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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 306 out of 7,116

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VAERS ID: 1638914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction, Asthenia, Chest pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USJNJFOC20210849932

Write-up: BODY ACHES; CHEST PAIN; A LOT OF THINGS; WEAKNESS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced chest pain. On AUG-2021, the patient experienced a lot of things. On AUG-2021, the patient experienced weakness. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, weakness, body aches, chest pain and a lot of things was not reported. This report was non-serious.


VAERS ID: 1638921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210851544

Write-up: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.


VAERS ID: 1638944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness: Diabetes; Drug allergy; Swelling
Preexisting Conditions: Comments: Patient had problem with salt and swelling for which she uses diuretic.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210852943

Write-up: ITCHINESS; DIFFICULTY BREATHING; PAIN IN ARM AND LEG; HEADACHE; This spontaneous report received from a consumer concerned a 6 decade old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: drug allergy, diabetes, and swelling, and other pre-existing medical conditions included: Patient had problem with salt and swelling for which she uses diuretic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Concomitant medications included insulin for diabetes. On AUG-2021, the patient experienced itchiness. On AUG-2021, the patient experienced difficulty breathing. On AUG-2021, the patient experienced pain in arm and leg. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and leg, headache, itchiness and difficulty breathing was not reported. This report was non-serious.


VAERS ID: 1640944 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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 describes feeling like he has a "heavy chest and shortness of breath" three days after his first vaccine. Patient describes that is has continued on and off. Seen by provider, unremarkable exam, EKG ordered, patient encouraged to continue with vaccination series.


VAERS ID: 1640963 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Infection, Medical device removal, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine
Current Illness: Recovering from bilateral mastectomy.
Preexisting Conditions: Na
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling on opposite side, resulted in spreading of infection. Had to get the expander removed.


VAERS ID: 1641005 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Myalgia, Oedema peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Swollen painful underarm, muscle pains, fatigue


VAERS ID: 1641098 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Mobility decreased
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Pt. states that after receiving the 1st dose of Phizer 07/31/2021, started experiencing symptoms 08/01/2021 of dizziness, fatigued, pain in the left hip, difficulty moving left leg, and joint pain. Pains have increased since having the 1st dose, back pain consistent. No noted Primary visit. Still continuing to experience symptoms.


VAERS ID: 1641328 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: no
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm swollen, red, warm to touch and itchy


VAERS ID: 1641463 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dysgeusia, Fatigue, Pain, Palpitations
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: 1) Strong metal taste in mouth for several days. 2) Sore/Tired. 3) My heart was pounding so hard it made me light headed. This lasted for a few days.


VAERS ID: 1641513 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-23
Onset:2021-08-01
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN EL3246 / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Condition aggravated, Dyspnoea, Hypercapnia, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, metoprolol, formoterol, buspirone, lovastatin
Current Illness:
Preexisting Conditions: COPD, CVA, afib, chronic respiratory failure
Allergies: no known allergies
Diagnostic Lab Data: SARS COV2 Covid 19 PCR 08/01/2021, result positive
CDC Split Type:

Write-up: Admitted on 8/1/21. Received J&J vaccine on 1/23/21. Patient presents with SOB that started that morning. Diagnosed with acute respiratory failure with hypoxia and hypercapnea and COVID pneumonia. Treated with COVID protocol, steroids, antibiotics and remdesivir. Patient improved and was transferred to a rehab facility on 8/9/21.


VAERS ID: 1641571 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-01
Onset:2021-08-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Echocardiogram abnormal, Heart rate increased, Laboratory test, Pericarditis, Red blood cell sedimentation rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro
Current Illness: None known
Preexisting Conditions: Migraines, possible underlying rheumatologic issue vs celiac dz (has been seeing GI specialist, rheumatologist evaluation/impression was that she did NOT have inflammatory issue but she is having evaluation again). Depression hx.
Allergies: None
Diagnostic Lab Data: Echocardiogram August 2021 Lab work August 2021 shows elevated Sed Rate (52)--will be referred to rheumatologist to see if this is underlying rheumatologic issue vs secondary to other cause.
CDC Split Type:

Write-up: Patient with pericarditis finding on echocardiogram done in August. Unknown onset, pt had started wearing a watch and saw that her HR was elevated. She states she became aware of rapid HR and became worried about it when it was over 150 so went to ER, had normal initial work up, after eval here and cardiology referral the pericarditis was found, so onset time is unknown.


VAERS ID: 1641751 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-11
Onset:2021-08-01
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Haematuria, Lethargy, Mental status changes, Pyrexia, SARS-CoV-2 test positive, Urinary tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tubulointerstitial diseases (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? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 08/01/2021: Presented to ED via EMS due to altered mental status, fever, and lethargy x 2 days prior to admission. Patient tests positive for COVID, UTI with hematuria, with 89% 02 sat on room air. 08/02/2021: Patient mental status improvement. 08/03/2021: Patient had 94% O2 sat on room air after oxygen removal and was discharged.


VAERS ID: 1642270 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Menstrual disorder, Menstruation delayed
SMQs:, Fertility disorders (broad)

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

Write-up: Late/missed period


VAERS ID: 1642287 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

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

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

Write-up: PATIENT REPORTED HIVES STARTING SOON AFTER SHE LEFT FOLLOWING HER FIRST DOSE OF PFIZER COVID VACCINE


VAERS ID: 1642964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Negative (less than 1.00)
CDC Split Type: USJNJFOC20210849914

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient undergone laboratory test SARS-CoV-2 IgG (Immunoglobulin G) antibody (ARF COV-2 AB IGG SPIKE), semi quantitative which came negative (less than 1.00) (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190792.; Sender''s Comments: V0: 20210849914-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1642970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple sclerosis, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Optic nerve disorders (broad), Demyelination (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety; Depression; Hypersensation skin; Muscle spasms; Pain; Restless leg syndrome; Sleep disorder; Tremor; Vitamin D decreased
Preexisting Conditions: Medical History/Concurrent Conditions: Back surgery; Gallbladder operation; Knee operation; Lumbar discectomy; Post-traumatic stress disorder; Salpingectomy; Urinary urgency
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210851690

Write-up: UPTICK IN MULTIPLE SCLEROSIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included: knee surgery, back surgery, gall bladder surgery, lumbar (l5) discectomy, post traumatic stress disorder, fallopian tube removal, and bladder urgency, and concurrent conditions included: depression, anxiety, muscle spasms, tremors, restless leg syndrome, low vitamin D levels, pain, sleep issues, and tactile sensation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient was fully vaccinated but contracted covid and experienced suspected clinical vaccination failure and on an unspecified date, the patient experienced uptick in multiple sclerosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uptick in multiple sclerosis, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191183.; Sender''s Comments: V0: 20210851690-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210851690-Covid-19 vaccine ad26.cov2.s-Uptick in multiple sclerosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1642997 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Headache, Insomnia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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: Abstains from alcohol; Migraine; Non-smoker; Ulcer
Preexisting Conditions: Comments: Patient has no drug abuse or illicit drug use and have no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210854959

Write-up: NOT ABLE TO SLEEP ALL NIGHT; FELT LIKE RUN OVER BY A TRUCK; TEMPERATURE, BURNING UP; BAD HEADACHE; This spontaneous report received from a parent concerned a 48 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: migraines, ulcer, non smoker, and non alcohol, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug use and have no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like run over by a truck. On AUG-2021, the patient experienced temperature, burning up. On AUG-2021, the patient experienced bad headache. On 25-AUG-2021, the patient experienced not able to sleep all night. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine was not applicable. The outcome of the not able to sleep all night, temperature, burning up, bad headache and felt like run over by a truck was not reported. This report was non-serious.


VAERS ID: 1643004 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210855201

Write-up: ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 76 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 allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 26-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854749 and 20210855614.


VAERS ID: 1644338 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007C21A / 1 LA / OT

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

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

Write-up: Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021 at 4:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by the reporter. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Patient demographics and anatomical location updated.


VAERS ID: 1644339 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / OT

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

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

Write-up: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It is reported that 1 Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01 PM on 31-JUL-2021. Patient received his second dose of Moderna COVID-19 Vaccine from a vial that was expired (21 hours and 20 minutes at 67.2 Fahrenheit steady temperature). No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-273129, MOD-2021-273149, MOD-2021-273286, MOD-2021-273448, MOD-2021-273721 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up document received and patient race, ethnicity and patient anatomical location of second dose is updated.


VAERS ID: 1644362 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / OT

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

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

Write-up: Expired Vaccine administered to patient; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error). On 01-Aug-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported No treatment medication was reported. Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2 degree Fahrenheit) beyond 12 hours. The vial was first punctured at 01:01 PM on 31-Jul-2021 and that was when it was first moved to the room temperature. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: significant follow up received on 12-Aug-2021 included updated patient''s race information.


VAERS ID: 1644376 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Chest pain, Dizziness, Dyspnoea, Ear pain, Fatigue, Headache, Lymph node pain, Lymphadenopathy, Mobility decreased, Myalgia, Nasopharyngitis, Neck pain, Otorrhoea, Pyrexia, Rhinorrhoea, Vaccination site induration, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PAXIL [PAROXETINE HYDROCHLORIDE]; LAMOTRIGINE
Current Illness: Bipolar disorder; Depression.
Preexisting Conditions: Medical History/Concurrent Conditions: Endometrial disorder NOS (Endometriosis); Hysterotomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: pain had spread into the back of my skull and very tender; extreme pain and swelling in left lymph node; Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node; Sinus issues like colds; extreme pain in neck; unable to turn neck; sick at my stomach; double ear ache; lots of drainage in ears, nose and throat; no energy; out of breath; lots of drainage in ears; dizziness; sore in chest when breathing; severe cold symptoms; soft ball size knot grow at the injection site; extreme fatigue; body aches; Arm where she got the shot is very sore; feverish; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (extreme pain and swelling in left lymph node), HEADACHE (pain had spread into the back of my skull and very tender) and LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Endometrial disorder NOS (Endometriosis) and Hysterotomy in July 2018. Concurrent medical conditions included Depression and Bipolar disorder. Concomitant products included LAMOTRIGINE from 10-Jul-2021 to an unknown date for Bipolar affective disorder, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) from 15-Feb-2018 to an unknown date for Depression. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) (seriousness criterion hospitalization). On 02-Aug-2021, the patient experienced LYMPH NODE PAIN (extreme pain and swelling in left lymph node) (seriousness criterion hospitalization). On 03-Aug-2021, the patient experienced HEADACHE (pain had spread into the back of my skull and very tender) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASOPHARYNGITIS (Sinus issues like colds), NECK PAIN (extreme pain in neck), MOBILITY DECREASED (unable to turn neck), ABDOMINAL DISCOMFORT (sick at my stomach), EAR PAIN (double ear ache), RHINORRHOEA (lots of drainage in ears, nose and throat), ASTHENIA (no energy), DYSPNOEA (out of breath), OTORRHOEA (lots of drainage in ears), DIZZINESS (dizziness), CHEST PAIN (sore in chest when breathing), NASOPHARYNGITIS (severe cold symptoms), VACCINATION SITE INDURATION (soft ball size knot grow at the injection site), FATIGUE (extreme fatigue), MYALGIA (body aches), VACCINATION SITE PAIN (Arm where she got the shot is very sore) and PYREXIA (feverish). The patient was hospitalized on 02-Aug-2021 due to LYMPH NODE PAIN and LYMPHADENOPATHY. At the time of the report, LYMPH NODE PAIN (extreme pain and swelling in left lymph node), HEADACHE (pain had spread into the back of my skull and very tender), LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) and VACCINATION SITE INDURATION (soft ball size knot grow at the injection site) had not resolved and NASOPHARYNGITIS (Sinus issues like colds), NECK PAIN (extreme pain in neck), MOBILITY DECREASED (unable to turn neck), ABDOMINAL DISCOMFORT (sick at my stomach), EAR PAIN (double ear ache), RHINORRHOEA (lots of drainage in ears, nose and throat), ASTHENIA (no energy), DYSPNOEA (out of breath), OTORRHOEA (lots of drainage in ears), DIZZINESS (dizziness), CHEST PAIN (sore in chest when breathing), NASOPHARYNGITIS (severe cold symptoms), FATIGUE (extreme fatigue), MYALGIA (body aches), VACCINATION SITE PAIN (Arm where she got the shot is very sore) and PYREXIA (feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included anti-depressants and over the counter medication. Treatment information was not provided. The patient applied heating pad for her symptoms. The patient reported that she the swelling on her left side has gotten bigger from the bottom of her neck and now up to her back. Physician (friend) advised to use compresses and massage was noted. Company comment: 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 09-Aug-2021: Follow up received included additional Information received included patient demographics, historical conditions, concomitants, new events, case upgraded to serious and start date of event were added and event oucomes were updated.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1644401 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-06-29
Onset:2021-08-01
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 LA / OT

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

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

Write-up: Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings; Has spots all over his body /Arm pits and waist rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings) and RASH (Has spots all over his body /Arm pits and waist rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U37C21A and 037C21A) for COVID-19 vaccination. The patient''s past medical history included Chickenpox. On 29-Jun-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021 at 3:00 AM, the patient experienced RASH (Has spots all over his body /Arm pits and waist rash). On 01-Aug-2021 at 3:00 PM, the patient experienced HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency and STEROIDS (oral) ongoing from 08-Aug-2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings) and RASH (Has spots all over his body /Arm pits and waist rash) had not resolved. No concomitant medications reported. Shingles outbreak after second vaccine. Patient had arm pits and waist rash as first observation of the reaction No other know causes. Patient was in recovery. Patient had A+ blood type Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information received contains dose 2 information, vaccine facility information added, narrative supplement updated .


VAERS ID: 1644515 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
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: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Muscle spasms, Ovulation disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KETAMINE; LEXAPRO; XANAX; GABAPENTIN; AMPHETAMINE; ADDERALL
Current Illness: Depression (Patient takes a newly FDA-approved medication for her severe depression.); Pregnancy (Patient had planned both her pregnancies before and was unlikely that she miscalculated her ovulation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: late period since 2nd dose; heavy period; affected ovulation; started to have cramps; a few days ago she had spotting; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Patient had planned both her pregnancies before and was unlikely that she miscalculated her ovulation) and Depression (Patient takes a newly FDA-approved medication for her severe depression.). Concomitant products included KETAMINE, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM (XANAX), GABAPENTIN, AMFETAMINE (AMPHETAMINE) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting). On an unknown date, the patient experienced MENSTRUATION DELAYED (late period since 2nd dose) and HEAVY MENSTRUAL BLEEDING (heavy period). At the time of the report, MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) outcome was unknown. No treatment medications were reported. The patient would be taking a pregnancy test soon. This case was linked to MOD-2021-281053 (Patient Link).


VAERS ID: 1644532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)

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

Write-up: diarrhea first three days; headache; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea first three days), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included OMEPRAZOLE for an unknown indication. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On 01-Aug-2021, the patient experienced DIARRHOEA (diarrhea first three days). At the time of the report, DIARRHOEA (diarrhea first three days) had resolved, HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.


VAERS ID: 1644649 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Fatigue, Feeling abnormal, Hypertension, Induration, Lethargy, Muscle tightness, Nodule
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; VITAMIN D NOS; ESTROGEN; HYDROCHLOROTHIAZIDE; SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No medical History information was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: high
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: lethargic; Very tired; tightness while stretching; her body and chest feeling like underwater; blood pressure high; a hard painful bump; painful bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high) and INDURATION (a hard painful bump) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical History information was provided by the reporter. Concomitant products included IBUPROFEN, VITAMIN D NOS, ESTRADIOL (ESTROGEN), HYDROCHLOROTHIAZIDE and SERTRALINE for an unknown indication. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Very tired). In August 2021, the patient experienced MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump) and NODULE (painful bump). At the time of the report, LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump), NODULE (painful bump) and FATIGUE (Very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.


VAERS ID: 1644653 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-20
Onset:2021-08-01
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 1 - / OT

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

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

Write-up: He doesn''t feel well; Now he feels nauseated; He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (He doesn''t feel well), HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts) and NAUSEA (Now he feels nauseated) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts). On an unknown date, the patient experienced MALAISE (He doesn''t feel well) and NAUSEA (Now he feels nauseated). At the time of the report, MALAISE (He doesn''t feel well) and NAUSEA (Now he feels nauseated) outcome was unknown and HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications were reported.


VAERS ID: 1644681 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007D21A / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVIL [IBUPROFEN]
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: nausea/ nausea is killing me; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever). At the time of the report, NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information was provided by the reporter.


VAERS ID: 1644693 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088021A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Feeling hot, Lymphadenopathy, Myalgia, Rash, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Covid arm with swelling; Redness; Arm felt hot; Rash; Swollen lymph node under arm; Achy all last week; Tired all last week; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash), LYMPHADENOPATHY (Swollen lymph node under arm), MYALGIA (Achy all last week) and FATIGUE (Tired all last week). At the time of the report, SWELLING (Covid arm with swelling) and ERYTHEMA (Redness) had not resolved, FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) outcome was unknown and MYALGIA (Achy all last week) and FATIGUE (Tired all last week) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and medical history were not provided by the reporter. Treatment medicine were not provided.


VAERS ID: 1644782 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dizziness, Fatigue, Feeling cold, Headache, Nausea
SMQs:, Anaphylactic reaction (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: light headed; Felt very cold; Every time they coughed they had a pain in their head; Nauseous; Extremely tired; Headache was stronger were they couldn''t open their eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous) and FATIGUE (Extremely tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn''t open their eyes). At the time of the report, DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn''t open their eyes) outcome was unknown. No concomitant medication information was provided. After the second dose patient couldn''t lay on their side. No treatment medication were provided. This case was linked to MOD-2021-283875 (Patient Link).


VAERS ID: 1644837 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Arthralgia, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (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: USMODERNATX, INC.MOD20212

Write-up: shoulder pain with numbness down into my fingers; shoulder pain with numbness down into my fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers). At the time of the report, HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was reported. Reporter did not allow further contact


VAERS ID: 1645039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Alabama  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: body temperature; Result Unstructured Data: patient temperature got high after working in 103 degrees Fahrenheit temperature in the woods and stated that he was fine
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Overheated; Muscles hurt; Chills; Felt fatigued; Feverish; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish). On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Overheated). At the time of the report, BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: increased (High) patient temperature got high after working in 103 degrees Fahrenheit temperature in the woods and stated that he was fine. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. This case was linked to MOD-2021-286538 (Patient Link).


VAERS ID: 1645108 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
SMQs:

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

Write-up: red spot at at injection spot; injection site sore and itchy; right arm at injection site swollen; right arm at injection site sore; covid arm; good size patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot) and VACCINATION SITE SWELLING (right arm at injection site swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (injection site sore and itchy). On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at at injection spot). In August 2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore). At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received contains. New event of injection site sore was added. Coding was corrected for the events injection site itching and redness


VAERS ID: 1645165 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Mobility decreased, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Cannot even stand; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant was not provided. Treatment was not provided. Reporter did not allow further contact


VAERS ID: 1645267 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back surgery (An inserted metal in the spine and right shoulder blade)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: itching on the right side of the back/Itching at the vaccination site; sensation prevented her for sleeping; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The patient''s past medical history included Back surgery (An inserted metal in the spine and right shoulder blade). On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRURITUS (itching on the right side of the back/Itching at the vaccination site). In August 2021, the patient experienced INSOMNIA (sensation prevented her for sleeping). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. The sensation started after vaccination, but it shortly disappeared, then started at the shoulder blade. She also commented that the sensation prevented her for sleeping. Patient also took steroid cream to alleviate the symptoms.


VAERS ID: 1645283 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-15
Onset:2021-08-01
   Days after vaccination:17
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: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: I now have covid pneumonia; I was covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (I now have Covid pneumonia) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (I was covid positive). On an unknown date, the patient experienced COVID-19 PNEUMONIA (I now have covid pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (I now have covid pneumonia) and COVID-19 (I was covid positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Reporter did not allow further contact; Sender''s Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.


VAERS ID: 1646046 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 - / UNK RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abnormal dreams, Initial insomnia
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (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 INC202100976586

Write-up: Trouble staying asleep having very strange vivid dreams; Trouble staying asleep having very strange vivid dreams; This is a spontaneous report from contactable consumer, the patient. A 33-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 31Jul2021 at 15:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 01Aug2021 at 00:00, the patient had trouble staying asleep and had very strange vivid dreams. The patient was typically a sound sleeper and could not recall about the dreams or details when woke up the following morning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events trouble staying asleep and had very strange vivid dreams were recovering at the time of this report. The lot number for BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1646109 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Body temperature decreased, Dysgeusia, Hypoaesthesia oral, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (known allergies: Yes)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:low grade temperature
CDC Split Type: USPFIZER INC202100984890

Write-up: within 30 seconds of vaccine i had a strong metal taste in my mouth; Lips numb; Very bad pain in left arm; Low grade temp in the evening; Bad pain in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) in the left arm on 01Aug2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported but not specified. On 01Aug2021 within 30 seconds of vaccination, the patient experienced strong metal taste in her mouth, lips were numb and a few hours later, the patient experienced very bad pain in her left arm and shoulder, also a low-grade temperature in the evening. On 01Aug2021, in the evening, the patient underwent lab tests and procedures which included body temperature which was of low grade. The events 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metal taste in mouth, lips were numb, very bad pain in left arm, bad pain in shoulder and low-grade temperature were recovering at the time of this report.


VAERS ID: 1646113 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EWO217 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USPFIZER INC202100985078

Write-up: Left leg soreness; Pins and needles almost feels like restless leg syndrome - like I need to be moving leg around.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the left arm on 01Aug2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients'' medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefaclor (CECLOR) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Aug2021, the patient experienced left leg soreness, pins and needles which almost felt like restless leg syndrome - like she needed to move her leg around. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left leg soreness, pins and needles which almost felt like restless leg syndrome- like she needed to move her leg around was not resolved at the time of this report.


VAERS ID: 1646121 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 592671000001 / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100985349

Write-up: body aches; chills; joint pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 592671000001) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 01Aug2021 at 23:00 the patient experienced body aches, chills, joint pain and fever. Therapeutic measures were taken as a result of events included treatment with paracetamol (TYLENOL) for pain and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events general body pain, chills, joint pain and fever were recovering at the time of this report.


VAERS ID: 1646124 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, 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: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:101.1 Units:{DF}; Comments: Fever of 101.1
CDC Split Type: USPFIZER INC202100985490

Write-up: Fever of 101.1; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa7485) via an unspecified route of administration in the left arm on 30Jul2021 at 15:00 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 06:00, the patient experienced fever of 101.1. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/ department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (MOTRIN) 400 mg. On 01Aug2021 at 06:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.1 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 101.1 was unknown at the time of this report.


VAERS ID: 1646131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 EW0196 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test, Headache, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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
Allergies:
Diagnostic Lab Data: Test Name: antibodies; Result Unstructured Data: Test Result:really good.
CDC Split Type: USPFIZER INC202100985629

Write-up: Fever; Nausea; Headache; Fainted twice this morning; This is a spontaneous report from a contactable consumer. This consumer reported events for both herself and her daughter. This case refers to reporter''s daughter. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. The patient''s concomitant medications were not reported. On 01Aug2021, patient experienced fainted twice this morning , fever, nausea , headache . In the place where patient had vaccine, they only say to take Tylenol (treatment), or to go to emergency room. The mother does not want to go there. She is wondering if she can skip the second dose as she does not want to put in danger her daughter''s life. The patient underwent lab tests which included antibody test for COVID-19 on unknown date and she has really good antibodies. Outcome of the events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1646159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-08-01
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Headache, Herpes simplex, Immune system disorder, Lip injury
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100986064

Write-up: anxiety/ I started feeling, little shaky, little nervous, like anxious; bottom lip broke out; the vaccine affected her immune system; I have a slight headache; It''s breaking out, and it''s breaking out like Herpes simplex; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Jul2021, (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included psychogenic seizures from an unknown date and unknown if ongoing.The patient concomitant medications were not reported. Caller stated she was doing really well until yesterday specifically last night (01Aug2021) she felt anxiety and her bottom lip broke out (patient started feeling, little shaky, little nervous, like anxious). Caller stated it was almost as if she chewed on it and she may have but she did not know if she did. Caller stated she generally did not have the same kind of anxiety she was experiencing but she could feel anxiety and she was diagnosed with psychogenic seizure disorder because she was abused as a child. Caller stated when she was younger she had a lot of anxiety and she worked through it with therapy and it seemed to subside. Caller stated maybe it was just the way the vaccine affected her immune system as to why she felt anxiety. Caller stated she knows people who have had COVID-19 and they felt like they were not functioning correctly but there was nothing in the brain wrong but she thinks they call them long haulers or something like that. On an unspecified date in 2021, the patient experienced bottom lip broke out, the vaccine affected her immune system, have a slight headache, it was breaking out and breaking out like herpes simplex but it was not that bad. Consumer meant it was just slightly swollen. The clinical outcome of the events were unknown. Information on the lot/batch number has been requested.


VAERS ID: 1646182 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100986880

Write-up: I have the shot yesterday morning at 10:30, I have had since headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on 01Aug2021 10:30 as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medication was not reported. On 01Aug2021 the patient had the shot yesterday morning at 10:30, since then had headache. Patient had a question, if patient could take the shot yesterday morning at 10:30 have had since headache. Patient just want to know if patient can take a 200 mg Ibuprofen or can take an Aspirin, or if patient can take a Naproxen just to get the headache better. When probed for the manufacturer, patient stated, it was a Pfizer Covid-19 Vaccine. Patient was informed about the role of Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. The clinical outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646192 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-29
Onset:2021-08-01
   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 FA6780 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Dry skin, Erythema, Exfoliative rash, Full blood count, Lymphadenopathy, Peripheral swelling, Rash
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphadenectomy (When they did the operation for the cancer they had removed some lymph nodes); Metastases to lymph nodes; Nervous breakdown; Ovarian cancer stage IV; Ovarian operation; Peripheral swelling (Because they took out a lot of lymph nodes)
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Complete blood test; Result Unstructured Data: Test Result:Some of the markers are a little bit high
CDC Split Type: USPFIZER INC202100987360

Write-up: Rash between the body and the leg / Fairly large rash where her body meets the torso/ Rash in the stomach; Very red two spots; looks like scary and red; Legs are swollen more; Legs are swollen more; lymph nodes are swelling up; 2 inch by 1 inch rash on right inner thigh, rough and scaly/ 3/4 inch round rash left inner thigh, rough and scaly; It still fells kind of rough; This is a spontaneous report from a contactable consumer (patient''s husband). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: FA6780) intramuscularly on 29Jul2021 at 14:40 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization.Medical history included stage 4 ovarian cancer, ovarian cancer that ended up going into the lymphatic system, operation for the ovarian cancer, removed some lymph nodes (when they did the operation for the cancer they had removed some lymph nodes), had a nervous breakdown many years ago and she has normally a little bit of swelling in her legs (because they took out a lot of lymph nodes), all from unspecified dates and unspecified if ongoing. The patient had no history of adverse events following prior vaccinations. Family medical history relevant to the adverse events was reported as none. Concomitant medications included diazepam (tablet; strength: 5mg) taken for nervous breakdown from an unspecified date and ongoing at 5mg, 4 times a day, as needed. The patient had not had any prior vaccines within 4 weeks of the COVID-19 vaccine. The patient had not had any additional vaccines administered on the same date of the COVID-19 vaccine. On 01Aug2021 ("3 days later"), the patient experienced rash between the body and the leg / fairly large rash where her body meets the torso/ rash in the stomach, very red two spots; looks like scary and red, legs are swollen more, lymph nodes are swelling up, 2 inch by 1 inch rash on right inner thigh, rough and scaly/ 3/4 inch round rash left inner thigh, rough and scaly and It still fells kind of rough. The course of the events was reported as follows: The reporter stated that his wife received the Pfizer vaccine on the 29th (Thursday), and yesterday, 01Aug2021 (Sunday) she had a reaction and ended up with a fairly large rash where her body meets the torso (between the body and the leg). It was very noticeable, and she noticed it when she woke up in the morning. It was where the legs meet the torso, almost between the legs on each side. The rash was fairly large but there were 2 smaller areas (very red two spots). Regarding the two spots, one was about 2 inches wide high and about 1 inch wide and the other area about 3/4 of an inch in diameter where it was not only red, but it was scary. The reporter did not know how else to explain it, but it looked scary and red. They were pretty round, were really red and rough. It was not like normal skin. They were on the inside of the thighs, the 2 spots mentioned. One side was larger and the other was smaller. It was red but glazed over and looked kind of rough, maybe not rough but not smooth skin. It was also on her legs. The reporter stated that the patient had ovarian cancer which went into her lymph nodes. Her lymph nodes were swelling up because her legs were swelling up. When they did the operation for the cancer, they had removed some lymph nodes, because the cancer went from the ovarian cancer to lymphatic cancer. She had normally a little bit of swelling in her legs because they took out a lot of lymph nodes, but the legs were swollen more than they normally were. It was like the legs swelled up. Was in the lower stomach and probably the lymph system swelled up. Whatever it was, stopped the flow. They called the drug store, which the paper said to do, the first thing yesterday. They recommended she take Benadryl, which she had. She took 2 tablets. She took one at 2:00pm and the other at 6:00pm. She did not take medicine very well. After she took it, the rash, redness was down, somewhat. The major part on her legs had gone down quite a bit. The 2 spots had only gone down a little bit. The stomach had gone down fairly less. It went along her scar, where they cut her, it turned really red. (No additional information provided on the scar or cut mentioned). The rash still felt kind of rough, and when the reporter turned it over (as reported), noted that the one was now 3 inches long and 1 inch wide. The other leg, the left leg spot was 3/4-inch round. They had turned like a brownish color and were still very scaly. There was a red line outlining the area. The redness had gone down quite a bit. The large redness was barely gone. The 2 spots were still very scaly and had now turned more brownish. The adverse events did not require a visit to the emergency room or to the physician office. The reporter stated that the patient was about to call her physician. Relevant tests were reported as none. Within the last two weeks, the patient had a complete blood test done at the cancer facility. She had complete bloodwork about 5 days before the vaccine. With cancer, they did everything, and it was back the way it should be (as reported). Some of the markers were a little bit high. The reporter stated that the second dose was scheduled for 19Aug2021 at 2:40pm. He was concerned if the patient should get the second dose. He asked whether the patient should get the second shot. He was advised to contact the primary care provider for medical advice. The reporter was surprised with how the rash went down as much as it did with the Benadryl. He asked if the rash was a common reaction. He knew it was listed but he wanted to know if there were a number of people who have had this reaction. He stated he would leave it up to the physician (regarding the second dose). He also reported that the patient had to have a scan to see if the lymph nodes had reduced in swelling because they could lead to a false positive. They were kind of going back and forth because she had the cancer of the lymphatic system and 1 reaction. According to the reports on paper from both Pfizer and Moderna, it did affect the lymph nodes. Because she was a cancer patient, her doctor who she had seen about 5 days before the shot was adamant that she got the vaccine. The clinical outcomes of the events rash between the body and the leg / fairly large rash where her body meets the torso/ rash in the stomach, very red two spots; looks like scary and red, 2 inch by 1 inch rash on right inner thigh, rough and scaly/ 3/4 inch round rash left inner thigh, rough and scaly and It still fells kind of rough were recovering/resolving after treatment with Benadryl and the clinical outcomes of the events legs are swollen more and lymph nodes are swelling up were not recovered/not resolved.


VAERS ID: 1646193 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FC3180 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary mass, Computerised tomogram, Foot fracture, Inappropriate schedule of product administration, Pain, Pain in extremity, Tumour pain, X-ray
SMQs:, Malignancy related conditions (narrow), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Polycystic ovarian syndrome (I have PCOS.)
Preexisting Conditions: Medical History/Concurrent Conditions: Foot fracture ("have a little fracture and I went to a fracture")
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Broken foot. I have a little fracture and I went t; Test Name: X-ray; Result Unstructured Data: Test Result:Broken foot. I have a little fracture and I went t
CDC Split Type: USPFIZER INC202100987370

Write-up: she had a broken foot; My body hurts; My arm hurt terribly; from the elbow it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; Second dose on 01Aug2021; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FC3180) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00, reported as 11:00 or 12:00, (at 37-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome from an unknown date and ongoing and broke her foot from an unknown date and unknown if ongoing, reported as having a "little fracture and went to a fracture" for which she was given 3 paracetamol (TYLENOL) and ibuprofen but didn''t taken them. The patient did not receive any vaccines prior to the COVID vaccine. Concomitant medications included multivitamins from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number FA6780) in the left arm on 19Jul2021 at 11:00, reported as 11:00 or 12:00, for COVID-19 immunisation. The patient stated she was calling because she received her second vaccination yesterday (as of 02Aug2021). She stated that on that day, nothing was wrong, and she woke up this morning (as of 02Aug2021) and her arm hurt terribly, on the beneath there was a hard mass that hurt when she pressed it and it was hurting all the time and her body hurt. She reported it was not like she had the flu or was sick, her body just hurt; further reporting she was driving, and a few rain drops fell on her and it hurt, everything hurt. She stated from the elbow it hurt, underneath the arm there was a hard mass and it is not as big as the hard one and it hurt. She stated just moving her arm trying to do something, that all hurt "super bad" like "anytime anybody rushes up against me somebody rush me, rain drop fell on me, I hurt, it hurts, I hurt, it cannot be normal." The patient reported having no lab tests; she had an x-ray and computerised tomogram (CT) scan on the "17th" which indicated she had a broken foot and a little fracture that went to a facture. She stated she didn''t treat the events because she read that she shouldn''t take ibuprofen to address her issue and that it might effect the efficacy of the vaccine. She inquired what she should do. The clinical outcomes of her body hurt; her arm hurt terribly/from the elbow it hurt; and hard mass that hurts/underneath the arm there is a hard mass and it is not as big as the hard one and it hurts were not recovered. The outcome of the other event was unknown.


VAERS ID: 1646233 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Cough, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:100.6; Comments: At 08:00; Test Date: 20210802; Test Name: Nasal swab; Test Result: Negative
CDC Split Type: USPFIZER INC202100992576

Write-up: Soar throat; Cough; Temperature of 100.6; Body aches; This is a spontaneous report received from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an intramuscular route of administration in the left arm on 27Jul2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Concomitant medications were not reported. On 01Aug2021 at 08:00, the patient had sore throat, cough, temperature of 100.6 (unspecified units) and body aches. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, cough, temperature of 100.6 and body aches were resolving at the time of this report.


VAERS ID: 1646249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Covid-19; Test Result: Positive
CDC Split Type: USPFIZER INC202100992905

Write-up: Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive.; Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive; This is a spontaneous report from two contactable consumers. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) dose 1, single and dose 2 single; both given via an unspecified route of administration, on an unspecified date, for covid-19 immunization. The patient''s medical history included the patient was exposed to an individual that was COVID positive. Concomitant medications were not reported. The patient was not pregnant during the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient tested positive for covid-19 on 01Aug2021 and experienced covid-19 symptoms after being exposed to an individual that was covid positive. The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. No treatment was administered for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.


VAERS ID: 1646263 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100993061

Write-up: dizzy; This is a spontaneous report from a contactable consumer (patient''s mother). A 28-year-old male patient (reporter''s son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 28 years old, on 01Aug2021 (Sunday) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) at single dose for COVID-19 immunisation. After the second vaccination, the patient experienced dizzy all day long on 01Aug2021, yesterday (02Aug2021) too and today (03Aug2021). The reporter asked if this was normal. The outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1646276 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 EW0180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100993212

Write-up: Pain, swelling and redness at injection site; Pain, swelling and redness at injection site.; Pain, swelling and redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 31Jul2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 20:00, the patient experienced pain, swelling and redness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, swelling and redness at injection site was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646278 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN 5318 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Nasal Swab Rapid Test; Test Result: Positive
CDC Split Type: USPFIZER INC202100993258

Write-up: I have been diagnosed with COVID-19 via rapid test (non-PCR); I have been diagnosed with COVID-19 via rapid test (non-PCR); This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN 5318), both via an unspecified route of administration, administered in left arm, on 26Jan2021 (pending clarification) at single doses for COVID-19 immunization. Patient had no medical history and no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 via rapid test (non-PCR) on 01Aug2021. The events resulted in emergency room/department or urgent care. No treatment was given for the events. The outcome of the events was reported as not recovered


VAERS ID: 1646294 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID19 test by PCR; Test Result: Positive
CDC Split Type: USPFIZER INC202100993840

Write-up: Positive COVID19 test by PCR; Positive COVID19 test by PCR; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) (at the age of 61-year-old) as dose 1, single for covid-19 immunisation. Medical history included HBP. There were no concomitant medications. On 01Aug2021 12:00, the patient experienced positive covid19 test by pcr. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. Upon follow-up on 04Aug2021, the product Quality Complaint group provided additional investigational results which indicated the following: 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. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6203 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. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. 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. The outcome of the events were reported as recovering.; Sender''s Comments: The reported Covid 19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The case will be reassessed if additional information becomes available on the vaccination dates of the second dose.


VAERS ID: 1646297 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 EW0153 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
SMQs:, Angioedema (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: CALCIUM; MULTIVITAMINS [VITAMINS NOS]; TRIAMTERENE HCTZ; VITAMIN B COMPLEX; VITAMIN D [COLECALCIFEROL]; VITAMIN E [TOCOPHEROL]; VERAPAMIL; ZINC
Current Illness: Blood pressure high; Meniere''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (had it twice in 2014 and 2017); COVID-19 (in Dec and Jan)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100993978

Write-up: heat was a sign of an allergic reaction; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0153) via an unspecified route of administration, administered in right upper arm towards back of arm, on 31Jul2021 at 09:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure high and Meniere''s disease; cancer wherein the patient had it twice in 2014 and 2017, and COVID-19 on unspecified date in Dec and Jan. Concomitant medications included calcium taken for an unspecified indication from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for high blood pressure, and Meniere''s disease which is an inner ear disease and it helps with the fluid from an unspecified start date and ongoing; vitamin b complex taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication from an unspecified start date and ongoing; verapamil taken for hypertension from an unspecified start date and ongoing; and zinc taken for an unspecified indication, start and stop date were not reported. On 01Aug2021, it was reported that the patient experienced big red area size of a nickel around the injection site and each day it was getting bigger and bigger; this area was red, raised, hot, and later added itchy (medically significant). This area was concerning to her because the redness was spreading. It is now very big, halt the size of the palm of her hand. It was itchy, red, raised, hot. The patient mentioned she took allergy shots in the past and knew that heat was a sign of an allergic reaction. The patient took diphenhydramine (BENADRYL) as a treatment. The patient started to notice this redness around injection site the next day. She brushed against her arm and was rubbing her forearm and felt a knot. She looked at it and noticed it was red and then later on it started itching and hot. At end of call, the patient reiterated she was just concerned about the heat coming from her arm. It was hot and spreading. The outcome of the events was not recovered.


VAERS ID: 1646302 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-06-07
Onset:2021-08-01
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination the patient diagnosed with COVID-19)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result: YES; Comments: Prior to vaccination, the patient diagnosed with COVID19; Test Date: 20210801; Test Name: Rapid Test; Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: USPFIZER INC202100994128

Write-up: A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), intramuscular, administered in Arm Right on 07Jun2021 20:00 (Age at vaccination 47 years) as dose 2, single, dose 1 intramuscular, administered in Arm Right on 17May2021 20:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient diagnosed with COVID-19). There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. On 01Aug2021, the patient experienced lack of efficacy. Patient was diagnosed with positive covid-19 test on 01Aug2021. Patient was not received treatment for event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021 Nasal Swab. Facility where the most recent COVID-19 vaccine was administered at pharmacy. Patient was visited to physician office. Vaccine Facility information available. Outcome of events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646313 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-02-25
Onset:2021-08-01
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19; Test Result: Positive.
CDC Split Type: USPFIZER INC202100994257

Write-up: tested positive for COVID and had received their COVID vaccines; tested positive for COVID and had received their COVID vaccines; This is a spontaneous report from a contactable Nurse. A 33-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (at the age of 32-year-old) (Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunization. The patient past medical history and concomitant medication was not reported. On 01Aug2021, the patient tested positive for COVID and had received their COVID vaccines. This report is from a registered nurse who has a patient that tested positive for COVID and had received his COVID vaccines. She has two people who have tested positive for COVID who had received their COVID vaccines in Jan2021 and Feb2021 on site and she figured it would be better to call about this. Caller says that the patients reported to her because they must if they are sick on site or have COVID symptoms and that all must go through her. The caller didn''t test him but he had tested outside and sent the caller the positive reports. The caller received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient had tested positive on Sunday, 01Aug2021. The event outcome was unknown. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on plausible dose event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events. Linked Report(s): US-PFIZER INC-202100996959 same reporter, drug, AE, different patient.


VAERS ID: 1646332 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Covid-19 Antibody test; Test Result: Positive
CDC Split Type: USPFIZER INC202100994483

Write-up: positive for COVID with symptoms; This is a spontaneous report from a Pfizer sponsored program contactable consumer or other non hcp. A 16-year-old female patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0198)), dose 1 via an unspecified route of administration on 27Jul2021 (age at the time of vaccination was 16-year-old) as dose 1, single for COVID-19 immunisation.The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced positive for COVID-19 with symptoms. The reported stated that her both daughters got COVID shot and they both tested positive for COVID; unfortunately, they actually took COVID test yesterday and they tested positive dates for her 2 daughters, they were 14 and 16 years old and unfortunately after taking the first dose they experience side effects. The patient had the first day that she got it that night she threw up. She was little nauseated, she threw up she also had, she had body ache. She had not lot of temperature like, she was gone up to maybe 98 point something but that is or 99 but that is it and she has, she said she is been getting to like middle cough and she just doesn''t feel good, but my, because they have not felt good. I took them, they got their shot the vaccine on the 27. The reporter think it was the Tuesday or Wednesday of last week and yesterday I took them to get COVID shot and they both tested positive for COVID. So, my question is what I from here on I mean do they tested positive for COVID. The reporter will not be able to, and I need to get some information and that was what I need to do. Otherwise, I would I am sorry about that. Reporter was informed that the Pfizer Medical Information department is the concerned department. Reporter was unwilling to complete the report hence further probing could not be done. Hence, limited information was available over the call. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 01Aug2021. The outcome of the event was unknown.


VAERS ID: 1646338 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Depression; Postpartum state; Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100995222

Write-up: hives; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 31Jul2021 (batch/lot number and expiry date unknown) at 31 years of age as dose 1, single for covid-19 immunization in pharmacy or drug store facility. Medical history included anxiety, depression, recently postpartum, sulfa allergies. The patient was not diagnosed with COVID-19, prior to vaccination. The patient''s concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Aug2021, the patient experienced hives. The event was reported non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient received antihistamines and prednisone as treatment due to the event. The outcome of the event was recovering. The lot number for bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1646340 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 LA / -

Administered by: Pharmacy       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100995369

Write-up: I started having hear palpitations two days after vaccine they come and go; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in Arm Left on 30Jul2021 15:00 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. 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 heard palpitations two days after vaccine on 01Aug2021 16:00, they come and go. No treatment was received for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646341 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: temperature; Result Unstructured Data: Test Result:gone up to 98 point something but that is or 99; Comments: gone up to maybe 98 point something but that is or 99 but that is it; Test Date: 20210801; Test Name: Covid; Test Result: Positive
CDC Split Type: USPFIZER INC202100995498

Write-up: took COVID test yesterday and tested positive with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient''s mother) reported for a 16-year-old female patient (reporter''s daughter). This is the second case out of the 2 cases. A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0198), dose 1 via an unspecified route of administration on 27Jul2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "took COVID test yesterday and tested positive with symptoms" on 01Aug2021. The consumer took her daughter (patient), she got her shot, the vaccine on the 27. She thought it was the Tuesday or Wednesday of the previous week and the previous day. The consumer reported that unfortunately after taking the first dose her daughter experienced side effects. On the night of vaccination, the patient threw up. She was little nauseated and had body ache. She did not had lot of temperature like she was gone up to maybe 98 point something but that was or 99 but that was it. She was been getting to like middle cough and she just did not feel good. The consumer took her to get COVID shot and she tested positive for COVID. The patient underwent lab tests and procedures which included body temperature: gone up to 98 point something but that is or 99 (gone up to maybe 98 point something but that is or 99 but that is it) in Jul2021 and sars-cov-2 test: positive on 01Aug2021. So the consumer''s question was what she from here on, she mean do they tested positive for COVID. Has to be (incomplete sentence). She also asked when do her daughter have to take the other shot. The outcome of the event was unknown.


VAERS ID: 1646365 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Unknown  
Vaccinated:2019-09-01
Onset:2021-08-01
   Days after vaccination:700
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Condition aggravated, Herpes zoster
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100997940

Write-up: Shingles; abdominal pain symptoms; worsening of rheumatoid arthritis symptoms; This is a spontaneous report from a contactable other-HCP. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration in Apr2021 (age at the vaccination 63-year-old), dose 2, single dose for covid-19 immunization and tofacitinib citrate (XELJANZ, Formulation: Tablet, Lot number was not reported) at 5 mg twice daily via oral from Sep2019 to an unspecified date for rheumatoid arthritis. The patient''s medical history included rheumatoid arthritis. Historical vaccine included bnt162b2 for covid-19 immunization in Mar2021 (age at 64 years, dose 1 and No events reported.). Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine (Mar/Apr2021). The initial start of therapy on Sep2019 with several stops and restarts for different reasons. The patient experienced shingles, followed by shingles vaccines, abdominal pain symptoms on 01Aug2021. Patient reported worsening of rheumatoid arthritis symptoms due to missed doses in 2021, with some improvement noted since restart and MD awareness not stated and no other details provided. The patient received treatment for the adverse event worsening of rheumatoid arthritis. The outcome of the events was unknown. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1646389 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
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: PHENTERMINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FIBER; CRANBERRY; GINKGO [GINKGO BILOBA]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (known allergies to penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100998870

Write-up: Body started to feel tingling and numb; Body started to feel tingling and numb; This is a spontaneous report from a contactable consumer, the patient. A 42-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 on an unknown date in Aug2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), polycarbophil calcium (FIBER), ascorbic acid, vaccinium spp (CRANBERRY), ginkgo biloba (GINKGO) and D all for unknown indications, from an unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021 about 10 minutes after injection the patient experienced body started to feel tingling and numb (like patient was given novicane at the dentist). The events did not result in doctor or other healthcare professional office/clinic visit, and 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 reported event. The clinical outcome of the event body started to feel tingling and numb was recovering at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1646398 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-03-04
Onset:2021-08-01
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EI9269 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210801; Test Name: COVID-19 Rapid antigen testing; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202100999120

Write-up: 1st Dose 19Feb2021/2nd Dose 04Mar2021; COVID-19 positive test results; COVID-19 positive test results; This is a spontaneous report from a contactable consumer.A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EI9269), via an unspecified route of administration, administered in Arm Left on 04Mar2021 as dose 2, single and first dose via unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: EL9262) as dose1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had covid-19 prior to vaccination. Post vaccination the patient was tested for COVID-19. On 01Aug2021, the patient had COVID-19 positive test result and on an unspecified date, there was Inappropriate schedule of vaccine administered. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests which included rapid result antigen test: positive on 01Aug2021 nasal Swab. The patient had not yet recovered from COVID-19 positive test results. Follow-up attempts are completed. No further information is expected


VAERS ID: 1646407 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202100999244

Write-up: face was flushed, its red; face was flushed, its red; doesn''t feel bad he just doesn''t want to do anything; This is a spontaneous report from a contactable consumer (patient''s wife). A 7-decade-old (in their 80''s) male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 02Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021 and 03Aug2021, noticed that patient and his wife were both doing good but patient face was flushed on Aug2021. Wife was wondering if it was connected to the shot, it was red. Patient works out in the yard. Patient had not been outside or in the sun. Patient does not feel bad he just does not want to do anything. Patient otherwise were doing well with no other concerns. Patient was advised to consult with his doctor/healthcare provider about for what patient experienced, as his doctor/healthcare provider was most familiar with his medical condition, clinical history, how his treatment has been conducted and any relevant information to his specific case, his doctor/healthcare provider was in the best position to advise him about the appropriate action to take. The outcome of all the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up


VAERS ID: 1646418 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-03-26
Onset:2021-08-01
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high (high blood pressure); COVID-19 (spouse''s (wife) positive COVID test)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100999356

Write-up: Potential COVID infection based upon symptoms and my spouse''s positive COVID test; Potential COVID infection based upon symptoms and my spouse''s positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP7534), via an unspecified route of administration on 26Mar2021 (at the age of 49-years-old) as dose 2, single; and received first dose of BNT162B2 (Lot Number: EN6205), via an unspecified route of administration on 05Mar2021 (at the age of 48-years-old) as dose 1, single; both for COVID-19 immunization at other. Medical history included asthma and high blood pressure. Family history included positive COVID-19 test of spouse (wife) on 01Aug2021. Concomitant medication was not reported and had no relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, patient not been tested for COVID-19. On 01Aug2021, Patient experienced potential COVID-19 infection based upon symptoms and spouse''s positive COVID-19 test. Reporter assessed the events as non-serious. No hospitalization prolonged reported and no treatment received. The outcome of the events were not recovered at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-07-24
Onset:2021-08-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101000054

Write-up: Abnormally heavy menstrual bleeding; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0198), intramuscular in left arm on 24Jul2021 05:00 PM as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient''s medical history was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. No know allergies were reported. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Aug2021 the patient experienced abnormally heavy menstrual bleeding reported as non-serious. No treatment was received due to the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolving. Follow-up (10Aug2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Pain, Paraesthesia
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: Medical History/Concurrent Conditions: Sulfonamide allergy (known_allergies: sulfur)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101001678

Write-up: Numbness in hands, fingers and arms (Both); Tingling sensation in fingers and hands; Twinging in hands and body.; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged elderly male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 31Jul2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfur (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included statin from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Aug2021 at 00:00, the patient experienced numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of events numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body were not resolved at the time of this report.


VAERS ID: 1646493 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fall, Feeling abnormal, Near death experience
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101003531

Write-up: Just in case I die because of the vaccine; I feel real bad, I feel like everything around me is moving; Light-headed; I feel like, I am gonna fall down whenever I am walking or whenever I am sitting down; I got a burning sensation in my chest, I feel like its burning; It just uncomfortable that it burns; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Aug2021 in left arm at single dose, dose unknown for COVID-19 immunisation at the age of 36-year-old. Lot number was FA7485. There was no medical history. The concomitant medications were unknown. In Aug2021, the patient reported just in case the she die because of the vaccine, she experienced she felt real bad, she felt like everything around me was moving, Light-headed, she felt like she was going to fall down whenever she was walking or whenever she was sitting down, she got a burning sensation in her chest, she felt like it was burning; it was just uncomfortable that burned. The patient was treated with ADVIL. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646506 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Headache, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATIVAN; NAPROXEN; VICODIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neck pain
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101005617

Write-up: Horrible headache pain; chest feels heavy; very tired; Rash under left arm and Rash on right armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 01Aug2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neck pain. The patient had no known allergies to medications, food or other products. Concomitant medications included lorazepam (ATIVAN), naproxen (MANUFACTURER UNKNOWN) and hydrocodone bitartrate, paracetamol (VICODIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 01Aug2021 at 12:30, 30 minutes after vaccination, the patient experienced rash under left arm which was of size 5x3 inches, chest felt heavy and the patient was very tired. On 02Aug2021, next morning after the vaccination, the patient experienced horrible headache with pain rate of 10 which lasted for 2 days and rash on right arm pit that was same as the left arm. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event horrible headache pain was resolved on 04Aug2021, events rash under left arm, rash on right armpit, chest felt heavy and very tired were not resolved at the time of report.


VAERS ID: 1646527 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-30
Onset:2021-08-01
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202101006510

Write-up: Patient was diagnosed with COVID-19; Patient was diagnosed with COVID-19; This is a spontaneous report from a non-contactable pharmacist. A 25-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 30Apr2021 at the age of 25-years-old as dose 2, single, dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine 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.The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination. On 01Aug2021 the patient experienced patient was diagnosed with covid-19, experiencing loss of smell, loss of taste, sore throat, cough, mild congestion, similar to seasonal allergies. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Au g2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information provided the lack of efficacy of the vaccine BNT162B2 cannot be excluded. The case will be reassessed if any new information is reported.


VAERS ID: 1646531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Breakthrough positive COVID case; Test Result: Positive
CDC Split Type: USPFIZER INC202101006587

Write-up: Breakthrough positive COVID case; Breakthrough positive COVID case; This is a spontaneous report from a contactable consumer or other non-hcp. An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration; in Mar2021 as dose 2, single; and in 2021 as dose 1, single; both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient experienced breakthrough positive COVID case. The patient underwent lab tests and procedures which included Breakthrough positive COVID case in Aug2021. It was unknown if the patient received any treatment for the event Breakthrough positive COVID case. The clinical outcome of "Breakthrough positive COVID case" was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1646532 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Haematemesis, Haemoptysis, Headache, Thrombosis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Infective pneumonia (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: Cough; COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101006611

Write-up: coughed clots of blood; her head started to hurt from thinking about what happened; After it happened, when she started to cough blood, it has not occurred again. Caller previously stated the condition had worsened; threw blood; describes it as a blood clot; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 02Aug2021 10:00 (Lot Number: EW0180) at the age of 55-year-old as single dose for covid-19 immunisation. Medical history included covid-19 and cough. Prior vaccinations, no other vaccinations within four weeks prior to the first administration was taken. There was no family medical history relevant to events. No relevant tests were done. The patient''s concomitant medications were not reported. Caller received the first dose of the Pfizer Covid-19 vaccine on Monday 02Aug2021, before she got the vaccine he told the vaccine administrator that she had had Covid-19 and as a consequence still had cough so she asked if she could get the vaccine and they said yes, from time to time she coughs, it is not very often but when it happens it hits her strong and coughs phlegm. She usually coughs, but today, the cough has blood in it. She coughed up clotted blood. About 10 minutes ago she coughed but instead of expelling phlegm, she threw blood, she describes it as a blood clot in Aug2021, she didn''t know if it was because of the coughing effort, she would like to know if this may be due to the vaccine. She also mentioned that after this her head started to hurt from thinking about what happened on 05Aug2021. It happened 10 minutes ago. Patient confirmed information above. Instead of phlegm, she coughed clots of blood on 05Aug2021. She had been coughing the whole time before she got the shot. After it happened, when she started to cough blood, it has not occurred again. Caller previously stated the condition had worsened in Aug2021. She was not on any medication. She only took paracetamol (TYLENOL) for the pain. These events did not require emergency room or physician office. She was going to call the clinic to see if she can be checked, but had not been yet. Outcome of coughed clots of blood and when she started to cough blood, it has not occurred again/previously stated the condition worsened was not recovered, of other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646579 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Cerebrovascular accident, Dizziness, Loss of consciousness, Nervous system disorder, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101008138

Write-up: stroke-like symptoms; episodes of passing out/seizure like reaction; episodes of passing out/seizure like reaction; experiencing prolonged neurological issues; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), tow doses both via an unspecified route of administration, administered in right arm on an unspecified date (at 28-year-old, not pregnant at time of vaccination) as single dose, for COVID-19 immunization. Medical history included allergies: amide, PCOS (polycystic ovarian syndrome). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin (METFORMIN) taken for PCOS, thyroid medication. On 01Aug2021 the patient was experiencing prolonged neurological issues. She had multiple episodes of passing out/seizure like reaction. Presenting at hospital with stroke-like symptoms. Nearly a week later she still had dizziness and neurological issues. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Pending additional testing. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Cerebrovascular accident, Loss of consciousness, Seizure cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.


VAERS ID: 1646605 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-04
Onset:2021-08-01
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, Vaccination site pain
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101010117

Write-up: Arm sore near injection site; Arm sore near injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Aug2021, the patient experienced arm sore near injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event arm sore near injection site was unknown at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up


VAERS ID: 1646615 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FA7485 / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Pain, Pruritus, Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:101.5; Test Name: Nasal swab; Test Result: Negative ; Comments: covid test result=Negative
CDC Split Type: USPFIZER INC202101011293

Write-up: Fever of 101.5; Chills; Body aches; Headache; Injection site pain; redness; hot; Swelling; Right arm itching that radiated to back and part of left shoulder; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 31Jul2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took naproxen(MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 10Jul2021 at 10:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 01Aug2021 at 08:00 the patient experienced fever of 101.5 the next day and chills/body aches. Headache for 24 hours the following day. Injection site pain, redness, hot and swelling. Right arm itching that radiated to back and part of left shoulder for 5 days following injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.No therapeutic measures were taken as a result of the events. On an unknown date the patient underwent nasal swab SARS CoV-2 virus test and the result was negative. On 01Aug2021 at 08:00, the patient checked body temperature and the result was fever of 101.5(unspecified units). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 101.5, chills, body aches, headache for 24hours, vaccination site pain, redness, hot, swelling and right arm itching that radiated to back and part of left shoulder were resolving at the time of this report.


VAERS ID: 1646627 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-06
Onset:2021-08-01
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: Pain, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101012096

Write-up: arm pain; body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Aug2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient explains that she got her first dose and patient experiencing body aches and arm pain on an unspecified date in Aug2021. She took Tylenol but mentions that it does not work for her. She would like to take ibuprofen and wants to know if it would be ok or is Tylenol the only thing recommended. Therapeutic measures were taken as a result of arm pain and body aches. The outcome of the events was unknown. Information about batch/lot number has been requested.


VAERS ID: 1646700 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Unknown  
Location: North Carolina  
Vaccinated:2021-08-02
Onset:2021-08-01
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: Fall, Feeling abnormal, Gait disturbance, Head injury, Neuropathy peripheral, Seizure
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Iritis; Seizures (Verbatim: menstrual seizures)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015147

Write-up: I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I have neuropathy in my head so bad. It''s very hard for me to write.; I can barely walk.; I am suffering so bad; This is a spontaneous report from a contactable consumer (patient). A 90-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 90 years old) as dose 1, single for COVID-19 immunization. Medical history included menstrual seizure, iritis. Concomitant medication included "lot of medications" as reported by the patient. No other vaccine was administered prior to COVID vaccine. The patient experienced "i had a seizure before, i got down and head hit on the wall" on 06Aug2021, "i have neuropathy in my head so bad, it''s very hard for me to write, i am suffering so bad, i can barely walk" on an unspecified date on Aug2021. Patient have lot of medical problems, and lot of health issues but well. Patient wouldn''t feeling that bad, just the few weeks before, patient was diagnosed with iritis and have history of having menstrual seizures. Patient took the vaccination this past Monday (02Aug2021) and patient was going on well. This Friday (06Aug2021) after patient took it, When patient was walked into the room that, patient go to wait. Patient had a seizure before, patient got down and head hit on the wall. Patient took the first one on Monday and due to take second which the 23rd of this month. What to do. Patient was suffering so bad. Patient don''t feel up to, have neuropathy in head so bad It''s very hard for patient to write. Outcome of all the events were unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.


VAERS ID: 1646721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Illness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015630

Write-up: I cannot see; Blurred vision; I am sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA7485 and expiry date was not reported), via an unspecified route of administration, on 05Aug2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient reported that she did not feel well after this vaccine. She should never done it. She did not want it; now she was sick, and she cannot see, everything was blurry on an unspecified date in Aug2021. She was not doing too well and concerned about her vision. She wanted to go to hospital. Outcome of the events was unknown.


VAERS ID: 1646751 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Antibody test, Body temperature, Chills, Cough, Erythema, Feeling hot, Head discomfort, Hyperhidrosis, Leukaemia, Pain in extremity, Pyrexia, SARS-CoV-2 test, Scratch
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOROMETHOLONE; KETOROLAC TROMETHAMINE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure); Cholesterol blood excessive (Verbatim: Cholesterol); COVID-19 (that I have had COVID for 8 months); Pacemaker syndrome
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:No more have antibodies; Test Date: 20210803; Test Name: Fever; Result Unstructured Data: Test Result:101.6; Test Name: Covid-19 Test; Result Unstructured Data: Test Result:COVID; Comments: that I have had COVID for 8 months
CDC Split Type: USPFIZER INC202101017835

Write-up: my arm is as red as it can be; My arm is as red as it can be, it''s feverish; Still be this feverish and red and sore; Chills; Sweating; Fever of 101.6; just scratch it really bad; I have recently been diagnosed with Leukemia; cough; head congestion; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FA6780, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 78-year-old) as dose 1, single for covid-19 immunization. The patient medical history included blood cholesterol, blood pressure, covid-19 and she had pacemaker. Concomitant medications included fluorometholone, ketorolac tromethamine, unspecified heart medicine, unspecified cholesterol medicine, unspecified blood pressure medicine, she taken eyedrops (two different eyedrops) all taken for unknown indications and apixaban (ELIQUIS) a blood thinner from an unknown date. It was reported that, patient got the first vaccine monday morning, her arm was as red as it could be, it''s feverish, and she went this morning to show the pharmacist what it looked like and they advised her to call, because it is not normal for the five days, and still be this feverish and red and sore. She did find on Monday that she had took it but Tuesday afternoon was when she started getting feverish, chills, sweating and her ran a fever of 101.6 and then her arm started getting red and feverish (confirmed that date as 03Aug2021). She did find that on Monday, she was pleased that it did not seem like anything on Monday. She has had COVID for 8 months, she is a long hauler. She still has cough and head congestion on an unspecified date in Aug2021, she have had mini anti-biotics (Unspecified medications), nothing has helped and I have recently been diagnosed with Leukemia on an unspecified date in Aug2021 (further clarification unknown). Well, it''s been maybe three weeks. No, it was a week ago this past Tuesday, she didn''t remember the date was, because they needed to check to see if she has antibodies, because she has had antibodies up until now and that''s why she didn''t had vaccine. But they called her and told her that she no more have antibodies, and that she needed to get the vaccine, because she was getting ready for the chemotherapy on the 18th, the pill and the infusion. She didn''t see an expiration date on here, she got it on 02Aug2021 (02Aug2021). There is no expiration date on here, it was scheduled for the second one at 23Aug (23Aug2021). The patient has just taken Tylenol as treatment and she have put ice pack on it. No, it kind of reduces the pain on it, she just wanted to claw it, she just wanted to get in there and just scratch it really bad on an unspecified date in Aug2021. She did take ''Xyzal'' allergy medicine, she taken it every night. Tylenol helped some but it''s not taking the care of the problem. The patient underwent lab tests and procedures which included antibody test: no more have antibodies on 2021, body temperature: 101.6 on 03Aug2021, Covid-19 Test: covid (that I have had COVID for 8 months) on an unspecified date. Therapeutic measures were taken as a result of her arm is as red as it can be, her arm is as red as it can be, it''s feverish, still be this feverish and red and sore, chills, sweating, cough, head congestion, fever of 101.6. The outcome for events her arm is as red as it can be, her arm is as red as it can be, it''s feverish, Still be this feverish and red and sore, chills, sweating, cough, head congestion, fever of 101.6 was not recovered and outcome was unknown for other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646761 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Dizziness, Fall, Fatigue, Headache, Influenza like illness, Joint swelling, Malaise, Nasal congestion, Oropharyngeal pain, Pharyngeal inflammation, Pharyngeal swelling, Scratch, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101021965

Write-up: tired; fell down the stairs; low energy/weak; felt dizzy/lightheaded; scratches in her legs, her knees that several inches long; injection site had pain; cold or flu feeling; throat was swollen, painful and was congested in that area; felt like something rushed to her throat and nostril area; headache; swelling pain in the left shoulder; pain in shoulder; started feel congested; mild throat inflammation; she feeling like sick every day; This is a spontaneous report from a contactable consumer or other non-HCP. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180), dose 1 via an unspecified route of administration, on right shoulder, on 06Aug2021 17:00 (at the age of 55-years-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. The patient had no medical history (including any illness at time of vaccination) and no family medical history relevant to adverse event. The patient concomitant medications were not reported. The patient had no other products. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). She was calling regarding the Pfizer Covid vaccine. She got the Pfizer Covid vaccine on 06Aug2021, (Friday) evening around 5:00pm. After that, she has been having side effects nonstop and it was now day 4. She was a little bit concerned that she would get long term side effects that were impacting her health and well-being for the rest of her life. She was active and completely healthy with no medical issues or medication whatsoever and never got ill. Now, for 4 days, she has been feeling these side effects. She was feeling a little frustrated. She knows people who got the Pfizer at Giant and had no side effects. She was healthier than those people. She had the vaccine Friday at 5:00pm on 06Aug2021 and 20 to 30 minutes later, she felt like something rushed to her throat and nostril area. It was swollen, painful and she was congested in that area. That lasted about an hour. Right after that, she had a headache from around both ears, pressing into the head. That lasted for a couple of hours. The following day, Saturday, the headaches continued but they were not as severe. The patient was asking why she was having headache, swelling pain in the left shoulder after getting the first dose of the Pfizer covid-19 vaccine. The swelling in the throat was not as severe. It felt like a cold or flu feeling. She never got the cold or flu in her life but she was imagining it would be like that. She was 100 percent a healthy individual who has never had any health problems. The side effects were like the cold, flu and fever but she does not know. She assumed it was like the cold or flu, from the nostril area. Saturday, the headaches were not as severe. They continued and the headache felt like the head was pressurized throughout the day. It felt like it was better than the day before. On 08Aug2021, Sunday she felt better, concern was that she was very tired. Saturday, she slept in the afternoon. She just felt very tired. She guessed that was ok. She knows that was one of the side effects, fatigue. Sunday, she had low energy, but she felt dizzy. She fell down the stairs, the concrete stairs and got scratches, several inches long. She has never fallen before. States that she can send photos. It was because she was lightheaded. The scratches were on her legs and knees. She never felt like that before in her life. The vaccine was her downfall. She has been really weak and dizzy but, better than she was on Saturday. She felt like a 90-year-old lady. She used to exercise on the treadmill and run 5k every Saturday. She also did weight-lifting every week. Now, she was not in that shape. She just wants to take it slow. This morning she still felt pressurized in the head and was still very tired. Around 8 30, her left shoulder started to feel pain. Her injection was in the right shoulder. The injection site had pain Saturday, then went away. She was wondering if she can get cancer from this. She was very upset and concerned about her future. Treatment: In her life, if she has pain or whatever, scratches, they bleed than they dried. They just naturally heal themselves. She was not a believer in medications. Maybe that was why she was so healthy. She was not into medication. If there was a pain, she would rather heal naturally. Because she was concerned about side effects with medication, she does not take medication. If it was something she can tolerate, she just tolerates it. She asked can she have long term side effects. Would she get cancer. The whole part of her left shoulder, will it get worse. Would she find out she has heart issues or some long-term side effects, not temporary pain. The long term was what she was concerned about. The scratches, they were nothing, they heal. She now understands that the vaccine won''t be complete without the second dose. She heard the side effects were more severe with the second dose. Now she was thinking that, and it makes her worried and scared. She was terrified. Was a little bit weird, that they used alcohol to wipe the site. It was closest to the bone. Could that be the reason, The Harris Teeter version was different than the other versions. She knows people who got the Pfizer Covid vaccine at Giant Pharmacy. She would like to provide additional information that her husband took the same vaccine the day before. The studies she saw were that 79 percent of the side effects were women. The healthier you were the more side affects you get. Maybe that applied to her. Indication: It was mandated or going to be mandated. For the greater good, for the country to get over this, the vaccine numbers had to be higher and to get over the number. She wants to travel to China and hasn''t been visiting China where her family was. It has been 6 years. Her father was here for more than 4 years, then the funeral. He was paralyzed and couldn''t return after that. Then Covid, and to go to go to China, you must be fully vaccinated. She called her doctor, and they said the soonest they could see her was tomorrow at 10:00am. She was totally healthy. To be honest, in case Covid hits, assuming she was not vaccinated, she would not even know. It would naturally occur, and she would not even know. She asked was it normal to experience all of these symptoms. She asked was the vaccine the same formulation wherever she take it and was the dose of the vaccine the same for men and women. She asked If she take the second dose of the vaccine at a different location, she would still be considered vaccinated, she need to take the second dose in 3 weeks right. The patient not required visit to emergency room and physician office. The patient had no relevant test done. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:2021-03-21
Onset:2021-08-01
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101022327

Write-up: Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot no: EP7534) via intramuscular route of administration, administered on 21Mar2021 as single dose for covid-19 immunisation. The patient was not pregnant at the time vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was diagnosed with covid-19 was unknown. The patient receives any other vaccines within 4 weeks prior to the covid vaccine was unknown. It was reported that the patient was symptomatic to covid in the week of 05Aug2021. On an unspecified date in Aug2021 the patient tested positive for covid. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included Covid-19 test which was resulted positive. The patient was recovering from the covid. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1646844 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-08-07
Onset:2021-08-01
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: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Asthma, Diarrhoea, Dizziness, Fatigue, Illness, Nausea, Pain, Pain in extremity, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (he has allergies); Asthma; Attention deficit hyperactivity disorder; Cardiac disorder (narrowing of the main vein in his heart, to do open heart surgery but it fixed itself)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101024395

Write-up: Rash on leg and left hand, top of hands/Rash; itching on top of the left hand started today; weakness; Diarrhea; feeling tired; Light-headed; Stomach pain; felt sick to stomach; felt sick; body aching; his arm is sore/soreness in arm; Says his asthma acted up; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Aug2021 (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself, hypersensitivity from an unknown date and unknown if ongoing he has allergies. The patient''s concomitant medications were not reported. On Aug2021, the patient experienced, nausea and says his asthma acted up. On 08Aug2021, the patient experienced his arm is sore/soreness in arm, diarrhoea, feeling tired, light-headed, stomach pain, felt sick to stomach; felt sick, body aching. On 09Aug2021, the patient experienced weakness. On 10Aug2021, the patient experienced top of hands/rash, itching on top of the left hand started today a rash on leg and left hand, top of hands/rash. Reporter reports her son received the first dose of the Pfizer Covid 19 vaccine on 07Aug2021 and 24 hours later he began to experience side effects of soreness in the arm, diarrhea, and rash, feeling tired and lightheaded, stomach pain, and now today he began to have a rash on the leg and left hand. He has ADHD, has asthma and a heart condition. Had called to verify that these are side effect. Reporter clarifies patient had ADHD, asthma, and heart condition at birth before administration of product. Later provides patient was born with a heart condition, with narrowing of the main vein in his heart, instead it was going straight. They were going to do open heart surgery, but it fixed itself. Therapeutic measures were taken as a result of, itching on top of the left hand started today (pruritus), says his asthma acted up (asthma). The outcome of the event arm was sore/soreness in arm, weakness, diarrhoea, feeling tired, felt sick to stomach; felt sick, body aching, says his asthma acted up was unknown and the remaining all events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646846 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Haemorrhage, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: VITAMIN B12 [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood (after her daughters were born especially the last one 13 years ago); COVID-19; Irregular menstruation; Vaginal delivery (3 births (her children are 27, 21, and 13 years old))
Allergies:
Diagnostic Lab Data: Test Date: 202010; Test Name: Covid-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101024482

Write-up: when she got her second dose on that Friday, within 2 hours, she was back to heavy bleeding.; In the last 48 hours, she started passing blood clots again; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0186) via an unspecified route of administration in right arm on 06Aug2021 (at 48 years)as single dose for covid-19 immunisation. Medical history included Covid 19 virus from Oct2020 and did have a change to her menstrual cycles after having the Covid 19 virus. She would have a period then she would skip a period, she has had 3 vaginal births (her children are 27, 21, and 13 years old). She doesn''t have a history of bleeding disorders; she had big blood clots after her daughters were born especially the last one 13 years ago. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported.On 10Jul2021 (at the age of 48 years) patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0181) in right arm for covid-19 immunisation and 9 days later she was passing large golf ball sized clots, experienced abnormal vaginal bleeding that got heavier and heavier, HCPs think maybe the type of vaccine (mRNA) led her to possibly have early diagnosis of uterine cancer, she lost so much blood had to have transfusion, she had her period a week previously so knew it wasn''t time for one( It was heavy for the first 7 days, wouldn''t stop, then got heavier), thickened endometrium, complex hyperplasia, was frustrated, had hemoglobin at 8/ 5.Patient got a Rubella shot when she was 18 years old (30 years ago, as reported) and she got encephalitis after the Rubella vaccine. She had severe headaches for 3 weeks. The doctor thought it was related to the Rubella vaccine.On 06Aug2021, she got her second Covid 19 vaccine and in the night (within 2 hours) she was back to heavy bleeding, she started bleeding heavily even though she took medroxyprogesterone 10 mg. She''s still bleeding now after the second Covid 19 vaccine. The caller thought her bleeding was related to the Covid 19 vaccine but her doctor thinks she''s crazy. In the last 48 hours (Aug2021), she started passing blood clots again. Medroxyprogesterone wasn''t stopping it this time .The outcome of bleeding was not recovered; outcome of blood clots was unknown.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101023313 Same patient/Vaccine, different event, different vaccine dose


VAERS ID: 1646854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-04
Onset:2021-08-01
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: Anosmia, Chills, Dizziness, Headache, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101025229

Write-up: fainting after first vaccine; Headache, after first vaccine; Fever, after first vaccine; Chills, after first vaccine; Dizziness; Loss of smell after first vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age 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 04Aug2021 (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Agent states the Caller took her first dose of the Pfizer vaccine on 04Aug2021. Agent states the Caller reports having a headache, fever, chills, dizziness and fainting, and loss of smell, all on Aug2021. Caller confirms she is calling about the Pfizer COVID vaccine. Caller states she was calling her doctor, because she still had some dizziness and a loss of smell, and all of her other symptoms went away. Caller states she was trying, to make an appointment with her doctor, and they told her to call Pfizer. So she is not really sure what to do. The outcome of the events dizziness and a loss of smell was not recovered, for other events was recovered in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646855 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101025337

Write-up: arm that I got the shot in is reddened and swollen and there is pain; arm that I got the shot in is reddened and swollen and there is pain; tiny little red spots; tiny little bit of aching; a little itchy all over too; arm was really sore and hurting and I noticed it had turned red; my arm is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 58-Year-Old female patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Aug2021 single dose in left arm for COVID-19 immunisation. Lot number was FA7484. Medical history and concomitant medications were unknown. On 14Jul2021, the patient received first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and she experienced sore in arm (lot number FA6780). On unknown date, the patient received a flu shot for immunization (inflamed, painful). The patient experienced arm that got the shot in was reddened and swollen and there was pain, tiny little red spots; tiny little bit of aching, a little itchy all over too, arm was really sore and hurting and it had turned red, arm was very uncomfortable. Little spots treated with antibiotics cream; the patient also received Benadryl and a Claritin, Ibuprofen 200 milligram. The outcome of the events was unknown.


VAERS ID: 1646872 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-04
Onset:2021-08-01
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: PCR; Test Result: Positive ; Comments: covid test type post vaccination = Nasal Swab
CDC Split Type: USPFIZER INC202101027906

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other health care professional. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose (lot number EL3248) on Jan2021 05:45, 2nd dose (lot number EL3248, as reported) on 04Feb2021 06:00, both at 61-year-old intramuscular in left arm for Covid-19 immunization. Medical history was not provided. There was no other medications in two weeks. There was no other vaccine in four weeks. It was unknown if patient had covid prior vaccination. There was no known allergies. Patient experienced symptoms of covid starting on 01Aug2021, and was tested positive for covid PCR Nasal swab on 05Aug2021. Treatment was unknown. Outcome of the event was not resolved.; Sender''s Comments: The possibility of Covid19, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.


VAERS ID: 1646906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID; Result Unstructured Data: Test Result: Positive.
CDC Split Type: USPFIZER INC202101029054

Write-up: This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not tested positive for covid-19. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included covid test which resulted positive. It was reported that on an unspecified date in Aug2021 the patient was symptomatic and tested positive for covid-19. It was further reported that the patient was not hospitalized. The patient received the treatment for the events was unknown. The patient was resolving from the event covid-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1646907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101029055

Write-up: Tested positive for COVID and was symptomatic. I was able to confirm the person was NOT hospitalized.; Tested positive for COVID and was symptomatic. I was able to confirm the person was NOT hospitalized.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. On an unknown date in Aug2021, the patient was tested positive for covid and was symptomatic. It was confirmed that the patient was not hospitalized due to the event. On an unknown date in Aug2021, the patient had lab test to Sars-cov-2 infection and results were positive with symptomatic symptoms. It was unknown if the patient was treated for the event. The outcome of the event was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1646909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
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: Arthropod sting, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101029089

Write-up: Bitten by wasps; Itchiness; Local reaction / local irritation; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient reported she was bitten by wasps on Saturday afternoon, 07Aug2021, and she was taking Benadryl 25mg three times a day for the wasps bite as well as for itchiness and local reaction/local irritation on an unknown date in Aug2021. The events were reported as non-serious. The patient was scheduled to have her second dose on 11Aug2021 and would like to know if she can continue with the vaccination as scheduled. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.


VAERS ID: 1646947 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Puerto Rico  
Vaccinated:2021-08-08
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101030088

Write-up: stroke (brain); This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN , SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced stroke (brain) (caused hospitalization) in Aug2021 days after vaccination with outcome of unknown. The patient was hospitalized due to the event from Aug2021. It was reported that the stroke was a reaction due to the vaccine. The lot number for bnt162b2 was not provided and will be requested during follow-up.


VAERS ID: 1646958 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Blood cholesterol, Chest pain, Hypersomnia
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:was good; Comments: year ago
CDC Split Type: USPFIZER INC202101030684

Write-up: First time she fell asleep for 20 hours; She was only awake for like 4 and half hours and then she got back to sleep and slept for another 12 hours; That seems like a lot of sleep; Chest pain; Back pain; This is a spontaneous report from a contactable consumer. This consumer reported for her 12-year-old female patient (reporter''s daughter) that: A 12-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0173), via an unspecified route of administration in Arm left on 03Aug2021 as single dose for covid-19 immunisation. Concomitant medications included multivitamin (Gummy Vitamins). Patient was allergic to sometimes antibiotic. She has had about a year ago, they pricked her finger to test for cholesterol and that was good. Patient did not receive any other vaccine prior to covid vaccine. It was reported that she had a Covid vaccine, the first one on 03Aug2021 and she came home, and she slept for 20 hours, woke up with chest pain and back pain and she stayed up for 4 or more hours and then she fall back asleep and slept for about another 12 hours and then she seems okay. Caller called the doctor and they said to give her 2 children chewable Tylenol. It was the chewable one, it is 160 mg each and she had two. Caller wanted to report it and see if it was safe for her to get the second vaccine on 24Aug2021 and make sure that she was okay because that seems like a lot of sleep, chest pain and reporter was worried. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646972 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Angina pectoris, Chest discomfort, Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Malaise
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101033249

Write-up: feeling off; felt very sick/don''t feel too well; Out of breath; Upset stomach; uncomfortable feeling in chest; Tired; Very dizzy all the time; heart is hurting very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Aug2021 (Lot Number: EW0186, unknown expiration; at the age of 30 years old) as dose number unknown, single for COVID-19 immunisation. Medical history reported as none. The patient''s concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine shot on Friday, 06Aug2021. She experienced feeling off on 06Aug2021. It''s been 4 days and symptoms are getting worse. She felt very sick and just don''t feel too well in Aug2021. The patient also experienced out of breath, upset stomach, and her heart is hurting very uncomfortable in Aug2021. She has uncomfortable feeling in chest, was tired, and very dizzy all the time in Aug2021. The patient took one ibuprofen yesterday (on 09Aug2021). The patient asked what she should do now and if she should go to the ER. The patient had not yet recovered from feeling off, while unknown outcome for the remaining events. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1646981 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-07
Onset:2021-08-01
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: Dehydration, Diarrhoea, Feeding disorder, Headache, Malaise, Myalgia, Nausea, Pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101033922

Write-up: sick/not feeling well; ache; diarrhea; headache; dehydration; hasn''t been able to eat and she is only eating popsicles; nausea; vomiting; muscle pain and aches; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 07Aug2021 (at the age of 62 years) as dose 1, single for covid-19 immunisation. The patient medical history included Covid-19 on an unspecified date. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat, nausea and vomiting. This was the patients first day out of bed, she reported being very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat and she was only eating popsicles. Patient said her main concern has been her nausea and vomiting. Patient said that she did not experience coughing or shortness of breath, like when she had covid. Patient asked how these side effects will last. Patient stated that she was terrified to get the second dose of the vaccine and was thinking about not taking the second dose. Patient added that she contacted her doctor about her symptoms from the first dose and was informed that she could not be seen because of the risk. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1646984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ear infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101033988

Write-up: ear infection; This is a spontaneous report from a non-contactable consumer and a employee. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dosefor covid-19 immunisation. Medical history was none. Patient was not pregnant. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ear infection on Aug2021. The event resulted in Doctor or other healthcareprofessional office/clinic visit. Treatment included antibiotic. The outcome of the event was recovered on an unknown date. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-07
Onset:2021-08-01
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: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101034627

Write-up: welts to the lower part of her back; lower part of her back that are itching; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Aug2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the Pfizer COVID vaccine on this past Saturday 07Aug2021, patient stated she has welts to the lower part of her back that were itching and spreading to her lower legs on unknown date in Aug2021. Patient was looking for treatment recommendations. The outcome for the events was reported as unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1647004 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-09
Onset:2021-08-01
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: Face oedema, Mouth swelling, Oral pain, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tooth fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101034765

Write-up: her mouth hurts and had swelling; her mouth hurts and had swelling; swollen face; puffy lips; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, spontaneous. This 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 09Aug2021 at 37-year-old for Covid-19 immunization. Medical history included broken tooth. Concomitant drug were not provided. She had a broken tooth and asked "If you have an infection in the body will the vaccine make it worst?". Few minutes after her 1st dose her mouth hurts and had swelling. She woke up the next morning with swollen face and puffy lips. It was further reported that went on Monday to get her vaccine and received her first dose. Instantly her mouth started hurting. Hours later, her mouth and left side of face started swelling up. She researched everything and did not find that if a person had a broken tooth prior to the COVID Vaccine, that person should not get the vaccine. The 2nd dose would be on 30Aug2021. Outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1647046 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: covid-19 test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101036145

Write-up: PCR: Covid-19 Positive and related symptoms; PCR: Covid-19 Positive and related symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-Year-old male (patient) that, A 40-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration on Apr2021 (at the age of 40-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced PCR: COVID-19 positive and related symptoms (drug ineffective) (medically significant). PCR: COVID-19 positive and related symptoms (COVID-19) (medically significant). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test as positive (Nasal Swab). No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No prolonged hospitalization. Therapeutic measures were taken as a result of adverse events. Treatment received for the adverse event was Advil. The outcome of the events was unknown. Follow-up(12Aug2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. The response included that: Awareness date: 11Aug2021, EA: 11Aug2021 and Full vaccinated Best. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1647053 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Cystitis, Dyspnoea, Flatulence, Investigation, Laboratory test, Muscle spasms, Myocardial infarction, Prostatic pain, Prostatitis, SARS-CoV-2 test, Sinusitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TESTOSTERONE; KLONOPIN
Current Illness: Testosterone low
Preexisting Conditions: Medical History/Concurrent Conditions: Sleep difficult
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: pressure; Result Unstructured Data: Test Result:went up; Test Date: 202108; Test Name: tested; Result Unstructured Data: Test Result:they ruled him out; Test Date: 202108; Test Name: labs and tests; Result Unstructured Data: Test Result:nothing showed up; Test Date: 202108; Test Name: Covid swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101037175

Write-up: started having spasms in the prostate area; Prostatitis; hard time being able to breathe, almost every 10 seconds; pain in the chest; it felt like gas, but it was more than gas; he felt pressure in his prostate; thought he was coming down with a bladder infection; pressure went up; he was coming down with a sinus infection; felt like he was having a heart attack; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right at the age of 59-year-old on 07Aug2021 11:15 (Lot Number: FC3180; Expiration Date: Mar2022) as single dose for COVID-19 immunisation. Medical history included ongoing low testosterone, trouble sleeping at night. Concomitant medications included testosterone taken for low testosterone from an unspecified start date and ongoing; clonazepam (KLONOPIN) taken for trouble sleeping at night/ help him sleep from an unspecified start date and ongoing. The patient previously took steroids and experienced respiratory distress. The caller states he just called the people he had gotten the shot from and they recommended him to call Pfizer. He states what happened was Saturday morning around 11am, he received the first vaccination shot from Pfizer. He states about midnight, he was watching TV, and then all of a sudden, at first it felt like gas then he ended up having a hard time being able to breathe, it was almost every 10 seconds , like a wave on 08Aug2021. He states it was more than gas, he had pain in the chest area on 08Aug2021. Any position he put himself into it didn''t help. He states he took Phazyme, the max dose, and it didn''t touch it, he didn''t know what to do. He had considered going to the emergency room because his pressure went up (Aug2021) and at one point he was just thinking he had to go to the emergency room. He had seen a doctor and he said the emergency room is filled with Covid patients, and he doesn''t need to expose himself so he stopped himself from going. He states it lasted for 3 hours, it was non-stop, but it finally subsided. He doesn''t know exactly what happened but about 0330, he was finally able to drift off to sleep. It felt like he was having a heart attack (Aug2021). He states he''s had a reaction before that was very similar when he had a steriod shot years ago, he told the doctor and the doctor told him that he should never take a steriod shot again because it gave him some kind of respiratory distress. He does not know what happened, he just needed to report this. The person that he spoke with said according to CDC guidelines, only if he went to the emergency room is when they say not to get the second shot and he would have had he known COVID patient were not there. He states he did go to the urologist Monday, he thought he was coming down with a bladder infection within an hour of getting the shot on 07Aug2021, he felt pressure in his prostate on 07Aug2021, he started having spasms on 09Aug2021 morning about 5:00. He states the urologist said he''s gone through a patient who was in pain and having pressure in the prostate and he did lots of labs and tests (Aug2021) and nothing showed up. The doctor said the best guess is its a side effect of the Covid shot, and there is nothing to do but time and it will wear off. Started feeling pressure down there: He states that Saturday morning, within the hour, he started feeling pressure down there, it subsided, then it would come and go. He states he woke up Monday (09Aug2021) morning about 5:00 and it started spasming and that''s when he called the urologist and he was diagnosed with prostatitis and the doctor said it would go away with time. He doesn''t have prostate problems. Prostatitis: diagnosed 09Aug2021, ongoing, persisting. He states it has subsided, not enough even to mention. Monday was the worst and then that afternoon he felt like he wasn''t spasming. It may happen once or twice during the day but it subsides quickly. He states he doesn''t even know, he is scared to take the second shot. It was asked if the call handler recommend taking the second shot. States it''s probably not a good time right now to be transferred, he will call them later. He states he went to see doctor about another reason and he thought he had COVID, he was coming down with a sinus infection (Aug2021), and the doctor said go ahead and get him tested (Aug2021) with everything going on so they ruled him out and they gave him a Covid swab (Aug2021) and that came back negative and the doctor started telling him what was going on and the doctor scared him to the point where he said he was going to get the injection.The patient underwent lab tests and procedures which included blood pressure measurement: went up in Aug2021, laboratory test: nothing showed up in Aug2021, investigation: they ruled him out in Aug2021, sars-cov-2 test: negative in Aug2021. Therapeutic measures were taken as a result of events (Treatment: Over the counter Phazyme 250 mg, 12 gel capsules, took 2, box says only allowed to have 2 within a 24 hour period). Not visit to Emergency Room. AE(s) require a visit to Physician Office (on Monday, but he diagnosed with prostatitis, he went to the urologist). The outcome of event ''hard time being able to breathe, almost every 10 seconds'' ''pain in the chest'' ''it felt like gas, but it was more than gas'' was recovered on 08Aug2021. The outcome of event ''thought he was coming down with a bladder infection'' ''he felt pressure in his prostate'' was recovering. The outcome of prostatitis was not recovered. The outcome of other events was unknown.


VAERS ID: 1647059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-10
Onset:2021-08-01
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: Fatigue, Lethargy, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101038257

Write-up: Really really lethargic; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Aug2021, after first dose of vaccination (received 18 hours ago-from the report time), patient was really lethargic or had tiredness because it seems like patient was just sleeping. Outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647065 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: PCR/Nasal Swab; Test Result: Positive.
CDC Split Type: USPFIZER INC202101039592

Write-up: This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Apr2021 (at the age of 37 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced PCR Covid Positive and related symptoms of disease (medically significant) on unspecified date in Aug2021. The patient received treatment of Advil in response to event. The patient been tested for COVID-19 since the vaccination. the patient underwent lab test included PCR/Nasal Swab with positive result on unspecified date in Aug2021. The outcome of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1647068 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
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: Arthralgia, Gait inability, Myalgia, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101040003

Write-up: unable to walk due to extreme knee pain; unable to walk due to extreme knee pain; Extreme itchiness all over body; shooting muscle pain all over body; This is a spontaneous report from a non-contactable Healthcare professional (patient herself). A 30-year-old female patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 05Aug2021 at 03:30 PM (at the age of 30-year old) at single dose for COVID-19 immunization at pharmacy/drug store. Relevant medical history was none. Concomitant medications were not reported. On 07Aug2021, 24-48 hours after shot the patient was unable to walk due to extreme knee pain. One week after shot the patient experienced extreme itchiness and shooting muscle pain all over body. No treatment was received due to events. They resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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