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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 398 out of 8,010

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VAERS ID: 1763102 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Blood test, Dyspnoea, Fatigue, Headache, Myalgia, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: To many to list. Contact me for copy of meds.
Current Illness: To many to list
Preexisting Conditions: Heart. Lungs. Kidneys. Sternal oesteomylitis with deep wound infection staph and another infection of mersa. Again to many things to list
Allergies: To many to list.
Diagnostic Lab Data: Many blood tests taken. Many ER visits. Primary visits. Urgent care.
CDC Split Type:

Write-up: Headache. Extreme muscular and joint pain in entire body. The pain was incredible. Burning skin. Chronic tiredness. Difficulty breathing. Abdominal pain. It was very bad. Now 6 weeks post still joint pain and muscle pain. Have new thing that started on 10/02/2021


VAERS ID: 1764643 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, Dizziness, Electrocardiogram, Fibrin D dimer, Full blood count, Headache, Heart rate increased, Muscle twitching, Tremor, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood work (CBC, D-Dimer) EKG Referral to see heart specialist to monitor elevated Heart Rate
CDC Split Type:

Write-up: Dizziness/vertigo, Headaches, Tremors/Shaking, Muscle Twitches throughout body, elevated BP for 2 days after vaccine and elevated heart rate. All have been persistent since the day of vaccine.


VAERS ID: 1764658 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-14
Onset:2021-08-25
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1764690 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-05
Onset:2021-08-25
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 UN / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1765076 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Amenorrhoea, Blood pressure increased, Blood test normal, Chest pain, Electrocardiogram normal, Influenza like illness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Fertility disorders (broad), Hypoglycaemia (broad)

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

Write-up: Received Phizer Vaccine on 08/23/21. Experienced flu-like symptoms on 08/24/21. On 08/25/21 at 9:30pm woke up from sharp pain in the right upper chest. Started shaking uncontrollably. Due to severity of the symptoms had to go to the ER. When got to the ER had a blood pressure around 140/105. Covid -19 test was negative blood work, EKG were performed and were negative for blood clots and signs of heart attack. Was given Aspirin and discharged from the hospital. Despite no history of High Blood pressure had a blood pressure of around 140/100 for the next 2-3 weeks. Did not get my menstrual period since getting the vaccine. Last menstrual period was 08/08/21. Not sure if it?s ok to get second shot. Employer request proof of full vaccination.


VAERS ID: 1765115 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-07
Onset:2021-08-25
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018B21A / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1765188 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2020-12-22
Onset:2021-08-25
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / UNK - / -

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

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

Write-up: Covid19


VAERS ID: 1765212 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-19
Onset:2021-08-25
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / UNK - / -

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

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

Write-up: Covid19


VAERS ID: 1765282 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-06-29
Onset:2021-08-25
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BW01180 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 UN / SYR

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

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

Write-up: COVID19


VAERS ID: 1765332 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Muscle spasms, Pain, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 2 ultrasound tests on 2 separate visits.
CDC Split Type:

Write-up: Painful cramping a few days after the 2nd shot, followed by miscarriage several days later, confirmed by 2 separate ultrasound doctor''s visits. Baby died around 6 to 7 weeks into pregnancy.


VAERS ID: 1765390 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-14
Onset:2021-08-25
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 RA / IM

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

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

Write-up: COVID POSTIVE


VAERS ID: 1765463 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: significant blurred vision


VAERS ID: 1765540 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasortum, synthetic, aspirin, vitamin D3, B12
Current Illness: none
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: blood pressure bottomed out, shortness of breath.


VAERS ID: 1767195 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Nausea, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101103014

Write-up: Sore arm,; fatigue,; nausea,; diarrhea; abdominal cramps,; body aches,; headache; tiredness; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 24Aug2021 14:45 (at the age of 21-year-old), in the left arm, as dose 2, single for COVID-19 immunization. The patient''s medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity from an unknown date and unknown if ongoing. Patient''s historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Aug2021 16:30 (at the age of 21-year-old), in the left arm, as dose 1, single for COVID-19 immunization. Patient did not take any other vaccine within four weeks and received other medication within two weeks. Patient had not been tested for COVIID before vaccination and patient had tested for post vaccination as negative. On 25Aug2021 at 07:00, the patient experienced sore arm, fatigue, nausea, diarrhea, abdominal cramps, body aches, headache, tiredness. Treatment was not taken. On 24Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test negative. The clinical outcome of events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1767389 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disease recurrence, Extra dose administered, Lymph node pain, Lymphadenopathy, Neuralgic amyotrophy, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: FINASTERIDE; ATORVASTATIN; ACITRETIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease (other medical history: Mild CAD, Migraine, Psoriasis); Migraine (other medical history: Mild CAD, Migraine, Psoriasis); Psoriasis (other medical history: Mild CAD, Migraine, Psoriasis); Sulfonamide allergy (known allergies: Sulpha)
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101236141

Write-up: Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Return occurrence of Parsonage-Turner Syndrom affecting left arm/back/neck-hand and first two digits.; Swollen and painful left lymph node; Swollen and painful left lymph node; receiving 3rd dose of vaccine; receiving 3rd dose of vaccine; This is a spontaneous report from a contactable other HCP. A 53-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Arm Right on 25Aug2021 10:45 as DOSE 3, SINGLE (at the age of: 53-year-old) for covid-19 immunization. Medical history included coronary artery disease other medical history: Mild CAD, Migraine, Psoriasis , migraine other medical history: Mild CAD, Migraine, Psoriasis , psoriasis other medical history: Mild CAD, Migraine, Psoriasis , Sulfonamide allergy as known allergies: Sulpha. Facility where the most recent COVID-19 vaccine was administered as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received other medications within 2 weeks of vaccination as Finasteride, Atorvastatin, Acitretin. Concomitant medication(s) included finasteride (FINASTERIDE); atorvastatin (ATORVASTATIN); acitretin (ACITRETIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 08Sep2021, the patient experienced return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits. On 08Sep2021 the patient experienced swollen and painful left lymph node. On 25Aug2021 10:45 the patient experienced receiving 3rd dose of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021. Therapeutic measures were taken as Steroids, gabapentin as a result of return occurrence of parsonage-turner syndrom affecting left arm/back/neck-hand and first two digits, swollen and painful left lymph node. The outcome of event receiving 3rd dose of vaccine was unknown. The outcome of rest all event was not recovered. Follow-up (22Sep2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1767762 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-07-21
Onset:2021-08-25
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 - / 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.MOD20213

Write-up: Vaccine administered 5 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medications were not provided by the reporter. This case was linked to MOD-2021-332834 (Patient Link).


VAERS ID: 1767763 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-07-21
Onset:2021-08-25
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 - / 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.MOD20213

Write-up: Vaccine administered 20 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-332843 (Patient Link).


VAERS ID: 1768092 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-08-25
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 UN / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1768271 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, COVID-19, Cardiac monitoring, Colonoscopy, Computerised tomogram, Dyspnoea, Echocardiogram, Endoscopy upper gastrointestinal tract, Gastrointestinal haemorrhage, Haemoglobin decreased, Influenza, Laboratory test, Magnetic resonance imaging, SARS-CoV-2 test positive, Tachycardia, Tachypnoea, Transfusion, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations: Following flu vaccine
Other Medications: Metoprolol, Isosorbide, lisinopril, Armour thyroid, pantoprazole,cymbalta, tizanidine
Current Illness: HTN, CAD, High cholesterol, GERD, hypothyroid
Preexisting Conditions: Same
Allergies: None
Diagnostic Lab Data: Blood work, echocardiogram, ultrasound, cat scan, blood transfusions, upper endoscopy, colonoscopy, capstudy, cardiac monitoring (outpatient) MRI
CDC Split Type:

Write-up: Flu symptoms at first, then becoming worse Positive covid test September 10, 2021 GI bleed 9/21/21 Hospitalized 9/22/21 Severe Tachycardia/tachypnea/shortness of breath during hospitalization Hgb from. 14 to 8 in 5 days


VAERS ID: 1768417 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-01
Onset:2021-08-25
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dehydration, Dizziness, Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain, SARS-CoV-2 test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil and Discovy for prep
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: COVID Rapid Test - negative Urgent Care
CDC Split Type: vsafe

Write-up: Nausea; dizziness; headache; dehydration; body chills; tiredness; muscle aches; fatigue; sore throat. Those symptoms lasted about five days. I went to Urgent Care on the 29th of August for Rapid COVID test - result was negative. No treatment. Note: I had the Hepatitis B vaccine on 2/23/21 - 1st dose of three (have not had any other doses yet) And had an Influenza vaccine - within the last month -after I had the above adverse health events


VAERS ID: 1769671 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-03-05
Onset:2021-08-25
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Public       Purchased by: ?
Symptoms: Biopsy, Cutaneous vasculitis, Petechiae, Purpura
SMQs:, Severe cutaneous adverse reactions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Fetzima, lamotrigine, l-methylfolate
Current Illness: None
Preexisting Conditions: Depression/anxiety
Allergies: None
Diagnostic Lab Data: 9/13/21 Punch Biopsy
CDC Split Type:

Write-up: Leukocytoclastic vasculitis began occurring in 8/21 and has continued to present. Presents as petechaie and purpura on the feet, legs, inner arms and stomach.


VAERS ID: 1771489 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 LA / IM

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

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

Write-up: Patient was not 18 years old at the time vaccine was administered.


VAERS ID: 1771608 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Catheterisation cardiac abnormal, Coronary arterial stent insertion, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin
Current Illness: HTN
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: 8/25/2021 admitted to hospital with MI
CDC Split Type:

Write-up: pt experienced an MI the day after his second dose of Covid vaccine and had cardiac cath and stinting x2 of coronary artery.


VAERS ID: 1771616 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-20
Onset:2021-08-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Limb discomfort, Neck pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Patient has reaction in her arm and pain from her shoulders to her neck.


VAERS ID: 1771620 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F33184 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aptiom 800mg, Paxil 20mg, Ibuprofen 800mg, Flexeril 10mg
Current Illness: Epilepsy, degenerative joint disease, Scoliosis, Pernicious Anemia, anxiety w/ panic disorder, PCOS, ADHD, OCD, BPD, sinus tachycardia
Preexisting Conditions: N/A
Allergies: Phenergan, Anafranil, Lamictal, Okra, Ginger
Diagnostic Lab Data: Got Albuterol Inhaler from Sept 2021 & nebulizer Rx Oct 2021. Seen teledoc Dr virtual visit during this time as well.
CDC Split Type:

Write-up: 1st 8/24/21 vaccine- Side effects started 8/25/21: SOB, upper arm soreness, fatigue & lasted 2 days. SOB lasted about 6 days. 2nd 9/14/21 vaccine- Side effects started 9/15/21: Fever 99-100.4?F, fatigue, SOB, body aches, upper arm soreness much more severe than 1st vaccine, SOB, O2 staying in 93-98% average of 95%. All subsided within 48-72hrs, SOB lasting weeks.


VAERS ID: 1771764 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-01-28
Onset:2021-08-25
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 2 RA / IM

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

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

Write-up: Tested Positive for Covid. Supposely had 1st vaccine on 1/7/2021 but not in immunization registry.


VAERS ID: 1771925 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-24
Onset:2021-08-25
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0332 / 2 RA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1771950 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-24
Onset:2021-08-25
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EP6955 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea, Fatigue, Pneumonia, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cardiovascular disease
Allergies:
Diagnostic Lab Data: 08/25/2021 Antigen+ COVID-19 test at Urgent Care; 09/03/2021 PCR+ COVID-19 test at Medical Center
CDC Split Type:

Write-up: Breakthrough COVID-19 case with symptom onset 8/25/2021: Fever, Shortness of breath/difficulty breathing, Fatigue or tiredness, Chills, Cough. Hospitalized 9/3/2021-9/6/2021. Pt was seen in the ED in late August with a positive Covid test. Pt was d/c home and told to come back if she felt worse. Xray was normal at that time. Pt was admitted when she came back to the ED on 09/03/2021. Pt then had a positive chest Xray for pneumonia


VAERS ID: 1772078 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Confusional state, Dizziness, Head discomfort, Headache, Hyperhidrosis, Inflammation, Laboratory test, Malaise, Nausea, Pyrexia, SARS-CoV-2 test negative, Sinus congestion, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan; XANAX; CIALIS
Current Illness: No
Preexisting Conditions: Arthritis
Allergies: Penicillin
Diagnostic Lab Data: COVID test; Labs were done, but nothing significant came of them
CDC Split Type: vsafe

Write-up: The following morning, I had extreme dizziness. That persisted for days. There were other symptoms too I had a low-grade fever the 2nd day. It never got over 100.2. I had severe sinus congestion. My head felt stuffy. I felt in a state of confusion. I had extreme postnasal drip and sweating. I also experienced joint aches and nausea and headaches. I just had overall feeling if being unwell. I felt a fullness in my chest in my heart area. I had mucus draining from everywhere. About the 3rd day of feeling this way, I went to an urgent care. A COVID test that was done, came back negative. I was given a medication for inflammation but it was not helpful. The bulk of these symptoms lasted approx. 2 weeks. I am still dealing with dizziness. It is random and will come up out of nowhere. I had a tele visit with my PCP who suggested Mucinex D for help with the nasal drip. This helped but caused some heart palpitations. Also, my heart palpitations increased all while going through this. My heart does not feel healthy. It feels different now, it feels heavy.


VAERS ID: 1772578 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Intermenstrual bleeding, Oropharyngeal pain, Productive cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

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

Write-up: sore throat, fever, mucus production,cough, spotting


VAERS ID: 1772606 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-02-26
Onset:2021-08-25
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / SC

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Dyspnoea, Viral infection
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune 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: Allopurinol, amlodipine, celebrex, ambien, macrobid, valacyclovir, skelaxin, lyrica, lasix, tramadol, nexium
Current Illness: None
Preexisting Conditions: Osteo-arthritis, gerd, kidney disease
Allergies: Morphine, bactrim
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough virus infection...coughing, shortness of breath, loss of taste and smell


VAERS ID: 1773643 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Blood cyanide, Blood test, Catheterisation cardiac, Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Feeling cold, Fibrin D dimer, Hypoaesthesia, Immunisation, Inappropriate schedule of product administration, Magnetic resonance imaging, Myocardial infarction, Near death experience, Off label use, Pyrexia, Troponin
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia (He was in the Hospital due to Covid Pneumonia); Heart transplant; Hospitalization (He was in the Hospital due to Covid Pneumonia).
Allergies:
Diagnostic Lab Data: Test Name: CYA; Result Unstructured Data: Test Result: Unknown Result; Test Name: Blood Work; Result Unstructured Data: Test Result: Unknown Result; Test Name: Cardiac catheterization; Result Unstructured Data: Test Result: Unknown Result; Test Name: chest X-ray; Result Unstructured Data: Test Result: Unknown Result; Test Name: CAT scan; Result Unstructured Data: Test Result: Unknown Result; Test Name: D-dimer; Result Unstructured Data: Test Result: Unknown Result; Test Name: MRI; Result Unstructured Data: Test Result: Unknown Result; Test Name: Troponin; Result Unstructured Data: Test Result: Unknown Result.
CDC Split Type: USPFIZER INC202101306157

Write-up: We almost "lost" him; He was having kind of heart attacks but he wasn''t; Severe Chest pain; they said he may never get rid of the pain in his Chest; he went blind for an hour; Arm numbness on left side of his arm; lost all feeling on his left side; Fever; He was freezing and it was very bad; He couldn''t breath, they put him on oxygen; He had Booster shot 3 months in between but they said it should be received in between 6 months.; He had Booster shot 3 months in between but they said it should be received in between 6 months.; He had Booster shot 3 months in between but they said it should be received in between 6 months.; This is a spontaneous report from a contactable consumer (patient''s wife). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: EW0177) (at the age of 60-years-old) as dose 3, single for COVID-19 immunisation. Medical history included heart transplant recipient and was in the hospital due to COVID Pneumonia. He had COVID before the shot (vaccination) and he spent 5 days in ICU in Jan2021. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 16Apr2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 07May2021; both at the age of 60-years-old for COVID-19 immunisation and experienced minimal side effects like sore arm, just aches and pains, nothing major for his first two doses of Pfizer vaccine. Patient was taking a lot of unspecified concomitant medications. The patient''s heart transplant office called and said that he can get his Booster shot, so he got the Booster shot on Wednesday on 25Aug2021. On 29Aug2021, he had severe chest pain, he went blind for an hour. He had arm numbness on the left side of his arm. He had fever, he was freezing and it was very bad. When they got him finally stabilized so to transport him and got him down to the Hospital and they did all the test, the transplant office, our local Doctors and then he had to go see a Neurologist all said that it was an adverse reaction due to the Booster shot. He had Booster shot 3 months in between but they said it should be received in between 6 months. Neurologist said the patient may never get rid of the pain in his chest. Reporter stated, they almost "lost" (not clarified) him and now he is having this side effect this lasting forever. Patient was hospitalized from 29Aug2021 and discharged from the hospital on 02Sep2021, he had a Neurology appointment like he lost all feeling on his left side. He had chest X-ray. The blood work was done troponin, CYA, D-dimer. When probed for reason of Hospitalization, reporter stated, the main side effect was severe pain in the chest. When they put him in the Ambulance he was on the Machine, he was having kind of heart attacks, so they rushed him to the Hospital. By the time he got there, he couldn''t breathe. They put him on oxygen. He also had to have Cardiac catheterization. When probed for any laboratory test, reporter stated, he was in the Hospital they did an MRI, a CAT scan. When probed for any treatment for the events, reporter stated, patient was given Nitro Pills, Morphine, they gave him "Dalada" (further not clarified), and they gave him Ativan. They tried to take that pain away. Outcome of event blind was recovered on 29Aug2021 while rest of events was recovered on 02Sep2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1775224 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Gait disturbance, Headache, Injection site pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (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: Bystolic, Benicar, pantoprazole, Wellbutrin, daily vitamin
Current Illness: Arthritis in hips, shoulder and knees.
Preexisting Conditions: High blood pressure, arthritis, skin disease
Allergies: Strawberries, codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache started in about 5 minutes. I got the Covid vaccine in my right arm. A few days later, my arm was in a lot of pain. At the same time, my hip and down to my knee, the pain was horrible. For 3 weeks, I had to hold on to almost everything when trying to walk . . . the wall, furniture, kitchen cabinets, etc. I also had a very hard time getting to my vehicle, almost fell every time. And, when going into the grocery store (which is the only place I went while in the pain for 3 weeks) I had a hard time walking from the parking lot into the store, then holding on to the cart obviously helped me do shopping. After the 2nd shot, I was still in pain in my hip for about 2 more weeks.


VAERS ID: 1776333 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Crestor, Eztibe
Current Illness: None
Preexisting Conditions: None
Allergies: Steriods
Diagnostic Lab Data: Dr visit for physical Mentioned vertigo feeling
CDC Split Type:

Write-up: Vertigo approximately 3 hours after shot


VAERS ID: 1776481 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-02
Onset:2021-08-25
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough, Fatigue, Headache, Myalgia, Nausea, SARS-CoV-2 test positive, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None Reported
Allergies:
Diagnostic Lab Data: SARS CoV 2 Antigen Positive on 9/1/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose # 1 3/5/2021 Dose #2 4/2/2021. C/O chills, muscle aches, loss of taste/smell, headache, fatigue, cough, and nausea/vomiting. Onset 8/25/2021


VAERS ID: 1776487 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-30
Onset:2021-08-25
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Impaired work ability, Injection site pain, Laboratory test, Pain, Pyrexia, Sperm concentration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Sperm count test and scheduled for labs test on 10/12/2021 hormone and urinalisis
CDC Split Type: vsafe

Write-up: 08/25/2021 patient received notification from a fertility specialist of possible low sperm count and this was present issue prior to the vaccination. Immediately after the second vacination 03/30/2021 experienced aches, pains all over body, soreness at injection site, feverish, lack of appetite, fatigue and missed a day of work.


VAERS ID: 1776674 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-29
Onset:2021-08-25
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Myalgia, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None Reported
Allergies:
Diagnostic Lab Data: COVID Antigen Positive 8/25/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 4/1/2021 Dose #2 4/29/2021. C/O muscle aches, runny nose, fatigue, and cough, onset 8/25/2021


VAERS ID: 1776693 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-07-03
Onset:2021-08-25
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Electrocardiogram normal
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: EKG - normal The doctor said he may have experienced an inflammation in the heart.
CDC Split Type: vsafe

Write-up: Breathing problems Difficulty in taking a deep breath He was given Motrin by the doctor.


VAERS ID: 1777096 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-01
Onset:2021-08-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023M20A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amnesia, Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalopathy/delirium (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: SPINAL BIFIDA
Allergies: N/A
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient experienced memory loss after vaccination and more on her second dose of the vaccine. She also had a stroke though they believe the stoke to be possibly unrelated to the vaccine


VAERS ID: 1777339 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenopia, Decreased appetite, Fatigue, Headache, Nausea, Pain, Sensory disturbance, Tension headache, Tinnitus
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Hearing impairment (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: Women''s multi vitamin - daily
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 8/25/21 - body ache in shoulders 10pm, Intense headache began. Tension was around the entire hairline. I had to hold my head all night. 08/26/21 - Headache/tension continued. 1 caplet Tylenol taken at 0445. No relief. No appetite. Drank lots of water to stay hydrated. Body aches continued. Slight nausea. Headache/tension eye strain.Slept more. 7pm took walk and was exhausted after walk. Went to bed early. Headache/tension persisted. Took Tylenol. 08/27/21 - Headache/tension/eye strain - continued. Intensity changed throughout the day. When laying down at night, metallic ringing in ears, heartbeat in head, head tension continued, "carbonation fizzes" sensation from occipital area of head down neck. This remained the same for five weeks.


VAERS ID: 1779144 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-06
Onset:2021-08-25
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray normal, Cough, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-Vitamin; zinc; Vit D
Current Illness: none
Preexisting Conditions: heartburn
Allergies: Singulair
Diagnostic Lab Data: 18th of September, 2021- Lung x-rays - looked ok; tested for COVID - negative result
CDC Split Type: vsafe

Write-up: Persistent cough. We tried Prednisone and a course of Augmentin along with some cough suppressant - Benzonatate 100 mg as needed to help with the cough. That course didn''t work. We tried Albuterol - just doing some of that with the cough suppressant. It''s still there (the cough). I was told it was a viral or bronchitis since it didn''t respond to the previous treatment. Was told to give it some time. The facility that I went to initially gave me the antibiotic and the prednisone did lung x-rays and COVID test. After the course of the prednisone and antibiotics and I was referred to my doctor''s telehealth NP and she put me on Albuterol - 24th of September.


VAERS ID: 1782260 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

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

Write-up: sore arm for one day


VAERS ID: 1782776 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-23
Onset:2021-08-25
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018B21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: COVID 19


VAERS ID: 1782827 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Fatigue, Hidradenitis, Loss of personal independence in daily activities, Nausea, Pain, Thyroid mass, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft, Zyrtec, Vitamin D
Current Illness: Chronic auto immune disorders, but all were in remission leading up to vaccination
Preexisting Conditions: History of ulcerative colitis, celiac disease and hidradenitis suppurativa. Regular fatigue and pain from inflammation. Occasional nausea (possibly related to removal of large intestine in 2004).
Allergies: Allergy to CT contrast dye
Diagnostic Lab Data: Nausea - Sept. 3, Thyroid Nodule - Sept. 13 office visit, Ultrasound - Sept. 20 Ultrasound,
CDC Split Type:

Write-up: To be transparent, the current issues may not a result of the vaccine. However, about 7 to 10 days after receiving it, my immune system became hyper-stimulated. I am currently having flare up of my hidradenitis suppurativa, which has been in remission for years. I needed to have a prescription for Zofran due to almost constant nausea that went on for days. My fatigue and general body pains are intense, and I am barely able to participate in my normal life functions. In addition, I developed a 5.7 cm nodule on my Thyroid about 3 weeks after receiving the vaccine that was not present before.


VAERS ID: 1782903 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-15
Onset:2021-08-25
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048A21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782929 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-18
Onset:2021-08-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 061E21A / UNK - / -

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

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

Write-up: COVID 19


VAERS ID: 1782930 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-16
Onset:2021-08-25
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen 1000mg daily 650mg prn for pain/fever amitriptyline 10mg HS apixaban 2.5mg BID atorvastatin 10mg HS bacitracin topical prn for wounds betamethasone topical 0.1% topical BID calcium vitamin D 600mg-10mcg BID cholecalciferol 25m
Current Illness: None documented
Preexisting Conditions: paroxysmal atrial fibrillation, chronic diastolic heart failure, dementia, rheumatoid arthritis, osteoporosis.
Allergies: celecoxib - unknown cephalexin hydrochloride - diarrhea codeine - unknown diclofenac - unknown rofecoxib - unknown tramadol - palpations vicodin - unknown vioxx - swelling
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient contracted COVID after being fully vaccinated Unknown - done at facility where patient stays


VAERS ID: 1783005 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-04-09
Onset:2021-08-25
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anosmia, COVID-19, Cough, Nasal congestion, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; lisinopril; hydrochlorothiazide; multivitamin; vit D; vit B; magnesium; calcium; low dose aspirin; omega 3: glucosamine chondroitin
Current Illness: No
Preexisting Conditions: No
Allergies: Morphine
Diagnostic Lab Data: COVID tests 3 at home and pharmacy, positive results
CDC Split Type: vsafe

Write-up: I was out of state and I thought I had allergies. Had to do a lot of screening to even go there right now. I started to feel like I had allergies on Saturday, Sept 25th. I was flying home that day so I didn''t think anything of it. I was very congested. He asked me to take a home test. It was positive. I took that on Sunday on the 26th. I took another one on Tuesday the 28th (home test). I went in a for a professional test on the 30th at local pharmacy all tests came back positive. OTC cold medicine, Dayquil, Nightquil; and some cough medicine Robitussin; cough, congestion, loss of smell. No body aches etc, just felt like a cold or allergies. I had those symptoms for about a week. Had a phone consult with nurse at doctor''s office. September 10th, Pneumonia shot, 2nd Sept 10th; Flu Shot on September 15th. I received these before going to out of state.


VAERS ID: 1783224 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-05
Onset:2021-08-25
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anosmia, Headache, Malaise, Oropharyngeal pain, SARS-CoV-2 test negative
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

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

Write-up: Sore throat, headache, loss of smell, feeling ill.


VAERS ID: 1783612 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Tongue spasm
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Sexual dysfunction (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: unknown
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient reported Bell''s Palsy-like symptoms. A drooping face, numbness, twitching/spasms of the tongue. This lasted for a few weeks, the patient reported.


VAERS ID: 1783779 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045CZ1A / UNK - / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None. I couldn''t get an appointment with my gynocologist until the end of October.
CDC Split Type:

Write-up: I am peri-menopausal; I did not have my period for four months prior, and then only very lightly. Within hours of getting my first Moderna vaccine, I started to menstruate, and very heavily. The bleeding has continued, in various flow levels, for eight weeks now, with only a few days without any blood or spotting. Blood is unusually red, and I''m getting cramps and headaches that are reminiscent of when I had my period as a younger woman.


VAERS ID: 1784830 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-08-25
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atypical pneumonia, C-reactive protein increased, COVID-19, Chest X-ray abnormal, Cough, Inflammatory marker test, Lung opacity, Pain, Pneumonia viral, Pyrexia, SARS-CoV-2 test positive, White blood cell count
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 47 yr old male with no significant PMHx who presented to the ED due to cough, fevers, body aches secondary to COVID19. Pt states that he began having symptoms on 08/17 and he went and got tested as well as his wife. They both tested positive. Pt states his symptoms progressively worsened so he presented to the ED. On admission his temp was 98.7, his white count is stable, CRP inflammatory is elevated. His chest x-ray shows mild patchy bilateral airspace opacities supportive of viral/atypical pneumonia. He was given steroids in the ED. Pt is being admitted for further care.


VAERS ID: 1657559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-08-31
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? 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: 20210825; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 36.5 AU/ML, less than 50.0, Negative
CDC Split Type: MXJNJFOC20210857487

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age of unknown race and ethnicity. 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 and expiry date: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient was tested for the IGG spike in the clinical laboratory of hospital and experienced confirmed immunological vaccine failure and Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 36.5 AU/ML, less than 50.0, Negative. 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 90000191344.; Sender''s Comments: V0: 20210857487-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: 1660545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101108155

Write-up: feeling of tightness in the chest as if he could not breathe well; feeling of tightness in the chest as if he could not breathe well; tingling in the arm; Light-headed feeling; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection) via an unspecified route of administration on 25Aug2021 08:15 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced after about an hour, an hour and a half of vaccination, she began to feel a tingling in the arm, ''light-headed'' feeling and constriction in the chest, as if he couldn''t breathe well. It was reported that feeling of tightness in the chest as if she could not breathe well considered as medically significant. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1664422 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dysmenorrhoea, Hyperhidrosis, Muscle spasms, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROPRANOLOL
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cramps; sweaty; light headed; nauseous; Period pains; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25850064) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), HYPERHIDROSIS (sweaty) and DYSMENORRHOEA (Period pains) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included PROPRANOLOL for Anxiety. On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramps) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty) (seriousness criterion medically significant), DIZZINESS (light headed) and NAUSEA (nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (cramps) and HYPERHIDROSIS (sweaty) had not resolved, DYSMENORRHOEA (Period pains) was resolving and DIZZINESS (light headed) and NAUSEA (nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1664863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210855660

Write-up: DIZZINESS; MUSCLE PAIN; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 4 decade old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered to deltoid on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced dizziness, muscle pain and headache. The patient was hospitalized (date and duration unspecified). The patient received inpatient treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, dizziness and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210855660- covid-19 vaccine ad26.cov2.s-Dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210855660- covid-19 vaccine ad26.cov2.s - Muscle pain, Headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1668081 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Hyperhidrosis, Nightmare, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tight chest; Arm pain; Fever; Nightmares; Sweating; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25853090) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight chest), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever), NIGHTMARE (Nightmares) and HYPERHIDROSIS (Sweating) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NIGHTMARE (Nightmares) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). On 26-Aug-2021, PYREXIA (Fever), NIGHTMARE (Nightmares) and HYPERHIDROSIS (Sweating) had resolved. At the time of the report, CHEST DISCOMFORT (Tight chest) was resolving and PAIN IN EXTREMITY (Arm pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. 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. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; 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. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1668377 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Dizziness, Feeling abnormal, Headache, Nausea, SARS-CoV-2 test, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON
Current Illness: Painful periods
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pain injection site; Dizziness; Spaced out; Weakness; Stomach cramps; Headache; Temperature elevation; Nausea; Vomiting; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25851659) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), BODY TEMPERATURE INCREASED (Temperature elevation), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Pain injection site), DIZZINESS (Dizziness), FEELING ABNORMAL (Spaced out), ASTHENIA (Weakness) and ABDOMINAL PAIN UPPER (Stomach cramps) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Painful periods. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON) for Painful periods. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain injection site) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), FEELING ABNORMAL (Spaced out) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), BODY TEMPERATURE INCREASED (Temperature elevation), NAUSEA (Nausea), VACCINATION SITE PAIN (Pain injection site), DIZZINESS (Dizziness), FEELING ABNORMAL (Spaced out) and ASTHENIA (Weakness) had not resolved and VOMITING (Vomiting) and ABDOMINAL PAIN UPPER (Stomach cramps) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. Treatment medication were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. 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. Reporter did not allow further contact; 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: 1668380 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Injection site pain, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; Migraine type headaches; Nausea; Injection site pain; Chest pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25852654) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), MIGRAINE (Migraine type headaches), NAUSEA (Nausea), INJECTION SITE PAIN (Injection site pain) and CHEST PAIN (Chest pain) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 02-Feb-2021 to 07-Feb-2021. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MIGRAINE (Migraine type headaches) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) and CHEST PAIN (Chest pain) was resolving and MIGRAINE (Migraine type headaches), NAUSEA (Nausea) and INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. , Patient has not tested positive for COVID-19 test No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.; 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1668437 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-25
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, 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: 20210825; Test Name: polymerase chain reaction; Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: GBPFIZER INC202101115668

Write-up: vaccination failure; I have tested positive for COVID; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old female patient (not pregnant) received the second dose and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 01Jun2021 at 14:00 (Lot Number: ER7812) on the left arm, first dose on 10May2021 at 14:15 (Lot Number: ET1831), both via an unspecified route of administration at the age of 49-year-old as single does for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient wasn''t diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn''t received other vaccines within 4 weeks prior to the COVID vaccine. The patient didn''t received other medications within 2 weeks of vaccination. On 25Aug2021, the patient had tested positive for COVID. The patient underwent lab tests and procedures which included polymerase chain reaction and positive on 25Aug2021 via Nasal Swab. No treatment was received. The outcome of events was recovering.


VAERS ID: 1668947 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-25
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: Pyrexia; Test Date: 20210825; Test Name: coronavirus test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC202101099216

Write-up: This is a spontaneous report from a contactable Pfizer colleague (patient) received via Regulatory Authority. A non-pregnant 35-year-old adult female patient received the first single dose of BNT162B2 (COMIRNATY intramuscular injection, Lot number EW4811, Expiration date 31Jul2021), on 30Jun2021 at 10:15 (the day of vaccination, at the age of 35-year-old), as Dose 1 single and second single dose of BNT162B2 (COMIRNATY intramuscular injection, Lot number EY0572, Expiration date 31Oct2021), on 21Jul2021 at 10:15 (the day of vaccination, at the age of 35-year-old), as Dose 2 single; both via an intramuscular route of administration, in the left arm, for COVID-19 immunization. The patient had no other medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 25Aug2021 at 13:00 (1month and 4 days after the vaccination), the patient had coronavirus test positive. Symptoms were pyrexia at 37.5 degrees centigrade and cough. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19, on 25Aug2021 of nasal swab and coronavirus test was positive. The outcome of the event COVID-19 was not recovered with treatment including Huscode, CALONAL, Lasvic. No follow up attempts are possible. No further information is expected. Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 cannot be excluded for the eported LOE events. The case will be reassessed once new information is available.


VAERS ID: 1669735 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: GBMODERNATX, INC.MOD20212

Write-up: Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25847299) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Fainting) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 25-Aug-2021, SYNCOPE (Fainting) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications are reported. No treatment medications are reported. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.


VAERS ID: 1669736 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25847872) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1. On 25-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and VOMITING (15mins stated felt better). At the time of the report, THROMBOSIS (blood clots) and VOMITING (15mins stated felt better) had resolved and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Lab investigation BP: 146/108 and Pulse : 93. Patient is not enrolled in clinical trial. 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.; 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: 1669743 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Headache, Myalgia, Nausea, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; Headache; Shooting pain; Fatigue; Appetite lost; Tummy ache; Generalised muscle aches; This case was received (Reference number: GB-MHRA-ADR 25850127) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Generalised muscle aches), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Shooting pain), FATIGUE (Fatigue), DECREASED APPETITE (Appetite lost) and ABDOMINAL PAIN (Tummy ache) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included PARACETAMOL for an unknown indication. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN (Shooting pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Generalised muscle aches), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Shooting pain), FATIGUE (Fatigue), DECREASED APPETITE (Appetite lost) and ABDOMINAL PAIN (Tummy ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had Redness of smallpox on vaccine site and Palpations. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.


VAERS ID: 1669747 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Injection site pain, Lymphadenopathy, Maternal exposure during breast feeding
SMQs:, Extravasation events (injections, infusions and implants) (broad), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Headache; Injection site pain; Swollen lymph nodes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25851019) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. No treatment information mentioned. 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. This case was linked to MOD-2021-299009 (Parent-Child Link). See case MOD-2021-299009 for details regarding the child case.; 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: 1669750 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-25
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002021 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest pain, Chills, Diarrhoea, Headache, Lymphadenopathy, Muscular weakness, Myocarditis, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Body tmeperature; Result Unstructured Data: increased; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: shivering; muscles cramps; chest pain; Swollen lymph nodes; Diarrhea; Headache; Shivers; Myocarditis; This case was received via RA (Reference number: GB-MHRA-ADR 25851983) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (muscles cramps), CHEST PAIN (chest pain), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (shivering), HEADACHE (Headache), CHILLS (Shivers) and MYOCARDITIS (Myocarditis) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002021) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscles cramps) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 25-Aug-2021, CHILLS (Shivers) had resolved. At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache) and MYOCARDITIS (Myocarditis) was resolving, MUSCULAR WEAKNESS (muscles cramps), CHEST PAIN (chest pain) and CHILLS (shivering) outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter stated that 12 hours after vaccination, patient had extreme shivering for 3 hours, raised temperature, head aches, muscles cramps, chest pain, inflammation of injection arm, neck and left chest, diarrhea Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1671650 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chest pain; Chest pain precordial; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25850993) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) and CHEST PAIN (Chest pain precordial) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started) on 01-Aug-2021. Concomitant products included PARACETAMOL from 01-Jan-2021 to an unknown date for Muscle pain. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced CHEST PAIN (Chest pain precordial) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant). On 26-Aug-2021, CHEST PAIN (Chest pain precordial) had not resolved. At the time of the report, CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that, chest pain comes and goes in sharp pangs in exactly the same place. Adverse reaction did not occur as a result of an exposure during pregnancy. Laboratory details included ECG, blood pressure and blood sugar. No treatment details were provided. 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1671651 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Complex regional pain syndrome, Deep vein thrombosis, Fatigue, Haematoma muscle, Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity, SARS-CoV-2 antibody test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: CHLORPHENAMINE MALEATE; GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: left; trapezius; crps; Muscle ache; feeling exhausted; Swelling; Stiffness; Pain foot; Pain neck; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25851002) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (left), SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN IN EXTREMITY (Pain foot), NECK PAIN (Pain neck), HAEMATOMA MUSCLE (trapezius), COMPLEX REGIONAL PAIN SYNDROME (crps) and MYALGIA (Muscle ache) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suppressed lactation and Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included CHLORPHENAMINE MALEATE from 25-Jan-2021 to an unknown date for Cholinergic urticaria, GABAPENTIN from 01-Apr-2014 to an unknown date for Complex regional pain syndrome. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain foot) (seriousness criterion medically significant) and NECK PAIN (Pain neck) (seriousness criterion medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (left) (seriousness criterion medically significant), HAEMATOMA MUSCLE (trapezius) (seriousness criterion medically significant), COMPLEX REGIONAL PAIN SYNDROME (crps) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (feeling exhausted). At the time of the report, DEEP VEIN THROMBOSIS (left), HAEMATOMA MUSCLE (trapezius), COMPLEX REGIONAL PAIN SYNDROME (crps), MYALGIA (Muscle ache) and FATIGUE (feeling exhausted) outcome was unknown and SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN IN EXTREMITY (Pain foot) and NECK PAIN (Pain neck) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The injection site of vaccination was left arm. Patient was diagnosed with Complex regional pain syndrome (CRPS) in the lower left limb, pain from left hip to toes leg feels on fire more so than usual. Patient had muscle ache in left trapezius and left side of neck, was feeling exhausted, could not sleep. After the first dose of vaccination, patient had rash at vaccine site 14 days after vaccine, stayed for 2 days , joints ached. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.


VAERS ID: 1671655 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Immunisation, Pyrexia, Tinnitus, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: 38 C
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: vaccination; started; evening; Pain in the site of injection; Fever; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25852451) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of IMMUNISATION (vaccination), TINNITUS (started), VOMITING (evening) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Asthma. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced IMMUNISATION (vaccination) (seriousness criterion medically significant), TINNITUS (started) (seriousness criterion medically significant), VOMITING (evening) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Pain in the site of injection). At the time of the report, IMMUNISATION (vaccination), TINNITUS (started) and VOMITING (evening) was resolving, PYREXIA (Fever) had not resolved and VACCINATION SITE PAIN (Pain in the site of injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Body temperature: 38 (High) 38 C. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. The patient had very mild pain in the site of injection. The patient also had fever, that had started in the evening of the day of vaccination and was still persisting a day afterwards. No treatment information was provided by the reporter. 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. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.; 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. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1671660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pyrexia, Vomiting
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Vomiting; Headache; Shivers; This case was received(Reference number: GB-MHRA-ADR 25853582) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL for Headache. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 25-Aug-2021, CHILLS (Shivers) had resolved. At the time of the report, PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced loss of appetite after vaccination. No relevant treatment medication information provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Limited information regarding these events and their onset dates has been provided at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Limited information regarding these events and their onset dates has been provided at this time.


VAERS ID: 1671661 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Migraine, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizzy; I felt very fatigued; My arm is swelled up where I had my vaccine; Fever; Chills; Migraine; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25853903) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PYREXIA (Fever), CHILLS (Chills) and MIGRAINE (Migraine) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Migraine. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant), FATIGUE (I felt very fatigued) and PERIPHERAL SWELLING (My arm is swelled up where I had my vaccine). At the time of the report, DIZZINESS (Dizzy) had resolved, PYREXIA (Fever), CHILLS (Chills) and MIGRAINE (Migraine) was resolving and FATIGUE (I felt very fatigued) and PERIPHERAL SWELLING (My arm is swelled up where I had my vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. The patient was not pregnant, The patient was not currently breastfeeding. The report mentioned that the patient had the vaccine on the 25th of August 2021. At around 5 pm on the 25th of August, the patient started to get really bad chills even though her body temperature was boiling. She felt very fatigued and went to bed at around 9 pm. She didn''t sleep much right the night due down to feeling dizzy with a really bad migraine and being too hot but also feeling too cold. Her arm swelled up where she had my vaccine. 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. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events Dizziness, Pyrexia, Chills and Migraine were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, these events are not considered serious. Moreover, the patient''s medical history of Migraine is a confounding factor that may play a possible contributory role.; 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. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events Dizziness, Pyrexia, Chills and Migraine were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, these events are not considered serious. Moreover, the patient''s medical history of Migraine is a confounding factor that may play a possible contributory role.


VAERS ID: 1671665 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Influenza like illness, Insomnia, Nausea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Like a bad flu; Rash with well-defined edge on shoulder; Minimal sleep; Headache; Nausea; Fever; Dizziness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25856044) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and DIZZINESS (Dizziness) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 21-Dec-2019 to 26-Dec-2019. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and INSOMNIA (Minimal sleep). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Like a bad flu) and RASH (Rash with well-defined edge on shoulder). On 26-Aug-2021, HEADACHE (Headache) was resolving, NAUSEA (Nausea), PYREXIA (Fever) and DIZZINESS (Dizziness) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Like a bad flu), INSOMNIA (Minimal sleep) and RASH (Rash with well-defined edge on shoulder) outcome was unknown. Concomitant medication and treatment medication were not reported. After first dose of vaccination patient experienced mild nausea for 4 hours that evening and 6 days later a 10cm x 20cm rash with well-defined edge on shoulder. Patient after second dose of vaccine had bad nausea for 12 hours that evening with severe headache, bad fever, mild dizziness, for 8 hours before fading. Patient had a bad flu, concentrated into primarily 8 hours and had minimal sleep until the morning of the following day and was able to go to work at 3pm. Patient has not tested positive for COVID-19 since having the vaccine. 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1671669 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Malaise, Myalgia, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: GBMODERNATX, INC.MOD20212

Write-up: worst i''ve felt whilst being ill; shaking; shivering; Body has been aching; Feverish; This case was received via regulatory authority on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (worst i''ve felt whilst being ill), TREMOR (shaking), CHILLS (shivering) and PYREXIA (Feverish) in a 34-year-old male 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 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (worst i''ve felt whilst being ill) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and MYALGIA (Body has been aching). At the time of the report, MALAISE (worst i''ve felt whilst being ill), TREMOR (shaking), CHILLS (shivering) and MYALGIA (Body has been aching) outcome was unknown and PYREXIA (Feverish) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. No concomitant medications were provided. Treatment medications was not provided. 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1676508 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-25
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chest pain; Perimyocarditis; This case was received via RA (Reference number: -MHRA-ADR 25858996) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Perimyocarditis) and CHEST PAIN (chest pain) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MYOCARDITIS (Perimyocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain). At the time of the report, MYOCARDITIS (Perimyocarditis) was resolving and CHEST PAIN (chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drugs were reported. No treatment information was reported. Chest pain early morning of 25/08/21. ECG and troponin consistent with perimyocarditis. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1676512 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: peaked at 39 C; Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25861409) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 27-Aug-2021, PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. On 25-Aug-2021, Body temperature: peaked at 39 c (High) peaked at 39 C. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medications were not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Seriousness captured from Regulatory Authority reporting.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Seriousness captured from Regulatory Authority reporting.


VAERS ID: 1676520 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Fatigue, Hallucination, Hypopnoea, Illness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hallucination; Sickness; Muscle ache; Cold sweat; Shallow breathing; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25864498) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination), ILLNESS (Sickness), MYALGIA (Muscle ache), COLD SWEAT (Cold sweat), HYPOPNOEA (Shallow breathing) and FATIGUE (Fatigue) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), HYPOPNOEA (Shallow breathing) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucination), ILLNESS (Sickness), MYALGIA (Muscle ache), COLD SWEAT (Cold sweat), HYPOPNOEA (Shallow breathing) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. After vaccination, first 10 hours was fine. Next 24-30 hours patient experienced all the events. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. 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.; 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: 1676732 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Guillain-Barre syndrome, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101129046

Write-up: Guillain-Barre syndrome; weakness; pyrexia; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 46-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 24Aug2021 (the day of vaccination) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patients detailed information was not provided. On 25Aug2021, the patient experienced pyrexia, on 27Aug2021, the patient experienced weakness and on 28Aug2021, the patient experienced Guillain-Barre syndrome. It was reported that from 25Aug2021 to 26Aug2021, the patient experienced pyrexia. On 27Aug2021, the patient experienced weakness and visited orthopedics, the patient was recommended for neurology. On 28Aug2021, the patient was diagnosed with Guillain-Barre syndrome by a privacy physician of a privacy Hospital, the department of neurology. The information was informed from the pharmacist (the report) of the hospital, the pharmacist confirmed the details and had an examination. The outcome of events was unknown. The physician who diagnosed the patient send the detail information as PMDA to Ministry of Health, Labour and Welfare, follow-up report was refused. It was unknown whether the events was caused by the BNT162B2 or not. The seriousness was not provided. It was unknown whether the events related to the BNT162B2 or not. The adverse events occurred after using the product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Guillian barre syndrome cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1676862 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904784

Write-up: BRADYCARDIA; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102829] concerned a 20 year old male patient of unspecified race and ethnicity . The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A and expiry: unknown) dose was not reported, 1 total, administered on 25-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, at 09:00, the patient experienced symptoms of bradycardia, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bradycardia, and dizziness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210904784-COVID-19 VACCINE AD26.COV2.S- Bradycardia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1678072 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Disturbance in attention, Dizziness, Dizziness postural, Dysarthria, Ear pain, Head discomfort, Headache, Hyperhidrosis, Migraine, Palpitations, Pyrexia, SARS-CoV-2 test, Sinus pain, Spinal pain, Sweating fever
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest ache; Migraine; Heart racing; Sweating; Dizzy on standing; Dizziness; Slurred speech; Concentration loss; Fever; Sweating fever; Ear ache; Headache; Pain in spine; Sinus pain; Head pressure; This case was received via regulatory authority on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever), HEADACHE (Headache), EAR PAIN (Ear ache), PYREXIA (Fever), SPINAL PAIN (Pain in spine), SINUS PAIN (Sinus pain), HEAD DISCOMFORT (Head pressure), CHEST PAIN (Chest ache), MIGRAINE (Migraine), PALPITATIONS (Heart racing), HYPERHIDROSIS (Sweating), DIZZINESS POSTURAL (Dizzy on standing), DIZZINESS (Dizziness), DYSARTHRIA (Slurred speech) and DISTURBANCE IN ATTENTION (Concentration loss) 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 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), EAR PAIN (Ear ache) (seriousness criterion medically significant), SPINAL PAIN (Pain in spine) (seriousness criterion medically significant), SINUS PAIN (Sinus pain) (seriousness criterion medically significant) and HEAD DISCOMFORT (Head pressure) (seriousness criterion medically significant). On an unknown date, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHEST PAIN (Chest ache) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), DYSARTHRIA (Slurred speech) (seriousness criterion medically significant) and DISTURBANCE IN ATTENTION (Concentration loss) (seriousness criterion medically significant). At the time of the report, SWEATING FEVER (Sweating fever), EAR PAIN (Ear ache), PYREXIA (Fever), SPINAL PAIN (Pain in spine), CHEST PAIN (Chest ache), PALPITATIONS (Heart racing) and DYSARTHRIA (Slurred speech) had resolved, HEADACHE (Headache), SINUS PAIN (Sinus pain), HEAD DISCOMFORT (Head pressure) and MIGRAINE (Migraine) had not resolved and HYPERHIDROSIS (Sweating), DIZZINESS POSTURAL (Dizzy on standing), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Concentration loss) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product usage were not provided. Treatment details were not provided. 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.; 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: 1678102 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005240 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, Myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis, Suspicion of myocardial infarction; Myocarditis, Suspicion of myocardial infarction; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP081824) on 27-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case was reported by a physician via a medical representative. On an unknown date, the patient received the 1st dose of this vaccine. On 22-Aug-2021, at 15:00, the patient received the 2nd dose of this vaccine. On 23-Aug-2021, pyrexia developed. On 24-Aug-2021, although pyrexia was alleviated, chest pain and difficulty in breathing developed. On 25-Aug-2021, feeling queasy and back pain also developed, and the patient visited the reporting hospital. Myocarditis and myocardial infarction were suspected. Blood test and echography were performed. On an unknown date, the patient was transferred to another hospital and had continued to be hospitalized. The outcome of Myocarditis and suspicion of myocardial infarction was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a report of serious cardiac events in a 29 years old male whose medical history was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.


VAERS ID: 1678112 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial tachycardia, Body temperature, Chest pain, Echocardiogram, Electrocardiogram, Heart rate, Pyrexia, Troponin, Ventricular extrasystoles
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Temperature; Result Unstructured Data: 38 degree Celsius; Test Date: 2021; Test Name: Echocardiography; Result Unstructured Data: no abnormalities; Test Date: 2021; Test Name: ECG; Result Unstructured Data: no ST changes; Test Date: 20210825; Test Name: heart rate; Result Unstructured Data: 150-200 bpm; Test Date: 2021; Test Name: Troponin test; Test Result: Negative; Result Unstructured Data: Negative
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Atrial tachycardia; Ventricular extrasystoles; Pyrexia; Chest pain; This case was received via Pharmaceuticals (Reference number: 2021TJP085897) on 27-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case, initially reported to the Devices Agency (DA) by a pharmacist, was received via the DA (Ref, v21125004). On an unknown date, the patient received the 1st dose of this vaccine. On 24-Aug-2021, at 10:30, the patient received the 2nd dose of this vaccine. On 25-Aug-2021, at 03:00, the patient had pyrexia in the upper 38s degrees Celsius. The patient noted chest pain and palpitations visited a nearby physician. Atrial tachycardia with heart rate (HR) of 150 to 200 bpm and frequent ventricular extrasystoles were noted. Verapamil hydrochloride was injected intravenously, but the symptoms did not resolve, and the patient was referred to a hospital and admitted the hospital. During the course of events, troponin was negative, ECG showed no ST changes, and echocardiography showed no abnormalities; thus, myocarditis was considered negative. Fever was alleviated with fluid replacement and oral administration of acetaminophen, and the symptoms of arrhythmia disappeared with the alleviation of fever. The outcome of pyrexia, ventricular extrasystoles, and atrial tachycardia was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This is a report of serious Ventricular extrasystoles and other events in an 18 years old male, whose medical history was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1678621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101119047

Write-up: Tachycardia; arrhythmic; This is a spontaneous report from a non-contactable consumer (Family member) via Pfizer sales representative. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced tachycardia and arrhythmic, both on 25Aug2021. The outcome of the events was unknown. Clinical course: 67 years old male. Tachycardia and arrhythmic post vaccination. Patient sent to hospital, for full cardio work up. Patient put on rate limiting medication and sent for consult for a possible cardio version. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1679983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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:
Current Illness: Melanoma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Negative
CDC Split Type: FRJNJFOC20210907367

Write-up: URTICARIA GIANT; This spontaneous report received from a physician via a Regulatory Authority (Regulatory Authority, FR-AFSSAPS-TO20217356) on 02-SEP-2021 and concerned a 59 year old male. The patient''s weight was 95 kilograms, and height was 164 centimeters. The patient''s concurrent conditions included melanoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 dosage forms, 1 total administered on 20-AUG-2021 for covid-19 vaccination.The drug start period was reported as 6 days. Duration of drug administration was reported 1 day. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-AUG-2021, the patient experienced urticaria giant. Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from urticaria giant. This report was serious (Other Medically Important Condition).


VAERS ID: 1680007 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-08-25
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; This case was received Reference number: GB-MHRA-ADR 25851991) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002621) for COVID-19 vaccination. No Medical History information was reported. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter. Patient experienced debilitating headache.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Very limited information regarding this event has been provided at this time


VAERS ID: 1680507 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Insomnia, Mouth ulceration, Pyrexia, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: flemmy throat; Sleeplesness; Fatigue; Injection site pain; High temperature; This case was received via regulatory authority (Reference number: 25845298) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplesness), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain), MOUTH ULCERATION (flemmy throat) and PYREXIA (High temperature) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (Sleeplesness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and MOUTH ULCERATION (flemmy throat) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Sleeplesness), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain) and MOUTH ULCERATION (flemmy throat) outcome was unknown and PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: no (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment medications provided. The reporter reported that patient experienced High temperature, very sore arm, flemmy throat, feeling very tired and unable to sleep. Patient was not tested positive for COVID-19 since having the vaccine and also Patient was not enrolled in clinical trial. 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..; 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: 1680526 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; IMPLANON
Current Illness: Mixed anxiety and depressive disorder; Polycystic ovary
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: hours; nausea; receiving; Vomiting; Diarrhoea; This case was received via RA (Reference number: -MHRA-ADR 25850997) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), FEELING ABNORMAL (hours), VOMITING (Vomiting), NAUSEA (nausea) and PYREXIA (receiving) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Mixed anxiety and depressive disorder and Polycystic ovary. Concomitant products included CITALOPRAM from November 2014 to an unknown date for Mixed anxiety and depressive disorder, ETONOGESTREL (IMPLANON) from July 2018 to an unknown date for Polycystic ovary. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (hours) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant) and PYREXIA (receiving) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea) had resolved with sequelae, FEELING ABNORMAL (hours), NAUSEA (nausea) and PYREXIA (receiving) had resolved and VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced diarrhoea 4 hours after receiving the vaccine. It occured again after another 4 hours followed by nausea and vomiting.Nausea occured 8 hours after receiving the vaccine and resolved soon after vomiting. Patient vomited only once. Patient has not tested positive for COVID-19 since having the vaccine. Treatment information were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.; 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. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1680531 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

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

Write-up: lost consciousness; pale; Faint; This case was received via MHRA (Reference number: GB-MHRA-ADR 25855263) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness) and SYNCOPE (Faint) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant) and PALLOR (pale). On 25-Aug-2021, SYNCOPE (Faint) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness) and PALLOR (pale) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was not enrolled in clinical trial. No concomitant medication details was provided. Patient, after about 5 minutes lost consciousness while sat on the chair and went very pale and was moved onto the floor and came around once his legs were elevated. No treatment medication details was provided. 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.; 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: 1680913 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPPFIZER INC202101098894

Write-up: Afebrile Clonic-tonic convulsions; This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority. A 13-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) intramuscular, administered in Arm Left on 24Aug2021 12:00 AM (as reported) (at the age of 13 years old) (Lot Number: FF3622; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunisation. Patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. On 25Aug2021 at 08:00, the patient experienced Afebrile Clonic-tonic convulsions. Last for 2 minutes. The event resulted in Doctor or other healthcare professional office/clinic visit. The reporter classified the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered without treatment on 25Aug2021 08:02.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event generalized tonic-clonic seizures and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1680957 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cold sweat, Depressed level of consciousness, Hyperventilation, Hypoaesthesia, Nausea, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (20 years ago Food allergy (with numbness)); Numbness (20 years ago Food allergy (with numbness))
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:around 90; Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:111/92; Comments: improved; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210825; Test Name: SPO2; Result Unstructured Data: Test Result:reduced to 80% %; Test Date: 20210825; Test Name: SPO2; Test Result: 98 %; Comments: improved
CDC Split Type: JPPFIZER INC202101103872

Write-up: Anaphylaxis; consciousness decreased; queasy; cold sweat; SPO2 was reduced to 80%; hyperpnoea; Numbness of limbs; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124715. The patient was a 36-year-old male. On 25Aug2021 at 10:54 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) at the age of 36-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.1 degrees Centigrade (25Aug2021). There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status): 20 years ago, Food allergy (with numbness). Concomitant medication was not reported. On 25Aug2021 at 11:05 (the day of vaccination), the patient experienced anaphylaxis. On 25Aug2021(the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: About 10 minutes after vaccination, queasy and cold sweat appeared. Blood pressure was around 90. SPO2 was reduced to 80%. It also makes the patient felt consciousness decreased. Drinking water was possible, and the patient ingested as much as possible. There is also hyperpnoea, and numbness of limbs appeared. After follow-up, blood pressure and SPO2 improved. The final vital is SPO2 98%, blood pressure 111/92. Observation time was about 30 minutes. Patient was recovered from the events on 25Aug2021. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases: unknown. The reporting physician commented as follows: nothing special. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680994 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004734 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram, Echocardiogram, Electrocardiogram, Myocarditis, Oxygen saturation, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38.7? Celsius; Test Date: 20210825; Test Name: blood pressure measurement; Test Result: Inconclusive ; Result Unstructured Data: 114/71 mmHg; Test Date: 20210825; Test Name: SpO2; Test Result: Inconclusive ; Result Unstructured Data: 98%; Test Date: 20210825; Test Name: electrocardiogram; Result Unstructured Data: abnormal; ST elevation; Test Date: 20210825; Test Name: echocardiography; Result Unstructured Data: abnormal; ventricular motion disorder; Test Date: 20210825; Test Name: coronary CT; Test Result: Negative ; Result Unstructured Data: no thrombus
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; Pericarditis; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP084948) on 28-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21125064). On an unknown date, the patient received the 1st dose of the vaccine. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 23-Aug-2021, at 13:45, the patient received the 2nd dose of the vaccine. At night, the patient experienced pyrexia of 38.7 degrees Celsius. On 24-Aug-2021, pyrexia subsided. On 25-Aug-2021, at 12:00, the patient had chest pain which was noted both on exertion and at rest. Dyspnea did not develop. The patient visited a health management center. On arrival, BP 114/71 mmHg, P 79, SpO2 98%, and KT 36.7 degrees Celsius. Twelve-lead electrocardiogram was performed and revealed ST elevation, and the patient visited a nearby physician. At the nearby hospital, electrocardiogram was performed and showed ST elevation. An echocardiography revealed no apparent disorder in ventricular wall motion. A blood test revealed elevated cardiac deviation enzymes. A coronary CT showed no signs of thrombus. The patient was diagnosed with probable myocarditis and pericarditis after administration of this vaccine. On 27-Aug-2021, the symptoms were ongoing and unchanged. The outcome of myocarditis and pericarditis was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a RA report of Myocarditis and Pericarditis 1 day after receiving the second dose of the product, in a 19 years old male whose medical history was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Date of first dose was not provided, thus appropriateness of product administration schedule is not assessable.


VAERS ID: 1682325 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111784

Write-up: Rectal bleeding; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251901345690-ICMNP. Safety Report Unique Identifier GB-MHRA-ADR 25849376. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FE8087), dose 2 via an unspecified route of administration on 25Aug2021 as dose 2, single for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as dose 1, single for COVID-19 immunization. The patient experienced rectal bleeding on 25Aug2021.. Bright red blood when passing stools. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the event was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682336 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Migraine, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117855

Write-up: Acute migraine; Joint ache; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261108145320-AD7VP. Safety Report Unique Identifier GB-MHRA-ADR 25853050. A 24-years-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection) via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. The patient previously received BNT162B2 for COVID-19 immunisation (dose number: 1). On 25Aug2021 the patient experienced nausea and on 26Aug2021, experienced acute migraine, joint ache. The patient underwent lab tests and procedures which included COVID-19 virus test with no-negative covid-19 test. The outcome of the events were resolving. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1682343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117628

Write-up: pain in my arm; swelling in my armpit; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261259485280-H5703, Safety Report Unique Identifier GB-MHRA-ADR 25853661. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087), dose 2 via an unspecified route of administration on 24Aug2021 as a single dose for COVID-19 immunization. Medical history included lactation decreased. The patient''s historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced pain in my arm and swelling in my armpit on 25Aug2021. Had pain in my arm from the evening of the vaccine until now about 48 hours on. Yesterday evening - when more than 24 hours had passed, she noticed swelling in my armpit closest to the arm she received her vaccine in. Patient spoke to 111 and they suggested she speak to my GP. Had a telephone appointment with the Nurse today almost 48 hours after vaccine and suggested it might be a swollen lymph node. Has suggested monitoring it until tomorrow and then seeing he doctor if it''s no better. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative (No - Negative COVID-19 test) on 25Aug2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Migraine, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101117735

Write-up: Lymph node pain; Migraine headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261546467530-QNYJ6. [Safety Report Unique Identifier: GB-MHRA-ADR 25864474] A 22-year-old female patient received second dose of BNT162B2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, lot number and expiry date: not reported) dose 2 via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from 15Jul2021 to 22Jul2021. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, lot number and expiry date: not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced migraine headache. On 26Aug2021, the patient experienced lymph node pain. On 16Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of migraine headache was recovered on 26Aug2021. The outcome of lymph node pain was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1682365 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Migraine, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117612

Write-up: Fever; Migraine; Dizzy spells; Joint ache; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262257544930-AB8VZ, Safety Report Unique Identifier GB-MHRA-ADR 25857077. A patient of unspecified age and gender received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: FE3380) via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history of Migraine was reported. Allergic to penicillin - had anaphylactic response to taking it 3 years ago. Allergic to ibuprofen - makes me vomit Allergic to cefaclor (drug only given to infants) - severe rash. Patient has not had symptoms associated with COVID-19.Concomitant medication(s) included paracetamol taken for migraine, start and stop date were not reported. The patient experienced fever on 26Aug2021, nausea on 25Aug2021, migraine on 26Aug2021, dizzy spells on 26Aug2021 and joint ache on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Additional information: All symptoms started in the night, 4 hours after having vaccine, others started when woke up 12 hours later. Temperature of 39.9 with still increasing throughout day. Taken paracetamol at regular intervals. Allergic to penicillin, ibuprofen and cefaclor. Seems a more extreme reaction compared to those around the patient - family/friends. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of fever, nausea, dizzy spells and joint ache was not recovered. The outcome of migraine was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1683437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Nausea, Pallor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood pressure decreased; Result Unstructured Data: Test Result:72 mmHg; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101106109

Write-up: Anaphylactic shock; Blood pressure decreased to 72 mmHg; pallor of the face; Feeling queasy; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 33-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient experienced anaphylactic shock, blood pressure decreased to 72 mmhg, pallor of the face, feeling queasy on 25Aug2021 with outcome of recovering. Therapeutic measures were taken as a result of all events. Clinical course: On 25Aug2021 (after the vaccination), the patient experienced Anaphylactic shock: blood pressure decreased to 72 mmHg, pallor of the face and feeling queasy. As a subsequent treatment, bosmin injection was performed. The events were recovering after a while. After that the patient came home by car. The reporter classified the events as non-serious. The reporter stated that the events were definitely related to the BNT162B2. The lot number for the vaccine, 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 Anaphylactic shock, Blood pressure decreased , Pallor and Nausea 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: 1685824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Malaise
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101103593

Write-up: woke up with chest pain; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN)), via an unspecified route of administration on 24Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Aug2021, the patient woke up with chest pain and feeling unwell due to which the patient visited emergency room. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1685921 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7208 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Inappropriate schedule of product administration, Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLANAX [NAPROXEN SODIUM]; VITAMIN D NOS; TOPIRAMATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Arthritis; Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101109269

Write-up: edema on the face; swelling of the mouth on the right side; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient) received through COVAES portal. The patient reported events after first and second dose of the vaccine. This case is for event after the second dose. A 49-year-old female patient (not pregnant) received second dose of bnt162b2 (COMIRNATY; Lot Number: FD7208) via an unspecified route of administration in Arm Left on 25Aug2021 at 03:15 am (at 49 years) as single dose for covid-19 immunisation. Medical history included arthritis, epilepsy and she was very allergic (unspecified). No covid prior to vaccination and not tested post vaccination. Concomitant medications included (FLANAX), vitamin D nos and topiramate, and Hair, Skin and Nails v (as reported), all taken for an unspecified indication, start and stop date were not reported. Previously on 25May2021 at 12:00 am patient took the first dose of the vaccine (lot FA7478) in right arm for covid-19 immunisation and experienced hives all over body, red patches and lips started to swell.On 26Aug2021 at 03:45 am the patient experienced edema on the face and swelling of the mouth on the right side described as follows: After the 2nd dose she had edema on the face at the same morning with swelling of the mouth on the right side - lips and face on the left side near the eyes. Patient took antiallergic. Outcome of the events was not recovered.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101115916 Same reporter, patient, product, but different dose and AE.


VAERS ID: 1685942 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dental discomfort, Fatigue, Intracranial pressure increased, Nausea, Pain in extremity, Sleep disorder, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia areata; Autoimmune disorder; Bee sting hypersensitivity; Endometriosis; Illness (gets extremely ill taking hormones/birth control/estrogen etc); IV flush (I also coded for an unknown reason from an I.V flush 5 months ago before a surgery); Penicillin allergy; Rosacea; Sulfonamide allergy; Surgery (I also coded for an unknown reason from an I.V flush 5 months ago before a surgery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101108959

Write-up: Cranial pressure strong enough to feel pressure in top row of teeth stemming from top of head; Cranial pressure strong enough to feel pressure in top row of teeth stemming from top of head; Delay in processing visually; Nausea that woke me up out of a deep sleep; Nausea that woke me up out of a deep sleep; Sore arm; Fatigue; This is a spontaneous report received from a contactable (Other healthcare Professional) who is also the Patient for a 29-year-old (female) patient. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD7204), dose 1 via an unspecified route of administration, administered in Arm Left on 25Aug2021 19:30 (at the age of 29-years-old) as dose 1, single for covid-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included Alopecia areata, rosacea, endometriosis. Undiagnosed autoimmune disorder where my body rejects and gets extremely ill taking hormones/birth control/estrogen etc. also coded for an unknown reason from an I.V flush 5 months ago before a surgery. The patient had allergy to penicillin, amoxicillin, sulpha, sulpha drugs and bee stings. Concomitant medication(s) received within 2 weeks of vaccination included ibuprofen (ongoing) for an unspecified indication. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Aug2021 20:45, the patient had cranial pressure strong enough to feel pressure in top row of teeth stemming from top of head. Nausea that woke her up out of a deep sleep. Delay in processing visually. Fatigue. Sore arm. No hospitalization prolonged. The patient did not receive any treatment. Outcome of the event was not recovered. Device Date was 26Aug2021.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the event Intracranial pressure increased and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1686872 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: FRMODERNATX, INC.MOD20213

Write-up: Anaphylactic reaction; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NT20213521) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214021) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. It was reported that the patient had no postpartum plus 4 months company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Translation received on 07-Sep-2021, contains No Significant Information; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


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