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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 300 out of 7,116

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VAERS ID: 1589377 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Illness, Muscle spasms, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005878

Write-up: Vomiting; cramps; Sickness; nauseated; Diarrhea; cramps in belly; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041425006220-YWATE. Safety Report Unique Identifier GB-MHRA-ADR 25754022. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) at the age of 23-year-old as SINGLE DOSE for COVID-19 immunisation. Medical history included Lactation decreased, suspected COVID-19 from 07Apr2020 and ongoing, migraine. Concomitant medication(s) included codeine phosphate, paracetamol (CO-CODAMOL) taken for migraine, start and stop date were not reported. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced vomiting on an unspecified date, cramps on an unspecified date, sickness on 03Aug2021, nauseated on 02Aug2021, diarrhea on 02Aug2021, cramps in belly on 02Aug2021. The case was reported as serious due to medically important condition. The outcome of the events Sickness, nauseated and Diarrhea was not recovered, the outcome of the events Vomiting, cramps, and cramps in belly was recovering. The clinical course was reported as follows: "The night after getting the vaccine, I noticed cramps in my belly, nausea, and diarrhoea 4 times. The next morning I was still nauseated and diarrhea". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589383 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD88B / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005937

Write-up: Nausea; Headache; Fever; Fatigue; This is a spontaneous report from a contactable consumer or other non-professional. This is a report received from the regulatory authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108041527420020-BCAXK], Safety Report Unique Identifier [GB-MHRA-ADR 25754459]. A 40-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: FD88B), via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history included pregnancy. The patients concomitant medications were not reported. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient experienced fever and fatigue on 02Aug2021, nausea and headache on 03Aug2021. The patient not had symptoms associated with COVID-19. The patient not had a COVID-19 test. The events were reported eventually medically significant. The outcome of the events was recovered for Nausea on 04Aug2021, recovering for fever, headache, fatigue. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza like illness, Insomnia, Ocular discomfort, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005785

Write-up: headache; tiredness; Flu like symptoms; I also struggled to sleep on the night of the jab; pressure behind the eyes; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041918396710-7PXUF, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25756193. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Lot Number: FE3143) as dose 2, single, and via an unspecified route of administration on unknown date as dose 1 single for COVID-19 immunisation. Medical history included suspected covid-19 from 07Jan2021 to 17Jan2021. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Approx 8/10 hours after vaccination I began to develop flu like symptoms. Including headache, pressure behind the eyes and tiredness. I also struggled to sleep on the night of the jab. These symptoms were identical after both my 1st and 2nd jab. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Jan2021 Yes - Positive COVID-19 test. Outcome of event Flu like symptoms was recovering, of others was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-02
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Feeling abnormal, Headache, Menstrual disorder, Pneumonia, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Lactation decreased; Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012884

Write-up: pneumonia; headache; knocked out; period came on early; felt incredibly weak; Headache dull; Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108050803411150-RSF4V. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8813), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, pneumonia from 2019 to an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Patient was not enrolled in clinical trial. The patient concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, headache, knocked out, period came on early. On 02Aug2021, the patient experienced fever and headache dull. The patient felt incredibly weak, this headache wouldn''t go away, her period came on early and had a fever for 3 days. She was knocked out for two days. All the events were reported as serious-medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. Patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of events period came on early, pneumonia, headache and knocked out was unknown. The clinical outcome of events headache dull and fever was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589492 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia, Somnolence, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting; Food poisoning; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012766

Write-up: Fainting; muscle pain; fever; headache; fatigue; Vomiting; tired; slept; nauseous; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051400212120-V35GH. Safety Report Unique Identifier GB-MHRA-ADR 25759781. A 32-year-old non pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on 02Aug2021 at 08:30 (at the age of 32years), as a single dose for COVID-19 immunisation. Medical history included food poisoning (over the last few years if I have had food poisoning (vomiting) then this has been accompanied by fainting episodes too), suppressed lactation, and syncope, were from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was unknown), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. After receiving second dose of vaccine at on 02Aug2021 (at 8.30am), at 4.30pm, patient felt tired and nauseous, went to bed, slept until 7.30pm, 11pm vomiting started, then went back to bed and slept. Work up on Tuesday (03Aug2021) at 4.30am, there was more vomiting, followed by bought of fainting and vomiting until approx. 6am. Tuesday (03Aug2021) morning and afternoon fever, fatigue, headache and muscle pain. No relevant investigations or tests conducted. The outcome of the event fainting was recovered on an unknown date in 2021, and the other events was recovering. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: ''None'' No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101012821

Write-up: Headache; Tiredness; Aches & pains in legs; This is a spontaneous report from a contactable consumer or other non HCP received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051530067030-XX0ZG, Safety Report Unique Identifier GB-MHRA-ADR 25760334. A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date and unknown if ongoing Unsure when symptoms started Unsure when symptoms stopped. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient experienced headache, tiredness, aches & pains in legs on 02Aug2021. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Yes - Positive COVID-19 test) on an unspecified date. The outcome of event Tiredness was not recovered; outcome of event headache was recovering and outcome of event Aches & pains in legs was recovered. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1589763 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Allergy alert test, Anaphylactic reaction, Bradycardia, Dyspnoea, Electrocardiogram, Hyperhidrosis, Hypotension, Palatal oedema, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Urgent allergy test booked; Result Unstructured Data: Test Result:unknown results; Test Name: electrocardiography; Result Unstructured Data: Test Result:RS 60 bpm
CDC Split Type: ITPFIZER INC202101010465

Write-up: Syncope; Hypotension; Oedema uvula; Bradycardia; Diaphoresis; Dyspnea; Suspected anaphylaxis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-765953. A 27-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF7481; Expiration Date: 30Nov2021), dose 1 intramuscular, administered in Arm Left (left shoulder) on 02Aug2021 11:23 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced syncope, hypotension, oedema uvula, bradycardia, diaphoresis, dyspnea, suspected anaphylaxis. The events syncope, hypotension, oedema uvula, bradycardia, diaphoresis, dyspnea led to hospitalization and the events syncope, bradycardia and suspected anaphylaxis were considered medically significant. The patient underwent lab tests and procedures which included allergy alert test: unknown results and Alerted 118, performed electrocardiogram: RS 60 bpm on an unspecified date. Therapeutic measures were taken as a result of syncope, hypotension, oedema uvula, bradycardia, diaphoresis, dyspnea. Suspected anaphylaxis (mild edema of the uvula, diaphoresis, syncope, bradycardia, hypotension, subjective dyspnea) in subjects with a mute allergological history and silent APR. Actions taken (Peripheral venous catheter placement, administration of crystalloids 500 cc (cubic centimetre) + Solu-Medrol 1000 mg intravenous bolus + Trimeton 1 vial intravenously in 100 cc (cubic centimetre) slow flux + glucose 1 vial intravenously. Oxygen 6 L/min mask with reservoir. Reporter comment: Patient receiving 1st dose of Covid19 vaccine with Comirnaty (Pfizer/BioNTech). Silent remote pathological history, silent allergological history. Immediately after vaccine administration syncope, diaphoresis, hypotension, bradycardia, mild oedema of the uvula, subjective dyspnoea. Urgent allergy test booked. The outcome of events was recovering. Reporter comment: Patient receiving 1st dose of Covid19 vaccine with Comirnaty (Pfizer/BioNTech). Silent remote pathological history, silent allergological history. Immediately after vaccine administration syncope, diaphoresis, hypotension, bradycardia, mild oedema of the uvula, subjective dyspnoea. Urgent allergy test booked.


VAERS ID: 1589846 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Condition aggravated, Oropharyngeal discomfort
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101000912

Write-up: Pharynx strange sensation of (symptom aggravated); Pharynx strange sensation of (symptom aggravated); This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21122418. A 40-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: EY0583; Expiration Date: 31Oct2021), via an unspecified route of administration on 02Aug2021 17:11 (at the age of 40-years-old) at dose 2, single for covid-19 immunization. The patient had relevant med history of bronchial asthma. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees Centigrade. Event onset date was reported as 02Aug2021 17:30. The course of the event was as follows: 15 minutes after vaccination, Pharynx strange sensation of appeared. Then, the strange sensation was increased and EPIPEN was given. 5minutes later, the symptom became better. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Pharyngeal swelling(mild), but the symptom aggravated, so the patient was given EPIPEN 0.3. On 02Aug2021 (the day of vaccination), the outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589860 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia oral, Vital signs measurement
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Medical History/Concurrent Conditions: Urticaria chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210802; Test Name: Vital signs; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202101001754

Write-up: Numbness lips; This is a spontaneous report from a contactable physician. This is a report received from the Pharmaceuticals and Medical Devices Agency (PMDA). The regulatory authority report number is v21122371. A 37-year and 5-month-old female patient received BNT162B2 (COMIRNATY; lot number: FF0843 and expiration date: 31Oct2021), via an unspecified route of administration on 02Aug2021 at 15:13 (the day of vaccination), at the age of 37-year and 5-month-old), dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 36.4 Centigrade. Medical history included urticaria chronic. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation and experienced dyspnoea, vomiting, diarrhoea. The clinical course of the event was as follows: On 02Aug2021 at 15:13 (the day of the vaccination), the patient had numbness lips. Vital signs were stable and there were no wheezing or stenotic sounds on auscultation. After intramuscular injection of polaramine, the patient symptoms disappeared and the condition was stable, and went home. The outcome of the event was unknown. The reporter classified the event as non-serious and the causality between the event and BNT162B2 as unassessable. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1589880 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Contusion, Fall, Loss of consciousness, Pallor, Presyncope, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210802; Test Name: vital signs; Result Unstructured Data: Test Result:No abnormal vital signs; Comments: No abnormal vital signs
CDC Split Type: JPPFIZER INC202101003138

Write-up: Vasovagal reflex; Pallor facial; fell forward (right frontal bruise?); right frontal bruise; Loss of consciousness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122484. The patient was a 28-year old male (age at vaccination). Body temperature before vaccination on 02Aug2021 was 35.8 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 02Aug2021 at 15:05 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot# FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 02Aug2021 at 15:16 (11 minutes after vaccination), the patient experienced vasovagal reflex. On 02Aug2021(the day of vaccination), the outcome of the events was recovered. The course of the event was as follows: Loss of consciousness and fell forward (right frontal bruise?), Pallor facial. Regained consciousness while moving to a stretcher. No abnormal vital signs. No treatment after that. The reporting physician classified the event as non-serious and assessed that the event related to bnt162b2.


VAERS ID: 1589883 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
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: 20210802; Test Name: PCR; Test Result: Positive
CDC Split Type: JPPFIZER INC202101004357

Write-up: PCR positive; PCR positive; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first vaccination was tested PCR positive in the time between the first and second dose, and was considering whether get the second vaccination. The patient was resting at home. On 15Jul2021, received the first dose. Second dose was scheduled on 04Aug2021, PCR positive on 02Aug2021, and was postponed today. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events


VAERS ID: 1589955 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: PCR; Test Result: Negative ; Comments: covid test, Nasal Swab
CDC Split Type: JPPFIZER INC202101029618

Write-up: Pericarditis; This is a spontaneous report from a contactable pharmacist received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 45-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 24Jul2021 (Batch/Lot number was not reported) (at age of 45-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 was unknown. The patient experienced pericarditis (hospitalization, life threatening) on 02Aug2021 (9 days after the vaccination). The patient was hospitalized for pericarditis from 06Aug2021 (13 days after the vaccination) to an unknown date. Event details: On 02Aug2021 (9 days after the vaccination), the patient experienced Palpitations, Chest pressure sensation, general malaise, Dyspnoea exertional, and hospitalized from 06Aug2021 for Pericarditis. The event resulted in hospitalization and Life-threatening. The outcome of the event was recovered with treatment including rest and observing(as reported). Since the vaccination, the patient has been tested for COVID-19, included ''On 09Aug2021(16 days after the vaccination), PCR test by Nasopharyngeal swab with result of Negative''. The outcome of the event was resolved on unknown date. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event pericarditis and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1589998 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP068391

Write-up: Anaphylaxis (blood pressure decreased); This case was received via Agency Regulatory Authority (Reference number: 2021TJP068391) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case was reported by a physician via a medical representative. Anaphylaxis was assessed as serious by the Regulatory Authority. On 02-Aug-2021, at 13:28, the patient received the 1st dose of this vaccine. After the vaccination, the patient''s blood pressure decreased (80), so treatment with drip infusion was performed on the spot. The symptoms soon resolved, and the patient returned home. The outcome of anaphylaxis (blood pressure decreased) was reported as recovered. Follow-up investigation will be impossible. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590051 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072228

Write-up: Syncopal attack; Vasovagal reflex; This case was received via Pharmaceuticals (Reference number: 2021TJP072228) on 06-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21123139). Syncopal attack was assessed as serious by the MAH. On 02-Aug-2021, at 10:11, the patient received the 1st dose of this vaccine. At 10:16, after the vaccination, syncopal attack developed. The patient recovered consciousness soon. The patient improved at rest. There were no gastrointestinal, respiratory, or skin symptoms. Vasovagal reflex was considered. The outcome of syncopal attack and vasovagal reflex 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.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590052 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004495 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072229

Write-up: Syncope attack; Vasovagal reflex; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP072229) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a (physician), was received via the PMDA (Ref, v21123140). Syncope attack was assessed as serious by the MAH. On 02-Aug-2021, at 08:20, the patient received this vaccination (number of vaccinations is unknown). The patient experienced a syncope attack after vaccination. Consciousness improved soon. The patient recognized improvement in bed rest. No symptoms of digestive system, respiratory system, skin. It is considered to be a vasovagal reflex. The outcomes of vasovagal reflex and syncope attack were recovered, 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: It is considered to be a vasovagal reflex.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.


VAERS ID: 1590102 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Headache, Hyperventilation, Hypoaesthesia, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Convulsion
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP073410AA

Write-up: Hyperventilation attack (headache, difficulty in breathing, feeling numbness of limbs, lower abdominal pain); Strange feeling of pharynx; Hyperventilation attack (headache, difficulty in breathing, feeling numbness of limbs, lower abdominal pain); Hyperventilation attack (headache, difficulty in breathing, feeling numbness of limbs, lower abdominal pain); Hyperventilation attack (headache, difficulty in breathing, feeling numbness of limbs, lower abdominal pain); This case was received via Pharmaceuticals (Reference number: 2021TJP073410AA) on 05-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This case, initially reported to the Agency (A) by a (physician), was received via the A (Ref, v21122397). On an unknown date, the patient received the 1st dose of this vaccination. On an unknown date, the patient experienced a pyrexia and malaise. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 02-Aug-2021, at 09:50, the patient received the 2nd dose of this vaccination. At 10:20, the patient had a headache. At 10:30, the patient had a difficulty in breathing, feeling numbness of limbs, strange feeling of pharynx, lower abdominal pain. It was a symptom of hyperventilation attack. After an occupational health physicians examination, the patient was transported to the hospital by ambulance. At the time of visit, the patient had a tachypnoea, however, there was no other vital abnormality. There were a strange feeling of pharynx and lower abdominal pain. The patient went home, because the symptoms was improved after administrating H1, H2 blocker. The outcomes of hyperventilation attack (headache, difficulty in breathing, feeling numbness of limbs, lower abdominal pain), strange feeling of pharynx were resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590146 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Chest pain, Dizziness, Hyperhidrosis, Hypoaesthesia, Pain, Tachycardia, Tremor, Vision blurred
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101029240

Write-up: high blood pressure; chest pain; chest sting; hand tremor; sweating; blurry vision; dizziness; numbness of extremities; tachycardia; This is a spontaneous report from a contactable consumer (patient). Received via email. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: unknown), 02Aug2021 (at the age of 30-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient experienced tachycardia. On an unspecified date patient experienced high blood pressure, hand tremor, sweating, blurry vision, dizziness, chest pain, numbness of extremities, chest sting. Patient stated symptoms were present for about 3 hours, the time she was under observation. Fortunately, the symptoms were decreasing, but till date she still have some of them, such as tachycardia, dizziness and throbbing in the chest. She is consulting with a cardiologist and they are conducting several studies to verify that everything is fine. The outcome of events tachycardia, dizziness and chest sting was not recovered. Outcome for events high blood pressure, hand tremor, sweating, blurry vision, chest pain and numbness of extremities was unknown. Follow-up is need.


VAERS ID: 1590584 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824604

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095970] concerned a 38 year old female 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: 213C21A, expiry: unknown) dose was not reported, frequency time 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 11:10 the patient experienced elevated blood pressure (BP) and she underwent laboratory test included: Blood pressure with result 200/120 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210824604 -COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)


VAERS ID: 1590586 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210826248

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA-PH-PHFDA-300095935] concerned a 45 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 11:03, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210826248-COVID-19 VACCINE AD26.COV2.S-Elevated Blood pressure-.This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590603 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824122

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095983] concerned a 61 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: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 14:54, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 12-AUG-2021. Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from non serious to serious (other Medically Important Condition).; Sender''s Comments: V1: Additional version created as following information was amended: Event (elevated blood pressure) seriousness was updated from non serious to serious (other Medically Important Condition). 20210824122-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590857 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-08-02
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Electrocardiogram, Myocarditis, SARS-CoV-2 test, SARS-CoV-2 test positive, Troponin I
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: SARS-CoV-2 antigen test; Test Result: Positive ; Result Unstructured Data: COVID-19 antigen test positive; Test Date: 20210802; Test Name: Electrocardiogram; Result Unstructured Data: ST elevation in IIaVF and ST depression in V1; Test Date: 20210802; Test Name: Troponin I; Result Unstructured Data: increased; Test Date: 20210802; Test Name: Blood creatine phosphokinase; Result Unstructured Data: 70 U/L; Test Date: 20210802; Test Name: Blood creatine phosphokinase MB; Result Unstructured Data: 35U/L; Test Date: 20210802; Test Name: Coronary angiogram; Result Unstructured Data: coronary arteries were free of stenosis on coronary angiography (CAG)
CDC Split Type: JPTAKEDA2021TJP072317

Write-up: Myocarditis; SARS-CoV-2 antigen positive; This case was received via a Regulatory Authority (Reference number: 2021TJP072317) on 11-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This case, initially reported to a Regulatory Authority, was received via the PMDA (Ref, v21122903). On 26-Jun-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.5 degrees Celsius. On 31-Jul-2021, at 16:00, the patient received the 2nd dose of this vaccine. On 01-Aug-2021, pyrexia in the 38 degrees Celsius range developed. On 02-Aug-2021, at 10:00, the patient developed chest pain upon awakening. The patient visited a nearby hospital, and an electrocardiogram showed ST elevation; thus, the patient visited another hospital, and an electrocardiogram showed ST elevation in IIaVF and ST depression in V1. Blood test showed increased troponin I, creatine kinase (CK) of 70 U/L, and CK-MB of 35 U/L. The patient was diagnosed with myopericarditis and required hospitalization. Because the patient tested positive for SARS-CoV-2 antigen, the patient was transported to the hospital with a referral. All the items of multi-item nucleic acid tests were negative at the time of admission, and the coronary arteries were free of stenosis on coronary angiography (CAG). The patient received the diagnosis of myocarditis. The outcome of myocarditis and SARS-CoV-2 antigen positive was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Since the patient experienced myocarditis after the vaccination, the event is highly likely an adverse reaction.; Sender''s Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 antigen test positive and mRNA-1273 is assessed as not applicable. For Myocarditis: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, concurrent COVID-19 antigen test positive might be a confounding factor.


VAERS ID: 1590929 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Administration site pain, Blood pressure increased, Dermatitis allergic, Dizziness, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEBILET
Current Illness: Aneurysm cerebral; Arterial hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20210831993

Write-up: FAINTING; DIZZINESS; BLOOD PRESSURE INCREASED; ALLERGIC SKIN REACTION; HEADACHE; ADMINISTRATION SITE PAIN; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, RO-NMA-2021-SPCOV12184] concerned a 47 year old female. The patient''s weight was 74 kilograms, and height was 158 centimeters. The patient''s concurrent conditions included aneurysm cerebral, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C17-02 expiry: UNKNOWN) 1 dosage forms (total dose: 0.5 ml), 1 total, administered on 02-AUG-2021 for covid-19 immunisation. Concomitant medications included nebivolol hydrochloride for arterial hypertension. On 02-AUG-2021, the patient experienced fainting, dizziness, blood pressure increased, allergic skin reaction, headache and administration site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, dizziness, blood pressure increased, allergic skin reaction, headache, and administration site pain on 03-AUG-2021. This report was serious (Life Threatening).; Sender''s Comments: V0:20210831993-COVID-19 VACCINE AD26.COV2.S-Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1591023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Akinesia, Angiocardiogram, Cardiovascular disorder, Chills, Coronary artery dissection, Echocardiogram, Hypokinesia, Malaise, Myocardial infarction, Thrombocytopenia, Ventricular hypokinesia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Corongraphy; Result Unstructured Data: Test Result:spontaneous dissection at the distal left; Comments: spontaneous dissection at the distal left anterior descending artery (LAD); Test Name: Echocardiography; Result Unstructured Data: Test Result:hypo/akinesia apical
CDC Split Type: BEPFIZER INC202101054243

Write-up: hypo/akinesia apical; Chills; Akinesia; Myocardial infarction; Hypokinesia; based on spontaneous coronary dissection; Malaise; Cardiovascular problem; Thrombocytopenia; This is a spontaneous report from a contactable physician downloaded from the EMA EudraVigilance-WEB regulatory authority number BE-FAMHP-DHH-N2021-103941. A 28-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not provided. On 02Aug2021, the patient experienced chills (shivering), akinesia, myocardial infarction, hypokinesia, based on spontaneous coronary dissection (coronary artery dissection), malaise, cardiovascular problem (cardiovascular disorder), thrombocytopenia. The clinical course was reported as follows: Myocardial infarction based on spontaneous coronary dissection. All events reported as medically significant, hospitalized, and life-threatening. Lab data included Coronarography: spontaneous dissection at the distal LAD; Echocardiography: hypo/akinesia apical on unspecified date. Treatment received for events with drug therapy including antiplatelet therapy, neurohormonal blockade. Outcome of events was recovering. Reporter comments: Treatment - Yes Drug therapy: antiplatelet therapy, neurohormonal blockade. Evolution of the ADR - Recovering. Examinations - Coronarography: spontaneous dissection at the distal LAD Echocardiography: hypo/akinesia apical. ADR description - Myocardial infarction based on spontaneous coronary dissection. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Echocardiogram, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:no result available; Test Name: echocardiography; Result Unstructured Data: Test Result:no result available
CDC Split Type: DEPFIZER INC202101056131

Write-up: Lung embolism both sides; This is a spontaneous report from a not-contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB WWID reported as E2B Company Number DE-PEI-202100164941 from the Healthcare Authority. A 32-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 28Jul2021 (Batch/Lot Number: FE8405) at the age of 32-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: FD5996) at the age of 32-year-old as single dose for COVID-19 immunization. On 02Aug2021, the patient experienced lung embolism both sides. The patient performed echocardiography, computed tomography. Differential diagnosis excluded: pneumonia, heart failure, pneumothorax, left-Sided Heart Failure. Reaction(s) / Event(s) Assessed by PEI, Result of Assessment" "D. Unclassifiable". The event resulted in hospitalization. The outcome of event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1592227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (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? 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: DEJNJFOC20210839163

Write-up: MYOCARDITIS; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines] concerned a 22 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-AUG-2021, the patient experienced myocarditis, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210839163-Covid-19 vaccine ad26.cov2.s-Myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1592515 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210832145

Write-up: BRAIN FOG AND CONFUSION; FACIAL PARESTHESIA; SCALP PARESTHESIA; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, ES-AEMPS-972240] concerned a 46 year old male. The patient''s weight was 85 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-05 expiry: UNKNOWN) dose was not reported, 1 total administered on 11-JUN-2021 for covid-19 vaccination. The drug start period and drug last period was 53 days. No concomitant medications were reported. On 02-AUG-2021, the patient experienced brain fog and confusion, facial paresthesia and scalp paresthesia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial paresthesia on 02-AUG-2021, and had not recovered from brain fog and confusion, and scalp paresthesia. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210832145-covid-19 vaccine ad26.cov2.s -Brain fog and confusion. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210832145-covid-19 vaccine ad26.cov2.s -facial paresthesia , scalp paresthesia. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1592804 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MERCILON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012665

Write-up: Numbness in leg; Blurred vision; Numbness in hand; Pins and needles; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202108050941177250-2H4XR, Safety Report Unique Identifier GB-MHRA-ADR 25758288. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FD8813) (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding and was not enrolled in clinical trial. Concomitant medication included desogestrel, ethinylestradiol (MERCILON) taken for contraception from 01Jan2019 to an unspecified stop date. The patient experienced numbness in hand, pins and needles and blurred vision on 02Aug2021, numbness in leg on 05Aug2021. The events were reported as serious (Other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 02Aug2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Dizziness, Lacrimation increased, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Lacrimal disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005824

Write-up: Blurring of eyes; Watering eyes; Eyes heavy feeling of; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is . The 36-years-old male patient received DOSE 2 of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection) via an unspecified route of administration on 01Aug2021 as DOSE 2 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection) via an unspecified route of administration on an unknown date as for COVID-19 immunisation. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 02Aug2021 the patient experienced blurring of eyes, watering eyes, eyes heavy feeling and dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jul2021 No - Negative COVID-19 test. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Tinnitus
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012567

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108050914557000-NXKFX; safety report unique identifier: GB-MHRA-ADR 25758238). A 36-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Jul 30, 2021, single dose, for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient was not pregnant, nor currently breastfeeding. Concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, batch/lot# not known, expiry date: not reported), on an unspecified date, single dose, for COVID-19 immunization. The patient experienced chest pain on Aug 2, 2021, with outcome of recovered on Aug 4, 202; tinnitus on Aug 2, 2021, with outcome of not recovered; and back ache on Aug 2, 2021, with outcome of not recovered. Serious events (medically significant) by the regulatory authority. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1592875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Joint range of motion decreased, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012696

Write-up: Armpit pain; can''t move arm too much; gland in armpit is swollen and feels raised; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is G-MHRA-WEBCOVID-202108051054248990-OSB2A, Safety Report Unique Identifier -MHRA-ADR 25758691. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced gland in her armpit was swollen and feels raised. She can''t move her arm too much due to the armpit pain. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event armpit pain was not recovered while of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012479

Write-up: Spotting vaginal; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number: GB-RA-WEBCOVID-202108051225006000-CUS6D; Safety Report Unique Identifier: GB-RA-ADR 25759047. A 30-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Jul2021 (Batch/Lot Number: Not known) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced spotting vaginal. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on. Spotting vaginal outcome was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-02
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Influenza like illness, Lethargy, Lymph node pain, Lymphadenopathy, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pain of skin, Paralysis, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012730

Write-up: This is a spontaneous report from a contactable consumer (patient) received from the Agency. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 08Feb2021 (Lot Number: FF3319) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. Unsure if patient has had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Concomitant medications included citalopram and propranolol. On unspecified date, the patient experienced unable to move (paralysis), sore arm, muscle pain, lymph node under my arm swollen, unable to walk at normal speed, nor walk for very long at all, muscles feel weak and shaky and tire from walking very short distances. On 02Aug2021, the patient experienced lymph node pain, headache, flu like symptoms, chills, skin pain, muscle stiffness, lethargy. On 03Aug2021, the patient experienced generalized muscle weakness, nausea. "Sore arm, unable to move it for 2 days from the evening. Flu like symptoms that evening, with chills, headache and overall skin and muscle pain with stiffness. That lasted for the evening and the two days following. Lymph node under my arm swollen and painful, has not gone away. With that I have a great deal of nausea and am unable to walk at normal speed, nor walk for very long at all. Muscles feel weak and shakey when used and I tire from walking very short distances, such as across the room." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on unspecified date. Outcome of the events unable to move (paralysis), sore arm, muscle pain, generalized muscle weakness, lymph node pain, nausea, lethargy, lymph node under my arm swollen was not recovered. Outcome of the events headache, flu like symptoms, chills, skin pain, muscle stiffness was recovered on 04Aug2021. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592914 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Nausea, Off label use, Product use issue, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012737

Write-up: vomiting; nausea; lower back pain; Stomach cramps; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051352221030- AXMID, Safety Report Unique Identifier is GB-MHRA-ADR 25759770.This consumer reported information for both mother and fetus/baby. This is the maternal report. Only this case is serious. A 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Aug2021 at the age of 32 years old (Batch/Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. The patient experienced vomiting, nausea, lower back pain and maternal exposure during breast feeding all on an unspecified date; stomach cramps on 03Aug2021. The events were reported as serious (medically significant). Clinical course was reported as follows: The day after my vaccine, along with the nausea and eventual vomiting listed as common symptoms, I had very strong stomach cramps unless I was curled up in a ball on my side. It improved after I eventually vomitted close to 7 hours later. I now have what feels like period cramps despite not being due a period for another 3 weeks, and lower back pain, but they are not so severe that I cannot work. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test with No - Negative COVID-19 test result on an unknown date. The patient was recovering from stomach cramps while patient has not recovered from vomiting, nausea and lower back pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592920 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, Dyspnoea, Extrasystoles, Heart rate increased, Heart rate irregular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012916

Write-up: struggle to inhale; fast beats; misses a beat; Heartburn; Heartbeats irregular; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051446504870-2A5CU, Safety Report Unique Identifier GB-MHRA-ADR 25759946. An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced struggle to inhale on an unspecified date, fast beats on an unspecified date, heartburn on 02Aug2021, heartbeats irregular on 02Aug2021, misses a beat on an unspecified date. Extremely bad heartburn which has only occurred very early in the morning while sleeping. It has woken him up two days in a row. He had also been experiencing an irregular heartbeat. It almost feels like his heart "misses a beat" and then catches up with itself in a sequence of extremely fast beats. When this occurs, he struggled to inhale for a brief second. patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events struggle to inhale, fast beats was recovering; of the events heartburn, heartbeats irregular was not recovered, of the event misses a beat was unknown. The report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592946 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dyspnoea, Hallucination, Headache, Hyperhidrosis, Malaise, Memory impairment, Muscle twitching, Muscular weakness, Myalgia, Pyrexia, Respiratory rate increased, SARS-CoV-2 test, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101013008

Write-up: muscles sore; wheezy; hallucinating/Hallucination; unwell; memory goes hazy; sweaty/Sweating; Muscle weakness; Headache; Twitches; breathing became fast but laboured and wheezy; breathing became fast but laboured and wheezy; Fever/feverish; Joint pain; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108051715346530-KASSJ, safety report unique identifier is GB-RA-ADR 25760975. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Aug2021 (at the age of 27 years old) (Lot Number: Ff3319) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced muscles sore (medically significant) on an unspecified date, wheezy (medically significant) on an unspecified date, hallucinating/hallucination (medically significant) on an unspecified date, unwell (medically significant) on an unspecified date, memory goes hazy (medically significant) on an unspecified date, sweaty/ sweating (medically significant) on an unspecified date, fever / feverish (medically significant) on 02Aug2021, joint pain (medically significant) on 02Aug2021, muscle weakness (medically significant) on an unspecified date, headache (medically significant) on an unspecified date, twitches (medically significant) on an unspecified date, breathing became fast but laboured and wheezy (medically significant) on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No-Negative COVID-19 test) on an unspecified date. Clinical course: 12 hours after vaccine very quickly turned feverish. Joints were all agony if moved. Approximately 14 hours after vaccine and memory went hazy. Patient struggled to move any muscle and could not walk or change position. He was told by his partner that he was not responding to her when she spoke to me and appeared to be hallucinating. He was told breathing became fast but laboured and wheezy. 22 hours after the jab he woke up very sweaty but otherwise back to normal. For the rest of that day his mind was hazy and joints and muscles sore. Very strange. He has not ever felt that unwell. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event fever/feverish was recovered on 03Aug2021, of the event joint pain was recovering, of the event breathing became fast but laboured and wheezy was unknown, of the other events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Electrocardiogram, Feeling abnormal, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dementia (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 Name: blood pressure test; Result Unstructured Data: Test Result:unknown results; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101012945

Write-up: palpitations; He don''t feel himself and he feel slow; Palpitation; This is a spontaneous report from a contactable consumer(patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051943340420-POYKJ, Safety Report Unique Identifier GB-MHRA-ADR 25761502. A 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. The patient experienced palpitations on an unspecified date with outcome of recovering , palpitation on 02Aug2021 with outcome of not recovered, He don''t feel himself and he feel slow on an unspecified date with outcome of unknown. All events were assessed as serious with medically significant. It was reported that he don''t feel himself and he feel slow and he have constant palpitations. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Data included ECG(electrocardiogram), blood tests and blood pressure test on unknown date with unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101012682

Write-up: High temperature; Cold; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108052244130010-3EQ75, Safety Report Unique Identifier GB-MHRA-ADR 25762654. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (batch/lot number was not reported) as dose 1, single for Covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced cold on 02Aug2021 and high temperature on 05Aug2021. Outcome of the events was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. Additional information: Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593023 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101013025

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number (GB-MHRA-WEBCOVID-202108052310384900-RVSQQ). Safety Report Unique Identifier (GB-MHRA-ADR 25762686). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Medical history included suppressed lactation. Concomitant medication included Ramipril taken for Blood pressure high. The patient previously took the first dose bnt162b2 on unknown date for covid-19 immunization. The patient experienced swollen lymph nodes on 02Aug2021 with outcome of recovered on 04Aug2021. Seriousness criteria reported as medical significant. The patient underwent lab tests and procedures which included sars-cov-2 test negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1593033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negetive; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012599

Write-up: Insomnia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108060057486930-Y7LZL, Safety Report Unique Identifier is GB-MHRA-ADR 25762773. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced insomnia on 02Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The event was reported as serious, medically significant by the health authority. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014563

Write-up: Pain menstrual; This is a spontaneous report from a contactable consumer or non-health care professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060839146630-KTQIE. Safety Report Unique Identifier GB-MHRA-ADR 25763670. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included suppressed lactation. The patient received historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications were not reported. On 02Aug2021, the patient experienced pain menstrual which was assessed as serious (medically significant). The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014280

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number GB-MHRA-WEBCOVID-202108060914282940-AVGIK, Safety Report Unique Identifier GB-MHRA-ADR 25763836. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration on 01Aug2021 as dose 2, 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. Concomitant medication included fluoxetine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) on an unknown date as dose 1, single for COVID-19 immunisation. On 02Aug2021, the patient experienced diarrhea. Diarrhoea started the day after vaccine. The day of the vaccine she had some cramping in her stomach. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 04Aug2021, the event was recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1593101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Dyspnoea, Maternal exposure during breast feeding, Off label use, Palpitations, Product use issue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Neonatal exposures via breast milk (narrow), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014389

Write-up: shortness of breath; Maternal exposure during breast feeding; difficulty speaking for around 1.5 hours; Off label use; Drug use in unapproved population; Palpitations; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061111095550-QK8IP, Safety Report Unique Identifier GB-MHRA-ADR 25764396. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Jul2021 as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) for covid-19 immunization. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. On an unspecified date The patient experienced shortness of breath, maternal exposure during breast feeding, difficulty speaking for around 1.5 hours, off label use, drug use in unapproved population. On 02Aug2021 palpitations. Events were consider as medical significant. The outcome of event palpitations was resolving and for all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101020042 same drug, different patient, different event.


VAERS ID: 1593109 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Cough, Decreased appetite, Dizziness, Dysstasia, Fatigue, Movement disorder, Muscular weakness, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014565

Write-up: I felt so weak; I could barely move; unable to get up; Dizzy; Appetite lost; Joint pain; Painful cough; Sore throat; Muscle weakness; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061142384250-M5HS9, Safety Report Unique Identifier GB-MHRA-ADR 25764607. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (At the age of 28 year old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has 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 fatigue (medically significant) on 02Aug2021 with outcome of not recovered, dizzy (medically significant) on 03Aug2021 with outcome of not recovered, appetite lost (medically significant) on 03Aug2021 with outcome of not recovered , joint pain (medically significant) on 03Aug2021 with outcome of not recovered , painful cough (medically significant) on 03Aug2021 with outcome of not recovered , sore throat (medically significant) on 03Aug2021 with outcome of not recovered , muscle weakness (medically significant) on 03Aug2021 with outcome of not recovered , she felt so weak (medically significant) on an unspecified date with outcome of unknown , she could barely move (medically significant) on an unspecified date with outcome of unknown , unable to get up (medically significant) on an unspecified date with outcome of unknown. Clinical course was the following "So far I have been in bed for 5 days and unable to get up. It started with fatigue which was expected then the next day I could barely move I felt so weak and dizzy. The pain in my joints had me in tears. Doesn''t seem right that it should last this long". The patient underwent lab test which included sars-cov-2 test: negative on an unspecified date. Patient was not enrolled in clinical trial. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593146 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014581

Write-up: Cramp in hand; Hand rash/Extensive rash of forearm; This is a spontaneous report from a contactable consumer. This report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108061653547190-LYVEC. Safety Report Unique Identifier GB-MHRA-ADR 25766643. A 33-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1, via an unspecified route of administration on 31Jul2021 with unspecified Batch/Lot number as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced cramp in hand (medically significant) on 02Aug2021 with outcome of not recovered, hand rash/Extensive rash of forearm (medically significant) on 02Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Contusion, Lymphadenopathy, SARS-CoV-2 test, Vaccination site mass
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014876

Write-up: Injection site lump; Bruise; Swollen lymph nodes; Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108062027189010-PQDDX, Safety Report Unique Identifier GB-MHRA-ADR 25767928. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Aug2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced injection site lump (medically significant) on 03Aug2021, bruise (medically significant) on 03Aug2021, armpit pain (medically significant) on 02Aug2021, swollen lymph nodes (medically significant) on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event Armpit pain was recovered, of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Chest pain, Constipation, Ear pain, Hallucination, Hypersensitivity, Lymphadenopathy, Musculoskeletal stiffness, Photophobia, Pyrexia, Respiration abnormal, SARS-CoV-2 test, Sinusitis, Vertigo
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014453

Write-up: Abnormal breathing; Chest pain; Glands swollen; Allergic reaction; Vertigo; Ear pain; Constipation; Neck stiff; Bedridden; Light sensitivity to eye; Sinusitis; Fever; Hallucination; This is a spontaneous report from a contactable consumer (patient) received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108062247407960-TFEQQ, Safety Report Unique Identifier GB-MHRA-ADR 25768860. A 26-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Aug2021, as a single dose for COVID-19 immunization. The patient''s medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient has not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 02Aug2021, the patient experienced hallucination, fever, and sinusitis. On 03Aug2021, the patient experienced bedridden, light sensitivity to eye, constipation, and neck stiff. On 04Aug2021, the patient experienced glands swollen, allergic reaction, abnormal breathing, chest pain, vertigo, and ear pain. The patient had Covid vaccine and then a day later was really tired - woke up in the middle of the night unable to breathe, couldn''t stand up. Next day fell over whilst hallucinating and have vertigo at the same time. Throat had swollen and gland swollen that she could breathe, eat it drink anything. None of these were mild as suggested. She had to phone GP who suggested Urgent care due to the reaction of the vaccine. Young healthy person who hadn''t been ill in a year beforehand with no allergies. Could not go to work and lost a week''s worth of money. Knowing that another vaccine needs to be had was basically saying of you end up in hospital at least you won''t hurt anyone else. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021. Outcome of the event hallucination was recovered on 06Aug2021 and light sensitivity to eye was recovered on 05Aug2021. Outcome of the events glands swollen and allergic reaction was recovering and for all other events, it was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593255 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Medical History/Concurrent Conditions: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014294

Write-up: Headache; Ache; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108070704113970-GHULG, Safety Report Unique Identifier GB-MHRA-ADR 25769624. A 34-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 01Aug2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not recovered), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient''s medical history included suspected COVID-19 (unsure when symptoms started and when symptoms stopped) from an unknown date and unknown if ongoing, and inflammatory bowel disease (taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 02Aug2021, the patient experienced headache, ache, and nausea. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Outcome of the event nausea was recovering and for all other events, it was recovered on 05Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593335 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, 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 INC202101014547

Write-up: Swollen glands; Lymph gl; Swollen lymph nodes; 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-202108071730234220-SC21V, Safety Report Unique Identifier GB-MHRA-ADR 25770775. A 33-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) at the age of 33-year-old, dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FD8813) as dose 2, single for COVID-19 Immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced swollen glands on an unspecified date with outcome of unknown, lymph gl on an unspecified date with outcome of unknown, swollen lymph nodes on 02Aug2021 with outcome of recovering. Seriousness criteria of the events was medically significant. Patient has not had symptoms associated with COVID-19.Not had a COVID-19 test. The clinical course was reported as follows: Lymph gland under left armpit swollen for 4 days after second dose in left arm. Other aches and suspected swollen glands all down left side of body. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 0884 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Axillary pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014943

Write-up: 4-5 lumps at the left armpit; Armpit pain; This is a spontaneous report from a contactable consumer (patient)received from the Regulatory Authority.). The Regulatory Authority report number is GB-MHRA-WEBCOVID-202108080051027730-UUMEK, Safety Report Unique Identifier GB-MHRA-ADR 25770797. A female patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), dose 1 via an unspecified route of administration, administered in arm Left on 27Jul2021 (Batch/Lot Number: FF 0884) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial, has not had symptoms associated with COVID-19, did not have a COVID-19 test. The patient experienced armpit pain (disability) on 02Aug2021 with outcome of not recovered, 4-5 lumps at the left armpit (disability) on an unspecified date with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-02
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 antibody test
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result: positive for anti-spike protein antibody; Comments: positive for anti-spike protein antibody.
CDC Split Type: HKPFIZER INC202101046138

Write-up: CONFIRMED CASE OF COVID-19; CONFIRMED CASE OF COVID-19; This is a spontaneous report from a non-contactable healthcare professional via The Regulatory Authority (regulatory authority number: not provided), based on information received from BioNtech SE manufacturer control number: HK-Fosun-2021FOS002934, license party for bnt162b2 (COMIRNATY). This is one of two reports. As of 0:00 am, 05Aug2021, announced two additional confirmed cases of COVID-19 after vaccination with COMIRNATY. This case reported for 1 of 2 cases that confirmed COVID-19 after vaccination. A 24-year-old female patient (case No. 11998) started to receive 1st and 2nd dose of Tozinameran (COMIRNATY) (lot number: unknown) on 17Mar2021 and 09Apr2021 respectively for COVID-19 immunization. Vaccination route and dosing frequency of both doses were not reported. Medical history, concomitant medication(s) and past product were not reported. On 02Jul2021, the patients blood specimen tested positive for anti-spike protein antibody. Her symptom onset was on 02Aug2021. The event Confirmed case of COVID-19 was considered as Important Medical Event. 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 06Aug2021. This is one of two reports received from the same reporter and this case has been linked with others. Link numbers are as follows: 2021FOS002934 (master case) and 2021FOS002935. The causality assessment for the events Drug ineffective, Asymptomatic COVID-19 as per reporter was Possible and (BioNtech SE) was Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Linked Report(s): HK-PFIZER INC-202101046142 Same drug and event, different patient.


VAERS ID: 1593566 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003186 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling cold, Headache, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via Agency (Reference number: 767855) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE, FEELING COLD, HEADACHE and VOMITING in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003186) for COVID-19 vaccination. The patient''s past medical history included Neurasthenia. Concomitant products included OXCARBAZEPINE for an unknown indication. On 02-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Aug-2021, the patient experienced SYNCOPE (seriousness criterion medically significant), FEELING COLD (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). At the time of the report, SYNCOPE, FEELING COLD, HEADACHE and VOMITING was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up document contains no new information; Reporter''s Comments: Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1593581 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

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

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

Write-up: MIOCARDITE; This case was received via Medicines Agency (Reference number: 768410) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (MIOCARDITE) in a 14-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter once a day. On 02-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (MIOCARDITE) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (MIOCARDITE) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. 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. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1593584 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Neck pain, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via regulatory authority (Reference number: 768590) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN , OROPHARYNGEAL PAIN and LYMPHADENOPATHY in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 immunisation. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced NECK PAIN (seriousness criterion disability), OROPHARYNGEAL PAIN (seriousness criterion disability) and LYMPHADENOPATHY (seriousness criterion disability). At the time of the report, NECK PAIN, OROPHARYNGEAL PAIN and LYMPHADENOPATHY had not resolved. No concomitant medications were reported. Treatment information was not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1593668 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal sensation in eye, Body temperature, Facial paralysis, Headache, Taste disorder
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain contusion; Insomnia; Subarachnoid haemorrhage (without sequel)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101023555

Write-up: Taste disorder of left tongue; Left eye strange sensation of; Facial palsy; Acute onset of headache; This is a spontaneous report from contactable physicians received from the Agency. Regulatory authority report number is v21122660. A 53-year and 0-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0348, Expiration date 31Oct2021), at the age of 53 years old, on 30Jul2021 at 11:18 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees Centigrade. Patient''s medical history according to the Vaccine Screening Questionnaire included insomnia, brain contusion and subarachnoid haemorrhage (without sequel). The patient''s concomitant medications were not reported. On 30Jul2021 at 11:18 (the day of vaccination), the patient received the first dose of BNT162B2. On 02Aug2021 at 14:00 (3 days and 2 hrs 42 min after the vaccination), the patient experienced facial palsy. On 03Aug2021 (4 days after the vaccination), the patient was admitted to the hospital. On 06Aug2021 (7 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 02Aug2021 at around 14:00, the patient experienced acute onset of headache. Around 16:00, the patient became aware of left eye strange sensation of. Water spilled from left corner of the mouth when the patient brushed teeth. On 03Aug2021, the symptom did not recover and left eye strange sensation of aggravated. After that, the patient ate something that was not sweet, but felt sweet, so the patient became aware of taste disorder of left tongue. After visiting clinic, the patient was introduced to visit our hospital. It was diagnosed as facial palsy and the patient was hospitalized. The patient was being administrated with steroid via DIV. The outcome of events was not recovered. The reporting physician classified the event as serious (hospitalized from 03Aug2021) and assessed that the event was related to BNT162B2. Other possible cause of the event such as any other diseases was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1594001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-02
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101038855

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (report number: SE-MPA-2021-070845). A 51-year-old male patient received the second dose of BNT162B2 (Comirnaty, batch/lot# FD6840), via an unspecified route of administration, on Jul 1, 2021, single dose, for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication not reported. On Aug 2, 2021, one month after the second vaccination dose, bone marrow thrombosis and swelling in the right leg and knee. The patient went to the emergency room where they found a blood clot. The outcome of events: not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1624578 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Chest discomfort, Diarrhoea, Dyspnoea, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IBUPROFEN ORIFARM; TOBRADEX; ALVESCO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Eye infection; Eye inflammation; Muscle pain; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101018843

Write-up: Pressure on the chest; Dyspnoea; Nausea; Muscle soreness; Headache; Diarrhea; Upset stomach; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0082332. A 39-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC5029; Expiration Date: 31Oct2021), via an unspecified route of administration on 02Aug2021 (at the age of 39-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included asthma, muscle pain, pain, eye infection and eye inflammation. Concomitant medications included paracetamol ("PARACETAMOL SCANPHARM") taken for pain from 03Sep2019 to an unspecified stop date, ibuprofen (IBUPROFEN ORIFARM) taken for muscle pain from 25Feb2021 to an unspecified stop date, dexamethasone, tobramycin (TOBRADEX) taken for eye infection from 06Feb2020 to an unspecified stop date and ciclesonide (ALVESCO) taken for asthma from 18Sep2020 to an unspecified stop date. The patient received historical vaccine including bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC5029; Expiration Date: 31Oct2021), via unspecified route of administration on 22Jun2021 for COVID-19 immunization and had no adverse reaction. On 02Aug2021, the patient experienced pressure on the chest, nausea, muscle soreness, headache, diarrhea, dyspnoea and upset stomach. The outcome of the events headache, diarrhea, dyspnoea and upset stomach was not recovered. The outcome of the other events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1624944 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Cerebrovascular accident, Emotional distress, Facial paralysis, HIV test, Hemiplegia, Hypoaesthesia oral, Magnetic resonance imaging, Malaise, SARS-CoV-2 test, Shock
SMQs:, Anaphylactic reaction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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; HIV pre-exposure prophylaxis; Stroke; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: HIV test; Result Unstructured Data: Test Result:Unknown results; Test Name: HIV test; Test Result: Negative ; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201020; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101021455

Write-up: stroke; shock; mental health has been compromised; I wasn''t feeling well at all; Bell''s palsy; paralysis went onto the right side of his face; I started to feel my teeth and lips started to get some kind of numbness; Paralysis/ left side of his body and face was completely paralysed; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210808103011. Safety Report Unique Identifier GB-MHRA-ADR 25771297. A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (at the age of 26 year old) (Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included stroke, suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped), and PrEP (specific use of antiviral drugs as a strategy for HIV/AIDS prevention) from unknown dates and COVID-19 from 20Oct2020. The patient''s concomitant medications were not reported. The patient experienced stroke and shock on an unspecified date, started to feel his teeth and lips started to get some kind of numbness, and paralysis/ left side of his body and face was completely paralysed on 02Aug2021, he wasn''t feeling well at all, Bell''s palsy, and paralysis went onto the right side of his face on 03Aug2021, and mental health has been compromised on an unknown date. On the 02Aug2021, at 14:00pm patient attended to the Vaccination Center to get his second dose of the Pfizer Vaccine. He stayed in during 20min after he got vaccinated and then head to his place and 1h later he started to feel his teeth and lips started to get some kind of numbness, he didn''t really expected this was going to be as hard as it''s been. All of a sudden around 17:00pm the left side of his face was completely paralysed. He went to visit his partner and around 20/21h he was laying down in bed and felt the left side of his body and face was completely paralysed, he couldn''t move, he couldn''t feel anything on that part of his body. He recall himself trying to call 111 for him to try to get an ambulance until 3:30am, however, they couldn''t attended to assist him. His partner called back 111 and they did a video consultation and by that time around 4am he was able to move his body again, the video consultation was for then to make sure there was no indication of being a Stroke. They try to get them an appointment to be able to attended to the hospital and be able to be assisted as soon as possible, however he wasn''t feeling well at all and he couldn''t go to the hospital. The following morning Tuesday the 03Aug, he woke up around 13h and he wasn''t feeling well at all, once he woke up, he felt realised that the paralysis went onto the right side of his face, where it''s currently affecting him. His partner decided to take him to the hospital and they got there around 15h. He had to wait until he was assisted. The first nurse who help him, she was super nice and very understanding. She check once again for any sign of a stroke and then, she mentioned it could be something called Bell''s Palsy. The nurse needed to consult with a doctor. Once this Dr (a lady) came and she was assisting the patient. She made a few questions regarding what happened and she also mentioned it could be a Bell''s Palsy, however, due to half of his body was paralysed, she was not sure this was going to be this condition (Bell''s Palsy). At some point she asked the patient if had taken or was taking any regular medications, he mentioned he used to take PrEP (Pre-exposure prophylaxis is the use of medications used to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent, usually a virus. The term typically refers to the specific use of antiviral drugs as a strategy for HIV/AIDS prevention.) When he mentioned this to the Dr, she asked him what PrEP was? And also, why he used to take this meditation? He had to explain himself, and mentioned he was gay and the reason why he used to take PrEP. He felt she was being very judgemental and he felt somehow very uncertain if she was a good Dr or not? He felt very humiliated in that moment. The Dr had to get a consultant with 2/3 more specialist and she mentioned that he was taking prep and that he was homosexual. He overheard she was discussing the fact that PrEP might have been the cause of this reaction in my face. Straight away she mentioned that they were going to take some blood sample, to double check his HIV Status. Per se. he told her he was negative and she questioned him, how do you know? He said, well he has just attended the previous week to Sexual Health Clinic and that his results were negative. Either way, they took the blood samples and she refer him for an MRI the next morning and discharge him. The following morning, Wednesday the 04Aug, he went back to (Name) Hospital for his MRI, at 9 am he was supposed to check in with Dr (name), as he was going to talk about the blood samples results and the MRI results. This didn''t happened until 10:30am the same Wednesday. He was on his own in the hospital and once hegot to see the Dr, there were a few more practitioners with him and that was very overwhelming, he seated in a room with 5 Drs and he couldn''t make any sense of what they were saying he was a bit in shock because of what''s happening to me. The only thing he recall is that Dr (name) referred him to Neurophysiology the sahim morning. Once the neurophysiologist saw him, he went back to see Dr (name) and he mentioned that the results were that there was a delay muscle response from his facial and neck muscles and that definitely what has happened to his face it''s a condition called Bell''s palsy, however because of the paralysis in his body and they weren''t sure if this had occurred because of the vaccine, once again they mentioned they needed to take blood samples because of the fact that he used to take PrEP and they wanted to make sure he was HIV Negative. He felt this day the medicine was trying to blahim HIV to be the causes of what has happened to his face. Being a gay man it''s very disrespectful when a Dr who has seen plenty of cases related to COVID 19, blames the fact that a disease can cause Bell''s Palsy, but also the fact that a two Dr were telling him that he might be HIV Positive, he felt very scared and humiliated as he mentioned before. Today 8Aug, he was in his flat, not wanting to go out because of the reaction he has had to the second Pfizer vaccine. He knows there has been a lot of people who might have been lucky enough not to has any bad reactions to this jab. His mental health has been compromised, his confidence. Just because of the fact that they need to get this vaccine for at least be able to travel and visit our families abroad. He has had a bad reaction to his second dose of Pfizer Vaccine and it has compromised his mental health. Patient is not enrolled in clinical trial. He will have to go back to (name) Hospital for another MRI and also for another HIV test. The events were reported as medically significant and disabling. The patient underwent lab tests and procedures which included covid-19 virus test: positive on 20Oct2020 Yes - Positive COVID-19 test, HIV test: negative, HIV test: unknown results and MRI: unknown results on an unknown date. The outcome of stroke, shock, and numbness mouth was recovering, paralysis/ left side of his body and face was completely paralysed was not recovered, while the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624955 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Eye disorder, Limb discomfort, Malaise, Nausea, Photopsia, Vitreous floaters, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101017240

Write-up: nausea; vomiting; unwell; light flashes in both eyes; right arm felt bruised and heavy; right arm felt bruised and heavy; eye disturbance: floaters, squiggly lines, spiderweb; eye disturbance: floaters, squiggly lines, spiderweb; This is a spontaneous report from contactable consumers. This is a report received from the regulatory authority. The regulatory authority report number is , Safety Report Unique Identifier . A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) (at the age of 40-year-old) as dose 2, single for COVID-19 immunization . Medical history included pregnancy from an unknown date and unknown if ongoing.The patient''s concomitant medications were not reported. On 02Aug2021, the patient received vaccine early morning, no side effects until late evening, the patient experienced right arm felt bruised and heavy, then developed eye disturbance: floaters, squiggly lines, spiderweb and light flashes in both eyes. Next day (03Aug2021), the patient still having eyes disturbance accompanied by nausea and vomiting and an overall unwell feeling. The outcome of the events was recovering. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1624959 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Decreased appetite, Dizziness, Fatigue, Limb discomfort, Musculoskeletal chest pain, Nausea, Pain, Paraesthesia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101026760

Write-up: Pins and needles; Fatigue extreme; Nausea; Pain; decreased appetite; dizziness; fatigue; heaviness in injection site (Left arm); Pain and heaviness in injection site (Left arm).; Pain in left side of body (under arm, shoulder, ribs); Pain in left side of body (under arm, shoulder, ribs); Pain in left side of body (under arm, shoulder, ribs); This is a spontaneous report from a contactable consumer received from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202108041155411280-KXLVP. Safety Report Unique Identifier (GB-MHRA-ADR 25752869). A 37-year-old female non-pregnant patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Fe3380), via an unspecified route of administration on 02Aug2021 (37-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included Lactation decreased from an unknown date and unknown if ongoing. Relatively fit and healthy. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced, fatigue extreme and nausea on 02Aug2021, pins and needles on 03Aug2021. On an unspecified date on 2021, the patient experienced decreased appetite, dizziness, fatigue, pain, Pain and heaviness in injection site (Left arm), Pain in left side of body (under arm, shoulder, ribs). Immediate dizziness/ nausea followed by extreme fatigue. Nausea and extreme fatigue persistent and ongoing. Pins and needles started within 24 hrs of vaccine- all over body and what feels like internally. Ongoing but helped by paracetamol. Pain and heaviness in injection site (Left arm). Pain in left side of body (under arm, shoulder, ribs) 30+ hrs ongoing but helped with paracetamol. Increased water intake. The events were reported as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 28Jun2021 Negative COVID-19 test. The outcome of the events nausea, pins and needles, fatigue extreme was not recovered and recovering for other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624963 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Disturbance in attention, Fatigue, Hypoaesthesia, Lymphadenopathy, Neck pain, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Comments: No other illnesses or medicines Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014621

Write-up: pain; numbness; Neck pain; Glands swollen; Pains in legs; Concentration loss; Tiredness in legs/tiredness; Fatigue/tired; Pain in arm; no energy; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061129510400-LA2UR. Safety Report Unique Identifier GB-MHRA-ADR 25764560. A 36-years-old male patient received the second dose of BNT162B2, via an unspecified route of administration on 01Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient has no medical history and concomitant medications (no other illnesses or medicines). Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test . The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunisation. The patient experienced pain and numbness on an unspecified date with outcome of unknown, tiredness/tiredness in legs on 02Aug2021 with outcome of recovering, fatigue/tired on 02Aug2021 with outcome of not recovered, pain in arm on 02Aug2021 with outcome of recovered on 04Aug2021, no energy on 02Aug2021 with outcome of not recovered, glands swollen on 03Aug2021 with outcome of not recovered, pains in legs on 03Aug2021 with outcome of not recovered, concentration loss on 03Aug2021 with outcome of not recovered and neck pain on 04Aug2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Really tired, no energy, pain and tiredness in legs, glands swollen at ear and on neck. Struggling to concentrate. Days off work due to this . No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1624974 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Fatigue, Hyperhidrosis, Pain, Productive cough, Pyrexia, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high; Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014594

Write-up: Chesty cough with yellow/green phlegm; Pain/Body aches; Tiredness; Fever/High temperature; Body sweats; Loss of appetite; Respiratory infection; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108070629123720-QRUCZ, Safety Report Unique Identifier GB-MHRA-ADR 25769485. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 02Aug2021 (at the age of 36 years old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Concomitant medications were not reported. The patient experienced respiratory infection on 02Aug2021, chesty cough with yellow/green phlegm, pain/body aches, tiredness, fever/high temperature, body sweats, loss of appetite all on an unspecified date. The events were medically significant. The patient underwent other lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 03Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Therapeutic measures were taken as a result of pain/body aches and included treatment with paracetamol that does not help with the pain. Outcome of the respiratory infection was recovering while of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1624990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101021830

Write-up: Arthritis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108080854194980-B0YUY, Safety Report Unique Identifier GB-MHRA-ADR 25771181. A 32-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suppressed lactation, rheumatoid arthritis and taking regular medicines. The patient had not been diagnosed but on anti inflammatorys and pain relief for joint pain. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medication included regular medicines for rheumatoid arthritis, and anti inflammatorys and pain relief for joint pain. The patient experienced Arthritis on 02Aug2021. The patient had Flared up joint pain in all joints. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of the event was not resolved. The event was serious with medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1625717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DULOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101016956

Write-up: Miscarriage; Headache; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00655086. A 33-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number: FE4728, expiration date unknown) via an unspecified route of administration on 01Aug2021 at 0.3 mL for COVID-19 immunisation. Medical history was not reported. Concomitant medications included duloxetine. Patient previously received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) on 25Jun2021 for COVID-19 immunization and the first Covid vaccination took place before pregnancy. Patient had no previous COVID-19 infection. Other diagnostic procedures was Echo with unknown results. The patient experienced miscarriage (other medically important condition) on 02Aug2021, headache on 02Aug2021. This was the second Covid vaccination, which took place at a pregnancy duration of about 4 weeks. The miscarriage occurred 1 day after this vaccination. The first Covid vaccination took place before pregnancy. Headache was treated with unknown treatment. Outcome of miscarriage was unknown, of headache was not recovered. No follow-up attempts are possible; no further information expected.


VAERS ID: 1625771 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839378

Write-up: Cough; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300098302] concerned a 66 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 25-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-AUG-2021, the patient experienced cough, and was hospitalized (date unspecified). On an unspecified date, the patient experienced body malaise, arthralgia and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cough was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839378-COVID-19 VACCINE AD26.COV2.S- cough. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1628979 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Troponin; Result Unstructured Data: Test Result:226 pg/mL
CDC Split Type: DEPFIZER INC202101026572

Write-up: Myocarditis; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB DE-PEI-202100158292. A 13-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: 1E021A) (at the age of 13 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 11Jul2021 (at the age of 13 years) for covid-19 immunisation. The patient experienced myocarditis (hospitalization) on 02Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included troponin: 226 pg/ml on 02Aug2021. Comirnaty/Myocarditis/PEI/D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1630386 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hallucination, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Moderna.; This case was received (Reference number: 768916) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION in an 18-year-old male patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced HALLUCINATION (seriousness criterion medically significant), PYREXIA, FATIGUE and HEADACHE. At the time of the report, HALLUCINATION, PYREXIA, FATIGUE and HEADACHE had resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. Batch number of the suspect product is unknown. Reporter''s causality was assessed as Not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1630844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210846529

Write-up: FACIAL PALSY; This spontaneous report received from a physician by a Business partner (EMEA EVHUMAN NLP, PT-INFARMED-B202108-770) on 23-AUG-2021 was received on 23-AUG-2021 and concerned a 25 year old male. The patient''s weight was 58 kilograms, and height was 171 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05) .5 ml, administered on 31-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-AUG-2021, the patient experienced facial palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of facial palsy was not reported. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1634324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-02
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:No heartbeat of baby
CDC Split Type: GBPFIZER INC202101069399

Write-up: Maternal exposure during pregnancy; miscarriage / early miscarraige; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108171728557980-VHYXI. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Fa1027, expiry date: not reported), dose 1 via an unspecified route of administration on 16Jun2021 as single dose for covid-19 immunisation. Medical history included pregnancy, Patient no longer pregnant at the time of reporting. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. On 02Aug2021, the patient experienced early miscarriage/ miscarriage. On an unspecified date, the patient experienced maternal exposure during pregnancy. Additional information as reported: Got pregnant. The mother reported she became pregnant while taking bnt162b2. Had vaccine 1/2 after Had early miscarriage 8 weeks after. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). On an unspecified date, the patient underwent lab tests and procedures which included scan: no heartbeat. The baby died on an unspecified date. The autopsy was bit performed. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1634439 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 304492 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermatitis bullous, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (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: ITMODERNATX, INC.MOD20212

Write-up: ; This case was received (Reference number: IT-MINISAL02-769637) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DERMATITIS BULLOUS in a 14-year-old female patient who received mRNA-1273 (batch no. 304492) for Immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Intramuscular) .5 milliliter. On 02-Aug-2021, the patient experienced DERMATITIS BULLOUS (seriousness criterion medically significant) and URTICARIA. At the time of the report, DERMATITIS BULLOUS and URTICARIA had not resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1634665 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Pyrexia, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210845368

Write-up: PARESTHESIA; FEVER UP TO 40?C; TACHYCARDIA; This spontaneous report received from a health care professional via a regulatory authority (EMEA EVHUMAN NLP, PT-INFARMED-F202108-498) concerned a 22 year old male. The patient''s weight was 88 kilograms, and height was 173 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-04 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 02-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-AUG-2021, the patient experienced tachycardia, fever up to 40?c. On 03-AUG-2021, the patient experienced paresthesia. On an unspecified date , the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia on 02-AUG-2021, and paresthesia, and fever up to 40?c on 03-AUG-2021. This report was serious (Hospitalization Caused / Prolonged).; Reporter''s Comments: Did a Medication Error Occur? No Other information: Besides the fever up to 40?C that did not cease with paracetamol 1000 nor with Brufen 600, after 4 hours, there was an episode of paresthesia, numbness and lack of sensibility in the limbs, upper and lower, which lasted for about 4 to 5 hours, there was also an episode of tachycardia with about 2 hours.


VAERS ID: 1642161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101054006

Write-up: Pregnancy loss <20 weeks gestation/miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB with regulatory authority report number FR-AFSSAPS-RS20212625. A 26-year-old pregnant female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), intramuscularly administered in arm left on 19Jul2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. SARS-CoV-2 test was negative on 10Jul2021. 19Jul2021: dose 1 of COMIRNATY. 2 weeks later, on 02Aug2021, the patient experienced pregnancy loss <20 weeks gestation/miscarriage. Additional information obtained by the regulatory authority: date of last menstrual period: 23Jun2021. Delivery due date: 30Mar2022. Due date at the time of miscarriage: 5 weeks and 5 days of amenorrhea. In total, miscarriage at 5.7 weeks of pregnancy 2 weeks after dose 1 COMIRNATY in a 26-year-old woman. Gestation period when reaction/event was observed in the foetus: 5.7 week. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The outcome of the event was not recovered. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1656881 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auditory nerve disorder, Blood count, Blood creatinine, Blood urea, C-reactive protein, Contusion, Discomfort, Fall, Fatigue, Head injury, Headache, Localised oedema, Loss of consciousness, Malaise, Neuralgia, Physical examination, Tremor, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: blood count; Result Unstructured Data: Test Result:Normal; Test Date: 20210802; Test Name: creatinine; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: urea; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: C-reactive protein; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: Cardiovascular, pulmonary and neurologically; Result Unstructured Data: Test Result:Cardiovascular, no chest pain, no palpitation, no; Comments: Cardiovascular, no chest pain, no palpitation, no sign of heart failure, the heartbeat is regular with no audible murmur. At the pulmonary level, the patient is eupneic in ambient air. No signs of respiratory distress. Neurologically: Glasgow (G) 15 oriented in time and space. No sensory-motor deficit. No sign of focalization. No ocular motor impairment.
CDC Split Type: FRPFIZER INC202101054589

Write-up: loss of consciousness/consciousness loss; headache; appearance of discomfort just before loss of consciousness; Tremors/shakiness; Fatigue; several bruises; Feeling sick; heavy fall; big bump on the head; frontal edema after the fall; vagal discomfort; Hearing/auditory nerve disorder; Visual disturbance NOS; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20215359. An 18-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm, at age 18 years, on 02Aug2021, in the afternoon (Batch/Lot Number: FE7010) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient did not have history of COVID and has not been tested. It was unknown if the patient was pregnant at the time of vaccination. On 02Aug2021, time period of 4 hours after vaccination, there was persistent headaches, appearance of discomfort just before loss of consciousness/consciousness loss which resulted in a heavy fall. Tremors/shakiness during unconsciousness. Hearing/auditory nerve disorder and visual disturbances on regaining consciousness lasting 20 minutes. Consequence: A big bump on the head, fatigue, damaged glasses, several bruises. The patient was also feeling sick. Emergency department report: Patient was hospitalized on 02Aug2021 for discomfort with loss of consciousness, tremors, no biting of the tongue, no loss of urine, headache, fatigue and several bruises. Cardiovascular, no chest pain, no palpitation, no sign of heart failure, the heartbeat is regular with no audible murmur. At the pulmonary level, the patient is eupneic in ambient air. No signs of respiratory distress. Neurologically: Glasgow (G) 15 oriented in time and space. No sensory-motor deficit. No sign of focalization. No ocular motor impairment. In terms of trauma: frontal edema after the fall. Overall: vagal discomfort in the context of COVID vaccination. Patient stable. The patient underwent lab tests on 02Aug2021 that includes blood count, creatinine, C-reactive protein and urea that are all normal. The outcome of the events loss of consciousness, tremors/shakiness, hearing/auditory nerve disorder, visual disturbance, and feeling sick was recovering; while for the rest of the events, it was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1660491 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Cerebral venous sinus thrombosis, Heparin-induced thrombocytopenia test, Platelet count
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: 202108; Test Name: Fibrinogen; Result Unstructured Data: Stable; Test Date: 202108; Test Name: Heparin-induced thrombocytopenia test; Result Unstructured Data: VIPIT confirmed on HITS testing; Test Date: 202108; Test Name: Platelet count; Result Unstructured Data: stable
CDC Split Type: IEJNJFOC20210854372

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report received from a physician via regulatory authority (IE-HPRA-2021-082921) on 26-AUG-2021 and concerned a 21 year old male of unknown race and ethnicity. The patient''s weight was 70 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported expiry: unknown) dose was not reported, 1 total, administered on 22-JUL-2021 for covid-19 immunisation. The drug start period was 11 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-AUG-2021, the patient experienced cerebral venous sinus thrombosis, and was hospitalized (date unspecified). Laboratory data included: On AUG-2021, Fibrinogen (NR: not provided) stable, Heparin-induced thrombocytopenia test (NR: not provided) VIPIT confirmed on HITS testing, and Platelet count (NR: not provided) stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cerebral venous sinus thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).


VAERS ID: 1662875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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:
CDC Split Type: ATJNJFOC20210857948

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042358) was received on 27-AUG-2021 and concerned a 59 year old male of unknown 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, route of admin not reported, batch number: XD985 expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). Case is associated with Product Quality Complaint.


VAERS ID: 1664019 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Erythema, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101056197

Write-up: Generalized pruritus; Oedema Quincke''s; Erythema; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-NY20213433. A 13-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FE1573), intramuscular on 02Aug2021 (at the age of 13years) as dose 2, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced generalized pruritus, oedema Quincke''s (angioedema), and erythema. It was also reported as on 02Aug2021: occurrence of erythema of the chest, stomach, back, neck and legs; occurrence of Quincke''s oedema; occurrence of generalised pruritus (even on the scalp). The patient was hospitalized on an unspecified date. The patient underwent lab tests and procedures on 10Feb2021which included Sars-Cov-2 test: negative. The outcome of events was not recovered. Conclusion: Erythema, angioedema and generalized pruritus in a 13-year-old girl 1 hour after the second injection of COMIRNATY vaccine (Batch FE1573). Admitted to hospital. Not recovered The case qualifies as a suspected unexpected serious adverse reaction according to the business rules for safety messages applicable within the Economic Area (Medicines Agency/H/20665/04/Final Rev 2). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1665824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210903002

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042912) on 01-SEP-2021 concerned a 20 year old female of an 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, route of admin not reported, batch number: XD975, and expiry: unknown) dose was not reported, frequency time was 1 total administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus) infection and had vaccination failure. 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).


VAERS ID: 1667951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aceruloplasminemia; Diabetes mellitus insulin-dependent; Retinopathy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210857945

Write-up: COVID-19 pneumonitis; Vaccination failure; This spontaneous report received from a physician by a Regulatory Authority (FR-AFSSAPS-MA20213290) was received on 27-AUG-2021 and concerned a 62 year old female with an unspecified race and ethnic origin. The patient''s weight was 68 kilograms, and height was 150 centimeters. The patient''s concurrent conditions included: aceruloplasminemia, retinopathy, and diabetes mellitus insulin-dependent. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-05 expiry: Unknown) 1 dosage forms with frequency 1 total administered on 08-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced vaccination failure and on 09-AUG-2021, the patient developed covid-19 pneumonitis and was hospitalized (date and days unspecified). Treatment with Covid-19 vaccine ad26.cov2.s was withdrawn on 08-JUL-2021. The patient had not recovered from covid-19 pneumonitis, and vaccination failure. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint.


VAERS ID: 1679936 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF06881911 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bicuspid aortic valve
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101088835

Write-up: Vasovagal reaction; Fainting with loss of consciousness; Fainting with loss of consciousness; This is a spontaneous report from a contactable consumer (patient''s mother) downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-ST20213142. A 12-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in the left arm on 02Aug2021 09:35 (Batch/Lot Number: FF06881911) (at the age of 12-years-old) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included bicuspid aortic valve (also reported as aortic bicuspidia) from 04Jul2009 and ongoing, followed by a cardiologist. The patient''s concomitant medications were not reported. On 02Aug2021, after 10.5 hours, the patient experienced fainting with loss of consciousness twice at the end of the day around 6 PM. The patient also experienced vasovagal reaction on 02Aug2021. The events were considered medically significant. The events required visit with a general practitioner. Contact with the mother on 13Aug2021 to reassure her and communicate the steps to take for Dose 2 to her. The outcome of vasovagal reaction was recovered on 02Aug2021, while outcome of fainting with loss of consciousness was unknown. Reporter''s Coments: Medical History of Covid: Dose 1 left arm batch FF0688. Statement made by the patient''s mother- injection at 9:35 a.m., at 10.5 hours Fainting with loss of consciousness twice at the end of the day around 6 p.m. Medical history: AORTIC BICUSPIDIA, followed by a cardiologist. visit with a general practitioner. contact with the mother on 13Aug to reassure her and communicate the steps to take for Dose 2 to her.


VAERS ID: 1683431 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysphoria, Dyspnoea, Restlessness, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101104598

Write-up: Dyspnoea; unrest; dysphoria; tachycardia; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is v21124648. The patient was a 16-year 9-month old male. Body temperature before vaccination was 36.4 degree centigrade. On 02Aug2021 at 15:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot#FF3622 Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 16-year-old. On 02Aug2021 at 15:30 (30 minutes after the vaccination), the patient experienced dyspnoea, unrest and dyspnoea, at unknown time on 02Aug2021, patient had tachycardia. On 03Aug2021, the outcome of the event was recovered. The course of the event was as follows: On 02Aug2021, the patient received corona vaccine (Pfizer), during the observation, dyspnoea and dysphoria were appeared, and then lie in bed and continue to observe. The dyspnoea became more and more serious, and the patient began to feel unrest and emergently transferred to hospital, just in case, the patient was hospitalized. In the hospital, tachycardia occurred from time to time, but there was no major problem. On 03Aug2021 at 12:00, the events were recovering, and the patient discharged. On 03Aug2021, the patient was observed at home, at 22:00, the patient felt dyspnoea and visited emergency room. The patient was prescribed with anti-histamine drug, and then went home. The reporting other hcp classified the event as serious (hospitalized from 02Aug2021 to 03Aug2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was nor provided.


VAERS ID: 1697505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-08-02
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 1436 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Diabetes mellitus, Diplopia, Dizziness, Fatigue, Glycosylated haemoglobin, Headache, Maternal exposure during pregnancy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Diabetes mellitus (father - type 2 mother - type 1); Drug hypersensitivity; Dysphagia; Familial risk factor (father - psoriasis mother - multiple scleriosis); Seafood allergy; Seasonal allergy; Weight loss (Weight loss of around 9kg over the past year)
Allergies:
Diagnostic Lab Data: Test Name: fasting glucose level; Result Unstructured Data: Test Result:260; Test Name: HbA1C (hemoglobin A1c test); Test Result: 10 %
CDC Split Type: DEPFIZER INC202101124759

Write-up: Diabetes mellitus; fatigue/tiredness; occasional dizziness; Occasional headaches; double vision; she became pregnant while taking bnt162b2; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100174568. A 28-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 29Jun2021 (Batch/Lot Number: FC 1436) as dose 1, single for covid-19 immunisation. Medical history included seafood allergy, grasses allergy, paracetamol allergy, familial risk factor (father - psoriasis mother - multiple scleriosis), family history of diabetes mellitus (father - type 2, mother - type 1), Weight loss of around 9kg over the past year, dysphagia from Feb2021, covid-19 in Aug2020. The patient''s concomitant medications were not reported. The patient experienced diabetes mellitus (permanent damage, possibly disability) on 02Aug2021 with outcome of not recovered. Patient was admitted to the emergency department and hospitalized due to the event. The mother reported she became pregnant while taking bnt162b2. Clinical course was reported as following: Admission in the emergency department for first the manifestation of diabetes mellitus after a fasting glucose level of 260 and an HbA1C (hemoglobin A1c test) of 10% were found in routine laboratory tests ordered by a general practitioner. The patient reported fatigue, tiredness and occasional dizziness in the recent time period. Patient denies polyuria and polydypsia. Weight loss of around 9kg over the past year. Appetite remains unchanged. Occasional headaches are experienced. The patient also reports the occurrence of double vision. The patient states that her voice has been deeper since around February of this year. Dysphagia since around the same time. The patient contracted COVID-19 in Aug2020 and was vaccinated with Biontech (first vaccine dose) on 29Jun2021 (batch: FC1436). The outcome of other events was unknown. The HA assessed the causality between bnt162b2 and the events was D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1697827 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Dry eye, Dyspnoea, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210918408

Write-up: DRY EYES; ABDOMINAL CRAMPS; CHILLS; PAIN IN ARM; PYREXIA; DYSPNOEA; This spontaneous report received from a consumer by a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021154729) on 08-SEP-2021 and concerned a 17 year old male of unspecified race and ethnic origin. The patient''s weight was 108 kilograms, and height was 188 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Lot XE395 expiry: Unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced dyspnoea, abdominal cramps, chills, pain in arm and pyrexia. On 03-AUG-2021, patient experienced dry eyes. On an unspecified date, the patient was hospitalized. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dyspnoea, chills, pain in arm, abdominal cramps, and pyrexia, and had not recovered from dry eyes. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: Are you or the affected person aware of any allergies? If yes, which? Pollen, Hay Indications regarding risk factors or underlying conditions None that I am aware of / Arm was hurting, I went home all was good, a little tired I laid myself in bed I was hot getting out from under the covers ice-cold Eyes after 8 hours dry and somewhat painful cramping during respiration when in inhale deeply Fever that has subsided but all the rest is still present


VAERS ID: 1518792 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NyQuil Friday night
Current Illness: None
Preexisting Conditions: None
Allergies: Augmentin
Diagnostic Lab Data: Blood work 08-01-2021 IV Hydration 08-01-2021
CDC Split Type:

Write-up: Vasovagal syncope episode.


VAERS ID: 1518823 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Injection site swelling, Lymphadenopathy, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal, Vitamin D, Zinc, Vitamin C
Current Illness: None
Preexisting Conditions: None
Allergies: Not known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 12:30 AM Sunday August 1 woke up with tingling and heart beating fast. Took blood pressure 117/85 and heart rate was 86. Also noticed right arm where injection occurred, has swollen lymph node. After 2 hours, at 2:30 AM Sunday August 1 heart rate went down to 68.


VAERS ID: 1518856 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bruxism, Muscle twitching, Nausea, Palpitations, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: I had a seizure at around 4:00 AM in the morning. I woke up having some heart palpitations and feeling very nauseous. I got up out of bed to get some water, and then I immediately collapsed. My dad in the other room heard me fall and later told me that I was twitching and clenching my jaw for about a minute before I regained consciousness. It never happened to me before, so I''m certain that it was because of the vaccine.


VAERS ID: 1518859 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear discomfort, Fatigue, Head discomfort, Headache, Sinus congestion, Tinnitus
SMQs:, 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: Risperidone, Hydroxyzine, Fluvoximine, multivitamin, D3, B Complex, Vitamin E, L-methylfolate, Xyzal
Current Illness: None known, outside of mental health issues
Preexisting Conditions: Depression, anxiety,
Allergies: Non known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Tinnitus, sinus congestion, "fullness in head & ears", headache, fatigue; all presented upon awakening Sunday 7/1 (11:30)


VAERS ID: 1518864 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient that he does not take take any medications or over the counter supplements/medications
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient''s wife was with him while he was waiting the 15 minutes. She stated that he was feeling nauseous and dizzy. When I went to check on him, he was sloughed over to the right side of his chair with his eye closed. The wife tried to talk to him, but he was unresponsive for a little while. When he came back to responding, he was sweaty and said that he felt like he went to sleep. I had one of my technicians call 911. His wife believes that he had a seizure. He was sweaty and pale. The EMT ended up taking him to go to the hospital to get checked out.


VAERS ID: 1518875 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Feeling abnormal, Injection site reaction, Pain in extremity, Peripheral swelling, Pruritus, Skin reaction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: I took a picture of my arm. If it gets worse I will go back to medical facility.
CDC Split Type:

Write-up: I have Covid arm. My arm hurts. My arm is swollen, red, and itchy and is raised. It is the size of an orange or maybe a little bigger. Yesterday I felt like I was ran over by a car. I can upload a picture if you need to see it.


VAERS ID: 1518877 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7487 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (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: Statin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tingling in shot arm left


VAERS ID: 1518883 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

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

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

Write-up: Patient vomited about 7 minutes after receiving vaccine. Provided the patient with a trash can and cold pack. She felt fine after another 20 minutes and left with her companion/driver


VAERS ID: 1518885 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Skin reaction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: Patient began feeling tingling in hands and fingers. Their hands and feet began to swell and turn red.


VAERS ID: 1518891 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye movement disorder, Refusal of treatment by patient, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure was taken 74/50
CDC Split Type:

Write-up: Patient had a seizure within 2 minutes after administration of vaccine. While she was seated, her arms and legs started moving, eyes rolled back, she kicked off her shoe. She never left the chair. I had my technincian call EMS. I took her blood pressure and it was 74/50. EMS tended to her and took her out of pharmacy on stretcher. When they got outside to ambulance, she and her husband denied further treatment and refused to go to hospital. She rested in a chair then left after 15 minutes of feeling ok.


VAERS ID: 1518896 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Topamax, setraline, losartin, amlopadine, Zyrtec, lyrica, meloxicam, B-12, vitamin c
Current Illness: None
Preexisting Conditions: High Blood pressure, asthma, allergies
Allergies: Penicillin, gabapentin, morphine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Period was set to start day after I received the vaccine. It did start as usual but few days after I?m noticing I?m bleeding extra heavy. I asked the pharmacist and he said it could be an adverse effect. I?m bleeding thru super tampons and within 20 mins of changing a tampon. There?s no pain or intense cramping. There?s also no other weird side effects going on. Maybe just bad timing, I didn?t think about getting the vaccine the same time my period was supposed to start. It was a last minute decision to get it.


VAERS ID: 1518908 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Nausea, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: other-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: pt presents to the pharmacy around 12pm for the second dose of pfizer ,I asked pt if he is feeling ok today and any side effect from the 1 st dose, pt said he is fine and no symptoms from the previous shot, but pt presents a little pale and anxious. After giving the shot, I told the pt to stay on seat for 15 minutes, recommend him to take acetominophen after lunch if he starts to feel headache or flu like symptoms . After 10 minutes , pt starts to have nausea and vomit , no other sympt


VAERS ID: 1518913 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Hyperhidrosis, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness, significant diaphoresis, pale skin. Blood pressure 81/50 mmHg. Pharmacist observed patient closely. In approximately 5 minutes, blood pressure returned to normal (125/88 mmHg), color returned, and sweating ceased. Patient reported previous vasovagal response to injections, although not to initial covid vaccination. Patient asked to step outside due to feeling cold, and later left under his own power.


VAERS ID: 1518935 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: Patient reported previous sensitivity/syncope to vaccines. Waited the required 15 minute time post vaccination and had a seat with her legs elevated, felt anxious, and fell suddenly nauseous and vomited in the immunization administration area. Pharmacist helped clean up, offered emergency services to patient which were declined. Took some time to clean up and we provided comfort measures while she recovered. Following vomiting episode patient was ok to leave the area.


VAERS ID: 1518942 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (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:

Write-up: tingling in fingers on left hand arm that vaccine was administered in


VAERS ID: 1518944 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA B0P00QG.S00935@ / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Head injury, Loss of consciousness, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted a minute inside the vaccine waiting area after receiving the vaccine and hit his head on the ground but regained consciousness quickly after. Took patient''s blood pressure and it read 104/60 which was low. Patient said he had a similar reaction to this when he received a tetanus vaccine back then but did not indicate that to us beforehand. Patient chose to go to the ER via the ambulance to check out possible head injuries.


VAERS ID: 1518947 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Patient stated she gets lightheaded when she gets vaccines
Other Medications: none known
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient vomited approximately 5-10 minutes after receiving the vaccine,


VAERS ID: 1518948 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope, Throat tightness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: high blood pressure, high cholesterol
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: after getting the vaccine, about 2 min later, pt stated that he was have syncope and feels like his throat is closing up. we called 911 and checked on patient and measure his blood pressure and was 135/105. after a few min i checked his blood pressure again and it was 135/90. when ambulance came, they check his Oxygen and blood pressure and all were normal.


VAERS ID: 1518962 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

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

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

Write-up: Mistakenly administered J&J to patient under 18 years of age.


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