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From the 11/19/2021 release of VAERS data:

Found 894,019 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 462 out of 8,941

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VAERS ID: 1816495 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101359669

Write-up: severe joint pain; muscle pain; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110111132567030-FDL9A, Safety Report Unique Identifier is GB-MHRA-ADR 26059897. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Sep2021 (Lot Number: FF8222, Expiry date not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Historical vaccine included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) on 31Jan2021 for COVID-19 immunisation. The patient experienced severe joint pain on an unspecified date with outcome of not recovered and muscle pain on 01Oct2021 with outcome of not recovered; off label use and interchange of vaccine products on 27Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The events severe joint pain and muscle pain were reported as serious, medically significant by the health authority, while the other events were non-serious. Case narrative: Severe joint and muscle pain, lasting up to now, 10 days. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1816511 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101359608

Write-up: Fever chills; Leg pain; This is a spontaneous report from a contactable consumer or other non-health care professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110111436301980-QXYHG, Safety Report Unique Identifier GB-MHRA-ADR 26060666. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch Number: FF8222), via unspecified route of administration on 25Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was not enrolled in clinical trial. On 27Sep2021, patient experienced fever chills and leg pain. The case assessed as serious (medically significant). The outcome of the events fever chills was resolved on 30Sep2021, and leg pain was resolved with sequelae. No follow up attempts were needed. No further information was expected.


VAERS ID: 1816568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest pain, Diarrhoea, Electrocardiogram, Headache, Nausea, Panic reaction, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:some minor things notes but discharged; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101367694

Write-up: Diarrhoea; nausea; Chest pain; anxiety attacks; physical symptoms similar to panic; Headache; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110121655217000-XFZBJ, Safety Report Unique Identifier GB-MHRA-ADR 26067740. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 24Sep2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included chest pain. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously took prednisolone approx 6 years ago. On 27Sep2021, the patient experienced chest pain and nausea. Chest pain continued all the time low level and anxiety attacks or physical symptoms similar to panic (no history of mental health/ anxiety). The patient also experienced headache on 27Sep2021. On 05Oct2021, the patient experienced diarrhoea. On 07Oct2021, the patient went to emergency department (ED) with increased chest pain. Electrocardiogram (ECG) showed some minor things notes but discharged. The event caused disability and were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the diarrhoea was recovered on 06Oct2021, of the anxiety attacks or physical symptoms similar to panic was unknown, while of the remaining 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: 1816766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis bullous, Erythema, Flushing, Periorbital swelling
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), 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: ITPFIZER INC202101347263

Write-up: red blisters in the legs and face; red blisters in the legs and face; Swollen eyes; red blisters in the legs and face; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-796018. A 20-year-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: 1F1005A; Expiration Date: 31Dec2021) intramuscular in Arm Left (left shoulder) on 26Sep2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously on 05Sep2021 at 18.27 patient took the first dose of bnt162b2 (COMIRNATY; Lot Number: FF8288; Expiration Date: 31Dec2021) in left shoulder for covid-19 immunisation. On 27Sep2021 the patient experienced erythema bullosum, flushed face, puffy eyes and redness of legs, described as follows: red blisters in the legs and face and swollen eyes. Actions taken included antihistamine. Impact on quality of life was 5/10. Final outcome of the events was recovering. Sender''s comment: 1st dose Comirnaty 05Sep2021 at 18.27 left shoulder Lot: FF8288 exp. 31Dec2021.


VAERS ID: 1816829 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body temperature, C-reactive protein, Electrocardiogram, Myocarditis, Pyrexia, Troponin I, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? 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: 20210928; Test Name: CK; Result Unstructured Data: Increased; Test Date: 20210928; Test Name: CK-MB; Result Unstructured Data: Increased; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: High-38 degrees Celsius developed Cel; Test Date: 20210928; Test Name: CRP; Result Unstructured Data: Increased; Test Date: 20210928; Test Name: Electrocardiogram; Result Unstructured Data: showed extensive ST elevationtroponin I was elevated; Test Date: 20210929; Test Name: Troponin I; Result Unstructured Data: Test Result:Increased; Test Date: 20210928; Test Name: WBC; Result Unstructured Data: Test Result:Increased
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; Pyrexia; This case was received via regulatory authority (Reference number: JP-2021TJP108201) on 15-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority(Ref, v21129412). On an unknown date, the patient received the 1st dose of this vaccine. On 26-Sep-2021, the patient received the 2nd dose of this vaccine. On 27-Sep-2021, pyrexia in the 38 degrees Celsius developed. On 28-Sep-2021, in the morning, acute myocarditis developed. Chest tightness developed. The patient visited a nearby physician. Electrocardiogram showed extensive ST elevation. Blood test showed increased CK, CK-MB, CRP, and WBC. On 29-Sep-2021, the patient was referred to the reporting department. Echocardiography showed no abnormalities, but troponin I was elevated. The patient was hospitalized with a diagnosis of acute myocarditis. On 02-Oct-2021, the symptoms were confirmed as resolved. The outcome of pyrexia and acute myocarditis 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.; Reporter''s Comments: This vaccine is highly likely to be the cause.; Sender''s Comments: This case concerns a 17 year old male patient with no relevant medical history, who experienced the expected event of myocarditis and the unexpected event of pyrexia. The event myocarditis occurred approximately 2 days after the second dose of the Moderna COVID-19 vaccine. The event pyrexia occurred on the first day after the second dose. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1816896 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8021 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Body temperature increased, Diarrhoea, Dizziness, Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain, Paraesthesia, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: body temperature; Result Unstructured Data: Test Result:Fever greater than or equal to 38 Celsius degrees; Test Date: 20210928; Test Name: test COVID-19; Test Result: Negative
CDC Split Type: MXPFIZER INC202101360180

Write-up: Rhinorrhea; Oropharyngeal pain; Myalgia; Facial paresthesia; Syncope; Fever greater than or equal to 38 Celsius degrees; Headache; Asthenia; Fatigue; Body Temperature Increased; Dizziness; Nausea; Vomit; Abdominal pain; Diarrhea; This is a spontaneous report from a non-contactable Other Health Care Professional. This is a report received from Regulatory Authority via email. Regulatory authority report number is 17870-10. A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 27Sep2021 (Lot Number: FH8021; Expiration Date: 01Jan2022) at the age of 24-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no infectious disease in the last 15 Days prior to vaccination. Patient was healthy before vaccination and had no allergies. On 27Sep2021, the patient experienced fever greater than or equal to 38 Celsius degrees, headache, asthenia/fatigue, body temperature increased, dizziness, nausea, vomit, abdominal pain, diarrhea. Timeframe between vaccination and starting of symptoms reported as 2 hours. On 28Sep2021, the patient experienced rhinorrhea, oropharyngeal pain, myalgia, facial paresthesia, syncope. Clinical course reported as follows:?"female patient who went for vaccination on 27Sep2021 to the PRIVACY center, who reported that 2 hours after the application she started headache, fever, vomiting, nausea and diarrhea. She took paracetamol to improve her symptoms. on 28Sep2021 a rapid covid test was performed was negative, however, rhinorrhea, pharyngeal pain, myalgia, syncope and facial paresthesia were added." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1817671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Insomnia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101360670

Write-up: Bell''s palsy; Insomnia; Myalgia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 636825. A 25-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021 the patient experienced bell''s palsy, insomnia, myalgia. The outcome of 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: 1817687 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Mouth swelling, Nausea, Paraesthesia, Swelling face, Tongue paralysis, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (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: AUPFIZER INC202101360735

Write-up: Tongue paralysis; Facial paralysis; Mouth swelling; Paraesthesia; Swelling face; Vomiting; Nausea; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 636876. A 44-years-old female patient received unknown dose of BNT162B2 (COMIRNATY, solution for injection, batch/lot number was not reported) via an unspecified route of administration on 27Sep2021 (at the age of 44-years-old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced facial paralysis, tongue paralysis, mouth swelling, nausea, paraesthesia, swelling face, and vomiting. Onset time in days was reported as 0 days. Outcome of all the events was resolved on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1817694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101360803

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 637310. A 25-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date and second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date, both as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021 patient experienced bell''s palsy. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1818942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-09-27
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM 0477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210927; Test Name: sars-cov-2 test; Test Result: Positive ; Comments: CT values 18/16
CDC Split Type: DEPFIZER INC202101350165

Write-up: runny nose; sore throat; limb pain; Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-202100203286. A 35-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EM 0477) as dose 2, single and dose 1 via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EJ6796) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid-19, vaccination failure on 27Sep2021, also: runny nose, sore throat, and limb pain on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 (CT values 18/16). The outcome of the events was unknown. The PEI assessment for all the events with the suspect product Comirnaty is: B. Indeterminate. Sender''s comment: Initials: PRIVACY. PCR proof from 27Sep2021 positive, CT values 18/16 Symptoms: runny nose, sore throat and limb pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1819040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Tic
SMQs:, Dyskinesia (broad), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101350112

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20215288. A 12-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: UNKNOWN) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced tic on 27Sep2021. The patient had strong twitching of the head, in the hospital was diagnosed with Tic disorder. Previously, 2 days earlier, patient started menstruating (no earlier experienced). No underlying diseases/allergies. The report is serious (medically significant). 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: 1819058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Babinski reflex test, Blood electrolytes, Blood glucose, Blood pressure measurement, Body temperature, Coma scale, Computerised tomogram head, Facial paralysis, Heart rate, Hemiplegia, Neurological examination, Oxygen saturation, Pupillary light reflex tests, Respiratory rate, Visual analogue scale
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; AMLODIPINE; ENALAPRIL; LACTULOSE; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Dementia; Gastroduodenal ulcer; Hypertension arterial; Incontinence urinary; Loss of personal independence in daily activities (living in a residential care home); Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Babinski reflex; Test Result: Negative ; Comments: -/-; Test Date: 20210927; Test Name: blood electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: Capillary blood sugar; Result Unstructured Data: Test Result:0.89 g/l; Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/61 mmHg; Test Date: 20210927; Test Name: body temperature; Result Unstructured Data: Test Result:33.4 Centigrade; Test Date: 20210927; Test Name: Glasgow score; Result Unstructured Data: Test Result:10; Comments: eyes: 4, verbal: 2, motor: 4; Test Date: 20210927; Test Name: Glasgow score; Result Unstructured Data: Test Result:12; Comments: y4v2m6 (eyes 4, verbal 2, motor 6); Test Date: 20210927; Test Name: Computerised tomography brain scan; Result Unstructured Data: Test Result:no haemorrhagic or ischaemic accident; Comments: Absence of evidence for a haemorrhagic or recent established ischaemic accident. Good permeability of the supra-aortic trunks, in particular of the vertebrobasilar system. Significant short stenosis, on calcium plaque, of the right V4 segment (left vertebral dominance); Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:51; Comments: unit: /min; Test Date: 20210927; Test Name: Deep tendon reflex; Test Result: Negative ; Comments: - / -; Test Date: 20210927; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210927; Test Name: photomotor reflex; Test Result: Positive ; Comments: + / +; Test Date: 20210927; Test Name: Respiratory rate; Result Unstructured Data: Test Result:14; Comments: unit: /min; Test Date: 20210927; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:not assessable
CDC Split Type: FRPFIZER INC202101350117

Write-up: left central facial paralysis; right hemiplegia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB - [FR-AFSSAPS-AN20213869]. An 88-year-old female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection) intramuscular on 21Sep2021 (Batch/Lot Number: FG7911) as dose 3 (booster), single for COVID-19 immunisation. Medical history included incontinence urinary, cataract, hypertension arterial, osteoporosis, dementia, and gastroduodenal ulcer. Patient with GIR (iso-resources group) 1 (living in a residential care home). Person is at risk of developing a serious case of COVID-19 disease. No Prior COVID-19 infection. No medical history of allergy hypersensitivity. Concomitant medications included alprazolam 0.5 mg, 1 tablet at bedtime, amlodipine 5 mg, 1 capsule in the evening, enalapril 20 mg, 1 tablet in the morning, lactulose 10 g/15 ml, 1 sachet in the morning and paracetamol (DOLIPRANE) 1000 mg, 1 capsule morning, noon and evening. The patient took the first dose of COMIRNATY on 17Feb2021 batch EK9788, the second dose of COMIRNATY on 10Mar2021 batch EP9605 for COVID-19 immunisation. On 27Sep2021 (6 days after a 3rd dose), patient experienced left central facial paralysis and right hemiplegia, responded to orders on the left side, slow execution. Clinical Examination at the emergency department on 27Sep2021: Temperature: 33.4 degrees Celsius, Respiratory rate: 14/minute; Oxygen saturation: 98%, Blood pressure 132/61 mmHg, Heart rate: 51/min, Glasgow score: 10 points for which the eyes: 4, verbal: 2, motor: 4 and 12 points y4v2m6 (eyes 4, verbal 2, motor 6), Visual Analogue Scale: not assessable, photomotor reflex +/+, Deep tendon reflex -/-, Babinski reflex (BB) -/-, Capillary blood sugar: 0.89 g/l, normal blood electrolytes and Computerised tomography brain scan: Absence of computerised tomography evidence for a haemorrhagic or recent established ischaemic accident. Good permeability of the supra-aortic trunks, in particular of the vertebrobasilar system. Significant short stenosis, on calcium plaque, of the right V4 segment (left vertebral dominance). Patient went to the emergency department and returned home. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1819083 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Creatinine urine, Nephrotic syndrome, Protein urine, Urine analysis, Urine protein/creatinine ratio
SMQs:, Chronic kidney disease (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELLCEPT; ZYRTEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Grass allergy; Haematuria (since the age of 8); Nephrotic syndrome (without high blood pressure)
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: urinary creatinine; Result Unstructured Data: Test Result: normal; Test Date: 20211005; Test Name: Proteinuria; Result Unstructured Data: Test Result: 0.43 g/l; Test Date: 20210927; Test Name: urine test; Result Unstructured Data: Test Result: discovery of proteinuria; Comments: discovery of proteinuria on the urine test strip (2 crosses), no clinical symptoms; Test Date: 20211007; Test Name: urine test; Result Unstructured Data: Test Result: Urinary test strip still positive; Comments: Urinary test strip still positive (2 crosses) --$g nephrologist''s advice: increase in the dose of CELLCEPT to 700 mg 2/day + CORTANCYL 20 mg/day; Test Date: 20211005; Test Name: Proteinuria/creatininuria ratio; Result Unstructured Data: Test Result: 51.
CDC Split Type: FRPFIZER INC202101356414

Write-up: Nephrotic syndrome; Disease aggravation; This is a spontaneous report from a contactable consumer (patient) from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-LY202111819. A 19-year-old male patient received bnt162b2 (COMIRNATY), dose 1 parenteral on 25Sep2021 (Batch/Lot Number: FG6273) as dose 1, single for covid-19 immunisation. Medical history included pure idiopathic nephrotic syndrome without high blood pressure, haematuria since the age of 8, and grass allergies. It was reported that the patient had relapses of his nephrotic syndrome 1/year. In 2020, after 3 years without a relapse, it was decided to stop treatment with mycophenolate mofetil hydrochloride and patient had relapse 3 months later. In May2021, the patient had a new episode during the peak grass season (allergy) and had an addition of corticosteroids. Concomitant medications included CELLCEPT taken for nephrotic syndrome, ZYRTEC, and corticosteroids at the time of relapses of the nephrotic syndrome. It was reported that in Sep2021, about 1 week before vaccination, the patient appeared to relapse according to the father (no further information). On 27Sep2021, the patient experienced nephrotic syndrome and disease aggravation. On 27Sep2021, there was discovery of proteinuria on the urine test strip (2 crosses), no clinical symptoms. On 05Oct2021, patient had a lab test performed in the city which showed urinary creatinine normal, proteinuria at 0.43 g/L (< 0.15), and proteinuria/creatininuria ratio at 51 mg/mmol (< 50). On 07Oct2021, urinary test strip still positive (2 crosses). Nephrologist''s advice was to increase in the dose of Cellcept to 700 mg 2/day + Cortancyl 20 mg/day. In summary, a recurrence of proteinuria on Day 2 of vaccination, without clinical signs, in a patient with a poorly stabilised nephrotic syndrome. Outcome of events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1819274 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Off label use
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: MINI PILL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101367798

Write-up: Prolonged heavy periods; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110120823084560-75BDL and Safety Report Unique Identifier GB-MHRA-ADR 26064650. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8288), dose 3 via an unspecified route of administration on 27Sep2021 (at the age of 38-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. No recent past medical history. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant at the time of vaccination and not currently breast-feeding. Concomitant medication included norethisterone (MINI PILL) taken for an unspecified indication, start and stop date were not reported (18 months). On 27Sep2021, the patient had a booster and off-label use. On 10Oct2021, the patient experienced prolonged heavy periods. It was reported that very heavy period 2 weeks post vaccine. Been on mini pill for 18 months and periods had stopped, so now this was very unusual. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of the event prolonged heavy periods was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis, Inappropriate schedule of product administration
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101367746

Write-up: Facial drooping; Palsy Bells; First dose on 02Jan2021/Second dose on 27Sep2021; This is a spontaneous report from a contactable physician received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110121535026750-FSR2Y and Safety Report Unique Identifier GB-MHRA-ADR 26066420. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 27Sep2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 02Jan2021 as dose 1, single for COVID-19 immunization. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced facial drooping. On 03Oct2021, the patient experienced palsy bells. Therapeutic measures were taken as a result of facial drooping and included treatment with oral Prednisolone. 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: 1819321 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hypoaesthesia, Immunisation, Joint range of motion decreased, Malaise, Myalgia, Off label use, Pain in extremity, Product administered at inappropriate site
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVOREL; LACTIC ACID; OMEPRAZOLE; UTROGESTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticular disease; Hip replacement; HRT; Indigestion; Ischaemic heart disease; OA hip
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101367726

Write-up: Pain in arm; Shivering; Muscle ache; injection was given too high up into shoulder not deltoid; deadness in arm; unable to lift/ move even 2cm above hip for 2-3days; unwell; received third dose of BNT162B2; received third dose of BNT162B2; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110121920279290-CYA6D, and Safety Report Unique Identifier is GB-MHRA-ADR 26067842. A 57-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 27Sep2021 (lot number: FJ5782) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Diverticular disease, OA hip, hip replacement, ischaemic heart disease, hormone replacement therapy (HRT), and indigestion. OA hip awaiting hip replacement surgery, Diverticular disease. On HRT for bone and heart disease prevention. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included estradiol (EVOREL) taken for hormone replacement therapy from 01Aug2021; lactic acid; omeprazole taken for indigestion from 01Jul2021; progesterone (UTROGESTAN) taken for hormone replacement therapy from 01Aug2021. The patient experienced pain in arm on 27Sep2021 with outcome of recovered on 01Oct2021, shivering on 27Sep2021 with outcome of recovered on 29Sep2021, muscle ache on 27Sep2021 with outcome of recovered on 30Sep2021, deadness in arm, unable to lift/ move even 2cm above hip for 2-3days and unwell on 27Sep2021 with outcome of unknown, and injection was given too high up into shoulder not deltoid on 27Sep2021 with outcome of unknown. The events were assessed as serious, other medically important condition. Patient was an HCP experienced as immunized nurse (a covid19 vaccinator for PCN). Injection was given too high up into shoulder not deltoid which caused intense pain in arm and deadness. Unable to lift/ move even 2cm above hip for 2-3days. Feeling as if lactic acid build up in arm and whole body. Systemically unwell. No redness /heat swelling at arm, no fever (I think), no SE from dose 1 or 2. This was 6m booster dose (as reported). No relevant investigations or tests conducted, patient took analgesia rest and fluids. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-27
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101374134

Write-up: Heavy periods/ Continuous period even when on the pill which stopped the periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110130957391120-4RS49. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 26070381. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Fe3380), dose 1 via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for covid-19 immunization. Patient has not had symptoms associated with COVID-19. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced heavy periods/continuous period even when on the pill which stopped the periods on 27Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date Negative COVID-19 test. Therapeutic measures were taken as a result of heavy periods/continuous period even when on the pill which stopped the periods. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819547 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dysphonia, Face oedema, Facial nerve disorder, Investigation, Muscle tightness, Neuropathy peripheral, Oedema mouth, Oedema peripheral, Overdose, Phlebitis, Quality of life decreased, Tachycardia, Tongue oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (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), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic contact dermatitis; Allergic reaction to wasp sting; Allergy to venom; Autoimmune thrombocytopenia; Breast carcinoma NOS (cancer left breast, operated); Latex allergy; Malignant breast lump removal; Nickel sensitivity; Oculo-respiratory syndrome (oculorinitis); Osteopenia; Pancytopenia (Live pancytopenia); Papilloma; Pathological fracture; Thrombopenia (Untreated autoimmune thrombocytopenia); Uterine fibroma
Allergies:
Diagnostic Lab Data: Test Name: ALLERGOLOGICAL EXAMINATIONS; Result Unstructured Data: Test Result:unknown results; Test Name: impact on quality of life; Result Unstructured Data: Test Result:8/10
CDC Split Type: ITPFIZER INC202101356761

Write-up: edema of the left hemiface; edema of the tongue; oedema of oral cavity; dysphagia; dysphonia; tachycardia; neuropathy of the face, neck and upper thorax; neuropathy of the face; with a strong sense of constriction; edema of the lower limbs; phlebitis of the right hand; Impact on quality of life (8/10); overdose; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-796305. A 63-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via intramuscular on 27Sep2021 at 10:33 AM (at the age of 63-year-old; lot number: FF2834, Expiry date: 30Nov2021) as DOSE 2, 3 ML SINGLE for COVID-19 immunisation. Medical history included latex allergy, allergic contact dermatitis (contact dermatitis to nickel, latex and silicone), allergy to venom, allergy to wasp poison, osteopenia (serious osteopenia with pathological fractures), breast carcinoma nos (cancer left breast, operated), pancytopenia (live pancytopenia/ mild pancytopenia), oculo-respiratory syndrome (oculorinitis), thrombopenia (untreated autoimmune thrombocytopenia), nickel sensitivity, uterine fibroma, that all from unknown date and unknown if ongoing; and papilloma of the uvula. Concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot number: FF7481, Expiry date: 30Nov2021), via an unspecified route of administration in left deltoid on 16Aug2021 at 12:57 PM as single dose for COVID-19 immunisation and the patient experienced tinnitus. On 27Sep2021 (as reported), the patient experienced edema of the left hemiface, edema of the tongue, of the oral cavity with dysphagia and dysphonia, tachycardia, neuropathy of the face, neck and upper thorax with a strong sense of constriction, oedema of the lower limbs, phlebitis of the right hand; and that events reported as hospitalized and resulted in consultations with regional physicians (general practitioner, continuity assistance, allergological examinations). The patient received an overdose to 3 ml single dose of bnt162b2 on 27Sep2021 at 10:33. Lab data included allergological examinations with unknown results, impact on quality of life was 8/10, both on unspecified date. Outcome of events phlebitis of the right hand, Impact on quality of life (8/10) and overdose was unknown, while of the other events was not recovered. Reporter comment: Edema of the left hemiface, edema of the tongue, of the oral cavity with dysphagia and dysphonia, tachycardia, neuropathy of the face, neck and upper thorax with a strong sense of constriction, oedema of the lower limbs, phlebitis of the right hand. She suffers from untreated autoimmune thrombocytopenia, mild pancytopenia, allergy to wasp venom, contact dermatitis to nickel, latex and silicone, oculorhinitis of probable allergic nature, serious osteopenia with pathological fractures, papilloma of the uvula, uterine fibroma, previously operated left breast carcinoma.; Reporter''s Comments: Summary of Reporter Comment: the patient experienced edema of the left hemiface, edema of the tongue, of the oral cavity with dysphagia and dysphonia, tachycardia, neuropathy of the face, neck and upper thorax with a strong sense of constriction, oedema of the lower limbs, phlebitis of the right hand.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101131485 same patient, different dose/events


VAERS ID: 1819700 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Blood test, Cough, Dysstasia, Eczema, Erythema, Eye pain, Gait disturbance, Hand dermatitis, Headache, Pain in extremity, Pyrexia, Suspected COVID-19
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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; Asthma-like condition; Common cold
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: blood collection; Result Unstructured Data: Test Result:unknown result; Test Date: 202110; Test Name: blood collection; Result Unstructured Data: Test Result:unknown result
CDC Split Type: JPPFIZER INC202101353612

Write-up: eczema on hands, arms and legs; Pyrexia; Headache; the eczema on legs started to be painful; it was also difficult to stand and walk; it was also difficult to stand and walk; Cough; it was holey and swollen, and when the reporter saw "erythema" on the Internet, the reporter thought it looked like this; it was like symptoms of asthma; The reporter was worried about the possibility of anaphylaxis; The reporter thought it was COVID-19; eczema on hands, arms and legs; Eye pain/pain deep in the eyes; This is a spontaneous report from a contactable consumer (parent). The patient was a 21-year-old male. On 25Sep2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included common cold in 2018 (not ongoing), asthma-like condition in 2018 (not ongoing), allergy. Previously the patient received paracetamol (CALONAL) not ongoing for pyrexia and experienced drug ineffective and epinastine hydrochloride (ALESION) not ongoing for pyrexia and experienced drug ineffective. Concomitant medications were not reported. After vaccination the patient experienced pyrexia, headache, eye pain/pain deep in the eyes, then symptoms became worse gradually. On 29Sep2021 eczema occurred on arms and legs. The patient said that the eczema on legs started to be painful in legs, it was also difficult to stand and walk. On 11Sep2021 the patient visited the doctor. The pain was gone, there was eczema on hands, arms and legs, it was 11Sep2021, the second dose was close. The patient said there was nothing on the vaccination date, gradually pyrexia and headache occurred. And the eyes, the date of vaccination was the day 0, on the second day, the patient thought eyes were going to explode, that''s how much painful the eyes were. The patient received blood collection on 11Sep2021 (results unknown). It was so serious that the eczema did not disappear even after 16 days, the doctor tried to press the eczema with a transparent ruler and it disappeared. It disappeared when it was cold, and when the body warms up, it became red all over again. The eczema was probably not going to go away. Since 29Sep2021 night eczema occurred, there had been no change in terms of eczema. It disappeared when it was cold, it appeared again when it was warm. The doctor just told the patient to cool it down because it came out due to dilated blood vessels. The condition got better, except for the eczema, and only the eczema remained. Cough occurred, the patient thought it was like symptoms of asthma. When the patient went to the doctor again in Oct2021, the patient was told that he would be given medicine (containing steroid) for the cough to expand trachea, and then the patient received blood collection and the results would come out in 4 or 5 days. It was holey and swollen, and when the reporter saw "erythema" on the Internet, the reporter thought it looked like this. The event pyrexia persisted until 04Oct2021. On 05Oct2021, the pain in leg recovered. The reporter was worried about the possibility of anaphylaxis. The reporter thought it was COVID-19. Pyrexia recovered on 04Oct2021, eczema on legs started to be painful recovered on 05Oct2021. Outcome of all other events was unknown. The events eczema on hands, arms and legs; pyrexia, headache, eye pain/pain deep in the eyes, the eczema on legs started to be painful, it was also difficult to stand and walk, it was holey and swollen, and when the reporter saw "erythema" on the internet, the reporter thought it looked like this; it was like symptoms of asthma required physician office visit. The events the reporter was worried about the possibility of anaphylaxis, the reporter thought it was COVID-19, eczema on hands, arms and legs were medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Cerebrovascular accident, Dizziness, Facial paralysis, Hemiplegia
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (on ACE-I)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101363053

Write-up: Cerebrovascular accident; Facial paralysis; Hemiplegia; Agitation; dizziness; This is a spontaneous report from a contactable physician from the regulatory authority. Regulatory authority report number is AEFI-A-034530. A 59-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included HTN (hypertension) on ACE-I. Concomitant medication included ACE-I. The patient experienced agitation (hospitalization) on 27Sep2021 20:05, cerebrovascular accident (hospitalization) on 27Sep2021 20:05, dizziness (hospitalization) on 27Sep2021 20:05, facial paralysis (hospitalization, medically significant) on 27Sep2021 20:05, hemiplegia (hospitalization) on 27Sep2021 20:05. Clinical course: about 11:30 sudden onset right side weakness. has right facial droop, arm and leg weakness. no HA, palps, CP or sob. no antiplatelet/anticoagulants. HTN, on ACE-I. no h/o CVA/TIA. 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: 1820162 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-27
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101363071

Write-up: chest discomfort (pounding heart); Dyspnoea; palpitations; This is a spontaneous report from a contactable consumer (patient) from the regulatory authority. Regulatory authority report number is AEFI-A-036084. A 57-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Aug2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 27Sep2021 at 16:26, the patient experienced chest discomfort (pounding heart), dyspnea and palpitations. The events resulted in hospitalization. The outcome of 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: 1820197 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-27
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Chronic diarrhoea; Ferropenic anaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: Myocarditis; Pericarditis; This case was received via European Medicines Agency (Reference number: PT-INFARMED-J202110-48) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) in a 23-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The patient''s past medical history included Chronic diarrhoea and Ferropenic anaemia. On 19-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. On 27-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) to be possibly related. No concomitant medication details was reported. No treatment medication details was reported. Company comment: This case concerns a 23 year old female patient with no relevant medical history reported, who experienced serious expected AESI of myocarditis and pericarditis after second dose of mRNA-1273. The events occurred 40 days after second dose of mRNA-1273. The re-challenge is unknown as the events occurred after second dose and the outcome is recovering at the time of report. The benefit risk relationship of vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation received on 20-OCT-2021 contains significant information that include all event description as reported updated and suspected product dose text updated. On 20-Oct-2021: Follow-up received and added other relevant medical history.; Sender''s Comments: This case concerns a 23 year old female patient with no relevant medical history reported, who experienced serious expected AESI of myocarditis and pericarditis after second dose of mRNA-1273. The events occurred 40 days after second dose of mRNA-1273. The re-challenge is unknown as the events occurred after second dose and the outcome is recovering at the time of report. The benefit risk relationship of vaccine is not affected by this report


VAERS ID: 1820254 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Chills, Temperature intolerance
SMQs:, Anaphylactic reaction (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: Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2
CDC Split Type: TWPFIZER INC202101424629

Write-up: CHEST TIGHTNESS; FEAR OF COLD/Cold intolerance; SHAKING/Shivers; This is a spontaneous report from a non-contactable healthcare professional (Regulatory authority report number: TW-TFDA-TVS-1100008495), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003881), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received The regulatory authority report number is TW-TFDA-TVS-1100008495. A 13-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 23-Sep-2021 via Intramuscular at unspecified dosage frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced chest tightness, fear of cold/cold intolerance and shaking/shivers on 27-Sep-2021. On 26-Sep-2021, the patient''s body temperature was normal; On 27-Sep-2021, the patient went to the school with temperature of 36.2, fear of cold and shaking, The patient self-complained chest tightness, and had connected to the doctor. The patient went to a hospital, the physician said that the situation was okay, after the medicine, the symptoms are relieved. The patient was informed to take medical treatment if the symptoms aggravated and were told to drink more water and rest. On 29-Sep-2021, the patient had no uncomfortable, it was reported that "and the case means that the return will confirm the actual situation with the case". Chest tightness, fear of cold and shaking met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment between the drug bnt162b2 and the events chest tightness, Cold intolerance, Shivers, was assessed as possible by the reported and the company (BioNTech SE).


VAERS ID: 1820256 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Headache, Investigation, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: tests; Result Unstructured Data: Test Result:normal
CDC Split Type: TWPFIZER INC202101424636

Write-up: HEADACHE; STOMACH ACHE; THE CHEST IS VERY PAINFUL; WANT TO VOMIT; CAN''T BREATHE; This is a spontaneous report from a non-contactable other healthcare professional via Center for disease control (Regulatory authority report number: TW-TFDA-TVS-1100008518), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003897), license party for bnt162b2 (COMIRNATY). A 17-year-old female patient started to receive first dose of BNT162B2 (COMIRNATY, Solution for injection, batch number: 1G042A-CDC) via intramuscular route on 27Sep2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. The patient medical history, concomitant medications and past product were not reported. The patient experienced headache, stomach ache, the chest was very painful, want to vomit and cannot breathe on 27Sep2021. The patient went to a hospital. On 28Sep2021, the patient said underwent some tests, all of which were normal. It was reported that after the drug, after returning to the medicine, the symptoms were relieved, but there was still chest pain, even more worse. It was reported that can inform the hospital, tell more water, rest, parents can understand. The events headache, stomach ache, the chest was very painful, want to vomit and cannot breathe met the seriousness criterion of hospitalization. The patient received treatment for the events. Causality assessment for headache, stomach ache, chest pain, nausea, breathing difficult as per reporter and company (BioNTech SE) is possible. At the time of the report, the outcomes of headache, stomach ache, want to vomit and cannot breathe were recovering, the outcome of chest was very painful was not recovered. Follow-up closed, no further information is possible.


VAERS ID: 1820259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Cardiac disorder, Chest pain, Electrocardiogram, Heart rate, Myocardial necrosis marker, Myocarditis, Oxygen saturation, Respiratory rate
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 Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/75 mmHg; Test Date: 202109; Test Name: blood draw; Result Unstructured Data: Test Result:unknown result; Comments: hospitalized for pediatric cardiac consultation and secondary blood draw; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210927; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: Units:{beats}/min; Test Date: 20210927; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:Normal; Test Date: 20210927; Test Name: O2 saturation; Test Result: 100 %; Test Date: 20210927; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units:{breaths}/min
CDC Split Type: TWPFIZER INC202101424491

Write-up: suspected myocarditis; heart problems; CHEST PAIN; This is a spontaneous report from a non-contactable healthcare professional via the RA (Regulatory authority report number: TW-TFDA-TVS-1100008315), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003912), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the RA. The regulatory authority report number is TW-TFDA-TVS-1100008315. A 13-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 23-Sep-2021 via Intramuscular at 0.3 ml/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest pain 4 days after vaccination (27-Sep-2021). At 09:05 am of 27-Sep-2021, the patient was accompanied by classmates to the school health center, looked easy, self-complaint said that there was a chest pain situation. After inquiry, it was informed that after the first dose of vaccination on 23-Sep-2021, the patient had no discomfort at home. On 27-Sep-2021, the patient began to be uncomfortable in class and had milk tea for breakfast. Therefore, the school nursing teacher temporarily stopped stimulating drinks. Immediate measurement of life signs: body temperature: 36.5 degrees C, heartbeat: 100 times/min, breathing: 18 times/min, blood pressure: 118/75mmHg, blood oxygen: 100%. Then the school nursing teacher notified the parents to pick up the patient, and reminded them directly to big hospital for emergency treatment. At 10:30 am, the patient and parent went to a hospital for emergency treatment, where the patient was diagnosed with suspected myocarditis and waited for electrocardiogram (ECG) and blood supply (cardiac enzyme). At 12:05 pm, it was reported that ECG was normal, heart enzymes were normal, and myocarditis was temporarily ruled out, but there might have been other heart problems. The doctor would have time to diagnose cardiac. At 15:20 pm, it was reported that the patient was still in the new hospital to be hospitalized for cardiac consultation and secondary blood draw. At 19:07 pm, it was reported that "health Call to answer the case It is expected that 9/29 (3) will recontiate. Inquiring the case, if there is a case in front of the vaccine, there will be chest pain situations, and inquiry, the case agreed to notify the VAERS system, and informing the Health Center will continue to call the case, the case is consent". Chest pain met the seriousness criterion of hospitalization. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the events was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company (BioNTech SE) assessed the event ''chest pain'' as possible with Comirnaty. No follow-up attempts are possible; information. No further information is expected.


VAERS ID: 1820260 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Eosinophil percentage, Eosinophilia, Haematocrit, Haemoglobin, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Red cell distribution width
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Eosinophil percentage; Test Result: 5.8 %; Test Date: 20210927; Test Name: Hematocrit; Test Result: 26.2 %; Test Date: 20210927; Test Name: Haemoglobin; Result Unstructured Data: Test Result:7.2 g/dl; Test Date: 20210927; Test Name: MCH; Test Result: 16.9 pg; Test Date: 20210927; Test Name: MCHC; Result Unstructured Data: Test Result:27.5 g/dl; Test Date: 20210927; Test Name: MCV; Result Unstructured Data: Test Result:61.4; Comments: Units:fL; Test Date: 20210927; Test Name: Red cell distribution width; Test Result: 18.9 %
CDC Split Type: TWPFIZER INC202101424485

Write-up: CHEST PAIN; EOSINOPHILIC WHITE BLOOD CELL INCREASED EOSINOOPHILIA; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority(Regulatory authority report number: TW-TFDA-TVS-1100008324), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003913), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008324. A 15-year-old female patient received a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route as dose number unknown, single for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest pain and "eosinophilic white blood cell increased Eosinoophilia" (as reported) on 27-Sep-2021. At 16:00 of 24-Sep-2021, the patient received the vaccine. At 9:00 of 27-Sep-2021, the patient had chest pain. At 19:04 on the same day, due to the symptoms that did not improve, the patient went to the hospital for examination and medical treatment. The blood cell value was abnormally: hemoglobin (Hb) was 7.2 g/dl, hematocrit (HCT) was 26.2 %, mean cell volume (MCV) was 61.4 fl, mean cell haemoglobin (MCH) was 16.9 pg, mean cell haemoglobin concentration (MCHC) was 27.5 g/dl, red cell distribution width (RDW) was 18.9%, and Eosino PhiliL was 5.8%. At 23:08 on the same day, the patient consciously felt that chest pain relieved and the physician prescribed Diclofenac 25mg Tid, Iwell Tid and Cyproheptine 4mg Bid, and the condition recurrence or deterioration needed to be observed. Chest pain and "eosinophilic white blood cell increased Eosinoophilia" met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the chest pain was recovering, the outcome of "the eosinophilic white blood cell increased Eosinoophilia" was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for drug bnt162b2 with the events chest pain and eosinophilia per reporter and per company (BioNTech SE) was possible. No follow-up attempts are possible, information on the batch/lot number could not be obtained.


VAERS ID: 1820262 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G043A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Capillary nail refill test, Capillary nail refill test abnormal, Cold sweat, Dizziness, Heart rate, Heart rate decreased, Hypersensitivity, Hypotension, Pain assessment, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: BP; Result Unstructured Data: Test Result:98/62; Test Date: 20210927; Test Name: BP; Result Unstructured Data: Test Result:61/43; Test Date: 20210927; Test Name: Capillary nail refill test; Result Unstructured Data: Test Result:refilling time $g 2 secs; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:62; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:58; Test Date: 20210927; Test Name: Pain response; Result Unstructured Data: Test Result:unclear case
CDC Split Type: TWPFIZER INC202101424497

Write-up: SEVERE ALLERGIC REACTION; SYNCOPE; BP 61/43; HR 58; cold sweat; whole body weak; dizziness; capillary nail refill test: "refilling time $g 2 secs"; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (Regulatory authority report number: TW-TFDA-TVS-1100008342), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003915), license party for bnt162b2 (COMIRNATY). A 20-year-old male patient received BNT162B2 (COMIRNATY), dose 1, unknown route of administration on 27Sep2021 (Lot Number: 1G043A; Expiration Date: 17Jan2022) (at the age of 20-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced severe allergic reaction and syncope. On 27Sep2021, after receiving BNT162B2 vaccine, the patient had cold sweat, whole body weak, dizziness, capillary nail refill test: "refilling time $g 2 secs", BP: 61/43, HR: 58, the pain response and it was reported that "unclear case". The patient was immediately given Bosmin (1: 1000) via injection into the external muscle of the right thigh at 0.3ml. In less than three minutes, the patient was awake. As of the ambulance arrived, blood pressure had gradually increased: BP: 98/62, HR: 62 (unspecified date in 2021). Severe allergic reaction and syncope met the seriousness criterion of other medically important condition. At the time of the report, the outcome of the event syncope was recovered on 27Sep2021; "BP 61/43" and "HR 58" was recovering; and for other events was unknown. Drugs: COMIRNATY. Causality Assessment: Allergic reaction and Syncope; Per Reporter: Possible; Per Company (BioNTech): Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424704

Write-up: SKIN ITCHY; SKIN RASH (NON-INJECTION SITE); This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority based on information received by Pfizer from BioNtech SE (manufacturer control number: RA-2021FOS003925), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority report number is RA-TVS-1100008413. A 15-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 24-Sep-2021 via Intramuscular at 0.3 ml/unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced skin itchy and skin rash (non-injection site) on 27-Sep-2021. It was reported that "110/9/24 in the morning of the three business workers campuses inoculation vaccine (hospital enters the school), the school is notified today, and the visitors are in 18:15 Electron Union case mobile phone, the case Mother listening, care about a case, the case said that after the case". The patient complained of itch. On 27-Sep-2021, the patient found that the whole face had a red rash and went to dermatology department, the patient was given Total anti-tissue amine drugs and ointments (unspecificed). On 28-Sep-2021, the patient did not go to school and said that he was still on treatment but still had a rash. It was reported that "the martial arts have need to continue to observe, because there may be anti-subtranes, The mother''s mother needs to pay attention to other symptoms, and today to assist in the adverse reactions." On 28-Sep-2021, the patient was still treated the vaccine adverse reactions, the patient indicated that the symptoms have gradually improved, it was reported that "the preliminary precautions have been repeatedly prepared, and the case is known. There is no other adverse symptoms, continuously reciprocal". Skin itchy and Skin rash (non-injection site) met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for COMINARTY for events skin itchy and skin rash (non-injection site) was possible per reporter and per company (BioNtech SE). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1820271 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Echocardiogram, Myocardial necrosis marker, Myocarditis, Palpitations, Pericarditis, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:no abnormalities; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:normal; Test Name: life signs; Result Unstructured Data: Test Result:stable
CDC Split Type: TWPFIZER INC202101424675

Write-up: MYOCARDITIS (MYOCARDITIS); ACUTE PERICARDITIS; CHEST PAIN; INTERMITTENT PALPITATION; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional for Regulatory Authority (regulatory authority number: TW-TFDA-TVS-1100008443), based on information received by Pfizer from BioNTech (manufacturer control number: TW-Fosun-2021FOS003931), license party for bnt162b2. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008443. A 21-year-old male patient started to receive 1st dose of BNT162B2 (batch number: unknown) on 25-Sep-2021 via intramuscular of 0.3 ml/unspecified dosing frequency for COVID-19 immunization. No Medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced myocarditis, acute pericarditis, chest pain, intermittent palpitation and chest tightness on 27-Sep-2021. On 28-Sep-2021, due to the symptoms of the patient did not improve, it was reported that "the medical treatment of acute pericarditis and close upholds". The following was to track care: At present, the case was clear, the cardiac ultrasound had no abnormalities. The blood test report and the myocardial enzyme were normal. The life signs were stable, and the patient was hospitalized for observation on the 8th floor of the hospital. Myocarditis, acute pericarditis, chest pain, intermittent palpitation and chest tightness met the seriousness criterion of caused/prolonged hospitalization. The actions taken for BNT162B2 regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for BNT162B2 for events myocarditis, acute pericarditis, chest pain, intermittent palpitation and chest tightness was possible as per reporter and as per company (BioNTech). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Headache
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424524

Write-up: CHEST PAIN; HEADACHE; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008454), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003933), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008454. A male patient with age unknown started to receive a dose of Tozinameran (COMIRNATY) with unknown dose number in series (batch number: unknown) on 27-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No Medical history was reported. Concomitant medications and past product were not reported. The patient experienced headache, chest tightness and chest pain on the same day after vaccination (27-Sep-2021). Chest pain met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Causality assessment for the events Headache, Chest tightness, Chest pain was possible as per reporter and company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood creatine phosphokinase, Blood test, Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CK; Result Unstructured Data: Test Result:CK value was higher; Test Date: 2021; Test Name: blood draw; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101424529

Write-up: CHEST TIGHTNESS; BREATHING WAS NOT SMOOTH; ASTHMA; This is a spontaneous report from a non-contactable healthcare professional via Regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008475), based on information received by Pfizer (manufacturer control number: TW-Fosun-2021FOS003935), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008475. A 16-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 24-Sep-2021 via intramuscular at 0.3 ml/unspecified dosing frequency for COVID-19 immunization. No medical history was reported . Concomitant medication(s) and past product were not reported. The patient experienced chest tightness, breathing was not smooth and asthma on 27-Sep-2021. On 24-Sep-2021, the patient was given BNT vaccine and then returned home. On 26-Sep-2021, the patient had no physical abnormalities. On 27-Sep-2021, the patient developed asthma, chest tightness and breathing. On 28-Sep-2021, there was no improvement in patient''s symptoms, so the school notified the parents of bringing the patient back. The patient was taken to hospital to seek medical treatment. F/u, chest X-ray (cxr.), electrocardiogram (ekg), and blood draw were performed. On an unspecified date, the patient returned to see reports, indicating that the creatine kinase (CK) value was higher. The patient would continue to be observed. It was reported that "Business school protection paper notice the vaccine adverse reactions, assist in the communication, and the case, the case is listening, cares about the case of the case, and the case said that he has come to the hospital today. It may be able to learn tomorrow, will look at it again. It has been paid attention to the martial arts and continues to reciprust". Chest tightness, breathing was not smooth and asthma met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Drug: bnt162b2 Asthma,Laboured breathing,Chest tightness Per Reporter = Possible Per Company (BioNTech SE)= Possible


VAERS ID: 1820276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (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: TWPFIZER INC202101424698

Write-up: CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008487) based on information received by Pfizer (manufacturer control number: TW-Fosun-2021FOS003938), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory authority The regulatory authority report number is TW-TFDA-TVS-1100008487. A female patient with unknown age started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 26-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest tightness on 27-Sep-2021 after vaccination . It was reported that "no chest tightness juspnea, chest tightness juspnea, chest tightness juspnea, chest tightness just now sympt iii symples symples symples symptoms symptom symples symptoms symptoms symptom symptoms symptomes symples symptoms symptoms symptoms symptoms symptrose information symples symptoms symptoment symptoms". Chest tightness met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcome of the event was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company assessed the event ''chest tightness'' as possible with Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase, Body temperature, Decreased appetite, Electrocardiogram, Fatigue, Myocarditis, Physical examination, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thalassemia
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: APTT; Test Result: 47.2 s; Test Date: 20210930; Test Name: CPK; Result Unstructured Data: Test Result:77 IU/l; Test Date: 20210929; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210927; Test Name: ECG; Result Unstructured Data: Test Result:Sinus Bradycardia.; Test Date: 20210929; Test Name: ECG; Result Unstructured Data: Test Result:Sinus; Test Date: 20210930; Test Name: Physical examination; Result Unstructured Data: Test Result:No injected pharynx and breathing sounds bilateral; Comments: No injected pharynx and breathing sounds bilateral clear, without . rales, wheezing, ear drum no injected, abdomen soft ovoid, BS normoactive
CDC Split Type: TWPFIZER INC202101406370

Write-up: TIRED; FEVER; LOSS OF APPETITE; MYOCARDITIS (MYOCARDITIS); This is a spontaneous report from a non-contactable healthcare professional via (Regulatory authority report number: TW-TFDA-TVS-1100008619), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004043), license party for bnt162b2 (COMIRNATY). A 15-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY, Solution for injection, batch number: 1G042A-CDC), dose1 on 24-Sep-2021 via intramuscular as dose 1, single for COVID-19 immunization. Medical history included thalassemia. Concomitant medication and past product were not reported. The patient experienced tired, fever, loss of appetite, myocarditis on 27-Sep-2021. On 27-Sep-2021, patient had chest tightness off and on after BNT vaccine, so on the new house branch cardiac medical treatment. ECG showed sinus bradycardia. The patient was given orally PAran Tab 500mg 1 bid, colchicine 0.5mg 1 # BID, for 7 days. On 29-Sep-2021, the symptoms of chest pain, chet tight appetite, malaise and headache and low-grade fever 37.2 Centigrade did not improve, so the patient was admitted to the new house branch paediatrics emergency for treatment. On 29-Sep-2021, ECG (Paediatric OPD) showed sinus after the diagnosis and treatment. The patient was given orally PAran Tab 500mg 1# TID, Buwecon 0.125mg 1# TID, DAILYCARE Actibest Sc tablet 1# TID, Indoy (Inteban) CAP 25mg 1# TID, Strocain Tab 5mg 1# TID. On 30-Sep-2021, dry mucosa, poor intake and poor activity, lower urine output were also noted, Thus, the patient was brought to OPD for help.The results of physical examination showed no injected pharynx and breathing sounds bilateral clear, without rales, wheezing, ear drum no injected, abdomen soft ovoid, BS normoactive. Due to chest pain with dizziness and dehydration, the patient was admitted for further evaluation and management. Lab data showed CPK 77 U/L, APTT 47.2 SEC. Tired, fever, loss of appetite, myocarditis met the seriousness criterion of caused hospitalization and myocarditis was considered as important medical event. At the time of the report, the outcome of tired, fever, loss of appetite, myocarditis was unknown. The Causality Assessments of Comirnaty for Tiredness, Fever, Loss of appetite, Myocarditis was Possible as per Reporter and Company. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1820322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dizziness, Echocardiogram, Electrocardiogram, Myocarditis, X-ray
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: Blood test; Result Unstructured Data: Test Result:unknown result; Test Date: 20210929; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:unknown result; Test Date: 20210929; Test Name: EKG; Result Unstructured Data: Test Result:unknown result; Test Date: 20210929; Test Name: X-ray; Result Unstructured Data: Test Result:unknown result
CDC Split Type: TWPFIZER INC202101419163

Write-up: chest pain; MYOCARDITIS (MYOCARDITIS); dizziness; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority number: TW-TFDA-TVS-1100008697), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS004085), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority report number is TW-TFDA-TVS-1100008697. A 13-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. Concomitant medication(s) and past product were not reported. The patient experienced myocarditis on 27-Sep-2021. The patient experienced dizziness on 27-Sep-2021 and chest pain on 28-Sep-2021. Company parents recommended medical treatment on 27-Sep-2021 and 28-Sep-2021. From 28-Sep-2021 to 29-Sep-2021, the patient should be rest at home. On 29-Sep-2021, the patient went to hospital and underwent pumgmentation, Electrocardiography (EKG), cardiac ultrasound and X-ray. Diagnosis was heart rhythm and myocarditis. On 30-Sep-2021, please leave. It was report that "the heart of left to right, oral pain canal". At present, the rule of the hospital was return treatment. Myocarditis was considered as an Important Medical Event. The patient underwent lab tests and procedures which included blood test: unknown result on 29Sep2021. The actions taken for Tozinameran (COMIRNATY) regarding the myocarditis, dizziness and chest pain were not applicable. At the time of the report, the outcomes of myocarditis (myocarditis), dizziness and chest pain were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company (BioNTech SE) assessed the event ''myocarditis'' as possible with Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820345 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: blood test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: TWPFIZER INC202101424633

Write-up: CHEST PAIN; DYSPNEA; This is a spontaneous report from a non-contactable healthcare professional Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008259), based on information received by Pfizer (manufacturer control number: TW-Fosun-2021FOS004143), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received. The regulatory authority report number is TW-TFDA-TVS-1100008259. A 13-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain and dyspnea on 27-Sep-2021. The patient complained about chest pain and dyspnea on the morning of 27-Sep-2021 (3 days after vaccination). Emergency blood test was performed. And oral diclofenac was given from the hospital. Chest pain and dyspnea met the seriousness criterion of Cause/prolong hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company assessed the events ''chest pain'', ''dyspnea'' as possible with Comirnaty.


VAERS ID: 1820347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G043A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate decreased, Hypotension, Oxygen saturation, Oxygen saturation decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:71/50 mmHg; Comments: 15:00; Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:89/52 mmHg; Comments: 15: 09; Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:125/77 mmHg; Comments: 15: 11; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:56; Comments: Units:{beats}/min 15:00; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Comments: Units:{beats}/min 15: 09; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:73; Comments: Units:{beats}/min 15: 11; Test Date: 20210927; Test Name: Oxygen saturation; Test Result: 96 %; Comments: 15:00; Test Date: 20210927; Test Name: Oxygen saturation; Test Result: 100 %; Comments: 15: 09; Test Date: 20210927; Test Name: Oxygen saturation; Test Result: 100 %; Comments: 15: 11
CDC Split Type: TWPFIZER INC202101424694

Write-up: SYNCOPE; LOW BLOOD PRESSURE; HEART RATE LOW; OXYGEN SATURATION LOW; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008284) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS004165), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008284. A 20-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G043A-CDC) on 27-Sep-2021 via intramuscular at 0.5 ml with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced Syncope on 27-Sep-2021. At 14:45 of 27-Sep-2021, the patient received Vaccination. At 15:00, the patient felt the head was unilaterally stable when left from the position after rest. The blood pressure 71/50, heartbeat 56, blood oxygen 96%, gives oxygen. At 15: 05, physician indicates bosmin 0.5ml muscle Injection, At 15: 09 blood pressure 89/52, heartbeat 86, blood oxygen 100%. At 15: 11 blood pressure 125/77, heart beat: 73, blood oxygen 100%, rescue sent to hospital. Syncope, low blood pressure, low heart rate and low oxygen saturation met the seriousness criterion of Caused / Prolonged Hospitalisation. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality between he reported events and COMIRNATY was reported as possible by the reporter and the company. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820348 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dizziness, Electrocardiogram, Infarction, Pleural effusion, X-ray
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Cardiac hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210927; Test Name: ECG; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210927; Test Name: X-ray; Result Unstructured Data: Test Result:Lung water
CDC Split Type: TWPFIZER INC202101424710

Write-up: PULMONARY EFFUSION; CHEST PAIN; DIZZINESS; INFARCTION; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008291) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS004167), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008291. A 13-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not specified) on 27-Sep-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history included congenital cardiac hypertrophy. Concomitant medications and past product were not reported. The patient experienced chest pain (it was reported as Thoking) on both sides, slight dizziness on 27-Sep-2021. At 10:00 of 27-Sep-2021, it was reported that the patient had a tatty in the vital heart near the vaccine. At 10:30 of 27-Sep-2021, symptoms were not alleviated, and it is necessary to send medical attention via a doctor. The parents of the patient were contacted and rushed to the hospital. At 10:40 of 27-Sep-2021, the patient was sitting on ambulance to REDACTED. At 10:45, the patient arrived the hospital. At 10:50, the patient went to the emergency department to check. At 10:57, during the consultation of the Doctor, the patient complained that both sides of the chest (about 4 -5 points in pain), the pain is slightly relieved, slight dizziness, no cold, no diarrhea, no vomiting symptoms. 11:02 Ready to take an electrocardiogram, X-ray, blood. 11:28 Complete ECG, X-ray and blood test. The current electrocardiogram didn''t show abnormalities, the symptoms of the patients were slowly alleviated. 11:48 The other test reports were available, indicating current infarction (it was reported as anux infarction) and lung water. The doctor thought these might be due to the patient''s congenital cardiac hypertrophy. The doctor prescribed medication of anti-infarction and painkillers. The follow-up observation on the heart of the child''s heart would be required. 12:05 the patient left the hospital with parents. Chest pain on both sides, slight dizziness, infarction and lung water met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were recovering. The outcomes of events were unknown. Initial report was received on 13-Oct-2021. Causality Assessment of the events Chest pain, Dizziness, Infarction, Pulmonary effusion was reported as possible Per Reporter and per company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820349 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Chest pain, Dizziness, Echocardiogram, Mitral valve disease, Productive cough
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Infective pneumonia (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: Test Date: 20210927; Test Name: Chest X-ray; Result Unstructured Data: Test Result:there was a sputum in the lungs; Test Date: 20210928; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:discovered mild mitral valve
CDC Split Type: TWPFIZER INC202101424489

Write-up: DIZZINESS; CHEST PAIN; mild mitral valve; sputum in the lungs; This is a spontaneous report from a non-contactable health care professional via regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008336), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004186), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008336. A 14-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. On 27-Sep-2021, electrocardiogram and chest X-ray were performed, and found that there was a sputum in the lungs and it was reported that "other non-distracted". The patient experienced dizziness and chest pain on 28-Sep-2021. On 28-Sep-2021, it was reported that "Electrician case, the main hospitalization of the case". Currently, the patient had no chest pain and it was reported that "the spiritual appetite". The heart supersonic just finished discovering that mild mitral valve. The patient was informed that there was a need for the Negative Ministry of Health and continued Care. Dizziness and chest pain met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the dizziness was unknown and the outcome of the chest pain was recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment Dizziness ;chest pain Per Reporter=Possible Per Company=Possible


VAERS ID: 1822041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-27
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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211051170

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-051251) on 25-OCT-2021 and concerned a 52 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: XD975 expiry: unknown) dose was not reported, 1 total, administered on 18-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1822072 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361551

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number: 639118. A 27-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Sep2021 (Batch/Lot number was not reported) as dose number unknown, as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On 27Sep2021, the patient experienced abortion spontaneous. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-27
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep venous thrombosis proximal; Embolism pulmonary; Popliteal artery thrombosis; Thrombosis of leg deep venous
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Normal, no thrombus; Comments: No extension on the cardiac chambers.; Test Date: 20211005; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm, no repolarization disorder; Test Date: 20211005; Test Name: HR; Result Unstructured Data: Test Result:89 bpm; Test Date: 20211005; Test Name: Cardiac Doppler ultrasound; Result Unstructured Data: Test Result:No sign of cardiac incompetence
CDC Split Type: FRPFIZER INC202101370483

Write-up: Thrombosis of leg deep venous; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-TO20218431. A 50-year-old female patient received BNT162B2 (COMIRNATY; Lot Number was not reported), intramuscular, on 13Sep2021, as dose 2, single, for COVID-19 immunization. The patient''s medical history included popliteal artery thrombosis from 2007, thrombosis of leg deep venous from 2014, deep venous thrombosis proximal from 2016, and embolism pulmonary from 2016. The patient''s concomitant medication included acetylsalicylate lysine (KARDEGIC). On 27Sep2021 (14 days after vaccination), the patient experienced thrombosis of leg deep venous or deep vein thrombosis of the leg. The patient required hospitalization from 2021. The patient underwent consultation on 05Oct2021 for cardiac Doppler ultrasound and there was no sign of cardiac incompetence. There was no angina, no dyspnea, and no palpitations. The patient underwent other laboratory tests and procedures on 05Oct2021 which included electrocardiogram (ECG) which records a regular sinus rhythm, no repolarization disorder; heart rate (HR) at 89 bpm; cardiac ultrasound: normal, no thrombus, no extension on the cardiac chambers. In conclusion, the patient had total thrombotic episode which occurred at day 14 of the vaccination. The patient was in the process of recovery. The patient was recovering from the event. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.


VAERS ID: 1822643 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Blood alkaline phosphatase increased, Blood creatine, Blood pressure measurement, Body temperature, Chills, Decreased appetite, Fatigue, Hypotension, Immunisation, Insomnia, Liver injury, Malaise, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test, Urine flow decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Biliary system related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Meniere''s disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:200; Test Name: ALP; Result Unstructured Data: Test Result:301; Test Name: Creatine; Result Unstructured Data: Test Result:rose to 372 from 88; Comments: Creatine rose to 372 from 88; Test Name: BP; Result Unstructured Data: Test Result:77/53; Test Name: BP; Result Unstructured Data: Test Result:70/50; Comments: Lowest BP was 70/50; Test Name: temperature; Result Unstructured Data: Test Result:$g39degrees; Comments: temperature at home and was$g39degrees; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373992

Write-up: myalgia; anorexia; fevers; insomnia; unwell; malaise; poor urine; febrile; chills; Hypotension; Acute liver injury; Acute kidney injury; off label use; Booster; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110130943574220-WPXJ2. Safety Report Unique Identifier is GB-MHRA-ADR 26070279. The 57-year-old female patient received DOSE 3 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot Number: FF8222) via an unspecified route of administration on 27Sep2021 (at the age of 57-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The medical history included menieres disease, clinical trial participant, type 2 diabetes mellitus. The patient concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. On 27Sep2021 the patient experienced acute liver injury, acute kidney injury, booster and off label use, on 28Sep2021 hypotension, on an unspecified date myalgia, anorexia, fevers, insomnia, unwell, malaise, poor urine, febrile, chills. The event seriousness for all events was reported as medically significant. The patient underwent lab tests and procedures which included alanine aminotransferase: 200, blood alkaline phosphatase increased: 301, blood creatine: rose to 372 from 88 on Creatine rose to 372 from 88, blood pressure measurement: 77/53, blood pressure measurement: 70/50 on Lowest BP was 70/50 , sars-cov-2 test: negative on No - Negative COVID-19 test , body temperature: $g39degrees on temperature at home and was$g39degrees. Therapeutic measures were taken as a result of fevers. The outcome of the event acute liver injury, acute kidney injury was recovering, hypotension was resolved on 28Sep2021, myalgia, anorexia, fevers, insomnia, unwell, malaise, poor urine, febrile, chills was resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Fatigue, Headache, Hypersensitivity, Immunisation, Lethargy, Lymphadenopathy, Muscle spasms, Muscular weakness, Off label use, Pain, Palpitations, Pyrexia, SARS-CoV-2 test, Sinus tachycardia, Tachycardia, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dystonia (broad), 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), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Urinary tract infection bacterial (E. Coli.)
Preexisting Conditions: Medical History/Concurrent Conditions: Pericarditis (History of pericarditis.)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210930; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101426515

Write-up: Pyrexia; Tachycardia sinus; Lethargy; Shortness of breath; Fatigue/unusual tiredness; Chest pain; Heart palpitations; Racing heart (tachycardia); cramping to lower legs; under arm gland swelling; Headache; Pain; limb weakness; allergic reaction; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110202003317190-ODWGQ, Safety Report Unique Identifier GB-MHRA-ADR 26100576. A 36-year-old female patient received BNT162B2 (COMIRNATY), dose 3 via an unspecified route of administration on 27Sep2021 (Lot Number: FG3712) as single dose for covid-19 immunisation. Medical history included pericarditis from 2012, ongoing urinary tract infection bacterial E. Coli. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pyrexia, tachycardia sinus, lethargy, shortness of breath, fatigue/unusual tiredness, chest pain, heart palpitations, racing heart, cramping to lower legs, under arm gland swelling, headache, pain, limb weakness and allergic reaction, all on 27Sep2021 with outcome of not recovered. Clinical course was reported as chest pain, fatigue (unusual tiredness), heart palpitations, shortness of breath, tachycardia sinus, racing heart (tachycardia). 2-3 hours post booster vaccine developed extreme tachycardia, pyrexia, lethargy, limb weakness, under arm gland swelling and intense pain, cramping to lower legs, headaches. Symptoms lasted 2 weeks and reoccurred again. Put on beta blockers, antihistamine, antibiotics. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date, COVID-19 virus test: negative on 30Sep2021 (No - Negative COVID-19 test), ultrasound scan: unknown results on unknown date. This case is reported as serious: life threatening and other medically important condition. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822963 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Postmenopausal haemorrhage
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: POMEGRANATE; EVENING PRIMROSE OIL [OENOTHERA BIENNIS]; RED GINSENG [PANAX GINSENG ROOT]; MULTIVITAMINS [VITAMINS NOS]; VITAMIN C [ASCORBIC ACID]; REDORMIN [HUMULUS LUPULUS HOPS;VALERIANA OFFICINALIS ROOT]; CENOVA QUICK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRPFIZER INC202101281218

Write-up: It had been 6 months since menopause, but vaginal bleeding occurred like menstruation; pain in the lower abdomen; The pain''s level was similar to menstrual cramps; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY), intramuscularly administered in Arm Left on 25Sep2021 12:00, at 51-year-old, as single dose (Batch/Lot Number: Unknown) for covid-19 immunization. Medical history included menopause from 2021 to an unknown date. The patient previously received first dose of bnt162b2 (COMIRNATY), intramuscularly administered in Arm Left on 21Aug2021 at 14:00, at 51-year-old, as single dose (Batch/Lot Number: Unknown) for covid-19 immunization. Concomitant medications included pomegranate; oenothera biennis (EVENING PRIMROSE OIL); panax ginseng root (RED GINSENG); multivitamins [vitamins nos]; vitamin c [ascorbic acid]; humulus lupulus hops, valeriana officinalis root (REDORMIN); cetirizine hydrochloride (CENOVA QUICK). All concomitant drugs taken for an unspecified indication, start and stop date were not reported. Prior to the COVID vaccine, the patient was not diagnosed with COVID-19 and received no other vaccines within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated: It had been 6 months since menopause, but vaginal bleeding occurred like menstruation after vaccination on 27Sep2021. The amount was similar to menstruation, and there was pain in the lower abdomen on 27Sep2021. The pain''s level was similar to menstrual cramps, and the symptoms gradually subsided. Menstruation continued, but the amount was gradually decreasing. The patient got no treatment for all events. The outcome of all events was recovering. No follow-up attempts are possible; information about batch number cannot be obtained. No further information expected. Amendment: This follow-up report is being submitted to amend previously information: recode the events and upgrade to serious.


VAERS ID: 1822973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Bone pain, C-reactive protein, Chest pain, Dyspnoea, Fibrin D dimer, Myalgia, Myocarditis, N-terminal prohormone brain natriuretic peptide, Pyrexia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), 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), Other ischaemic heart disease (narrow), Osteonecrosis (broad), Tendinopathies and ligament disorders (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: ESCITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210930; Test Name: CRP; Result Unstructured Data: Test Result:C-reactive protein amount increased; Test Name: d-dimer; Result Unstructured Data: Test Result:Increase amount; Test Name: NTproBNP; Result Unstructured Data: Test Result:Increase amount; Test Date: 20210930; Test Name: Troponin; Result Unstructured Data: Test Result:Troponin amount increased
CDC Split Type: LTPFIZER INC202101374857

Write-up: Chest pain with radiation to left arm and lower jaw; Myocarditis; Chest pain in heart area; Muscle pain; Bone pain; Fever (38 C); Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number LT-SMCA-4332. A 35-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not provided), dose 2 via an unspecified route of administration on 27Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medication included Escitalopram 10 mg tablet for depression. On the same day after vaccination (27Sep2021) the patient experienced fever till 38 C, muscle pain, bone pain and dyspnea. On 30Sep2021 chest pain in heart area and myocarditis occurred. Heart pain started to radiate to the left arm and lower jaw. The patient was hospitalized at Heart failure and defects Department. Events chest pain, myocarditis were reported as serious: causing hospitalization, medically significant, events: dyspnea reported as medically significant, events muscle pain, bone pain, fever (38 c) reported as non-serious. Event chest pain in heart area was considered serious. The patient was hospitalized for chest pain with radiation to left arm and lower jaw, myocarditis from an unknown date to 05Oct2021. The patient underwent lab tests and procedures which included: body temperature: 38 centigrade on 27Sep2021, c-reactive protein increased: c-reactive protein amount increased on 30Sep2021, troponin: troponin amount increased on 30Sep2021, fibrin d dimer: increase amount on an unspecified date and n-terminal prohormone brain natriuretic peptide: increase amount on an unspecified date. At the time of report, events Chest pain with radiation to left arm and lower jaw, Myocarditis, Dyspnea, Chest pain in heart area, Muscle pain, Bone pain, fever were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Headache, Loss of consciousness, Nasal congestion, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:results unknown; Test Date: 20210716; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101363873

Write-up: pass out/syncope/fainting; pass out/syncope/fainting; Headache; feeling stuffy/dyspnea/feeling short of breath; feeling stuffy/dyspnea/feeling short of breath; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00689464. A 16-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FF2834), via an unspecified route of administration on 26Sep2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from 16Jul2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced pass out/syncope/fainting, headache and feeling stuffy/dyspnea/feeling short of breath on 27Sep2021. The events required physician office visit. The patient underwent lab tests and procedures which included blood test: results unknown on an unspecified date and corona, confirmed with test: positive on 16Jul2021. The outcome of all events was not recovered. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no fainting and feeling short of breath Additional information ADR: day after vaccination, passed out several times and feeling short of breath COVID-19 Previous COVID-19 infection: disease symptoms: quite Other diagnostic procedures: blood test at the family doctor No follow-up attempts are possible, No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no fainting and feeling short of breath Additional information ADR: day after vaccination, passed out several times and feeling short of breath COVID-19 Previous COVID-19 infection: disease symptoms: quite Other diagnostic procedures: blood test at the family doctor


VAERS ID: 1823020 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Deafness, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101396840

Write-up: Deafness; Not feeling well; Cold shivers; Nausea; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory authority-WEB, regulatory authority number NL-LRB-00690885. A 28-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number: FF2834; expiration date: not reported) via an unspecified route of administration on 27Sep2021 (at the age of 28-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included multivitamins (vitamins nos) taken for an unspecified indication, start and stop date were not reported. On 27Sep2021, the patient experienced deafness, not feeling well, cold shivers and nausea. Drug-reaction, time Interval between beginning of drug administration and start of reaction / event for malaise it was 25 minutes, for chills and deafness 4 hours and for nausea 3 hours. The outcome of the event cold shivers recovered on 30Sep2021, not feeling well and nausea recovering and deafness was not recovered. No follow-up attempts are possible, batch number already obtained.


VAERS ID: 1823171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-09-27
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 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: 20210927; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positive IU international unit(s)
CDC Split Type: PTPFIZER INC202101388294

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from regulatory authority report number PT-B202110-616 with Safety Report Unique Identifier PT-B202110-616. A 39-year-old female patient received bnt162b2 (COMIRNATY COVID-19 vaccine, solution for injection, lot number: FE8235), via intramuscular on 02Aug2021 as dose 2, 0.3 ml single for covid-19 immunisation and received first dose of received bnt162b2 (COMIRNATY COVID-19 vaccine, solution for injection, lot number: FE6029), via intramuscular on 05Jul2021 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown the patient was pregnant. The patient experienced vaccination failure and covid-19 on 27Sep2021. Approximately 2 months after completing the Comirnaty vaccine schedule, the patient presented with COVID-19., confirmed by a positive PCR test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely dry cough and nasal congestion on 26Sep2021. On 27Sep2021 the patient was confirmed with diagnosis of COVID-19. The patient lab test which included SARS-CoV-2 PCR test was positive (Positive IU international unit(s)) on 27Sep2021. The outcome of the event COVID-19 was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information- First dose: Comirnaty, 05Jul2021, Lot FE6029. Second dose: Comirnaty, 02Aug2021, Lot FE8235. Onset of symptoms on 26Sep2021: dry cough and nasal congestion. Positive PCR test at 27Sep2021


VAERS ID: 1823202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-09-27
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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:
CDC Split Type: PTPFIZER INC202101397035

Write-up: Drug ineffective; COVID-19; This is a spontaneous report from a contactable other HCP (health care professional) downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-T202110-47. A 68-years-old male patient received second dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA8016), via intramuscular route on 28May2021, as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced drug ineffective, and COVID-19. The outcome of the events was recovering. The reporter''s assessment of the causal relationship of the drug ineffective with the suspect product was possible. Method of assessment: unknown. No follow-up attempts possible. No further information expected. Follow-up (20Oct2021): New information reported from the same other HCP downloaded from the regulatory authority-WEB (PT-INFARMED-T202110-47) which included: Non serious. PT-INFARMED-T202110-47. No follow-up attempts possible. No further information expected.


VAERS ID: 1823216 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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: ADHD; Blood pressure low
Preexisting Conditions: Medical History/Concurrent Conditions: Pelvic inflammatory disease; Pyelonephritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101370548

Write-up: Muscle pain; Vaccination site swelling; headache; Fatigue aggravated; fever; dizziness; Vaccination site redness; pain at vaccination site; Chills; nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (non-HCP) downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB SE-MPA-2021-087298. A 30-year-old female patient received the second dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Ff2832) via an unspecified route of administration on 27Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure low, ongoing ADHD, pyelonephritis that was not ongoing and previous pelvic inflammatory disease that was not ongoing, all from unspecified dates. Concomitant medications were not reported. The patient previously received the first dose of a COVID-19 vaccine (MANUFACTURER UNSPECIFIED) via an unspecified route of administration on an unspecified date and experienced ongoing fatigue. On 27Sep2021, the patient experienced muscle pain, vaccination site swelling, headache, fatigue aggravated, fever, dizziness, vaccination site redness, pain at vaccination site, chills and nausea. The events were all serious for permanent disability. The course of the events was reported as follows: The patient would only get the reported side effects during the evening / night in addition to the fatigue that the patient felt after the first dose, but it got worse from the second dose. The patient would feel completely healthy during the day. The clincial outcomes of the events muscle pain, vaccination site swelling, headache, fatigue aggravated, fever, dizziness, vaccination site redness, pain at vaccination site, chills and nausea were not recovered/not resolved.


VAERS ID: 1823254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Monoparesis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: SIJNJFOC20211053084

Write-up: PARESTHESIA OF THE RIGHT TIBIA; PARESIS OF THE DORSIFLEXORS OF THE RIGHT FOOT; This spontaneous report received from a physician via Regulatory authority (SI-JAZMP-NCPHV-2021SI0965_0965) on 26-OCT-2021 and concerned a 33 year old male of unspecified race and ethnic origin. 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 ABZ5320 expiry 31-MAY-2023) 1 dosage forms,1 total, administered on 16-SEP-2021 for covid-19 vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced paresthesia of the right tibia and paresis of the dorsiflexors of the right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paresthesia of the right tibia and paresis of the dorsiflexors of the right foot was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1823267 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G043A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Heart rate, Heart rate increased, Hypotension, Oxygen saturation, Oxygen saturation decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:74/33 mmHg; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:116; Comments: beats/min; Test Date: 20210927; Test Name: SPO2; Test Result: 92 %
CDC Split Type: TWPFIZER INC202101424687

Write-up: SYNCOPE; awareness change; LOW BLOOD PRESSURE; OXYGEN SATURATION LOW; HEART RATE HIGH; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008249), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003885), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008249. An 18-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: 1G043A) on 27Sep2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunisation. Medical history, concomitant medications and past product were not reported. The patient experienced syncope and awareness change on 27Sep2021. On 27Sep2021, the patient received inoculation of BNT vaccine and experienced syncope. BP: 74 / 33mmHg, SPO2: 92%. HR (heart rate): 116 beats/min, after the patient recovers awareness, contact the ambulance transfer. Syncope and awareness change, low blood pressure, Oxygen saturation low and Heart rate high met the seriousness criterion of Caused / Prolonged Hospitalisation. At the time of the report, the outcomes of syncope and awareness change were recovered, the outcomes of low blood pressure, low SPO2 and high heart rate were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Syncope, Low blood pressure, Oxygen saturation low, Heart rate high- Per reporter: Possible, Per Company (BioNTech SE): Possible No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823268 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G043A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Oxygen saturation, Oxygen saturation decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:93/57 mmHg; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:67; Comments: Units:{beats}/min; Test Date: 20210927; Test Name: Oxygen saturation; Test Result: 93 %
CDC Split Type: TWPFIZER INC202101424690

Write-up: SYNCOPE; LOW BLOOD PRESSURE; OXYGEN SATURATION LOW; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008250), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS003888), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008250. A 39-year-old male patient received a dose of Tozinameran (COMIRNATY) (batch number: 1G043A) on 27-Sep-2021 via intramuscular at dose number unknown, single for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced syncope and awareness change on 27-Sep-2021. On 27-Sep-2021, the patient experienced syncope during the inoculation of BNT vaccine. BP: 93 / 57mmHg, SPO2: 93% HR: 67, after patient recovery, contact the ambulance transfer. Syncope and awareness change, low blood pressure and low SPO2 met the seriousness criterion of Caused / Prolonged Hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of syncope and awareness change were recovered. The outcomes of low blood pressure and low SPO2 were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for COMIRNATY with the events syncope, low blood pressure, and oxygen saturation low per reporter and per company (BioNtech SE) was possible. No follow-up attempts are possible.


VAERS ID: 1823271 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (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: TWPFIZER INC202101424619

Write-up: CHEST TIGHTNESS; This is a spontaneous report from a non-contactable health care professional via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008521. This report is based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003899), license party for BNT162b2 (COMIRNATY). A 16-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 27-Sep-2021 at unspecified dosage regimen for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced chest tightness on 27-Sep-2021. On 27-Sep-2021, the patient given 1st dose of vaccination, At night, the patient went to a Hospital. On 29-Sep-2021, the patient had no chest tightness or other uncomfortable symptoms, and it was reported that "the case will be given a case due to the release of the original notification". Chest tightness met the seriousness criterion of hospitalization. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Event Chest tightness was possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1823280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Body temperature, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Echocardiogram, Heart rate, Hypertension, Oxygen saturation, Troponin
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), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: CPK; Result Unstructured Data: Test Result:298.0; Comments: Units:U/L; Test Date: 20210927; Test Name: CK-MB; Result Unstructured Data: Test Result:25; Comments: Units:U/L; Test Date: 20210928; Test Name: CK-MB; Result Unstructured Data: Test Result:21; Comments: Units:U/L; Test Date: 20210929; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:58-72 mmHg; Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:182/110 mmHg; Comments: high; Test Date: 20210929; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:130-152 mmHg; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210928; Test Name: cardio echo; Result Unstructured Data: Test Result:no pericardial effusion, perseved systolic functio; Comments: no pericardial effusion, perseved systolic function; Test Date: 20210929; Test Name: Heart rate; Result Unstructured Data: Test Result:58-91; Test Date: 20210927; Test Name: Pulse rate; Result Unstructured Data: Test Result:86; Comments: Units:{beats}/min; Test Date: 20210927; Test Name: oxygen saturation; Test Result: 99 %; Test Date: 20210927; Test Name: Troponin; Result Unstructured Data: Test Result:5 ng/L; Test Date: 20210928; Test Name: Troponin; Result Unstructured Data: Test Result:below 3 ng/L
CDC Split Type: TWPFIZER INC202101424802

Write-up: CHEST TIGHTNESS; DIFFICULTY BREATHING; DIZZINESS; CHEST PAIN; blood pressure high; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008464), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003934), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008464. A 17-year-old male patient (Height: 183 cm, weight: 110 kg) started to receive a dose of Tozinameran (COMIRNATY) with unknown dose number in series (batch number: unknown) on 24-Sep-2021 via at unspecified dose/unspecified dosing frequency for COVID-19 immunization. Medical history included hypertension, in the hospital''s heart internal medicine clinic medical treatment (On 10-Apr-2021, the patient began to take Doxazosin HS PO for 28 days; on 26-Apr-2021, the patient began to take AMLODIPINE / VALSARTAN BID PO for 12 days). Patient''s usual blood pressure control was not good. The patient experienced chest tightness, difficulty breathing, dizziness, chest pain and blood pressure high on 27-Sep-2021. On 27-Sep-2021, the patient felt chest tightness, difficulty breathing and dizziness, and to the hospital for emergency medical treatment. Emergency vital signs indicated that patient''s oxygen saturation (O2SAT) was 99 %, body temperature was 36.5 degree centigrade, pulse was 86 {beats}/min (it was reported that "pulse: 86 times/score: 12 times/divided") and blood pressure was 182/110 mmHg. Emergency and blood test were performed. DICLOFENAC SOD. 1 # bid pc Po and Valsartan # Stat Po were given for chest pain, suspicion of myocarditis and blood pressure high. The patient was admitted to ICU for hospitalization. On the same day, patient''s creatine kinase isoenzymes (CKMB) was 25 U/L (H), blood creatine phosphokinase (CPK) was 298.0 U/L, hypersensitive troponin (HS Troponint) was 5 ng/L. On 28-Sep-2021, patient''s CKMB was 21 U/L, HS Troponint was below 3 ng/L. Cardio echo indicated no pericardial effusion, preserved systolic function. According to the results of the examination, myocarditis/myocardial enlarged inflammation had been excluded. VOREN 50 mg E.M.C CAP (Dich) pc Po and Diovan 160 mg Tab (Valsartan) 0.5 # qd Po were given. On 29-Sep-2021, blood pressure systolic (SBP) was 130-152 mmHg, blood pressure diastolic (DBP) was 58-72 mmHg, heart rate (HR) was 58-91. The patient currently felt chest tightness. On the evening of 29-Sep-2021, the patient was transferred to the general ward, and the hospital observation was continued. Chest tightness, difficulty breathing, dizziness, chest pain and blood pressure high met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the events was recovering. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible Causality Assessment: Events of Chest tightness; Difficulty breathing; Dizziness; Chest pain was possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823285 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Respiration abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Respiratory failure (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: TWPFIZER INC202101424622

Write-up: ABNORMAL BREATHING; HEADACHE; NAUSEA; VOMIT; DIZZINESS; This is a spontaneous report from a non-contactable health care professional via Regulatory Authority (regulatory authority number: TW-TFDA-TVS-1100008511), based on information received by Pfizer (manufacturer control number: TW-Fosun-2021FOS003942), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008511. A 16-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medications and past product were not reported. The patient experienced headache, nausea and vomit on 28-Sep-2021. On 27-Sep-2021, it was reported that "there was a dizziness to see the tumey". Patient''s symptoms still had not been alleviated and there was a breathing phenomenon. Patient then went to a hospital and would turned to another hospital for medical factors. After the treatment of physicians, it was recommended to be observed. The following was to track care. Headache, nausea and vomit met the seriousness criterion of Caused/Prolonged Hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Events of Headache, Nausea, Vomiting, Dizziness, Abnormal breathing were possibly related to COMIRNATY as per reporter and Company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Diarrhoea, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: EKG; Result Unstructured Data: Test Result:normal
CDC Split Type: TWPFIZER INC202101415308

Write-up: SHORTNESS OF BREATH; DIARRHEA; CHEST PAIN; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable health care professional via regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008661), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004071), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008661. A 17-year-old female patient started to receive an unknown dose of Tozinameran (COMIRNATY) (lot/batch number and expiry date not reported) on 27-Sep-2021 via unknown route as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient had no past medical history and no history. Smoking and drinking history were unknown. Concomitant medication(s) and past product were not reported. On 27-Sep-2021, the patient experienced chest pain, chest tightness and on 28-Sep-2021 the patient experienced diarrhea and dyspnea. At 1pm on 24-Sep-2021,the patient received BNT vaccine. At 4pm on 27-Sep-2021, the patient experienced chest pain and chest tightness. At 6:50am on 28-Sep-2021 the patient experienced shortness of breath and diarrhea 1 time, no fever , no cough and no rhinorrhea. EKG: normal. The following was tracking care. Chest pain, chest tightness, diarrhea and dyspnea met the seriousness criterion of other medically important condition. At the time of the report, the outcomes of chest pain, chest tightness, diarrhea and dyspnea were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment: Events Chest pain, Chest tightness, Shortness of breath and Diarrhea were assessed as serious and possibly related to Comirnaty per reporter and company (BioNTech SE).


VAERS ID: 1823302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Headache, Myocardial necrosis marker, Nausea, Respiration abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Respiratory failure (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: 20210927; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:abnormal; Test Date: 20210927; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:normal; Comments: the myocardial enzyme did not find abnormalities
CDC Split Type: TWPFIZER INC202101419293

Write-up: NAUSEA; CHEST DISCOMFORT; DIZZINESS; RESPIRATION ABNORMAL; HEADACHE; This is a spontaneous report from a non-contactable healthcare professional via Taiwan Center for Disease Control (Regulatory authority report number: TW-TFDA-TVS-1100008885), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004100), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008885. A 16-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC ) on 25-Sep-2021 via intramuscular at 0.3 ml and unknown frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced headache, chest discomfort, breathing was not smooth/respiration abnormal, nausea and dizziness on 27-Sep-2021, which had been in the trial of the three hospitals. However, the symptoms had not improved the emergency medical treatment. The test found that the electrocardiogram was abnormal. The myocardial enzyme did not find abnormalities. The patient returned after a few hours. At 16:31 on 01-Oct-2021, it was informed by telephone follow-up of this case that the patient still had a chest pain at present. Occasionally, it was necessary to vigorously inhale. On 08-Oct-2021, other reciprocners to see the report and must be careful to care about a case. It was reported that "physical condition, the case was known, after the case, the case agreed to influe, and the following year would then call, and the case was understood". Nausea, chest discomfort, breathing is not smooth, dizziness and headache met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the nausea, chest discomfort, breathing is not smooth, dizziness, headache were not applicable. At the time of the report, the outcomes of nausea, chest discomfort, breathing is not smooth, dizziness, headache were unknown. Initial report was received on 13-Oct-2021. COMIRNATY: Causality Assessments: Nausea; Chest discomfort; Dizziness; Respiration abnormal; Headache: Per Reporter and Per Company was possible. Follow-up closed, no further information is possible.


VAERS ID: 1823310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood test, Chest pain, Chills, Electrocardiogram
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: blood drawing; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101424693

Write-up: CHEST PAIN; CHILLS; FOCAL WEAKNESS; ABDOMINAL PAIN; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: TW-TFDA-TVS-1100008255) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS004139), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008255. A 13-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain, chills, abdominal pain and focal weakness on 27-Sep-2021 (3 days after vaccination). The patient was sent to Ed due to chest discomfort for 1 day with left upper arm denied fever, chills, abdominal pain and focal weakness. Emergency blood drawing and ECG were performed. The patient was discharged after oral drug treatment with diclofenac. Chest pain, chills, abdominal pain and focal weakness met the seriousness criterion of hospitalization. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424620

Write-up: CHEST PAIN; CHEST TIGHTNESS; PALPITATION; This is a spontaneous report from a non-contactable health care professional via regulatory authority(regulatory authority number: TW-TFDA-TVS-1100008267), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004148), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008267. A 14-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain, chest tightness and palpitation on 27-Sep-2021. Emergency consultation on 27-Sep-2021: The patient complained of chest pain and tightness and palpitation this morning (3 days after vaccination). It was reported "only pumping Blood heart map". The patient was discharged with oral diclofenac. Chest pain, chest tightness and palpitation met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. The primary reporter and BioNTech SE assessed the causal relationship between bnt162b2 and events as possible. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823313 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Blood test, Chest pain, Faeces soft
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101424688

Write-up: CHEST PAIN; EPIGASTRIC FULLNESS; SOFT STOOLS; This is a spontaneous report from a non-contactable healthcare professional via the Agency Regulatory Authority- (regulatory authority number: TW-TFDA-TVS-1100008279), based on information received by Pfizer from BioNtech (manufacturer control number TW-Fosun-2021FOS004161), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008279. A 43-year-old male patient started to receive 1st dose (COMIRNATY) (batch/lot number and expiry date not reported) on 25Sep2021 via unknown route as DOSE 1, SINGLE for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain, epigastric fullness and soft stools on 27Sep2021. At 18:55 on 22Sep2021, the patient was in the hospital for medical treatment. At 10:13 on 25Sep2021, the patient was in the Health Center for medical treatment. At 08:58 on 27Sep2021, the patient was in the hospital for medical treatment. The patient had chest discomfort for 2 days after vaccination, with epigastric fullness, soft stools without tarry stools. no dysuria, no hematuria. He was treated with pyroxicam injection in emergency department. Blood tests were performed. He was discharged from the hospital with oral diclofenac. Chest pain, epigastric fullness and soft stools met the seriousness criterion of hospitalization. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13Oct2021. Follow-up closed, no further information is possible. Causality assessment: Events Soft stools, Epigastric fullness, and Chest pain were assessed as serious (hospitalization) and possibly related to Comirnaty per reporter and company (BioNTech).


VAERS ID: 1823314 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424720

Write-up: TRANSIENT ALTERATION OF AWARENESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority. (Regulatory authority report number: TW-TFDA-TVS-1100008309), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004179), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008309. A 22-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not specified) on 27-Sep-2021 via unknown route of administration at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced awareness change on 27-Sep-2021. On 27-Sep-2021, just after inoculated BNT vaccine, it was reported that the patient experienced awareness of ceremonium oxygen. And current consciousness was recovered. Appearance was an upset face color. Awareness change met the seriousness criterion of other medically important condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment between Comirnaty and the event awareness change/transient alteration of awareness was possible per reporter and company (Possible). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823315 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest discomfort, Dyspnoea, Product administered to patient of inappropriate age
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424510

Write-up: HEART PAIN; BREATHING DIFFICULTIES; CHEST TIGHTNESS; Patient was 8-years-old; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (Regulatory authority report number: TW-TFDA-TVS-1100008349), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004196), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008349. A 8-year-old male patient started to received a dose of Tozinameran (COMIRNATY) (batch/lot number and expiry date were not reported) on 27Sep2021 (age at vaccination was 8 years) via unknown route as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced breathing difficulties, heart pain and chest tightness on 27Sep2021. Heart pain was considered as an Important Medical Event. Breathing difficulties and chest tightness were considered as non-serious. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13Oct2021. Follow-up closed, no further information is possible. Causality assessment: Events Breathing difficult, Cardiac pain, Chest tightness were assessed possibly related to Comirnaty per reporter and company (BioNTech SE).


VAERS ID: 1824896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Intraventricular haemorrhage, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: Comments: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20211053905

Write-up: INTRAVENTRICULAR HAEMORRHAGE; INTRACEREBRAL BLEED; SUBARACHNOID HEMORRHAGE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-049396) on 26-OCT-2021 and concerned a 62 year old male. The patient''s weight was 80 kilograms, and height was 190 centimeters. The patient''s pre-existing medical conditions included: none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total, administered on 14-SEP-2021 for product use for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-SEP-2021, the patient experienced intraventricular haemorrhage, intracerebral bleed and subarachnoid hemorrhage. 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 outcome of the intraventricular haemorrhage, intracerebral bleed and subarachnoid hemorrhage was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1825953 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, COVID-19, Chest X-ray, Decreased appetite, Drug ineffective, Productive cough, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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: CARDIO ASPIRIN; MAGNESIUM; TORASEMIDE; ESOMEPRAZOLE [ESOMEPRAZOLE SODIUM]; ESCITALOPRAM; MEMANTINE; LISINOPRIL [LISINOPRIL DIHYDRATE]; ATORVASTATIN;EZETIMIBE; ALFUZOSIN; VIT D [ERGOCALCIFEROL]; TRESIBA; NOVORAPID
Current Illness: Arterial hypertension; Arterial insufficiency (Peripheral arterial insufficiency of lower extremities stage IIA in right lower extremity); Chronic renal failure; Cognitive disorder; Diabetes with unspecified complication (Type 1 diabetes mellitus with micro and macrovascular complications); Dyslipidaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Chest X-ray; Result Unstructured Data: vascular redistribution with no clear focal area; Test Date: 20210927; Test Name: C-reactive protein; Result Unstructured Data: 30mg/L; Test Date: 20210927; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210927; Test Name: SARS-CoV-2 antibody test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210909; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Nasopharyngeal swab came back positive for SARSCoV-; Severe SARS-CoV-2 infection despite 2 doses of the vaccine; SARS-CoV-2 infection; Lack of appetite; Asthenia; Wet cough; Rhinorrhea; Febrile state; This regulatory authority case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Nasopharyngeal swab came back positive for SARSCoV-), COVID-19 (SARS-CoV-2 infection), DECREASED APPETITE (Lack of appetite), ASTHENIA (Asthenia), PRODUCTIVE COUGH (Wet cough), RHINORRHOEA (Rhinorrhea), PYREXIA (Febrile state) and DRUG INEFFECTIVE (Severe SARS-CoV-2 infection despite 2 doses of the vaccine) in a 79-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for SARS-CoV-2 immunisation. The patient''s past medical history included Ischemic stroke in 2014. Concurrent medical conditions included Arterial hypertension, Arterial insufficiency (Peripheral arterial insufficiency of lower extremities stage IIA in right lower extremity), Cognitive disorder, Diabetes with unspecified complication (Type 1 diabetes mellitus with micro and macrovascular complications), Chronic renal failure and Dyslipidaemia. Concomitant products included ACETYLSALICYLIC ACID (CARDIO ASPIRIN), MAGNESIUM, TORASEMIDE, ESOMEPRAZOLE SODIUM (ESOMEPRAZOLE [ESOMEPRAZOLE SODIUM]), ESCITALOPRAM, MEMANTINE, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), ATORVASTATIN, EZETIMIBE (ATORVASTATIN;EZETIMIBE), ALFUZOSIN, ERGOCALCIFEROL (VIT D [ERGOCALCIFEROL]), INSULIN DEGLUDEC (TRESIBA) and INSULIN ASPART (NOVORAPID) for an unknown indication. In March 2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced DECREASED APPETITE (Lack of appetite) (seriousness criteria hospitalization and medically significant), ASTHENIA (Asthenia) (seriousness criteria hospitalization and medically significant), PRODUCTIVE COUGH (Wet cough) (seriousness criteria hospitalization and medically significant), RHINORRHOEA (Rhinorrhea) (seriousness criteria hospitalization and medically significant) and PYREXIA (Febrile state) (seriousness criteria hospitalization and medically significant). On 29-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant). On 01-Oct-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Nasopharyngeal swab came back positive for SARSCoV-) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (Severe SARS-CoV-2 infection despite 2 doses of the vaccine) (seriousness criteria hospitalization and medically significant). At the time of the report, SARS-COV-2 TEST POSITIVE (Nasopharyngeal swab came back positive for SARSCoV-), COVID-19 (SARS-CoV-2 infection), DECREASED APPETITE (Lack of appetite), ASTHENIA (Asthenia), PRODUCTIVE COUGH (Wet cough), RHINORRHOEA (Rhinorrhea), PYREXIA (Febrile state) and DRUG INEFFECTIVE (Severe SARS-CoV-2 infection despite 2 doses of the vaccine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On 27-Sep-2021, C-reactive protein: 30 (abnormal) 30mg/L. On 27-Sep-2021, Chest X-ray: abnormal (abnormal) vascular redistribution with no clear focal area. On 27-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive and negative (Negative) negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered SARS-COV-2 TEST POSITIVE (Nasopharyngeal swab came back positive for SARSCoV-), COVID-19 (SARS-CoV-2 infection), DECREASED APPETITE (Lack of appetite), ASTHENIA (Asthenia), PRODUCTIVE COUGH (Wet cough), RHINORRHOEA (Rhinorrhea), PYREXIA (Febrile state) and DRUG INEFFECTIVE (Severe SARS-CoV-2 infection despite 2 doses of the vaccine) to be possibly related. It was reported 79-year-old male patient was known for treated high blood pressure, Peripheral arterial insufficiency of lower extremities stage IIA in right lower extremity, Cognitive impairment, Type 1 diabetes mellitus with micro and macrovascular complications, Stage 3 Chronic kidney disease, Treated dyslipidemia, Ischemic stroke in the posterior fossa: Stenosis of the basilar trunk artery narrowed by 80-90% (proximal section) (2014). The laboratory results showed a mild inflammatory syndrome with CRP at 30 without leukocytosis and thrombocytopenia, kidney failure with creatinine at 160 (stable) and pro- BNP at 1,800. Nasopharyngeal swab came back positive for SARS-CoV-2. The chest x-ray shows vascular redistribution with no clear focal area. Serology assays for SARS-CoV-2 positive for anti-S at 461 U/mL, negative for anti-N. On 29-Sep-2021 patient was thereafter hospitalised for care on. It was reported that patient was given treatment with calciparine 5000U 2x/d was put in place. Usual treatment: Aspirin cardio Magnesium Torasemide Esomeprazole Escitalopram Memantine Lisinopril Atorvastatin + ezetimibe Alfuzosin VitD 1x/week Insulin Tresiba Novorapid. Company comment -This case concerns a 79 year old male with no relevant history who experienced the serious AESI of COVID-19 and Drug ineffective (per RA) and other related events approximately 6 months after the second dose of mRNA-1273. Re-challenge is not applicable as it is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The event Drub ineffective is reported by the RA; however, as the dates of the doses are unknown the criteria for LOE is not met. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translated document received on 22 Oct 2021 which included Patient medical comments and events updated with translated term. Lab data added. Sender''s comment updated.; Reporter''s Comments: This patient presented with severe SARS-CoV-2 pneumonia around 6 months after the second injection of the Covid-19 vaccine. A phase 3 study that allowed the registration of the Moderna Covid- 19 Vaccine included around 30,000 people and showed that the vaccine has 94% efficacy, based on the number of symptomatic Covid-19 infections reported in each group; 11 cases out of 14,134 with the vaccine versus 185 cases out of 14,073 with the placebo (1). In studies carried out "in real life", an efficacy of more the 90% was also observed after the second dose (2,3). According to the latest detailed report of the French authorities compiling the pharmacovigilance reports up to 1st July concerning this vaccine, 3 cases of SARS CoV-2 infection were declared out of 2,028,218 people having received the 2 injections of the Moderna Covid-19 Vaccine. For comparison, 474 SARS CoV-2 infections were reported with the Comirnaty vaccine, which has been used much more however (16,381,126 people with 2 injections) (4). Thus, the efficacy of the vaccine, even though it is extremely high, is not 100%, and especially with the development of variants, a certain number of infections in vaccinated people is not surprising. CONCLUSION The causality of the Moderna Covid-19 Vaccine in the occurrence of SARS CoV-2 pneumonia (treatment failure) is considered possible; Sender''s Comments: This case concerns a 79 year old male with no relevant history who experienced the serious AESI of COVID-19 and Drug ineffective (per RA) and other related events approximately 6 months after the second dose of mRNA-1273. Re-challenge is not applicable as it is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The event Drub ineffective is reported by the RA; however, as the dates of the doses are unknown the criteria for LOE is not met.


VAERS ID: 1826325 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthmatic crisis, Rash
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Pneumopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101378641

Write-up: Asthma crisis; Skin eruption/skin rash; This is a spontaneous report received from a contactable physician downloaded from the Agency WEB, regulatory authority number FR-AFSSAPS-PO20215152. A 32-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FG7387), via intramuscular route of administration, administered in arm left on 02Sep2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history included asthma and pneumopathy. The patient''s concomitant medications were not reported. Patient did not develop symptoms of COVID 19 infection and patient has not been tested. He was not considered to be at risk of developing a severe form of COVID 19 disease. On 27Sep2021, the patient experienced asthma crisis and skin eruption/skin rash. Patient presents a vesperal asthma attack associated with a skin rash. Patient visited the physician office for the event rash. Outcome of events was recovered (recovered without sequelae) on 04Oct2021. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1826353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-09-27
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101401818

Write-up: Herpes zoster/Abdominal shingles; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report was downloaded from the regulatory authority [FR-AFSSAPS-AN20213947]. A 89-year-old female patient received BNT162B2 (COMIRNATY; Batch/Lot Number: EX6537), via intramuscular route on 05May2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and the concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY; Batch/Lot Number: ER9470) via intramuscular route 07Apr2021 as dose 1, single for COVID-19 immunization and experienced urinary incontinence and abdominal pain. The patient experienced herpes zoster/abdominal shingles on 27Sep2021. The outcome was not recovered for the reported events. No follow-up attempts are possible. No further information expected. ; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101379303 Same patient and drug, different dose, events


VAERS ID: 1826957 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-27
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 immunisation, Chest pain, Electrocardiogram, Investigation, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: ECG; Result Unstructured Data: Findings consistent with pericarditis; Test Date: 20210927; Test Name: Investigation; Result Unstructured Data: No myocardial affection
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Chest pain/Pericarditis; Chest pain/Pericarditis; Chest pain/Pericarditis; This case was received Reference number: NO-NOMAADVRE-E2B_00055904) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain/Pericarditis) and PERICARDITIS (Chest pain/Pericarditis) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included No adverse reaction with Comirnaty. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced CHEST PAIN (Chest pain/Pericarditis) (seriousness criterion hospitalization) and PERICARDITIS (Chest pain/Pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Chest pain/Pericarditis). At the time of the report, CHEST PAIN (Chest pain/Pericarditis), PERICARDITIS (Chest pain/Pericarditis) and COVID-19 IMMUNISATION (Chest pain/Pericarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, Electrocardiogram: abnormal (abnormal) Findings consistent with pericarditis. On 27-Sep-2021, Investigation: abnormal (abnormal) No myocardial affection. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered CHEST PAIN (Chest pain/Pericarditis) and PERICARDITIS (Chest pain/Pericarditis) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (Chest pain/Pericarditis). No concomitant medications were reported. No treatment medications were reported. This is a regulatory case concerning a 30 year-old, male patient with clinical history of previously administered Comirnaty products for Vaccination without adverse reaction, who experienced the unexpected serious event of CHEST PAIN, the expected (AESI) serious event of PERICARDITIS and other non-serious adverse event. The events occurred 24 days after the first dose of Spikevax vaccine, second doses of COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translation received on 21-Oct-2021: Event verbatim was updated.; Sender''s Comments: This is a regulatory case concerning a 30 year-old, male patient with clinical history of previously administered Comirnaty products for Vaccination without adverse reaction, who experienced the unexpected serious event of CHEST PAIN, the expected (AESI) serious event of PERICARDITIS and other non-serious adverse event. The events occurred 24 days after the first dose of Spikevax vaccine, second doses of COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1827105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Echocardiogram, Heart rate variability test, Pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: Blood test; Result Unstructured Data: Test Result:not report; Test Date: 20210930; Test Name: Doppler echocardiography; Result Unstructured Data: Test Result:not report; Test Date: 20210929; Test Name: Heart rate variability test; Result Unstructured Data: Test Result:not report; Test Date: 20210930; Test Name: Pain; Result Unstructured Data: Test Result:10 points into 3 points
CDC Split Type: TWPFIZER INC202101438397

Write-up: CHEST PAIN; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008638), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003982), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008638. A 16-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 23-Sep-2021 via intramuscular at 0.3 ml dosing frequency for COVID-19 immunization. Concomitant medication(s) and past product were not reported. The patient experienced chest tightness on 27-Sep-2021. The patient experienced pain when the left chest on 29-Sep-2021. On 23-Sep-2021 13:20 in the afternoon, vaccination BNT . On 27-Sep-2021 the patient experienced characteristic chest tightness. Pain in the left chest (climbing stairs). On 29-Sep-2021, report notice district health center. The following was to track care. In the afternoon, the campus collectively vaccinated the BNT vaccine on 27-Sep-2021. The students showed chest tightness. During the left chest, the pain (climbing stairs). It was reported that "On 28-Sep-2021 parents with students to thehospital, wear 24 schools current electrogram monitoring (10/5 (2) reciprocation to see the report). On 29-Sep-2021, the cardiac examination and blood test report of hospital in the evening once again. On 30-Sep-2021 the lower edge of the left chest was still painless, sleep or static no such symptoms, but the symptoms were obvious when the activity or climb the stairs, and there would be 2-3 exercises per hour. The pain index was full of 10 points into 3 points. It was expected that on 01-Oct-2021 partial foundation arranged with a heart supersonic examination. On 01-Oct-2021 reciprocation to see the report. The actions taken for Tozinameran (COMIRNATY) regarding the chest tightness and pain when the left chest were not applicable. At the time of the report, the outcomes of chest tightness and pain when the left chest were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible


VAERS ID: 1827107 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure diastolic, Blood pressure measurement, Body temperature, Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram, Investigation, Pulse waveform abnormal, Respiration abnormal, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (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: 20210927; Test Name: diastolic pressure; Result Unstructured Data: Test Result:67; Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:123/69 mmHg; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210927; Test Name: CXR; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: EKG; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: shrinkage pressure; Result Unstructured Data: Test Result:123; Test Date: 20210927; Test Name: Anacrotic pulse; Result Unstructured Data: Test Result:69; Comments: Units:/min; Test Date: 20210927; Test Name: Abnormal breathing; Result Unstructured Data: Test Result:20; Comments: /min
CDC Split Type: TWPFIZER INC202101415304

Write-up: CHEST TIGHTNESS; CHEST PAIN; Anacrotic pulse; Abnormal breathing; This is a spontaneous report from a non-contactable health care professional via regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008659), based on information received by Pfizer from BioNTech (manufacturer control number: TW-Fosun-2021FOS004069), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008659. A 16-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 27-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization.Concomitant medication(s) and past product were not reported. On 27-Sep-2021,the patient experienced chest tightness and chest pain after vaccination . At 3pm on 27-Sep-2021 the patient received the first BNT vaccine, after which chest pain and chest tightness was subsequent. Then the patient went to the hospital emergency and main complaint about chest pain, chest tightness, but chest pain was not very painful. The physician arranged, EKG was normal, CXR was normal, blood pressure 123/69 mmHg, shrinkage pressure 123, diastolic pressure 67, anacrotic pulse 69/min, abnormal breathing 20/min, body temperature 37.3 degree C. After diagnosis and treatment, the patient went home for observation, followed up the treatment in the outpatient department, and was given discharge tissue (Acetaminophen 500 mg / Tab (1TB) .po.q6h prn.2 days). Chest pain and chest tightness met the seriousness of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the chest pain and chest tightness were not applicable. At the time of the report, the outcomes of chest pain and chest tightness were unknown. Initial report was received on 13-Oct-2021. Comirnaty: Causality assessment: Chest tightness and Chest pain: per reporter and and per company was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1828157 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Hyperpyrexia, Hypothermia, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia; malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia; malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia; malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia; This case was received via Regulatory Authority Reference number: IT-MINISAL02-799576) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia), HYPOTHERMIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia), CHILLS (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) and MALAISE (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunisation. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 27-Sep-2021, the patient experienced HYPERPYREXIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) (seriousness criterion medically significant), HYPOTHERMIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) (seriousness criterion medically significant), CHILLS (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) (seriousness criterion medically significant) and MALAISE (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia), HYPOTHERMIA (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia), CHILLS (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) and MALAISE (malaise with hypothermia in the lower limbs and muscle and joint stiffness, shaking tremors lasting 2-3 h, hyperpyrexia 40, asthenia) had resolved with sequelae. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter. Company comment This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected events of hyperpyrexia, hypothermia, chills and malaise. The event occurred same day after the first dose of mRNA 1273 vaccine. The rechallenge was unknown as the event happened after the first dose which resolved at the time of report but no information about second dose is available as the patient is due for second dose. The benefit-risk relationship of vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. patient done with Body temperature test on unknown date and results was unknown Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation document received on 25 Oct 2021 included event verbatim updated.; Reporter''s Comments: Accertamenti ancora in corso, a breve cartella clinica post degenza in clinica neurologica richieste informazioni di follow up al segnalatore in merito a doc.clinica. In; Sender''s Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected events of hyperpyrexia, hypothermia, chills and malaise. The event occurred same day after the first dose of mRNA 1273 vaccine. The rechallenge was unknown as the event happened after the first dose which resolved at the time of report but no information about second dose is available as the patient is due for second dose. The benefit-risk relationship of vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1829785 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: DEMODERNATX, INC.MOD20213

Write-up: Chills; Pyrexia; Injection site pain; This case was received via Regulatory Authority (Reference number: DE-PEI-202100203840) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Pyrexia) and INJECTION SITE PAIN (Injection site pain) in a 38-year-old female patient who received mRNA-1273 (batch no. 3004233) for Prophylactic vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273(Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced CHILLS (Chills) (seriousness criterion hospitalization), PYREXIA (Pyrexia) (seriousness criterion hospitalization) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion hospitalization). On 29-Sep-2021, CHILLS (Chills) and PYREXIA (Pyrexia) was resolving. On 30-Sep-2021, INJECTION SITE PAIN (Injection site pain) had resolved. No concomitant medication were reported. No treatment information was provided by the reporter. Follow-up received on 22-OCT-2021 included no new information Company comment: This case concerns a 38-year-old, female with no relevant medical history reported, who experienced the serious unexpected per reported severity events of Chills, Pyrexia, Injection site pain. The events occurred 1 day after the second dose administration. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 25-OCT-2021 contains no new information.; Reporter''s Comments: Do you or the person affected have any known allergies? If yes, which? No; Sender''s Comments: This case concerns a 38-year-old, female with no relevant medical history reported, who experienced the serious unexpected per reported severity events of Chills, Pyrexia, Injection site pain. The events occurred 1 day after the second dose administration. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report.


VAERS ID: 1829818 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-27
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intention tremor, Resting tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (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: ESMODERNATX, INC.MOD20213

Write-up: Resting tremor; Trembling; This case was received via Regulatory Agency (Reference number: ES-AEMPS-1026163) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESTING TREMOR (Resting tremor) and INTENTION TREMOR (Trembling) in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005703 and 214016) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced RESTING TREMOR (Resting tremor) (seriousness criterion medically significant) and INTENTION TREMOR (Trembling) (seriousness criterion medically significant). At the time of the report, RESTING TREMOR (Resting tremor) and INTENTION TREMOR (Trembling) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 23-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Company Comment : This is a regulatory case concerning a 14 year-old, female patient with no clinical history who experienced the unexpected serious events of RESTING TREMOR AND INTENTION TREMOR The events occurred approximately 4 days after the second dose of Spikevax. The rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translated received on 25-Oct-2021 as translated event verbatim and dosage text updated.; Sender''s Comments: This is a regulatory case concerning a 14 year-old, female patient with no clinical history who experienced the unexpected serious events of RESTING TREMOR AND INTENTION TREMOR The events occurred approximately 4 days after the second dose of Spikevax. The rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1830069 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Immunisation, Migraine, Nausea, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Stoma site bleeding; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Ulcerative colitis (had bowel removed and has stoma so not taking medication)
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Comments: High; Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101392840

Write-up: Drug ineffective; SARS-CoV-2 infection; Migraine; Nausea; High temperature; Painful arm; Off label use; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110150938243570-L09I8, Safety Report Unique Identifier GB-MHRA-ADR 26081358. A 45-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FG3712), via an unspecified route of administration on 27Sep2021 (at the age of 45-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history included colitis ulcerative, stoma site haemorrhage, suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped), inflammatory bowel disease all from an unknown date and unknown if ongoing. Took medications for inflammatory bowel disease (crohn''s disease, ulcerative colitis- had bowel removed and has stoma so not taking medication). The patient concomitant medications were not reported. Patient was not enrolled in clinical trial. Historical vaccine included first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration dose 1 on 28Jan2021 and dose 2 on 10Mar2021 as dose 1 and dose 2, single for COVID-19 immunization. The patient received third dose of bnt162b2 on 27Sep2021 (off label use and booster) and experienced painful arm on same day. The patient experienced nausea and high temperature on 28Sep2021, migraine on 01Oct2021. On 13Oct2021, the patient experienced SARS-CoV-2 infection and drug ineffective. The patient underwent lab tests and procedures which included, body temperature: high on 28Sep2021 and COVID-19 virus test: positive Yes - Positive COVID-19 test on 13Oct2021. Outcome of painful arm, nausea, high temperature, migraine was recovered on an unspecified date 2021. Outcome of SARS-CoV-2 infection was not recovered. No follow up attempts are needed. No further information is expected.


VAERS ID: 1830296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Back pain, Blood pressure increased, Blood pressure systolic, Chest pain, Exercise tolerance decreased, Headache
SMQs:, Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (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: Headache (from time to time)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure systolic; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210927; Test Name: blood pressure systolic; Result Unstructured Data: Test Result:160 mmHg
CDC Split Type: GRPFIZER INC202101393309

Write-up: could not run; heart pain; chest pain; back pain, where the heart is; blood pressure increased from 110 mmHg to 160 mmHg; having headaches constantly; This is a spontaneous report from a non-contactable consumer and from medical information team. A male patient in his 30s (31 or 32 years old) received first dose of received bnt162b2 (COMIRNATY), intramuscular on 27Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included headaches from time to time. He received no concomitant medications. He was athletic and run and exercised regularly. After the vaccination on 27Sep2021, his blood pressure increased from 110 mmHg (systolic) to 160 mmHg. It passed after a while 27Sep2021. He has also been feeling heart pain at times (ongoing). He experienced pain in the chest and back, where the heart is. In the past he had headaches from time to time, but after the vaccination he was having headaches constantly. He has planned a brain MRI. On 18Oct2021, he was supposed to have the second dose, but when he discussed the AEs at the vaccination center they told him to re-schedule it for next week, when they will have a cardiologist available on site. He also reported that from day one he had symptoms. He couldn''t run. The outcome of the events was not recovered. Case status. No follow-up attempts possible. No further information expected.


VAERS ID: 1830330 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Motor dysfunction
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101384519

Write-up: Sthenic deficity persistent left brachiocrural with difficulty to perform normal daily and work activities; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority number IT-MINISAL02-798020. A 34-years-old male received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was FG7387 and 30Nov2021) via an intramuscular route of administration, administered in Deltoid Right on 22Sep2021 (at 09:34) (age at the time of vaccination was 34-years-old) as DOSE 1, 0.3ml SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced Sthenic deficity persistent left brachio-crural with difficulty to perform normal daily and work activities. The clinical outcome of event was Not recovered. Reporter comment: appeared to the undersigned after the administration of the first dose of the COMIRNATY vaccine of currently persistent left brachio-crural stenic deficiency, impeding the normal performance of one''s daily and work activities. No follow-up attempts are needed. No further information expected.; Reporter''s Comments: appeared to the undersigned after the administration of the first dose of the Cominarty vaccine of currently persistent left brachio-crural stenic deficiency, impeding the normal performance of their daily and work activities.


VAERS ID: 1830353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Diarrhoea, Echocardiogram, Magnetic resonance imaging heart, Myocarditis, Pyrexia, Red blood cell sedimentation rate, Troponin I, Underdose
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Medication errors (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dust allergy
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:increase; Test Date: 20211008; Test Name: Echocardiogram; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: hypokinesia; Result Unstructured Data: Test Result:hypokinesia apical segments of the left ventricle; Comments: apical segments of the left ventricle; Test Date: 20211013; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: ESR; Result Unstructured Data: Test Result:increase; Test Date: 20211008; Test Name: Troponin I; Result Unstructured Data: Test Result:4172 ng/L
CDC Split Type: ITPFIZER INC202101398783

Write-up: On the 08th current month onset of oppressive thoracic pain with access to the emergency room.; Diagnosis of myopericarditis, admission to the cardiological intensive care unit.; Onset with fever; Onset with diarrhoea; Vaccine Underdose; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)WEB. The regulatory authority report number is IT-MINISAL02-799059. An 18-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in arm right (right shoulder) on 27Sep2021 at 17:26 (Batch/Lot Number: FF2382; Expiration Date: 31Dec2021) as DOSE NUMBER UNKNOWN (BOOSTER), 0.3 ug SINGLE (however dose number was also reported as dose 1) for covid-19 immunisation. Medical history included dust allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 27Sep2021, the patient received underdose of vaccine. On 05Oct2021, the patient experienced onset with fever and diarrhoea. On 08Oct2021, the patient experienced onset of oppressive thoracic pain with access to the emergency room and diagnosis of myopericarditis, admission to the cardiological intensive care unit. The patient underwent lab tests and procedures which included detection of a notable increase in myocardial cytolysis indices, Troponin 4172ng / L, and of the inflammation indices of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP): increase; echocardiography showed; hypokinesia: apical segments of the left ventricle on an unspecified date, echocardiogram with unknown results on 08Oct2021, magnetic resonance imaging heart: unknown results on 13Oct2021 and mild pericardial detachment exam in progress. The outcome of the events was not recovered. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1830370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Heart rate, Nausea, Oxygen saturation, Physical examination
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:135/89; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Name: CHEST X-RAY; Result Unstructured Data: Test Result:Normal; Test Name: Electrocardiography; Test Result: Negative ; Test Name: heart rate; Result Unstructured Data: Test Result:84; Test Name: oxygen saturation; Test Result: 99 %; Test Name: physical examination; Result Unstructured Data: Test Result:Diffuse vesicular murmur,; Comments: rhythmic heart sounds.
CDC Split Type: ITPFIZER INC202101405868

Write-up: Nausea; Pain precordial/ Thoracalgia; Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-799880. A 26-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FG3739; Expiration Date: 31Dec2021), intramuscular, administered in Arm Left on 24Sep2021 at 15:02 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced nausea, pain precordial/ thoracalgia and dyspnea. It was reported that, the patient was admitted to emergency room and administered perfalgan 1 vial intravenous. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure: 135/89, chest x-ray: normal, heart rate: 84, oxygen saturation: 99 %, physical examination: diffuse vesicular murmur (rhythmic heart sounds), electrocardiography: negative , blood test: normal. Therapeutic measures were taken as a result of nausea, pain precordial/ thoracalgia and dyspnea which included tachipirina 1000 3 per day as needed. The outcome of all the event was recovered on 05Oct2021. Reporter comment: Admitted to emergency room for chest pain that had been persisting for a few days associated with nausea and subjective dyspnea. Blood pressure 135/89, heart rate 84, oxygen saturation 99%, chest physical examination: Diffuse vesicular murmur, rhythmic heart sounds. After therapy, remission of symptoms. Goes back to doctor with diagnosis of nonspecific thoracalgia, therapy with Tachipirina 1000 3 per day as needed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830406 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cystitis, Cystitis haemorrhagic, Haematuria, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tubulointerstitial diseases (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: Cystitis (he patient had a history of something like Cystitis several years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101383357

Write-up: there was a little Haemorrhage, it might be Cystitis; Haemorrhage; Cystitis; something like Haematuria; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 27Sep2021 09:00 (at the age of 50 years old) (Lot Number: FH0151; Expiration Date: 31Dec2021) as dose 1, single for COVID-19 immunisation. Medical history included something like cystitis several years ago. The patient''s concomitant medications were not reported. On 27Sep2021 at 18:00, the patient experienced something like haematuria. The patient visited the nearby Urology clinic the next day. On an unspecified date, the doctor said that since there was a little haemorrhage, it might be cystitis. Events were treated with an antibiotic for 5 days. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101413388 same reporter/patient; different dose/event


VAERS ID: 1830410 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101384082

Write-up: Headache; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129505. A -year and 11-month-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FF4204; Expiration Date: 31Oct2021), via an unspecified route of administration on 25Sep2021 (at the age of 14-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient past drug included FLUTIDE, PRANLUKAST, and SEREVENT. The patient experienced headache on 27Sep2021. The patient was hospitalized for headache (headache) from 07Oct2021 to 14Oct2021. The clinical course was as follows: on 27Sep2021 (2 days after the vaccination), the patient experienced Headache. On 27Sep2021, her headache aggravated. Ibu (illegible) was used. On 29Sep2021, the patient visited the hospital for consultation. The drug was changed to CALONAL. However, the symptom did not improve. On 07Oct2021 (12 days after the vaccination), the patient was admitted to the hospital. On 07Oct2021, the patient visited another hospital where she was regularly visit for chronic headaches, and the patient was admitted to the hospital. On 07Oct2021 (12 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as serious (Hospitalized from 07Oct2021 to 14Oct2021) and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were Migraine/Chronic headaches. Has the reaction already been reported to the manufacturer? No (Unknown: There was no information available in our hospital, and it was unknown in the other hospital) The reporting physician commented as follows: (Hospital where the patient admitted: the other hospital. Physician: the doctor)


VAERS ID: 1832778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-09-27
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101391481

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority AT-BASGAGES-2021-050102. This is the first of two reports for the same containing Lack of Efficacy scenario. A 49-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06Jul2021 (Lot Number: FE6208) as dose 2, single, dose 1 intramuscular on 25May2021 (Lot Number: FC0681) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced vaccination failure and sars-cov-2 infection on 27Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021, Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101404267 same patient, different event, different scenario


VAERS ID: 1834328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tachycardia (Tachycardia when riding a bicycle)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101394693

Write-up: Tachycardia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021187704, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100203678. A 16-year-old female patient received unknown dose number of BNT162B2 (COMIRNATY), via an unspecified route of administration on 25Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history included first tachycardia when riding a bicycle. Concomitant medications were not reported. On 27Sep2021, the patient experienced tachycardia with outcome of not recovered. This report is serious - hospitalization. Sender''s comments: Do you or the person concerned have any known allergies? If yes, which ones? Yes / First Tachycardia when riding a bicycle. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834637 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Arthropathy, Fatigue, Immunisation, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Arthritis (broad), Medication errors (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393171

Write-up: Painful knee; off label use; booster; product use for unapproved combination; weak knee joints; tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110151201460470-GFK2B, Safety Report Unique Identifier GB-MHRA-ADR 26082136. A 76-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2153), via an unspecified route of administration, on 27Sep2021 (at the age of 76-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient''s medical history included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr). Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS, batch/lot number was unknown) via an unspecified route of administration, on 27Sep2021, as single dose, for an unspecified indication. The patient experienced weak knee joints, tiredness on an unspecified date in 2021, painful knee on 28Sep2021 (1 day after the third dose), product use for unapproved combination, off label use and booster on 27Sep2021. Patient has weak knee joints, arthritis flare-up in wrists and fingers and tiredness. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The seriousness criteria of the events weak knee joints, tiredness and painful knee were reported as disability. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (no - negative covid-19 test) on 13Sep2021. Outcome of the events weak knee joints, tiredness was unknown and outcome of the event painful knee was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1834659 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Myalgia, Nausea, Off label use, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400556

Write-up: Headache; Muscle pain; Chills; Fatigue extreme; Pain injection site; Nausea; Generalised joint pain; off label use; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161818023840-PY1GQ. Safety Report Unique Identifier GB-MHRA-ADR 26085090. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE8087), dose 3 via an unspecified route of administration on 27Sep2021 (Age at vaccination was coded as 57-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced headache, muscle pain, chills, fatigue extreme, pain injection site, nausea and generalised joint pain, and reported off label and booster on 27Sep2021. The events seriousness reported as disability for headache, muscle pain, chills, fatigue extreme, pain injection site, nausea and generalised joint pain. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events headache and fatigue extreme was resolving, muscle pain and chills was resolved on an unknown date in 2021, nausea was resolved 30Sep2021, pain injection site was resolved 04Oct2021 and generalised joint pain was resolved on 11Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834756 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-09-27
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lumbar puncture, Primary headache associated with sexual activity, SARS-CoV-2 test, Scan
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Lumbar puncture; Result Unstructured Data: Test Result:normal; Test Date: 20211002; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202101400680

Write-up: Coital headache; headache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110180813538370-ZVZI1, Safety Report Unique Identifier GB-MHRA-ADR 26085881. A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FF3319 and expiry date was not reported), via an unspecified route of administration, on 21Jul2021, as dose 2, single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW3143 and expiry date was not reported), via an unspecified route of administration, on 12Jun2021, as dose 1, single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced headache. On 27Sep2021, the patient experienced coital headache and hospitalized on an unspecified date. The post-coital headache has happened twice in a week and was happens again if he started a sexual activity, and still could happen when he started doing sex mostly happens after the sex. The headache last more than 8 hours. he did a scan and lumber puncture, and everything was normal. The patient underwent lab tests and procedures which included lumbar puncture and scan: with normal result on an unspecified date and sars-cov-2 test: negative on 02Oct2021 No - Negative COVID-19 test. Outcome of the event headache was recovering and for another event, it was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1835019 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-27
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210927; Test Name: Body temperature; Result Unstructured Data: 37 Cel (degree Celsius); Test Date: 20210927; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 infection; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP110262) on 21-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This case was reported by a vaccine recipient via the Drug Information Center. COVID-19 infection was assessed as serious by the MAH. On 07-Sep-2021, around 10:00, the patient received the 1st dose of the vaccine. On 27-Sep-2021, cough and pyrexia of low 37 degrees Celsius range developed. The patient visited a medical institution and tested positive for a PCR test. COVID-19 infection was confirmed, and the patient healed him/herself at home. On 09-Oct-2021, COVID-19 infection resolved, and recuperation at home was finished. The outcome of COVID-19 infection was reported as resolved. Follow-up investigation will not be possible because of non-cooperation of the reporter. Company Comment: 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 62-year-old, male patient with no relevant medical history, who experienced the unexpected events of COVID 19. The event occurred approximately 20 days after the first dose of Moderna COVID-19 Vaccine. The patient had cough and pyrexia of low 37 degrees Celsius range and visited a medical institution where he tested positive for a PCR test. COVID-19 infection was confirmed, and the patient healed at home. Twelve days later COVID-19 infection resolved, and recuperation at home was finished. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The medical history remains a confounder. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in the source document, however, there was no information in the source document supporting that the events resulted in a serious medical condition.


VAERS ID: 1835147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 20210927; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101404843

Write-up: Possible vaccine failure; COVID-19; This is a spontaneous report from a contactable other health care professional downloaded from the Regulatory Authority-WEB, received from Regulatory authority report number PT-INFARMED-T202110-41 with Safety Report Unique Identifier PT-INFARMED-T202110-41. A 46-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via intramuscular route on 30Jul2021 (Lot Number: FE8235) as DOSE 2, 0.3 ML SINGLE and dose 1 via unspecified route on an unspecified date (Lot Number: unknown) as DOSE 1, 0.3 ML SINGLE both for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced COVID-19, with possible vaccine failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 (Positive Iu international unit). The clinical outcome of event Covid-19 was resolving. The reporter''s assessment of the causal relationship of the [Drug Ineffective and COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1835171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-09-27
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101384171

Write-up: Facial paresis/left side of her face stopped working; This is a spontaneous report from a contactable consumer downloaded from a Regulatory Authority. The regulatory authority number is SE-MPA-2021-088311. A 31-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 03Aug2021 (lot number: FE8235), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced facial paresis. The patient went to the emergency room when the left side of her face stopped working. The outcome of the event was not resolved. The health authority assessed this report as serious (permanent disability). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1835836 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-09-27
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via a regulatory authority (Reference number: AT-BASGAGES-2021-050632) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3001939 and 3001531) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Company comment- This case concerns a 79-year-old, female patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 26th Oct 2021 contains no new information.; Sender''s Comments: This case concerns a 79-year-old, female patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1835853 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

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

Write-up: Dyspnoea; Tachycardia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NY20214729) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication. Concurrent medical conditions included Migraine (Prone to migraines). On 21-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment medications reported. Rechallenge was done and outcome was unknown. Company comment: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and tachycardia. The events dyspnoea and tachycardia occurred 6 days after the first dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. Vaccination with Pfizer''s Cominarty COVID-19 vaccine could be potentially confounder. The benefit-risk relationship of Spikevax is not affected by this report. The regulatory authority reported the same events associated with Spikevax and Comirnaty vaccination, without specifying the application date of Pfizer?s product, hence it is not possible to determine whether the adverse event could be related to one or the other vaccine. Dyspnea and tachycardia in a 17-year-old woman 6 days after the first injection of the COMIRNATY vaccine. Recovered 2 days later. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 27 Oct 2021. Other relevant history is updated. Reporter''s comments is updated.; Sender''s Comments: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and tachycardia. The events dyspnoea and tachycardia occurred 6 days after the first dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. Vaccination with Pfizer''s Cominarty COVID-19 vaccine could be potentially confounder. The benefit-risk relationship of Spikevax is not affected by this report. The regulatory authority reported the same events associated with Spikevax and Comirnaty vaccination, without specifying the application date of Pfizer?s product, hence it is not possible to determine whether the adverse event could be related to one or the other vaccine.


VAERS ID: 1835854 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Paresthesia; Hypoaesthesia; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-PC20214919) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paresthesia) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. EU/1/20/1507) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced PARAESTHESIA (Paresthesia) (seriousness criterion medically significant) and HYPOAESTHESIA (Hypoaesthesia). At the time of the report, PARAESTHESIA (Paresthesia) and HYPOAESTHESIA (Hypoaesthesia) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 27-Sep-2021. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 38-year-old female patient, with no relevant history reported, who experienced the serious unexpected AESI event of Paraesthesia and the unexpected non serious AESI event of Hypoaesthesia. The events occurred the same day of the first dose of Moderna COVID-19 Vaccine. The rechallenge was assessed as Not applicable by the RA and conservatively this information is retained in the case, however, rechallenge could be considered unknown, as the events happened immediately after the first dose of Moderna COVID-19 Vaccine and no information from the second dose is provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Route of administration information was given as injection prick. Company comment: This case concerns a 38-year-old female patient with no relevant medical history who experienced serious unexpected event of Paraesthesia and non-serious unexpected event of Hypoaesthesia. The events occurred on the same day after the first dose of Spikevax. As per SD, no rechallenge was done, and, therefore, recurrence is not applicable. Very limited information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 27 OCT 2021, translated route of administration information.; Sender''s Comments: This case concerns a 38-year-old female patient, with no relevant history reported, who experienced the serious unexpected AESI event of Paraesthesia and the unexpected non serious AESI event of Hypoaesthesia. The events occurred the same day of the first dose of Moderna COVID-19 Vaccine. The rechallenge was assessed as Not applicable by the RA and conservatively this information is retained in the case, however, rechallenge could be considered unknown, as the events happened immediately after the first dose of Moderna COVID-19 Vaccine and no information from the second dose is provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1837288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Disturbance in attention, Fatigue
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Concentration loss; COVID-19; Ehlers-Danlos syndrome; Excessive daytime sleepiness; Fatigue
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:unknon results; Comments: problems; Test Date: 20210927; Test Name: blood pressure; Result Unstructured Data: Test Result:unknown results; Comments: abnormal
CDC Split Type: BEPFIZER INC202101394930

Write-up: fatigue/ fatigue extreme; lack of concentration and difficulty studying; Blood pressure abnormal; This is a spontaneous report from a contactable consumer (parent) downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107737. A 14-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Sep2021 (Lot Number: FF4222) as single dose for covid-19 immunisation. Medical history included Ehler Danlos disease, covid-19, very intense fatigue (sleeps almost all day), lack of concentration and difficulty studying, BP problems. The patient''s concomitant medications were not reported. The patient experienced fatigue/ fatigue extreme (disability) on 27Sep2021, lack of concentration and difficulty studying (disability) on 27Sep2021, blood pressure abnormal (disability) on 27Sep2021. The patient suffered from a long covid for 7 months with very intense fatigue (sleeps almost all day), lack of concentration and difficulty studying, BP problems. Since the vaccination, the very intense fatigue and the lack of concentration have returned again. With the impossibility of following the courses normally. No improvement since onset of symptoms. They were going to have to cancel the second vaccine. Situations - Other: The poorly tolerated vaccine. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1837457 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, Hypersensitivity
SMQs:, Angioedema (broad), Parkinson-like events (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101414922

Write-up: Hypersensitivity reaction; Dysphonia; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021-25599. A 16-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FE8235), via intramuscular, on 27Sep2021 (at the age of 16-year-old) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 27Sep2021, the patient had hypersensitivity reaction and dysphonia. The events were reported serious because requiring hospitalization. The patient had recovered from the events on 27Sep2021. Sender''s comments: The case is serious and unlabeled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as probable. A causal relationship between COMIRNATY and hypersensitivity, dysphonia was assessed as being probable/likely No follow-up attempts are possible. No further information is expected.


VAERS ID: 1837754 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCPT7 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blepharospasm, Dizziness, Magnetic resonance imaging, Nervous system disorder, Paraesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Chronic coronary syndrome; Migraine; Panic attacks (due to claustrophobia)
Allergies:
Diagnostic Lab Data: Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101394705

Write-up: Paresthesia; the right half of the body (arm and leg) became weaker; Objects fell out of hand, everything started to shake; eye flickering was a frequent occurrence; dizziness; neurological failures began in the legs; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number is DE-PEI-CADR2021187300. A 23-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 27Sep2021 (Batch/Lot Number: SCPT7) as dose number unknown, 0.3ml single (at the age of 23 years old) for COVID-19 immunization. Medical history included migraine, panic attack due to claustrophobia, cardiac arrhythmia and chronic coronary. There were no concomitant medications. The patient experienced paresthesia (hospitalization, 3 days), dizziness, neurological failures began in the legs all on 27Sep2021, the right half of the body (arm and leg) became weaker, objects fell out of hand, everything started to shake and eye flickering was a frequent occurrence on 28Sep2021. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown results on an unspecified date. The outcome of paresthesia was recovering and other events was unknown. Sender comment: Do you or the person concerned have any known allergies? If so, what are they? No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1837849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-27
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Blood test, Eye disorder, Facial paresis, Investigation, Lip disorder, Physical examination, Reduced facial expression
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Blood test normal; Result Unstructured Data: Test Result:Strictly normal; Test Date: 20210927; Test Name: Analytical; Result Unstructured Data: Test Result:rigorously normal; Test Date: 20210927; Test Name: Pitres sign; Result Unstructured Data: Test Result:+; Test Date: 20210927; Test Name: Physical Examination; Result Unstructured Data: Test Result:non-epiphoric eupneic afebrile; Comments: GGC (good general condition), Pitres sign +, deviation of the labial commissure to the left, non-disfiguring at rest
CDC Split Type: ESPFIZER INC202101394884

Write-up: Bell''s palsy; weakness of one side of the face; difficulty making facial expressions; cannot close the right eye; deviation of the labial commissure to the left; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority-WEB, regulatory authority number ES-AEMPS-1025996. A 25-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 10Sep2021 (Batch/Lot Number: FG7898) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was not pregnant. Historical vaccine included COMIRNATY 1st dose (batch/lot number: FF2832) on 13Aug2021 for COVID-19 immunisation. The patient experienced bell''s palsy, weakness of one side of the face, difficulty making facial expressions, cannot close the right eye and deviation of the labial commissure to the left on 27Sep2021 with outcome of recovering. Further ADR description stated that the patient suddenly presented on 27Sep2021 weakness of one side of the face, difficulty making facial expressions, cannot close the right eye (went to the Emergency Room). She had not had a fever, no pain, has not been in contact with patients with influenza syndrome, has not felt cold. Has not been in contact with toxics, non-trauma. No personal history of interest. Physical Examination: non-epiphoric eupneic afebrile GGC (good general condition), Pitres sign +, deviation of the labial commissure to the left, non-disfiguring at rest. Analytical: rigorously normal. Main Diagnosis: Idiopathic (Bell''s) facial palsy type II of House Brackmann. Treatment included prednisone, vitamin complex B and artificial tears. Follow-up: The average recovery time was between 4-6 weeks, reaching up to 6 months for full recovery. Refer to ophthalmology if she will have dry eyes. The patient underwent lab tests and procedures which included blood test: strictly normal on 27Sep2021; analytical: rigorously normal on 27Sep2021; Pitres sign + on 27Sep2021. Therapeutic measures were taken as a result of the events. The events resulted to Emergency Room Visit. No follow up attempts are possible. No further information is expected.


VAERS ID: 1837925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / 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? 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: 20210927; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:190/110 mmHg
CDC Split Type: FRPFIZER INC202101397835

Write-up: Crisis hypertensive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-DJ20214029. A 50-year-old male patient received bnt162b2 (COMIRNATY, dispersion to be diluted for injection. COVID-19 mRNA vaccine (modified nucleoside)), dose 1 intramuscular on 20Sep2021 (Batch/Lot Number: FG7387) 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 crisis hypertensive on 27Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 190/110 mmhg on 27Sep2021. Therapeutic measures were taken as a result of crisis hypertensive. Clinical summary: The declarant reports the occurrence, one week after the injection, of a surge of arterial hypertension (tension at 190/110) in this patient not known to be hypertensive. She specifies: LOXEN given quickly. In total, 50-year-old patient who presented a hypertensive crisis on Day 7 of a 1 dose of COMIRNATY. NB: A drug is coded in substance when the specialty name is not known. No follow-up attempts possible. No further information expected.


VAERS ID: 1838036 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute vestibular syndrome, Balance disorder, Condition aggravated, Dizziness, Ear discomfort, Immunisation, Off label use, Paresis, Tinnitus, Vertigo, Vestibular disorder, Vestibular function test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (narrow)

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: Hypertension (Both fairly well controlled); Type 2 diabetes mellitus (Both fairly well controlled)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Formal vestibular assessment; Result Unstructured Data: Test Result:acute unilateral (right sided) vestibular failure; Comments: Formal vestibular assessment carried out in Aug2021 were suggestive of acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis
CDC Split Type: GBPFIZER INC202101419389

Write-up: Vertigo/Vestibular vertigo; vomiting; Acute vestibular syndrome; Tinnitus; Dizziness; Balance disorder; Ear feels clogged/unilateral ear ''fullness''; seem to have got aggravated about 2 weeks after the booster COVID-19 vaccine; acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis; acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis; booster COVID-19 vaccine; booster COVID-19 vaccine; This is a spontaneous report from a contactable physician. This is second of two reports. The first report is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110171927505620-APVHR. A 59-year-old patient of an unspecified gender received third dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- FF8222) via an unspecified route of administration on 27Sep2021 as dose 3, (booster) single (at the age of 59-years-old) for COVID-19 immunization. Patient medical history included hypertension and type 2 diabetes mellitus (both fairly well controlled). The concomitant medications included influenza vaccine (split virion, inactivated) taken for immunization from 14Oct2021 to 14Oct2021 at a frequency of single dose. Historical vaccine received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route on 31Dec2020 as dose 1, single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER1749) via an unspecified route of administration on 18Mar2021 as dose 2, single for COVID-19 immunization, and experienced vertigo, vomiting, acute vestibular syndrome, vestibular vertigo, tinnitus, dizziness, balance disorder, ear feels clogged/unilateral ear fullness, acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis. Patient did not have a COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced vertigo, vomiting, acute vestibular syndrome, vestibular vertigo, tinnitus, dizziness, balance disorder, ear feels clogged/unilateral ear ''fullness'', acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis/ear disorder, and seem to have got aggravated about 2 weeks after the booster COVID-19 vaccine on an unspecified date in Oct2021. The patient underwent lab tests and procedures which included vestibular function test with result as acute unilateral (right sided) vestibular failure on an unspecified date in Aug2021. Formal vestibular assessment carried out on an unspecified date in Aug2021 were suggestive of acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis. The report did not relate to possible blood clots or low platelet counts. It started with severe vertigo, one episode of vomiting and tinnitus on 03May2021. Was treated by GP with prochlorperazine for about 2 weeks. The vertigo and tinnitus resolved in about 2 weeks but there was constant and persistent dizziness, balance disorder and unilateral ear fullness ever since. The symptoms appeared about 6 weeks after the second COVID-19 vaccine (Pfizer) dose and seem to have got aggravated about 2 weeks after the booster COVID-19 vaccine (Pfizer) dose. The outcome of events vertigo, vomiting, acute vestibular syndrome, vestibular vertigo, tinnitus, dizziness, balance disorder, ear feels clogged/unilateral ear ''fullness'', acute unilateral (right sided) vestibular failure and significant right-sided lateral canal paresis/ear disorder, and seem to have got aggravated about 2 weeks after the booster COVID-19 vaccine was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101400525 Same Patient/Product, Different Dose/Event


VAERS ID: 1838240 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative.
CDC Split Type: GBPFIZER INC202101417467

Write-up: Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is -202110201448131180-NBLF5, Safety Report Unique Identifier 26098868. A 29-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection), dose 1 via an unspecified route of administration on 25Sep2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Patient last menstrual period date was 17Oct2017. The patient''s concomitant medications were not reported. The patient previously took mirena. On 27Sep2021, the patient experienced vaginal bleeding (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test resulted in negative on an unspecified date. The clinical case narrative included: The patient had menstrual bleeding when on the mirena coil and have not had periods since being on this contraception. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of the event was recovered with sequel on 28Sep2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1838340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bipolar disorder, Cognitive disorder, Condition aggravated, Depression, Feeling of despair, Hunger, Hyperphagia, Loss of personal independence in daily activities, Memory impairment, Mood swings, Obsessive thoughts, Panic attack, Paranoia, Suicidal ideation
SMQs:, Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; Bipolar II disorder; Depression; Eating disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101414978

Write-up: MEMORY IS BAD; WORSENING OF DEPRESSION SYMPTOMS TO THE POINT OF DESPAIR; SUICIDAL; HEAD IS ALL OVER THE PLACE /NUMBNESS AND CONFUSION; EXCESSIVE HUNGER; RAPID CYCLING OF BIPOLAR MOOD; WORSENING OF DEPRESSION SYMPTOMS TO THE POINT OF DESPAIR / RAPID CYCLING OF BIPOLAR MOOD; WORSENING OF DEPRESSION SYMPTOMS TO THE POINT OF DESPAIR / FELT ABSOLUTE DESPAIR AFTER THIS VACCINE; RAPID CYCLING OF BIPOLAR MOOD; OBSESSIVE PARANOID THOUGHTS; HOW CAN A PERSON GO ABOUT THEIR DAILY ACTIVITIES IF THE VACCINE CAUSES SUCH NUMBNESS AND CONFUSION; OBSESSIVE PARANOID THOUGHTS; BAD PANIC ATTACKS; I HAVE AN EATING DISORDER BUT SINCE THIS VACCINE I CANNOT STOP EATING; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. Regulatory authority report number [IE-HPRA-2021-085317], Safety Report Unique Identifier [IE-HPRA-2021-085317]. A 37-years-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included depression, bipolar ii disorder, eating disorder, anxiety disorder. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) taken for depression, start and stop date were not reported. The patient experienced memory is bad on, worsening of depression symptoms to the point of despair, suicidal, head is all over the place /numbness and confusion, excessive hunger, rapid cycling of bipolar mood, worsening of depression symptoms to the point of despair / rapid cycling of bipolar mood, worsening of depression symptoms to the point of despair / felt absolute despair after this vaccine, rapid cycling of bipolar mood, obsessive paranoid thoughts, how can a person go about their daily activities if the vaccine causes such numbness and confusion, obsessive paranoid thoughts, bad panic attacks, i have an eating disorder but since this vaccine i cannot stop eating on 27Sep2021. Initial report received by the HPRA on 06Oct2021 from a member of the public reporting on behalf of herself. This report concerned a 37-year-old female who experienced panic attack, memory impairment, depression, condition aggravated, feeling of despair, mood swings, obsessive thoughts, hunger, cognitive disorder, paranoia, suicidal ideation, hyperphagia, bipolar disorder, loss of personal independence in daily activities following vaccination with Comirnaty, for COVID-19 immunization. Clinical course of events were reported as; On 22Sep2021, the patient was vaccinated with the first dose of Comirnaty (batch details unknown). 6 days later, on 27Sep2021, the patient experienced bad panic attacks, worsening of depression symptoms to the point of despair, rapid cycling of bipolar mood and obsessive, paranoid thoughts. She described feeling ""absolute despair after this vaccine, suicidal."" It was outlined in the report that the patient had an eating disorder but since the receiving the vaccine she experienced excessive hunger and could not stop eating. It was reported that the patient experienced memory impairment, described as ""memory is bad"" and their head was all over the place. The reporter commented on the effect on daily activities, due to the numbness and confusion caused by the vaccine. The reporter stated that the use of this vaccine needs to be looked at in people with mental health issues, as to exacerbate symptoms in those with pre-existing mental health issues could prove to be fatal. At the time of reporting the patient had not recovered. The clinical outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1838413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG5263 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Condition aggravated, Electrocardiogram, Investigation, Malaise, Office visit, Pericarditis, Ultrasound Doppler
SMQs:, Systemic lupus erythematosus (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
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: EUTIROX; DOBETIN [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hypothyroidism (after thyroid removal); Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:pericarditis with pericardial detachment; Test Name: investigation; Result Unstructured Data: Test Result:suspected endometriosis; Test Name: Cardiological examinations; Result Unstructured Data: Test Result:unknown; Test Name: cardiac color Doppler ultrasound; Result Unstructured Data: Test Result:unknown
CDC Split Type: ITPFIZER INC202101463851

Write-up: subsequent diagnosis of pericarditis with pericardial detachment; Pain in the heart; Malaise; condition aggravated; This is a spontaneous report from a contactable consumer reporting information for same patient. This is second of two reports, for the second dose. The first report was downloaded from regulatory authority report number IT-MINISAL02-801707. A 47-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 22Sep2021 (Batch/Lot Number: FG5263) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypothyroidism due to thyroid removal and suspected endometriosis. Concomitant medications included levothyroxine sodium (EUTIROX); cyanocobalamin (DOBETIN). The patient previously received first dose of bnt162b2 (COMIRNATY), dose 1 on 18Aug2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. The patient reports pain in the cardiac region that also occurred a few days after 1st dose of 18Aug2021 which was followed by investigations up to the first diagnosis of pericarditis; the clinical picture seems to be improving and the treating family doctor and cardiologist do not consider the patient exempt from the second dose which is regularly inoculated on 22Sep2021. After 5 days of second dose on 27Sep2021, the pain in the cardiac area reappears in a more violent and acute way. Several ECGs are performed to reach the diagnosis of "pericarditis with pericardial detachment" again. At the follow-up the patient confirms a much more intense and disabling symptomatology following the last dose with consequent state of malaise lasting more than 3 weeks. Pain in the heart and subsequent diagnosis of pericarditis with pericardial detachment after both doses of Comirnaty and significantly more acute and intense after the second. The patient experienced pain in the heart, subsequent diagnosis of pericarditis with pericardial detachment, malaise, condition aggravated on 27Sep2021 with outcome of not recovered. Events were assessed serious as life threatening. The patient received Cardiological examinations, cardiac color Doppler ultrasound every week; Brufen 600 mg x 3 / day, Colchicine tablet 1 mg / day for events. The events resulted Physician Office Visit. Reporter''s comments: Hypothyroidism due to thyroid removal and suspected endometriosis for which clinical investigations are underway. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Hypothyroidism due to thyroid removal and suspected endometriosis for which clinical investigations are underway.


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