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

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



Case Details (Reverse Sorted by Onset Date)

This is page 387 out of 8,010

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VAERS ID: 1702701 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:170/110 mmHg
CDC Split Type: PHPFIZER INC202101146388

Write-up: Elevated BP; This is a spontaneous report from a contactable other health professional (HCP). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102681. A 45-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0350), intramuscular on 26Aug2021 (at the age of 45-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 26Aug2021 at 13:22. The patient underwent lab tests and procedures which included blood pressure measurement: 170/110 mmhg on 26Aug2021. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702704 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD59969 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:180/100
CDC Split Type: PHPFIZER INC202101146402

Write-up: Elevated BP: 180/100; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102607. A 75-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 at the age of 75 years old (Lot Number: FD59969) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP: 180/100 on 26Aug2021 12:10 with outcome of recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702706 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:170/110 mmHg
CDC Split Type: PHPFIZER INC202101146410

Write-up: Elevated BP; This is a spontaneous report from a contactable other health professional (HCP). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102671. A 50-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0350), intramuscular on 26Aug2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 26Aug2021 at 14:02. The patient underwent lab tests and procedures which included blood pressure measurement: 170/110 mmhg on 26Aug2021. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702707 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:173/114 mmHg
CDC Split Type: PHPFIZER INC202101146412

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102675. A 53-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0350), intramuscular on 26Aug2021 (at the age of 53years) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP (blood pressure) on 26Aug2021 13:40. The patient underwent lab tests and procedures which included blood pressure measurement: 173/114 mmHg on 26Aug2021. The outcome of event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702929 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: PTMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: PT-INFARMED-R202108-3800) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced BACK PAIN (seriousness criterion disability). On 28-Aug-2021, BACK PAIN had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant product was provided by the reporter. No treatment medication 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 event, a causal relationship cannot be excluded.; Reporter''s Comments: 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: 1703168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-26
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? Yes
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: Medical History/Concurrent Conditions: Cerebral bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101150091

Write-up: CEREBRAL HAEMORRHAGE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-078444. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Cerebral bleeding from 2016 and not ongoing. The patient''s concomitant medications were not reported. The patient experienced cerebral hemorrhage (disability, life threatening) on 26Aug2021. cerebral bleeding about 3 weeks after dose 2 vaccination. Outcome of the event was Recovered/resolved with sequelae. Report assessed as serious, life threatening, disability. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1703170 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: Medical History/Concurrent Conditions: Epileptic seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: Epileptic seizure; This case was received via regulatory authority (Reference number: SE-MPA-2021-078449) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Epileptic seizure. On 10-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 26-Aug-2021, the patient experienced EPILEPSY (seriousness criteria hospitalization and medically significant). On 27-Aug-2021, EPILEPSY had resolved. No concomitant medication provided. No treatment information mentioned. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Translation received on 06-SEP-2021:contain no new information.; Sender''s Comments: This is a RA report of Seizure after the second dose of the product in a 45 years old male with antecedent of seizures, whose concomitant medication was not provided. The event was serious as per regulatory authority and hospitalization, and was resolved at the time of the report. 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: 1703757 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: BEPFIZER INC202101149578

Write-up: Shivering; Costal chondritis; Fever; Abdominal infection; Nausea; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105908. A 22-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Aug2021 (Lot Number: FE2625) as Dose 2, single at the age of 22-years-old for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever, shivering, nausea, abdominal infection, costal chondritis, all on 26Aug2021 with outcome of recovering. Seriousness criteria for all events was disability. ADR description: Acute stitches in the abdominal and costal region. The twinges beginning about 8 hours after the injection. Ephemeral twinges (not constant), frequency every few minutes. No treatment received. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1703759 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: BEPFIZER INC202101149657

Write-up: Shivering; Fever; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-105932. A 14-years-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration, on 26Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 26Aug2021, the patient experienced shivering and fever. Treatment: none. The adverse events were assessed as serious (disability). Clinical outcome of the adverse event was recovering at time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous incomplete
SMQs:, Termination of pregnancy and risk of abortion (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: AUPFIZER INC202101139857

Write-up: Abortion spontaneous incomplete; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 612550. A 30-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced abortion spontaneous incomplete on 26Aug2021. The outcome of the 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: 1705327 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101149615

Write-up: dyspnoea; Pulmonary embolism; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB number DE-PEI-CADR2021171393, Safety Report Unique Identifier DE-PEI-202100179018. A 62-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 26Aug2021, dyspnoea on 28Aug2021. The event seriousness criteria was hospitalization. Therapeutic measures were taken as a result of events. The outcome of event pulmonary embolism was not recovered; of event dyspnoea was unknown. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses None / dyspnoea on 28Aug. Intensive care unit with lysis therapy. Event assessment: Comirnaty/ event Pulmonary embolism/regulatory authority/Result of Assessment: Unclassifiable. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected.


VAERS ID: 1705663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast tenderness, Haemorrhage, Menstruation irregular, Mood swings, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Dystonia (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bleeding; Cramp; Mood swings; Withdrawal symptom
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152109

Write-up: Irregular periods; tender breasts; cramping; Heavily bleeding and spotting; mood swings; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109021504082440-ADQ5O with Safety Report Unique Identifier GB-MHRA-ADR 25887055. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: fe3380) via an unspecified route of administration on 19Aug2021, as a single dose for COVID-19 immunisation. Medical history included mood swings, cramp, bleeding, withdrawal symptom and the patient had not taken any medication. The patient was not pregnant and was not breastfeeding at the time of report. The patient was not enrolled in clinical trial. The patient did not have symptoms associated with COVID-19. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC9001) via an unspecified route of administration on 20Jun2021 as a single dose for COVID-19 immunisation. On 26Aug2021, 7 days after the vaccination, the patient experienced irregular periods and on an unknown date in 2021, the patient experienced heavily bleeding, spotting, mood swings, tender breasts and cramping. The clinical course was reported as follows: A week after finishing her period (always very regular), the patient started feeling period like symptoms spotting, cramping, tender breasts, mood swings. Then the patient started spotting and heavy bleeding as if she had her period again, only one week after she had just had it. These symptoms were more extreme than normal. Since the patient had read several articles that link irregular periods to the COVID vaccination and she have spoken to a doctor. She would like to report it as a symptom, so other menstruating individuals were aware of the possible side-affects and didn''t worry that they may have a serious health condition - like she did. Patient did not test positive for COVID-19 since having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events heavily bleeding/spotting, irregular periods and mood swings were not resolved, while that of tender breasts, cramping was unknown at the time of report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1705672 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Lymph node pain, Lymphadenopathy, Muscle fatigue, Nasal congestion, Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Somnolence, Staring
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; DESOGESTREL; IBUPROFEN; PARACETAMOL; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drowsiness; Hay fever; Irregular periods; Muscle fatigue; Pain; Throat swelling; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152046

Write-up: Swollen lymph nodes; Fever; flu like symptoms like a blocked nose and slightly aching throat; blocked nose; slightly aching throat; Headache; Muscle fatigue; Drowsiness; Aching in limb/ ache in the arm that was injected started almost immediately; Staring; lymph nodes in the armpit area of the injected arm became swollen and painful.; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109021642573610-PGCC7, Safety Report Unique Identifier GB-MHRA-ADR 25887795. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in arm on 26Aug2021 as a single dose for COVID-19 immunisation. Medical history included muscle fatigue, throat swelling, drowsiness, hay fever, irregular periods, pain and vitamin D deficiency. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. On an unknown date, the patient underwent COVID-19 virus test and the result was found to be negative. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) for hay fever from unknown date and unknown if ongoing, desogestrel (MANUFACTURER UNKNOWN) from an unknown date in Jun2021 for irregular periods and unknown if ongoing, ibuprofen (MANUFACTURER UNKNOWN) for pain from unknown date and unknown if ongoing, paracetamol (MANUFACTURER UNKNOWN) for pain from unknown date and unknown if ongoing, and vitamin D (MANUFACTURER UNKNOWN) for vitamin D deficiency from unknown date and unknown if ongoing. On an unknown date in 2021 the patient experienced staring and lymph node pain. On 26Aug2021, the patient experienced aching in limb and drowsiness. On 27Aug2021 the patient experienced flu like symptoms, headache, and muscle fatigue. On 28Aug2021 she experienced fever; On 30Aug2021 she experienced swollen lymph nodes. The clinical course was reported as follows: It was reported that the ache in the arm that was injected started almost immediately, followed by headache, drowsiness and muscle fatigue (along with other flu like symptoms like a blocked nose and slightly aching throat), after most of those relaxed, the lymph nodes in the armpit area of the injected arm became swollen and painful. No treatment was received by the patient besides regular painkillers such as paracetamol (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) and stayed well hydrated. The events were reported as serious for being medically significant and causing disability. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of staring, aching in limb, flu like symptoms like a blocked nose and slightly aching throat and muscle fatigue was recovering; clinical outcome of drowsiness, swollen lymph nodes was not recovered while the outcome of lymph node pain was unknown. The clinical outcome of fever was recovered on an unknown date in 2021; while the event headache was recovered on 29Aug2021, after the duration of 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-08-26
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Phlebectomy, Superficial vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Varicose veins
Allergies:
Diagnostic Lab Data: Test Name: saphenectomy; Result Unstructured Data: Test Result:unknown result; Comments: Already operated on unspecified date.; Test Date: 20210826; Test Name: enous Doppler ultrasound evaluation; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC202101155083

Write-up: extended superficial venous thrombosis on the left medial thigh already operated with saphenectomy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-778423. A 37-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF2752, Expiration Date: 30Nov2021) intramuscular, administered in right deltoid on 25Jul2021 16:46 (at the age of 37-year-old) as dose 1, 0.3 mL single for covid-19 immunisation. Medical history included varicose vein from 02Dec2010 to 31Aug2021. The patient''s concomitant medications were not reported. On 26Aug2021 the patient experienced extended superficial venous thrombosis on the left medial thigh already operated with saphenectomy. The patient received venous Doppler ultrasound evaluation and fondaparinux (specific therapy) as a treatment and waiting vascular surgical evaluation. Extended Superficial Vein Thrombosis medial distal veins of the left thigh, not involving the deep circulation. On an unspecified date the patient underwent lab tests and procedures which included ultrasound doppler and saphenectomy with unknown results. The patient underwent lab tests and procedures which included ultrasound doppler unknown result on 26Aug2021 and saphenectomy on an unspecified date with unknown result. Therapeutic measures were taken as a result of extended superficial venous thrombosis on the left medial thigh already operated with saphenectomy (thrombophlebitis superficial). Outcome of the event was not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1706221 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:160/100
CDC Split Type: PHPFIZER INC202101146377

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority . Regulatory authority report number PH-PHFDA-300102615. A 30-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD5996) (at the age of 30-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021 10:02, the patient experienced elevated BP. The patient underwent lab tests and procedures which included blood pressure measurement: 160/100 on 26Aug2021. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706222 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:150/100
CDC Split Type: PHPFIZER INC202101146379

Write-up: Elevated BP; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300102641. A 39-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular route on 26Aug2021 (Batch/Lot Number: FD5996) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP (medically significant) on 26Aug2021 09:40 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement:150/100 on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706223 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:190/100
CDC Split Type: PHPFIZER INC202101146380

Write-up: Elevated BP; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102661 A 44-year-old female patient received BNT162B2 (COMIRNATY) intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated bp on 26Aug2021 at 15:45. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 26Aug2021. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706224 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertensive crisis
SMQs:, 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:193/118 mmHg
CDC Split Type: PHPFIZER INC202101146385

Write-up: Elevated BP / blood pressure: 193/118 mmHg; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300102673. A 52-year-old male patient received BNT162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) (at the age of 52 years old) dose number was unknown, single dose for Covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced elevated BP, blood pressure of 193/118 mmHg on 26Aug2021 at 15:59. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706225 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:170/100 mmHg
CDC Split Type: PHPFIZER INC202101146386

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300102676. A 55-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021, at the age of 55-years-old, (Lot Number: FD0350) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 26Aug2021 15:41, the patient experienced elevated BP (medically significant).The patient underwent lab tests and procedures which included blood pressure measurement: 170/100 mmhg on 26Aug2021. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706226 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg
CDC Split Type: PHPFIZER INC202101146387

Write-up: Elevated BP; This is a spontaneous report from a contactable Other Health Professional received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102678.A 49-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) (at the age 49-year-old) (at the age of 49-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 26Aug2021 14:38 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 160/100 mmhg on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706227 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:176/101 mmHg
CDC Split Type: PHPFIZER INC202101146389

Write-up: elevated blood pressure (BP) at 176/101 mmHg; This is a spontaneous report from a contactable other healthcare professional (HCP). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102683. A 52-year-old male patient received BNT162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) (at the age of 52-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated blood pressure (BP) at 176/101 mmHg on 26Aug2021 at 12:51. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706229 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:170/90
CDC Split Type: PHPFIZER INC202101146406

Write-up: Elevated BP; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102647. A 68-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FD5996), intramuscular on 26Aug2021 (at 68 years old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced elevated BP (medically significant) on 26Aug2021 09:50. The patient underwent lab tests and procedures which included blood pressure measurement: 170/90 on 26Aug2021. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706230 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:206/109
CDC Split Type: PHPFIZER INC202101146408

Write-up: Elevated BP/blood pressure: 206/109; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102666. A 51-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 26Aug2021 (Lot Number: FD0350) as dose number unknown, single (at the age of 51 years old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 26Aug2021 13:00. The patient underwent lab tests and procedures which included blood pressure: 206/109 on 26Aug2021. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706231 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:190/100 mmHg
CDC Split Type: PHPFIZER INC202101146409

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional (hcp). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102669. A 50-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD0350, expiry date not reported), intramuscular on 26Aug2021 (at the age of 50 years old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced elevated bp, reported as medically significant, on 26Aug2021 13:28. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 mmhg on 26Aug2021. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706232 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:185/128; Comments: elevated
CDC Split Type: PHPFIZER INC202101146413

Write-up: elevated bp with blood pressure measurement of 185/128 [units unknown]; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102679. A 55-year-old male patient received bnt162b2 (COMIRNATY), at vaccination age of 55-year-old intramuscular on 26Aug2021 (Lot Number: FD0350) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021 13:42, the patient experienced elevated bp with blood pressure measurement of 185/128 [units unknown]. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706233 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:150/100 mmHg
CDC Split Type: PHPFIZER INC202101146414

Write-up: Elevated BP at 150/100 mmHg; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority, (Regulatory Authority report number: PH-PHFDA-300102680). A 48-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FD0350; Expiration date was not reported), intramuscular on 26Aug2021 as dose number unknown, single, for COVID-19 immunization. The patient''s medical history was and concomitant medications were not reported. On 26Aug2021 (15:07), the patient had elevated blood pressure (BP) at 150/100 mmHg. The event was assessed as serious (medically significant). The outcome of the event was recovered on an unspecified date in 2021.


VAERS ID: 1706234 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), 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: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:191/159 mmHg
CDC Split Type: PHPFIZER INC202101146415

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional (HCP), received from the Regulatory Authority. Regulatory authority report number: PH-PHFDA-300102682. A 61-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) as dose number unknown, single (at the age of 61-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated blood pressure (BP) on 26Aug2021 at 15:35. The patient underwent lab tests and procedures which included blood pressure measurement: 191/159 mmHg on 26Aug2021. The event resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706371 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-26
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Autoimmune disorder, Chromaturia, Haemoglobin, Haemoglobin decreased, Jaundice, Pulmonary fibrosis, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypogammaglobulinemia
Allergies:
Diagnostic Lab Data: Test Name: Hemoglobin; Result Unstructured Data: Test Result:Low; Test Name: white blood; Result Unstructured Data: Test Result:Increased
CDC Split Type: TNPFIZER INC202101168957

Write-up: pulmonary fibrosis; Severe anemia; drop in hemoglobin to 5 g / 100 ml; sharp rise in white blood cells; Triggering of a severe outbreak of autoimmune disease; brown urine; Yellowing of the face; This is a spontaneous report from a contactable consumer (patient) and a physician via COVID-19 Vaccine Adverse Event Reporting System. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Aug2021 (Batch/Lot Number: FF2153) (at the age of 52 years) as dose number unknown, single for covid-19 immunisation. Medical history included hypogammaglobulinaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced pulmonary fibrosis, severe anemia, drop in hemoglobin to 5 g / 100 ml, sharp rise in white blood cells, triggering of a severe outbreak of autoimmune disease, all on an unspecified date, all reported as serious due to hospitalization and reported as life-threatening with outcome of not recovered. The patient also experienced brown urine on unknown date and yellowing of the face on 26Aug2021, both with outcome of not recovered. Therapeutic measures were taken as a result of events pulmonary fibrosis, severe anemia, drop in hemoglobin to 5 g / 100 ml, sharp rise in white blood cells, yellowing of the face.


VAERS ID: 1707953 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Feeling cold, Rash
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Feeling of total lack of energy; Rash; Coldness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25913085) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling of total lack of energy), FEELING COLD (Coldness) and RASH (Rash) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced FEELING COLD (Coldness) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 28-Aug-2021, FEELING COLD (Coldness) had resolved. On 29-Aug-2021, RASH (Rash) had resolved. On 31-Aug-2021, ASTHENIA (Feeling of total lack of energy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided. Treatment medication were not reported. Patient was not enrolled in Clinical Trial. Company Comment: This case concerns a 48-year-old, female patient with no relevant medical history who experienced serious unexpected events of asthenia, feeling cold and rash. The events occurred approximately 1 day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 48-year-old, female patient with no relevant medical history who experienced serious unexpected events of asthenia, feeling cold and rash. The events occurred approximately 1 day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1708118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise, Myalgia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101142517

Write-up: Injection site reaction; Myalgia; Feeling unwell; Fatigue; Shivering; Headache; Arthralgia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number is BE-FAMHP-DHH-N2021-105842. A 25-year-old female patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 25Aug2021 at 20:02 as dose 2, single for COVID-19 immunisation. Medical history included smoker. Concomitant medications were not reported. On 26Aug2021 at 11:00, the patient experienced injection site reaction, myalgia, feeling unwell, fatigue, shivering, headache, and arthralgia. The events are serious (disability). There was no treatment for the events. The outcome of the events was unknown. Reportercomment: Treatment - No Evolution of the adverse drug reaction - Adverse drug reaction description - I received my injection at 8.02pm and the symptoms started the following day at 11.00am, becoming much worse in the afternoon.. More information on the time relationship (adverse drug reaction) - no end date yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the adverse drug reaction - Adverse drug reaction description - I received my injection at 8.02pm and the symptoms started the following day at 11.00am, becoming much worse in the afternoon.. More information on the time relationship (adverse drug reaction) - no end date yet


VAERS ID: 1708119 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Dizziness, Fatigue, Feeling of body temperature change, Headache, Insomnia, Malaise, Myalgia, Nausea, Palpitations, Pyrexia, Tinnitus, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: BEPFIZER INC202101149781

Write-up: Insomnia; Ear buzzing; Shivering; dizziness; Fever; Chest pain; Fatigue; Feeling hot and cold; Myalgia; Nausea; Headache; Malaise; Arthralgia; Palpitations; Head spinning; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-105843. A 22-years-old female patient received bnt162b2, via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In the night, around 4:00 am, the patient started to have insomnia. As soon as she got up, she experienced dizziness and buzzing. She could hardly get up or stand. Hot, cold, chills, nausea, joint and muscle pain, headache. She suffered from chest pains and felt her heart was racing. The patient experienced fever (disability), chest pain, fatigue, feeling hot and cold, myalgia, nausea, headache, malaise, arthralgia, palpitations, head spinning, ear buzzing, and shivering on 26Aug2021 with outcome of recovering. Patient also experienced insomnia on 26Aug2021 04:00 with outcome of recovering and dizziness on 26Aug2021 with outcome of unknown. Patient did not receive treatment. Reporter comment: Treatment: NO No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment: NO


VAERS ID: 1709507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-26
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood test, Cardiac arrest, Computerised tomogram coronary artery, Electrocardiogram
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Coronary angiogram; Result Unstructured Data: Test Result:in good health; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:in good health; Test Date: 2021; Test Name: Computerised tomogram coronary artery; Result Unstructured Data: Test Result:in good health; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:in good health
CDC Split Type: DKPFIZER INC202101194477

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number DK-DKMA-WBS-0087350 with Safety Report Unique Identifier DK-DKMA-ADR 25884844. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: FE2090; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 for COVID-19 immunisation on 23May2021 (Batch/Lot Number: FA7812; Expiration Date: 30Sep2021). The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest (hospitalization, life threatening) on 26Aug2021 with outcome of recovered on 26Aug2021. The patient was treated with AED and insertion of ICD. The patient underwent lab tests and procedures which included EKG, computerised tomogram coronary artery, coronary angiogram, blood test and all in good health in 2021. Causality: The reporter states that there was no conclusion on anything and that all test results showed that the patient was in good health. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709525 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood glucose, Blood pressure measurement, Cardiac arrest, Cardio-respiratory arrest, Chest pain, Coma scale, Computerised tomogram, Depression, Dyspnoea, Generalised tonic-clonic seizure, Heart rate, Loss of consciousness, Oxygen saturation, Respiratory rate, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism (3-4 beers day); Anxiety disorder; Breast neoplasm (5 years ago currently without treatment); Migraine; Smoker (5/10 cigarettes day)
Allergies:
Diagnostic Lab Data: Test Name: glycemia; Result Unstructured Data: Test Result:80; Test Name: BP; Result Unstructured Data: Test Result:110/70; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Name: CT skull; Result Unstructured Data: Test Result:No image of intra- or extraaxial bleeding; Comments: or lesions; Test Name: HR; Result Unstructured Data: Test Result:80; Test Name: Sat O2; Result Unstructured Data: Test Result:98; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20
CDC Split Type: ESPFIZER INC202101194802

Write-up: Cardio-respiratory arrest; Loss of consciousness; Convulsion; anxiety and depressive state; anxiety and depressive state; clonic tonic seizure; dyspneic sensation; chest pain; asystole; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number ES-AEMPS-996065. A 37-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 26Aug2021 (Lot Number: FF2832) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included Smoker 5/10 cigarettes day, alcoholism 3-4 beers day, anxiety disorder, migraine, breast neoplasm 5 years ago currently without treatment. The patient''s concomitant medications were not reported. The patient previously took metamizole, diclofenac and tramadol and all experienced allergy. The patient experienced convulsion, loss of consciousness on 26Aug2021 with outcome of recovered on 30Aug2021; cardio-respiratory arrest on 27Aug2021 with outcome of recovered on 27Aug2021, asystole on 27Aug2021, dyspneic sensation and chest pain on 30Aug2021. Patient comes apparently stable to second dose of covid19 vaccine, when she leaves the vaccination center (doubtful) loss of consciousness attended again in the outpatient clinic that is oriented as unconscious-convulsion-cardiorespiratory arrest, 2 cycles of compressions are performed and she recovers consciousness, being oriented Glasgow (GSC) 15. There has been no relaxation of sphincters or another clinic. Blood pressure (BP) 110/70, Heart rate 80, Respiratory rate 20, Saturation O2 98, glycemia 80. Subsequently, she presents episodes of doubtful disconnection from the environment with generalized muscle contraction, self-limited in a few seconds, recovering consciousness again and oriented. No alterations in monitoring during episodes. Diazepam ev is administered. transfer to hospital for evaluation. CT skull: No image of intra- or extraaxial bleeding or lesions suggesting supratentorial acute/subacute ischemia is identified. No alterations in the morphology and density of the brain, cerebellar or trunk parenchyma are detected. Ventricular system and convexity grooves of normal size and morphology. No displacement of midline structures is observed. Perimesencephalic cisterns and basal books. Cerebellar tonsils of normal arrangement. No significant hoseous alterations in the shell or at the base of the skull. Paranasal breasts and pneumatized mastoids. Evolution: Upon arrival, patient GCS 15. While waiting for a visit, she performs oscillating and changing tonic movements of limbs, which can be corrected externally, lasting a few seconds with subsequent full recovery of level of consciousness, without postcritication, relaxation of sphincters, cyanosis or other alterations. Guedel has been introduced which she has tolerated both with apparently diminished level of consciousness and when conscious. Physical exploration is normal. With diagnostic guidance of conversion disorder with seizures or convulsions. It is treated with anxiolytic and analgesic and the patient leaves voluntarily discharged. On 27Aug she visits again the emergency room of the outpatient clinic where they witness again loss of consciousness and asystole and they return to do CPR maneuvers recovering with episode of clonic tonic seizure so they administer clonazepam. Later they explain post-critical. She is referred back to hospital that orients to mixed adaptive disorder of anxiety and depressive state. On 30Aug outpatient consultation for dyspneic sensation and probable chest pain due to CPR maneuvers. Diagnostic guidance: Comicial crises vs conversive syndrome. Atypical chest pain probably due to recent CPR maneuvers. Pending electrocardiogram (EEG), the last days has presented episodes compatible with electoral crises pending neurology and pending urine culture result. High in treatment with paracetamol 1 g / 8h and signs of re-consultation. The outcome of other events was unknown. Seriousness of events convulsion, cardio-respiratory arrests and loss of consciousness were provided as life-threatening and hospitalized. No follow up attempts are possible. No further information is expected.


VAERS ID: 1709741 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, Hot flush, Influenza, Lower respiratory tract infection, Malaise, Pyrexia, SARS-CoV-2 test, Sinusitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: CODEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain
Allergies:
Diagnostic Lab Data: Test Date: 20201017; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153182

Write-up: Hot flashes; Tiredness/Exhaustion; Chest infection; Sinus infection; Breathlessness; Feverish; Cough; Flu symptoms; Dizziness; Feeling unwell; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-202109041710029880-3I0O7. Safety Report Unique Identifier: GB-MHRA-ADR 25896630. A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 26Aug2021 (age at Vaccination: 33-year-old) as single dose for COVID-19 immunization. Medical history included back pain from 22Dec2019 to an unknown date. Concomitant medication(s) included codeine (MANUFACTURER UNKNOWN) taken for back pain from 22Dec2019 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 26Aug2021, the patient experienced dizziness, feeling unwell. On 27Aug2021, the patient experienced feverish, cough, flu symptoms. On 28Aug2021, the patient experienced chest infection, sinus infection, breathlessness, tiredness/exhaustion. On 29Aug2021 the patient experienced hot flashes. The event was reported as serious with seriousness criteria Disability. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on 17Oct2020. The outcome of all events was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1709819 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Electrocardiogram, Feeling abnormal, Migraine, Myalgia, Photophobia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold; Diarrhea; Muscular pains; Tight chest
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result: Unknown results
CDC Split Type: GBPFIZER INC202101153276

Write-up: within; hours; Fever / temperature going up and down over a period of several hours 37.5 to 38.7; Fever chills / feeling very cold; Diarrhea; Muscular pains; Migraine; This is a spontaneous report from a contactable consumer (parent) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109031743075250-DGAWH. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as single dose (at age of 16 years old) for COVID-19 immunization. Medical history included chest discomfort, myalgia, diarrhoea, nasopharyngitis. The patient''s concomitant medications were not reported. The patient had not had symptoms associated with COVID-19, had not had a COVID-19 test, and was not enrolled in clinical trial. The reporter suggested the dosage amount given to teenagers should be less than a full grown adult. Reporter''s daughter (the patient) had a very strong immune response and I thought that the dose was too much for her. She was a very fit athlete. The patient experienced "within" ("photophobia" as provided by RA) on an unspecified date with outcome of recovering, "hours" ("spaced out" as provided by RA) on an unspecified date with outcome of recovering, fever (described as temperature going up and down over a period of several hours 37.5 to 38.7) on 27Aug2021 with outcome of recovered on 28Aug2021, fever chills (also described as feeling very cold) on 27Aug2021 with outcome of recovered on 28Aug2021, diarrhea on 27Aug2021 with outcome of recovered on 28Aug2021, migraine (also described as headache beginning within 4 hours of vaccine, intense and bad enough to be in bed next day) on 26Aug2021 with outcome of recovered on 28Aug2021, muscular pains in left arm and into chest on 27Aug2021 with outcome of recovered on 28Aug2021. The patient underwent lab tests and procedures which included electrocardiogram (ECG): unknown results on an unknown date. The patient had not tested positive for COVID-19 since having the vaccine. The case was provided as a serious report by RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1709886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Fungal skin infection, Nipple disorder, Nipple inflammation, Nipple pain, Nipple swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Functional lactation disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Swelling
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101153074

Write-up: left nipple had been swelling; a sort of fungus now growing on his left nipple; a red swelling to the upper left a cross from the left nipple; Nipple inflammation; Nipple pain/ tender; Nipple disorder; This is a spontaneous report from a contactable consumer (patient''s parent) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109041401411810-9JPYJ and Safety Report Unique Identifier GB-MHRA-ADR 25896459. A 16-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FE3380), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunization. Medical history included swelling. The patient was normally fit and healthy. He 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 nipple disorder on 26Aug2021, nipple pain on 29Aug2021, nipple inflammation on 02Sep2021, the events were medically significant. The patient left nipple had been swelling and tender, there was a sort of fungus now growing on his left nipple followed by a red swelling to the upper left a cross from the left nipple. The reporter and patient went to the doctor on the 03Sep2021 and he was given antibiotics oral and an antibiotic cream, he was to be seen again next week. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome events nipple disorder, nipple pain, nipple inflammation was not recovered, of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1710245 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Echocardiogram, Interchange of vaccine products
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Percutaneous transluminal coronary angioplasty; Posteroinferior myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Echocardiogram abnormal; Result Unstructured Data: Echocardiogram abnormal
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Moderna in data 20/08/21. Interchange of vaccine products; This case was received via a regulatory authority (Reference number: IT-MINISAL02-778657) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION in a 48-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Posteroinferior myocardial infarction on 26-Aug-2021 and Percutaneous transluminal coronary angioplasty on 27-Aug-2021. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) at an unspecified dose. On 26-Aug-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, ACUTE MYOCARDIAL INFARCTION and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Echocardiogram: abnormal (abnormal) Echocardiogram abnormal. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Additional lab data included was on 26 Aug 2021, Angiograph coronary was performed. No results were provided. Company Comment : There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as vaccination dates and patient''s medical his tory and outcome. No further information is expected.; Sender''s Comments: There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as vaccination dates and patient''s medical his tory and outcome. No further information is expected.


VAERS ID: 1710492 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Feeling cold, Headache, Myalgia, Nausea, Pain in extremity, Pyrexia, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (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: Iron; Tran [Tranexamic Acid]
Current Illness:
Preexisting Conditions: Comments: No medical history information provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00046835) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE, PAIN IN EXTREMITY, MYALGIA, ARTHRALGIA, VACCINATION SITE PAIN, PYREXIA, NAUSEA, HEADACHE and FEELING COLD in a 37-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. No medical history information provided. Concomitant products included IRON and TRANEXAMIC ACID (TRAN [TRANEXAMIC ACID]) for an unknown indication. On 26-Aug-2021 at 8:55 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (seriousness criterion medically significant), MYALGIA (seriousness criterion medically significant), ARTHRALGIA (seriousness criterion medically significant), VACCINATION SITE PAIN (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant), NAUSEA (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant) and FEELING COLD (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced SYNCOPE (seriousness criterion medically significant). On 27-Aug-2021, SYNCOPE, PYREXIA, NAUSEA, HEADACHE and FEELING COLD had resolved. At the time of the report, PAIN IN EXTREMITY, MYALGIA, ARTHRALGIA and VACCINATION SITE PAIN was resolving. No treatment details were added. The patient reported that side effects came 10-12 hours after vaccination. Most of the side effects lasted for 12 hours. The patient reported about getting a sick leave. 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. The events were assessed as serious as per Regulatory Authority report.; 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. The events were assessed as serious as per Regulatory Authority report.


VAERS ID: 1710574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-18
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: 20210826; Test Name: COVID-19 antigen test; Result Unstructured Data: Unknown
CDC Split Type: PTJNJFOC20210929548

Write-up: Vaccination failure; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-B202108-3759) on 15-SEP-2021 and concerned a 19 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-01 expiry: UNKNOWN) .5 ml, 1 total, administered on 07-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccination failure, covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Unknown. The dose of covid-19 vaccine ad26.cov2.s was not changed. The outcome of the vaccination failure and covid-19 was not reported. This report was serious (Other Medically Important Condition). Case is associated with Product Quality Complaint.; Reporter''s Comments: Other information - TRAg positive on 26-Aug-2021 Fever, odynophagia, nasal congestion, myalgia


VAERS ID: 1710646 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy (Allergic to sesame seeds, almonds and hazelnuts, previously had reactions that resulted in hospital visits.)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: ANAFYLAXIS; This case was received via regulatory Agency (Reference number: SE-MPA-2021-080043) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (ANAFYLAXIS) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in 2021. Concurrent medical conditions included Food allergy (Allergic to sesame seeds, almonds and hazelnuts, previously had reactions that resulted in hospital visits.). On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (ANAFYLAXIS) (seriousness criterion medically significant). On 26-Aug-2021, ANAPHYLACTIC REACTION (ANAFYLAXIS) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. Company Comment: This case concerns a 23 year old female patient with relevant medical history of nut allergy and COVID-19 who experienced the expected event of anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation received on 15-Sep-2021 includes allergic history information and dosage text as first dose; Sender''s Comments: This case concerns a 23 year old female patient with relevant medical history of nut allergy and COVID-19 who experienced the expected event of anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1710649 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Appendicitis
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: appendicit; This case was received via Regulatory Authority (Reference number: SE-MPA-2021-080371) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of APPENDICITIS (appendicit) in a 20-year-old female patient who received mRNA-1273 (batch no. 3005238) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced APPENDICITIS (appendicit) (seriousness criteria hospitalization and medically significant). At the time of the report, APPENDICITIS (appendicit) was resolving. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Company Comment: This case concerns a 20 year old female with no medical history provided who experienced the unexpected event of Appendicitis one day after vaccination. No re-challenge was noted. the benefit-risk relationship of is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation document received on 15-SEP-2021 contains no new information.; Sender''s Comments: This case concerns a 20 year old female with no medical history provided who experienced the unexpected event of Appendicitis one day after vaccination. No re-challenge was noted. the benefit-risk relationship of is not affected by this report.


VAERS ID: 1710653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-26
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (risk factor in the form of obesity)
Allergies:
Diagnostic Lab Data: Test Name: ct; Result Unstructured Data: Test Result:massive pulmonary embolization
CDC Split Type: SEPFIZER INC202101180604

Write-up: DVT RIGHT LOWER LEGS/Deep vein thrombosis leg; Pulmonary embolism/MASSIVE Pulmonary EMBOLISATION; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is SE-MPA-2021-080804. A 41-year-old male patient received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for COVID-19 immunisation. Medical history included asthma from 2020 and ongoing and obesity (risk factor in the form of obesity). The patient''s concomitant medications were not reported. Reported suspect adverse events were deep vein thrombosis leg and pulmonary embolism on 26Aug2021. The physician stated that the man had days to weeks after the vaccination increased dyspnoea and on the 26Aug2021 his condition got worse and sought emergency care on the 27Aug2021, almost 2 months after the vaccination. According to the physician, suspected DVT right lower leg was noted, and CT showed massive pulmonary embolization. There is however no known malignancy, no heredity but there is a risk factor in the form of obesity, otherwise, no other risk factor was identified. It appears in the report that the laboratory investigation regarding thrombosis is not yet complete. Report was assessed as serious, life threatening. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1714750 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gait disturbance, Headache, Heart rate increased, Malaise, Myalgia, Nausea, Presyncope, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: BEPFIZER INC202101155259

Write-up: Heart rate increased; Myalgia; Nausea; Shivering; Dizziness; Vomiting; Vertigo; Headache; Weakness; Fatigue; Gait disorder; Malaise; Presyncope; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-106036. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 (Lot Number: FG3716) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced heart rate increased, myalgia, nausea, shivering, dizziness, vomiting, vertigo, headache, weakness, fatigue, gait disorder, malaise, presyncope, which were considered disability. The patient''s adverse drug reaction description was seeing black in front of the eyes, turning away, difficulty walking. The patient received treatment for the adverse events, most side effects had gone away on their own, but patient had also taken paracetamol. The outcome of the events was recovered on 27Aug2021. Reportercomment: Treatment - Yes Most side effects have gone away on their own. Also taken Paracetamol. Evolution of the adverse drug reaction - Recovered. Adverse drug reaction description - Vomiting, seeing black in front of the eyes, turning away, dizziness, weakness, difficulty walking, increased heart rate No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Treatment - Yes Most side effects have gone away on their own. Also taken Paracetamol. Evolution of the adverse drug reaction - Recovered Adverse drug reaction description - Vomiting, seeing black in front of the eyes, turning away, dizziness, weakness, difficulty walking, increased heart rate


VAERS ID: 1714786 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Not specified
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: 38.5 C
CDC Split Type: CZJNJFOC20210934538

Write-up: Flu-like symptoms; This spontaneous report received from a physician by a Regulatory authority (EVHUMAN Vaccines, CZ-CZSUKL-21010442) on 17-SEP-2021 and concerned a 19-year-old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Not specified. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 1 dosage forms, 1 total administered on 26-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 26-AUG-2021, the patient experienced flu-like symptoms (rigoring, fever, headache, fatigue, malaise). Laboratory data included: Body temperature (NR: not provided) 38.5 C (Celsius). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1714804 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210932925

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100189587) was received on 17-SEP-2021 and concerned a 47 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms,1 total, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced thrombosis of venous sinuses. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombosis of venous sinuses. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).


VAERS ID: 1714853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Bilirubin conjugated, Blood bilirubin, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haemoglobin, Heart rate, Influenza, Myocarditis, Pericarditis, Platelet count, Pyrexia, SARS-CoV-2 test, Troponin I, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Cardiac Auscultation; Result Unstructured Data: Test Result:no pericardial rubbing; Comments: no murmurs; Test Date: 20210825; Test Name: birilirubin; Result Unstructured Data: Test Result:0.7; Test Date: 20210825; Test Name: Bi; Result Unstructured Data: Test Result:2.5; Test Date: 20210825; Test Name: Ck; Result Unstructured Data: Test Result:166; Test Date: 20210825; Test Name: CPK; Result Unstructured Data: Test Result:166; Test Date: 20210825; Test Name: Creatinine; Result Unstructured Data: Test Result:0.69; Test Date: 20210825; Test Name: glucose; Result Unstructured Data: Test Result:95; Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/70; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210825; Test Name: C-reactive protein; Test Result: 1.06 mg/dl; Test Date: 20210826; Test Name: Doppler echocardiography; Result Unstructured Data: Test Result:Acute myopericarditis; Comments: Left ventricle not dilated or hypertrophic. Slight mean inferolateral hypokinesia. Preserved global systolic function. Diastolic pattern type I. AI not dilated. Aortic root, aortic arch and thoracic aorta of normal caliber. Coronary arteries with normal outlet. Trivalva aortic valve, normofunctioning. Normofunctional mitral valve, with veils and ring of normal morphology. Normofunctional tricuspid valve, with trivial physiological regurgitation. No data suggestive of Pulmonary Hypertension. Undilated right ventricle with preserved global systolic function. No pericardial effusion. Hyperrefrigence and thickening of parietal pericardium in the inferior and inferolateral region that extends to the pericardial lower face of the right ventricle. Dilated inferior venous system with preserved respiratory phasics.; Test Date: 20210826; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm; Comments: lower PR descent with avR ascent, narrow QRS with J point elevation and ST convexity with positive T on the lower side and V5-6. Normal QTc. Not extrasystolia.; Test Date: 20210825; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:147; Comments: Normal ions.; Test Date: 20210825; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.6; Test Date: 20210825; Test Name: Heart rate; Result Unstructured Data: Test Result:70; Test Date: 20210825; Test Name: platelets; Result Unstructured Data: Test Result:290000; Test Date: 20210622; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210826; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: cnTnI; Result Unstructured Data: Test Result:0.6; Comments: 1.105 -- 0.835; Test Date: 20210826; Test Name: Troponin I; Result Unstructured Data: Test Result:0.59 ng/ml; Test Date: 20210826; Test Name: Troponin I; Result Unstructured Data: Test Result:0.835 ng/ml; Comments: at 23:27; Test Date: 20210826; Test Name: Troponin I; Result Unstructured Data: Test Result:1.105 ng/ml; Comments: at 18:28; Test Date: 20210826; Test Name: Troponin I; Result Unstructured Data: Test Result:0.594 ng/ml; Comments: at 11:55; Test Date: 20210825; Test Name: White blood cells; Result Unstructured Data: Test Result:9200
CDC Split Type: ESPFIZER INC202101155612

Write-up: Myocarditis; Pericarditis; Flu symtoms; fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-989178. A 18-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 23Aug2021 (Batch/Lot Number: FE6029) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis and pericarditis (hospitalization) on 26Aug2021 while flu symptoms and fever on an unspecified date. It was reported an 18-year-old male patient who went to the emergency room for presenting constant, localized chest pain that varied with breathing and that bothered him mainly at rest. It does not seem to refer worsening with the decubitus but some improvement with the sedation inclined forward. Upon arrival at the emergency room improvement of the clinic with conventional analgesia. On 23Aug he was vaccinated with the first dose of Pfizer covid 19 vaccines. At 48 hours he began with a flu-like condition and a thermometrada fever of 37.8 degree C that subsided in a self-limiting way. During his admission he evolves favorably with disappearance of the chest pain clinic and without presenting fever again. CardioRM pending. The patient underwent lab tests and procedures which included Cardiac Auscultation: no pericardial rubbing on 25Aug2021(no murmurs), bilirubin conjugated: 0.7 on 25Aug2021, blood bilirubin: 2.5 on 25Aug2021, blood creatine phosphokinase: 166 on 25Aug2021, blood creatine phosphokinase: 166 on 25Aug2021, blood creatinine: 0.69 on 25Aug2021, blood glucose: 95 on 25Aug2021, blood pressure measurement: 130/70 on 25Aug2021, body temperature: 37.8 centigrade on 25Aug2021, c-reactive protein: 1.06 mg/dl on 25Aug2021, echocardiogram: acute myopericarditis on 26Aug2021 (Left ventricle not dilated or hypertrophic. Slight mean inferolateral hypokinesia. Preserved global systolic function. Diastolic pattern type I. AI not dilated. Aortic root, aortic arch and thoracic aorta of normal caliber. Coronary arteries with normal outlet. Trivalva aortic valve, normofunctioning. Normofunctional mitral valve, with veils and ring of normal morphology. Normofunctional tricuspid valve, with trivial physiological regurgitation. No data suggestive of Pulmonary Hypertension. Undilated right ventricle with preserved global systolic function. No pericardial effusion. Hyperrefrigence and thickening of parietal pericardium in the inferior and inferolateral region that extends to the pericardial lower face of the right ventricle. Dilated inferior venous system with preserved respiratory phasics), electrocardiogram: sinus rhythm on 26Aug2021(lower PR descent with avR ascent, narrow QRS with J point elevation and ST convexity with positive T on the lower side and V5-6. Normal QTc. Not extrasystolia), glomerular filtration rate: 147 on 25Aug2021 Normal ions, haemoglobin: 14.6 on 25Aug2021, heart rate: 70 on 25Aug2021, platelets: 290000 on 25Aug2021, SARS-CoV-2 PCR test: Negative on 22Jun2021 and SARS-CoV-2 PCR test: Negative on 26Aug2021, cnTnI: 0.6 on 25Aug2021, Troponin I: 0.59, 0.835, 1.105, 0.594 on 26Aug2021, White blood cells: 9200 25Aug2021. The outcome for event Myocarditis and Pericarditis was recovered on 30Aug2021while rest was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716119 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding; Pregnancy (Estimated due date: 03Jan2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101133695

Write-up: Maternal exposure during pregnancy/Patient was exposed to the vaccine Second-trimester (13-28 weeks); Maternal exposure during breast feeding; Maternal exposure during breast feeding; Inappropriate schedule of vaccine administered; Felt faint; This is a solicited report from the regulatory authority Card Vaccine Monitor program from a contactable consumer. This is the second of three reports. The first report was received from the regulatory authority, regulatory authority report number GB-MHRA-YCVM-202107011900325300-LZ36I, Safety Report Unique Identifier GB-MHRA-ADR 25578733. This consumer reported information for both mother and baby. This is the maternal report for the second dose of the vaccine. A 37-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) second dose, via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: FE3380, age at vaccination: 37-years-old) as a single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination. Medical history included ongoing pregnancy with estimated due date: 03Jan2022, ongoing breast feeding, vitamin/ folic acid supplementation from an unknown date and unknown if ongoing. The patient had no symptoms associated with COVID-19. She has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in a clinical trial. Concomitant medication included folic acid (400 ug) taken for vitamin supplementation, start and stop date were not reported. Historical vaccine information included the patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FD5613) as a single dose for COVID-19 immunisation and experienced Maternal exposure during pregnancy, Maternal exposure during breast feeding and painful arm. On 26Aug2021, the patient received the second dose of the BNT162B2 vaccine. On 26Aug2021, the patient experienced maternal exposure during pregnancy/patient was exposed to the vaccine second-trimester (13-28 weeks), maternal exposure during breast feeding and felt faint. The patient experienced inappropriate schedule of vaccine administered on 26Aug2021. The patient was pregnant while taking BNT162B2. The patient was at 21 weeks of pregnancy (2 Trimester 13-28 weeks) at exposure. The last menstrual period was on 01Apr2021. The patient was due to deliver on 03Jan2022. Seriousness criteria was reported as medically important condition. The patient did not think the vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Jun2021. The outcome of the maternal exposure during pregnancy, second-trimester and maternal exposure during breast feeding was unknown and event felt faint was recovered on 26Aug2021. The reporter''s assessment of the causal relationship of the events [Maternal exposure during pregnancy/Patient was exposed to the vaccine Second-trimester (13-28 weeks), Maternal exposure during breast feeding (Off label use), Maternal exposure during breast feeding (Drug use in unapproved population), Felt faint, inappropriate schedule of vaccine administered] with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Follow-up (12Sep2021): New information received from a contactable consumer via the regulatory authority included: Reaction Data (case upgraded to serious). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association,the event felt faint was assessed related to suspect product BNT162B2 or comirnaty. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : GB-PFIZER INC-2021829542 Same Patient/Product, Different Dose/Event;GB-PFIZER INC-202101133698 Mother/ Baby case


VAERS ID: 1716174 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 210197 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Inappropriate schedule of product administration, Paralysis, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN TRIHYDRATE;FLUCLOXACILLIN SODIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: BRPFIZER INC202101161916

Write-up: Dose 1: 03Jun2021 / Dose 2: 25Aug2021; Feeling of loss of strength, as if my body was paralyzing, extreme weakness, feeling faint; Feeling of loss of strength, as if my body was paralyzing, extreme weakness, feeling faint; Headaches (upper skull).; Feeling of loss of strength, as if my body was paralyzing, extreme weakness, feeling faint; This is a spontaneous report from a contactable consumer (patient) received through regulatory authority portal. A 42-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left on 25Aug2021 17:00 (Batch/Lot Number: 210197) as DOSE 2, SINGLE, vaccinated at age of 42 years old, for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Patient received the first dose of bnt162b2 (COMIRNATY) on 03Jun2021 09:00 (Batch/Lot number: Ew0199), at the age of 42 years old, for covid-19 immunisation. Concomitant medication included amoxicillin trihydrate, flucloxacillin sodium [AMOXICILLIN TRIHYDRATE;FLUCLOXACILLIN SODIUM]) taken for an unspecified indication, start and stop date were not reported. The patient experienced Headaches (upper skull). Feeling of loss of strength, as if my body was paralyzing, extreme weakness, feeling faint. All this since the day of the second dose. I''m desperate because every day I feel worse. Events started from 26Aug2021 13:00. Adverse events result in: Doctor or other healthcare professional office/clinic visit/ Emergency room/department or urgent care. No treatment received. Patient had SARS-CoV-2 test on 21Dec2020 with negative result. Outcome of events was not recovered.


VAERS ID: 1716299 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Echo-doppler; Result Unstructured Data: Test Result:thrombosis of a left fibular vein
CDC Split Type: FRPFIZER INC202101160508

Write-up: thrombosis of a fibular vein; thrombosis of a fibular vein; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number is FR-AFSSAPS-CN20212870. A 50-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 24Aug2021 (Batch/Lot Number: FF2834) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No history of COVID-19. No PCR test history. The patient experienced thrombosis of a left fibular vein (medically significant) on 26Aug2021 with emergency echo-Doppler. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest pain, Decreased appetite, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Mixed development disorder (Unclear combined developmental disorder)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade
CDC Split Type: ATPFIZER INC202101155972

Write-up: progressive weakness; Loss of appetite; Temperature 37.6?C; persistent increasing retrosternal pain; Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-043475. A 17-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 25Aug2021 (lot number: FD6840) Intramuscularly at single dose for COVID-19 immunisation. Medical histories included: ongoing Mixed development disorder. Concomitant drugs were not reported. Historical vaccine included the first dose of bnt162b2 (COMIRNATY) (Batch/lot number: Unknown) for COVID-19 immunisation. On the night of 26Aug2021 to 27Aug2021, the patient suffered from increasing retrosternal pain, a temperature of 37.6 ? C, progressive weakness, dyspnoea and a loss of appetite. At hospital patient received Ibuprofen 600 mg, Pantoloc 40mg. The outcome of the events was recovered in 2021. The causality assessment for all the events with the suspect product Comirnaty was Probable/Likely. No follow-up attempts possible. No further information expected.


VAERS ID: 1716632 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
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: Medical History/Concurrent Conditions: Depression (untreated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101160411

Write-up: Fatigue extreme; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20215938. A 19-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 25Aug2021 (Batch/Lot Number: FG4493) as dose number unknown, single for COVID-19 immunisation. Medical history included depression (untreated). The patient''s concomitant medications were not reported. The patient experienced fatigue extreme (medically significant) on 26Aug2021 with outcome of unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716715 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-08-26
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / OT

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: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101159705

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PV20212615. A 29-year-old female patient received BNT162B2 (COMIRNATY, lot number: FA7082) second dose intramuscular on 26May2021 at 0.3 ml single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had Non-serious Covid on 26Aug2021, patient at home. Symptoms: cough, headache. Variant: requested but not known by the declarant. On 26Aug2021, SARS-CoV-2 test: Positive. On 26Aug2021: occurrence of Vaccination failure. The outcome of the events was not recovered. This is a non-serious report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716815 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Pain in extremity, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bone graft (in jaw when she was 21); Chest pain; Cold; Dust allergy; Lung disorder (when she was 3 of a bad cold); Palpitations; Pulse rapid; Sinus disorder; Tonsillitis (Tonsils taken out 3 weeks after 7th birthday in the year 2000); Viral infection (affected lining of stomach when she was 8)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101153315

Write-up: Palpitations; Heart fluttering; Chest pain; Painful arm; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109041509243430-JT026, Safety Report Unique Identifier GB-MHRA-ADR 25896514. A 28-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 26Aug2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunization. Medical history included viral infection (affected lining of stomach when she was 8), bone graft (in jaw when she was 21), cold, palpitations, heart rate increased, chest pain, allergic to dust, suffer from sinus trouble, tonsils (tonsils taken out 3 weeks after 7th birthday in the year 2000) and punctured lung (when she was 3 of a bad cold). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On 26Aug2021, the patient had painful arm, on 31Aug2021, patient had heart fluttering, chest pain and on an unspecified date, the patient had palpitations. 4-5 days after the second dose of Pfizer, she had ended up with slight chest pain, feeling pulse in bottom of neck and heart palpitations and fluttery. If this continues, she would be seen by a hospital and not taking no for an answer as she works for a broadcaster. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event palpitations, heart fluttering, chest pain was not resolved, and painful arm was resolved on 28Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Insomnia
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168049

Write-up: Insomnia; Dose 1 on 25Jun2021; dose 2 on 26Aug2021; This is a spontaneous report from a contactable consumer. This is the second of 2 reports. The first report is downloaded from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109060127252330-BZNEI. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (batch/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 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included beclometasone dipropionate (CLENIL MODULITE); salbutamol sulfate (VENTOLIN). The patient previously took the first dose of BNT162B2 on 25Jun2021 for covid-19 immunisation and experienced shortness of breath. The patient experienced insomnia on 02Sep2021 with outcome of not recovered. The case was reported as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101160995 Same patient/Drug/Reporter, different dose and event.


VAERS ID: 1717221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Myocarditis, Scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 20210826; Test Name: Scan; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.
CDC Split Type: IEPFIZER INC202101155533

Write-up: MYOCARDITIS; SHARP PAIN IN THE CHEST; WOKE FROM HIS SLEEP WITH SHORTNESS OF BREATH / COULD NOT BREATHE; This is a spontaneous report from a contactable consumer. downloaded from the Agency Regulatory Authority, regulatory authority number IE-HPRA-2021-083670. Sender''s (Case) Safety Report Unique Identifier-IE-HPRA-2021-083670. A 27-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Aug2021 (Lot Number was not reported) as single dose and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Jul2021 (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced myocarditis, sharp pain in the chest, woke from his sleep with shortness of breath / could not breathe. The events were reported as medically significant. On 26Aug2021 the patient underwent lab tests and procedures which included echocardiogram was unknown results and results not provided, scan was unknown results and results not provided. It was reported that, initial report received by the Regulatory Authority on 31Aug2021 from a member of the public (patient''s relative). They attended the Accident and Emergency (A&E) at 5:30 am and the patient was given painkillers (unspecified) until further investigations. ECHO (echocardiogram), scan and other tests (unknown) were performed. The reporter outlined that myocarditis was confirmed. The patient was treated with colchicine 500 mcg. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-08-26
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Diarrhoea, Rhinitis, SARS-CoV-2 test, Vaccination failure, Vertigo
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (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: 20210827; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101156090

Write-up: Positive antigen swab; Vaccination failure; Symptomatic with diarrhea; Symptomatic with rhinitis; Symptomatic with vertigo; Symptomatic with asthenia; This is a spontaneous report received from a contactable Health Professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-778400. A 33-year-old female patient received BNT162B2 (COMIRNATY) intramuscularly at 0.3 ml single, administered in right arm, as second dose on 05Mar2021 (lot number EP2166, expiration date 31May2021), intramuscularly at 0.3 ml single, administered in left arm, as first dose on 11Feb2021 (lot number EJ6790, expiration date 31May2021), for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced Positive antigen swab and considered vaccination failure, symptomatic with asthenia, rhinitis, vertigo and diarrhea. The patient underwent lab test which included Covid-19 antigen test positive on 27Aug2021. The patient had not recovered from the events at the time of reporting. Investigation Result Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6790 and EP2166. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-26
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 RA / OT

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: 20210826; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: positive molecular swab in the vaccinated subject
CDC Split Type: ITPFIZER INC202101156093

Write-up: vaccination failure; positive molecular swab in the vaccinated subject; This is a spontaneous report from a contactable other Health Care Professional (HCP) downloaded from the Regulatory Authority-WEB:IT-MINISAL02-778401. A 38-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm right (reported as right shoulder) on 09Jul2021 (Lot Number: FE7010; Expiration Date: 31Oct2021) at 0.3 ml single dose, dose 1 intramuscular, administered in arm right (reported as right shoulder) on 04Jun2021 (Lot Number: FC1131; Expiration Date: 30Sep2021) at 0.3 ml single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced vaccination failure, positive molecular swab in the vaccinated subject on 26Aug2021. The events were serious for being medical significant. The patient underwent lab tests included COVID-19 PCR test: positive on 26Aug2021. The outcome of events was not recovered.


VAERS ID: 1717324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: ITPFIZER INC202101155354

Write-up: Pain chest; Laboured breathing; Difficult digestion; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-779179. A 43-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left (left shoulder) on 21Aug2021 (Lot Number: FG4686) as Dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pain chest, laboured breathing, difficult digestion, all on 26Aug2021 with outcome of not recovered. Events were reported as serious with disability. Therapeutic measures were taken as a result of all events as use of Aspirin and anti-inflammatory drugs (NSAIDs). It is reported impact on quality of life (9/10). Sender comment: follow up on the treatment of the event and resolution is requested.


VAERS ID: 1717333 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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: Medical History/Concurrent Conditions: Myocarditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Agency (Reference number: IT-MINISAL02-779576) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS and CHEST PAIN in a 30-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The patient''s past medical history included Myocarditis on 01-Jan-2011. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant) and CHEST PAIN (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS and CHEST PAIN was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. No treatment information was provided. This report was updated from non-severe to severe due to hospitalization. Company Comment: This case concerns a 30-year-old, male patient with previous relevant medical history of Myopericarditis ,who experienced the unexpected event of Chest pain and and the expected event of Myocarditis. The events occurred 3 days after first dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The events were considered related to the product, the reporter did not provide any causality assessments. The medical history of Myopericarditis remains a confounder. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Initial translation document received on 14-SEP-21, does not contain any new information (NNI) On 13-Sep-2021: Historical condition added.; AUG 30, 2021 RA [Regulatory Authority (this report is updated from NON-SEVERE to SEVERE due to hospitalization. RA [Regulatory Authority: requested follow-up information from the reporter regarding the medical documentation relating to the case. Pending; Sender''s Comments: This case concerns a 30-year-old, male patient with previous relevant medical history of Myopericarditis ,who experienced the unexpected event of Chest pain and and the expected event of Myocarditis. The events occurred 3 days after first dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The events were considered related to the product, the reporter did not provide any causality assessments. The medical history of Myopericarditis remains a confounder. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1717387 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-26
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-21
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: 20210826; Test Name: COVID-19 positive; Test Result: Positive
CDC Split Type: JPPFIZER INC202101154907

Write-up: The patient was going to receive the second dose on 28Aug2021, but he was told COVID-19 positive on 26Aug2021.; The patient was going to receive the second dose on 28Aug2021, but he was told COVID-19 positive on 26Aug2021.; This is a spontaneous report from a contactable consumer (patient) via health authority. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), first dose via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) as DOSE 1,SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Aug2021 the patient received the first dose. The patient was going to receive the second dose on 28Aug2021, but he was told COVID-19 positive on 26Aug2021. So the patient cancelled vaccination of 28Aug2021, and received antibody cocktail therapy on 29Aug2021. The patient underwent lab tests which included COVID-19: positive on 26Aug2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717486 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol allergy (Redness and itching due to allergy to alcohol); Allergy to animal (Redness and itching due to allergy to cat and dog skin); Dermatitis due to cosmetics (Redness and itching due to allergy to cosmetic)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP089931) on 08-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This case, initially reported to the regulatory authority by a vaccinator except for a physician, was received via the regulatory authority (Ref, v21126130). Anaphylaxis was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.0 degrees Celsius. On 26-Aug-2021, at 09:15, the patient received the 2nd dose of this vaccine. At 09:28, difficulty breathing, queasy, palpitations, and rash in the neck developed. Anaphylaxis was noted. Adrenaline 0.3 mg was intramuscularly injected. At 09:38, while symptoms improved, difficulty breathing persisted. D-Chlorpheniramine baleate 1A was injected intravenously. At 10:08, symptoms improved. The patient returned home after confirmation of recovery. The outcome of anaphylaxis was reported as recovered. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 42 year old female patient with a history of allergy to animals, cosmetics, who experienced the expected event of anaphylaxis reaction.The occurred approximately 13 minutes after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1720436 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Asthenia, Dizziness, Dyspnoea, Malaise, Myalgia, Nausea, Polymerase chain reaction, SARS-CoV-2 antibody test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sjogren''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: PCR-Test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:unknown; Test Date: 20210903; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: DEPFIZER INC202101167600

Write-up: fainting; severe dizziness; nausea; malaise; extreme weakness; shortness of breath; anxiety; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: SCRW2), via an unspecified route of administration, administered in arm left on 26Aug2021 at 10:30 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. Medical history included sjogren''s syndrome from an unknown date and unknown if ongoing. The patient''s 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. Since the vaccination, the patient has been tested for COVID-19. On 26Aug2021 at 10:45, the patient experienced fainting, severe dizziness, nausea, malaise, extreme weakness, shortness of breath, anxiety, muscle pain, joint pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Reported Event: fainting shortly after vaccination, followed by a prolonged loss of fainting, severe dizziness, nausea, malaise, extreme weakness, shortness of breath, anxiety, shortness of breath, muscle pain, joint pain. No prolonged hospitalization, No seriousness criteria reported. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test was unknown on an unspecified date, PCR test was negative (nasal swab) on 30Aug2021, SARS-COV-2 antibody test was negative (nasal swab) on 03Sep2021. Therapeutic measures were taken as a result of dizziness, nausea, malaise, extreme weakness, shortness of breath , anxiety, muscle pain, joint pain, fainting. The patient received infusion, CT, pain medication as treatment medication for all the events. Outcome of all the events was not recovered.


VAERS ID: 1720759 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176048

Write-up: Shivering; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109071334363680-IXDHB, Safety Report Unique Identifier GB-MHRA-ADR 25906648. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not pregnant and was not currently breastfeeding. The patient did not have a COVID-19 test. On 26Aug2021, the patient experienced shivering, which was reported as serious for being medically significant. The patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the event shivering was recovered on 28Aug2021, after the duration of 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720915 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Decreased appetite, Dyspnoea, Fatigue, Hyperhidrosis, Inappropriate schedule of product administration, Pneumonia, Polymerase chain reaction, Productive cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Polymerase chain reaction; Test Result: Negative
CDC Split Type: GBPFIZER INC202101190923

Write-up: pneumonia in left lung; coughing phlegm (mucus); fever; sweating; chills; shortness of breath that happens while doing normal activities or even while resting; Chest pain that''s worse when you breathe or cough; feelings of tiredness or fatigue; loss of appetite; received bnt162b2 first dose on 24Jun2021 14:30 and second dose on 26Aug2021 12:15; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: FE8087), via an unspecified route of administration, administered in Left Arm on 26Aug2021 12:15 (At the age of 33-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included none. There were no concomitant medications. Patient had no allergies. Historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in Left arm on 24Jun2021 14:30 (At the age of 33-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19. It was reported that on 06Sep2021 12:00 patient experienced pneumonia in left lung, coughing phlegm (mucus), fever, Sweating, chills, shortness of breath that happens while doing normal activities or even while resting, Chest pain that''s worse when you breathe or cough, Feelings of tiredness or fatigue, Loss of appetite. The patient underwent lab tests and procedures on 06Sep2021 which included polymerase chain reaction: negative. After 15 days, diagnosed with pneumonia in left lung. adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of pneumonia in left lung, coughing phlegm (mucus), fever, sweating, chills, shortness of breath that happens while doing normal activities or even while resting, chest pain that''s worse when you breathe or cough, feelings of tiredness or fatigue, loss of appetite and included treatment with Antibiotics. Facility where the most recent COVID-19 vaccine was administered is Other. The event pneumonia in left lung was medically significant, other events were non-serious. The outcome of the event Chest pain that''s worse when you breathe or cough not recovered, Outcome of other events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.


VAERS ID: 1721046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cardiac disorder, Dyspnoea, Headache, Hypotension, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101163414

Write-up: TWINGE IN THE HEART; heart fatigue; NAUSEA; HEADACHE; SHORTNESS OF BREATH; LOW BLOOD PRESSURE; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB IT-MINISAL02-779586. A 48-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm (reported as ''left shoulder'') on 25Aug2021 at 15:30 (Lot Number: FG6273; Expiration Date: 30Nov2021) as dose 2, single for COVID-19 immunization. Medical history included allergy to mites on an unknown date. The patient''s concomitant medications were not reported. The patient experienced twinge in the heart, heart fatigue, nausea, headache, shortness of breath and low blood pressure on 26Aug2021. The outcome of the events was recovering.; Reporter''s Comments: ALLERGY TO MITES


VAERS ID: 1721319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-08-26
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

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: 20210826; Test Name: COVID-19 antigen test; Test Result: Positive.
CDC Split Type: PTPFIZER INC202101193960

Write-up: This is a spontaneous report from a contactable nurse from the Regulatory Authority. This is a report received from the regulatory authority report number PT-INFARMED-B202108-3752 with Safety Report Unique Identifier PT-INFARMED-B202108-3752. A 37-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: ER7812, Expiry date: not reported), dose 2 intramuscular on 12Mar2021 as dose 2, 0.3 ml single, and dose 1 (COMIRNATY, Solution for injection, Batch/Lot number: EP9598, Expiry date: not reported), intramuscular on 19Feb2021 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, approximately 5 months after completing the Comirnaty vaccine schedule, the patient experienced COVID-19. The patient manifested symptoms associated with COVID-19, namely cough, myalgia, nasal congestion, anosmia, and ageusia. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 26Aug2021. The reporter''s assessment of the causal relationship of the Vaccination failure, COVID-19 with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The outcome of event was unknown. Other information TRAg (rapid antigen tests) positive on 26Aug2021. Cough, myalgia, nasal congestion, anosmia, and ageusia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1721321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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? 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: 20210826; Test Name: COVID-19 antigen test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210937849

Write-up: POSSIBLE VACCINE FAILURE; COVID-19; This spontaneous report received from a health care professional via Regulatory Authority(EVHUMAN Vaccines, PT-INFARMED-B202108-4072) on 20-SEP-2021 concerned a 23 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-01 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 30-JUL-2021 for covid-19 immunisation. Duration of drug administration was 0 days. No concomitant medications were reported. On 26-AUG-2021, the patient experienced possible vaccine failure and covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible vaccine failure and covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information- Positive TRAg on 26-Aug-2021 Rhinorrhea and anosmia


VAERS ID: 1721343 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210934537

Write-up: BLOOD PRESSURE HIGH; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202108-3923) on 17-SEP-2021 concerned a 38-year-old male of unspecified race and ethnic origin. The patient''s weight was 87 kilograms, and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) 0.5 ml, 1 total, administered on 26-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced blood pressure high (high arterial pressure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure high was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1722126 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aspartate aminotransferase, Chills, Dizziness, Enuresis, Malaise, Nausea, Pyrexia, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: Anemia (Borderline Anemia); Borderline hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Felt faint; bed; Well; Fever; Got; Shivering; Nausea; Vaginal bleeding; This case was received via RA (Reference number: GB-MHRA-ADR 25935006) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint), VAGINAL HAEMORRHAGE (Vaginal bleeding), ENURESIS (bed), MALAISE (Well), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Shivering) in a 25-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. Concurrent medical conditions included Borderline hypertension and Anemia (Borderline Anemia). On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), ENURESIS (bed) (seriousness criterion medically significant), MALAISE (Well) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and ASPARTATE AMINOTRANSFERASE (Got). On 26-Aug-2021, NAUSEA (Nausea) and CHILLS (Shivering) had resolved. On 27-Aug-2021, VAGINAL HAEMORRHAGE (Vaginal bleeding) had resolved. At the time of the report, DIZZINESS (Felt faint), ENURESIS (bed), MALAISE (Well), PYREXIA (Fever) and ASPARTATE AMINOTRANSFERASE (Got) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. On the evening after vaccine administration (25Aug2021), the patient started to feel unwell, described as ''no energy, tired''. She went to bed and that was when the fever and shivering started. By the next morning (26Aug2021), that''s when she begun having strong feeling of nausea which was increased when getting up or walking around. She took paracetamol at regular intervals. The patient felt faint when she got out of bed as well. By the evening, she could get out of bed to the sofa. But when she went to the toilet there was blood after wiping (in the middle of my cycle). It was only a little, then the next day as well. Symptoms resolved 24 hours after receiving the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 25-year-old, female subject with medical history of anemia, who experienced the unexpected events of malaise, pyrexia, chills, nausea, dizziness, vaginal haemorrhage, enuresis and aspartate aminotransferase. The events malaise, pyrexia and chills occurred on the day of administration of the second dose; the events nausea, dizziness, vaginal haemorrhage, enuresis and aspartate aminotransferase occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The medical history of anemia, which may cause the events dizziness and malaise, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, there was no mention in the case narrative that the events ''enuresis'' and ''aspartate aminotransferase'' occurred; however, the events were retained per Regulatory Authority report.; Sender''s Comments: This case concerns a 25-year-old, female subject with medical history of anemia, who experienced the unexpected events of malaise, pyrexia, chills, nausea, dizziness, vaginal haemorrhage, enuresis and aspartate aminotransferase. The events malaise, pyrexia and chills occurred on the day of administration of the second dose; the events nausea, dizziness, vaginal haemorrhage, enuresis and aspartate aminotransferase occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The medical history of anemia, which may cause the events dizziness and malaise, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, there was no mention in the case narrative that the events ''enuresis'' and ''aspartate aminotransferase'' occurred; however, the events were retained per Regulatory Authority report.


VAERS ID: 1722334 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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: AUPFIZER INC202101170021

Write-up: Syncope; dizziness; headache; nausea; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 614430. A 46-year-old female patient received BNT162B2 (COMIRNATY) on 26Aug2021 (at age of 46-year-old) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced Dizziness, Headache, Nausea, Syncope on 26Aug2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Dyspnoea, Fatigue, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: AUPFIZER INC202101170182

Write-up: Syncope; Chest pain; Cold sweat; Dyspnoea; Fatigue; Tremor; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 615245. A 34-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reaction reported as chest pain; cold sweat; dyspnoea; fatigue; syncope; tremor on 26Aug2021. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Decreased appetite, Lethargy, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: AUPFIZER INC202101170236

Write-up: Bradycardia; Decreased appetite; Lethargy; Presyncope; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 615701. A 16-year-old female patient received bnt162b2 (COMIRNATY) on unknown date (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 26Aug2021, patient experienced Bradycardia; Decreased appetite; Lethargy; Presyncope. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: AUPFIZER INC202101170376

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 616118. A 46-year-old male patient received BNT162b2 (COMIRNATY) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced Pericarditis on 26Aug2021. The outcome of 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: 1722385 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101170529

Write-up: Myocarditis; Chest pain; Nausea; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 616495. An 18-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis, chest pain, and nausea on 26Aug2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1722415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Food craving, Mental impairment, Nausea, Thirst, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101173077

Write-up: Mental impairment; Fatigue; Food craving; Injection site pain; Nausea; Thirst; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 617494. A 36-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fatigue; food craving; injection site pain; mental impairment; nausea; thirst all on 26Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1723478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis, Pulmonary embolism
SMQs:, Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: AUPFIZER INC202101173198

Write-up: Pericarditis; Pulmonary embolism; This is a spontaneous report from a contactable other hcp via the Administration (A). Regulatory authority report number is 617766. A 24-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single; dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pericarditis and pulmonary embolism on 26Aug2021. The outcome of the events was resolved in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1723479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: AUPFIZER INC202101173205

Write-up: Deep vein thrombosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The Regulatory authority report number is 617887. A 29-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced deep vein thrombosis on 26Aug2021 (7 days after vaccination). The event outcome was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, Troponin
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: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Results not specified; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Test Result:Results not specified; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Results not specified; Test Date: 202108; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:Perimyocarditis; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result:Elevated at 300-and-somthing
CDC Split Type: DKPFIZER INC202101174539

Write-up: Perimyocarditis; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number DK-DKMA-WBS-0087104. A 31-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Aug2021 (Batch/Lot Number: FC1433) as single dose for covid-19 immunisation. There is no information regarding patient medical history or concurrent conditions. The patient is reported as otherwise healthy. There is no information regarding past medication. There is no information regarding concomitant medication. On 26Aug2021, 16 days after the first vaccination, the patient developed Perimyocarditis. The ADRs were by the reporter reported as resulting in hospitalisation on an unknown date in Aug2021. The patient was treated with Hjertemagnyl (Acetylsalicylic Acid), unspecified betablockers, morphine and nitroglycerine due to the ADR. Test results on Aug2021 included EKG, results not specified; blood test, results not specified; troponin, elevated at 300-and-something; CT scan, results not specified; cardiac MRI, perimyocarditis. The outcome of event perimyocarditis was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Parotitis, SARS-CoV-2 test, Ultrasound scan
SMQs:, Oropharyngeal infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: COVID-19; Discopathy
Allergies:
Diagnostic Lab Data: Test Date: 20200924; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210827; Test Name: Neck ultrasound; Result Unstructured Data: Test Result:inflammatory left parotid; Comments: inflammatory left parotid hypertrophy, associated with significant subcutaneous soft tissue oedema and sub-angulo-maxillary, left jugulo-carotid adenopathies.
CDC Split Type: FRPFIZER INC202101166335

Write-up: fatigue; Parotiditis; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number FR-AFSSAPS-PB20215973. A 47-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 12Aug2021 (Batch/Lot Number: FE2707) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Discopathy, covid-19 from 24Sep2020. The patient''s concomitant medications were not reported. The patient experienced parotiditis (disability, medically significant) on 26Aug2021. Sudden onset on 26Aug of inflammatory left parotid hypertrophy, significant oedema of the subcutaneous soft tissue, neck ultrasound on 27Aug. Treatment: amoxicillin. pain ++, disfigured, liquid diet, sick leave from work, severe fatigue, evolution of the swelling, Ear, Nose, Throat Emergency Room, change of treatment: rovamycin, metronidazole, acupan, spasfon, paracetamol. At Day 14 from her 1st injection she presented with parotid hypertrophy with pain. Neck ultrasound (27Aug2021): inflammatory left parotid hypertrophy, associated with significant subcutaneous soft tissue oedema and sub-angulo-maxillary, left jugulo-carotid adenopathies. Patient first put on AMOXICILLIN, then given the evolution of the oedema, was transferred to the Ear, Nose Throat Emergency Room and treatment was changed:(ROVAMYCINE 3MUi and METRONIDAZOLE 500MG (3x/day for 10 days). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Sep2020. Outcome of the event parotiditis was not recovered. Outcome of other event was unknown.


VAERS ID: 1724432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Malaise, Menstrual disorder, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amenorrhoea NOS (due to contraception); Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190668

Write-up: Abnormal period, before the vaccine I hadn''t had a period for 8 months due to contraception.; Complete loss of energy; Severe headaches; Fever/high temperature; general malaise; Injection site pain; 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-EYC 00260098), Safety Report Unique Identifier (GB-MHRA-ADR 25913545). A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via a parental route of administration on 21Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication(s) included medroxyprogesterone acetate (DEPO-PROVERA) taken for contraception. On 26Aug2021, the patient experienced complete loss of energy; severe headaches; fever/high temperature; general malaise; injection site pain and on 28Aug2021 patient experienced, abnormal period, before the vaccine i hadn''t had a period for 8 months due to contraception. The patient was taking COVID vaccine - Pfizer - first dose for: To go abroad. The seriousness of events was reported as Medically significant. The clinical outcome of event abnormal period, before the vaccine i hadn''t had a period for 8 months due to contraception was not recovered; other events outcome was recovered on 30Aug2021; outcome of event severe headaches was recovered on 02Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724811 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Addison''s disease (Addison''s disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20210933975

Write-up: FACIAL PARALYSIS; NUMB LIPS; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300050640) on 17-SEP-2021 concerned a 44 year old female. The patient''s weight was 53 kilograms, and height was not reported. The patient''s concurrent conditions included: addison''s disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 0.5 ml, 1 total, administered on 26-AUG-2021 for covid-19 vaccination. The duration of drug administration was 1 days. (Vaccination session: Mass campaign). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced facial paralysis and numb lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numb lips, and facial paralysis. This report was serious (Other Medically Important Condition).


VAERS ID: 1724833 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Chest pain, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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: Test Name: angio CT; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:changes in ventricular repolarization; Comments: changes in ventricular repolarization.; Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Test Name: Troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: ITPFIZER INC202101174740

Write-up: The patient presented with chest pain; Myopericarditis; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-779471. A 30-year-old male patient received bnt162b2 (COMIRNATY), first dose, via an unspecified route of administration on 22Aug2021 (Lot Number: FG7387) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient presented with chest pain on 26Aug2021, myopericarditis on 26Aug2021. All events were required hospitalization. The patient underwent lab tests and procedures which included angio CT: unknown results, electrocardiogram (ECG): changes in ventricular repolarization, magnetic resonance imaging (MRI): unknown results, troponin: increased. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724898 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Guillain-Barre syndrome, Muscular weakness, Musculoskeletal stiffness, Neuropathy peripheral, Oedema peripheral, Peripheral swelling, Volume blood
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Arthritis (broad), Immune-mediated/autoimmune 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: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Climacteric; Collagen disorder; Rheumatism; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood test; Result Unstructured Data: Test Result:it was more like swelling of fingers rather than; Comments: Guillain-Barre syndrome; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210826; Test Name: blood volume; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101170346

Write-up: peripheral nerve disorder NOS; Guillain-Barre syndrome; two hands'' fingers weakness; oedema fingers; Stiffness; swelling of fingers; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126039. A 44-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration on 25Aug2021 at 10:30 (the day of vaccination, at the age of 44-years-old), as dose 1, single for COVID-19 immunization. The patient had a family history of grandfather and daughter had a tumor disease. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included urticaria. Medical history included climacteric, rheumatism and collagen disorder. Concomitant medication included ongoing fexofenadine taken orally for urticaria. Body temperature before vaccination, on 25Aug2021, was 36.4 degrees Centigrade. On 26Aug2021 in the morning (1 day after the vaccination), the patient experienced two hands'' fingers weakness, peripheral nerve disorder NOS, oedema fingers, stiffness and swelling of fingers. The course of the event was as follows: on 06Sep2021, contacted from the patient and came to the hospital in the evening. On 26Aug2021 (the next day of vaccination), it was difficult to hold the smartphone with the left hand when wakened up, and out of force. On 28Aug2021 (3 days after vaccination), the patient could not put any strength in both hands only in the morning (stiffness in the morning?, as reported). On 30Aug2021 (5 days after vaccination), there was similar symptoms other than morning. 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 a possibility of rheumatism, collagen disorder, taken blood test on the day of the report, on 07Sep2021. The reporting physician commented as follows: grip strength was relatively high, no left and right difference, no blood volume abnormality on 26Aug2021, no edema of both lower legs, no vaccination site induration; based on blood test on 26Aug2021, reporter felt that it was more like swelling of fingers rather than Guillain-Barre syndrome. There was also a possibility of climacteric. The outcome of the events was unknown.


VAERS ID: 1725110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-08-26
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 - / OT

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101193963

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory authority report number [PT-INFARMED-B202108-3735] with Safety Report Unique Identifier [PT-INFARMED-B202108-3735]. A 53-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD1921, Expiry date was not reported) via intramuscular route of administration on 08Jun2021 as DOSE 1, 0.3 ML SINGLE for and second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE6029, Expiry date was not reported) via intramuscular route of administration on 06Jul2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter stated that, seven weeks after completing the Comirnaty vaccine schedule (on 26Aug2021), the patient presented with COVID-19 and vaccine failure of the mRNA vaccine, confirmed by a positive rapid antigen test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely odynophagia and mild cough, starting two days before the test. The reporter commented referring the symptoms since 24Aug2021, which devalued (odynophagia, slight cough), better since 27Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 26Aug2021. The patient will be discharged on 02Sep2021. The outcome for the events was unknown. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Other information-Refers symptoms since 24Aug, which devalued (odynophagia, slight cough), better since 27Aug2021. TRAg+ (Rapid antigen test positive) in the medical appointment on 26Aug (Ds (Diagnostic) COVID-19). Will be discharged on 02Sep2021 (recovery). Vaccines 08Jun2021 Comirnaty Lot: FD1921 06Jul2021 Comirnaty Lot: FE6029


VAERS ID: 1725154 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: SEPFIZER INC202101166684

Write-up: Menstrual disorder; FEVER; CHILLS; BODY PAIN; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-080808. A 23-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 (at the age of 23-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced fever, chills, and body pain. On 28Aug2021, two days after the vaccination, the patient experienced menstrual disorder and ended after four days. There was no further information included in the report regarding the menstruation. The events were assessed as serious, disability. Outcome of event menstrual disorder was recovered on 01Sep2021; while outcome of the rest of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1725156 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Sleep disorder, Vaccination site pain, Vaccination site pruritus
SMQs:

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: SEPFIZER INC202101166773

Write-up: Headache; Sleep disorder; Vaccination site pruritus; Vaccination site pain; Tiredness; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authorities-WEB, regulatory authority number SE-MPA-2021-080819. A 33-year-old (also the age at time of vaccination) male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had tiredness, sleep disorder, vaccination site pain and vaccination site pruritus occurred the same day as the vaccination (26Aug2021). Then, headache occurred four days after the vaccination (30Aug2021). The patient had not yet recovered from sleep disorder and tiredness; recovered from vaccination site pruritus on 28Aug2021; recovering from vaccination site pain while unknown for headache. Report assessed as serious, disability. No follow-up attempts are possible, information regarding the batch/lot number cannot be obtained.


VAERS ID: 1725856 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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? 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: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via regulatory agency (Reference number: 2021TJP087672) on 06-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This case was reported by a physician via a medical representative. Myocarditis was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccine. On 22-Aug-2021, the patient received the 2nd dose of this vaccine. A few days later, the patient felt chest pain and visited a nearby hospital. There were no abnormalities on electrocardiogram. On 26-Aug-2021, the patient visited an emergency room. ST elevation, troponin T, CK elevation, and myocarditis were noted. On an unknown date, myocarditis resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 19-year-old male patient with no details on previous relevant medical history, who experienced the expected event/s of Myocarditis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 5 days after the second dose of Spikevax. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The event was considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax vaccine is not affected by this report.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 19-year-old male patient with no details on previous relevant medical history, who experienced the expected event/s of Myocarditis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 5 days after the second dose of Spikevax. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The event was considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1726014 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis
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: ATPFIZER INC202101180446

Write-up: Epistaxis/Recurrent nosebleeds; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number: AT-BASGAGES-2021-043646. A 28-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, at age 28 years, on 26Aug2021 (Batch/Lot Number: FE8244) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the evening after the second vaccination until the time of reporting, the patient experienced epistaxis/recurrent nosebleeds. The outcome of the event was not recovered/not resolved. This case is reported as serious. Relatedness of Comirnaty to event Epistaxis: Source of assessment: Reporter. Result of Assessment: Related No follow-up attempts are possible. No further information is expected.


VAERS ID: 1728576 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood gases, Blood potassium, Blood sodium, C-reactive protein, C-reactive protein increased, COVID-19, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Fibrin D dimer, Fibrin D dimer increased, Glomerular filtration rate, Haemoglobin, Liver function test, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Pleural effusion, SARS-CoV-2 test, Serum ferritin, Thrombocytopenia, Thyroid gland scan abnormal, Tracheal deviation, Troponin
SMQs:, Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LODIXAL; BISOPROLOL; BURINEX; COMBODART; LIXIANA; SIPRALEXA; LORMETAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac function test normal; Cardioversion; Cerebral aneurysm (unruptured); Coronary atherosclerosis (conservative, medial); CVA (CVA with fatal disorders (Apr2018) ikv VKF and deficient R/ compliance(NOAC)); Heart failure; Heart failure with reduced ejection fraction; Hypercholesterolemia; Hyperplasia of prostate; Hyperthyroidism; Malaria; Mini mental state examination normal
Allergies:
Diagnostic Lab Data: Test Name: bicarbonate; Result Unstructured Data: Test Result:38 mmol/L; Test Name: calcium; Result Unstructured Data: Test Result:1.03 mmol/L; Test Name: chloride; Result Unstructured Data: Test Result:89 mmol/L; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:328; Comments: unit/Litre; Test Name: Arterial blood gas; Result Unstructured Data: Test Result:pH 7.48; Test Name: potassium; Result Unstructured Data: Test Result:2.7 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Name: thorax computed tomography; Result Unstructured Data: Test Result:areas with frosted aspect situated in both lungs; Comments: areas with frosted aspect situated in both lungs, most visible in the base of the upper lobe both ways and the base of lower lobe both ways which are frequently seen in Covid-19 pneumonia. Limited pleural effusion on the left. No pathological glands could be seen at the mediastinal level. Left retrosternal side of thyroid gland has embedded calcifications and a significant deviation of trachea to the right. Decision Abnormalities typically seen in Covid-19 pneumonia; Test Name: C-reactive protein; Result Unstructured Data: Test Result:168.5; Test Name: D-dimers; Test Result: 110 mg/dl; Test Name: Estimated glomerular filtration rate; Test Result: 57 mL; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.1 g/dl; Comments: normocytic; Test Name: liver tests; Result Unstructured Data: Test Result:disturbed; Test Name: saturation; Test Result: 85 %; Test Name: Partial pressure of carbon dioxide; Result Unstructured Data: Test Result:50 mmHg; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:109; Test Name: pO2; Result Unstructured Data: Test Result:47 mmHg; Test Date: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: ferritin; Result Unstructured Data: Test Result:1072 mmol/L; Test Name: troponins; Result Unstructured Data: Test Result:0.055 ng/ml
CDC Split Type: BEPFIZER INC202101180270

Write-up: Retrosternaal double shielded link with insignificant calcifications; thrombopenia 109; saturation 85%; D-dimer 1110 mg / ml; CRP 168.5; Retrosternaal double shielded link with insignificant calcifications; Improved pleura-uststorting links; Drug ineffective; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-106146. An 83-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Feb2021 (Batch/Lot Number: 4293254) as DOSE 2, SINGLE, and received the first dose of BNT162B2 (COMIRNATY) on unspecified date (lot number not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Benign prostate hypertrophy, malaria, hypercholesterolemia, coronary atherosclerosis: Apr2017 (PRIVACY):conservative,medial 2017: Cardiac examination: normal findings 2017: valvular heart failure, for which cardioversion 2018: cerebrovascular accident (CVA) with fatal disorders (Apr2018) ikv valvular heart failure and deficient R/ compliance (novel oral anticoagulants) + cerebral aneurysm art communicans anterior in 2019, valvular heart failure and heart failure with reduced ejection fraction, in treatment at cardio PRIVACY (regional hospital) + Hyperthyroidism in 2019, and Mini-Mental State Examination 26/30 in 2021. Concomitant medications included verapamil hydrochloride (LODIXAL); bisoprolol; bumetanide (BURINEX); dutasteride, tamsulosin hydrochloride (COMBODART); edoxaban tosilate (LIXIANA); escitalopram oxalate (SIPRALEXA); lormetazepam; all taken for unspecified indications, start and stop dates were not reported. On 26Aug2021, the patient experienced retrosternaal double shielded link with insignificant calcifications (hospitalization), thrombopenia 109 (hospitalization), saturation 85% (hospitalization), D-dimer 1110 mg/ml (hospitalization), CRP 168.5 (hospitalization), retrosternaal double shielded link with insignificant calcifications (tracheal deviation) (hospitalization), improved pleura-uststorting links (hospitalization), drug ineffective (hospitalization, medically significant), covid-19 (hospitalization, medically significant) , and covid-19 pneumonia (hospitalization, medically significant). The patient underwent lab tests and procedures which included hemoglobin 11.1 gram/decilitre, normocytic, thrombocytopenia 109, D-dimers 1110 miligram/mililitre, Sodium 139 mmol/litre, Potassium 2.7 millimoles/litre, chloride 89 millimoles/litre, Calcium 1.03 millimoles/litre, ferritin 1072 micrograms/litre, Estimated glomerular filtration rate 57 mililitre/minute, disturbed liver tests, Creatine Kinase 328 Units/Litre, troponins 0.055 nanograms/mililitre, C-reactive protein 168.5 Arterial blood gas: pH 7.48, partial pressure of carbon dioxide 50 millimeters of mercury, bicarbonate 38 millimole/litre, pO2 47 millimeters of mercury, saturation 85%, Coronavirus disease: 26Aug2021 tested positive thorax computed tomography: Multi-slice spiral computed tomography study reconstructed according to axial, coronal, and sagittal slice direction without contrast using low-dose technique. Images in pulmonary window setting show areas with frosted aspect situated in both lungs, most visible in the base of the upper lobe both ways and the base of lower lobe both ways which are frequently seen in Covid-19 pneumonia. Limited pleural effusion on the left. No pathological glands could be seen at the mediastinal level. Left retrosternal side of thyroid gland has embedded calcifications and a significant deviation of trachea to the right. Decision Abnormalities typically seen in Covid-19 pneumonia. Covid-19 Reporting and Data System 4 (limited pleural effusion left atypical). See also Polymerase Chain Reaction test correlation. Left retrosternal lobe of thyroid gland has embedded calcifications. The patient was hospitalized due to the events. Therapeutic measures were taken as a result of the events which included dexamethasone, ceftriaxone, and oxygen therapy. The outcome of the events was unknown. Reporter''s comment: Treatment - Yes Admission, Dexamethasone, Ceftriaxone, oxygen therapy Evolution of the adverse drug reaction Drug ineffective - Adverse drug reaction description - Coronavirus disease infection No follow-up attempts are possible, no further information is expected.; Reporter''s Comments: Summary of Reporter comment: Treatment - Yes Admission, Dexamethasone, Ceftriaxone, oxygen therapy Evolution of the adverse drug reactionDrug ineffective - Adverse drug reaction description - Coronavirus disease infection


VAERS ID: 1728858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-08-26
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood fibrinogen, Body temperature, C-reactive protein, Chest pain, Dyspnoea, Electrocardiogram, Fibrin D dimer, General physical condition, Intercostal neuralgia, Nausea, Palpitations, Physical examination, Platelet count, Troponin, Vertigo, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disorder circulatory system (Circulatory problems in general for months.); Lightheadedness (Dizziness has not yet been clarified); Nonsmoker (No Nicotine); Stress symptoms (this occurs especially in stressful situations.)
Preexisting Conditions: Comments: Keine Pille, Nichtraucherin, schlank; keine Grunderkrankungen
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Roentgen; Result Unstructured Data: Test Result:Diaphragm elevation right; Comments: X-ray lung heart standing in two planes dated 29aug2021 findings: Pleural sinus clear. No signs of congestion. No pneumonic infiltrative processes delineable. The heart is normally configured. The aorta unremarkable Diaphragmatic elevation on the right side.; Test Date: 20210829; Test Name: CK; Result Unstructured Data: Test Result:163; Comments: Units: U/l; Test Date: 20210829; Test Name: Fibrinogen; Result Unstructured Data: Test Result:2.6 g/l; Test Date: 20210829; Test Name: Temp; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210829; Test Name: CRP; Result Unstructured Data: Test Result:below the detection limit; Test Date: 20210829; Test Name: EKG; Result Unstructured Data: Test Result:Unremarkable; Test Name: D-Dimer ( restl. Labor unauff ); Result Unstructured Data: Test Result:0.8; Test Date: 20210829; Test Name: D-Dimer ( restl. Labor unauff ); Result Unstructured Data: Test Result:0.8; Test Date: 20210829; Test Name: General physical condition; Result Unstructured Data: Test Result:Passable; Test Date: 20210829; Test Name: Physical examination; Result Unstructured Data: Test Result:No findings; Comments: Hearth: r,r,nf Lungs: vesicular breath sound bilaterally, no Crackles, eupnea. Abdomen: soft, no OS, no RS, DG brisk. Finger-nose test no findings., diadochokinesis unremarkable, strength unremarkable and motor function in extremities unremarkable, arm-retaining test unremarkable. Line gait no findings; Test Date: 20210829; Test Name: Thrombocytes; Result Unstructured Data: Test Result:288; Comments: Units: G/l; Test Date: 20210829; Test Name: Troponin T hs; Result Unstructured Data: Test Result:<3.0 pg/mL
CDC Split Type: ATPFIZER INC202101180483

Write-up: dyspnea; severe spinning dizziness; recurring Vertigo; Thoracic pain; Intercostal neuralgia; Nausea; Heart racing; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-043482. A 17-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Jul2021 (Lot Number: not reported) as second dose, single for covid-19 immunisation. Medical history included ongoing non-smoker (No Nicotine); lightheadedness, disorder circulatory system and stress symptoms from 29Jun2021 and ongoing (circulatory problems in general for months, dizziness has not yet been clarified, this occurs especially in stressful situations). The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) on unspecified date (Lot Number: not reported) as first dose, single for covid-19 immunisation and experienced general condition deterioration, drop in performance, and weight loss. The patient experienced severe spinning dizziness; recurring vertigo, heart racing, nausea on 26Aug2021. The patient experienced dyspnea, intercostal neuralgia, thoracic pain on 29Aug2021. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 163 u/l on 29Aug2021; blood fibrinogen: 2.6 g/l on 29Aug2021; body temperature (temp): 36.3 centigrade on 29Aug2021; c-reactive protein: below the detection limit on 29Aug2021; electrocardiogram (EKG): unremarkable on 29Aug2021; D-Dimer ( restl. Labor unauff ): 0.8 on unspecified date and on 29Aug2021; general physical condition: passable on 29Aug2021; physical examination: no findings on 29Aug2021 (heart: r,r,nf; Lungs: vesicular breath sound bilaterally, no Crackles, eupnea; Abdomen: soft, no OS, no RS, DG brisk; Finger-nose test no findings., diadochokinesis unremarkable, strength unremarkable and motor function in extremities unremarkable, arm-retaining test unremarkable; Line gait no findings); thrombocytes: 288 g/l on 29Aug2021; Troponin T hs: less than 3.0 pg/ml on 29Aug2021; Roentgen: diaphragm elevation right on 29Aug2021 (x-ray lung heart standing in two planes dated 29aug2021 findings: Pleural sinus clear. No signs of congestion. No pneumonic infiltrative processes delineable. The heart is normally configured. The aorta unremarkable. Diaphragmatic elevation on the right side). Outcome of all the events was recovering. Sender''s comment: Comment from the Federal Office for Safety in Healthcare/ Agency for Health and Food Safety: Follow-up information has been requested. Relatedness Assessment: Rotatory vertigo: Probable/Likely Method of assessment: regulatory authority assessment Source of assessment: Health Care Professional No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-BASGAGES-2021-043716


VAERS ID: 1728888 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ORG-100030215 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Dysmenorrhoea, Fatigue, Headache, Heavy menstrual bleeding, Lymphadenopathy, Malaise, Myalgia, Nausea, Polymenorrhoea, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: BEPFIZER INC202101180289

Write-up: Painful lumps under armpit arm; Painful lumps under armpit arm; Myalgia; Fatigue; Periods passed 5 days early; Headache; Arthralgia; Fever; with more intense pain and bleeding; Injection site reaction; Nausea; with more intense pain and bleeding; Malaise; This is a spontaneous report from a contactable consumer downloaded from the WEB. The regulatory authority number is BE-FAMHP-DHH-N2021-106150. A 32-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 (at the age of 32-years-old) (Batch/Lot Number: ORG-100030215) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced painful lumps under armpit arm, myalgia, fatigue, periods passed 5 days early, headache, arthralgia, fever, with more intense pain and bleeding, injection site reaction, nausea and malaise. The events were further described as: injection site reaction, fever, malaise, fatigue, nausea, arthralgia, myalgia, headache, menstrual cycle shortened, menstrual cramps, menstrual flow excessive, swollen lymph nodes and armpit pain. The patient received paracetamol for the events. The events were considered serious, disability. The patient recovered from the events on 30Aug2021 (also reported as recovering). Reporter comment: Treatment - Yes Paracetamol Evolution of the Adverse Drug Reaction - Recovering Adverse drug reaction description - Monthly period came in 5 days early with more serious pains and bleeding. Painful lumps under armpit of the arm where the vaccination was performed, after 4 days no longer painful but still present. Headache lasted 4 days. Other side effects 24-48 hours; Reporter''s Comments: Treatment - Yes Paracetamol Evolution of the Adverse Drug Reaction - Recovering Adverse drug reaction description - Monthly period came in 5 days early with more serious pains and bleeding. Painful lumps under armpit of the arm where the vaccination was performed, after 4 days no longer painful but still present. Headache lasted 4 days. Other side effects 24-48 hours


VAERS ID: 1729100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fundoscopy, Lumbar puncture, Magnetic resonance imaging head, Migraine, Nausea, Papilloedema, Tinnitus
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine (history of period-induced migraines); Rash face
Allergies:
Diagnostic Lab Data: Test Name: fundoscopy; Result Unstructured Data: Test Result:Papilloedema; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:opening pressure 28cm; Test Name: MRI brain; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202101190658

Write-up: whooshy sensation in the ears; nausea; Migraine headache; papilloedema; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109091655204680-SK3F1, Safety Report Unique Identifier [GB-MHRA-ADR 25919314]. A 16-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 25Aug2021 as dose 1, single for covid-19 immunization. Medical history included period-induced migraines from an unknown date and unknown if ongoing and rash face from an unknown date and unknown if ongoing. It was unsure if patient had symptoms associated with COVID-19. The patient did not have a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. It was stated that, on 26Jul2021, the patient experienced migraine headache. On unspecified dates, the patient experienced papilloedema, whooshy sensation in the ears and nausea. The event papilloedema was assessed as serious (medically significant). As per the additional details, it was reported that, in the 2 weeks following the vaccine the patient had experienced intermittent daily headaches and a whooshy sensation in the ears, worse on leaning forwards, associated with nausea. She had a history of period-induced migraines. Papilloedema on fundoscopy. The patient underwent lab tests and procedures on unspecified date which included fundoscopy with results papilloedema, lumbar puncture with opening pressure 28 cm and MRI brain (magnetic resonance imaging head) which was normal. It was unsure if patient was enrolled in clinical trial. The report was not related to possible blood clots or low platelet counts. The outcome for the events nausea and whooshy sensation in the ears was unknown and the outcome for the rest of the events was reported as not recovered, at the time of report. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1729461 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Dysphagia, Dyspnoea, Oedema peripheral, Oxygen saturation, Pain in extremity, Respiratory rate, Throat tightness, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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 (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BENTELAN; ZIRTEC
Current Illness: Fibromyalgia; Gastroesophageal reflux
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to excipient (vaccine excipient); Food allergy; Hypertension; Lactose intolerant; Latex allergy
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:140/70 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:36; Test Date: 20210826; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:100 : 99; Test Name: respiratory rate; Result Unstructured Data: Test Result:19; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:abnormal; Comments: On the left, in the subcalcaneal area, at the specific site of the pain reported by the patient, there is focal thrombosis of the medial plantar vein which is ectatic and non-compressible for a short distance. The remaining deep and superficial venous axis of the left lower limb appeared pervious and compressible. There is moderate incontinence of the saphenous-popliteal cross.
CDC Split Type: ITPFIZER INC202101174494

Write-up: pain in the left ankle since yesterday when she got out of bed; intense pain in the left lower limb (with atraumatic oedema at the level of the ankle); intense pain in the left lower limb (with atraumatic oedema at the level of the ankle); after about 10 minutes from administration of Pfizer vaccine on the left arm, appearance of a sense of the jugular constriction; after about 10 minutes from administration of Pfizer vaccine on the left arm difficulty to swallow and speak; after about 10 minutes from administration of Pfizer vaccine on the left arm dyspnea; Regulatory Authority This is a Non-Interventional Study report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-780324. A 47-years-old female subject received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 26Aug2021 (Lot Number: FG7387), at the age of 47-years-old, as dose 1, single for COVID-19 immunisation. Medical history included ongoing fibromyalgia, hypertension from an unknown date and unknown if ongoing, ongoing gastroesophageal reflux. Allergies: lactose intolerant, vaccine excipient, latex, peach allergy. Concomitant medications included betamethasone sodium phosphate (BENTELAN) taken for premedication from 25Aug2021 to 25Aug2021; cetirizine hydrochloride (ZIRTEC) taken for premedication from 25Aug2021 to 25Aug2021. After about 10 minutes from administration of Pfizer vaccine on the left arm, appearance of a sense of the jugular constriction, difficulty to swallow and speak, dyspnea on 26Aug2021 with outcome of recovering. The patient also experienced pain in the left ankle since yesterday when she got out of bed and intense pain in the left lower limb (with atraumatic oedema at the level of the ankle) on an unspecified date with outcome of unknown. The events were reported as serious (hospitalization). The clinical course included: recent evaluation, on 26Aug2021, at this Emergency Room due to an allergic reaction after the first dose of the Pfizer vaccine. evaluated and discharged with therapy (deltacortene and robilas 20 1 pill at night). Recent pathological history: the patient came to the Emergency Room because since yesterday evening she had a new lowering of her voice with difficulty to swallow. No fever at home. She reported pain in the left ankle since yesterday when she got out of bed. She reported that from the visit to the first aid station the symptomatology had not regressed completely, even though it does not appear to have worsened at present. Measures taken: on the spot she was treated with phlebocortid 250mg and trimeton, then transported to the Emergency Room. Follow-up on 30Aug2021, returned to the emergency room due to intense pain in the left lower limb (with atraumatic oedema at the level of the ankle). Follow-up on 26Aug2021, she went to the doctor: At home recommended Robilas 20mg 1 pill in the evening for 10 days, Deltacortene 25mg 1 pill on full stomach for 3 days, then 1/2 pill for 3 days, then 1/4 pill for 2 days then stop. Omeprazole 20mg 1 pill in the morning on a full stomach. Follow up of 09Sep2021 attached the resignation letters of the emergency room (26Aug2021 and 30Aug2021). The subject underwent lab tests and procedures which Ultrasound Doppler: abnormal. On the left, in the subcalcaneal area, at the specific site of the pain reported by the patient, there is focal thrombosis of the medial plantar vein which is ectatic and non-compressible for a short distance. The remaining deep and superficial venous axis of the left lower limb appeared pervious and compressible. There is moderate incontinence of the saphenous-popliteal cross. Respiratory rate: 19. Skin temperature: 36. Blood pressure: 140/70 mmHg. Oxygen saturation in air 100 : 99 on 26Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events throat tightness, dyspnea, dysphagia, arthralgia, peripheral edema and pain in extremity cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1729724 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypotension
Preexisting Conditions: Medical History/Concurrent Conditions: Vagal reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Consciousness disturbance; Vagal reaction; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP088553) on 06-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This case, reported by a physician, was received by RA via Moderna''s adverse reaction reporting site (TASK0021496), and reported to the regulatory authority by a physician, was received via the RA (Ref, v21125969). Consciousness disturbance was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 26-Aug-2021, at 18:20, the patient received the 1st dose of the vaccine. At 18:30, poorly feeling developed. At 18:35, vagal reaction developed, and the patient had transient consciousness disturbance. JCS: 1-3. In a few seconds, the level improved to JCS: 1-1. The symptom was alleviated while patient was in a supine position. Subsequently, the symptom resolved. The outcome of vagal reaction and consciousness disturbance was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. The outcome of vagal reaction and consciousness disturbance was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 40-year-old, female patient with relevant medical history of hypotension and vagal reaction, who experienced the unexpected event of altered state of consciousness. The event occurred approximately 15 minutes day after the first dose of Moderna COVID-19 Vaccine. Vagal reaction developed, and the patient had transient consciousness disturbance. The rechallenge was not applicable, as the event happened after the first dose and action taken was reported as not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Reporter''s Comments: It was possible that the patient experienced vagal reaction or orthostatic dysregulation, and underlying hypotension also may have been a factor. The patient had a history of 2 episodes of possible vagal reaction in the past.; Sender''s Comments: This case concerns a 40-year-old, female patient with relevant medical history of hypotension and vagal reaction, who experienced the unexpected event of altered state of consciousness. The event occurred approximately 15 minutes day after the first dose of Moderna COVID-19 Vaccine. Vagal reaction developed, and the patient had transient consciousness disturbance. The rechallenge was not applicable, as the event happened after the first dose and action taken was reported as not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1729733 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Contusion, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Arrhythmia; Fall; Bruise of head; Vasovagal reflex; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP093070) on 11-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, initially reported to the regulatory authority (RA) by a (physician), was received via the RA (Ref, v21127789). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 26-Aug-2021, at 11:10, the patient received the 2nd dose of this vaccine. At 11:15, vasovagal reflex developed after sitting in a chair. The patient lost consciousness and fell. The patient had bruise of head. Consciousness recovered immediately after leg elevation. At the time of checking vital signs, pulse rate: 59/min, blood pressure: 98/56, respiratory rate: 16 times/min, and SpO2: 98%. Facial flushing developed. The patient was raced to a hospital due to bruise of head. The general condition was stable at the time of transport to the hospital, and no abnormal findings were observed in blood test and head CT. Anaphylaxis and epilepsy were not suspected. Echocardiography showed no significant findings, but electrocardiography showed arrhythmia, and electrocardiography was re-examined after infusion to be normalized. Thereafter, the symptoms resolved. The outcome of vasovagal reflex, loss of consciousness, fall, bruise of head, and arrhythmia was reported as resolved. Follow-up investigation will be made. Company Comment: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness, Arrhythmia, Fall, Contusion and Presyncope. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Reporter''s Comments: The patient was raced to a hospital due to bruise of head.; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness, Arrhythmia, Fall, Contusion and Presyncope. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1729782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 29/25 BA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101197542

Write-up: GUILLIAN BARRE SYNDROME; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: 29/25 BA) as dose number unkown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was diagnosed with Guillain barre syndrome which caused hospitalization for 15 days from 26Aug2021. It was reported that the doctors attributed it to the Pfizer vaccine, she was given the vaccine from batch 29 / 25 BA and several cases similar to hers have arrived. The outcome of the event was not recovered.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-202101197544


VAERS ID: 1729863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Electrocardiogram, Laboratory test, Pericarditis, Ultrasound scan
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: X ray thorax; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: laboratory test; Result Unstructured Data: Test Result:unknown results; Test Name: echography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101179837

Write-up: Pericarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NL-LRB-00673787. A 14-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. The patient previously received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced pericarditis on 26Aug2021. Pericarditis is treated with ibuprofen. The patient underwent lab tests and procedures which included x-ray thorax: unknown results, electrocardiogram (ECG): unknown results, laboratory test: unknown results and echography: unknown results, all on unspecified dates. The outcome of the event was unknown. Therapeutic measures were taken as a result of pericarditis. Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes , ADRs: no pericarditis: Additional information ADR: 2 days after the 2nd vaccination. BSN available: yes Previous COVID-19 infection: No diagnostic procedures: ECG, chest X-ray, ultrasound, lab No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes , ADRs: no pericarditis: Additional information ADR: 2 days after the 2nd vaccination. BSN available: yes Previous COVID-19 infection: No diagnostic procedures: ECG, chest X-ray, ultrasound, lab


VAERS ID: 1729894 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: RAT; Test Result: Positive
CDC Split Type: PHPFIZER INC202101183128

Write-up: cough; RAT (+); fever; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number PH-PHFDA-300103721. A 65-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Aug2021 (Batch/Lot number was not reported) at the age of 64-years-old as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Aug2021, the patient had fever and dry cough. Then, fever and progression of cough was noted with positive rapid antigen test (RAT) on 27Aug2021. The patient was then hospitalized in 2021. The patient was recovering from the events. No follow-up attempts are possible, information regarding the lot/batch number cannot be obtained.


VAERS ID: 1729896 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8163 / UNK - / OT

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: PHPFIZER INC202101183135

Write-up: fainting; This is a spontaneous report from a contactable other health professional. This is a report received from the regulatory authority. The regulatory authority report number is PH-PHFDA-300103303. An 18-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 26Aug2021 (Batch/Lot Number: FE8163), at age 18 years old, as dose number unknown, single, for COVID-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. On 26Aug2021 14:00, the patient experienced fainting. The outcome of the event was resolved on an unspecified date. The health authority assessed this report as serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729965 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial pain, Headache, Interchange of vaccine products, Lymphadenitis, Off label use, Pain, Paraesthesia, Paraesthesia oral, Swelling, Swelling face, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: THPFIZER INC202101170719

Write-up: Lymphadenitis; The first dose was AstraZeneca; The first dose was AstraZeneca; pain and swelling from under ear to area of trachea; pain and swelling from under ear to area of trachea; swelling and pain at right side of the face; swelling and pain at right side of the face; tingling at legs and right side of mouth; tingling at legs and right side of mouth; pain at vaccination site; headache; This is a spontaneous report from a contactable consumer or other Non-HCP. A 49-year-old (pregnant-unknown) female patient received second dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via intramuscular route of administration, administrated in left arm on 26Aug2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization in hospital, and first dose of COVID-19 VACCINE ASTRAZENECA (COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19)), on an unspecified date, for COVID-19 immunization. The patient''s medical history included fruit protein allergy. The patient''s concomitant medications were not reported. On 26Aug2021, the patient experienced pain at vaccination site, headache; and on 02Sep2021 swelling and pain at right side of the face, tingling at legs and right side of mouth; and on 08Sep2021 pain and swelling from under ear to area of trachea; and on an unspecified date Lymphadenitis, the first dose was AstraZeneca. On 06Sep2021, the patient received antibiotic and painkillers via intravenous, but the patient did not get better. The patient said that the physician diagnosed her symptoms as Lymphadenitis. The reporting patient confirmed no hosp. The outcome of the events swelling and pain at right side of the face, pain and swelling from under ear to area of trachea was not recovered; and all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


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