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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 171 out of 8,753

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VAERS ID: 1841586 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Diarrhoea, Epistaxis, Fatigue, Localised infection, Palpitations, Peripheral swelling, Pyrexia, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417495

Write-up: Arm infection; Palpitations; Fatigue; Large arm swelling; Hives; Fever; Pain back; General debility; Diarrhoea; Nosebleed; This is a spontaneous report from a contactable Other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110201449017590-YO54A, Safety Report Unique Identifier GB-MHRA-ADR 26098876. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/ Lot number Fj5782), via an unspecified route of administration on 15Oct2021 (at the age of 41-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. 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. On 15Oct2021, patient experienced nosebleed and diarrhoea. On 16Oct2021 (after 1 day of vaccination), patient experienced large arm swelling, hives, fever, pain back and general debility. On 17Oct2021 (after 2 days of vaccination), patient experienced arm infection, palpitations and fatigue. The patient received 3 dose (Booster and off label use). Events were medically significant. No causality assessment was provided. The outcome of events diarrhoea was resolved on an unspecified dose in 2021, large arm swelling, hives, fever, pain back, arm infection, fatigue and general debility was not resolved and palpitations, nosebleed was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-10-15
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Blood test, Computerised tomogram, Confusional state, Memory impairment, SARS-CoV-2 test, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: Ct scan; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: X-rays; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101417836

Write-up: Memory loss; Confusion; Forgetfulness; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110202245506140-IZ7RS. Safety Report Unique Identifier is GB-MHRA-ADR 26102208. An 18-year-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Sep2021 as dose 2, single for COVID-19 immunization. Medical history and 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. On 15Oct2021, the patient experienced memory loss, confusion, forgetfulness. The patient underwent lab tests and procedures which included blood test, CT scan, x-ray, all with unknown results on an unspecified date and SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on 15Oct2021. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The outcome of all the events were not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1841618 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature abnormal, Cough, Dyspnoea, Immunisation, Influenza like illness, Malaise, Pain in extremity, Pain in jaw, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Dental implantation
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:Abnormal; Test Date: 20211019; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426418

Write-up: generally unwell; sore arm; persistent cough; flu like symptoms; breathless; temperature; aching in joints; Booster; Jaw pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110211235108580-CRUSE. Safety Report Unique Identifier GB-MHRA-ADR 26103801. A 60-year-old female patient received Booster dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not known, age at the vaccination: 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included suspected covid-19 from 15Oct2021 and ongoing. The patient''s concomitant medications were not reported. The patient had booster, off label use and experienced chronic left side jaw pain (had completed dental implant surgery in May this year) on 15Oct2021. The patient experienced generally unwell, sore arm, persistent cough, flu like symptoms, breathless, temperature, aching in joints on an unspecified date. This was day 6 and still unwell. It was reported that no report stated relating to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no-negative COVID-19 test) on 19Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of generally unwell, sore arm, persistent cough, flu like symptoms, jaw pain was recovering. The clinical outcome of breathless, temperature, aching in joints was unknown. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis). If yes, we will ask you some additional questions at the end of this report: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1841816 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3023 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall, Loss of consciousness, Seizure, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), 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? Yes, ? days
   Extended hospital stay? 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: 20211015; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211015; Test Name: vital signs; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202101410291

Write-up: Loss of consciousness; Convulsion/Seizure; fell down forward; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129669. A 18-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH3023, Expiration date 31Dec2021) via an unspecified route of administration on 15Oct2021 at 18:10 (the day of vaccination), as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 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). The course of the event was as follows: On 15Oct2021 at about 18:10, the patient was vaccinated with the first dose of COVID-19 vaccine. After a few minutes, there was Loss of consciousness. The patient fell down forward, and experienced Seizure for a few seconds. After that, the consciousness level recovered and vital signs were also stable. It was judged as serious adverse reaction and the patient was emergency transferred. On 15Oct2021 at 18:13 (3 minutes after the vaccination), the patient experienced Loss of consciousness and Convulsion. On 16Oct2021 (1 day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (hospitalization) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1841905 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0160 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:100/70 mmHg; Comments: 9:43 AM; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/70 mmHg; Comments: 10:15 AM
CDC Split Type: PHPFIZER INC202101418798

Write-up: Elevated BP (180/70 mmHg); This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111954. A 76-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FH0160), intramuscular on 15Oct2021 (at the age of 76-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. On 15Oct2021 10:15, the patient experienced elevated BP with outcome of recovered on 15Oct2021 10:30. The patient underwent lab tests and procedures which included blood pressure measurement: 100/70 mmHg on 15Oct2021 9:43 AM; then blood pressure measurement: 180/70 mmHg on 15Oct2021 10:15 AM. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841909 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH2528 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:200/100 mmHg; Comments: post vaccination
CDC Split Type: PHPFIZER INC202101418815

Write-up: Elevated BP (200/100 mmHg); This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111916. A 60-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FH2528), intramuscular on 15Oct2021 (at the age of 60-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced elevated BP with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 200/100 mmHg on 15Oct2021 post vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841911 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH2528 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:130/90; Comments: pre vaccination; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:200/120; Comments: post vaccination
CDC Split Type: PHPFIZER INC202101418836

Write-up: Elevated BP; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111914. A 59-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 15Oct2021 (Batch/Lot Number: FH2528) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 15Oct2021 11:55, the patient experienced elevated BP. The patient underwent lab tests and procedures which included blood pressure measurement: 130/90 on 15Oct2021 pre vaccination and blood pressure measurement: 200/120 on 15Oct2021 post vaccination. The outcome of the event was recovered on 15Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841913 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0160 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: 2:52 PM; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/120 mmHg; Comments: 3:30 PM; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:220/120 mmHg; Comments: 4:09 PM; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:230/120 mmHg; Comments: 4:30 PM
CDC Split Type: PHPFIZER INC202101418881

Write-up: Elevated BP /160/100 mmhg 2:52 PM, 180/120 mmhg 3:30 PM, 220/120mmhg 4:09 PM, 230/120 mmhg 4:30 PM; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111965. A 46-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 15Oct2021 (Batch/Lot Number: FH0160) as dose number unknown, single for COVID-19 immunization. It was unknown if the patient was pregnant. The patient''s medical history and concomitant medications were not reported. On 15Oct2021 14:52, the patient started to experienced elevated BP, 160/100 mmHg at 2:52 pm, 180/120 mmHg at 3:30 pm, 220/120 mmHg at 4:09 pm, and 230/120 mmHg at 4:30 pm. The patient was treated with captopril 50mg PO. The outcome of the event was recovered on 15Oct2021 at 16:45. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841918 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0160 / UNK - / OT

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

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: 20211015; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100 mmHg; Comments: 1:29PM; Test Date: 20211015; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/100 mmHg; Comments: 1:46PM
CDC Split Type: PHPFIZER INC202101463527

Write-up: elevated BP 1:29PM 180/100mmhg, 1:46PM 200/100 mmhg; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300113468. A 47-years-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular on 15Oct2021 at age of 47-years-old (Batch/Lot Number: FH0160) as single dose for covid-19 immunization. The medical history and concomitant medications were not reported. The patient experienced elevated blood pressure (BP) on 15Oct2021 at 1:29pm. The BP was 180/100 mmHg on 15Oct2021 at 1:29PM, 200/100 mmHg on 15Oct2021 at 1:46PM. The event was considered as serious per hospitalization and life threatening. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841973 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal 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: SEPFIZER INC202101415211

Write-up: Had bleeding in the eye (left) a few days later; This is a spontaneous report from a contactable consumer (patient) received via the regulatory authority. An 81-year-old female patient received third dose (booster) of BNT162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 14Oct2021 (Batch/Lot number was not reported) (at the age of 81-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received two doses of BNT162b2 (COMIRNATY) dose 1, administered in Feb2021 (lot/batch number: unknown) and dose 2 administered in May2021 (lot/batch number: unknown), both for COVID-19 immunization. The patient had not received any other vaccine within 4 weeks. The patient experienced bleeding in the eye (left) a few days later on 15Oct2021 at 12:00 with outcome of not recovered. The patient received no treatment for the event. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101438757 Same reporter, patient and product. Different event and dose.


VAERS ID: 1842485 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIPRALEXA
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20213

Write-up: heart rate of 100 bpm; Vomiting the next day in the morning; Fever; Nausea; Muscle pain; This case was received via the Regulatory Agency (Reference number: BE-FAMHP-DHH-N2021-107921) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate of 100 bpm), VOMITING (Vomiting the next day in the morning), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included ESCITALOPRAM OXALATE (SIPRALEXA) for an unknown indication. On 14-Oct-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced HEART RATE INCREASED (heart rate of 100 bpm) (seriousness criterion disability), VOMITING (Vomiting the next day in the morning) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). On 16-Oct-2021, HEART RATE INCREASED (heart rate of 100 bpm), VOMITING (Vomiting the next day in the morning), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle pain) had resolved. ADR description - Vomiting the next day in the morning, heart rate of 100 bpm at rest for 24 hours after vaccination (2nd dose). No treatment information was provided. Company comment: This case concerns a 31 year-old female patient with no reported medical history, who experienced the unexpected serious events of Heart rate increased, Vomiting, Pyrexia, Nausea, and Myalgia. The events occurred on the day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant was maintained for all events for consistency with the RA report, however the source document did not include information supporting the seriousness criteria. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation document received on 29-Oct-2021 and event verbatim and narrative updated.; Reporter''s Comments: Treatment - Evolution of the ADR: 24h ADR description ; Sender''s Comments: This case concerns a 31 year-old female patient with no reported medical history, who experienced the unexpected serious events of Heart rate increased, Vomiting, Pyrexia, Nausea, and Myalgia. The events occurred on the day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant was maintained for all events for consistency with the RA report, however the source document did not include information supporting the seriousness criteria.


VAERS ID: 1842524 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005891 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest pain, Electrocardiogram, Myocarditis, Pyrexia, Troponin, Troponin increased, Ultrasound scan, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Retinal pigment degeneration (Retinal pigment degeneration)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: 39 degrees Celsius; Test Date: 20211020; Test Name: Electrocardiogram; Result Unstructured Data: Normal; Test Date: 20211020; Test Name: Troponin; Result Unstructured Data: 1.170; Test Date: 20211022; Test Name: Troponin; Result Unstructured Data: 0.149; Test Date: 20211020; Test Name: Ultrasonography; Result Unstructured Data: Normal
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Suspected myocarditis; High troponin level; Lower sternal pain; Vaccination site pain; Pyrexia; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP112361) on 25-Oct-2021 and was forwarded to Moderna on 01-Nov-2021. This case, initially reported to the(PMDA) by a medical safety officer, was received via the PMDA (Ref,v21129895). Suspected myocarditis was assessed as serious by the MAH. On an unknown date, the patient received the 1st dose of this vaccine. On 15-Oct-2021, the patient received the 2nd dose of this vaccine. After the vaccination, vaccination site pain, pyrexia of high 39 degrees Celsius range developed. The symptoms were controlled by internal use of loxoprofen sodium hydrate. On 19-Oct-2021, in the morning, the patient was suddenly aware of lower sternal pain. NRS: 4-5/10. Thereafter, pain disappeared temporarily. On 20-Oct-2021, the patient experienced pain similar to that of the previous day and visited a medical institution. The patient said that the pain was aggravated by bending forward or deep breathing. Blood test, electrocardiogram, chest X-ray, and echocardiography were performed for suspected myocarditis. Blood test showed a high level of troponin of 1.170, but ultrasonography and electrocardiogram showed no abnormalities. On 22-Oct-2021, at the time of returning to the medical institution, blood test was normal with troponin of 0.149, and there were no symptoms, so the examination was finished. The symptoms were resolving. The outcome of vaccination site pain, pyrexia, lower sternal pain, suspected myocarditis, and high troponin level 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: This is a case of suspected myocarditis in a young man and then reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19 year old male patient, with no relevant medical history reported who experienced serious expected AESI of myocarditis (suspected myocarditis) after second dose of mRNA-1273. The event occurred 6 days after second dose. The re-challenge is unknown since the event occurred after second dose and the outcome is recovering. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1844594 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH TH0114 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Immunisation, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (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: AMLODIPINE; ASPIRIN (E.C.); CREON; DESUNIN; FOLIC ACID; FUROSEMIDE; MYCOPHENOLIC ACID; RAMIPRIL; CO-TRIMOXAZOLE; FEXOFENADINE; HYPROMELLOSE; LATANOPROST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions:; Systemic lupus erythematosus (I have Lupus)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417927

Write-up: barely woke at all; feeling a bit more alive/totally zonked; Extreme fatigue; patient received third dose of BNT162B2 /DOSE 3 (BOOSTER); This is a spontaneous report from a contactable consumer or other non health care professional (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00263937. Safety Report Unique Identifier GB-MHRA-ADR 26094494. A 79-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via parenteral route on 15Oct2021 (Lot Number: TH0114) as DOSE 3 (BOOSTER), SINGLE (at the age of 79 years) for COVID-19 immunization. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing. (I have Lupus). Concomitant medications included 5mg amlodipine; 75mg acetylsalicylic acid (ASPIRIN (E.C.); pancreatin (CREON); colecalciferol (DESUNIN); 5mg folic acid; 40mg furosemide; 500mg mycophenolic acid; 10mg ramipril; 80/400mg sulfamethoxazole, trimethoprim (CO-TRIMOXAZOLE); 120mg fexofenadine; hypromellose; latanoprost all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on an unspecified date in Jan2021 (Lot Number: UNKNOWN) as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on an unspecified date in Apr2021 (Lot Number: UNKNOWN) as DOSE 2, SINGLE for COVID-19 immunization and not had any side effects (No side effects at all on the day (was injected 0900 ish)). On 16Oct2021, the patient experienced extreme fatigue. The reporter stated that, days 2 and 3 OK, day 4, went back to bed in the afternoon and day 5 (20Oct2021) barely woke at all - totally zonked, by late evening feeling a bit more alive. The outcome of the event extreme fatigue was recovering and other events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder
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: Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417908

Write-up: Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191247428660-XMRZ9. Safety Report Unique Identifier GB-MHRA-ADR 26092504. A 60-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8288), via an unspecified route of administration on 13Oct2021 as dose 1, single for covid-19 immunization. Medical history included menopause (had an early menopause) from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took depo-medrone. The patient experienced menstrual cycle abnormal on 15Oct2021. It was reported that, patient reported stating she was 60 years old and had an early menopause. She was not had periods for many years, other than a few years ago when on the 2 occasions she had a steroid injection and had a period. This report did not relate to possible inflammation of the heart. Patient has not tested positive for COVID-19 since having the vaccine. The event reported as serious (Seriousness criteria-Other medically important condition). The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844639 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; CLOPIDOGREL; LACIDIPINE; LACTULOSE; LAXIDO; PERINDOPRIL; BENDROFLUMETHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417999

Write-up: Shoulder pain; Nausea; Headache; Tiredness; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191308238630-UYYVZ, Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 26092546. A 73-years-old female patient received BNT162B2 (COMIRNATY), dose 3 via an unspecified route of administration on 15Oct2021 (Batch/Lot Number: FJ5782) age at vaccination of 73-years-old, as single dose for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient received COVID-19 VACCINE ASTRAZENECA dose 1, on 02Feb2021 (Lot/batch-AB0006), as single dose for COVID-19 immunisation; the patient received COVID-19 VACCINE ASTRAZENECA dose 2, on 09Apr2021 (Lot/batch-PW40011) as single dose for COVID-19 immunisation.v Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported; lacidipine (LACIDIPINE) taken for an unspecified indication, start and stop date were not reported; lactulose (LACTULOSE) taken for an unspecified indication, start and stop date were not reported; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO) taken for an unspecified indication, start and stop date were not reported; perindopril (PERINDOPRIL) taken for hypertension, start and stop date were not reported; bendroflumethiazide (BENDROFLUMETHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shoulder pain (arthralgia) (medically significant) on 16Oct2021 with outcome of recovered with sequelae on an unspecified date, nausea (nausea) (medically significant) on 16Oct2021 with outcome of recovered with sequelae on an unspecified date, headache (headache) (medically significant) on 16Oct2021 with outcome of recovered on 18Oct2021, tiredness (fatigue) (medically significant) on 16Oct2021 with outcome of not recovered, off label use (off label use) (non-serious) on 15Oct2021 with outcome of unknown, interchange of vaccine products (interchange of vaccine products) (non-serious) on 15Oct2021 with outcome of unknown, booster (immunisation) (non-serious) on 15Oct2021 with outcome of unknown. The patient underwent lab tests which included sars-cov-2 test: negative on 14Sep2021. Therapeutic measures were taken as a result of the events. The clinical course was reported as follows: Customer had still and pain shoulder, nausea and tiredness. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Taken paracetamol". Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Monoparesis, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417922

Write-up: Right arm paresis; suspected covid-19; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110191846013310-X8ELL, Safety Report Unique Identifier GB-MHRA-ADR 26094075. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FG6431) via an unspecified route of administration in right arm, on 13Oct2021 as DOSE 3 (BOOSTER), SINGLE for Covid-19 immunisation. Patient medical history included immunodeficiency from an unknown date and unknown if ongoing. Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef. The patient concomitant medications were not reported. Patient was not currently breastfeeding. The patient had experienced suspected covid-19, right arm paresis on 15Oct2021. The patient had booster in right arm and cannot lift kettle her muscles very week and suspected covid-19 was ongoing. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date No - Negative COVID-19 test. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Outcome of right arm paresis, suspected covid-19 was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844658 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Fatigue, Interchange of vaccine products, Monoplegia, Off label use, Pain, Pain in extremity
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101418025

Write-up: Paralysis arm; right arm very painful; First and second dose of Astra Zeneca; First and second dose of Astra Zeneca; Shivering; Generalised aching; Appetite lost; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110191901513210-ET54O, Safety Report Unique Identifier is GB-MHRA-ADR 26094378. A 95-year-old male patient received third dose (booster) of BNT162B2 (COMIRNATY), via an unspecified route of administration (right arm) on 15Oct2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He was not enrolled in clinical trial. He has not had symptoms associated with COVID. 19 and not had a COVID-19 test. First and second dose of Astra Zeneca - no reaction. The patient experienced shivering, generalised aching, appetite lost, and tiredness on 15Oct2021; paralysis arm on 16Oct2021. Case narrative: Jab received at midday on Friday 15th October in his right arm. Later that day, right arm very painful, general feeling of extreme tiredness, aching across whole body, severe shivering, loss of appetite. Severe shivering and loss of appetite lasted 36 hours. General aching lasted 48 hours. Greatest concern to the patient was his upper right arm muscle has lost function currently. He can lift the lower arm (from the elbow) but he cannot lift his arm from the shoulder. This was not due to pain or discomfort; the upper arm muscle just didn''t seem to work. He has taken paracetamol to ease the general symptoms. These reactions were totally unexpected as he had no reaction at all to the first two vaccines (Astra Zeneca). He has not tested positive for COVID-19 since having the vaccine This report is not related to possible inflammation of the heart (myocarditis or pericarditis). The patient recovered from shivering and appetite lost on 18Oct2021 and from generalised aching on 19Oct2021. He was recovering from tiredness and not recovered from paralysis arm and right arm very painful. Case reported as serious by health authority (disability). No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1844678 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bloody discharge, Dysphagia, Interchange of vaccine products, Off label use, Oropharyngeal pain, Speech disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417900

Write-up: mucus; swallowing difficulty; difficulty; Sore throat; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110200834185410-BTGHN. Safety Report Unique Identifier GB-MHRA-ADR 26096708. An 82-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FJ5782), via an unspecified route of administration on 15Oct2021 (at the age of 82-years-old) as dose number unknown (initial Pfizer dose), single for COVID-19 immunisation. Medical history was not reported. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication. The patient previously received COVID-19 VACCINE ASTRAZENECA (Dose number and Lot number not reported), via an unspecified route of administration on 23Jan2020 for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient received initial Pfizer dose, and on an unspecified date, the patient experienced mucus, swallowing difficulty, difficulty (disorder speech). On 16Oct2021, the patient experienced sore throat. A sore throat and mucus causing difficulty in swallowing. This report not related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844685 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Immunisation
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: BISOPROLOL FUMARATE; RAMIPRIL; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial flutter
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101418119

Write-up: Tiredness; Diarrhea; Booster; 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-202110200944376540-N7FPX. Safety Report Unique Identifier is GB-MHRA-ADR 26097346. A 71-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 at the age of 71 years (Batch/Lot Number: FF8288) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included atrial flutter. Concomitant medications included BISOPROLOL FUMARATE taken for atrial flutter from 17Jan2017 to 22Jul2021; RAMIPRIL taken for atrial flutter from 17Jan2017 to 22Jul2021; WARFRIN taken for atrial flutter from 13Jan2017 to 22Jul2021. The patient previously took BNT162B2 DOSE 1 on 22Jan2021 and DOSE 2 on 09Apr2021 for Covid-19 immunization. The patient experienced tiredness and diarrhea on 15Oct2021. The events were assessed as serious (medically significant). The outcome of the events was recovered on 18Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844706 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Contusion, Fibrin D dimer, Platelet count, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (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: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown results; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown results; Comments: <150 ?-109/L?: Unknown
CDC Split Type: GBPFIZER INC202101417502

Write-up: possible blood clots; forearm bruising; Bruising; This is a spontaneous report from a contactable other hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110201455544520-XJERF, Safety Report Unique Identifier GB-MHRA-ADR 26098881. A male patient of an unspecified age received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration in 2021 (Lot Number: FF8288) as dose 2, single for COVID-19 immunisation. Medical history included non-tobacco user, hypertension. The patient has no history of, or current, malignancy, or intracranial malignancy or concurrent or recent intracranial infections. The patient had no recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had no recent trauma/head injury. Concomitant medication(s) included ramipril (RAMIPRIL) taken for hypertension, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced possible blood clots or low platelet counts (medically significant) on an unspecified date with outcome of unknown, forearm bruising opposite limb to vaccine (non serious) on an unspecified date with outcome of unknown, bruising (non serious) on 15Oct2021 with outcome of not recovered. The patient underwent lab tests and procedures which included: blood test: unknown results on an unspecified date, platelet count: unknown results on an unspecified date, fibrin D dimer: unknown results on an unspecified date. Patient had not a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. This report related to possible blood clots or low platelet counts. This report did not relate to possible myocarditis or pericarditis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Erythema nodosum, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101418089

Write-up: chesty cough; Off-label use; booster; Erythema nodosum; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The Regulatory authority report number [GB-MHRA-WEBCOVID-202110201754321810-D6KTS], Safety Report Unique Identifier [GB-MHRA-ADR 26099812]. A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 16Jan2021 to 01Feb2021. The patient''s concomitant medications were not reported. The patient previously received first dose and second dose of COVID-19 MRNA VACCINE BIONTECH, both on an unknown date for COVID-19 immunisation. The patient experienced chesty cough on an unspecified date, erythema nodosum on 15Oct2021, Off-label and booster on an unspecified date. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test Yes - Positive COVID-19 test on an unspecified date. The outcome of the event chesty cough was unknown and event erythema nodosum was not recovered. The clinical course was reported as follows: Patient had a chesty cough a few weeks ago and have now developed Erythema Nodosum. She believes this has been brought on by the vaccine. She has never reacted to any virus, illness or medication in this way before now. She recovered perfectly well from COVID-19 earlier in the year, and every other ailment since then. After she received the vaccine, the first illness she has had since, has brought about this reaction. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. None, perfectly fit and well before now. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844816 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426538

Write-up: Muscle ache; joint ache; Off Label Use; Booster; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110211541481340-1JFS6, Safety Report Unique Identifier is GB-MHRA-ADR 26104338. A 34-year-old female patient received third dose of BNT162B2 (COMIRNATY), dose 3 via an unspecified route of administration on 15Oct2021 (Lot Number: Ff8288) (at the age of 34-year-old) at dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient had off label (booster use). The patient experienced muscle and joint ache for 48h post injection on 16Oct2021. The outcome of the events was recovered on 19Oct2021. The events were medically significant. The patient underwent lab tests and procedures which included negative COVID-19 test on 15Oct2021. Patient last menstrual period date: 18Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-10-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, SARS-CoV-2 test
SMQs:, Hearing impairment (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: 20211018; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101429095

Write-up: Bell''''s palsy; 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-202110240150476900-21W7X, Safety Report Unique Identifier GB-MHRA-ADR 26114540. A 25-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Oct2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient is not currently breastfeeding. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as 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 bell''''s palsy on 15Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Oct2021. No report was related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1844965 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypertension, Malaise, Suffocation feeling, Vaccination site pain
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History Concurrent Conditions: Gastritis erosive; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101455041

Write-up: Malaise, hypertensive peak and pain in the arm at the site of the vaccine; Malaise, hypertensive peak and pain in the arm at the site of the vaccine; After 10 minutes from the vaccine sense of suffocation; Malaise, hypertensive peak and pain in the arm at the site of the vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-801762. A 48-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: FG3739, Expiration Date: 31Dec2021), intramuscular, administered in Arm Left on 15Oct2021 09:37 (at the age of 48-year-old) as dose 1, single for covid-19 immunization. Medical history included gastritis erosive and hypertension. Concomitant medication included enalapril. The patient previously took tachipirina and zimox d and experienced allergy and iodized lecithin and experienced rash and palpitations. On 15Oct2021, the patient experienced malaise, hypertensive peak and pain in the arm at the site of the vaccine. After 10 minutes from the vaccine the patient experienced the sense of suffocation. The patient carried out general visit and observation in emergency room. The patient administered slow flux 0.5 cc plus 19 vials. The clinical outcome of the events was recovering. Reporter comment: The vaccine was carried out after allergological consultation because the patient is allergic to tachipirina, zimox and iodized contrast medium iodized (skin rash and palpitations). No follow-up attempts were possible. No further information was expected.


VAERS ID: 1844976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-10-15
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain injury
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101463312

Write-up: brain injury likely neoplastic; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority number is IT-MINISAL02-802939. A 70-year-old male patient received second dose of BNT162B2 (COMIRNATY; solution for injection, Lot Number: EX3599, Expiry date: 31Aug2021) via intramuscular route of administration, administered in left arm (left shoulder) on 28Apr2021 as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY; solution for injection, Lot Number: ew2246, Expiry date: 31Jul2021) via an unspecified route of administration, on 07Apr2021 as dose 1, single for COVID-19 immunization. On 15Oct2021, the patient experienced brain injury likely neoplastic. On an unspecified date, the patient was hospitalized for the event. The outcome of the event was unknown. No follow-up attempts possible. No further information expected. COMIRNATY batch lot already obtained.


VAERS ID: 1845030 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure fluctuation, Burning sensation, Costovertebral angle tenderness, Dyspnoea, Erythema, Eye pruritus, Eyelid oedema, Face oedema, Fatigue, Localised oedema, Nausea, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (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:
Current Illness: Allergic reaction to bee sting; Allergy to chemicals (Allergy to perfumes, disinfectants); Chronic pyelonephritis
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (patient has experienced anaphylactic shock 2 times after bee sting)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20211107793

Write-up: EYE PRURITUS; COSTOVERTEBRAL ANGLE TENDERNESS; BLOOD PRESSURE FLUCTUATION; FATIGUE; ANAPHYLACTIC REACTION; BURNING SENSATION IN FACE; NAUSEA; ERYTHEMA FACIAL; EYELID OEDEMA; VOMITING; DIFFICULTY BREATHING; TACHYCARDIA; FACE OEDEMA; NECK OEDEMA; This spontaneous report received from a pharmacist via a Regulatory Authority [LV-SAM-2021106757] on 02-NOV-2021 and concerned a 58 year old female of unspecified ethnicity and race. The patient''s weight was 63 kilograms, and height was not reported. The patient''s past medical history included: anaphylactic shock, and concurrent conditions included: allergic reaction to bee sting, allergy to chemicals, and chronic pyelonephritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA6111 expiry: Unknown) 0.5 ml, 1 total, administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced face oedema, neck oedema, anaphylactic reaction, burning sensation in face, nausea, erythema facial, eyelid oedema, vomiting, difficulty breathing and tachycardia. On 16-OCT-2021, the patient experienced fatigue, costovertebral angle tenderness, blood pressure fluctuation. On 17-OCT-2021, the patient experienced eye pruritus. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction, burning sensation in face, nausea, erythema facial, vomiting, and difficulty breathing on 15-OCT-2021, and costovertebral angle tenderness on 22-OCT-2021, was recovering from eye pruritus, face oedema, neck oedema, fatigue, eyelid oedema, and blood pressure fluctuation, and the outcome of tachycardia was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1845133 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0160 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/100 mmHg mmHg; Comments: 9:32 AM; Test Date: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:210/90 mmHg mmHg; Comments: 10:34 AM
CDC Split Type: PHPFIZER INC202101418825

Write-up: Elevated BP; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111953. A 53-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 15Oct2021 (Batch/Lot Number: FH0160) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced elevated bp 09:32AM 180/100mmhg 10:34AM 210/90mmhg (medically significant). The patient underwent lab tests and procedures which included blood pressure measurement: 180/100 mmhg mmhg on 15Oct2021 9:32 AM , blood pressure measurement: 210/90 mmhg mmhg on 15Oct2021 10:34 AM. The outcome of the event was recovered on 15Oct2021 11:50. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845135 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211015; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:200/130 mmHg
CDC Split Type: PHPFIZER INC202101418832

Write-up: Elevated BP 200/130; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111888. A 57-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0350), intramuscular on 15Oct2021 (at the age of 57years) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated bp 200/130 on 15Oct2021 10:58 with outcome of recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845213 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis, Trigeminal neuralgia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (broad), Hearing impairment (broad)

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

Write-up: right facial palsy; suspicous trigeminal neuropathy; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (right facial palsy) and TRIGEMINAL NEURALGIA (suspicous trigeminal neuropathy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced FACIAL PARALYSIS (right facial palsy) (seriousness criterion medically significant) and TRIGEMINAL NEURALGIA (suspicous trigeminal neuropathy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (right facial palsy) and TRIGEMINAL NEURALGIA (suspicous trigeminal neuropathy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not reported. Treatment medication were not reported. On 15 Oct 2021, onset weakness over right facial muscle since this morning, to TSGH NEU OPD, mouth angle deviation to left side, facial expression: palsy over right side, Frontalis and elevation eye brow: weakness, right, eye closing: impairment, right, sensation: paresthesia over right face. A: right facial palsy, with suspicious trigeminal neuropathy after Moderna vaccine injection. Company Comment : This case concerns a 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of facial paralysis and trigeminal neuralgia. The events occurred approximately 2 days after the received dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as there''s no information available about the other dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of facial paralysis and trigeminal neuralgia. The events occurred approximately 2 days after the received dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as there''s no information available about the other dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1845519 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-10-15
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Deep venous thrombosis groin; This case was received via Agency (Reference number: FI-FIMEA-20215834) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Deep venous thrombosis groin) in a 25-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Oct-2021, after starting mRNA-1273 (Spikevax), the patient experienced DEEP VEIN THROMBOSIS (Deep venous thrombosis groin) (seriousness criteria hospitalization and medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep venous thrombosis groin) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No treatment medication details were provided. No concomitant medication details were provided. Company Comment: This case concerns a 25-year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event deep vein thrombosis occurred 36 days after the first dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 25-year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event deep vein thrombosis occurred 36 days after the first dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1845634 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-10-15
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / 1 LA / OT

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

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

Write-up: Skin breakout; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-MA20214443) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of RASH (Skin breakout) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 214032 and 214018) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced RASH (Skin breakout) (seriousness criterion medically significant). At the time of the report, RASH (Skin breakout) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company Comment: This case concerns a 41-year-old female patient, with no details on medical history provided, who experienced the serious unexpected event of RASH. The event occurred on the same day after receiving the second dose of Moderna COVID-19 vaccine. Rechallenge is not applicable since no information about further dosing is disclosed and the event''s outcome is not recovered. The benefit risk relation of Moderna COVID-19 vaccine is not affected by this report. Event seriousness was captured as per Regulatory Authority assessment, but there is no available information suggesting the event met the seriousness criteria. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation document received on 28-Oct-2021 contains updated dosing details and narrative.; Sender''s Comments: This case concerns a 41-year-old female patient, with no details on medical history provided, who experienced the serious unexpected event of RASH. The event occurred on the same day after receiving the second dose of Moderna COVID-19 vaccine. Rechallenge is not applicable since no information about further dosing is disclosed and the event''s outcome is not recovered. The benefit risk relation of Moderna COVID-19 vaccine is not affected by this report. Event seriousness was captured as per Regulatory Authority assessment, but there is no available information suggesting the event met the seriousness criteria.


VAERS ID: 1845719 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Coma scale, Dizziness, Gait disturbance, Muscular weakness, Vital signs measurement
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: BP; Result Unstructured Data: 159/79 mmHg; Test Date: 20211016; Test Name: Glasgow Coma Scale; Result Unstructured Data: GCS:E4V5M6; Test Date: 20211016; Test Name: Vital signs; Result Unstructured Data: Vital signs:36.9 ?, 69 beats per minute, 20 breaths per minute
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Weakness of limbs; Began to feel dizzy; Unstable in gait; This regulatory authority case was reported by a pharmacist and describes the occurrence of MUSCULAR WEAKNESS (Weakness of limbs), DIZZINESS (Began to feel dizzy) and GAIT DISTURBANCE (Unstable in gait) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion hospitalization), DIZZINESS (Began to feel dizzy) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Unstable in gait) (seriousness criterion hospitalization). The patient was hospitalized on 16-Oct-2021 due to DIZZINESS, GAIT DISTURBANCE and MUSCULAR WEAKNESS. At the time of the report, MUSCULAR WEAKNESS (Weakness of limbs), DIZZINESS (Began to feel dizzy) and GAIT DISTURBANCE (Unstable in gait) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2021, Blood pressure measurement: 159/79 (abnormal) 159/79 mmHg. On 16-Oct-2021, Coma scale: normal (normal) GCS:E4V5M6. On 16-Oct-2021, Vital signs measurement: normal (normal) Vital signs:36.9 ?, 69 beats per minute, 20 breaths per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. Company comment -This case concerns a 71 year old female patient with no relevant medical history, who experienced the serious unexpected events of muscular weakness, gait disturbance and dizziness. The events occurred approximately 2 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71 year old female patient with no relevant medical history, who experienced the serious unexpected events of muscular weakness, gait disturbance and dizziness. The events occurred approximately 2 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1845871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Neck pain, Photophobia, Tunnel vision
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101453175

Write-up: Tunnel vision; Dizziness; Headache; Nausea; Neck pain; Photophobia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 648585. A 38-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration, on 14Oct2021 at single dose (dose number unknown) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 15Oct2021, the patient had tunnel vision, dizziness, headache, nausea, neck pain, and photophobia. No seriousness criteria were provided. The patient had not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1845879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-10-15
   Days after vaccination:254
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EXELON; FOLAVIT; ASAFLOW; ATORVASTATIN AB; D-CURE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Breast cyst excision; Cerebrovascular accident; Cognitive impairment; Hypercholesterolemia; Transient ischemic attack; Tuberculosis
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: PCR test; Test Result: Positive.
CDC Split Type: BEPFIZER INC202101490336

Write-up: COVID-19 infection after vaccination; Drug ineffective; This is a spontaneous report from a contactable other healthcare professional from the Regulatory Authority. The regulatory authority number BE-FAMHP-DHH-N2021-108169. An 83-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EK9788), via an unspecified route of administration on 03Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included breast cyst excision and hypercholesterolaemia from an unknown date and unknown if ongoing, tuberculosis from 1963 to an unknown date, cerebrovascular accident from 2005 to an unknown date, transient ischaemic attack from 2005 to an unknown date, cognitive disorder from Nov2018 to an unknown date picture of amnestic mild cognitive impairment, and suspected evolution to Alzheimer''s disease from 30Jul2021 to an unknown date. Concomitant medications included EXELON, FOLAVIT, ASAFLOW, ATORVASTATIN, and D-CURE, all taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included COVID-19 Vaccine (manufacturer unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 15Oct2021, the patient had covid-19 infection after vaccination and complain of drug ineffective (medically significant). On 15Oct2021, the patient underwent lab tests and procedures which included sars-cov-2 test positive. Outcome of the events was unknown. No follow-up attempts possible. No further information expected. Treatment- Evolution of the ADR-.


VAERS ID: 1847352 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dizziness, Immunisation, Nausea, Off label use, Pain, Pain in jaw, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Osteonecrosis (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: DESOGESTREL
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 INC202101418047

Write-up: Jaw pain; Back pain; Ache; Off label use; Booster; Nausea; Dizziness; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110192230095770-U9VX4 and Safety Report Unique Identifier is GB-MHRA-ADR 26095450. A 28-year-old female patient received dose of BNT162B2 (COMIRNATY, Batch/Lot number and expiry date were not reported), via an unspecified route of administration on 15Oct2021 12:30 (age at vaccination was 28 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included desogestrel taken for an unspecified indication from 01Jun2011 to an unspecified stop date. Historical vaccine included first and second doses of Comirnaty on 13Jan2021 as dose 1, single and on 27Mar2021 as dose 2, single for COVID-19 immunization. The patient experienced nausea on 15Oct2021 with outcome of recovered on 18Oct2021, dizziness on 15Oct2021 with outcome of recovered on 18Oct2021, ache on 16Oct2021 with outcome of recovered on 18Oct2021, jaw pain on 17Oct2021 with outcome of recovered on 18Oct2021, and back pain on 16Oct2021 with outcome of recovering; off label use and booster on 15Oct2021 12:30 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative. The events were reported as serious, medically significant by the health authority. Narrative case summary and further information: Case narrative: Injection was at 12:30pm on the Friday. Waves of nausea with dizziness started around 5pm. Full body ache started midday Saturday. Sharp back pain then started on the Saturday night. Jaw pain then started around 11pm on the Saturday. 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. No further information is expected.


VAERS ID: 1847414 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFZ FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Heart rate, Heart sounds, Heart sounds abnormal, Interchange of vaccine products, Musculoskeletal stiffness, Myocarditis, Off label use, Palpitations, Pericarditis, Psychomotor hyperactivity, SARS-CoV-2 test, Sleep disorder, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:Increased; Test Name: heart sounds; Result Unstructured Data: Test Result:unknown result; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428823

Write-up: increased heartbeat and degree of hyperactivity; stiffness; Heart sounds; Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); possible inflammation of the heart (myocarditis or pericarditis); possible inflammation of the heart (myocarditis or pericarditis); woke him in the night periodically; AZ 1 & 2 jabs; AZ 1 & 2 jabs; 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-202110211013230520-FONKX, Safety Report Unique Identifier GB-MHRA-ADR 26103306. A male patient of an unspecified age received third dose (booster) of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (lot number: PFZ FF8222) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patent previously received first and second doses of COVID-19 VACCINE ASTRAZENECA for COVID-19 immunisation and experienced increased heartbeat and degree of hyperactivity. The patient experienced increased heartbeat and degree of hyperactivity, stiffness, heart sounds, fatigue/unusual tiredness, heart palpitations, and racing heart (tachycardia) on an unspecified date. Case narrative: Increased heartbeat and degree of hyperactivity, which woke him in the night periodically. Expected this for first one or two days after the booster (he had felt similar with the AZ 1 & 2 jabs) but this has gone on for almost a week now. He also periodically experienced a stiffness at the back of the skull/neck. This report is related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. No imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The patient was recovering from hyperactivity and stiffness; not recovered from heart sounds; while outcome of other events was unknown. Case reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Lipodystrophy (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: 20211021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101429238

Write-up: Mastalgia; dose 3 (booster); dose 3 (booster); This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110221354108740-ARRXI. Safety Report Unique Identifier GB-MHRA-ADR 26109259. A 47-year-old female patient received BNT162B2 (COMIRNATY COVID-19 MRNA VACCINE BIONTECH ), dose 3 via an unspecified route of administration on 15Oct2021 (Lot Number: Fg6431) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Historical vaccine included dose 1 and dose 2 both BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced mastalgia on 16Oct2021 with outcome of not recovered which was assessed as serious with medically significant. It was reported that Mastalgia to the point of unable to lie on front or exercise. Extremely painful. Had to some extent with 2 no vaccine also. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 21Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac infection, Dyspnoea, Fatigue, Heart rate, Immunisation, Off label use, Palpitations, Product use issue, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart; Result Unstructured Data: Test Result:racing; Test Date: 20211022; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101429102

Write-up: Fatigue/unusual tiredness; Shortness of breath; Racing heart (tachycardia); possible inflammation of the heart; Palpitations/Heart palpitations; received 3rd dose of BNT162B2 (COMIRNATY)/Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken on 13Oct2021; received 3rd dose of BNT162B2 (COMIRNATY); Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken on 13Oct2021; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110221358339040-L23DA, Safety Report Unique Identification Number: GB-MHRA-ADR 26109597 A male patient received 3rd dose of BNT162B2 (COMIRNATY) (Lot Number: FF8222) via an unspecified route of administration at single dose on 15Oct2021 for covid-19 immunisation. The patient medical history was not reported. Patient is not enrolled in clinical trial. The patient previously received first and second dose of BNT162b2 on unknown date for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 13Oct2021. The patient experienced palpitations/ Heart palpitations (medically significant) on 16Oct2021, fatigue/unusual tiredness (medically significant) on an unspecified date, shortness of breath (medically significant) on an unspecified date, racing heart (medically significant) on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test negative on 22Oct2021. It was reported that heart Palpitation, difficulty carrying out regular tasks since the booster dose. The reporter considered it was related to possible inflammation of the heart (myocarditis or pericarditis). No diagnosis made by a medical professional. The outcome of Palpitation was not resolved and for all other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1847478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, SARS-CoV-2 test, Vaccination site pain
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: Psoriatic arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428765

Write-up: patient received third dose of BNT162B2; patient received third dose of BNT162B2; Injection site pain; This is a spontaneous report from a contactable consumer received from the Regulatory AUTHORITY (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110221634282090-YJKHJ, Safety Report Unique Identifier GB-MHRA-ADR 26110117. A male patient of an unspecified age received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Batch/Lot Number: FF8288) as dose 3 (booster), single for COVID-19 immunisation. Medical history included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis) and psoriatic arthritis. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took naproxen for psoriatic arthritis and also previously received a dose of BNT162B2 on 20Jan2021 (dose number unknown) and another dose (dose number unknown) on an unspecified date, both for Covid-19 immunisation. The patient experienced injection site pain on 15Oct2021. The events were reported as serious (medically significant). The clinical course was reported as follows: pain comes and goes. Can be intense. Daily dose of naproxen sodium doesn''t seem to help. 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 08Oct2021. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of injection site pain was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847498 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hyperhidrosis, Immunisation, Off label use, SARS-CoV-2 test, Subcutaneous abscess
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211020; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428962

Write-up: Excess sweating; Pubic abscess; Fatigue extreme; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110222057087350-LRRV6 and Safety Report Unique Identifier GB-MHRA-ADR 26111390. A patient of unspecified age and gender received the third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously took the first, second dose of BNT162b2 for COVID-19 immunisation. The patient experienced fatigue extreme on 16Oct2021, excess sweating on 18Oct2021, pubic abscess on 17Oct2021. Case was reported other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 20Oct2021 No - Negative COVID-19 test. The outcome of the event excess sweating was recovered on 21Oct2021, of the event pubic abscess was not recovered, of the event fatigue extreme was recovering. 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: 1847572 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Depression, Psychological trauma, SARS-CoV-2 test
SMQs:, Depression (excl suicide and self injury) (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: 20211020; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428865

Write-up: psychological trauma; Anxiety; Depression; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110231718171210-F0JC1. Safety Report Unique Identifier GB-MHRA-ADR 26113939. A 31-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Batch/Lot Number: Fg6431) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 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 Patient is not pregnant, Patient is not currently breastfeeding. It was reported that the patient felt she was coerced into taking this vaccine due to the no jab no job policy enforced by the government for those who work in registered care homes. As a result since taking the vaccine, she felt she have suffered psychological trauma on an unspecified date as she did not actually want to take it given the risks it poses to her health. The patient experienced anxiety and depression on 15Oct2021. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 20Oct2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847675 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; ATORVASTATIN; IBUPROFEN; NATECAL D3; OMEPRAZOLE; RENNIE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal); Bone loss; Cluster headache; Dry eye; Heartburn; High cholesterol; Influenza; Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101429189

Write-up: This is a report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-YCVM-202110071245218550-TRUVM. Safety Report Unique Identifier GB-MHRA-ADR 26111720. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 15Oct2021 (Lot Number: FJ5782) as DOSE 3 (BOOSTER), SINGLE for COVID-19 vaccination, at the age of 68 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (COMIRNATY), via an unspecified route of administration on 21Jan2021 (Lot number: EK4243) as single dose for COVID-19 vaccination and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Lot number: ER1799) as single dose for COVID-19 vaccination. Medical history included Ulcerative colitis, dry eye syndrome, Osteopoenia, high cholesterol, cluster headache, influenza, Acid reflux (oesophageal), and Heartburn. Concomitant medications included INFLUENZA VIRUS VACCINE given (left arm) for influenza (24hrs before booster Covid vaccine), ATORVASTATIN taken for high cholesterol, IBUPROFEN taken for cluster headache, NATECAL D3 taken for osteopenia, OMEPRAZOLE taken for Acid reflux (oesophageal), RENNIE taken for heartburn. The patient experienced painful R arm on 16Oct2021. Event was reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 virus test negative (No - Negative COVID-19 test) on 20Jul2021. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The outcome of event painful R arm was recovered on 17Oct2021. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected. Based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported events of Painful R arm, Booster, and Off-label use cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


VAERS ID: 1847676 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Interchange of vaccine products, Myalgia, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101428784

Write-up: High temperature; Tiredness; Off label use; Interchange of vaccine products; Muscle pain; This is a solicited report from the Regulatory Authority from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-YCVM-202110140909080360-MLHPB, Safety Report Unique Identifier GB-MHRA-ADR 26110900. A 73-year-old female patient received third dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF8288), via an unspecified route of administration at single dose on 15Oct2021 (at the age of 73-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient not had symptoms associated with COVID-19. The patient not had a COVID-19 test. The patient previously received first dose of COVID-19 VACCINE ASTRAZENECA on 24Jan2021 and second dose of COVID-19 VACCINE ASTRAZENECA 10Apr2021 for COVID-19 immunization. The patient experienced high temperature on 16Oct2021, muscle pain on 15Oct2021, tiredness on 16Oct2021. The patient underwent lab tests and procedures which included body temperature was high on 17Oct2021. The patient was not enrolled in clinical trial. The events was reported as eventually medically significant. The outcome of the events was recovered for High temperature on 17Oct2021, Muscle pain on 18Oct2021, Tiredness on 18Oct2021.The reporter''s assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 1847728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Mouth haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: ITPFIZER INC202101419904

Write-up: I had bleeding from the mouth today; This is a spontaneous report from a contactable consumer via Regulatory Authority (regulatory authority reference number: IT-MINISAL02-800428), based on information received by Pfizer.(manufacturer control number IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-110514), license party for apixaban (ELIQUIS). This case was received via health authority (Reference number: IT-MINISAL02-800428) on 21-Oct-2021 and was forwarded to Regulatory Authority on 21-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of haemorrhage (Bleeding) in 69-year-old female patient who received apixaban (Eliquis) for Venous thromboembolism prophylaxis. Co-Suspect Products included tozinameran (Comirnaty) for COVID-19 immunisation. On an unknown date, the patient started Eliquis (Oral). On 13-Oct-2021, the patient started Comirnaty (Intramuscular) 1 dosage form, Total. On 15-Oct-2021, an unknown time after starting Eliquis, the patient experienced haemorrhage (seriousness criterion medically significant). The action taken with Eliquis (Oral) was unknown. At the time of the report, haemorrhage was resolving. The action taken with Comirnaty was unknown and causality was not provided for the same. For Eliquis (Oral), the reporter did not provide any causality assessments. Additional information from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-800428 includes: Previous coronavirus infection: yes - Last negative SARS-CoV-2 test: 2020-12-01 - Reaction time: 14:00 Anticoagulants for fibrillation treatment; COVID 19 COMIRNATY VACCINE (PFIZER) * 195FL 0.45ML: Administration site (left shoulder) Booster dose number (1). No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Healthcare facility PRIVACY - Influenza vaccination was not carried out - Concomitant conditions: Fibrillations - eliquis anticoagulant treatment - Previous coronavirus infection: yes - Last negative SARS-CoV-2 test: 2020-12-01 - Reaction time: 14:00; Sender''s Comments: Medical Evaluation Comment: This patient had hemorrhage after receiving apixaban therapy. This patient was also vaccinated with tozinameran for COVID-19. Based on the anticoagulant action of apixaban, its role in the reported bleeding event is considered as related to the suspect.


VAERS ID: 1847814 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3023 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Sudden hearing loss
SMQs:, Hearing impairment (narrow)

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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211012; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101429963

Write-up: Sudden hearing loss; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21129890. A 61-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot Number: FH3023; Expiration Date: 31Dec2021), via an unspecified route of administration on 12Oct2021 at 15:00 (the day of the vaccination), at the age of 61-years-old as dose 2, single for COVID-19 immunization. Patient history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included hypertension. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees centigrade on 12Oct2021. Event onset date was reported as on 15Oct2021 (3 days after the vaccination). The course of the event was as follows: On 12Oct2021, the patient received the second dose of the COMIRNATY. On 15Oct2021, the patient had sudden hearing loss. The patient was receiving the steroid as treatment in the hospital (recommended hospitalization for the patient, but outpatient treatment was underway due to personal reasons). On 19Oct2021 at the reporting time, hearing of the patient did not return. On 19Oct2021 (7 days after the vaccination), the outcome of the event was not recovered. The reporting physician classified the event as serious (risk of disability). The causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The possibility of the adverse reaction cannot be denied. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The possibility of the adverse reaction cannot be denied.


VAERS ID: 1847824 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK7441 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Computerised tomogram head, Gaze palsy, Mobility decreased, Neurological examination, Pyrexia, Seizure, Tonic convulsion, Urinary incontinence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), 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? 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: Medical History/Concurrent Conditions: Thyroiditis chronic; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood test; Result Unstructured Data: Test Result:no abnormal; Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20211015; Test Name: head CT; Result Unstructured Data: Test Result:no abnormal; Test Date: 20211015; Test Name: Neurological examination; Result Unstructured Data: Test Result:no abnormal
CDC Split Type: JPPFIZER INC202101430689

Write-up: Convulsion; tonic convulsion; Eyeballs raise upward; pyrexia; Urinary incontinence; unable to get up from bed; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129818. A 13-year and 3-month-old female (age at the 2nd dose of vaccination) female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FK7441; Expiration Date: 31Jan2022) via an unspecified route of administration, administered in Left shoulder on 14Oct2021 14:00 (the day of vaccination) (at the age of 13-years-old) at dose 2, single for covid-19 immunization. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status): Type 1 diabetes mellitus, Thyroiditis chronic, Insulin self-injection, Oral thyroid hormone preparation. Body temperature before vaccination was 36.5 degrees Centigrade. The patient''s concomitant medications were not reported. The patient previously took insulin, thyroid hormones. On 15Oct2021 at 7:00 (17 hours after the vaccination), the patient experienced pyrexia and Convulsion. On 15Oct2021 (1 day after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 14Oct2021, the patient received the 2nd dose of Pfizer COMIRNATY in the left shoulder. On the same day, there was no change in physical condition. On 15Oct2021, during sleep, upper / lower limb extension, tonic convulsion, eyeballs raise upward were observed. The symptoms settled in 3 minutes. The patient experienced urinary incontinence. Thereafter, eyes kept going out of focus and unable to get up from bed. An ambulance was requested and transferred to the reporting hospital. At the time of admission, the patient recovered consciousness. There were no abnormal on neurological examination. No abnormal on blood test and no abnormal on head CT. Due to difficulty in oral intake and background of Type 1 diabetes mellitus, the patient was hospitalized for follow-up purposes. The reporting physician classified the events as serious (caused hospitalization from 15Oct2021 to 16Oct2021) and assessed that the events were related to bnt162b2. There was no other possible cause of the event such as any other diseases. On 16Oct2021 (2 days after the vaccination), the outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1847829 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphoria, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging neck, Muscular weakness, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow), 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:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: head MRI; Result Unstructured Data: Test Result:no prominent abnormality; Test Date: 20211015; Test Name: Cervical Spine MRI; Result Unstructured Data: Test Result:no prominent abnormality
CDC Split Type: JPPFIZER INC202101430828

Write-up: Weakness of left upper and lower extremities; sensory disturbance of left upper and lower extremities; dysphoria; numbness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21130196. A 62-years-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not reported) as single dose (at the age of 62) for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. The patient experienced weakness of left upper and lower extremities on 15Oct2021, sensory disturbance of left upper and lower extremities on 15Oct2021, dysphoria on 15Oct2021, numbness on 15Oct2021. The patient was hospitalized from 15Oct2021. On 23Oct2021, the outcome of the event was recovering. The course of the event was as follows: On 15Oct2021, the patient received the COVID-19 vaccine. After the vaccination, the patient was followed up in a seated position. Within 15 minutes (as reported), the patient experienced dysphoria and weakness of left upper and lower extremities and numbness. The patient was referred to PRIVACY Hospital, Department of Neurology. At consultation, the patient had weakness and sensory disturbance of the left upper and lower extremities equivalent to MMT 4 and was admitted to the hospital. At admission, examinations including Head MRI and Cervical Spine MRI revealed no prominent abnormality that could be the cause for the symptoms. The symptoms were remaining but tending to improve. The reporting physician classified the event as serious (hospitalized from 15Oct2021) and assessed the causality between the event and the vaccines as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The symptoms developed about 15 minutes after the vaccination, and the onset was considered to be too early to say that it was the effect of the vaccine ingredients. However, there were no other abnormalities that could be the cause of the weakness and sensory disturbance, and the effect of the vaccine could not completely be excluded. Thus, it was unassessable. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up; Reporter''s Comments: The symptoms developed about 15 minutes after the vaccination, and the onset was considered to be too early to say that it was the effect of the vaccine ingredients. However, there were no other abnormalities that could be the cause of the weakness and sensory disturbance, and the effect of the vaccine could not completely be excluded. Thus, it was unassessable.


VAERS ID: 1847848 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005788 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Body temperature, C-reactive protein, C-reactive protein increased, Chest pain, Electrocardiogram, Heart rate, Pain in extremity, Pericarditis, Pyrexia, Troponin C
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Drug allergy (Allergy to headache drug)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 37.8 degree celsius; Test Date: 20211016; Test Name: Body temperature; Result Unstructured Data: 38.1 degree celsius; Test Date: 20211017; Test Name: CRP; Result Unstructured Data: Test Result: 1.13; Test Date: 20211016; Test Name: Electrocardiogram; Result Unstructured Data: no abnormal; Test Date: 20211017; Test Name: Electrocardiogram; Result Unstructured Data: ST-T in V2-6 decreased from the previous day.; Test Date: 20211022; Test Name: Electrocardiogram; Result Unstructured Data: Normalized.; Test Date: 20211016; Test Name: Heart rate; Result Unstructured Data: Sinus rhythm.; Test Date: 20211017; Test Name: Myocardial troponin I; Result Unstructured Data: Not elevated.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Increased CRP; Suspected pericarditis; Left precordial pain; Pyrexia; Left axillary pain; Arm pain; Pyrexia; This case was received via regulatory authority (Reference number: JP-2021TJP112722) on 27-Oct-2021 and was forwarded to Moderna on 01-Nov-2021. This case, initially reported to the regulatory authority by a pharmacist, was received via the regulatory authority (Ref, v21130075). The patient had a history of allergic symptoms due to an over-the-counter headache drug. On an unknown date, the patient received the 1st dose of this vaccine. Pyrexia of 37.8 degrees Celsius and arm pain developed overnight. On 15-Oct-2021, the patient received the 2nd dose of this vaccine. At night, left axillary pain developed. On 16-Oct-2021, around 02:00, the patient was awakened by pain. Throbbing pain developed. The patient also had pain when turning over in bed. At 08:00, after the patient woke up, left precordial pain and pyrexia gradually developed, and the patient visited an emergency outpatient department of the reporting hospital. The patient had pyrexia of 38.1 degrees Celsius at visit. Pain increased during inspiration. Heart rate was sinus rhythm. There was no abnormal electrocardiogram, skin eruption, or respiratory symptom. The patient was hospitalized for follow-up due to suspected pericarditis after the vaccination with this vaccine. On 17-Oct-2021, chest pain persisted. Repeated electrocardiogram was performed. ST-T in V2-6 decreased from the previous day, and CRP increased to 1.13. Myocardial troponin I was not elevated. On 22-Oct-2021, electrocardiogram was normalized, and chest pain tended to improve. The symptoms resolved, and the patient was discharged from the hospital. The outcome of pyrexia and chest pain after the 1st vaccination was unknown. The outcome of left axillary pain, left precordial pain, pyrexia, increased CRP, and suspected pericarditis after the 2nd vaccination was reported as resolved. Follow-up investigation will be made. Reporter comments continuation: The patient complained of chest pain even when breathing cold air during hospitalization. There were press reports that myocarditis developed after the vaccination with this vaccine; thus, the patient may have been concerned about the vaccination. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: After hospitalization, since there was an increase in CRP, it is considered that there was an inflammatory reaction due to the vaccination with this vaccine, but since myocardial troponin I was negative, it is difficult to determine that the patient had pericarditis.; Sender''s Comments: This is a regulatory authority case concerning a 17-year-old, male patient with medical history of drug allergy, who experienced the expected serious (hospitalization and AESI) event of Pericarditis and the unexpected serious (hospitalization) event of axillary pain, chest pain, pyrexia and C reactive protein increased. The events occurred approximately 2 days after the second dose of Moderna COVID 19 vaccine (lot# 3005788). Patient reported some non serious events after the first dose also. Patient was hospitalized due to the chest pain and electrocardiogram was performed showing ST-T in V2-6 decreased and CRP increased to 1.13. Myocardial troponin I was not elevated. Lab data and symptoms improved so patient was discharged. Outcome was resolved. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.


VAERS ID: 1847986 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211110736

Write-up: FEVER; CHILLS; This spontaneous report received from a consumer via a Regulatory Authority [RO-NMA-2021-SPCOV13586] concerned a 32 year old male. The patient''s weight was 76 kilograms, and height was 178 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: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 15-OCT-2021 for product use for unknown indication. No concomitant medications were reported. On 15-OCT-2021, the patient experienced fever (fever 39 degrees Celsius) and chills (severe chills). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever, and chills on 16-OCT-2021. This report was serious (Life Threatening).


VAERS ID: 1847987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211112909

Write-up: TUBERCULOSIS; This spontaneous report received from a consumer via a Regulatory Authority [RO-NMA-2021-SPCOV13650] concerned a 52 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, batch number was not reported) 1 dosage forms, 1 total administered on 30-SEP-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 15-OCT-2021, the patient experienced tuberculosis, and was hospitalized on an unspecified date and duration. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from tuberculosis. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).


VAERS ID: 1851674 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Fatigue, Hypersomnia, Vaccination site reaction
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101437021

Write-up: fatigue/fatigue extreme; injection site reaction; and lower back pain; Joint pain; slept for 3 days; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107867. A 35-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (batch/lot number: unknown) at 35 years of age as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced fatigue/fatigue extreme, injection site reaction (vaccination site reaction), and lower back pain (low back pain), joint pain (arthralgia), slept for 3 days. The patient informed that she experienced injection site reaction, fatigue, arthralgia, fatigue extreme, low back pain. The events were reported serious (disability). The patient did not receive treatment due to the events. The outcome of the events was recovered on 17Oct2021 (also reported as recovering). Reporter''s comments: Treatment - No. Evolution of the ADR - Under improvement. Situations - Other: ADR description - I slept for 3 days and had lower back pain. Stop Date/Time of all events: Fatigue, Vaccination site reaction, Back pain, Fatigue (slept for 3 days), Arthralgia: 17Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Under improvement. Situations - Other: ADR description - I slept for 3 days and had lower back pain. Stop Date/Time of all events: Fatigue, Vaccination site reaction, Back pain, Fatigue (slept for 3 days), Arthralgia: 17Oct2021.


VAERS ID: 1851723 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphonia, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: BHPFIZER INC202101434651

Write-up: VOICE CHANGE, FACIAL SWELLING, PUFFINESS, ANAPHYLACTIC REACTION WITHIN ONE HOUR POST VACCINATION.; VOICE CHANGE, FACIAL SWELLING, PUFFINESS, ANAPHYLACTIC REACTION WITHIN ONE HOUR POST VACCINATION.; VOICE CHANGE, FACIAL SWELLING, PUFFINESS, ANAPHYLACTIC REACTION WITHIN ONE HOUR POST VACCINATION.; This is a spontaneous report from a contactable pharmacist at regulatory authority. This is a report received via email from the National Health Regulatory Authority of Bahrain. The Regulatory Authority number was unknown. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 15Oct2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 09Feb2021 and second dose of bnt162b2 on 06Apr2021, both for covid-19 immunisation. On 15Oct2021, the patient experienced voice change, facial swelling, puffiness, anaphylactic reaction within one hour post vaccination. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1852159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Chest scan, Electrocardiogram, Heart rate, Heart rate increased, Scan with contrast
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211016; Test Name: lung images; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211016; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211015; Test Name: Resting pulse; Result Unstructured Data: Test Result:Resting pulse 110; Test Date: 20211015; Test Name: Resting pulse; Result Unstructured Data: Test Result:After just a shower 140; Test Date: 20211016; Test Name: pulmonary embolism tests with contrast medium; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FIPFIZER INC202101437710

Write-up: Chest pain; Heart rate increased/ high heart rate; This is a spontaneous report from a contactable other hcp (nurse) downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20215787. A 17-year-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 vaccine for covid-19 immunisation. The patient experienced chest pain, and heart rate increased/ high heart rate both on 15Oct2021 with outcome of not recovered. The patient was hospitalized from 16Oct2021 to 17Oct2021. The patient underwent lab tests and procedures which included blood tests: unknown results on 16Oct2021, lung images: unknown results on 16Oct2021, electrocardiogram: unknown results on 16Oct2021, resting pulse: resting pulse 110 on 15Oct2021, after just a shower 140 on 15Oct2021, and pulmonary embolism tests with contrast medium: unknown results on 16Oct2021. Chest pain and high heart rate. Resting pulse 110. After just a shower 140. The girl in question was 17 years old and healthy, and her classmates have the same symptoms. Overnight stay in the emergency room of PRIVACY Hospital 16Oct2021-17Oct2021, where all blood tests, lung images, electrocardiogram and pulmonary embolism tests with contrast medium were taken. Medicated with Bisoprolol to lower the heart rate. It is the 3rd Covid Pfizer Comirnaty vaccine dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1852372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-10-15
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101481341

Write-up: Uterine bleeding; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-ST20214005. A 45-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection) intramuscular on 13Sep2021 (Batch/Lot number: Unknown) as dose number unknown, 0.3mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced uterine bleeding (medically significant). The patient underwent lab tests and procedures which included SARS-CoV-2 test as negative on 14Oct2021. The outcome of the event was unknown. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1852388 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTAIR; SALAMOL [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antasthmatic drug level; Asthmatic
Allergies:
Diagnostic Lab Data: Test Date: 20211020; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101449678

Write-up: itchy; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number GB-MHRA-APPCOVID-20211020213933, Safety Report Unique Identifier is GB-MHRA-ADR 26110299. A 51-year-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Oct2021 as single dose for COVID-19 immunisation. The patient previously received the first dose on 22Jan2021 and second dose on 08Apr2021. Medical history included asthma and antasthmatic drug level. She has not had symptoms associated with COVID-19, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. She was being treated with high dose systemic steroids. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma, influenza vaccine (INFLUENZA VIRUS) taken for antasthmatic drug level and immunization from 26Sep2021, and salbutamol sulfate (SALAMOL) taken for asthma. The patient experienced itchy on 15Oct2021. Case narrative: Very itchy legs and itchy arms. No relevant investigations or tests conducted. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 20Oct2021. Outcome of event was not recovered. Case reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1852422 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Chills, Discomfort, Dyspepsia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lethargy, Malaise, Myalgia, Off label use, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: HUMALOG; LEVEMIR; METFORMIN; RAMIPRIL; SIMVASTATIN
Current Illness: Blood pressure high; Type I diabetes mellitus (well controlled)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101429092

Write-up: upper stomach pains; discomfort; lethargy; Headache; Chest pain; Chills; Generalised muscle aches; Exhaustion/fatigue/unusual tiredness; Felt generally ill/unwell; aches; indigestion; Off label use; Booster; Interchange of vaccine products; This is a spontaneous report from a contactable consumer (patient). This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110211447504530-MTEKN, safety report unique identifier is GB-MHRA-ADR 26104222. A 55-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 15Oct2021 (at the age of 55-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included ongoing type 1 diabetes mellitus (well controlled), ongoing blood pressure high. Am usually a very healthy person. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date Mar2019. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus from 1995 t; insulin detemir (LEVEMIR) taken for diabetes mellitus from 1995; metformin from 2010; ramipril taken for hypertension from 2010; simvastatin from 2010. The patient previously received first dose of COVID-19 VACCINE ASTRAZENECA, dose 1 on 19Jan2021 for Covid-19 immunisation; second dose of COVID-19 VACCINE ASTRAZENECA, dose 2 on 30Mar2021 for Covid-19 immunisation. The patient had vaccine at 15Oct2021 08:50. Evening of 15Oct2021, the patient felt like she had indigestion took gaviscon. Awoke just after 01:00 on 16Oct2021 with headache, chills, chest pain and generally feeling ill/unwell. Got up at about 07:15 on 16Oct2021. The patient took paracetamol and more gaviscon. Generally felt unwell, still had what felt like indigestion, aches and feeling exhausted. She felt really poorly until about 18:00 on 16Oct2021 and then started to feel a little better just some aches and lethargy remaining. The patient exhaustion/ fatigue/ unusual tiredness and generalised muscle aches on 16Oct2021. On 17Oct2021, the patient felt much better and back to normal. She has had some upper stomach pains and discomfort on an unspecified date. The patient experienced off-label use, Interchange of vaccine products and booster on 15Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. There is relate to possible inflammation of the heart (myocarditis or pericarditis).The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. The patient did not seek medical attention as she assumed indigestion. Only when checking side effects once better did she think it might have been something else. The outcome of the event off-label use, Interchange of vaccine products, booster, upper stomach pains and discomfort was unknown, the outcome of the event was resolved on 17Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1852501 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F66431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Immunisation, Influenza like illness, Lethargy, Lower respiratory tract infection, Off label use, Oropharyngeal pain, Pain in extremity, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20211022; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101439443

Write-up: Runny nose; Chest infection; Pain in arm; Flu-like aching; Coughing; Headache; High temperature; Lethargy; Sore throat; Booster; Off label use; This is a spontaneous report from a contactable other health care professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110242043556560-RZI46, Safety Report Unique Identifier GB-MHRA-ADR 26115273. A 63-year-old female patient received the third dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/ Lot Number: F66431), via an unspecified route of administration on 15Oct2021 (at the age of 63-year-old) as dose 3, (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose and second dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/ Lot Number: unknown) via an unspecified route of administration on an unspecified date; both as single dose for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. On 16Oct2021, the patient experienced headache, high temperature, lethargy and sore throat. On 17Oct2021, the patient experienced pain in arm, flu-like aching, coughing, on 19Oct2021 the patient experienced chest infection. The patient was prescribed 7 days course of antibiotics on 19Oct2021 and was still coughing which brings on a headache. She was still getting raised temperature on and off. On 22Oct2021, the patient experienced runny nose. The patient underwent lab tests and procedures which included COVID-19 virus PCR test on 20Oct2021 and the result was No - Negative COVID-19 test on 22Oct2021. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the events runny nose, chest infection, flu-like aching, coughing, headache, high temperature, lethargy, sore throat was not resolved, pain in arm was resolved on 21Oct2021. No follow-up attempts are needed; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1852770 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-10-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 1 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Chest pain
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Familial risk factor (with likely undiagnosed hypertension.); Hypertension; Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101436856

Write-up: Acute myocardial infarction; Thoracalgia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-800718. A 44-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FF2382; Expiration Date: 31Mar2022) via intramuscular route, administered in deltoid right on 09Oct2021 09:31 AM as dose 1, single for covid-19 immunisation; nandrolone decanoate (deca-durabolin), boldenone undecylenate, testosterone acetate via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to 08Oct2021 for recreational substance use. The patient''s medical history included hypertension and Tabaquism. Tobacco-addicted patient with family history of coronary artery disease, with likely undiagnosed hypertension. The patient''s concomitant medications were not reported. On 15Oct2021 the patient experienced acute myocardial infarction (hospitalization, medically significant) and thoracalgia (hospitalization). Therapeutic measures were taken as admitted to emergency room, treated with primary angioplasty of sub-occluded left anterior descending artery, currently hospitalised in Cardiology Intensive Care Unit. The outcome of events was reported as not recovered. Reporter comment: Tobacco-addicted patient with family history of coronary artery disease, with likely undiagnosed hypertension. Regular volitional use of anabolic steroids, the staging of which was reported, to the extent obtainable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Hallucination, Headache, Hyperpyrexia, Nausea, Skin odour abnormal, Urine odour abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:hyperpyrexia
CDC Split Type: ITPFIZER INC202101438318

Write-up: Hallucinations; Urine odour abnormal; Vomiting; Nausea; Headache; Hyperpyrexia; Prostration; Skin odour abnormal; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-801308. A 62-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 14Oct2021 (Lot Number: 1F1008A) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hallucinations (medically significant) on 15Oct2021, urine odour abnormal (medically significant) on 15Oct2021, vomiting (medically significant) on 15Oct2021, nausea (medically significant) on 15Oct2021, headache (medically significant) on 15Oct2021, hyperpyrexia (medically significant) on 15Oct2021, prostration (medically significant) on 15Oct2021, skin odour abnormal (medically significant) on 15Oct2021. The patient underwent lab tests and procedures which included body temperature: hyperpyrexia on 15Oct2021. Physician Office Visit for events. The outcome of events was recovered on 19Oct2021. Reporter comment: A few hours after the administration of the first dose, the patient experienced hyperpyrexia, vomiting, headache, hallucinations, prostration, disgusting odor emanating from skin and urine, also smelled by an external witness (wife). Symptoms lasted 4 days The patient refused the hospitalization suggested by his practitioner. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: A few hours after the administration of the first dose, the patient experienced hyperpyrexia, vomiting, headache, hallucinations, prostration, disgusting odor emanating from skin and urine, also smelled by an external witness (wife). Symptoms lasted 4 days The patient refused the hospitalization suggested by his practitioner.


VAERS ID: 1855139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Demyelinating polyneuropathy, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101451768

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 645970). A 37-year-old female patient received unknown dose number of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. On Oct 15, 2021, patient experienced demyelinating polyneuropathy and rash; outcome of recovered on an unspecified date in 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1855229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure timing unspecified, Premature separation of placenta
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101458417

Write-up: Maternal Drug Exposure; Premature separation of placenta; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority . Regulatory authority report number is 649274. This other health professional reported mother and fetus reports. This report is mother report. A 32-year-old female patient (pregnant) received BNT162B2 (COMIRNATY) on unknown date (lot number: unknown) via unknown route of administration at dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 15Oct2021, patient experienced Premature separation of placenta. On unknown date, patient experienced Maternal Drug Exposure. The outcome of the event Premature separation of placenta was recovering. The outcome of other event 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) : AU-PFIZER INC-202101500895 fetus case


VAERS ID: 1855422 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Hypotension, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy multiple; Fruit allergy (strawberries, kiwi); Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101501204

Write-up: Hypotension; Breathlessness; Tingling sensation in limb; Cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number CZ-CZSUKL-21011332. A 17-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Oct2021 (Lot Number: FF2832) (at age of 17-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing allergy to Penicillin, pollen, strawberries, kiwi, Allergy multiple. The patient''s concomitant medications were not reported. The patient previously took biseptol and experienced drug allergy, patient intramuscularly took the first dose of bnt162b2 (COMIRNATY) on 24Sep2021 (batch/lot number unknown) for covid-19 immunization. The patient experienced hypotension (life threatening) on 15Oct2021 with outcome of recovered, breathlessness (life threatening) on 15Oct2021 with outcome of recovered, tingling sensation in limb (non-serious) on 15Oct2021 with outcome of recovered, cough (non-serious) on 15Oct2021 with outcome of recovered. Therapy included Ventolin, Dithiaden, followed by medical help from Anesthesiology and Resuscitation department, Hydrocortisone and oxygen were given through cannula - adverse reactions stopped after about 45 minutes, on 15Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1855800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthmatic crisis, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Asthma (severe asthma since childhood)
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101444351

Write-up: Asthmatic crisis/asthma attack; Nausea; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20219802. A 27-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 14Oct2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included severe asthma since childhood. The patient''s concomitant medications were not reported. On 15Oct2021, the patient experienced asthmatic crisis/ asthma attack and nausea. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 14Oct2021. Outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855948 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: ATENOLOL
Current Illness: Hypertension (I have hypertension and glaucoma)
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma (I have hypertension and glaucoma)
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101450110

Write-up: diarrhea; Vomiting; Diarrhoea; DOSE 3 (BOOSTER); DOSE 3 (BOOSTER); DOSE 3 (BOOSTER); This is a spontaneous report from a contactable consumer (patient). This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110251041191800-UFORD, Safety Report Unique Identifier GB-MHRA-ADR 26116703. A 81-year-old female patient received third dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection) (Lot Number: FF8222), via an unspecified route of administration on 15Oct2021 16:00 (at the age of 81-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included ongoing hypertension, glaucoma (I have hypertension and glaucoma) from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Concomitant medication included atenolol taken for hypertension. Historical vaccine included Covid-19 Vaccine (Primary Immunization series complete but unknown manufacturer) dose 1 and dose 2 for Covid-19 immunization. On 15Oct2021 22:00 the patient experienced diarrhea, vomiting, and on an unknown date diarrhoea. Vomiting and diarrhoea started approximately six hours after having the vaccine (had the vaccine at 4.00 pm and symptoms started around 10.00 pm). She vomited twice and had several episodes of diarrhoea throughout the night. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent lab tests and procedures which included COVID-19 test: negative on 28Aug2021 (No - Negative COVID-19 test). The outcome of the events vomiting, diarrhoea was recovered on 16Oct2021 and recovering for diarrhea. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1855956 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF28888 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Instillation site warmth, Lethargy, Lymphadenopathy, Oral pain, Oropharyngeal pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: AMITRIPTYLIN; CALCICHEW D3; DOCUSATE; FEXOFENADINE; FOSTAIR; LORAZEPAM; MONTELUKAST; MORPHINE; OMEPRAZOLE; SERTRALINE; SOLIFENACIN; SPIRIVA; TIBOLONE; TOPIRAMATE; UNIPHYLLIN; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid dyspepsia; Acute migraine; Anxiety attack; Asthma; Chronic wheezing; Constipation; Fibromyalgia; Hay fever; Hormone therapy; Joint pain; Osteoarthritis generalised; Overactive bladder; Poor sleep; Psychotic disorder; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101449721

Write-up: Glands swollen; Sore mouth; Sore throat; Headache; Swollen arm; Instillation site warm feeling; Lethargic; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110251209233470-GNDAR, Safety Report Unique Identifier GB-MHRA-ADR 26117122. A 50-year-old female patient received third dose (booster) of COMIRNATY (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Oct2021 (lot number: FF28888) as single dose for COVID-19 immunisation. The patient previously received first and second doses of COVID-19 VACCINE for COVID-19 immunisation on unspecified dates. Medical history included suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped), Joint pain, Osteoarthritis generalized, Constipation, Hay fever, Asthma, Anxiety attack, Fibromyalgia, Acid dyspepsia, Psychotic disorder, Overactive bladder, Chronic wheezing, Hormone therapy, Acute migraine, and Poor sleep. She was not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medications included amitriptyline hydrochloride (AMITRIPTYLIN) taken for joint pain from 2006 to an unspecified stop date; calcium carbonate, colecalciferol (CALCICHEW D3) taken for osteoarthritis generalised, start and stop date were not reported; docusate (DOCUSATE) taken for constipation from Feb2008 to an unspecified stop date; fexofenadine (FEXOFENADINE) taken for Hay fever from 1999 to an unspecified stop date; beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma from 2019 to an unspecified stop date; lorazepam (LORAZEPAM) taken for Anxiety attack from 2020 to an unspecified stop date; montelukast (MONTELUKAST) taken for asthma from 1988 to an unspecified stop date; morphine (MORPHINE) taken for Fibromyalgia worsened from 2019 to an unspecified stop date; omeprazole (OMEPRAZOLE) taken for Acid dyspepsia from 2009 to an unspecified stop date; sertraline (SERTRALINE) taken for psychotic disorder from 2017 to an unspecified stop date; solifenacin (SOLIFENACIN) taken for Overactive bladder from 2010 to an unspecified stop date; tiotropium bromide monohydrate (SPIRIVA) taken for Chronic wheezing from 2019 to an unspecified stop date; tibolone (TIBOLONE) taken for hormone therapy from 2013 to an unspecified stop date; topiramate (TOPIRAMATE) taken for Acute migraine from 2019 to an unspecified stop date; theophylline (UNIPHYLLIN) taken for Asthma chronic from 1986 to an unspecified stop date; zopiclone (ZOPICLONE) taken for Poor sleep from 2020 to an unspecified stop date. The patient experienced lethargic on 15Oct2021; headache, swollen arm, and instillation site warm feeling on 16Oct2021; sore throat on 17Oct2021; sore mouth on 19Oct2021; glands swollen on 21Oct2021. Events were reported as medically significant by health authority. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. This report is not related to possible inflammation of the heart (myocarditis or pericarditis). Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856105 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BOOSTER FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry throat, Gingival swelling, Immunisation, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cholesterol; Diabetic; HIV positive (HIV-positive with symptoms or reduction in immune response); Pneumonia; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101457457

Write-up: dry throat; Lymph from underneath arm; swelling in gums; fever; off label use; booster; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110261719314840-O4TVQ and Safety Report Unique Identifier GB-MHRA-ADR 26124425. A 45-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Lot Number: Booster FF8288) as DOSE 3(BOOSTER) (at the age of 45 Years old), single dose for COVID-19 immunisation. Medical history included blood cholesterol, pneumonia, diabetes mellitus, anaemia, suspected covid-19 (Unsure when symptoms started, Unsure when symptoms stopped), HIV test positive with symptoms or reduction in immune response, Enzyme (as reported). Patient last menstrual period date was 06Sep2021. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine was 1st dose on 31Jan2021 (Lot Number: 1st dose EN1185) and 1st dose caused her shivers and body pain at night, really bad time; 2nd dose on an unspecific date for covid-19 immunization. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Feb2021 Yes - Positive COVID-19 test. The events were medically significant. Booster, next day fever until now she was sick with dry throat since left the Center and wake like chocking. Lymph from underneath arm gone, swelling in gums gone. Called GP but they said, do not worry it will go and did not put her through Doctor and Saturday called 111, Doctor prescribe her with Doxycycline antibiotics. Still having fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of fever and dry throat was recovering, Lymph from underneath arm and swelling in gums was recovered, other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1856129 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Menstrual disorder, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains (before use of hormonal contraception)
Allergies:
Diagnostic Lab Data: Test Date: 20211021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101457263

Write-up: Menstruation abnormal; Much heavier/longer (8 days so far and ongoing, normally no longer than 4 days); much more painful; off label use; Booster; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110262155482110-GI3KF, Safety Report Unique Identifier GB-MHRA-ADR 26125601. A non-pregnant 26-year-old female patient received 3rd dose (Booster) of BNT162B2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 15Oct2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included suffered severe menstrual pain before use of hormonal contraception. Concomitant medications included patient was currently on the implant contraceptive, had to take time off work. The patient previously took the 1st and 2nd single dose of COVID-19 Vaccine on an unspecified date for COVID-19 immunisation (Primary Immunization series complete but unknown manufacturer). 3 days after the booster dose (on 18Oct2021) patient''s period started, much heavier, longer (8 days so far and ongoing, normally no longer than 4 days) and much more painful. it was reported that these AEs were serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included COVID-19 virus test was negative on 21Oct2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1856969 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-10-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005790 / 2 - / OT

Administered by: Unknown       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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: left peripheral facial paralysis; This case was received via Regulatory Agency (Reference number: ES-AEMPS-1034727) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of FACIAL PARALYSIS (left peripheral facial paralysis) in a 14-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005790 and 214029) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced FACIAL PARALYSIS (left peripheral facial paralysis) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (left peripheral facial paralysis) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the expected event of facial paralysis. The event facial paralysis occurred 54 days after the second dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Translation received on 07-Nov-2021: Contains translated event verbatim; Sender''s Comments: This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the expected event of facial paralysis. The event facial paralysis occurred 54 days after the second dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1858825 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-10-15
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Muscle spasms, Myocarditis, Pericarditis, Pyrexia, Tachycardia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452999

Write-up: Myocarditis; Pericarditis; Anxiety; Injection site pain; Muscle spasms; Pyrexia; Tachycardia; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 648028. A 37-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 17Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Oct2021 (also reported as 59 days after vaccination), the patient experienced myocarditis, pericarditis, anxiety, injection site pain, muscle spasms, pyrexia and tachycardia. Outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1858917 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Dizziness, Migraine, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101466157

Write-up: fainting; Dizzy/dizziness; constipation; Migraines; nauseous; This is a spontaneous report from a contactable Consumer (Patient). A 25-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Oct2021 16:30 (Batch/Lot Number: Unknown) at age of 25 years old as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Oct2021 18:00, the patient experienced fainting, dizzy/dizziness, nauseous, constipation, migraines and can''t do anything alone, need assistance all the time. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received: Seeked care but no doctors were able to help. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1859929 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101468642

Write-up: Seizure; This is a spontaneous report from a contactable Other Health Professional, received from the regulatory authority. Regulatory authority report number is PH-PHFDA-300113102. A 12-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular on 15Oct2021 (12-year-old at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced seizure on 15Oct2021. As reported, minor adverse effect after COVID vaccine; seizure disorder. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1783823 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH N/A / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Myalgia, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: fever, myalgias, severe enough to require ambulance transport to ER, tachycardia


VAERS ID: 1784792 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF88U1 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Pain, Pain in extremity, Tremor, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: sore arm, throwing up, body pains, shaking, felt like he was going to pass out, impaired vision ( seeing purple and black spots)


VAERS ID: 1784807 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Abdominal pain, Menstruation irregular
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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: Insulin
Current Illness:
Preexisting Conditions: Type 1 diabetes
Allergies: Kiwi, latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had just finished my menses last week. I started again today with abdominal cramps. I am very scheduled and this is very unusual.


VAERS ID: 1784820 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-18
Onset:2021-10-14
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Patient received J+J vaccination on 5/15/2021 then received Pfizer vaccine as documented in this report.


VAERS ID: 1784861 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Migraine, Vaccine positive rechallenge
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: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bad migraine after 1st dose on 9/22/21. Extreme migraine after 2nd dose on 10/13/21


VAERS ID: 1784867 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-01
Onset:2021-10-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: A round bruise appeared three days after getting vaccinated and bruise was still clearly visible 11 days post-vaccination (10/12/2021.)


VAERS ID: 1784922 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pollakiuria, Urine output
SMQs:

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

Write-up: Significantly increased need to urinate and amount of urination


VAERS ID: 1784940 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2021-03-10
Onset:2021-10-14
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D, CoQ10, Multivitamin, Claritin, Advil, Citrus Bergamot extract
Current Illness: NA
Preexisting Conditions: Heartburn, Hyperlipidemia, smoker, Enthesopathy
Allergies: Rosuvastatin, Cat dander, Cholestyramine
Diagnostic Lab Data:
CDC Split Type:

Write-up: since the 2nd dose of Moderna, pt has had ringing in her ears. This has not resolved.


VAERS ID: 1784957 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-18
Onset:2021-10-14
   Days after vaccination:238
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor, Paxil, Protonix, Ativan, Penlac, Levothyroxine, Tylenol, Benadryl, Aspirin, Miralaz
Current Illness: None
Preexisting Conditions: Squamous cell carcinoma, palpitations, hyperlipdemia, vitamin d insufficiency, hypothyroidism, type 2 diabetes, prediabetes, anxiety, GERD
Allergies: CT dye, red dye, sulfa drugs, ciprofloxacin, nitrofurantoin, shellfish derived products
Diagnostic Lab Data: Positive RT-PCR Covid-19 Test
CDC Split Type:

Write-up: Tested positive for COVID-19 when fully vaccinated.


VAERS ID: 1784979 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Headache, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Headache, muscle aches, pain in the entire arm where I was given the shot


VAERS ID: 1785005 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30558A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Feeling hot, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Patient reported being light headed, short of breath/ hard time breathing, nauseous, and hot about 15 minutes after the shot. Administered 10ml of Benadryl to assist with breathing.


VAERS ID: 1785006 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin, lisinopril, levothyroxine,lasix, victoza, atenolol, amlodipine
Current Illness: na
Preexisting Conditions: diabetes, hypertension, anxiety, chf
Allergies: nkda
Diagnostic Lab Data: none at this time
CDC Split Type:

Write-up: patient received 2 doses of moderna in feb/march 2021


VAERS ID: 1785021 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Fall, Loss of consciousness
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), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin
Current Illness: No
Preexisting Conditions: No
Allergies: None
Diagnostic Lab Data: No
CDC Split Type:

Write-up: Into about 10 minutes after receiving the Pfizer COVID-19 vaccine, patient fell on the floor and passed out briefly for about 5 seconds, EMS called immediately, V/S at 1030 BP 111/70 HR 52 O2 SAT 99% RA. At 1032, V?S BP 123/74 HR 57 O2 SAT 99% RA, at 1035 V/S 117/81 HR 60 O2 SAT 99@ RA, at 10/40 V/S 108/76 HR 60 O2 SAT 99% RA, EMS arrived 1042, patient passed out again briefly for about 5 seconds, BP was 129/73. ER Doctor was on site from the beginning of the incident. Patient transported to Hospital ER for further evaluation.


VAERS ID: 1785024 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-11
Onset:2021-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165969 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Called and left voicemail for patient. Awaiting call back to see if she is experiencing any signs/symptoms.


VAERS ID: 1785034 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-10-11
Onset:2021-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2590 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Unknown. Unable to get in touch with patient. Patient does not have a phone number or e-mail on file. Called contact on file who stated I had the wrong number.


VAERS ID: 1785035 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-11
Onset:2021-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: 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: Domperidone, goats rue, blessed thistle, prenatal vitamin, birth control (for 1st vax only)
Current Illness: None
Preexisting Conditions: None
Allergies: Mold, ragweed
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swelling of Left supraclavicular lymphnode


VAERS ID: 1785042 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Extra dose administered, Fatigue, Headache, Incorrect dose administered, Interchange of vaccine products, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Vaccine Administration Error: wrong vaccine administered. Patient had two previous doses for Moderna COVID -19 Vaccine. Patient originally wanted an influenza vaccine. Patient experienced fatigue, nausea, vomiting, dizziness, headache and fever. Patient was seen at HCF. Final outcome unknown at this time.


VAERS ID: 1785051 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592. / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Balance disorder, Dizziness
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: dizziness, age 51, 9/28/2021, Pfizer COVID vaccine lot FE3592
Other Medications: metoprolol, gabapentin, ASA 81
Current Illness: depression
Preexisting Conditions: depression
Allergies: vancomycin, gentamicin
Diagnostic Lab Data: transported to ED
CDC Split Type:

Write-up: dizziness, feels like she will fall


VAERS ID: 1785062 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Lethargy, Loss of personal independence in daily activities, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Extreme muscle soreness and lethargy. Headache. Unable to perform daily tasks.


VAERS ID: 1785071 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Heart rate increased, Muscle spasms
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIOTHYRONINE SOD 25 MCG TAB hydrOXYzine HCl 25 MG Tablet
Current Illness: Mold Toxicity
Preexisting Conditions: interstitial cystitis
Allergies: Adhesive Tape
Diagnostic Lab Data:
CDC Split Type:

Write-up: Increased heart rate at 150 and Muscle Spasms


VAERS ID: 1785086 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: Unknown
Preexisting Conditions: Unknown
Allergies: Pencillin, amoxcillin, ciproflaxcin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported itchiness on her back, arms and neck. No redness observed. Patient given 25mg of Benadryl. Patient reported relief of itchiness.


VAERS ID: 1785129 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (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: unknown
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received booster dose of Pfizer. First 2 doses were Moderna. No adverse reaction or outcome.


VAERS ID: 1785143 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: Patient received Pfizer booster shot as 3rd dose, upon later investigation the patient had received Moderna as the first 2 shots. No adverse effects reported at this time. Will follow up with patient in the next couple days.


VAERS ID: 1785161 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30125BA / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic 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)

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

Write-up: fever, injection site pain, swelling- advised to take tylenol


VAERS ID: 1785163 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fall, Hyperhidrosis, Loss of consciousness
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), Accidents and injuries (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: -Patient has been fasting in the morning
Preexisting Conditions:
Allergies: Erythromycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: The vaccine was administered to the patient. The patient was a few minutes into his 15 minute observation period. He grabbed the attention of the technician who was observing and said he was feeling faint. She called me over and the patient started going down from his chair. He fell onto the floor from the the chair (bracing himself onto the floor) and was on the floor about 3 seconds. He got off of the floor really fast and stood up and I assisted him back to the chair. He was a aware that he just passed out. We got him some water and a medical emergency was called. He said he felt a little better after the water but was sweating a lot. Patient said he does not eat in the morning and fast. He said me sitting there talking to him was very helpful for him. He said he has fainted in the past but never from a vaccine. He hasn''t received a vaccine in over 10 years and was being mandated from his job. The emergency team evaluated him asked him did he wanted to be evaluated in the emergency room, patient declined. Patient was sweating a lot and the emergency team got him some juice and crackers for possible low blood sugar with fasting.


VAERS ID: 1785184 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 182286 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Condition aggravated, Migraine
SMQs:, Guillain-Barre 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: Aimovig taken on 10/9- taken once a month Tylenol
Current Illness: Non
Preexisting Conditions: Migraine
Allergies: Sensitivity to nuts, cheese and other migraine medication...Migraine triggers
Diagnostic Lab Data:
CDC Split Type:

Write-up: Debilitating migraine attack after receiving COVID vaccine. Roughly 12 hours after receiving vaccine.


VAERS ID: 1785190 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: HR 72, 99% , RR 12, BP 124/98
CDC Split Type:

Write-up: PT felt light headed and felt as though he was going to pass out.


VAERS ID: 1785195 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-03-12
Onset:2021-10-14
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / 1 RA / SYR

Administered by: School       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test negative
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: Prilosec, niacin, Benicar, tums, 9 am Limit or, zolpidem,
Current Illness: None
Preexisting Conditions: High blood pressure, high cholesterol, low testosterone
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 10/12/2021 the PA-C from facility ordered a covid 19 antibodies blood test. The results came back the morning of 8/14/21. It showed that I had zero antibodies.


VAERS ID: 1785198 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Muscle spasms
SMQs:, Dystonia (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Elders Dandos Syndrome and Mastositosis Syndrome
Allergies: KNDA
Diagnostic Lab Data: Normal blood pressure, pulse and pulse ox
CDC Split Type:

Write-up: We had a 38 y/o female in the office this morning who received her booster dose of Pfizer. Pt has e[episodes where she goes into muscle spasms but they don?t typically last as long as they are this morning. Pt states that she is being seen by her PCP and is being evaluated for a Cervical Disconnect syndrome. She received the vaccine and within about 15 seconds she went into a spasm that started in her and moved into the neck and continued. She would have the spasm ease up and then it would go back to it pulling her head back. This lasted about 20-30 minutes. 911 was called and they took her to the ER. Pts vitals were normal. She continued to talk and breath during the spasm. Dr. did come in and evaluate her and advised her to go to the ER.


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