrible/felt horrible, lethargic, severe headache, flank pain, extremely tired, bowel lining compromised by the blood clot, small clots within the SMV (superior mesenteric vein), bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs, clots in splenic vein, multiple bilateral clots in lungs/ bilateral pulmonary embolism, severe abdominal pain, low back pain, blood pressure increased, and platelet count decreased 37000, had not recovered from appetite impaired (never ate, could not keep anything down), multiple DVTS right leg, and felt sick, and the outcome of weight loss (15 lbs.), bleeding (sloughing off), post thrombotic syndrome and abdominal mesenteric ischemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a consumer concerned a 54-year-old white man who experienced thrombocytopenia (day 11) and multiple sites of thrombosis in pulmonary, intra-abdominal, and peripheral sites (day 17) after vaccine. Medical history included hypertension treated with lisinopril. On day 7, the patient experienced severe shaking/chills, felt terrible and sick, vomiting, lower back pain, blood pressure increased, lethargic, severe headache, appetite, extremely tired. On day 8: COVID-19 virus test Negative, Antiphospholipid antibodies Positive. On day 11, platelets were 37,000. On day 17, the patient experienced abdominal mesenteric ischemia, multiple bilateral pulmonary emboli, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and was admitted to intensive care. On day 18, the patient experienced multiple deep vein thrombosis right leg and bleeding. On day 21, the patient experienced bowel lining compromised by the blood clot with sloughing. On day 22, CT scan confirmed many clots. On day 23, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On day 24, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count improved to 230,000. On day 25, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life and he was being followed by hematology. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from-BC), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination. Additional information is requested.


VAERS ID: 1634881 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Muscle spasms, Nausea, Nightmare, Paranoia, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Comments: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210848955

Write-up: PARANOID THAT PATIENT HAD SARS SYNDROME; MUSCLE SPASMS IN FINGERS, TOES, AND BUTTOCKS; DISTURBING DREAMS AS IF PATIENT WAS IN A BARBER CHAIR AND SOMEONE WAS SPINNING PATIENT; SPINNING SENSATION DURING DREAMS AND WHEN AWAKE; FELT OFF/FELT LIKE HIT BY A TRUCK; FELT ILL; FEELING SUPER DUPER TIRED AND FATIGUE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced felt off/felt like hit by a truck. On 30-JUL-2021, the patient experienced felt ill. On 30-JUL-2021, the patient experienced feeling super duper tired and fatigue. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced headache. On 01-AUG-2021, the patient experienced disturbing dreams as if patient was in a barber chair and someone was spinning patient. On 01-AUG-2021, the patient experienced spinning sensation during dreams and when awake. On 08-AUG-2021, the patient experienced muscle spasms in fingers, toes, and buttocks. On an unspecified date, the patient experienced paranoid that patient had sars syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off/felt like hit by a truck, felt ill, feeling super duper tired and fatigue, fever, nausea, and headache, and disturbing dreams as if patient was in a barber chair and someone was spinning patient, spinning sensation during dreams and when awake, and muscle spasms in fingers, toes, and buttocks on AUG-2021, and the outcome of paranoid that patient had sars syndrome was not reported. This report was non-serious.


VAERS ID: 1636193 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-06-24
Onset:2021-07-30
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Anticoagulant therapy, Computerised tomogram abdomen abnormal, SARS-CoV-2 antibody test, SARS-CoV-2 test, Splenic infarction
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Nicotine abuse
Allergies: Latex
Diagnostic Lab Data: Second dose was on 7/22/21. Lot# 011D. Also at CVS Pharmacy 01320 Clinical history is a patient without any significant outside exposure (living at home with vaccinated girlfriend and vaccinated daughter and wearing masks outside at all times, no travel). Patient developed diffuse splenic infarcts. COVID PCR, SARS-CoV2 Ab IgM, IgG tests reactive on 8/9/21. COVID nucleocapsid test on 8/9/21 was negative. Diagnosis is vaccine induced splenic infarcts. CT Abdomen showed diffuse splenic infarcts.
CDC Split Type:

Write-up: Patient developed acute left upper quadrant severe abdominal pain several days after his second COVID-19 Moderna vaccine shot. Admitted 7/30/21 for CT Abdomen findings that showed diffuse splenic infarcts. Treated with parenteral blood thinner and transitioned to Eliquis (which he is on as of 8/26/21).


VAERS ID: 1636544 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-07-30
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest X-ray, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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

Write-up: Nausea, vomitting, weakness.


VAERS ID: 1636555 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-19
Onset:2021-07-30
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: SOB, Fever.


VAERS ID: 1636566 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Diarrhoea, Headache, Oropharyngeal pain, Pain, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Endometriosis, hypothyroid, migraine.
Allergies: Darvocet, Darvon, Demerol
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: Headache, diarrhea, body aches, sore throat.


VAERS ID: 1636594 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0067C1A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol. Pt contacted and no adverse reaction, pt states no problems


VAERS ID: 1636866 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0202 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Cough, Rash, Rhinorrhoea, Sinus congestion, Tonsillar hypertrophy
SMQs:, Anaphylactic reaction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZITHROMICINE TETIRIZINE ZENTEP MIRTAZAPINE COMPLETE MVW VITAMIN D3 GUANSACINE FLUTACAZONE OBUTEROL HYPERSALINE PUOMOZYNE FLOWVENT NORVITROPIN
Current Illness: CYSTIC FIBROSIS
Preexisting Conditions: poor weight gain gastro intestinal manifestations pulmonary manifestations pancreatic insufficiency eosinophioc politis feeding problems delay of gastric empyting feeding by gtube growth failure growth hormone deficiency gastostomy complications adhd
Allergies: SULFA MEDS
Diagnostic Lab Data: NONE
CDC Split Type: vsafe

Write-up: BODY RASH; SINUS CONGESTION; RUNNY NOSE; COUGH; SWOLLEN TONSILS.


VAERS ID: 1636932 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: 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:

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


VAERS ID: 1637129 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-10
Onset:2021-07-30
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025L20A / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abdominal pain upper, Blood thyroid stimulating hormone, Swelling, Thyroid mass, Ultrasound thyroid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Flu vaccine 2014, Age 45 years old, Dec 3, 2014 vaccine date
Other Medications: Kisqali 400mg Letrozole 2.5 mg
Current Illness: Breast Cancer Autoimmune Hepatitis
Preexisting Conditions: Breast cancer Autoimmune hepatitis
Allergies: No
Diagnostic Lab Data: TSH level-Aug 4 Thyroid Ultrasound-Aug 10
CDC Split Type:

Write-up: Severe epigastric pain-MD Visit GI referral Swollen thyroid nodule requiring MD visit, TSH blood level drawn, Thyroid ultrasound; resulted in grade 2 nodule requiring monitoring and yearly ultrasound


VAERS ID: 1637174 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-02-20
Onset:2021-07-30
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Diplopia, Magnetic resonance imaging head normal, Ophthalmological examination normal
SMQs:, Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Atorvastatin, Acetamide.
Current Illness:
Preexisting Conditions:
Allergies: Sulfa drugs, Latex, Seasonal allergies, Cats
Diagnostic Lab Data: eye exams, MRI scans
CDC Split Type: vsafe

Write-up: I am struggling with double vision, currently my eye exam, went to two doctors for second opinion. My retina, optical nerve is healthy. All MRI scans performed are unremarkable. I will see a eye specialist on Monday 08-30-2021. I have been struggling with double vision for the past 4 weeks. I have not recovered from the double vision.


VAERS ID: 1637238 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-06
Onset:2021-07-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 UN / UN

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

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

Write-up: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.


VAERS ID: 1637852 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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? 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: Numbness throughout arm that was injected. Pt explained that it only lasted a couple of hours.


VAERS ID: 1638435 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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

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

Write-up: ~18 hours of intermittent chills, fever as high as 102.5 degrees, very low energy, aches, difficulty sleeping. I took ~6 tylenol throughout the day which seemed to help for short bursts. My energy started coming back after ~18 hours but I didn''t feel back to 100% for at least a few days.


VAERS ID: 1638444 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal Oral Contraceptive (June?s 1/20); Elderberry
Current Illness: None known.
Preexisting Conditions: None known
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 12 hours after the vaccine at night. Fatigue came first and then the body aches and chills. The chills caused severe shivering that hurt and felt as if I had a high temperature when that was not true. I took a 1-2 500mg Tylenol every 4-6 hours. My temperature when chills were so bad was taken even when I had not taken any medication and did not reach a dangerously high level. Tylenol seemed to have little effect on the shakes and muscle aches. I weigh 100 pounds. A 1000mg of Tylenol usually works. Temperature was taken through the night about 3 hour intervals and did not reach above 100.1 F. However the chills and shakes were rough and lasted only about another 12 hours. Throughout the next day I felt severe fatigue as if I?ve had high fever but the fever has subsided within the same time period as the chills. That night (a little after 24 hours) I sweated enough to drench the sheets at night time. By around 32-36 hours after the vaccine I felt better maybe still a little tired. I wanted to report this symptoms because I had a tetnus booster 16 days prior to the vaccine. I wanted to not make an assumption but an observation that the chills cause such shivers that my muscles felt almost as if they were becoming fatigued from being tense for so long. Similar to how tetnus resides. Just an observation and to report as a good cause and effect. I have since a month later going to get my second vaccine soon have not yet seen any other adverse reaction.


VAERS ID: 1640972 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Amniotic fluid index decreased, Autopsy, Delivery, Exposure during pregnancy, Foetal death, Foetal growth restriction, Foetal heart rate abnormal, Induced labour, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal, DHA/omega, Vitamin D, zinc
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 8/5/21: Ultrasound showing the baby was measuring 17w2d but should have been at 18w1d, low amniotic fluid around the baby 8/7/21: Ultrasound showed the baby no longer had a heartbeat; followup ultrasound at hospital confirmed fetal demise 8/8/21: Delivered baby; autopsy showed no abnormal structural issues
CDC Split Type:

Write-up: I was 17 weeks and 2 days pregnant (from an IVF cycle with a donor egg) the day I received the vaccine. My baby stopped growing the same day I received the vaccine - (subsequent ultrasounds showed no growth beyond 17 weeks and 2 days. The baby''s heartbeat stopped sometime around one week after the vaccine. I had to get induced on Saturday August 7th and delivered the baby on Sunday August 8th. The reason listed on the autopsy is fetal demise.


VAERS ID: 1641376 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / N/A LA / IM

Administered by: Other       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: None reported
Current Illness: None reported
Preexisting Conditions: Kidney and liver transplant in year 2020
Allergies: None reported
Diagnostic Lab Data: none
CDC Split Type:

Write-up: At approximately 1420, Lead Nurse that patient had an appointment for a 2nd dose Moderna. Patient''s database record showed he received a complete series of Pfizer Covid Vaccine at Pharmacy and a single dose of Moderna Covid Vaccine (LOT# 037C21A, exp. 8/22/21) at the Vaccine POD on 7/30/2021. RN spoke with patient. Patient confirmed he received the completed series of the Pfizer Covid Vaccine. Patient also confirmed he received a single dose of the Moderna Covid Vaccine and scheduled that appointment as a 1st dose. Patient reported he had organ transplants in 2020 and had a Covid antibody test which showed no Covid antibodies. Patient''s PCP recommended he receive a complete series of the Moderna Covid Vaccine. Lead Nurse elevated situation to Leads. Lead Nurse educated patient on interim clinical considerations regarding additional doses, to follow up with PCP, and to sign up on v-safe. Patient verbalized understanding. Patient did not receive a 2nd dose of Moderna. At approximately 1455, patient left facility with unlabored respirations and steady gait.


VAERS ID: 1641378 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Arthralgia, Dysgeusia, Hypoaesthesia oral, Incomplete course of vaccination, Oral pruritus, Paraesthesia, Pruritus, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Two hours after shot: tingling in extremities, itching around face and neck, numbness and swelling in the tongue, itching on roof of the mouth, and a metallic taste. I also developed pain in my left shoulder which is still there after a month of receiving the shot. I called the pharmacy and they documented my symptoms and told me I was having an anaphylactic reaction and if I had any breathing issues to call emergency number. I was instructed not to get the second shot. Although my reaction was unpleasant and concerning, I was not having difficulties breathing and did not feel like I was in need of medical attention. I took some Benedryl which alleviated the itching. Tingling and numbness of my extremities and tongue lasted about 5 days. The metallic taste in my mouth lasted about two weeks. I still have pain in my shoulder.


VAERS ID: 1641379 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-19
Onset:2021-07-30
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 - / -

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient tested positive for COVID-19 and was hospitalized. Patient is fully vaccinated.


VAERS ID: 1641446 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 007D21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Incomplete course of vaccination, Peripheral swelling, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (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: Rosuvastatin Calcium, Vitamins C & D3; Zinc, Melatonin & Gaba Quercetin; occasional Advil and Ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: Super sensitive to most medications - no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: I experienced hives/swelling/redness with white spots on both hands, the fingers of both hands, both wrists and up both arms below the elbow about 2 hours after injection. I spoke with a triage nurse by phone who advised me to take 2 Benadryl and 2 Ibuprofen immediately to be followed by additional 1-pill doses as needed. My primary physician''s nurse practitioner subsequently diagnosed the condition as urticaria after reviewing the record entered by the triage nurse. I was advised to forego the second Moderna vaccine but obtain the Janssen vaccine after four weeks. I continue to experience the symptoms which are aggravated by heat. I met with a colleague of my primary care physician on August 24, 2021, who advised me to wait until the symptoms I am experiencing resolved, i.e., 2-3 months, before obtaining a second vaccine other than Moderna or Pfizer-BioNTech, specifically recommending consideration of the new vaccine to obtain approval for use.


VAERS ID: 1644348 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAZODONE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Fever ranges from 101 to 103 degrees F
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Had a little cough; Fever ranges from 101 to 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included TRAZODONE for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F). At the time of the report, COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101 to 103 degrees f (High) Fever ranges from 101 to 103 degrees F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information contain correction of spelling in patient first name.


VAERS ID: 1644361 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Neck pain, Nervousness, Odynophagia, Oropharyngeal blistering, Oropharyngeal pain, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: became nervous and went to the emergency room on Sunday in which they sent her home; Has blisters in back of throat; Neck is "so sore and swollen"; Neck is swollen; Throat is so sore it hurts to swallow; Throat is so sore it hurts to swallow; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Has blisters in back of throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced OROPHARYNGEAL BLISTERING (Has blisters in back of throat) (seriousness criterion medically significant), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow) and ODYNOPHAGIA (Throat is so sore it hurts to swallow). On 01-Aug-2021, the patient experienced NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL BLISTERING (Has blisters in back of throat), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow), ODYNOPHAGIA (Throat is so sore it hurts to swallow) and NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, COVID-19: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional treatment included a salt water gargle. Concomitant medication use included prescribed medications and supplements for which details were not provided. On 01-Aug-2021, the patient went to the emergency room and took a Strep throat test which came negative and patient was sent home. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-273688 (Patient Link).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1644724 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Headache, Myalgia, Paraesthesia, Pruritus, Rash, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID-19 (I was diagnosed Covid-19 positive about 60-70 days ago.); Fever; Joint pain
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Diagnosed Covid-19 positive about 60-70 days ago
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: headache; It''s glowing red, & has a streak on each side.; massive rash on the under side of both arms; severe itching; felt like a thousand needle pricks on my arms; sore arm; headache; Injection site "itched"; It was red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It''s glowing red, & has a streak on each side.) and RASH (massive rash on the under side of both arms) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 (I was diagnosed Covid-19 positive about 60-70 days ago.) on 11-Aug-2021, Fever on 11-Aug-2021 and Joint pain on 11-Aug-2021. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site "itched") and VACCINATION SITE ERYTHEMA (It was red around the injection site). On 31-Jul-2021, the patient experienced MYALGIA (sore arm) and the first episode of HEADACHE (headache). On 08-Aug-2021, the patient experienced ERYTHEMA (It''s glowing red, & has a streak on each side.) (seriousness criterion medically significant), RASH (massive rash on the under side of both arms) (seriousness criterion medically significant), PRURITUS (severe itching) and PARAESTHESIA (felt like a thousand needle pricks on my arms). On 11-Aug-2021, the patient experienced the second episode of HEADACHE (headache). The patient was treated with TRIAMCINOLONE (topical) at a dose of .5 percent twice a day and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (It''s glowing red, & has a streak on each side.), RASH (massive rash on the under side of both arms), PRURITUS (severe itching), PARAESTHESIA (felt like a thousand needle pricks on my arms), VACCINATION SITE PRURITUS (Injection site "itched"), VACCINATION SITE ERYTHEMA (It was red around the injection site) and MYALGIA (sore arm) outcome was unknown and last episode of HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Diagnosed Covid-19 positive about 60-70 days ago. 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. Patient stated that he was also instructed to take over the counter antihistamines for few days. He took 2 a day for 2 days then stopped, because it was not therapeutic. It has been reported that the patient has tried cold compresses and ice. But it only provided short relief. No concomitant medication details was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up received by safety 11-Aug-2021 contained no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1644772 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007D21A / 1 RA / OT

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

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

Write-up: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included ROSUVASTATIN and VITAMINS NOS for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was reported. The patient had an appointment on the 24th with PCP, to discuss the recommendation she was given to take J&J''s vaccine as a second dose. She was hesitant of taking it while still having symptoms.


VAERS ID: 1645079 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Eye pruritus, Headache, Paranasal sinus discomfort, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hashimoto''s disease; Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Fever; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Fever; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Fever for 2 weeks
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: itchy eyes; sinus pressure; itchy ears; Also experienced headache; 3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto''s disease and Immunocompromised. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks). On an unknown date, the patient experienced EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears) and HEADACHE (Also experienced headache). At the time of the report, EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101f (High) Fever. On 01-Aug-2021, Body temperature: 101f (High) Fever. In August 2021, Body temperature: 99.4f-99.6f (High) Fever for 2 weeks. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment information not reported.


VAERS ID: 1645939 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066D21A / 1 LA / IM

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

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

Write-up: Site: Pain at Injection Site-Mild


VAERS ID: 1645985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-30
   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 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, Vaccination site pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100974983

Write-up: pain; lymph nodes popping out under her left armpit and side of her left breast; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 14:35 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 03:00 the patient experienced pain, lymph nodes popping out under her left armpit and side of her left breast, injection site pain. Reporter, female, aged 63, received first dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 29Jul2021 at 2:35pm-2:40pm. This morning on 30Jul2021 around 3am she woke up with pain and noticed lymph nodes popping out under her left armpit and side of her left breast. She says the lumps her real bad. She received the shot on the right side but has no pain on the right side, just injection site pain if she presses on it but nothing severe. While on the phone she noticed she has a swollen one on her neck as well. Is this a side effect of the vaccine. Question: She has an upcoming biopsy bladder surgery on Wednesday, is it still okay to do. Outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1645995 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-29
Onset:2021-07-30
   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 EW0186 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; LIPITOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cholesterol; Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100975639

Write-up: heart is racing; This is a spontaneous report from a contactable consumer, the patient. A 64- year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 29Jul2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, anxiety and menopause. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and atorvastatin calcium (LIPITOR); all for unknown indication on unknown date, unknown if ongoing. Patient did not know of any allergies to food, medication or other products. On 30Jul2021 at 06:30, the patient experienced heart racing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event heart racing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart racing was not recovered at the time of this report.


VAERS ID: 1646032 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EYO584 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fatigue, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LYRICA; PROZAC; SEROQUEL; OMEPRAZOL; SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia; Anxiety; Dissociative identity disorder (DiD disorder); Esophageal acid reflux (acid reflux); Grass allergy (known allergies to spring grasses); Guillain Barre syndrome (Guillain-Barr?); Hypothyroidism; Pollen allergy (Known allergies to pollen); Post-traumatic stress disorder (PTSD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100976528

Write-up: Little bit of dizziness; Feeling pretty fatigued; Muscles were sore and aching; Left arm was fairly sore at injection spot; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EYO584) via an unspecified route of administration in the left arm on 30Jul2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome, hypothyroidism, alopecia, esophageal acid reflux (acid reflux), anxiety, PTSD (post-traumatic stress disorder), DiD (dissociative identity disorder). The patient had known allergies to pollen and grass (spring grasses). Concomitant medications included pregabalin (LYRICA), fluoxetine hydrochloride (PROZAC), quetiapine fumarate (SEROQUEL), omeprazole (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) from an unknown dates, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Jul2021 at 13:30, the patient left arm was fairly sore at injection spot. After a little over 24 hours, on 31Jul2021, the patient felt pretty fatigued, muscles were sore, aching and experienced little bit of dizziness. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm was fairly sore at injection spot, little bit of dizziness, pretty fatigued and muscles were sore and aching was not resolved at the time of this report.


VAERS ID: 1646035 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
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: Pain in extremity
SMQs:, 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: LEVOTHYROXINE; LEXAPRO; DEPO PROVERA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100976537

Write-up: Soreness in left arm where vaccine was given.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and hypothyroidism. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) "5 mg/10 mg"; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination which included medroxyprogesterone acetate (DEPO PROVERA) in the left arm on 09Jul2021. On 30Jul2021 at 17:30, the patient experienced soreness in left arm where vaccine was given. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in left arm where vaccine was given was resolving at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1646038 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Private       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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; GABAPENTINA; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100976562

Write-up: lost feeling in right leg with no feeling whatsoever in right foot; numbness in right arm cannot hold on to items; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jul2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes since an unspecified date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin glargine (LANTUS), gabapentin (GABAPENTINA) and tramadol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 04:00, the patient lost feeling in right leg with no feeling whatsoever in right foot, also numbness in right arm could not hold on to items. Therapeutic measures were not taken as a result of adverse event. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost feeling in right leg with no feeling whatsoever in right foot also numbness in right arm could not hold on to items was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1646045 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-29
Onset:2021-07-30
   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 EW0164 / 2 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Carpal tunnel syndrome, Hallucination, Limb discomfort, Pain in extremity, Skin discolouration
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (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: Seasonal allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100976584

Write-up: Hallucinations; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My arm hurt extremely bad; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) administered on the left arm on 29Jul2021 (15:00) as dose 2 single, with route of administration unspecified, for COVID-19 immunization at the public health department. Medical history included seasonal allergies. The patient''s concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber: ER8733; Expiration date was not reported) on 01Jul2021 (11:15) (at the age of 39 years old) on the right arm for COVID-19 immunization. On 30Jul2021 (21:30), the patient had hallucinations (to the point where she had almost caused harm to her child); left arm had felt like it had carpel tunnel and it looked purple/blue in color; and arm hurt extremely bad. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646050 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; SYNTHROID; POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: ECG; Result Unstructured Data: Test Result:indicated multiple events
CDC Split Type: USPFIZER INC202100977509

Write-up: 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness; Heart arrhythmia issues slowly subsided; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Jul2021 11:15 (Lot Number: EW0153) as dose number unknown, single (at 59 years old) for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine; levothyroxine sodium (SYNTHROID); potassium, all taken for an unspecified indication, start and stop date were not reported. The patient experienced 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness on 30Jul2021 12:00 PM with outcome of unknown, heart arrhythmia issues slowly subsided on 30Jul2021 12:00 PM with outcome of recovering. The clinical course was reported as follows: 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness. ECG indicated multiple events. Went to ER the next day. Admitted to hospital with multiple tests. Heart arrhythmia issues slowly subsided. No treatment required. The patient was hospitalized for the events for 1 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646076 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
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: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Dizziness, General physical health deterioration, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (known allergies: Sulfur); Latex allergy (known allergies: Latex); Penicillin allergy (known allergies: Penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100979369

Write-up: Light headed immediately afterwards; Loss of body function; Disoriented; Sleepy; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfur and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. On 30Jul2021 at 16:30, the patient felt light headed immediately afterwards. She also experienced loss of body function, felt disoriented and sleepy. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headed immediately afterwards, loss of body function, disoriented and sleepy were resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1646077 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Antibody; Result Unstructured Data: Test Result:UNKNOWN RESULTS
CDC Split Type: USPFIZER INC202100979438

Write-up: Injection site pain immediately after receiving vaccine; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration on 30Jul2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021, immediately after receiving the vaccine, the patient experienced injection site pain. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent antibody test and the result was unknown. The clinical outcome of the event injection site pain was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646083 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100979977

Write-up: facial swelling on the left side of the face; facial swelling on the left side of the face; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication and birth control (MANUFACTURER UNKNOWN) both from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 05:00 the patient experienced facial and lip swelling on the left side of the face. It was reported that the patient had filler on both the left and right side of the face but only the left side was swollen. Therapeutic measures were not taken as a result of the events. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial and lip swelling on the left side of the face was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646084 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
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: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100980138

Write-up: Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 30Jul2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had no allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 21:00, the patient experienced fever, chills and body ache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit or emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events, fever, chills and body ache was recovering at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1646091 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
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: Unknown       Purchased by: ?
Symptoms: Blood test, Chills, Investigation, Loss of consciousness, Pain, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood tests; Result Unstructured Data: Test Result:nothing has come up; Test Date: 20210731; Test Name: test for everything, infections and everything they can find; Result Unstructured Data: Test Result:can''t find anything
CDC Split Type: USPFIZER INC202100980739

Write-up: Loss of consciousness; Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient''s wife). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 30Sep2021), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were reported as none. The patient and his wife received the COVID-19 Pfizer vaccine last Friday, 23Jul2021, and it was reported that the patient was currently in the hospital due to loss of consciousness, fever, chills, and body aches which started on 30Jul2021. The patient was hospitalized from 31Jul2021. They have tested the patient for everything in the hospital on 31Jul2021, infections and everything they could find, but still couldn''t find anything. They''ve ran multiple blood tests, and nothing came up. When asked for the lot number, the reported stated that it''s 026569, it''s either P or F, and then A, 7484. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1646129 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   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: COVID-19, Dyspnoea, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic (she had first asthma attack and end up in hospital at age 4)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: pulse oximeter; Result Unstructured Data: Test Result:84 to 86 %; Comments: oxygen levels; Test Date: 20210801; Test Name: PCR COVID test; Test Result: Positive ; Test Date: 20210730; Test Name: Rapid COVID test; Test Result: Positive
CDC Split Type: USPFIZER INC202100985602

Write-up: diagnosed with COVID-19; shortness of breath; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for Patient (Reporter''s daughter). A 16-year-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Deltoid Left, on 29Jul2021 at 11:00 (age at vaccination: 16 years), as a single dose for COVID-19 immunization. The patient''s medical history included ongoing asthmatic (she had first asthma attack and end up in hospital at age 4). Concomitant medications were not reported. The reporter called on behalf of her daughter (patient) who received the COVID-19 Vaccine Thursday 29Jul2021. The next day, on 30Jul2021, after patient received the vaccine, the patient started having shortness of breath and her mother, ICU nurse, took her to the ER where she was diagnosed with COVID-19. The patient was hospitalized on an unspecified date. She had put the pulse oximeter on and oxygen level was 84 to 86%. The patient''s lungs and there were no crackles. The patient was taking shallow breaths. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. The reporter had questions regarding her 2nd dose of the vaccination and if the series will have to be restarted. Caller stated that when she was caring for patients in the ICU they were advising them at discharge to wait 6-8 weeks to get the vaccine after having COVID related illness/hospitalizations. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS- CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. While there was no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection was low in the months after initial infection but may increase with time due to waning immunity. Advised the caller that this document did not advise to restart the vaccination series but to wait until after isolation period and recovered from acute illness as noted above with no "designated minimal time interval." The patient underwent lab tests and procedures which included oxygen saturation: 84 to 86 % on 30Jul2021 oxygen levels, sars-cov-2 test: positive on 01Aug2021, sars-cov-2 test: positive on 30Jul2021. Outcome of the event shortness of breath was recovered on an unspecified date in 2021 and for another event, it was unknown. There was a Product Complaint and description of complaint included Caller''s daughter received first COVID19 Vaccine dose on Thursday. The next day she started having shortness of breath. Caller took her daughter to the hospital and she tested positive for COVID. The reason caller took her daughter to get tested is because her daughter is a severe asthmatic and said she was having trouble breathing. She had put the pulse oximeter on and oxygen level was 84 to 86%. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. COVID19 Vaccine: the writing is a little bad on the card. The lot number is FAY485 or FAYU85. It was first dose. Product strength and count size dispensed: unknown Additional lot numbers: n/a Is a sample of the product available to be returned, if requested (Y/N): Not Provided Packaging sealed and intact? Not Provided; Sender''s Comments: As there is limited information in the case provided, the causal association between the events covid-19 and dyspnea the suspect drug 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 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: 1646132 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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: METFORMIN; TRULICITY; JARDIANCE; PROTONIX [OMEPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100985633

Write-up: shortness of breath; chest tightness; hives; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0198), via an unspecified route of administration in left arm on 30Jul2021 at 14:15 (at the age of 54-years-old) at dose 1, single for COVID-19 immunisation. Medical history included diabetes type 2 and asthma. She has no history of COVID prior to vaccination. Concomitant medications included metformin, dulaglutide (TRULICITY), empagliflozin (JARDIANCE), and omeprazole (PROTONIX). The patient previously took lisinopril and IMITREX and experienced allergies to both. There were no other vaccines administered in four weeks. The vaccine was administered at a pharmacy or drug store. The patient was not tested for COVID post vaccination. On 30Jul2021 at 14:45, the patient experienced shortness of breath, chest tightness, and hives which required doctor or other healthcare professional office/clinic visit and treatment with steroids, BENADRYL, and ZYRTEC. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information in the case, the causal association between the events dyspnea, chest discomfort, urticaria 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 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: 1646172 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-03-12
Onset:2021-07-30
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction positive, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NADOLOL; VERAPAMIL HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Had positive PCR; Result Unstructured Data: Test Result:Positive; Test Date: 20210729; Test Name: SARS CoV2 RNA NAAT; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202100986522

Write-up: Became COVID symptomatic on 29Jul2021, Had positive PCR on 30Jul2021; Became COVID symptomatic on 29Jul2021, Had positive PCR on 30Jul2021; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6207) as dose 2, and first dose via an unspecified route of administration in left arm on 19Feb2021 (Batch/Lot Number: EN6207) as dose 1, single for COVID-19 immunization (at the age of 48-year-old). Medical history included hypertension. Concomitant medication(s) (in two weeks) included nadolol and verapamil hydrochloride taken for an unspecified indication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced became covid symptomatic on 29Jul2021, had positive pcr on 30Jul2021 (vaccination failure) (medically significant), nausea, congestion, fever, cough, malaise, headache on 29Jul2021. It was reported that patient received both vaccines. Became COVID symptomatic on 29Jul2021, Had positive PCR on 30Jul2021. Have had moderate symptoms, including congestion, fever, cough, malaise, headache, nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Hospitalization was not prolonged. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jul2021 Nasal Swab, SARS CoV2 RNA NAAT. Patient received symptomatic COVID treatment for the events. The outcome of the events was recovering at the time of last observation.; Sender''s Comments: Based on the information currently available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.


VAERS ID: 1646180 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hypersensitivity, Hypertension, Pruritus, Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Diagnosed at birth)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Temperature of 99; Result Unstructured Data: Test Result: 99.
CDC Split Type: USPFIZER INC202100986859

Write-up: This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot Number: EW0198), via an unspecified route of administration on 30Jul2021 (at the age of 21-years-old) at around 5-6:00pm administered in Arm Left on 30Jul2021 as a single dose for COVID-19 immunisation at pharmacy. Medical history included ongoing asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient adverse event was reported as none. The patient''s family medical history reported as none. On 30Jul2021, the patient experienced Severe allergy reactions, Began itching all over her body, Red rashes, Welts, Had high blood pressure, Temperature of 99, Shortness of breath. She is calling about the Pfizer Covid19 vaccine and states she wanted to report her side effects of the severe allergic reaction she had after she got the vaccine 1st dose on Friday 30Jul2021 and had the severe reaction later on the same day. Caller states she has the 1st dose of the Pfizer COVID19 vaccine on 30Jul2021 and began itching all over her body with red rashes and welts and everything and had high blood pressure, a temperature of 99, and shortness of breath. Caller states she also has asthma which later in the call states was diagnosed at birth. States her symptoms began around 8:00pm and from the Clinic she was rushed to the emergency room. States her paperwork says she got the first shot of Benadryl at 9:16pm that day and they immediately gave her the Benadryl shot in the clinic and the Benadryl shot did not work for her so they then rushed her to the emergency room;. States she has no lot, expiry date or NDC number to provide for the Benadryl shot from her paperwork but it says the Benadryl was given intramuscularly 25mg. States she got the Pfizer COVID19 vaccine around 5-6:00pm on 30Jul2021. Caller states for her reported symptoms as of right now they are minimal and she has the itching and was put on a few medications to help with breathing and itching and everything else and everything is minimal regarding the reported events at this time and they are not severe. States she was prescribed an Epipen to take with her everywhere and was told she could relapse and have an allergic reaction because of this but she has not used the Epipen yet and is at the pharmacy to get it but has not picked it up yet. She was given Prednisone 20mg and is taking three tablets of that per day and is not sure of the Epipen dosage and also takes Banophen 25mg and is taking one per day as needed by mouth. States she is taking Famotidine 20mg and takes two of those every day by mouth one in the morning and one at night. States for the Epipen, Famotidine, Banophen, and Prednisone she has no lots, expiry dates or NDC numbers to provide as she only has her paperwork with her at this time. Caller states the reported symptoms are ongoing and improved a minimal amount and she is still itching. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0 in it, but states it is EW0198 and states the expiry date and NDC are not written on the card. She does have severe allergy reactions and told the facility this and they said it was ok to get the Pfizer COVID19 vaccine and and they told her they had not seen anything like that reported and only had people fainting and that was it. No further details provided by the caller. States after the first shot of Benadryl given at the clinic which did not work, she was rushed to the emergency room and they had to give her an IV and gave her some more Benadryl by IV and Famotidine by IV and Pepcid by IV and they gave her a third one by IV which was Methylprednisolone. States she has no lots, dosages, NDC numbers or expiry dates to provide for the Benadryl, Famotidine, Pepcid, or Methylprednisolone. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0 in it, but states it is EW0198 and states the expiry date and NDC are not written on the card. Vaccine Supplemental Form completed in additional context. Caller states she is calling about the Pfizer Covid19 vaccine and states she wanted to report her side effects. States her paperwork says she got the first shot of Benadryl at 9:16pm that day and they immediately gave her the Benadryl shot in the clinic and the Benadryl shot did not work for her so they then rushed her to the emergency room. States she has no lot, expiry date or NDC number to provide for the Benadryl shot from her paperwork but it says the Benadryl was given intramuscularly 25mg. Caller states she was given Prednisone 20mg and is taking three tablets of that per day and is not sure of the Epipen dosage and also takes Banophen 25mg and is taking one per day as needed by mouth; states she is taking Famotidine 20mg and takes two of those every day by mouth one in the morning and one at night. States for the Epipen, Famotidine, Banophen, and Prednisone she has no lots, expiry dates or NDC numbers to provide as she only has her paperwork with her at this time. Caller states the reported symptoms are ongoing and improved a minimal amount and she is still itching. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0, but states it is EW0198 and states the expiry date and NDC are not written on the card. States after the first shot of Benadryl given at the clinic which did not work, she was rushed to the emergency room, and they had to give her an IV and gave her some more Benadryl by IV, Famotidine by IV, and Pepcid by IV and they gave her a third one by IV which was Methylprednisolone. States she has no lots, dosages, NDC numbers or expiry dates to provide for the Benadryl, Famotidine, Pepcid or Methylprednisolone. The adverse events resulted in Physician Office and Emergency Room visit. The outcome of the events was recovering.


VAERS ID: 1646229 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
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: Eye infection, Eye pain, Eye swelling, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis (diagnosed at age 14 months)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100992535

Write-up: eyes; infection; rash around her eyes with severe pain/rash on the bottom of her eye up to the top and side of her eyes/on her face and skin and not on the inside of her eyes but on the outer area; rash around her eyes with severe pain; put an ice pack on her eyes and they started to swell; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 27Jul2021 (about 4:40 to 4:45 pm) (batch/lot number and expiry date unknown) at 27 years of age as dose 1, single for covid-19 immunization administered in a pharmacy and not in a military facility. Medical history included ongoing rheumatoid arthritis diagnosed at age 14 months. There were no concomitant medications. The patient previously took Enbrel 50 mg once per week by injection that began taking many years ago. The patient did not receive prior vaccinations within 4 weeks. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient informed that she received the first dose of the Pfizer Biontech COVID19 vaccine on 27Jul2021 and on the following Friday morning (30Jul2021), she woke up with a rash around her eyes with severe pain. The patient informed that she put an ice pack on her eyes and they started to swell and she still has the rash on the bottom of her eye up to the top and side of her eyes and the pain went away because she had the ice pack on it. The patient informed that she already went to the doctor and gave her an antibiotic but was not working and that it was no help. It was still on her face and skin and not on the inside of her eyes but on the outer area. The patient informed that she went to the an HCP to make sure she was not getting pink eye because she has a newborn and was told it was not pink eye and it was not getting better. The patient informed that her HCP did not know what this was, and she got the Pfizer Covid vaccine and then started having this problem. The patient informed that she went to the (redacted) clinic and the HCP did not know what was wrong and gave her a medication doxycycline that did not work for the infection and it was 100 mg and she was taking one capsule by mouth every 12 hours and just started taking it yesterday and took the next dose this morning at 9:00 am but will not continue the doxycycline because it made her sick and she left work early and was vomiting and felt dizzy and lightheaded overnight and her eye was darker than when she put the ice pack on, and the redness and inflammation had gone away since then and she went to sleep. The patient informed that she had not done anything and had not itched her eyes and her eye was back to being severe red and purple like a black eye and the rash was getting worse. The patient informed that prior to receiving the vaccine, she never had issues with her eyes like no itching, no discoloration of the eyes, no swelling and no rashes around her eyes. The patient informed that she had not had something like this before and had not had prior issues with her eyes prior to the Pfizer COVID Vaccine and was feeling fine and went to sleep and woke up with her eyes like this and it was now Tuesday and her eye was still in the same position and nothing was working. The patient informed that she did go back to (pharmacy name) where she had the Pfizer Covid vaccine and the pharmacist told her to give Pfizer a call; states her reported symptoms started on the morning of 30Jul2021 and the symptoms were still that way and are the same as when they began. The patient informed that the events did not require emergency room visit, and physician office was yes. The outcome of the events was not recovered. The patient wanted to know if there is information about her side effect and its association with the vaccine. The patient was calling to ask for any information related to her symptoms and the Pfizer COVID vaccine. The lot number for bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1646265 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-05-04
Onset:2021-07-30
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 LA / OT

Administered by: Work       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? 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: 20210730; Test Name: Covid-19; Test Result: Positive.
CDC Split Type: USPFIZER INC202100993088

Write-up: Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable other healthcare professional (nurse). A 33-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021), via intramuscular route, administered in Left arm on 04May2021 at 06:30 as dose 2, single (at the age of 32 years) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021) via intramuscular, administered in Left arm on an unspecified date in Apr2021 at 06:30 as dose 1, single (at the age of 32 years), for covid-19 immunization, at clinic. Relevant medical history, concurrent conditions and relevant past drug history was unknown. It was unknown if the patient had received any other medications within 2 weeks of vaccination (concomitant medications unknown). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that, on 30Jul2021, the patient was positive for Covid-19. The event was reported as non-serious. The event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no hospitalization. No treatment was received. The outcome of the event covid-19 was recovering at the time of report. Product complaint investigation conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646339 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-29
Onset:2021-07-30
   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: Dizziness, Headache, Hypoaesthesia, Migraine, Movement disorder, Night sweats, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (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: Test Date: 20210802; Test Name: Covid-19 test Nasal Swab; Test Result: Negative.
CDC Split Type: USPFIZER INC202100995270

Write-up: fainted as I was walking to my daughters room; I cannot move around quickly without getting dizzy.; I cannot move around quickly without getting dizzy.; woke up in the middle of the night in a terrible sweat; headache; Felt a massive migraine; I later felt numbness in both of my calves down to my toes; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Jul2021 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. No other medical history reported. Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were reported as none. The patient received the first dose on 29Jul2021. She felt a massive migraine on 30Jul2021. She later felt numbness in both of her calves down to her toes. On 31Jul2021, she still had a migraine and then she woke up in the middle of the night in a terrible sweat worst she''d ever experienced. The patient then woke up on 01Aug2021 and fainted as she was walking to her daughter''s room. On 01Aug2021, she cannot move around quickly without getting dizzy. She still has calf numbness and a headache which started on 30Jul2021. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent Covid-19 test nasal swab: negative on 02Aug2021. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646405 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-10
Onset:2021-07-30
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Body temperature, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOXYL; PROGESTERONE; ESTROGEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Fever; Result Unstructured Data: Test Result: 100.3; Test Date: 20210803; Test Name: Covid test (PCR); Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: USPFIZER INC202100999219

Write-up: This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 10Feb2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 2, single and dose 1 via an unspecified route of administration, administered in arm left on 20Jan2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The patient medical history was not reported. Concomitant medications included LEVOXYL via oral route, progesterone via oral route and ESTROGEN patch via transdermal route. All taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated Although I had both doses of vaccine I still contracted COVID through a primary contact. Symptoms included (fever 100.3, chills, loss of taste, fatigue) and started on 30Jul2021. Covid test (PCR) confirmed positive on 03Aug2021. The events did not result in emergency room/ physician office visit. The patient underwent lab tests and procedures which included fever (body temperature): 100.3 on 30Jul2021 and Sars-Cov-2 test (Nasal Swab/ PCR): positive on 03Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Aug2021. Investigation report received from product quality complaints group. This report included that: Product-Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULA R 2ML MULTIPLE DOSE VIAL X 1, Lot: EL3248, Conclusion of Previously Completed: Investigation Conclusion. ID of Previously Completed. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. Consumer calling about the Pfizer COVID19 vaccine, and says that she got the injection twice, and each time she has gotten it and gotten tested after, each test is showing positive. She says the thing is, does Pfizer have information about this, because seems to be herd immunity. Caller does not clarify this last statement. She asks if anyone else has been reporting this. She clarifies that she goes to a nursing home and is tested every 14 days and all times prior to getting the vaccine doses she was negative. She says her first dose of the vaccine was on 26Dec2021, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She says as a medical worker she can wait 5 days after that for it to come up after being positive and after that if it is showing up negative she had to wait 24 hours to confirm negative test and pay again for the test within 24 hours, which was negative too. She says then the time next she got the shot on 16Jan2021 she went to go do the shot on this past Saturday, and then she went to go get tested and again it came back positive. Caller says that the information on the card is handwritten, NDC/EXP were not written on the card. She says the card says Pfizer COVID-19, and the first dose was on 26Dec2021 of LOT: EL5738 given in her right arm. She says that the second dose was 16Jan2021 of LOT EL3248 and it was given in her left arm. Caller says that the test she was given was the rapid test, a PCR test for COVID. Caller says that other than having positive tests for COVID she has had no symptoms. Product strength and count size dispensed: two doses. Additional lot numbers: EL3248. Is a sample of the product available to be returned, if requested, not provided. Packaging sealed and intact, not provided. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE EL3248 Lack Of Effect, Complaint Class: Product Use Attributes, Complaint Sub-Class: Lack Of Effect, (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE, BNT162B2, Product-Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Product-Type: RX, Product-Category: INJECTABLE, Sterile-Product: Yes. Medical-Device No. Lot#: EL3248. Batch-Expiry Year: 2021, Batch-Expiry Month: 04, Batch-Expiry Day: 30. Reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EL3248 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EL3248 pending review of lot genealogy. The investigation will include a review of the returned complaint sample and reserve samples, if necessary. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected. Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.


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