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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 362 out of 6,867

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VAERS ID: 1489957 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Difficulty sleeping; Wheezy; This regulatory authority case was reported by a non-health professional and describes the occurrence of INSOMNIA (Difficulty sleeping) and WHEEZING (Wheezy) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant) and WHEEZING (Wheezy) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Difficulty sleeping) and WHEEZING (Wheezy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information 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. Events seriousness was captured as per Regulatory Authority assessment in 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 was captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1489966 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cough, Fatigue, Night sweats
SMQs:, Anaphylactic reaction (broad), Arthritis (broad)

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

Write-up: Cough weak; Night sweats; Aching joints; Fatigue; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough weak), NIGHT SWEATS (Night sweats), ARTHRALGIA (Aching joints), FATIGUE (Fatigue) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002615) for COVID-19 vaccination. No Medical History information was reported. On 14-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 15-Jul-2021, the patient experienced COUGH (Cough weak) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, COUGH (Cough weak), NIGHT SWEATS (Night sweats), ARTHRALGIA (Aching joints), FATIGUE (Fatigue) and CHILLS (Chills) was resolving. 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. Action taken with mRNA-1273 in response to the events was not applicable.; 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: 1489969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bacille Calmette-Guerin scar reactivation, Inflammation
SMQs:

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

Write-up: inflammation; BCG scar inflammation; This regulatory authority case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation) and BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-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 15-Jul-2021, the patient experienced BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar inflammation). On an unknown date, the patient experienced INFLAMMATION (inflammation). At the time of the report, INFLAMMATION (inflammation) was resolving and BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar inflammation) had not resolved. Concomitant medications were not reported Treatment medications were not reported. . Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; 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: 1489995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: GALFER
Current Illness: Anemia iron deficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Felt very poorly; Felt faint; Fainted 3 times; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint) and SYNCOPE (Fainted 3 times) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia iron deficiency. Concomitant products included FERROUS FUMARATE (GALFER) from 27-May-2021 to an unknown date for Anemia iron deficiency. On 14-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 15-Jul-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant). 15-Jul-2021, the patient experienced SYNCOPE (Fainted 3 times) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Felt very poorly). On 15-Jul-2021, SYNCOPE (Fainted 3 times) had resolved. On 16-Jul-2021, DIZZINESS (Felt faint) had resolved. At the time of the report, FEELING ABNORMAL (Felt very poorly) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient has not tested positive for COVID-19 since having the vaccine, patient is not enrolled in clinical trial No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1490165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       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? 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: COPFIZER INC2021901228

Write-up: positive for COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021 the patient experienced positive for COVID-19 patient wanted to know if this could affect the application of the second dose and what to do in this case.The outcome of the event COVID-19 was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1490903 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Extreme tobacco craving
Current Illness: Nothing
Preexisting Conditions: Nothing
Allergies: Not tobacco
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 1491047 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: Miscarriage 3 days after vaccine (1st trimester loss)


VAERS ID: 1492163 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Pyrexia, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: MIRTAZAPINE; VENLAFAXINE; YASMIN
Current Illness: Underweight (BMI is 15.3)
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Thirst; Fever; Headache; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of THIRST (Thirst), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Underweight (BMI is 15.3). Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) for Birth control, MIRTAZAPINE and VENLAFAXINE for Depression. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced THIRST (Thirst) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, THIRST (Thirst) and PYREXIA (Fever) was resolving and HEADACHE (Headache) and MYALGIA (Muscle ache) had not resolved. No treatment information was provided. Patient reported the muscle ache is really bad and is patient''s whole body, like with flu. Never got this with first dose. 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: 1492167 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Myalgia, Pyrexia, SARS-CoV-2 test, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hives; Chills; Muscle ache; temperature elevated; Pain chest; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives), CHEST PAIN (Pain chest), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (temperature elevated) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced CHEST PAIN (Pain chest) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (temperature elevated) (seriousness criterion medically significant). On 16-Jul-2021, CHEST PAIN (Pain chest) had resolved. At the time of the report, URTICARIA (Hives) had resolved and CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (temperature elevated) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. 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: 1492169 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: EVOREL SEQUI; PARACETAMOL; SERTRALINE
Current Illness:
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: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Generalised muscle aches; Fever; Fatigue; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Generalised muscle aches) and PYREXIA (Fever) in a 44-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. Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (EVOREL SEQUI), PARACETAMOL and SERTRALINE for an unknown indication. On 15-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 15-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue), MYALGIA (Generalised muscle aches) and PYREXIA (Fever) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. 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 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. No further information is expected 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 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. No further information is expected at this time.


VAERS ID: 1492173 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Itchy rash; Swelling; This regulatory authority case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and SWELLING (Swelling) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Swelling. Concomitant products included FLUCLOXACILLIN for Swelling. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown and SWELLING (Swelling) 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. It was reported that patient was seen by pharmacist and General practitioner. Treatment medication were not reported. 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: 1492178 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Menstruation irregular, Muscle spasms, Polycystic ovaries, Pulmonary embolism
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; BUSCOPAN; CERAZETTE; LOPERAMIDE; MEBEVERINE; MEFENAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Polycystic ovarian syndrome; Stomach cramps (Buscopan was only used to treat it if the patient had stomach cramps)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: clot; bleeding; pcos; cramps; Irregular periods; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (clot) and HAEMORRHAGE (bleeding) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Stomach cramps (Buscopan was only used to treat it if the patient had stomach cramps), Lactation decreased, Polycystic ovarian syndrome and Anxiety. Concomitant products included DESOGESTREL (CERAZETTE) from 05-Dec-2004 to an unknown date for Heavy periods, HYOSCINE BUTYLBROMIDE (BUSCOPAN) from 25-Jun-2021 to an unknown date, LOPERAMIDE from 27-Mar-2020 to an unknown date and MEBEVERINE from 28-Jun-2021 to an unknown date for Irritable bowel syndrome, AMITRIPTYLINE from 25-Oct-2016 to an unknown date and MEFENAMIC ACID from 25-Oct-2016 to an unknown date for Polycystic ovarian syndrome. On 01-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 15-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular periods). On an unknown date, the patient experienced PULMONARY EMBOLISM (clot) (seriousness criterion medically significant), HAEMORRHAGE (bleeding) (seriousness criterion medically significant), POLYCYSTIC OVARIES (pcos) and MUSCLE SPASMS (cramps). At the time of the report, PULMONARY EMBOLISM (clot), HAEMORRHAGE (bleeding), POLYCYSTIC OVARIES (pcos) and MUSCLE SPASMS (cramps) was resolving and MENSTRUATION IRREGULAR (Irregular periods) had not resolved. Patient has not tested positive for COVID-19 since having the vaccine, has not had symptoms associated with COVID-19, has not had a COVID-19 test, is not pregnant, and is not currently breastfeeding. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the events has been provided at this time. Case causality is confounded by underlying polycystic ovarian syndrome.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Case causality is confounded by underlying polycystic ovarian syndrome.


VAERS ID: 1492179 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Chills, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: BECLOMETASONE; SALBUTAMOL
Current Illness:
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.MOD20212

Write-up: anxiety; chills; Migraine; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), ANXIETY (anxiety), CHILLS (chills) and PYREXIA (Fever) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concomitant products included BECLOMETASONE and SALBUTAMOL for Asthma. On 15-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 15-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (anxiety) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 16-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, MIGRAINE (Migraine) had not resolved and ANXIETY (anxiety) and CHILLS (chills) outcome was unknown. 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.. 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: 1492184 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac discomfort, Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Headache, Heart rate, Heart rate abnormal, Illness, Loss of consciousness, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: ECG; Result Unstructured Data: results were poor; Test Date: 20210715; Test Name: Heart rate; Result Unstructured Data: abnormal
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sickness; vomiting; Blackout; Chest pain; Shortness of breath; Heart pressure sensation of; Dizziness; Headache; Fever; Vomited; Heart rate abnormal; Stopped breathing; This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CARDIAC DISCOMFORT (Heart pressure sensation of), DIZZINESS (Dizziness), ILLNESS (sickness), VOMITING (vomiting), HEADACHE (Headache), PYREXIA (Fever), VOMITING (Vomited), HEART RATE ABNORMAL (Heart rate abnormal) and RESPIRATORY ARREST (Stopped breathing) in a 27-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 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization and medically significant), CARDIAC DISCOMFORT (Heart pressure sensation of) (seriousness criteria hospitalization and medically significant), PYREXIA (Fever) (seriousness criteria hospitalization and medically significant), VOMITING (Vomited) (seriousness criteria hospitalization and medically significant), HEART RATE ABNORMAL (Heart rate abnormal) (seriousness criterion hospitalization) and RESPIRATORY ARREST (Stopped breathing) (seriousness criteria hospitalization and medically significant). 15-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criteria hospitalization and medically significant) and HEADACHE (Headache) (seriousness criteria hospitalization and medically significant). On 16-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ILLNESS (sickness) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced VOMITING (vomiting) (seriousness criteria hospitalization and medically significant). On 15-Jul-2021, VOMITING (Vomited), HEART RATE ABNORMAL (Heart rate abnormal) and RESPIRATORY ARREST (Stopped breathing) had resolved. On 16-Jul-2021, DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Blackout) had resolved, CHEST PAIN (Chest pain) was resolving, DYSPNOEA (Shortness of breath), CARDIAC DISCOMFORT (Heart pressure sensation of) and HEADACHE (Headache) had resolved with sequelae and ILLNESS (sickness) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Electrocardiogram: (abnormal) results were poor. On 15-Jul-2021, Heart rate: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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: 1492190 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Back pain, Bone pain, Confusional state, Delirium, Diarrhoea, Dyspnoea, Headache, Illness, Lymphadenopathy, Miliaria, Oropharyngeal pain, Peripheral swelling, Pyrexia, Rash, Rash papular, Renal pain, Swelling, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Generalized raised red spots limbs; Confusion; Sore throat; Sickness; Kidney pain; Heat rash; Diarrhea; Patchy rash; Swollen glands; Backache; Breathlessness; Bone pain; Delirious; High temperature; Armpit pain; Headache; Fever chills; Swollen arm; Swelling; Swollen of face feeling; Fingers swollen feeling of; This regulatory authority case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious), OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling), ILLNESS (Sickness), RENAL PAIN (Kidney pain), PERIPHERAL SWELLING (Swollen arm), BACK PAIN (Backache), DYSPNOEA (Breathlessness), BONE PAIN (Bone pain), RASH PAPULAR (Generalized raised red spots limbs), CONFUSIONAL STATE (Confusion), SWELLING FACE (Swollen of face feeling), PERIPHERAL SWELLING (Fingers swollen feeling of), MILIARIA (Heat rash), DIARRHOEA (Diarrhea), RASH (Patchy rash), LYMPHADENOPATHY (Swollen glands), PYREXIA (High temperature), AXILLARY PAIN (Armpit pain), HEADACHE (Headache) and PYREXIA (Fever chills) in a 44-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. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), SWELLING FACE (Swollen of face feeling) (seriousness criterion medically significant), PERIPHERAL SWELLING (Fingers swollen feeling of) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), RENAL PAIN (Kidney pain) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant), DYSPNOEA (Breathlessness) (seriousness criterion medically significant), BONE PAIN (Bone pain) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), MILIARIA (Heat rash) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), RASH (Patchy rash) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced RASH PAPULAR (Generalized raised red spots limbs) (seriousness criterion medically significant). At the time of the report, DELIRIUM (Delirious), SWELLING (Swelling), DYSPNOEA (Breathlessness), SWELLING FACE (Swollen of face feeling), PERIPHERAL SWELLING (Fingers swollen feeling of), DIARRHOEA (Diarrhea), PYREXIA (High temperature) and PYREXIA (Fever chills) was resolving, OROPHARYNGEAL PAIN (Sore throat), RENAL PAIN (Kidney pain), PERIPHERAL SWELLING (Swollen arm), BACK PAIN (Backache), BONE PAIN (Bone pain), RASH PAPULAR (Generalized raised red spots limbs), CONFUSIONAL STATE (Confusion), MILIARIA (Heat rash), RASH (Patchy rash), LYMPHADENOPATHY (Swollen glands) and AXILLARY PAIN (Armpit pain) had not resolved and ILLNESS (Sickness) and HEADACHE (Headache) had resolved. 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: 1493313 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea, Pain in extremity, 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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; Nausea; High temperature; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), PYREXIA (High temperature) and PAIN IN EXTREMITY (Painful arm) in a 38-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 15-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 15-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (High temperature) was resolving and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2020, SARS-CoV-2 test: Positive. No concomitant medication information was mentioned. No treatment medication information was 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.; 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: 1493314 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever; Generalised muscle aches; Headache; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Generalised muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-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 15-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), MYALGIA (Generalised muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication information provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relevant treatment medication information 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. This case was linked to MOD-2021-261615. See case MOD-2021-261615 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: 1493318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TINZAPARIN SODIUM
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age 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 Suspected COVID-19 (Unsure when symptoms stopped) on 14-Mar-2020. Concurrent medical conditions included Pregnancy. Concomitant products included TINZAPARIN SODIUM from 15-May-2021 to an unknown date for Pregnancy. On 15-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 15-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). At the time of the report, HEADACHE (Headache) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Concomitant and treatment information not provided. Company Comment: This is a case of product exposure during pregnancy with associated AE of headache 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 of event was captured as provided by RA assessment.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of headache 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 of event was captured as provided by RA assessment.


VAERS ID: 1493567 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: DEJNJFOC20210739799

Write-up: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via company representative concerned a 3 decade old male. Initial information was processed along with the additional information received on 21-JUL-2021 The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cough, sniff and fever, and he was getting better steadily. Since 15-JUL-2021, the patient was in quarantine and had a high viral load. On the same day, he was tested positive for COVID-19 PCR test (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000186702.; Sender''s Comments: V0: 20210739799-Covid-19 vaccine -confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1496343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Platelet count decreased, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 2021; Test Name: platelet count; Result Unstructured Data: Test Result:Low; Comments: low platelet counts
CDC Split Type: GBPFIZER INC2021906977

Write-up: Faint; blood clots; low platelet counts; This is a spontaneous report from a contactable other healthcare professional received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151105436470-RIV3R, Safety Report Unique Identifier GB-MHRA-ADR 25655402. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ Lot Number: FA1027 and Expiration date was unknown), via an unspecified route of administration on 15Jul2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. On an unknown date in 2021, the patient experienced blood clots and low platelet counts. On 15Jul2021, the patient had faint. The patient underwent lab tests and procedures which included platelet count: low unknown date in 2021 (low platelet counts). The outcome of the event faint was recovered on 15Jul2021, and the other events were unknown. Reaction Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1496351 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: NAPROXEN
Current Illness: Arm injury
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feeling achy; Chills; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Feeling achy), CHILLS (Chills) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Arm injury. Concomitant products included NAPROXEN for Arm injury. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Feeling achy) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, MYALGIA (Feeling achy) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1496356 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-07-15
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Hyperhidrosis, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Sore throat; Drenching sweats; Feverish; Joint ache; Muscle ache; Headache; fever chills; This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Drenching sweats), PYREXIA (Feverish), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), HYPERHIDROSIS (Drenching sweats) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). 15-Jul-2021, the patient experienced PYREXIA (fever chills). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Drenching sweats), PYREXIA (Feverish) and PYREXIA (fever chills) was resolving and ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment information was provided. Patient had a negative Covid-19 test on an unknown date. Based on the current available information a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information a causal relationship cannot be excluded.


VAERS ID: 1496357 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and PYREXIA (Fever) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. Concomitant products included RAMIPRIL from 08-Jan-2021 to an unknown date for Hypertension. On 15-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 15-Jul-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. Batch number was unknown. Treatment medications were not provided. Action taken was not applicable. 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: 1496379 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Dizziness; 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 DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications information was not reported. Treatment information was not reported. 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. No further information is expected 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1496410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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: No medical history was reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Impetigo; This regulatory authority case was reported by a consumer and describes the occurrence of IMPETIGO (Impetigo) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced IMPETIGO (Impetigo) (seriousness criterion medically significant). At the time of the report, IMPETIGO (Impetigo) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant information was not provided. It was reported that patient developed Impetigo to right eye area 8 days post first vaccine. Patient was Seen by GP who prescribed him antibiotics. 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 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 the event, a causal relationship cannot be excluded.


VAERS ID: 1497628 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Body temperature, Headache, Myalgia, Oropharyngeal pain, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: The high temperature went up to 39C and lasted a couple of days.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sore throat; Backache; Headache; High temperature; Swelling arm; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Backache), PERIPHERAL SWELLING (Swelling arm), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (High temperature) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Headache and Back ache, at a dose of ''UNK dosage form, every 5 hours''. On 18-Jul-2021, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (High temperature) had resolved. At the time of the report, BACK PAIN (Backache), MYALGIA (Muscle ache) and HEADACHE (Headache) had not resolved and PERIPHERAL SWELLING (Swelling arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39 (High) The high temperature went up to 39C and lasted a couple of days.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. It was reported that patient had high temperature which went up to 39C and lasted a couple of days. Headache and lower back ache are terrible. 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 events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected 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 events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1499754 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 6379370749 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Dizziness, Erythema, Fatigue, Headache, Myalgia, Rash, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: pains; whole; body; chills/shivering; Dizziness; Muscle pain; Headache; Shivers; Swelling; Exhaustion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jul-2021 and was forwarded to Moderna on 18-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (pains), SWELLING (Swelling), ERYTHEMA (whole), DIZZINESS (Dizziness) and RASH (body) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 6379370749) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 15-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 15-Jul-2021, the patient experienced SWELLING (Swelling), MYALGIA (Muscle pain), HEADACHE (Headache), CHILLS (Shivers) and FATIGUE (Exhaustion). On 16-Jul-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced ABDOMINAL PAIN (pains), ERYTHEMA (whole) and RASH (body). At the time of the report, ABDOMINAL PAIN (pains), ERYTHEMA (whole) and RASH (body) outcome was unknown, SWELLING (Swelling) and FATIGUE (Exhaustion) had not resolved and DIZZINESS (Dizziness), MYALGIA (Muscle pain), HEADACHE (Headache) and CHILLS (Shivers) was resolving. Concomitant product was not provided. Treatment medication was not reported. Action taken was not applicable. Events includes shivering with unknown outcome and chills with unknown outcome was reported.; 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 and interconnectedness of the events, a causal relationship cannot be excluded.


VAERS ID: 1499781 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Facial paresis, Fatigue, Hyperhidrosis, Injection site bruising, Injection site pain, Injection site rash, Myalgia, Pain, Pyrexia, SARS-CoV-2 test, Sweating fever
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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 Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Acute headache; Sweating; Pain; Fever; Chills; Injection site rash; Injection site pain; Fatigue; Muscle pain; Injection site bruising; Sweating fever; Fever chills; This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARESIS (Acute headache), SWEATING FEVER (Sweating fever), HYPERHIDROSIS (Sweating), INJECTION SITE BRUISING (Injection site bruising), PAIN (Pain), INJECTION SITE RASH (Injection site rash), INJECTION SITE PAIN (Injection site pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), PYREXIA (Fever), PYREXIA (Fever chills) and CHILLS (Chills) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021 at 8:50 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), INJECTION SITE BRUISING (Injection site bruising) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced INJECTION SITE RASH (Injection site rash) (seriousness criterion medically significant). On an unknown date, the patient experienced FACIAL PARESIS (Acute headache) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at a dose of 1 dosage form. On 16-Jul-2021, SWEATING FEVER (Sweating fever) and PYREXIA (Fever chills) had resolved. On 17-Jul-2021, MYALGIA (Muscle pain) had resolved. On 18-Jul-2021, INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had resolved. On 19-Jul-2021, INJECTION SITE RASH (Injection site rash) had resolved. At the time of the report, FACIAL PARESIS (Acute headache), HYPERHIDROSIS (Sweating), PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills) had not resolved and INJECTION SITE BRUISING (Injection site bruising) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. No concomitant medications were provided by the reporter. The reporter stated that the muscle pain in injection site was spread to the whole body, especially lower back, legs and head. 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: 1499804 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Hot flush
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (mild asthma otherwise extremely healthy.)
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hot flushes; Armpit pain; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flushes), FATIGUE (Fatigue) and AXILLARY PAIN (Armpit pain) in a 23-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 Asthma (mild asthma otherwise extremely healthy.). On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced HOT FLUSH (Hot flushes) (seriousness criterion medically significant). At the time of the report, HOT FLUSH (Hot flushes), FATIGUE (Fatigue) and AXILLARY PAIN (Armpit pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. 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: 1500342 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-15
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: 40.5-42 graden Celcius (hyperpyrexia)
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA 40.5 42 grade Celsius) in a 37-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), MALAISE , INJECTION SITE PRURITUS , MYALGIA , CHILLS and FATIGUE. At the time of the report, HYPERPYREXIA , MALAISE , INJECTION SITE PRURITUS , MYALGIA , CHILLS and FATIGUE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Body temperature: 40.5- 42 (High) 40.5-42 grade Celsius (hyperpyrexia). No relevant concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1500418 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Fatigue, Feeling hot, Hyperhidrosis, Myalgia, Neck pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease
Preexisting Conditions: Crohn''s disease
Allergies:
Diagnostic Lab Data: Test Name: Body temp; Result Unstructured Data: 34?C.
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: This spontaneous case reported by a consumer, describes the occurrence of syncope (fainted) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 214004) for COVID-19 immunisation. The occurrence of additional events detailed below. Concurrent medical conditions included Crohn''s disease. Concomitant medications not provided. On Jul 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscularly; 1 dosage form. On Jul 15, 2021, patient experienced neck pain/neck aches and myalgia (injection arm aches). On Jul 16, 2021, patient experienced syncope/fainted (medically significant), hyperhidrosis/sweating/felt hot and was sweating again (medically significant), feeling hot/felt hot/felt hot and was sweating again (medically significant) and fatigue/very tired (medically significant). The patient was treated with Benuron (paracetamol) at a dose of 1g. At the time of the report, syncope (fainted) resolved; hyperhidrosis (sweating/felt hot and was sweating again), feeling hot (felt hot/felt hot and was sweating again), neck pain (neck aches), myalgia (injection arm aches) and fatigue (very tired) outcome unknown. Diagnostic results: On an unknown date, body temperature: 34?C (low). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscularly was unknown. 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: 1500457 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214001 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: SEMODERNATX, INC.MOD20212

Write-up: MYOKARDIT; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (MYOKARDIT) in an 18-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214001) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced MYOCARDITIS (MYOKARDIT) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (MYOKARDIT) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reported. 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.; 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.


VAERS ID: 1500928 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 093D21A / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Interchange of vaccine products, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: mixed series error - incorrect product administered for second shot - allowed to mix mRNA products but for moderna only recommended for 18 yr and over. Patient had exact same response to Pfizer as he did to Moderna -- the next day he had a fever / chills and tiredness , which all resolved within 24 hours . Did have some tylenol / advil in that time frame


VAERS ID: 1503330 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Hallucination, Headache, Neuralgia, Night sweats, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular 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 Date: 2021; Test Name: Body temperature; Result Unstructured Data: 39 degree Celsius; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 39.5 degree Celsius; Test Date: 20210714; 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: work up midway through the night in a sweat; drained sensation; Tiredness; Hallucinating; Chills; Head throbbing; Nerve pain; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating) in a 39-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 15-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 15-Jul-2021, the patient experienced HALLUCINATION (Hallucinating) (seriousness criterion medically significant), NEURALGIA (Nerve pain), DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (Head throbbing). On 16-Jul-2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced NIGHT SWEATS (work up midway through the night in a sweat) and FATIGUE (drained sensation). On 15-Jul-2021, HALLUCINATION (Hallucinating) had resolved. On 16-Jul-2021, NEURALGIA (Nerve pain) had resolved. On 17-Jul-2021, DIZZINESS (Dizziness) and CHILLS (Chills) had resolved. At the time of the report, NIGHT SWEATS (work up midway through the night in a sweat) and FATIGUE (drained sensation) was resolving and HEADACHE (Head throbbing) and FATIGUE (Tiredness) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 39 degree Celsius (High) 39 and 39.5 degree Celsius (High) 39.5. On 14-Jul-2021, SARS-CoV-2 test: no - negative Covid-19 test (Negative) No - Negative COVID-19 test. The patient had second dose of vaccination on 15 Jul 2021 by 9 O''clock in morning. By 5 PM he started having chills. He went to bed with temperature of 39 degree Celsius. Work up midway through the night in a sweat, sensation of skin coming off and things floating between. He Clenched fist but couldn''t move and fell back to sleep. He Woke back up an hour later with temperature 39.5 degree Celsius. No more hallucinations. Temperature remained at more than 38.5 degree Celsius until 18 Jul 2021. After which he had headaches and drained sensation. Zero side effects after my first vaccination. He was not enrolled in clinical trial. Concomitant medication not reported. Treatment medication not reported. 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: 1504160 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Contusion, Dermatitis allergic, Hypersensitivity, Myalgia, Nausea, Pain in extremity, Peripheral swelling, Pruritus, Rash, Rash erythematous, Rash pruritic, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Allergic reaction; Itchy; Lower back pain; Bruising; Rash; Nausea; Muscle pain; Allergic rash; Itchy rash; Swelling arm; Backache; Red rash; Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itchy), BACK PAIN (Lower back pain), CONTUSION (Bruising), RASH ERYTHEMATOUS (Red rash), PAIN IN EXTREMITY (Pain in arm), DERMATITIS ALLERGIC (Allergic rash), RASH PRURITIC (Itchy rash), PERIPHERAL SWELLING (Swelling arm), BACK PAIN (Backache), RASH (Rash), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 15-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 15-Jul-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and BACK PAIN (Backache) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash) (seriousness criterion medically significant), RASH PRURITIC (Itchy rash) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant), PRURITUS (Itchy) (seriousness criterion medically significant), BACK PAIN (Lower back pain) (seriousness criterion medically significant), CONTUSION (Bruising) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Jul-2021, BACK PAIN (Backache) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itchy), BACK PAIN (Lower back pain), CONTUSION (Bruising), RASH ERYTHEMATOUS (Red rash), PAIN IN EXTREMITY (Pain in arm), DERMATITIS ALLERGIC (Allergic rash), RASH PRURITIC (Itchy rash), PERIPHERAL SWELLING (Swelling arm), RASH (Rash), NAUSEA (Nausea) and MYALGIA (Muscle pain) 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. No relevant concomitant medications were reported. No treatment information was provided. The patient suffered an allergic reaction post vaccine one. After a few hours the top of the arm started to swell, and a red rash began spreading across upper arm. The rash got bigger and bigger over 3 days, was incredibly hot, very itchy and extremely painful to touch and was like very bad bruising throughout the arm and spreading far from the injection site. The rash reached down past my elbow and up to my shoulder. After the second day it spread into the armpit and became even more painful. On day 3, the patient visited the pharmacist for advice. Two more days of pain, itching and a spreading rash and now started to ease. The patient also suffered with extreme muscle pain for 3 days and lower back pain and nausea. The second vaccine reaction was significantly worse than the first. This case concerns a 39-year-old female with serious unexpected events of hypersensitivity, pruritus, rash erythematous, dermatitis allergic, rash pruritic, peripheral swelling, rash, back pain, contusion, pain in extremity, nausea and myalgia. Event onset 2 days after second dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 39-year-old female with serious unexpected events of hypersensitivity, pruritus, rash erythematous, dermatitis allergic, rash pruritic, peripheral swelling, rash, back pain, contusion, pain in extremity, nausea and myalgia. Event onset 2 days after second dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1504200 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-07-15
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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? Yes
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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 Virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: inappropriate schedule of vaccine administered; Muscle ache; Fever; Pain head; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Pain head) and MYALGIA (Muscle ache) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3001659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 15-Jul-2021 to 19-Jul-2021 for Body temperature increased. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Pain head) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 18-Jul-2021, HEADACHE (Pain head) and MYALGIA (Muscle ache) had resolved. On 19-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The treatment information was paracetamol for fever. 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 this events has been provided at this time. No further information is expected 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 events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time


VAERS ID: 1504209 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site pain, Overdose, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (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? 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: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: First; Dose; Fever; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (First), OVERDOSE (Dose), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (First) (seriousness criterion medically significant) and OVERDOSE (Dose) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 16-Jul-2021, PYREXIA (Fever) had resolved. On 18-Jul-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, SEIZURE (First) and OVERDOSE (Dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. 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. Coding and seriousness of events were captured as per Regulatory Authority assessment in 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. Coding and seriousness of events were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1504539 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 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? 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: JPTAKEDA2021TJP061591

Write-up: Anaphylaxis; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 19-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002618) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. On an unknown date, patient''s body temperature before vaccination was 36.7 degrees Celsius. On 15-Jul-2021, at 09:00, the patient received the 1st dose of this vaccine. At 13:30, the patient began to stagger while sitting. At consultation, the patient complained of general weakness and headache, and facial flushing and tachycardia were noted. The patient''s blood pressure was normal. Although several hours had passed since the vaccination, the patient was urgently transported because the symptoms were considered to be acute reactions to the drug. Intravenous drip was attempted, but the patient refused it, so no specific treatment was given on site, and the patient was taken to a hospital. No relevant concomitant medications were reported. 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: 1504541 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Electrocardiogram, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: Test Date: 20210715; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 120/78 mmHg; Test Date: 20210715; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 122/82 mmhg; Test Name: Body temperature; Result Unstructured Data: 36.7 degrees; Test Date: 20210715; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Abnormal Electrocardiogram showed only sinus bradycardia.; Test Date: 20210715; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 51/min; Test Date: 20210715; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 52/min; Test Date: 20210715; Test Name: SpO2; Test Result: Inconclusive ; Result Unstructured Data: 96%; Test Date: 20210715; Test Name: SpO2; Test Result: Inconclusive ; Result Unstructured Data: 99%
CDC Split Type: JPTAKEDA2021TJP061967

Write-up: Loss of consciousness; Vasovagal reflex (facial pallor, sinus bradycardia, sick feeling); This case was received via Regulatory Authority (Reference number: 2021TJP061967) on 16-Jul-2021 and was forwarded to Moderna on 24-Jul-2021. This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 23-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reflex (facial pallor, sinus bradycardia, sick feeling)). On 15-Jul-2021, LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reflex (facial pallor, sinus bradycardia, sick feeling)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Blood pressure measurement: 120/78 mmhg (Inconclusive) 120/78 mmHg and 122/82 mmhg (Inconclusive) 122/82 mmhg. On 15-Jul-2021, Electrocardiogram: inconclusive (Inconclusive) Abnormal Electrocardiogram showed only sinus bradycardia.. On 15-Jul-2021, Heart rate: 51/min (Inconclusive) 51/min and 52/min (Inconclusive) 52/min. On 15-Jul-2021, Oxygen saturation: 96% (Inconclusive) 96% and 99% (Inconclusive) 99%. On an unknown date, Body temperature: 36.7 degrees (normal) 36.7 degrees. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information 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.; 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: 1506107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRABELLA [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: (tested several times-never had covid-19)
CDC Split Type: DKPFIZER INC2021892135

Write-up: Drug ineffective; COVID-19; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Pfizer Medical Advisor. A 20-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular in arm left on 13Jul2021 at 18:11 as a dose 2, single for COVID-19 immunisation. The patient''s medical history was reported as none (the patient was healthy). The patient''s concomitant medications included ethinylestradiol, levonorgestrel (MIRABELLA [ETHINYLESTRADIOL;LEVONORGESTREL]), 1 tablet daily, taken for contraception, from an unspecified date. Historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: unknown), via intramuscular in arm left on 04Jun2021 as a dose 1, single for COVID-19 immunisation and experienced soreness in the throat, tiredness and discomfort, that lasted for about 3-4 days and fully recovered from the events. It was reported that, Pfizer colleague (Sr. Medical Advisor) called the Regulatory Authority to report an AE on behalf of her daughter. On 13Jul2021, after about 30 minutes of 2nd dose administration, the patient experienced discomfort, headache, pain in the throat, fever, chills, runny nose, decrease in sense of taste, severe tiredness, coughing, soreness in the whole body and COVID-19. The patient has been tested for COVID-19 several times but the results were always been negative (never had COVID-19). She had PCR test done yesterday, the answer came now and she was tested positive for Covid-19. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 virus test, resulted as negative, (tested several times-never had covid-19) and COVID-19 PCR test, resulted as positive on 15Jul2021. The outcome of the events was unknown.


VAERS ID: 1507121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / 2 - / -

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

Life Threatening? Yes
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: 20210715; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202100922877

Write-up: Date of start date of second dose on 09Jul2021 and first dose was on 18Mar2021; COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191547162090-JMX5O. A 40-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: BNT162b2) via an unspecified route of administration on 09Jul2021 as dose 2, single for covid-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient was not currently breastfeeding and was unsure if patient was enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. On 14Jul2021, the patient suspected to had covid-19. On 15Jul2021, the patient was positive for COVID-19 PCR test. Date of start date of second dose on 09Jul2021 and first dose was on 18Mar2021. It was reported that patient was PCR test positive, now on intubation. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 15Jul2021. The outcome of the event COVID-19 was not recovered and rest all events was unknown.


VAERS ID: 1507290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-15
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: covid; Test Result: Positive
CDC Split Type: ITPFIZER INC202100916953

Write-up: received first dose of covid 19 vaccine on 08Jun2021 and was tested positive with covid on 15Jul2021; received first dose of covid 19 vaccine on 08Jun2021 and was tested positive with covid on 15Jul2021; This is a spontaneous report from a contactable consumer via Regulatory Authority. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Jun2021, at single dose (Batch/Lot number was not reported) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated the patient received first dose of covid 19 vaccine on 08Jun2021 and was tested positive with covid on 15Jul2021. The outcome of events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1507460 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: normal
CDC Split Type: JPTAKEDA2021TJP061419

Write-up: Anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 19-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002618) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be related. Concomitant and treatment medication was not provided. The patient experienced the symptoms of generalized weakness, headache, facial flushing, and tachycardia four hours after the vaccination. The patient refused a treatment with drip infusion and was transported to the hospital. On 16-Jul-2021, after staying for a night at the hospital and being observed, the patient recovered from the symptoms and was discharged from the hospital. Treatments including drip infusion were offered, but the patient refused them, and therefore was transported to the hospital by ambulance. It was informed that the patient was going to be observed staying for a night at the hospital, but as of the morning on 16-Jul-2021, no information had been received about the symptoms and discharge. 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.; 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.


VAERS ID: 1507488 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Neuropathy peripheral, Oxygen saturation
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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: Meniere''s disease (Meniere''s disease (taking drug to control dizziness))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: BP; Result Unstructured Data: 134/79 mmHg; Test Date: 20210715; Test Name: BP; Result Unstructured Data: 148/87 mmHg; Comments: 97; Test Date: 20210715; Test Name: BT; Result Unstructured Data: BT - 36.9 ?Celsius; Test Date: 20210715; Test Name: HR; Result Unstructured Data: 71 beats per minute; Test Date: 20210715; Test Name: HR; Result Unstructured Data: 72 beats per minute; Test Date: 20210715; Test Name: SpO2; Result Unstructured Data: 99%; Test Date: 20210715; Test Name: SpO2; Result Unstructured Data: 97%
CDC Split Type: JPTAKEDA2021TJP061962

Write-up: Peripheral nerve disorder (numbness of both limbs); This regulatory authority case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both limbs)) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003658) for COVID-19 vaccination. Concurrent medical conditions included Meniere''s disease (Meniere''s disease (taking drug to control dizziness)). On 15-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both limbs)) (seriousness criteria hospitalization and medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both limbs)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Blood pressure measurement: 134/79 (High) 134/79 mmHg and 148/87 (High) 148/87 mmHg. On 15-Jul-2021, Body temperature: 36.9 (normal) BT - 36.9 ?Celsius. On 15-Jul-2021, Heart rate: 71 (normal) 71 beats per minute and 72 (normal) 72 beats per minute. On 15-Jul-2021, Oxygen saturation: 99 (normal) 99% and 97 (normal) 97%. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both limbs)) to be possibly related. No concomitant product information was provided. No treatment information was provided. 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.; 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.


VAERS ID: 1509389 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Investigation, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigations; Result Unstructured Data: Test Result:Neurological causes, Lyme disease were excluded; Comments: Neurological causes, Lyme disease etc. were excluded after investigations.; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Result not provided; Comments: After vaccination; Test Date: 20210715; Test Name: Pcr Test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: DEPFIZER INC202100916177

Write-up: Peripheral facial palsy on the right; This is a spontaneous report from a contactable consumer or other non hcp. A 31-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC1440) via an unspecified route of administration, administered in arm left on 11Jul2021 at 17:00 (at the age of 31-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn''t been tested for COVID-19. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historical vaccination included first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration, administered in arm left on 31May2021 at 17:00 (at the age of 31-year-old) (Batch/Lot Number: FC8889) for COVID-19 immunisation. On 15Jul2021 at 10:00, The patient experienced peripheral facial palsy on the right. The patient was hospitalized for peripheral facial palsy on the right for 2 days. He also taken Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included investigation: neurological causes, lyme disease were excluded on Neurological causes, Lyme disease etc. were excluded after investigations, sars-cov-2 test: result not provided on provided on an unspecified date after vaccination, sars-cov-2 test: negative on 15Jul2021 (Nasal Swab). Cortisone therapy was taken as treatment. Therapeutic measures were taken as a result of peripheral facial palsy on the right. The outcome of the event (facial paralysis) was recovering.


VAERS ID: 1510555 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E026A / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: DEPFIZER INC202100929720

Write-up: On the muscle of the right fibula 2 clots; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: 1E026A, Expiry date: unknown, at the age of 69-year-old), dose 2 via an unspecified route of administration, administered in Arm Left on 14Jul2021 04:15 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration, administered in left arm on 09Jun2021 01:00 (at the age of 69-year-old) (Batch/Lot Number: FA5833) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior and since the vaccination. On 15Jul2021 the patient experienced on the muscle of the right fibula 2 clots (thrombosis). The next day after the 2nd vaccination on the muscle of the right fibula 2 clots, which were diagnosed by the doctor under 5 cm length. The adverse event result in Doctor or other healthcare professional office/clinic visit The outcome of the event thrombosis was not recovered.


VAERS ID: 1510812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: Chronic migraine; Vestibular abnormalities; Vestibular migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021900556

Write-up: Head cold; Aching in limb; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107150640535800-5QRZH, Safety Report Unique Identifier GB-RA-ADR 25653768. A 33-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FE1510), via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. Medical history included vestibular migraine, Chronic migraine and Unilateral vestibulapathy. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient previously took first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient experienced head cold, aching in limb, headache on 15Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 14Jul2021 No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The seriousness was reported as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510950 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-15
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202100916945

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, on 08Jun2021, as single dose, for COVID-19 immunisation. The patient''s medical history was not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included unspecified birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took paracetamol with no adverse event. The patient experienced COVID-19 (medically significant) on 15Jul2021 with outcome of recovering. The event required physician office visit. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 15Jul2021. Therapeutic measures were taken as a result of the event and included treatment Fluimucil. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.


VAERS ID: 1510958 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Sensation of foreign body, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100910069

Write-up: Anaphylaxis; Pharyngolarynx foreign body feeling; sensation of Dyspnoea; Wheezing; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120002. A 22-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021), via an unspecified route of administration on 15Jul2021 15:35 (the day of vaccination) (at the age of 22-years), as Dose 1 single, for COVID-19 immunization and Body temperature before vaccination was 36.8 degrees Centigrade. The patient''s medical history was not reported. Family history was not provided. There were no 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). The patient''s concomitant medications were not reported. On 15Jul2021 at 15:45 (10 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: pharyngolarynx foreign body feeling, sensation of dyspnoea and wheezing appeared. On 16Jul2021 (1 day after the vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious (but the patient hospitalized from 15Jul2021 to 16Jul2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: Not provided. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510959 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Convulsions local, Cough, Dyspnoea, Hypoaesthesia, Nausea, Oxygen saturation, Oxygen saturation decreased, Paraesthesia, Tachypnoea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: Spo2; Test Result: 82 %; Comments: At 16:03, SpO2 82%,
CDC Split Type: JPPFIZER INC202100910520

Write-up: queasy; cough; At 16:03, SpO2 82%; dyspnoea; Tachypnoea; Anaphylaxis; convulsion of hands; finger tingling sensation; general numbness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21119929. A 23-year-old male received first dose of BNT162B2 (Comirnaty, solution for injection, lot number; EY0779, expiration date; 31Aug2021) via an unspecified route of administration on 15Jul2021 (the day of vaccination) (at the age of 23-year-old) at 15:10 as dose 1, single for covid-19 immunisation. Patient medical history included asthma bronchial (dates unspecified). Body temperature before vaccination was 36.2 degrees Centigrade on 15Jul2021. Concomitant medications were not reported. On 15Jul2021 15:58 (the day of the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: At 15:10, the patient received vaccination. At 15;15, after vaccination, finger tingling sensation, convulsion of hands. At time of planning to go back home after 30 minutes waiting, at 15:58, the patient experienced dyspnea, tachypnoea. At 16:03, SpO2 82%, oxygen started. Experienced cough, queasy. At 16:07, EPINEPHRINE 0.3mg intramuscularly injected. After that, had general numbness. At 18:00, improved. On 15Jul2021 (the day of the vaccination) the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was same symptoms occurred before but details unknown. The reporting physician commented as follows: Anaphylaxis was suspected but difficult to assess.


VAERS ID: 1510963 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Cough, Feeling cold, Hyperhidrosis, Hypertension, Nausea, Oxygen saturation, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:159/66; Test Date: 20210715; Test Name: SpO2; Test Result: 100 %
CDC Split Type: JPPFIZER INC202100911275

Write-up: cough; BP 159/66; wheezing; queasy; sweaty; feeling cold; anaphylaxis; This is a spontaneous report from a contactable other-HCP received from the regulatory authority. Regulatory authority report number is v21119942. A 46-year-old female received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration on 15Jul2021 at 09:35 (the day of vaccination) (at age of 46-years-old) as dose 1, single for COVID-19 immunization. The patient had a relevant medical history of asthma. Patient concomitant medication was not reported. On 15Jul2021 at unspecified time (the same day of the vaccination), the patient experienced reported anaphylaxis. On The course of the event was as follows: At 09:35, the patient received the vaccination. At 09:38, queasy, sweaty, and feeling cold occurred. At 10:05, cough, wheezing, route was secured. Solu-Medrol 125mg iv, BP 159/66, SpO2 100%. At 10:17, bosmin 0.3ml injected intramuscularly. At 10:24, symptoms improved. At 10:40, the patient still experienced queasy, Primperan 1A was added into iv. Symptoms were improved. On 15Jul2021 (the same day of the vaccination), the outcome of the events was recovered. The reporting physician/pharmacist classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Confirmed with medical institution, the events corresponded with anaphylaxis.


VAERS ID: 1511215 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; CARVEDILOL; PRAVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dilated cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021908162

Write-up: anaphylactic shock; This is a spontaneous report from a contactable physician received via COVID-A 55-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EW0201, Expiration date: 30Sep2021), via intramuscular route of administration, in Arm left, on 15Jul2021 at 13:30, the day of vaccination (at the age of 55-year-old), as a single dose for covid-19 immunization. The patient medical history included Idiopathic Dilated Cardiomyopathy. The patient concomitant medications included Enalapril, Carvedilol and Pravastatin within 2 weeks of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. On 15Jul2021 at 13:30 (as reported), the patient experienced anaphylactic shock. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care (as reported). Treatment included adrenaline subcutaneous injection 0.3 mg. Outcome of the event was recovered on an unspecified date in July 2021.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Anaphylactic Shock and the administration of the vaccine cannot be excluded.


VAERS ID: 1511218 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Sudden hearing loss
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: 38 point something degrees Celsius
CDC Split Type: JPTAKEDA2021TJP061960

Write-up: Sudden hearing loss; Pyrexia; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP061960) on 19-Jul-2021 and was forwarded to Moderna on 27-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 2-decade-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant) and PYREXIA (Pyrexia). The patient was treated with PREDNISOLONE on 17-Jul-2021 for Sudden hearing loss, at an unspecified dose and frequency. At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and PYREXIA (Pyrexia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Body temperature: 38 degree Celsius (High) 38 point something degrees Celsius. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was Not Applicable On 14-Jul-2021, in the early evening, the patient received the 1st dose of the vaccine (Batch number of was unknown) On 15-Jul-2021, the patient experienced sudden hearing loss and pyrexia of 38 point something degrees Celsius. On an unknown date, at unknown time, the patient visited an ENT physician, and prednisolone was prescribed. On 17-Jul-2021, the patient took prednisolone. Reporter assessed as possibly related to suspect product The outcome of sudden hearing loss and pyrexia was reported as ongoing and unchanged. Follow-up investigation will be impossible 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; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1511854 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-15
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis, Facial paresis, Headache, Oral pain, Pain in jaw
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Osteonecrosis (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: I am working on ship now I am in home country. In state I take Covid-19 vaccine. On 15 July I have pain in my mouth after 44 days of vaccination, pain in my jaw after realising my left side face muscle are week and not blink my left eye. When reached doctor he says u have facial paralysis (Bell?s palsy). Befor 15 July I have brain pain 2 day then accure Bell?s palsy. Then I realise it connect with my janssen vaccine. Just one day ago on social media I found Bell?s palsy related with janssen. Still I have Bell?s palsy taking medicine and seem to be I have improved my paralysed left side face but sometime I have headache . I am sure it?s related with janssen COVID-19 vaccine. So please help me out about my condition.


VAERS ID: 1512220 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Loss of consciousness, Palpitations, Paraesthesia, Throat irritation
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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: ATPFIZER INC202100908519

Write-up: 3-5 minutes after vaccination sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat, and very rapid onset of fainting; 3-5 minutes after vaccination sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat, and very rapid onset of fainting; 3-5 minutes after vaccination sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat, and very rapid onset of fainting; 3-5 minutes after vaccination sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat, and very rapid onset of fainting; 3-5 minutes after vaccination sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat, and very rapid onset of fainting; This is a spontaneous report from a contactable consumer or other non-health care professional (the patient) received from COVAES. A 31-years-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Batch/Lot Number: FE6208) via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at the age of 31-Years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination has not been tested for COVID-19. On the day of vaccination, after 3-5 minutes vaccination the patient experienced sudden tingling palms and soles, scratchy throat, sweating, rapid heartbeat and on an unspecified date, patient experienced with very rapid onset of fainting. Adverse event resulted in Doctor or other healthcare professional office / clinic visit. Treatment received for the adverse event as patient brought to a stable side length and examined. Outcome of the event was recovered on an unspecified date in 2021.


VAERS ID: 1512312 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Chills, Circulatory collapse, Feeling hot, Hyperhidrosis, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: DEPFIZER INC2021898982

Write-up: Circulatory collapse; Loss of balance; Feeling of heat; Chills; Sweat outbreak; Fever; This is a spontaneous report from a contactable consumer (patient). An 18-years-old male patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jul2021 14:45 (at the age of 18-year-old) (Batch/Lot Number: FD7958) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jul2021, started with a circulatory collapse and patient had loss of balance. After that, chills briefly followed by a sweat outbreak (a lot of sweat) and a continued feeling of heat and fever. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events feeling of heat, fever was not recovered and other events was recovering.


VAERS ID: 1513218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-07-15
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, Respiratory symptom, 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 Name: PCR; Result Unstructured Data: Test Result: Ct value: 19.74; Comments: No sequencing of the virus variant available.
CDC Split Type: ATPFIZER INC202100927114

Write-up: Vaccine failure symptomatic COVID-19 disease after complete immunization; Vaccine failure symptomatic COVID-19 disease after complete immunization/The patient underwent lab tests and procedures which included polymerase chain reaction: ct value: 19.74; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non-health care professional from the Regulatory Authority AT-BASGAGES-2021-37166. An 81-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 01Mar2021 at dose 1, single and received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 22Mar2021 at dose 2, single, both the doses for covid-19 immunization. Medical history and concomitant medications were not reported. On 15Jul2021 the patient experienced vaccine failure symptomatic covid-19 disease after complete immunization, respiratory symptom. The patient underwent lab tests and procedures which included polymerase chain reaction and ct value was 19.74 (No sequencing of the virus variant available). Outcome of the events was unknown. Reporter''s comments: Ct value: 19.74 no sequencing of the virus variant available. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1513599 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, 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), 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
CDC Split Type: GBPFIZER INC2021900313

Write-up: Fit (non-epileptic); This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107150543584270-MWIMI, Safety Report Unique Identifier: GB-MHRA-ADR 25653410. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fit (non-epileptic) on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the event was not recovered. Regulatory authority assessed the event as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Postnatal blues
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907311

Write-up: Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202107150741412430-W7W6N, Safety Report Unique Identifier GB-MHRA-ADR 25654174. A 32-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Fe1510), via unspecified route of administration at dose 2, single on 14Jul2021 for COVID-19 immunisation. Medical history included lactation decreased, postnatal blues. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included sertraline taken for postnatal blues. The patient experienced chest pain (medically significant) on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906777

Write-up: Vomited; Headache; This is a spontaneous report from a contactable consumer and other non-healthcare professional received from the Agency Regulatory Authority. The regulatory authority report number GB-MHRA-WEBCOVID-202107150838402320-GHIED. Safety Report Unique Identifier GB-MHRA-ADR 25654366. A 32-year-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Lot Number: FD5613), via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient concomitant medications were not reported. Patient was previously received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. On 15Jul2021, the patient experienced vomited and headache. The case classified as serious (medically significant). The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autism spectrum disorder, Epistaxis, Haemorrhage, Heart rate, Pain, Palpitations, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications: DULOXETINE; FERROUS FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Autism spectrum disorder; Lactation decreased; Post-traumatic stress disorder
Allergies:
Diagnostic Lab Data: Test Name: pulse; Result Unstructured Data: Test Result:114; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:90; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:88; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:104; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:108; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:96; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:118; Comments: bpm; Test Name: pulse; Result Unstructured Data: Test Result:82; Comments: bpm; Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021907283

Write-up: hypermobile spectrum disorder; bleeding; felt like her heart was beating harder; felt less painful.; Nosebleed; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107151121522290-RX2YR, Safety Report Unique Identifier GB-MHRA-ADR 25655607. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: FA1027), via an unspecified route of administration at dose 1, single on 13Jul2021 for COVID-19 immunisation. Medical history included lactation decreased, autism spectrum disorder, post-traumatic stress disorder, anaemia. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included duloxetine taken for post-traumatic stress disorder from 01Jun2017 to an unspecified stop date; ferrous fumarate taken for anaemia from 01Sep2020 to an unspecified stop date. The patient experienced hypermobile spectrum disorder on an unspecified date, bleeding on an unspecified date, nosebleed on 15Jul2021, felt like her heart was beating harder on an unspecified date. The patient had nosebleed, with clumps in it. Lasted about 20 minutes with clumps, was now just gently bleeding. She was anaemic, and had a diagnosis of Hypermobile Spectrum Disorder, incase this was relevant. Before her nosebleed she felt like her heart was beating harder than usual, so she sat and checked her pulse every 5 minutes for 60 seconds to get a bpm, resting. Over 20 minutes it varied from 114, 90, 88, 104, 108, 96, 118. It was currently slower at 82 and felt less painful. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events hypermobile spectrum disorder and bleeding was recovered, of the event nosebleed was recovering, of the event felt like her heart was beating harder and felt less painful was unknown. This report was serious with seriousness criteria medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular 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: Hay fever (No other medicines taken, other than standard hay fever tablets).
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021907223

Write-up: general loss of balance; Dizziness; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines Healthcare products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107151334168620-XVV1U, Safety Report Unique Identifier GB-MHRA-ADR 25656429. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration at single dose on 14Jul2021 for COVID-19 immunisation. Medical history included hay fever from an unknown date. No other medicines taken, other than standard hay fever tablets. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced general loss of balance on an unspecified date, dizziness on 15Jul2021. Case narrative: Dizziness and general loss of balance. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 12Jul2021 (No-Negative COVID-19 test). The outcome of the event general loss of balance was unknown, for event dizziness was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513715 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC2021906783

Write-up: feverish; fatigue; Suspected COVID-19; Headache; Leg pain; Fever; Tingling; This is a spontaneous report from a contactable consumer or other non hcp received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151345253710-QZRSH.,Safety Report Unique Identifier GB-MHRA-ADR 25656567. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 15Jul2021 as DOSE 2, SINGLE for Covid-19 immunization. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as Dose 1, Single for COVID-19 immunization. Felt feverish fatigue severe headache and arm pain then shooting pain down from buttock to ankle on the opposite side to vaccine administration point. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Medical history included suspected covid-19 from 15Jul2021 and ongoing. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced feverish, fatigue, suspected covid-19, on 15Jul2021 experienced headache, leg pain, fever, tingling. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Jul2021. The outcome of events feverish, fatigue, suspected covid-19 were unknown, for events headache, leg pain, tingling were not recovered and for event fever was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513716 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DRETINE; SPIRONOLACTONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907224

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107151351298050-GXHXQ], Safety Report Unique Identifier [GB-MHRA-ADR 25656592]. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Jul2021 (Lot Number: FD5613) as single dose for COVID-19 immunisation. Patient age at vaccination was 32-year-old. Medical history included lactation decreased and alopecia. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included drospirenone, ethinylestradiol (DRETINE) taken for alopecia from 01Jan2016 to an unspecified stop date; spironolactone taken for alopecia from 01Jan2017 to an unspecified stop date. The patient experienced diarrhea on 15Jul2021 with outcome of not recovered. Clinical course was reported as very severe watery diarrhea onset about 2 hours after the vaccine. No associated stomach pain or nausea but bad enough to not be able to do any normal activities. Patient was not enrolled in clinical trial. This case was reported as serious with seriousness criteria-other medically important condition. No follow up attempts are possible. No further information is expected.


VAERS ID: 1513726 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907353

Write-up: Syncope; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151539500880-XOAZV Safety Report Unique Identifier GB-MHRA-ADR 25657646. A 22-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-year-old on 15Jul2021 (Lot Number: FA1027) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced syncope on 15Jul2021. Treatment included First aid was given. Outcome of event was recovered on 15Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dry mouth, Fatigue, Headache, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test; Test Name: temperature; Result Unstructured Data: Test Result: high.
CDC Split Type: GBPFIZER INC2021906882

Write-up: Nausea; Headache; High temperature; Sore throat; Dry mouth; Painful arm; Fatigue; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151610454880-IQR2B, Safety Report Unique Identifier GB-MHRA-ADR 25657616 A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19; Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced fatigue on 15Jul2021. On an unspecified date, the patient experienced nausea, headache, high temperature, sore throat, dry mouth, and painful arm. The events were considered medically significant. The outcome of the event fatigue, headache and high temperature was not recovered. The outcome of the events nausea, sore throat, dry mouth and painful arm was recovering. The patient underwent lab tests and procedures which included Negative COVID-19 test on unknown date. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FDJ613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test
SMQs:, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021907313

Write-up: Shoulder pain; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107151719072490-OJRVH, Safety Report Unique Identifier GB-MHRA-ADR 25658150. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: fdj613), via an unspecified route of administration on 13Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced shoulder pain (medically significant) on 15Jul2021. Severe pain moving the shoulder began two days after vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907331

Write-up: swelling in arm; Swelling; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151722339310-PZ3MR, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25658164. A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. The patient''s concomitant medications were not reported. The patient experienced swelling in arm on an unspecified date, swelling on 15Jul2021. Swelling in arm pit and across chest. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Case was reported as serious, other medically important condition. No relevant investigations or tests conducted. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Outcome of swelling in arm was unknown and swelling was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906836

Write-up: Injection site pain; Headache; Dizziness; Joint pain; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151927501320-YWWBR, Safety Report Unique Identifier GB-MHRA-ADR 25658990. A 27-year-old female (not pregnant and not currently breastfeeding) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown) via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history included suppressed lactation from an unknown date and unknown if ongoing and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19, and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. On 15Jul2021, the patient experienced fatigue and on an unspecified date, the patient experienced with injection site pain, headache, dizziness, joint pain and muscle ache. All events were considered as medically significant. The outcome of the event joint pain was recovering, and the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Electrocardiogram, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:result unknown; Test Name: ECG; Result Unstructured Data: Test Result:Doctor did an ECG and was happy with the results
CDC Split Type: GBPFIZER INC2021907044

Write-up: breathlessness; Palpitations; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202107160202400970-1JRT6, Safety Report Unique Identifier GB-MHRA-ADR 25660490. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot number was not reported) (age at vaccination: unknown) as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced breathlessness on an unspecified date with outcome of not recovered, palpitations on 15Jul2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: unknown on an unspecified date, electrocardiogram: normal on an unspecified date. The clinical course was as follows: Just over 24 hours after receiving the Covid vaccine, the patient experienced palpitations for several hours and breathlessness. Called 111 and they sent her to A&E. Doctor did an ECG and was happy with the results so no further treatment needed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Blood pressure tested on an unknown date but result unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-15
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Myalgic encephalomyelitis; Post viral fatigue syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906846

Write-up: headache; dizziness; numbness in left arm; numbness in left arm and leg; Pins and needles; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107160718369330-P3YP3, Safety Report Unique Identifier GB-MHRA-ADR 25661289. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot Number: Et8885), via an unspecified route of administration on 04Jun2021 as dose 2, single for COVID-19 immunization. Medical history included immunodeficiency from an unknown date and unknown if ongoing Taking other treatments or medicines, not listed above, known to lower the immune response and i , post viral fatigue syndrome from an unknown date and unknown if ongoing , Unsure if patient has had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. On 15Jul2021, patient experienced pins and needles and on an unspecified date, the patient experienced headache, dizziness, numbness in left arm, numbness in left arm and leg. Additional information: Headache dizziness and pins and needles and numbness in left arm and leg. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (No-Negative COVID-19 test). The outcome of event for headache, dizziness, numbness in left arm, numbness in left arm and leg was unknown and for event pins and needles was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513961 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypersensitivity, Hyperventilation, Hypoaesthesia, Oropharyngeal discomfort, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (the reporter could not confirm about this)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100910301

Write-up: slight allergic reaction; Pharynx strange sensation of; tachycardia; numbness generalized; palpitations; hyperpnoea; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21119928. The patient was a 60-year-old female. Body temperature before the vaccinations was 36.8 centigrade. The patient''s medical history included LIDOCAINE and Xylocaine allergy (the reporter could not confirm about this, as reported). Concomitant medications were not reported. On 15Jul2021 at 14:08 (at age of 60-year-old), the patient received the first dose of BNT162B2(COMIRNATY, Solution for injection, Lot number: FC9880, expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Jul2021 at 14:10, the patient experienced tachycardia, pharynx strange sensation of and numbness generalized. The course of the event was as follows: the patient complained palpitations during observation. The patient lied on bed and pharynx strange sensation of appeared. Due to hyperpnoea and tachycardia, DIV started and solu-cortef 100mg was administered. The symptoms did not improve so the patient was sent to (Privacy hospital) by emergency ambulance. On an unspecified date, the outcome of the event was unknown. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was hyperpnoea and so on. The reporting physician commented as follows: it may be slight allergic reaction. After the patient was transferred by emergency ambulance, the physician at emergency site told the patient''s family it was anaphylaxis. An inquiry was made with the reporter and it was confirmed that it was not anaphylaxis.


VAERS ID: 1513980 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5432 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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: Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:184/107
CDC Split Type: JPPFIZER INC202100912996

Write-up: queasy; vomiting; headache; BP (184/107); This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21119934. A 45-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Jul2021 (Lot Number: EY5432; Expiration Date: 31Aug2021) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021 14:25 the patient experienced queasy, vomiting, headache, bp (184/107). Therapeutic measures taken as a result of the events included treatment with SOLU-CORTEF 250 mg/ normal saline 100ml. The outcome of the events was resolved on 15Jul2021. The patient underwent lab tests and procedures which included blood pressure (bp) measurement: 184/107 on 15Jul2021. Clinical course of the event was reported as follows: 18 minutes after vaccination, the patient experienced queasy, vomiting and headache. BP (184/107). The patient was treated with SOLU-CORTEF 250 mg/ normal saline 100ml. Subjective symptoms improved. 40 minutes after vaccination, the patient left the room. On 15Jul2021 (the day of vaccination), the outcome of event was recovered. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. Other possible cause of the event such as any other diseases was not provided. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-07-15
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 20210715; Test Name: PCR; Result Unstructured Data: Test Result:positive
CDC Split Type: JPPFIZER INC202100930486

Write-up: COVID-19; vaccination failure; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 89-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 06Jun2021, the day of vaccination as a single dose for covid-19 immunization and first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 16May2021, the day of vaccination (at the age of 89-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 13Jul2021 (36 days after the vaccination), symptoms appeared on July 13, PCR detection was carried out, and it was determined to be positive on July 15. The adverse events occurred after using the product. The outcome of event was unknown. The seriousness was not provided. Information on the lot number has been requested.


VAERS ID: 1514072 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure systolic, Body temperature, Cold sweat, Heart rate, Hyperhidrosis, Nausea, Peripheral coldness, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Blood pressure decreased within sBP90s mmHg; Result Unstructured Data: Test Result:sBP 90-99 mmHg; Test Name: sBP; Result Unstructured Data: Test Result:120s mmHg; Comments: Originally; Test Date: 20210715; Test Name: sBP; Result Unstructured Data: Test Result:92 mmHg; Comments: at 10:25; Test Date: 20210715; Test Name: sBP; Result Unstructured Data: Test Result:105 mmHg; Comments: at 10:50; Test Date: 20210715; Test Name: sBP; Result Unstructured Data: Test Result:121 mmHg; Comments: at 10:55; Test Date: 20210715; Test Name: sBP; Result Unstructured Data: Test Result:118 mmHg; Comments: finally; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: HR; Result Unstructured Data: Test Result:70s times/min
CDC Split Type: JPPFIZER INC2021895589

Write-up: Anaphylaxis; shock; whole body sweaty was obvious; whole body sweaty(Cold sweat) was obvious; queasy; Blood pressure decreased; Peripheral coldness; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution and via the Medical Devices Agency. The patient was a 24-year-old and 11 months male. Body temperature before vaccination on 15Jun2021 was 36.5 degrees Centigrade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamin supplements (brand name unknown) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient''s family history was unknown. There were no 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) as reported. On 15Jul2021 at 10:15 (the day of vaccination), the patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FC8736, expiration date: 30Sep2021) intramuscular route of administration in the arm left, at the age of 24 years old as dose 1, single, for COVID-19 immunisation. On 15Jul2021 at 10:25, the patient experienced anaphylaxis. Clinical course of events was reported as follows: On 15Jul2021 at 10:15, 0.3 mL of Comirnaty was injected intramuscularly into the upper left arm, and then the patient siting in a chair and waiting for observation. On 15Jul2021 at 10:25, the patient said about queasy and was transported to bed, kept lying, but whole body was sweaty (Cold sweat) which was obvious; peripheral coldness also was noted. sBP became 92mmHg and shock was confirmed (originally sBP was 120s mmHg). During observation, there was no vomiting, no cutaneous symptom or respiratory symptom. It was judged that the patient had an anaphylaxis due to cardiovascular (Blood pressure decreased, Peripheral coldness) and gastrointestinal symptoms (queasy) were observed. At 10:40, Adrenalin 0.3 mg was intramuscularly injected into the right thigh and intravenous drip of Sodium Chloride Solution 500 ml was initialed at the left elbow to secure a peripheral vein line. At 10:50, sBP was 105mmHg, at 10:55, sBP was 121mmHg. Digestive symptoms also improved. After accepted observation in the hospital, the patient was prescribed with Polaramine and Gaster orally, and was told 24-hour contact information, after that, the patient was considered could go home , and finally, sBP was 118mmHg, HR was 70s times/minute. On 15Jul2021, outcome of the events was recovering. The reporting physician classified the event as serious (medically significant), and related to bnt162b2. There was no other possible cause for the event such as any other diseases. The reporter also stated the events results in doctor or other healthcare professional office/clinic visit. Since vaccination, the patient has not been tested for COVID-19. The reporting physician commented as follows: "it was judged that anaphylaxis was occurred after CMT vaccination and adrenaline administration was necessary so we give this report."; Sender''s Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1514103 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Loss of consciousness, Muscular weakness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 110/60; Test Date: 20210715; Test Name: Pulse; Test Result: Inconclusive ; Result Unstructured Data: 76
CDC Split Type: JPTAKEDA2021TJP062785

Write-up: Loss of consciousness; Weakness of the toes of the left foot; Weakness of hands; This case was received via regulatory authority (Reference number: 2021TJP062785) on 19-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 30-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria hospitalization and medically significant) and MUSCULAR WEAKNESS (Weakness of hands). On 19-Jul-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of the toes of the left foot). The patient was hospitalized from 15-Jul-2021 to 16-Jul-2021 due to LOSS OF CONSCIOUSNESS. On 15-Jul-2021, LOSS OF CONSCIOUSNESS (Loss of consciousness) had resolved. At the time of the report, MUSCULAR WEAKNESS (Weakness of hands) and MUSCULAR WEAKNESS (Weakness of the toes of the left foot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Blood pressure measurement: 110/60 (Inconclusive) 110/60. On 15-Jul-2021, Heart rate: 76 (Inconclusive) 76. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness), MUSCULAR WEAKNESS (Weakness of hands) and MUSCULAR WEAKNESS (Weakness of the toes of the left foot) to be possibly related. Concomitant product use was not provided by the reporter. On 19-Jul-2021, the symptoms of weakness of the toes of the left foot and weakness of hands persisted. The patient visited the hospital again and the physician considered that the symptoms were not suggestive of anaphylaxis. Patient does not have fever. 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 the events, a causal relationship cannot be excluded.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1514945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 210A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Choking, Cough, Facial paresis, Hypertension, Muscle tightness, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: no known allergies, does not smoke and does not consume alcohol
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: BRJNJFOC20210757741

Write-up: FEELING OF CHEST TIGHTNESS; FEELING OF BODY TIGHTNESS; HIGH BLOOD PRESSURE; CHOKES WHILE EATING; TREMBLING; COUGHS; WEAKNESS IN THE BODY; WEAKNESS IN THE FACE; NAUSEA; This spontaneous report received from a patient concerned a 39 year old male of unspecified race and ethnicity. The patient''s height and weight were not reported. The patient''s had no known allergies, non-smoker and no alcohol intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 210A21A, and expiry: UNKNOWN) dose was not reported, once in total, administered on 26-JUN-2021 at an unspecified anatomical location for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, 19 days after receiving vaccination, the patient experienced feeling chest and body tightness, and high blood pressure, and was hospitalized on an unspecified date. While in the hospital, his blood pressure was controlled by medication. He was also tested for covid-19, which came back negative and had a series of medical exams performed, that all came back normal. He was released and recommended to seek a specialized doctor. He also reported feeling of weakness that increased with the passing of the day. He woke up feeling new, and then the weakness came and increased during the day. The weakness was in the body and face, but did not not incapacitate him. He sometimes coughed, choked while eating, and also experienced trembling. He reported internal weakness accompanied with a lot of nausea. He further reported that his symptoms did improve this week in comparison to last week, but still felt all the symptoms. He thought his symptoms might be associated with the Guillain Barre syndrome. The patient was treated with Bromoprida, Tramal (also reported as Tramo), AAS protect, "Dimitar", Vonau and unspecified blood pressure medicine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trembling, nausea, coughs, weakness in the body, weakness in the face, feeling of chest tightness, feeling of body tightness, high blood pressure and chokes while eating was recovering. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report received from a consumer concerns a 39-year-old male patient of unspecified ethnicity who experienced feeling chest and body tightness as well as high blood pressure 19 days after receiving the Janssen Covid-19 vaccine. The patient was hospitalized on an unspecified date; COVID-19 test was negative and the unspefied series of medical examination done were normal. The patient reported that that the weakness increased during the day, sometimes would cough/choked while eating, trembling, and nausea. The patient was treated with Bromoprida, Tramal (also reported as Tramo), AAS protect, "Dimitar", Vonau and unspecified blood pressure medicine. The events were reported as recovering. No other pertinent information reported. Information is limited in this case, and the occurrence of the events could represent background incidence in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.


VAERS ID: 1514954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Headache, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness: Allergic to dogs (His whole life.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100916796

Write-up: vertigo; extreme dizziness; bad headache; vomiting; Disorientated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in deltoid left, on 03Jul2021 at 16:15, as single dose, for COVID-19 immunisation. Medical history included ongoing allergic to dogs (his whole life). Concomitant medications were none. Prior vaccinations within 4 weeks were none. There were no concomitant medications. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 18May2021 for COVID-19 immunisation at the age of 43 years and experienced extreme dizziness, bad headache, vomiting and disorientated. The patient experienced extreme dizziness (medically significant) on 15Jul2021 with outcome of not recovered, bad headache (medically significant) on 15Jul2021 with outcome of not recovered, vomiting (non-serious) on 15Jul2021 with outcome of not recovered, disorientated (non-serious) on 15Jul2021 with outcome of not recovered, vertigo (non-serious) on an unspecified date with outcome of not recovered. No treatment has been administered. The events required physician office visit. The physician thought that his events looked more like vertigo than a reaction to the vaccine. The events were considered as non-serious. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-2021907276 Same patient/drug, different dose/events;CA-PFIZER INC-2021907276 Same patient/drug, different dose/events


VAERS ID: 1515816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-07-15
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid-19 pcr; Test Result: Positive ; Comments: CT value: 24.5 S-gene mutations: P681R
CDC Split Type: ATPFIZER INC202100927095

Write-up: Vaccine failure symptomatic COVID-19 disease after complete immunisation; covid-19; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority WEB AT-BASGAGES-2021-37194. A 62-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on 27Mar2021 as a dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Jul2021, Vaccine failure symptomatic COVID-19 disease after complete immunisation (vaccine failure) munisation (Medically significant) and Respiratory symptom. The patient underwent laboratory test which included, covid-19 pcr and patient was positive for COVID-19. at the time of this report event outcome was unknown. Reporter''s comment: CT value: 24.5 S-gene mutations: P681R. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtained.; Reporter''s Comments: CT-Wert: 24,5 S-Gen Mutationen: P681R


VAERS ID: 1515817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-07-15
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ct value; Result Unstructured Data: Test Result:17,3; Comments: positive
CDC Split Type: ATPFIZER INC202100927078

Write-up: Vaccination Failure Symptomatic COVID-19E Disease After Complete Immunization; Respiratory symptom; Symptomatic COVID-19; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37195. This serious spontaneous report was received from a Consumer or other non-health professional and concerns a Male patient of 52-Year-old received first dose of BNT162B2 (COMIRNATY, Formulation was Solution for injection, Lot Number: not reported), dose 1 via an unspecified route on 19Jan2021, DOSE 1, SINGLE and received second dose of BNT162B2 (COMIRNATY, Formulation was Solution for injection, Lot Number: not reported), dose 2 via an unspecified route on 09Feb2021 DOSE 2, SINGLE as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 15Jul2021, the patient experienced vaccination failure (vaccination Failure Symptomatic COVID-19E Disease After Complete Immunization), other, and respiratory symptom and on an unspecified date in 2021, the patient had Symptomatic COVID-19. The patient had lab test SARS-CoV-2 test result was positive and Ct value result was 17.3, no sequencing of the virus variant available. The outcome of all events was unknown. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained. Reporter''s Comments: Ct value: 17.3 no sequencing of the virus variant available


VAERS ID: 1515820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-07-15
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT value; Result Unstructured Data: Test Result:26.26; Comments: Ct value: 26.26 S-gene mutations: P681R.
CDC Split Type: ATPFIZER INC202100926764

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; Vaccination failure symptomatic COVID-19 disease after complete immunization; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non-health care professional from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37205. A 23-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, batch/lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 27Apr2021 as single dose and second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 18May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. It was reported that on 15Jul2021, patient experienced vaccination failure symptomatic covid-19 disease after complete immunization and other respiratory symptom. The patient underwent lab tests and procedures which included CT value: 26.26 S-gene mutations: P681R on an unspecified date. The outcome of the events was unknown. Reporter Comment: Ct value: 26.26 S-gene mutations: P681R. No follow-up activities possible. No further information expected. Batch/LOT numbers cannot be obtained.


VAERS ID: 1515821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-15
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid-19 pcr; Test Result: Positive; Comments: Ct value: 28.04 no sequencing of the virus variant available
CDC Split Type: ATPFIZER INC202100927074

Write-up: Vaccine failure symptomatic COVID-19 disease after complete immunisation; covid-19; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority AT-BASGAGES-2021-37210. A 23-year-old male patient received second dose BNT162B2 (COMIRNATY COVID-19 vaccine, solution for injection, batch/Lot Number: Unknown), via an unspecified route of administration on 27May2021 as single dose and first dose BNT162B2 (COMIRNATY COVID-19 vaccine, solution for injection, batch/Lot Number: unknown), via an unspecified route of administration on 20Apr2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccine failure symptomatic covid-19 disease after complete immunisation, covid-19 and respiratory symptom on 15Jul2021. The patient lab test included sars-cov-2 test was positive (Ct value: 28.04 no sequencing of the virus variant available) on an unknown date. The outcome of the events was unknown. Reporter''s comment: Ct value: 28.04 no sequencing of the virus variant available. Information about lot/batch# cannot be obtained. No follow-up attempts possible. No further information expected. Reporter''s Comments: Ct-value: 28,04 no sequencing of the virus variant available


VAERS ID: 1515860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Chills, Cyanosis, Dizziness postural, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (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: DEPFIZER INC202100921243

Write-up: black before eyes / fainting; chills; dizziness when lying down; blue lips; headache; pain in breast area; This is a spontaneous report received from a contactable consumer (patient). A 28-year-old female patient received a dose of BNT162B2 (COMIRNATY; lot number unknown) via an unspecified route of administration on 14Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Approximately 6 hours after vaccination the patient experienced chills and dizziness when lying down, afterwards blue lips and black before eyes / fainting. On the second day after vaccination the patient experienced headache and pain in breast area. The clinical outcomes of chills, dizziness when lying down, blue lips, black before eyes/fainting, headache and pain in breast area were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1516025 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Auscultation, Base excess, Basophil count, Blood bicarbonate, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, C-reactive protein, Computerised tomogram thorax, Deep vein thrombosis, Echocardiogram, Electrocardiogram, Eosinophil count, Fibrin D dimer, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Mean cell volume, Mean platelet volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin time, Pulmonary embolism, Syncope, Tachypnoea, Thrombocytopenia, Troponin I, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (sulfonamides); Thromboembolism (mother)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: APTT; Result Unstructured Data: Test Result:95,6 seconds; Test Date: 20210715; Test Name: APTT; Result Unstructured Data: Test Result:30,3 seconds; Test Date: 20210719; Test Name: APTT; Result Unstructured Data: Test Result:47,7 seconds; Test Name: auscultation; Result Unstructured Data: Test Result:CA: rhythmic, without murmurs. PA: bilateral CVM.; Test Date: 20210715; Test Name: base excess; Result Unstructured Data: Test Result:-0,2 mEq/l; Test Date: 20210719; Test Name: base excess; Result Unstructured Data: Test Result:-0,7 mEq/l; Test Date: 20210715; Test Name: basophil count; Result Unstructured Data: Test Result:0,04 x10 3/mm3; Test Date: 20210715; Test Name: basophil count; Result Unstructured Data: Test Result:0,5 %; Test Name: hco3; Result Unstructured Data: Test Result:incalculable; Test Date: 20210715; Test Name: hco3; Result Unstructured Data: Test Result:24.8 mEq/l; Test Date: 20210719; Test Name: hco3; Result Unstructured Data: Test Result:24.2 mEq/l; Test Date: 20210715; Test Name: chloride; Result Unstructured Data: Test Result:105 mEq/l; Test Date: 20210719; Test Name: chloride; Result Unstructured Data: Test Result:108 mEq/l; Test Date: 20210715; Test Name: CPK; Result Unstructured Data: Test Result:222; Test Date: 20210719; Test Name: CPK; Result Unstructured Data: Test Result:116; Test Date: 20210715; Test Name: Creatine-kinase isoenzyme; Result Unstructured Data: Test Result:less than 1 ng/ml; Test Date: 20210715; Test Name: creatinine; Result Unstructured Data: Test Result:0,97; Comments: mg%; Test Date: 20210719; Test Name: creatinine; Result Unstructured Data: Test Result:0,76; Comments: mg%; Test Date: 20210715; Test Name: derived fibrinogen; Test Result: 386 mg/dl; Test Date: 20210715; Test Name: Fibrinogen; Result Unstructured Data: Test Result:305; Comments: mg%; Test Date: 20210719; Test Name: Fibrinogen; Result Unstructured Data: Test Result:658; Comments: mg%; Test Name: glucose; Result Unstructured Data: Test Result:399; Comments: gasometry; Test Date: 20210715; Test Name: glucose; Result Unstructured Data: Test Result:113; Comments: mg%; Test Date: 20210719; Test Name: glucose; Result Unstructured Data: Test Result:108; Comments: mg%; Test Name: lactate; Result Unstructured Data: Test Result:11.3; Comments: gasometry; Test Date: 20210715; Test Name: lactic acid; Result Unstructured Data: Test Result:1,5 mEq/l; Test Date: 20210719; Test Name: lactic acid; Result Unstructured Data: Test Result:0,7 mEq/l; Test Name: potassium; Result Unstructured Data: Test Result:3.9; Comments: gasometry; Test Date: 20210715; Test Name: potassium; Result Unstructured Data: Test Result:3,7 mEq/l; Test Date: 20210719; Test Name: potassium; Result Unstructured Data: Test Result:3,9 mEq/l; Test Name: blood pressure; Result Unstructured Data: Test Result:88/50 mmHg; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Name: sodium; Result Unstructured Data: Test Result:139; Comments: gasometry; Test Date: 20210715; Test Name: sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210719; Test Name: sodium; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210715; Test Name: urea; Test Result: 32 mg/dl; Test Date: 20210719; Test Name: urea; Test Result: 19 mg/dl; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Name: thoracic CT; Result Unstructured Data: Test Result:Acute central and bilateral pulmonary thromboembol; Comments: Acute central and bilateral pulmonary thromboembolism, with involvement of the right main pulmonary artery and multiple left segmental branches. Thrombi are not seen in the jugular veins or in the right chambers. There are signs of overload of the right cavities with contrast reflux to the suprahepatic veins, forming a liquid level. There is no pleural or pericardial effusion. There are no significant thoracic lymph nodes. In the lung parenchyma there are bibasal consolidations with an associated atelectatic component, which could be related to pulmonary infarctions in the clinical context or with infectious pneumonia.; Test Date: 20210715; Test Name: c-reactive protein; Result Unstructured Data: Test Result:23,1 mg/l; Test Name: echocardiogram; Result Unstructured Data: Test Result:LV with preserved function, collapse in diastole.; Comments: LV with preserved function, collapse in diastole. RV dilated (approximately 56 mm baseline in diastole), severe dysfunction with TAPSE <10 mm. PSAP cannot be estimated. Paradoxical movement of the septum. Mc Conell sign. Thrombi are observed in the right atrium and over the tricuspid valve.; Test Name: echocardiogram; Result Unstructured Data: Test Result:LV size and preserved systolic function. Dilated R; Comments: LV size and preserved systolic function. Dilated RV, with severely reduced systolic function. Right chamber thrombi were not observed. Without IT that allows estimating PSAP. TAPSE RV: 0.96 cm.; Test Name: tte; Result Unstructured Data: Test Result:shows right ventricular dilation and describes thr; Comments: shows right ventricular dilation and describes thrombi inside the right atrium; Test Name: tte; Result Unstructured Data: Test Result:left ventricular function, thrombi were no longer; Comments: left ventricular function, thrombi were no longer seen in RA, intraventricular thrombus, RV also dilated; Test Name: ekg; Result Unstructured Data: Test Result:SR at 114 bpm, normal PR. Narrow QRS. No alteratio; Test Date: 20210715; Test Name: eosinophil count; Result Unstructured Data: Test Result:0,111 x10 3/mm3; Test Date: 20210715; Test Name: eosinophil count; Result Unstructured Data: Test Result:1,3 %; Test Date: 20210715; Test Name: fibrin d-dimer; Result Unstructured Data: Test Result:101505 ng/ml; Test Date: 20210715; Test Name: hematocrit; Test Result: 45 %; Test Date: 20210715; Test Name: hematocrit; Result Unstructured Data: Test Result:43,1 %; Test Date: 20210719; Test Name: hematocrit; Result Unstructured Data: Test Result:32,3 %; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.1; Comments: gasometry; Test Date: 20210715; Test Name: hemoglobin; Result Unstructured Data: Test Result:13,6; Comments: gr%; Test Date: 20210715; Test Name: hemoglobin; Result Unstructured Data: Test Result:14; Comments: g/dl; Test Date: 20210719; Test Name: hemoglobin; Result Unstructured Data: Test Result:11,2; Comments: gr%; Test Name: heart rate; Result Unstructured Data: Test Result:150; Comments: bpm; Test Name: heart rate; Result Unstructured Data: Test Result:130; Test Date: 20210715; Test Name: INR; Result Unstructured Data: Test Result:1,46; Test Date: 20210719; Test Name: INR; Result Unstructured Data: Test Result:1,06; Test Date: 20210715; Test Name: INR; Result Unstructured Data: Test Result:1,25; Test Date: 20210715; Test Name: lymphocyte count; Result Unstructured Data: Test Result:3,12 x10 3/mm3; Test Date: 20210715; Test Name: lymphocyte count; Result Unstructured Data: Test Result:35,9 %; Test Date: 20210715; Test Name: mcv; Result Unstructured Data: Test Result:99,1; Comments: fL; Test Date: 20210715; Test Name: mpv; Result Unstructured Data: Test Result:7,7; Comments: fL; Test Date: 20210715; Test Name: monocyte count; Result Unstructured Data: Test Result:0,49 x10 3/mm3; Test Date: 20210715; Test Name: monocyte count; Result Unstructured Data: Test Result:5,6 %; Test Date: 20210715; Test Name: neutrophil count; Result Unstructured Data: Test Result:4,93 x10 3/mm3; Test Date: 20210715; Test Name: neutrophil count; Result Unstructured Data: Test Result:56,7 %; Test Name: o2 saturation; Result Unstructured Data: Test Result:88-90 %; Comments: with FiO2 1; Test Name: o2 saturation; Test Result: 90 %; Comments: with FiO2 100%.; Test Date: 20210715; Test Name: o2 saturation; Result Unstructured Data: Test Result:66,9 %; Test Date: 20210719; Test Name: o2 saturation; Result Unstructured Data: Test Result:68,1 %; Test Date: 20210715; Test Name: pc02; Result Unstructured Data: Test Result:39 mmHg; Test Date: 20210719; Test Name: pc02; Result Unstructured Data: Test Result:40 mmHg; Test Name: pCo2; Result Unstructured Data: Test Result:76; Test Name: ph; Result Unstructured Data: Test Result:7; Test Date: 20210715; Test Name: ph; Result Unstructured Data: Test Result:7,4; Test Date: 20210719; Test Name: ph; Result Unstructured Data: Test Result:7,39; Test Date: 20210715; Test Name: pH; Result Unstructured Data: Test Result:7,4; Test Date: 20210719; Test Name: pH; Result Unstructured Data: Test Result:7,39; Test Date: 20210715; Test Name: platelet count; Result Unstructured Data: Test Result:123 x10 3/mm3; Test Date: 20210715; Test Name: platelet count; Result Unstructured Data: Test Result:91 x10 3/mm3; Test Date: 20210719; Test Name: platelet count; Result Unstructured Data: Test Result:229 x10 3/mm3; Test Date: 20210715; Test Name: po2; Result Unstructured Data: Test Result:37 mmHg; Test Date: 20210719; Test Name: po2; Result Unstructured Data: Test Result:38 mmHg; Test Date: 20210715; Test Name: procalcytonine; Result Unstructured Data: Test Result:0,06 ng/ml; Test Date: 20210715; Test Name: prothrombin time; Result Unstructured Data: Test Result:14,4 seconds; Test Date: 20210715; Test Name: prothrombin time; Test Result: 70 %; Test Date: 20210715; Test Name: troponin I high sensitivity; Result Unstructured Data: Test Result:154 ng/L; Test Date: 20210715; Test Name: leukocyte count; Result Unstructured Data: Test Result:0.0000000076 x10 3/mm3; Comments: x1000/ul; Test Date: 20210715; Test Name: leukocyte count; Result Unstructured Data: Test Result:8,710 x10 3/mm3; Test Date: 20210719; Test Name: leukocyte count; Result Unstructured Data: Test Result:0.000000006 x10 3/mm3; Comments: x1000/ul
CDC Split Type: ESPFIZER INC202100939729

Write-up: Thrombocytopenia; Pulmonary thromboembolism; Deep vein thrombosis leg; syncope; tachypnoea; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-947714. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Jun2021 (Batch/Lot Number: FE1248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing and allergy to sulphonamides and family history of Mother with thromboembolic disease. The patient''s concomitant medications were not reported. On 15Jul2021 the patient experienced, thrombocytopenia, pulmonary thromboembolism leading to hospitalization, deep vein thrombosis of leg leading to hospitalization. The patient was at work when he presented syncope witnessed by colleagues with complete recovery. Later, he notices respiratory distress, so he decides to go outside (new syncope in the elevator). Emergency Services found him sitting on a bench with significant tachypnoea. They decide to proceed with airway isolation due to respiratory failure. During transfer, remains hemodynamically stable without the need for vasoactive support. They perform portable TTE that shows right ventricular dilation and describes thrombi inside the right atrium. Administered a dose of enoxaparin 100 mg sc. Upon his arrival to the emergency room, he was hypotensive with a systolic blood pressure of 90 mmHg, HR 150 bpm, with sat 88-90% with FiO2 1. On gasometry, it appears mixed acidosis (pH 7) with hyperlacticaemia of 11.4 and pCO2 76. The foot of the bed shows RV dilation with flattening of the septum, intra-atrial thrombi, some of them in transit and over the tricuspid valve. Given the instability, it was decided to administer 10 mg of alteplase as a bolus and 90 mg as an infusion, administering 1/6 M HCO3 and volume load. We decided to enter the ICU without performing an imaging test due to extreme hemodynamic instability. We re-questioned his co-workers, he had been vaccinated a month ago with the first dose of Pfizer and refers to recent round trip to the coast, on the same day. Exploration on admission: BP 88/50 mmHg HR 130 bpm Sat 90% with FiO2 100%. Poor peripheral perfusion. Low sedation and analgesia effects. Connected to mechanic ventilation. pupils equal and reacting to light CA: rhythmic, without murmurs. PA: bilateral CVM. ABD: Soft and depressible. Limbs: no oedema. Distal pulses present. Apache score: 12. The patient underwent lab tests and procedures which included Haemoglobin (Hb) 14g / dL13.1-17.2 Haematocrit (Hct) 43.1% 39-50 Mean corpuscular volume (MCV) 99.1fl 81-101 Platelets ** 91 10 ^ 3 / ul 150-450 Mean platelet volume (MPV) 7.7 fL7.4-11.4 Leukocytes 8.710 ^ 3 / ul 4-10 Neutrophils 4.9310 ^ 3 / ul 2.00-7.00 Neutrophils 56.7% 40-80 Lymphocytes * 3.12 10 ^ 3 / ul 1.00-.00 Lymphocytes 35.9% 20- 40 Monocytes 0.4910 ^ 3 / ul 0.20-1.00 Monocytes 5.6% 2-10 Eosinophils 0.1110 ^ 3 / ul 0.02-0.50 Eosinophils 1.3% 1-6 Basophils 0.04 10 ^ 3 / ul 0.02-0.10 Basophils 0.5% 0.4-1.3 Proven thrombopenia, platelet aggregates are not observed. Coagulation Prothrombin time (PT) PT * 14.4 seconds 9.2-13.8 PT 70% 70-130 PT (INR) ** 1.25 ratio 0.8-1.2 D-dimer ** 101505 ng / mL 215-500 Coagulation comment: D-dimer result checked on the submitted sample. Assess according to the clinical context, in the case of observing discrepancies, it is advisable to send a new sample to rule out preanalytical error. Activated partial thromboplastin time (APTT) 30.3 seconds 23.2-40.2 APTT 0.98 ratio 0.75-1.3 Fibrinogen derived from TP 386mg / Dl 150-400.Cardiac markers Troponin I high sensitivity * 154ng / L 3-58 Creatine-kinase isoenzyme MB (mass) <1ng / mL 0.5-3.6- Markers of inflammation and sepsis C-reactive protein * 23.1 mg / L 1-3 Procalcitonin 0.06ng / mL 0-0.1. Therapeutic measures were taken as a result of this by Constant every 6 hours. Oxygen therapy for Sato2 <94%. Bed rest. Heparin Na 5000 U in 100 ml at 20 ml / h. Modify according to his doctors Omeprazole orally 20 mg at breakfast. Intravenous Paracetamol 1000 mg if pain. Outcome of event Thrombocytopenia was recovered on 19Jul2021 while Pulmonary thromboembolism, Deep vein thrombosis leg, syncope, tachypnoea was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1516229 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Skin reaction (after previous vaccine (unknown vaccine))
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100939819

Write-up: Edema Quincke''s; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-MP20215435. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in Arm Left on 15Jul2021 at 30 years old (Batch/Lot Number: FE7010) as single dose for covid-19 immunization. Medical history included ongoing allergic asthma, skin reaction after previous vaccine (unknown vaccine). Patient didn''t have a history of COVID-19. The patient''s concomitant medications were not reported. The patient experienced edema quincke''s on 15Jul2021. Clinical course: on 15Jul2021: 5 to 10 minutes after the injection, occurrence of angioedema (respiratory problems and edema of the uvula). Injection of Anapen 300 allowing clinical improvement. Hospitalization on 15Jul2021 for clinical and paraclinical monitoring. No recurrence of edema, stable hemodynamic state. On 16Jul2021: Hospital discharge with corticosteroid therapy 1mg/kg for 3 days and antihistamines for 10 days. The outcome of the event was recovered on 15Jul2021. Serious criteria for the case was reported as hospitalization, life threatening. No follow-up attempts possible. No further information expected.


VAERS ID: 1516324 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: IBUPROFEN; PROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Period pains
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909377

Write-up: shivering; fever; Chills; Fatigue; Headache; Swollen glands; Vaccination site pain; Sore arm; received first dose on 20May2021, second dose on 15Jul2021; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-202107170909201890-6KU80. Safety Report Unique Identifier GB-MHRA-ADR 25668149. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FD8813) (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Lactation decreased, Period pains, contraception from an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20May2021 (Lot number was not reported) DOSE 1, SINGLE for COVID-19 immunisation. Concomitant medications included ibuprofen taken for Period pains from 15Jun2020 to an unspecified stop date; progesterone taken for contraception from 17Nov2020 to an unspecified stop date. The patient experienced shivering, fever, chills, fatigue, headache, swollen glands on 16Jul2021, vaccination site pain and sore arm on 15Jul2021. Clinical course was reported as: Sore arm started about 8 hours after vaccine then chills and shivering started about 12 hours after vaccine. Then fever shortly after. Fatigue started about 18 hours after vaccine and chills returned. Headache started 28 hours after vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Jul2021 No - Negative COVID-19 test. The outcome of the event shivering, fever, fatigue and vaccination site pain was resolving, of the event headache and swollen glands was not resolved, of the event chills was resolved on 16Jul2021, of the event sore arm was unknown. The events were reported as serious due to medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516340 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908973

Write-up: Abnormal bruising around injection site; This is a spontaneous report from a contactable consumer (patient, self-reported) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00256351. Safety Report Unique Identifier GB-MHRA-ADR 25659784. A 20-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ff3319 and expiry date was not reported), via parenteral, on 15Jul2021 (age at vaccination: 20 years), as a single dose, 0.3 ml, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced abnormal bruising around injection site. Possibly, the patient was unsure if it was a reaction to the medicine or the way it was administrated. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516341 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908923

Write-up: Swollen armpit; Swollen armpit; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority; report number is GB-MHRA-EYC 00256361. Safety Report Unique Identifier is GB-MHRA-ADR 25661301. A 40-year-old female patient had received an unknown dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation:Solution for injection, Lot number was not reported) via parenteral on 14Jul2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On 15Jul2021,the patient experienced swollen armpit (lymphadenopathy).This event was considered as medically significant.The clinical outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516419 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, olfactory, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: HUMIRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Bronchiectasis; Crohn''s disease; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Iritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906992

Write-up: Olfactory hallucination/strong smell of cigarette smoke; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107150856452320-WS2GY], Safety Report Unique Identifier [GB-MHRA-ADR 25654464] A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: Not Known) dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as Dose 2, Single for COVID-19 immunisation. The patient previously received the first dose of COVID-19 VACCINE for COVID-19 immunisation on unknown date. Medical history included ankylosing spondylitis, bronchiectasis, iritis, crohn''s disease, rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr), inflammatory bowel disease from an unknown date; Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis). Patient has not had symptoms associated with COVID-19. Concomitant medication included adalimumab (HUMIRA) taken for ankylosing spondylitis from 10Jul2018 to an unspecified stop date. The patient experienced olfactory hallucination/strong smell of cigarette smoke on 15Jul2021 with outcome of recovering. Woke up in the night to a strong smell of cigarette smoke this has continued through the night and to the next day.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test negative on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Axillary pain, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: BISODOL 1; BUTEC; CO-CODAMOL; DULOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Night sweats; Pregnancy; Somnolence
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906886

Write-up: Armpit pain; very sore lump under arm; pain down one side of arm into hand; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151057159880-4WRCB Safety Report Unique Identifier GB-MHRA-ADR 25655465. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: FA1027) as dose 2, single for COVID-19 immunisation. Medical history included night sweats, fibromyalgia/ fibromyositis, sleepiness/ daytime sleepiness, pregnancy, from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included calcium carbonate, magnesium carbonate, sodium bicarbonate (BISODOL 1) from 2014 to an unspecified stop date; buprenorphine (BUTEC) from 2014 to an unspecified stop date; codeine phosphate, paracetamol (CO-CODAMOL) from 2013 to an unspecified stop date; duloxetine from 2013 to an unspecified stop date; all were taken for fibromyositis/fibromyalgia. The patient experienced armpit pain, very sore lump under arm causing referred pain down one side of arm into hand on 15Jul2021. The events were reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 13Jul2021 (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of armpit pain was not recovered, while the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-15
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, 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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907272

Write-up: Painful periods; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151127055310-DM0Q5. Safety Report Unique Identifier GB-MHRA-ADR 25655579. A 31-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), the first dose via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: Ew3143) as single dose for covid-19 immunisation. Medical history included lactation decreased from an unknown date, anxiety from an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included citalopram taken for anxiety, start and stop date were not reported. The patient experienced painful periods on 15Jul2021. Case narrative: Very painful period pains that were not soothed by medication or a hot water bottle for a good few hours. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event was reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 06Jul2021 (No - Negative COVID-19 test). Therapeutic measures were taken as a result of the event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516448 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL5 510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Investigation, Limb discomfort, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Obs; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC2021907124

Write-up: pain; heaviness in both legs; Body numbness, numbness; 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-202107151230282180-5GQH4, Safety Report Unique Identifier is GB-MHRA-ADR 25656049. A 38-year-old female patient received second dose of BNT162B2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL5 510), via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunization. Medical history included lactation decreased. She has not had symptoms associated with COVID-19. Not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date; numbness/body numbness on 15Jul2021. Case narrative: Numbness, unable to feel pain, heaviness in both legs. Relevant investigations or tests conducted: triaged at A&E. Obs normal. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from pain on an unspecified date, recovering from numbness/body numbness, while outcome of heaviness in both legs was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516456 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Fatigue, Nausea, Tinnitus, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907193

Write-up: Weakness; Unsteadiness; Fatigue; Tinnitus aggravated; Nausea; Cloudy vision; tinnitus; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151348406330-P8SBO, Safety Report Unique Identifier GB-MHRA-ADR 25656580. A 31-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Jul2021 for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced tiredness on 15Jul2021, tinnitus, weakness, unsteadiness, fatigue, tinnitus aggravated, nausea, cloudy vision on an unspecified date. The patient had unsteady on feet, tiredness, slight nausea, louder tinnitus than normal, body fatigue. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of nausea, cloudy vision was resolving, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Bone pain, Chills, Dizziness, Intermenstrual bleeding, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:high (38.6); Test Date: 20210715; Test Name: Temperature; Result Unstructured Data: Test Result:high; Test Date: 20210630; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907100

Write-up: Muscle ache; High temperature; Joint pain; Bone pain; Spotting menstrual; Shivering; Dizziness; Weakness/feeling weak; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151447203880-PLLYA, Safety Report Unique Identifier: GB-MHRA-ADR 25657067. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced feeling weak on an unspecified date; and muscle ache, high temperature, joint pain, bone pain, spotting menstrual, shivering, dizziness, and weakness on 15Jul2021. Clinical course reported: high temperature 38.6, quite strong bone and joint pain, muscle aches, a bit dizzy in the morning, shivering, feeling weak. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 30Jun2021. The outcome of the events dizziness was recovered on an unspecified date; and for the rest of events was not recovered. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516490 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Off label use, Panic reaction, Product use issue
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907248

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; dizzy; panicky; Dizzy spells; anxious; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107151706373840-MGGAH and Safety Report Unique Identifier GB-MHRA-ADR 25658031. A 43-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD5613), via an unspecified route of administration at the age of 43-year-old on 15Jul2021 at single dose for COVID-19 immunisation. Medical history included ongoing breast feeding. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. The patient''s concomitant medications were not reported. 5 minutes after she felt dizzy and anxious and panicky on 15Jul2021. The patient dizzy spells on 15Jul2021. The events were serious for being medical significant. The patient experienced maternal exposure during breast feeding on unspecified. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event dizzy spells was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100933784 Baby case


VAERS ID: 1516493 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nervousness, Pallor, 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: GBPFIZER INC2021907245

Write-up: fainted; pale; nervous; Faint; This is a spontaneous report from a contactable Pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202107151735213310-5UNA1), Safety Report Unique Identifier (GB-MHRA-ADR 25658184). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FD8813), via an unspecified route of administration at single dose on 15Jul2021 for COVID-19 immunization. The patient medical history was not reported. Unsure if patient had had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced fainted on an unspecified date, faint on 15Jul2021, pale on an unspecified date, nervous on an unspecified date. Case narrative: Patient appeared nervous, and looked pale after questioning but was happy to go ahead. Asked if had fainted after any previous vaccines - answered YES with every recent one. Asked if we could vaccinate sat on the floor, screen was used for privacy. Chaperone - Male Immunisation Assistant and female Pharmacist administered vaccine. Patient removed mask and fainted 2-3 minutes after vaccine. Carefully supported and laid on floor. Made speedy recovery following elevation of legs. Recovered Well. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event faint was recovered on 15Jul2021, while the other events were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516494 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907058

Write-up: Tiredness; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107151735234380-4STG3, Safety Report Unique Identifier GB-MHRA-ADR 25658309. A 32-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# FF3319), via an unspecified route of administration on 14Jul2021 as a single dose for COVID-19 immunization. His first dose was received on an unspecified date. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced tiredness and headache on 15Jul2021. The patient had not recovered from the events at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1516496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907168

Write-up: Rash; This is a spontaneous study report from a contactable Consumer. This is a report received from the regulatory authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107151814352360-YP8YP], Safety Report Unique Identifier [GB-MHRA-ADR 25658487] A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: Not Known) dose 1 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced rash (medically significant) on 15Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1516503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906958

Write-up: Tight chest; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107151910010510-C1NSA, Safety Report Unique Identifier GB-MHRA-ADR 25658872. A female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Not known), via unspecified route of administration at single dose on 15Jul2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. The patient experienced tight chest on 15Jul2021. Event was reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 17Jun2021. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906997

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107152018474880-UIA3F, Safety Report Unique Identifier GB-MHRA-ADR 25659342. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number: Not known) as dose 2, single for COVID-19 immunisation.first dose of COVID-19 VACCINE was received on unknown date for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced diarrhea on 15Jul2021 with outcome of not recovered.the event was considered as serious due to medically significant by HA.Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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