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

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



Case Details (Reverse Sorted by Onset Date)

This is page 290 out of 7,116

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VAERS ID: 1589496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphonia, Chills, Gastroenteritis norovirus, Haemoptysis, Oropharyngeal pain, Pharyngeal swelling, Productive cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012805

Write-up: fever; swollen throat; productive cough; shivers; sore throat; norovirus symptoms; Coughing blood; Loss of voice; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108051446031740-FSE0I, Safety Report Unique Identifier GB-MHRA-ADR 25759745. A 33-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, suspected covid-19 from 02Aug2021 to 05Aug2021. Patient received first dose of BNT162B2 via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced fever on an unspecified date, swollen throat on an unspecified date, productive cough on an unspecified date, shivers on an unspecified date, sore throat on an unspecified date, norovirus symptoms on an unspecified date, coughing blood on 04Aug2021, loss of voice on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 04Aug2021 No-Negative COVID-19 test. Additional Information: After receiving my second vaccine dose I lost my voice, after experiencing an extremely sore and swollen throat with a slightly productive cough. She also noticed small amounts of blood when blowing my nose/coughing. Along with this sore throat and slight cough I experienced a fever, shivers and flu-like aches (She realised these were common vaccine side effects) for about 48 hours. Her whole family and she had norovirus at the time she was vaccinated (she was not yet symptomatic when the vaccine was given and she developed norovirus symptoms at about the same time as she started to have vaccine side effects, about 12 hours after the jab). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of fever, swollen throat, productive cough, shivers, sore throat, norovirus symptoms was recovering. The outcome of coughing blood was recovered on 05Aug2021. The outcome of loss of voice was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589596 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anorectal discomfort, Dehydration, Dizziness, Dyspnoea, Headache, Heart rate, Night sweats, Pain in extremity, Palpitations, Rash, SARS-CoV-2 test, Thyroid function test, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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? Yes, ? days
   Extended hospital stay? 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: Negative ; Result Unstructured Data: Negative; Test Name: Thyroid function test; Result Unstructured Data: abnormal
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: heart rate; tried to look at my phone; dizzy; feeling somehting; painful arm; Blurred vision; Heart pounding; Difficulty breathing; Dehydration; Headache; Rash; Night sweat; Dizziness; This case was received via the Regulatory Authority RA (Reference number: 25782228) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEART RATE (heart rate), ANORECTAL DISCOMFORT (tried to look at my phone), DIZZINESS (dizzy), DIZZINESS (feeling somehting), PAIN IN EXTREMITY (painful arm), NIGHT SWEATS (Night sweat), DIZZINESS (Dizziness), VISION BLURRED (Blurred vision), DEHYDRATION (Dehydration), HEADACHE (Headache), RASH (Rash), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 10-Mar-2020 to 25-Mar-2020. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced NIGHT SWEATS (Night sweat) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On 04-Aug-2021, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), PALPITATIONS (Heart pounding) (seriousness criterion hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEART RATE (heart rate) (seriousness criterion hospitalization), ANORECTAL DISCOMFORT (tried to look at my phone) (seriousness criterion hospitalization), DIZZINESS (dizzy) (seriousness criterion hospitalization), DIZZINESS (feeling somehting) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (painful arm) (seriousness criterion hospitalization). On 04-Aug-2021, NIGHT SWEATS (Night sweat), DIZZINESS (Dizziness), VISION BLURRED (Blurred vision), DEHYDRATION (Dehydration), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) had resolved. On 10-Aug-2021, HEADACHE (Headache) was resolving. At the time of the report, HEART RATE (heart rate), ANORECTAL DISCOMFORT (tried to look at my phone), DIZZINESS (dizzy), DIZZINESS (feeling somehting), PAIN IN EXTREMITY (painful arm) and RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Thyroid function test: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant and treatment medications were reported Patient went through Blood Pressure test , blood test ,heart function test and a general physical tests from the doctor to test reactions, vision etc -all were confirmed as ok Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1589626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-08-03
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006105

Write-up: Dizziness; Fatigue; This is a solicited report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106191832153070-G4JAH. Safety Report Unique Identifier GB-MHRA-ADR 25753093. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 08Jun2021 (Lot Number: Ew3143) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient experienced dizziness (medically significant) on 04Aug2021, fatigue (medically significant) on 03Aug2021. The outcome of events was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No Follow-up attempts are needed. No further information is expected.; Sender''s Comments: As per available information, the causal association between the event dizziness, fatigue and the suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1589782 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via Medicines Agency (Reference number: 767144) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE and PYREXIA. FEBBRICOLA (37.5?c).) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 vaccination. Concurrent medical conditions included Peanut allergy and Pollen allergy (GRAMINACEE). On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 03-Aug-2021, the patient experienced SYNCOPE. (seriousness criterion medically significant) and PYREXIA. FEBBRICOLA (37.5?c).) (seriousness criterion medically significant). At the time of the report, SYNCOPE. FEBBRICOLA (37.5?c).) and PYREXIA DELLA. FEBBRICOLA (37.5?c).) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1589822 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Oxygen saturation, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (asthma with underlying disease.)
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:161/92; Comments: at 12:14 (14 minutes after the vaccination); Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before the vaccination; Test Date: 20210803; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100999741

Write-up: BP161/92; Vasovagal reflex; This is a spontaneous report from a contactable Physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21122311. A 50-years-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 12:00 (Batch/Lot Number: FF3622; Expiration Date: 30Nov2021) as single dose (at the age of 50) for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing asthma with underlying disease. The patient''s concomitant medications were not reported. On 03Aug2021 at 12:13 (13 minutes after the vaccination), the patient experienced vasovagal reflex. On 03Aug2021 at 12:14 (14 minutes after the vaccination), BP161/92, SpO2 98. The patient underwent lab tests and procedures which included blood pressure measurement: 161/92 on 03Aug2021 at 12:14 (14 minutes after the vaccination), body temperature: 35.2 centigrade on 03Aug2021 before the vaccination, oxygen saturation: 98 % on 03Aug2021. The events recovered on 03Aug2021 (the day of vaccination). The reporting physician classified the event as non-serious and the causality was not provided. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: I think that the Vasovagal reflex. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1589823 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Fall, Feeling abnormal, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (Febrile convulsion at 1 year old.); Hypotension
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: Test Result:79~52; Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202100999758

Write-up: Temporary Syncope; feels poorly; Blood pressure at that time is about 79~52; Vasovagal reflex; fell when standing up; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). Regulatory authority report number is v21122337. A 17-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 03Aug2021 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) (at the age of 17-year-old) as dose 1, single for COVID-19 immunization. Medical history included febrile convulsion (febrile convulsion at 1 year old) (also reported as family history) from 2004 to 2004, and hypotension. The patient''s concomitant medications were not reported. The patient was a 17-year 6-month old female. Family history was Febrile convulsion at 1 year old (as reported). Body temperature before vaccination was 36.3 centigrade on 03Aug2021. Patient''s history according to 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) included Febrile convulsion at 1 year old. On 03Aug2021 in the afternoon (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Aug2021 at 15:36 (the day of vaccination) (as reported), the patient experienced the following events. Clinical course was reported as follows: Temporary syncope due to feels poorly 5 minutes after injection (fell when standing up). Blood pressure at that time is about 79~52. Lasted within 2-3 minutes. Then gradually recovering from bed rest. It seems that the Vasovagal reflex is the main. Originally may had hypotension. On 03Aug2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was the patient may have been hypotension before. The reporting physician commented as follows: It seems to be the above, but the relationship with febrile convulsion in childhood is unknown.


VAERS ID: 1589852 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dizziness, Gait disturbance, Oxygen saturation
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: Test Result:170/98; Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: Test Result:149/98; Comments: at 13:15; Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/88; Comments: at 13:50; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination.; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210803; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101000962

Write-up: Dizziness; blood pressure increased; Waddling gait; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21122423. A 60-year and 3-month-old male patient received BNT162B2 (COMIRNATY; Lot Number: FE8162; Expiration Date: 30Nov2021), intramuscular on 03Aug2021 11:54 (at the age of 60-years and 3-months-old) as dose 1, single for COVID-19 immunization. Patient''s medical history was reported as none. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.7 degrees Centigrade. On 03Aug2021 at 11:54 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 03Aug2021 at 12:18 (24 minutes after the vaccination), the patient experienced dizziness, waddling gait and blood pressure increased. On 03Aug2021 (the same day of vaccination), the outcome of the event was recovering. The course of the event was as follows: The patient experienced dizziness and blood pressure increased. On 03Aug2021 at 11:54 (the moment of vaccination), the patient received COMIRNATY via intramuscular injection. On 03Aug2021 at 12:14, the patient went back to home after 20 minutes'' observation. On 03Aug2021 at 12:18 (24 minutes after the vaccination), the patient had waddling gait and dizziness. The patient visited hospital. The patient had dizziness symptom. Blood pressure was 170/98, Body temperature was 37.2 degrees Centigrade and SpO2 was 97%. On 03Aug2021 at 12:39 (45 minutes after the vaccination), blood pressure was 149/98. On 03Aug2021 at 13:15 minutes (81 minutes after vaccination), Adalat (5) 4L was administrated and patient was asked to take medicine via oral route. On 03Aug2021 at 13:50, blood pressure was 136/88. The patient went back home. The reporting physician(vaccinator) classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The outcome of the events was recovering. The reporting physician (vaccinator) commented as follows: The symptoms of giddiness and waddling gait got improved. Adalat (5) 4L was administrated (Blood pressure increased to over 170. The patient was asked to take medicine via oral route). The patient received observation at home.


VAERS ID: 1589857 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101001250

Write-up: vasovagal reflex; Syncope; This is a spontaneous report from a contactable physician (vaccinator) received from the A Regulatory authority; report number is v21122443. A 22-year and 11-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FE8206, Expiration date: 31Oct2021), via an unspecified route of administration, on 03Aug2021 at 09:58 (the moment of vaccination), at the age of 22-years and 11-month-old as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. 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). Body temperature before vaccination was 36.4 degrees centigrade on 03Aug2021. On 03Aug2021 at 09:58 (the moment of vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: Just after the vaccination, the patient experienced syncope for several seconds. After being moved to bed, line keep was received/administrated and the patient was under observation. The patient recovered 5 minutes later. After about 15-20 minutes of observation, the patient went back to home. On 03Aug2021 (the same day of the vaccination), the outcome of the events was recovered at 10:03. The reporting physician (vaccinator) classified the events as non-serious and assessed that the causality between the events and BNT162B2 as unassessable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589862 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101001861

Write-up: Vaccination site swelling; Vaccination site warmth; Vaccination site pain; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122444. A 19-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: EW0207; Expiration Date: 30Sep2021)via an unspecified route of administration, administered in Arm Right on 03Aug2021 15:37 (at the age of 19-years-old) at dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 03Aug2021 at 16:07(30 minutes after the vaccination), the patient experienced vaccination site swelling(arm right). The course of the event was as follows: After vaccination, vaccination site swelling, vaccination site warmth, vaccination site pain in the same area. Patient was polaramine, famotidine, drip of normal saline solution as treatment for the events. The symptoms disappeared. On 03Aug2021 (the same day of the vaccination), the outcome of the events was recovered. The reporter physician classified the events as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There was causality and recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589865 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Hypoaesthesia, Palpitations
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:178/84 mmHg; Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:179/99 mmHg; Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210803; Test Name: P; Result Unstructured Data: Test Result:130; Test Date: 20210803; Test Name: P; Result Unstructured Data: Test Result:150
CDC Split Type: JPPFIZER INC202101002074

Write-up: Palpitations; felt anxiety; numbness in both hands/numbness in both feet and ears; P130/P150; BP 178/84 / BP 179/99; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number is v21122417. A 48-year and 11-month-old female patient received BNT162B2 (COMIRNATY; lot number: EY0583 and expiration date: 31Oct2021), via an unspecified route of administration on 03Aug2021 at 15:00 (at the age of 48-year-old), dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.3 Centigrade. The patient had no medical history and concomitant medications were not reported. The clinical course of the event was as follows: On 03Aug2021, at 15: 10, the patient developed palpitations and received bed rest. The blood pressure (BP) was 178/84 mmHg and had pulse rate (P) of 130. The patient improved in a short time. The patient experienced palpitation again and felt anxiety. The patient experienced numbness in both hands. The blood pressure was 179/99 mmHg and pulse rate of 150. Moreover, the patient also experienced numbness in both feet and ears. Emergency transport to hospital. The reporter commented that the next day, the patient''s family contacted and said the patient was cured. The outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1589867 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, Brain natriuretic peptide, Cardiac failure chronic, Cerebral infarction, Electrocardiogram, Glycosylated haemoglobin, Hemiparesis, Hemiplegia, Investigation, Magnetic resonance imaging, Movement disorder, Ultrasound scan
SMQs:, Cardiac failure (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210804; Test Name: BNP; Result Unstructured Data: Test Result:600; Test Date: 20210804; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Atrial fibrillation; Test Date: 20210804; Test Name: HbA1c; Result Unstructured Data: Test Result:7.2; Test Date: 20210803; Test Name: examination; Result Unstructured Data: Test Result:left half was gradually paralyzed; Test Date: 20210804; Test Name: MRI; Result Unstructured Data: Test Result:acute cerebral infarction; Comments: MRI showed an acute Cerebral infarction in the right middle cerebral artery region.; Test Date: 20210804; Test Name: ultrasound; Result Unstructured Data: Test Result:no abnormal wall motion, left atrial enlargement,; Comments: no abnormal wall motion, left atrial enlargement, or intracardiac thrombus was observed on ultrasound.
CDC Split Type: JPPFIZER INC202101002442

Write-up: an acute Cerebral infarction in the right middle cerebral artery region.; Atrial fibrillation was observed on the electrocardiogram; probably Cardiac failure chronic caused atrial fibrillation; The left half was weak and could not move; The left half was weak; The left half was gradually paralyzed/left hemiplegia at present; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21122479. An 85-year-old (also reported as 85-year and 4-month-old) male patient received BNT162B2 (COMRIANTY Solution for injection), via an unspecified route of administration, on 03Aug2021 14:00 (Batch/lot number: EY0573; Expiration date: 30Sep2021), at age 85 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included diabetes mellitus and hypertension all from unknown dates, not reported if ongoing or not. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) (as reported). Concomitant medications included treatment for diabetes mellitus. Body temperature before vaccination on 03Aug2021 was 36.1 Centigrade. The event onset date was reported as on 04Aug2021 17:30 (next day of vaccination). The course of the event was as follows: On 03Aug2021 at 14:00 (the day of vaccination), the patient received the second dose of COMIRNATY. On 03Aug2021 at 17:30 (3 hours 30 minutes after the vaccination), the left half was weak and could not move, and the patient was examined, and the left half was gradually paralyzed. On 04Aug2021 (next day of vaccination), MRI showed an acute cerebral infarction in the right middle cerebral artery region. Atrial fibrillation was observed on the electrocardiogram, but no abnormal wall motion, left atrial enlargement, or intracardiac thrombus was observed on ultrasound. Diabetes mellitus HbA1c (Glycosylated haemoglobin) was 7.2, BNP (Brain natriuretic peptide) was 600, and probably cardiac failure chronic caused atrial fibrillation. Hypertension history, and treatment discontinued including diabetes mellitus, no oral administration, left hemiplegia at present. On 03Aug2021 (the day of vaccination), the patient was admitted to the hospital. The outcome of the events was unknown. The reporting physician classified the events as serious (hospitalized and can lead to disability) and the causality between the events and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were atrial fibrillation, diabetes mellitus, hypertension.


VAERS ID: 1589911 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Computerised tomogram, Dehydration, Dyspnoea, Heart rate, Heart rate increased, Oxygen saturation, Seizure, Tremor, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: QUETIAPINE; FLUNITRAZEPAM; LEXAPRO; ALPRAZOLAM; THEODUR; MONTELUKAST; THYRADIN S; BOIOGITO [ASTRAGALUS SPP. ROOT;ATRACTYLODES LANCEA RHIZOME;GLYCYRRHIZA SPP. ROOT;SINOMENIUM ACUTUM S; RED GINSENG [GASTRODIA ELATA;PANAX GINSENG]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Conversion disorder; Goitre; Recurrent depressive disorder; Somatoform disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:133/85; Comments: 15:15; Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:137/85; Comments: 15:55; Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:139/88; Comments: 16:00; Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination; Test Date: 20210803; Test Name: CT imaging; Result Unstructured Data: Test Result:unknown results; Comments: 16:15; Test Date: 20210803; Test Name: HR; Result Unstructured Data: Test Result:101; Comments: 15:15; Test Date: 20210803; Test Name: HR; Result Unstructured Data: Test Result:104; Comments: 15:55; Test Date: 20210803; Test Name: HR; Result Unstructured Data: Test Result:112; Comments: 16:00; Test Date: 20210803; Test Name: SpO2; Test Result: 98 %; Comments: 15:15; Test Date: 20210803; Test Name: SpO2; Test Result: 95 %; Comments: 15:55; Test Date: 20210803; Test Name: SpO2; Test Result: 97 %; Comments: 16:00
CDC Split Type: JPPFIZER INC202101008111

Write-up: Anxiety attack; wheezing before breakfast; HR 101/HR 104/HR 112; Non-epileptic seizure/Convulsion-like attack/Convulsion/Seizure; Dyspnoea; Tremulousness on limb; it seemed that the patient experienced Dehydration; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122499. A 37-year-old (reported as 37-year and 11-month-old) female patient received bnt162b2 (COMIRNATY intramuscular injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration on 03Aug2021 at 14:45 (at the age of 37-year-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination (03Aug2021) was 36.8 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included recurrent depressive disorder, conversion disorder, somatoform disorder, postoperative goitre and asthma bronchial. The patient''s concomitant medications included quetiapine tablets, flunitrazepam, escitalopram oxalate (LEXAPRO) tablets, alprazolam, astragalus spp. root/atractylodes lancea rhizome/glycyrrhiza spp. root/sinomenium acutum stem/zingiber officinale rhizome/ziziphus jujuba fruit (BOIOGITO), gastrodia elata/panax ginseng (RED GINSENG), theophylline (THEODUR) tablets, montelukast tablets and levothyroxine sodium (THYRADIN-S) tablets, all from unspecified date. On 03Aug2021 at 15:15 (30 minutes after the vaccination) (as reported), the patient experienced non-epileptic seizure. On 03Aug2021 (the day of vaccination), the patient was admitted to the hospital, and discharged on 04Aug2021 (1 day after the vaccination). On 04Aug2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: at 15:15, tremulousness on limb, dyspnoea appeared. Blood pressure (BP) 133/85, heart rate (HR) 101, oxygen saturation (SpO2) 98%. At 15:20, securing a route with 500 mL of normal saline. Adrenaline Injection 0.3 mg Intramuscular injection. Then the patient experienced convulsion-like attack (as reported). At 15:35, HORIZON Injection 2.5 mg intravenously. No symptom changed. After 4 minutes, the same dose was additionally administered, and convulsion disappeared. No dyspnoea. At 15:55, BP 137/85, HR 104, SpO2 95%. At 16:00, BP 139/88, HR 112, SpO2 97%. At 16:15, after CT imaging, the patient experienced a same seizure and after intravenous injection of HORIZON Injection 5 mg, seizure disappeared. Hospitalized for follow-up observation. At 21:25, the patient experienced dyspnoea and after inhaling procaterol (MEPTIN) air, the patient experienced seizure for a while. Intravenous injection of HORIZON Injection 5 mg. Seizure disappeared after about 20 minutes. At 08:00, the next morning. The patient experienced wheezing before breakfast. At the same time, seizure appeared. Intravenous injection of HORIZON Injection 5 mg and hydrocortisone sodium succinate (SOLU-CORTEF) injection 100 mg intravenous drip started. After about 10 minutes, seizure disappeared. Then the patient was discharged from the hospital and consulted family psychiatry. Consciousness was consistently clear and conversation was possible during seizure. Since the morning of the day of vaccination, the patient hadn''t eaten anything, and it seemed that the patient experienced dehydration. The reporting physician classified the events as serious (hospitalized from 03Aug2021 to 04Aug2021) and assessed that the causality between the events and bnt162b2 as unassessable. Other possible cause of the events such as any other diseases was that the patient had mental illness, and the events may be psychogenic triggered by vaccination. The outcome of the events was resolving. The reporting physician commented as follows (reporter''s comment): Vaccination episodes might have promoted anxiety attack and induced non-epileptic seizure.; Reporter''s Comments: Vaccination episodes might have promoted Anxiety attack and induced non-epileptic seizure.


VAERS ID: 1589928 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dyspnoea, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLARITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Anaphylaxis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101009883

Write-up: Anaphylaxis; rash from face to neck; dyspnea; vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122637. A 25-year-and 8-month-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC8736; Expiration Date: 30Sep2021), via an unspecified route of administration on 03Aug2021 14:20 (the day of the vaccination) (at the age of 25-year-and 8-month-old) as a single dose for COVID-19 immunisation. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient medical history included cat allergy (anaphylaxis) in 2019. Concomitant medication included clarithromycin from unspecified start date, route of administration and indication. On 03Aug2021 at 14:30 (10 minutes after the vaccination), the patient experienced anaphylaxis. The course of the events was as follows: Immediately after vaccination, rash from face to neck, dyspnea and vomiting were experienced. BOSMIN 0.3 ml subcutaneous injection and Solu-Medrol 125mg were administered and then rash from face to neck, dyspnea and vomiting were recovering. On 04Aug2021 (1 day after the vaccination), the outcome of events anaphylaxis was recovered. On 03Aug2021 (the day of the vaccination), the patient was admitted to the hospital. Hospitalized for follow-up. The next day discharged without any notice. The reporting physician classified the event as serious (caused hospitalization from 03Aug2021 to 04Aug2021), and the causality between the event and bnt162b2 as related. There was no other possible cause of the events. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1589929 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Discomfort, Dyspnoea, Heart rate, Oxygen saturation, Rash, Respiratory distress, Respiratory rate, Respiratory rate increased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Complex regional pain syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:144/96 mmHg; Comments: 15:25; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210803; Test Name: pulse; Result Unstructured Data: Test Result:95; Comments: 15:25; Test Date: 20210803; Test Name: SpO2; Test Result: 100 %; Comments: 15:25; Test Date: 20210803; Test Name: Respiratory rate; Result Unstructured Data: Test Result:24; Comments: 15:25
CDC Split Type: JPPFIZER INC202101010006

Write-up: respiratory distress; Cough became stronger; BP144 / 96; respiratory rate 24; Anaphylaxis; Discomfort; Dyspnoea; Skin eruption; This is a spontaneous report from a contactable physician received from a Regulatory Authority. Regulatory authority report number is v21122638. A 45-year and 2-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration on 03Aug2021 at 15:06 (the day of vaccination) (at the age of 45-year and 2-month) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees centigrade 03Aug2021. The patient medical history included allergy to whelk shellfish and ongoing complex regional pain syndrome (CRPS). Concomitant medications included unspecified medication for Complex regional pain syndrome. The patient previously took TRAMCET and experienced anaphylaxis. On 03Aug2021 at 15:21 (15 minutes after the vaccination), the patient experienced Anaphylaxis. On 03Aug2021 (the day of vaccination), the patient was admitted to the hospital (from 03Aug2021 to 04Aug2021). The course of the event was as follows: At 15:06, Corona vaccination. At 15:21, Discomfort and Dyspnoea. At 15:25, BP144/96, pulse 95, respiratory rate 24, SpO2:100%. At 15:35, Cough became stronger and respiratory distress tendency. At 15:40, BOSMIN 0.3ml Intramuscular injection, then Meptin inhalation, Solu-Medrol 125mg Intravenous injection. At 15:46, Cough disappeared and breathing became calm. Skin eruption that was present at the time of onset was alleviated, and the patient was hospitalized to see the progress just in case. On 04Aug2021 in the morning, the symptoms improving, and the patient was discharged. On 04Aug2021 (1 day after the vaccination), the outcome of the events was recovered. The reporting physician classified the event as serious (hospitalized from 03Aug2021 to 04Aug2021) and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases was not provided. The reporting physician commented as follows: Originally, it was considered that the risk was high because the patient had a history of anaphylaxis, but the patient was receiving treatment with CRPS at another hospital, and it was said that there was high possibility that it would become severe if got corona, vaccination was performed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1590003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Incorrect route of product administration, Underdose
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069197AA

Write-up: At the time of the vaccination, haemorrhage developed; The vaccine may have been mixed in the blood (Intramuscular formulation administered by other route); Vaccination underdose; This case was received via Regulatory Authority (Reference number: ) on 03-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case was reported by a person in charge of the vaccination venue via the Drug Information Center. Haemorrhage was assessed as serious by the MAH. On 03-Aug-2021, the patient received this vaccine (number of doses was unknown). At the time of the vaccination, haemorrhage developed. Hemorrhage volume was large, and the vaccine may have been mixed in the blood. There was also the possibility of leakage, and underdose was suspected. No 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: Hemorrhage volume was large, and the vaccine may have been mixed in the blood (intramuscular formulation administered by other route). Underdose and leakage were suspected.; Sender''s Comments: This case concerns a female of unknown age with a serious unexpected event of haemorrhage, and non-serious events of incorrect route of product administration and vaccination underdose. Event onset at the time of vaccination. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590039 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004227 / 2 - / -

Administered by: Unknown       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: Seafood allergy (Salmon roe)
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071969

Write-up: This case received via the regulatory authority (reference number: 2021TJP071969) on Aug 5, 2021 and forwarded to Moderna (Aug 17, 2021). This case reported by a physician via a medical representative. Convulsion assessed serious. On an unknown date, patient received the 1st dose of the vaccine. On Aug 3, 2021, patient received the 2nd dose of the vaccine. While waiting after the vaccination, patient experienced a convulsion for approximately 15 seconds; with outcome of resolved. Follow-up investigation will be made. Sender''s comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590049 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004226 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Asthma, Blood pressure measurement, Heart rate, Oxygen saturation, Peripheral coldness, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Normal; Test Name: Heart rate; Result Unstructured Data: Normal; Test Name: Pulse oximetry; Result Unstructured Data: Could not be measured because of peripheral coldness
CDC Split Type: JPTAKEDA2021TJP072225AA

Write-up: Consciousness disturbance (mild malaise, sleepiness, reaction decreased); Asthmatic attack; Peripheral parts was cold; Poor physical condition; This case was received via Regulatory Authority (Reference number: 2021TJP072225AA) on 05-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, reported by a physician, was received by RA via Modernas adverse reporting site (TASK0020721). On an unknown date, body temperature before the vaccination: 36.9 degrees Celsius. On 19-Jul-2021, at 13:15, the patient received the 1st dose of this vaccine. The patient had persisting mild malaise after the vaccination. On 04-Aug-2021, at 14:15, the patient visited a clinic with the chief complaint of strong sleepiness and malaise during work. There were no particular abnormalities in blood pressure and pulse rate. Oxygenation could not be measured by pulse oximeter because peripheral part was cold. The patient lay down on a bed in the clinic. Thereafter, the patient was seen by a physician every 15 minutes. At 15:15, reduced response to calls was found, and a call to 119 was made. At 15:20, the patient was rushed to a hospital. At 15:30, the patient arrived at the hospital. Further details were unknown, but clear cause could not be identified. Just after 18:00, conscious level improved. According to the report at this time, the symptoms were considered to be caused by asthma attack. The patient was hospitalized. On the morning of the day before the visit to the clinic, the patient told the patient''s coworkers about his/her poor physical condition. The patient''s condition rapidly worsened in the afternoon, and the patient visited the clinic. Asthma attack was suspected as another contributing factor although details were unknown. The outcome of consciousness disturbance (mild malaise, sleepiness, reaction decreased), asthma attack 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: The causal relationship between the events and the vaccine was unknown because the detailed information about the patient''s medical condition was unknown.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event asthma attack is confounded by patient?s history of previous asthma.


VAERS ID: 1590057 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004227 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy (Salmon roe allergy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072236

Write-up: Tonic convulsion; This case was received via Pharmaceuticals (Reference number: 2021TJP072236) on 06-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a (physician), was received via the PMDA (Ref, v21123148). Tonic convulsion was assessed as serious by the MAH. Feel dizzy at the time of blood test. On an unknown date, the patient received the 1st dose of this vaccination. On 03-Aug-2021, at 10:28, the patient received the 2nd dose of this vaccination. At 10:40, the patient developed a tonic convulsion for about 15 seconds during the waiting time. After that the patient was recovered and returned home. The outcome of tonic convulsion was recovered. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 20-year-old female with a serious unexpected event of tonic convulsion. Event latency 12 minutes after second dose mRNA-1273. Event resolved after 15 seconds. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590067 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004230 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Contusion, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion in childhood
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure measurement; Result Unstructured Data: 88/57 mmHg
CDC Split Type: JPTAKEDA2021TJP072257

Write-up: Loss of consciousness; Fall; Bruise of head; Vasovagal reflex (feels poorly, flash vision, facial pallor, decreased blood pressure, cold sweat, sweating); This case was received via agency (Reference number: 2021TJP072257) on 05-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to agency by a physician, was received via Moderna''s adverse reaction reporting site (TASK0020740). On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 03-Aug-2021, at 13:35, the patient received the 1st dose of this vaccine. At 13:40, during the follow-up in a sitting position, the patient was aware of feeling poorly and flash vision. Within 1 minute, loss of consciousness developed, and the patient fell to the right side of a chair. The right side of the head was bruised. Immediately after that, the patient recovered consciousness and was able to talk. Pallor facial, initially decreased blood pressure (88/57 mmHg), cold sweat, and sweating were noted. The patient was followed up in a supine position (taking oral rehydration solution at the patient''s request). The patient''s complexion gradually improved, and blood pressure recovered. It was judged as symptoms with vasovagal reflex. Although there were no neurological symptoms after bruise of head, the patient was instructed to visit a neurosurgeon. The patient walked home alone with an attendant. Insufficient sleep and dehydration were considered as other factors. The outcome of vasovagal reflex (feels poorly, flash vision, facial pallor, decreased blood pressure, cold sweat, and sweating), loss of consciousness, fall, and bruise of head 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.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were capture as serious per someone, agency report.


VAERS ID: 1590075 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Seafood allergy (Allergy to shellfish)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072267

Write-up: Anaphylaxis (facial flushing, vomiting); This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP072267) on 07-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a healthcare manager, was received via the PMDA (Ref, v21122770). On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 03-Aug-2021, at 13:15, the patient received the 1st dose of this vaccine. At 13:50. the patient had facial flushing and vomiting. Anaphylaxis was suspected. BP: 143/97, P:97, and Sp02: 99%. Administration of d-chlorpheniramine maleate and adrenaline was performed, and the patient was raced to a hospital. The outcome of anaphylaxis (facial flushing and vomiting) was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Anaphylaxis was suspected. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590083 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Thalamus haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dyslipidaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072282

Write-up: Loss of consciousness; Thalamus haemorrhage; Fall; This case was received via Company (Reference number: 2021TJP072282) on 07-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21123166). 10 years ago: cerebral infarction, paresis in right foot On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: unknown. On 03-Aug-2021, at 09:30, the patient received the 2nd dose of this vaccine. The patient was doing well 6 hours after the vaccination, but lost consciousness and fell 3 hours later. At 18:00. head CT revealed thalamus haemorrhage. Hypotensive cerebral haemorrhage may be another contributing factor. The outcome of loss of consciousness, fall, and thalamus haemorrhage was reported as ongoing and unchanged. 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: Not reported.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.


VAERS ID: 1590348 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? 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: LISINOPRIL TABLET 10MG / Brand name not specified; SELENE SULFIDE SUSPENSION 25MG/ML; PANTOPRAZOL TABLET MSR 40MG / Brand name not specified; METRONIDAZOL INFVLST 5MG/ML (INFUSION SOLUTION, 5MG/ML); FOLIC ACID TABLET 5MG; FOLIC ACID TABLET
Current Illness: Chills; Fever; Liver abscess (suspected liver abscess)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210830146

Write-up: MYOCARDITIS ON ADMISSION CHEST PRESSURE WITH RADIATION TO BOTH ARMS, ON ADDITIONAL EXAMINATION NO EVIDENCE OF MYOCARDIAL INFARCTION; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, NL-LRB-00656749] concerned a 45 year old male of unknown ethnic origin and race. The patient''s weight was 112 kilograms, and height was 194 centimeters. The patient''s concurrent conditions included chills, liver abscess, and fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 0.5ML, 1 dosage forms,1 total administered on 07-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included amlodipine, ceftriaxone, folic acid, hydrochlorothiazide/telmisartan, lisinopril, metronidazole, pantoprazole, selenium sulfide, and sodium phosphate dibasic. On 03-AUG-2021, the patient experienced myocarditis on admission chest pressure with radiation to both arms, on additional examination no evidence of myocardial infarction, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis on admission chest pressure with radiation to both arms, on additional examination no evidence of myocardial infarction. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210830146-COVID-19 VACCINE AD26.COV2.S-myocarditis on admission chest pressure with radiation to both arms, on additional examination no evidence of myocardial infarction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824522

Write-up: COUGHING OF BLOOD; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097058] concerned an 89 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on left arm on 31-JUL-2021 around 10:00 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 around 9:00, the patient had cough out tinge of blood once and was hospitalized for an unspecified days. The patient was monitored for the persistent of symptoms and was referred to MHO (Medical health officer). She was treated with ascorbic acid, and Lagundi (vitex negundo). On 05-AUG-2021, she had recovered from symptoms and was referred to the directly observed treatment strategy of tuberculosis (TB-DOTS) for direct sputum smear microscopy (DSSM). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing of blood on 05-AUG-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210824522- Covid-19 vaccine ad26.cov2.s-coughing of blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590771 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chills, Headache, Malaise, Migraine, Nausea, Pyrexia, Tremor, Vertigo, 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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TENORMIN 50
Current Illness:
Preexisting Conditions: Comments: The patient had hypertension treated by Tenormin 50. The patient doesn''t smoke, drink, and take drugs. The patient was allergic to sulfonamides. The patient had Covid at the end of October 2020, followed at the end of November by acute bilateral. The patient had pulmonary embolism and a clot of 5 cm in the right leg
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210835082

Write-up: CARDIAC ARRHYTHMIA; VIOLENT TREMORS PROBABLY DUE TO THE FACT THAT I WAS FREEZING DESPITE THE FEVER; MIGRAINE; DIZZINESS MAKING ME FALL; CHILLS; VOMITING; MALAISE; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-104159] concerned a 65 year old female of unknown race and ethnicity. The patient''s weight was 95 kilograms, and height was 180 centimeters. The patient had hypertension treated by Tenormin 50. The patient doesn''t smoke, drink, and take drugs. The patient was allergic to sulfonamides. The patient had Covid at the end of October 2020, followed at the end of November by acute bilateral. The patient had pulmonary embolism and a clot of 5 cm in the right leg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C16-05 expiry: Unknown) dose was not reported, 1 total, administered on 03-AUG-2021 for covid-19 immunisation. Concomitant medications included Tenormin 50 (atenolol). On 03-AUG-2021, the patient experienced cardiac arrhythmia, violent tremors probably due to the fact that was freezing despite the fever, migraine, dizziness making her fall, chills, vomiting, malaise, headache, nausea and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from violent tremors probably due to the fact that I was freezing despite the fever, nausea, migraine, dizziness making me fall, fever, headache, malaise, cardiac arrhythmia, chills, and vomiting. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - No Evolution of the ADR - Improving Situations - Other: This still experimental vaccine is the only cause. ADR description- 40 of fever, cardiac arrhythmia, violent tremors probably due to the fact that I was freezing despite the fever, dizziness making me fall, vomiting. One thing is sure- never again I will be injected with this filth. This 06/08 still diziness, migraine and a little arrhythmia. Information on the temporal link (ADR) - All the symp...; Sender''s Comments: V0- 20210835082-Covid-19 vaccine ad26.cov2.S- Cardiac arrhythmia, Violent tremors probably due to the fact that I was freezing despite the fever, Migraine, Dizziness making me fall. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210835082-Covid-19 vaccine ad26.cov2.S- Chills, Vomiting, Malaise, Headache, Nausea, Fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1590817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Heparin-induced thrombocytopenia test, Heparin-induced thrombocytopenia test positive, Platelet count, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Lumbar disc herniation
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Platelet count; Result Unstructured Data: thrombocytopenia; Test Date: 20210810; Test Name: Heparin-induced thrombocytopenia test; Result Unstructured Data: positive
CDC Split Type: FRJNJFOC20210834270

Write-up: HEPARIN-PLATELET FACTOR 4 ANTIBODY COMPLEX TEST POSITIVE; THROMBOSIS MULTIPLE; THROMBOCYTOPENIA; This spontaneous report was received from a physician via the Regulatory Authority, case reference number FR-AFSSAPS-SE20212123, and concerned a 57 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions or medical history included lumbar disc herniation. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number 21C13-02, expiry date not reported) 1 dosage forms, administered once in total on 23-JUL-2021 for COVID-19 vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced thrombosis multiple and thrombocytopenia (platelet count value and normal range not reported), and was hospitalized on an unspecified date. On 10-AUG-2021, the patient had a positive heparin-platelet factor 4 antibody complex test result. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from thrombosis multiple, heparin-platelet factor 4 antibody complex test positive and thrombocytopenia. This report was serious (life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous case received from a physician via Regulatory Authority via Regulatory Authority (FR-AFSSAPS-SE20212123) concerns a 57-year-old male patient who developed thrombosis multiple and thrombocytopenia 11 days after vaccination, and a positive heparin-platelet factor 4 (HPF4) antibody complex test 18 days after vaccination and was hospitalized on an unspecified day. Patient''s medical history included lumbar disc herniation. His height, weight and concomitant medications are not reported. Patient was not recovered from thrombosis multiple, thrombocytopenia and positive HPF4 antibody complex test. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), the low platelet count and temporal relationship to vaccination, thrombosis multiple and thrombocytopenia are assessed to have a plausible relationship with vaccination.


VAERS ID: 1590839 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect route of product administration, Laryngeal oedema, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Hypersensitivity (narrow), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Inappropriate route of vaccination; This case was received via regulatory authority on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of LARYNGEAL OEDEMA, URTICARIA and PYREXIA in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003655) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Cutaneous) .5 milliliter in total. On 03-Aug-2021, the patient experienced LARYNGEAL OEDEMA (seriousness criterion medically significant), URTICARIA (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). At the time of the report, LARYNGEAL OEDEMA, URTICARIA and PYREXIA had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. For mRNA-1273 (Spikevax) (Cutaneous), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, Laryngeal oedema, Urticaria and Pyrexia a causal relationship cannot be excluded. Causality for the event Incorrect route of product administration is not applicable; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Laryngeal oedema, Urticaria and Pyrexia a causal relationship cannot be excluded. Causality for the event Incorrect route of product administration is not applicable


VAERS ID: 1590867 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ETHINYLESTRADIOL/LEVONORGESTREL
Current Illness: Overweight (BMI 27.7)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via regulatory authority (Reference number: 00654725) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Overweight (BMI 27.7). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (ETHINYLESTRADIOL/LEVONORGESTREL) for an unknown indication. On 18-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PULMONARY EMBOLISM (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Very limited information regarding this event has been provided at this time. No further information is expected. Causality is confounded with patient''s underlying medical history and concomitant use of Ethinylestradiol/Levonorgestrel.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected. Causality is confounded with patient''s underlying medical history and concomitant use of Ethinylestradiol/Levonorgestrel.


VAERS ID: 1590930 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Muscle contracture, Pyrexia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ROJNJFOC20210829493

Write-up: SWELLING FACE; MIGRAINE; CONTRACTURE OF HANDS AND MUSCULAR CONTRACTURE; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, RO-NMA-2021-SPCOV12193] concerned a 32 year old female. The patient''s weight was 64 kilograms, and height was 170 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: 21C14-01 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced swelling face, migraine, contracture of hands and muscular contracture, and fever. The patient was hospitalized (date and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling face, fever, migraine, and contracture of hands and muscular contracture. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210829493-Covid-19 vaccine ad26.cov2.s -SWELLING FACE, MIGRAINE ,CONTRACTURE OF HANDS AND MUSCULAR CONTRACTURE . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210829493-Covid-19 vaccine ad26.cov2.s -FEVER. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1591024 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis, Malaise, Myalgia, Pain, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101054366

Write-up: Sweating; Fever; Headache; Malaise; Pain in the arm at the injection site; Muscle pain; Fatigue; Shivering; Joint pain; Pain in the whole body; This is a spontaneous report from a contactable consumer or other non HCP (patient) downloaded from the regulatory authority BE-FAMHP-DHH-N2021-104116. A 38-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in arm on 03Aug2021 at 9:00 am (at the age of 38-year-old; lot number: FE9174) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not provided. On 03Aug2021 at 18:00, the patient experienced sweating, fever, headache. On 03Aug2021, the patient experienced malaise, pain in the arm at the injection site (injection site pain), muscle pain (myalgia), fatigue, shivering, joint pain (arthralgia), pain in the whole body (general body pain). The clinical course was reported as follows: On the day of the injection received at 9:00 am, patient felt pain in his arm at the injection site. During the day, this pain spread to his whole body and from 6 pm he was sweating, had a fever and an excruciating headache. His body was shivering and it was the third night and he still have the symptoms. All events reported as life-threatening. Unknown if treatment received. Outcome of events was not recovered. Reporter comment: Treatment: Unknown. Evolution of the ADR: No improvement. Situations: Other: don''t know but would like to know. Examinations: None. No follow-up attempts possible. No further information expected.


VAERS ID: 1592175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood test, Chest pain, Fatigue, Headache, Irritability, Magnetic resonance imaging thoracic, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DAFALGAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:correct; Test Name: MRI of lungs; Result Unstructured Data: Test Result:correct
CDC Split Type: BEPFIZER INC202101055882

Write-up: Nausea; Irritability; Fatigue; Muscle pain; Headache; Anxiety attack; Thorax pain; This is a spontaneous report from a contactable consumer (the patient) downloaded from the regulatory authori] -WEB, regulatory authority number BE-FAMHP-DHH-N2021-104227. A 26-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 26Jul2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (DAFALGAN) taken for an unspecified indication from an unspecified date. The patient experienced nausea, irritability, fatigue, muscle pain, headache, anxiety attack and thorax pain on 03Aug2021. The events were serious with seriousness criteria of hospitalization, life threatening. Treatment information included: After a major anxiety attack she was taken to hospital and given tranquilizers. Examinations - Correct blood test and MRI of lungs. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592372 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fatigue; Fever; Myalgia; Headache; This case was received via Regulatory Agency (Reference number: 103813) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), MYALGIA (Myalgia) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), MYALGIA (Myalgia) (seriousness criterion disability) and HEADACHE (Headache) (seriousness criterion disability). On 03-Aug-2021, FATIGUE (Fatigue), PYREXIA (Fever), MYALGIA (Myalgia) and HEADACHE (Headache) was resolving. No relevant concomitant medication was reported. Treatment information was not provided. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1592501 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE3065 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Medical History/Concurrent Conditions: Overweight; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Acute myocardial infarction; This case was received via regulatory authority (Reference number: 969663) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. FE3065) for COVID-19 vaccination. The patient''s past medical history included Overweight and Smoker. On 29-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria hospitalization, medically significant and life threatening). On 05-Aug-2021, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 29-Jul-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient?s overweight and smoker condition could be potentially confounders or co-suspects for the events.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient?s overweight and smoker condition could be potentially confounders or co-suspects for the events.


VAERS ID: 1592597 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Bell''s palsy; This case was received via Medicines Agency (Reference number: 20213870) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of BELL''S PALSY (Bell''s palsy) in a 16-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced BELL''S PALSY (Bell''s palsy) (seriousness criterion medically significant). At the time of the report, BELL''S PALSY (Bell''s palsy) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not provided. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1592746 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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

Write-up: Embolism pulmonary; This case was received via Medicines Agency (Reference number: TO20216381) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Embolism pulmonary) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Tobacco user. On 28-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Embolism pulmonary) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1592796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
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: DOLIPRANE; LEXOMIL; BION 3 [ASCORBIC ACID;BIFIDOBACTERIUM BIFIDUM;CHROMIUM;FOLIC ACID;IODINE;IRON;LACTOBACILLUS GASSERI;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101021918

Write-up: Occurrence of tinnitus in the left ear (on the injection side of the vaccine therefore); This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) received. A 70-year-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE8244 ), via an unspecified route of administration, administered in left arm on 02Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (DOLIPRANE 1000); bromazepam (LEXOMIL); and ascorbic acid, bifidobacterium bifidum, chromium, folic acid, iodine, iron, lactobacillus gasseri, magnesium, manganese, molybdenum, nicotinamide, panax ginseng, pantothenic acid, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vaccinium myrtillus, vitamin b12 nos, vitamin d nos, xantofyl, zinc (BION 3 DEFENSE) taken for an unspecified indications from Aug2021 to an unspecified stop date. The patient previously took amoxicillin sodium (AMODEX) as past drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced an occurrence of tinnitus in the left ear (on the injection side of the vaccine therefore) on 03Aug2021. Moreover, the event resulted in consultation of a doctor or other health professional and led to a disability or permanent injury. The outcome of the event was not resolved at the time of this report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1592838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Lymph node pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (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: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012514

Write-up: Fever; Joint pain; Lymph node pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108040625157560-OIVTF, Safety Report Unique Identifier is GB-MHRA-ADR 25750975. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 02Aug2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON) from 02Aug2021. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on unspecified date (Lot number was not reported) for COVID-19 immunisation. On 03Aug2021, the patient experienced fever, joint pain, and lymph node pain in same side as injection. The paracetamol would not lower fever. The patient had negative COVID-19 virus test on unspecified date. The outcome of lymph node pain was recovering, while for the other events was recovered on 04Aug2021. The events were considered serious, medically significant. No follow-up attempts are possible; information about Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1592839 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Insomnia, Myalgia, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; CODEINE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]; SODIUM FEREDETATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anxiety; Chronic back pain; Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012716

Write-up: Muscle ache; Itchy all over body; Tiredness; Struggled to sleep; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202108040927221920-VNNVL. Safety Report Unique Identifier GB-MHRA-ADR 25751915. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 at 17:00 (Batch/Lot number was not reported), at the age 29-year-old, as dose 2, single for COVID-19 immunisation. Medical history included, anxiety, chronic back pain, contraception, anaemia from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included citalopram taken for anxiety, start and stop date were not reported; codeine taken for chronic back pain, start and stop date were not reported; ethinylestradiol, levonorgestrel (RIGEVIDON) taken for contraception, start and stop date were not reported; sodium feredetate taken for anaemia, start and stop date were not reported. The patient received the dose 1 of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced tiredness on 03Aug2021 with outcome of recovering, struggled to sleep on 03Aug2021 with outcome of recovering, itchy all over body on 04Aug2021 with outcome of not recovered, muscle ache on 04Aug2021 at 07:00 with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Had vaccine at 5pm and felt fine until about midnight when felt itchy all over body. Struggled to sleep due to this feeling and then next morning, 7am felt muscle aches and severe tiredness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592847 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Inappropriate schedule of product administration, Pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Date: 07/31/2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101012504

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108050836414860-U8W85; safety report unique identifier: GB-MHRA-ADR 25758959). A 30-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not known), via an unspecified route of administration, on Aug 3, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation. Patient has not had symptoms associated with COVID-19. Patient not pregnant, nor currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not known), via an unspecified route of administration, on Jun 3, 2021, single dose, for COVID-19 immunisation. The patient experienced pain (unspecified date) and painful hips (Aug 4, 2021). Clinical course reported: internal pain around hip joint could not be fully eased by lots of stretching/movement. Pain eased after painkillers and hot bath for 2 hours. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on Jul 31, 2021. The outcome of painful hips recovered on Aug 5, 2021; and pain unknown. Regulatory authority assessed the events serious (medically significant). No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1592874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Feels awful; Immunodeficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012894

Write-up: pain; Fever; Fatigue; Muscle ache; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051048460140-LPRWM and Safety Report Unique Identifier is GB-MHRA-ADR 25758651. A 46-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number unknown) as single dose for covid-19 immunisation. Medical history included feels awful, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response, e.g. immunodef). Patient had blood posining a while back the antibiotics they used the doctor said his imune system would not be like it was. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, headache on 03Aug2021, fever on 04Aug2021, fatigue on 04Aug2021, muscle ache on 04Aug2021. Patient took pain killers to tired to move for 2 days stayed in bed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Case was reported as serious, other medically important condition. Outcome of pain was unknown and the other events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592877 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: LEVOTHYROXINE; OXYBUTYNIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped); Unspecified hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20201004; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012749

Write-up: Swollen lymph nodes; Fever chills; General body pain; Exhaustion; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051104599040-AVELF, Safety Report Unique Identifier is GB-MHRA-ADR 25758731. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not known), dose 2 via an unspecified route of administration on 03Aug2021 at the age of 36 years at single dose for COVID-19 immunisation. Medical history included lactation decreased, suspected covid-19 from 01Oct2020 unsure when symptoms stopped, hypothyroidism. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included levothyroxine taken for hypothyroidism from 01Aug2018; oxybutynin taken for an unspecified indication. The patient experienced swollen lymph nodes on 04Aug2021, fever chills on 04Aug2021, general body pain on 04Aug2021, exhaustion on 03Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Oct2020 No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Case was reported as serious, other medically important condition. Outcome of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592879 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012565

Write-up: Migraine; Feverish; Exhaustion; Bone pain; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108051124164860-J3VVK, Safety Report Unique Identifier is GB-MHRA-ADR 25758769. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Lot Number: FD8813) (at the age of 33 year old) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced bone pain and exhaustion both on 03Aug2021; migraine and feverish both on 04Aug2021. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient recovered from feverish on 05Aug2021 while patient was recovering from migraine, bone pain and exhaustion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592900 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Musculoskeletal stiffness, Nausea
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012486

Write-up: headache; nausea; Neck stiffness/ 10 hours after vaccine stiff neck; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051253456870-JDVG8, Safety Report Unique Identifier is GB-MHRA-ADR 25759340. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Aug2021 (Batch/Lot Number: FE1510) as dose number unknown, single for COVID-19 immunisation. Medical history included headache from an unknown date. Concomitant medication included paracetamol (PARACETAMOL) taken for headache from 2021 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced headache, nausea and 10 hours after vaccine stiff neck/ neck stiffness all on 03Aug2021. It was reported that 10 hours after vaccine, stiff neck, headache, nausea. The events were assessed as serious (medically significant) by the regulatory authority. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient recovered from neck stiffness on 05Aug2021 while outcome for headache and nausea is unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1592918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial spasm, Blood test, Cardiovascular disorder, Fibrin D dimer, Fibrin D dimer increased, Paraesthesia, Urine analysis
SMQs:, Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: blood; Result Unstructured Data: Test Result:Normal; Comments: blood and urine tests all came back ok; Test Name: -Dimer; Result Unstructured Data: Test Result:216; Comments: slightly elevated at; Test Name: urine; Result Unstructured Data: Test Result:Normal; Comments: blood and urine tests all came back ok
CDC Split Type: GBPFIZER INC202101012485

Write-up: D-Dimer was slightly elevated at 216; Arteriospasm; Tingling of extremity; Unspecified circulatory system disorder; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-RA-WEBCOVID-202108051421517290-NLWQ5, Safety Report Unique Identifier GB-RA-ADR 25759886. A 33-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), dose 2 via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Concomitant medication included levothyroxine (Manufacturer unknown) taken for hypothyroidism from 2010 to an unspecified stop date. The patient experienced arteriospasm, unspecified circulatory system disorder and tingling of extremity on 03Aug2021; and D-Dimer was slightly elevated at 216 on an unknown date. It was reported that the patient had involuntary twitching of artery between right thumb and index finger. This stopped after some minutes. Shortly after, the patient felt tingling in the right arm (upper arm all the way down to fingers) as if in early stages of falling asleep. This was constant for about 12 hours and did not improve with movements of arm. Since then it happens only when the patient was using the phone or in bed. The outcome of the event arteriospasm was recovered on 03Aug2021, the outcome of tingling in extremity was recovering, the outcome of unspecified circulatory system disorder was not recovered ans the outcome of the event D-Dimer elevated was unknown. The events were considered medically significant. The patient underwent lab tests and procedures which included blood and urine tests; all came back ok. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient went to A&E. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592936 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Pain in extremity, Pain of skin, Paraesthesia, SARS-CoV-2 test, Sensory overload
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012996

Write-up: mind fog; sensory overload; Tingling in left arm; Skin ache or horrible to touch; Aching pain in hands, forearms, elbows; 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-202108051611305630-RH6V5. Safety Report Unique Identifier GB-MHRA-ADR 25760456. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included asthma. The patient''s concomitant medications were not reported. The patient experienced mind fog, sensory overload, tingling in left arm, skin ache or horrible to touch on an unspecified dates; aching pain in hands, forearms, elbows on 03Aug2021; all reported as serious as disability. 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. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 03Aug2021. The outcome of the event aching pain in hands, forearms, elbows was recovered in Aug2021 with sequelae, others was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592947 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis allergic, Dizziness postural, Fatigue, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101012993

Write-up: Allergic rash; Nausea; Headache; Dizzy on standing; Tiredness; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051720363920-2OMKZ, Safety Report Unique Identifier GB-MHRA-ADR 25760962. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 38-year-old on 03Aug2021 (Lot Number: Ff3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 from 24Oct2020 (Unsure when symptoms stopped), COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 for COVID-19 immunisation. The patient experienced nausea (medically significant) on 03Aug2021, headache (medically significant) on 03Aug2021, dizzy on standing (medically significant) on 03Aug2021, tiredness (medically significant) on 03Aug2021, allergic rash (medically significant) on 05Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date (Yes - Positive COVID-19 test). The outcome of event headache was recovering. The outcome of other events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1593009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Axillary pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (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: PAROXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012630

Write-up: Muscle ache; Anxious mood; Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108052112207690-OM6UR. Safety Report Unique Identifier GB-MHRA-ADR 25762018. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included chronic anxiety. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding and was not enrolled in clinical trial. Concomitant medication included paroxetine taken for chronic anxiety from 23Nov2010 to an unspecified stop date. The patient experienced armpit pain on 03Aug2021, muscle ache and anxious mood on 04Aug2021. The events were reported as serious (other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of muscle ache and anxious mood was not recovered while recovering for armpit pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593028 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negetive; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101013039

Write-up: Swollen lymph nodes; Fever; Dizziness; Tiredness; Headache dull; 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-202108052327589850-LEQVX, Safety Report Unique Identifier GB-MHRA-ADR 25762707. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 (Lot Number: FE3380) as dose 2, 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. Patient is not enrolled in clinical trial. The patient experienced swollen lymph nodes on 05Aug2021, fever on 04Aug2021, dizziness on 04Aug2021, tiredness on 03Aug2021, headache dull on 03Aug2021. Events were reported as serious with criteria of other medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negetive on unknown date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event swollen lymph nodes and tiredness was not recovered, of fever was recovered on 05Aug2021, of dizziness and headache dull was recovered on 04Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593032 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012589

Write-up: Lymph node pain; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108060049050380-MOKZT, Safety Report Unique Identifier is GB-MHRA-ADR 25762769. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 03Aug2021 (at the age of 33-years) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on unspecified date for COVID-19 immunisation. The patient experienced painful arm on 03Aug2021 with outcome of recovering and lymph node pain on 05Aug2021 with outcome of not recovered. The events were considered serious, medically significant. The patient had negative COVID-19 virus test on unspecified date. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1593041 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cold sweat, Cough, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012635

Write-up: fever; Headache; Nausea; Muscle pain; Cold sweat; Cough; Joint pain; Suspected COVID-19; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060641176030-MGC4G, Safety Report Unique Identifier GB-MHRA-ADR 25762881. A 20-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Lot Number: Ew3143) as dose 1, single at 20-year-old for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Aug2021, the patient had suspected COVID-19. On an unspecified date, the patient had fever, headache, nausea, muscle pain, cold sweat, cough, and joint pain. The outcome of the event fever was unknown, while the outcome of the remaining events was not recovered. The events were considered medically significant. The patient underwent lab tests and procedures which included negative COVID-19 test on 04Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593046 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Myocarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101014721

Write-up: High temperature; Cough; Fatigue; Myocarditis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108060804509410-GZPD5. Safety Report Unique Identifier is GB-MHRA-ADR 25763196. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) (at the age of 37-year-old) as DOSE 2, SINGLE for covid-19 immunisation. First dose of BNT162B2 was received on unknown date for COVID-19 immunisation. Medical history included suppressed lactation. Concomitant medications were not reported. History vaccine included first dose of bnt162b2 for covid-19 immunisation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced myocarditis on 03Aug2021 with outcome of recovering, high temperature on 04Aug2021 with outcome of recovered on 05Aug2021, cough on 04Aug2021 with outcome of recovered in Aug2021, fatigue on 04Aug2021 with outcome of recovered in Aug2021. All events were reported as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.


VAERS ID: 1593047 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19 (Patient has not had symptoms associated with COVID-19.); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210620; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101014690

Write-up: Numbness all over entire body particularly in chest and face; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108060814574810-ZRDJ7, Safety Report Unique Identifier GB-MHRA-ADR 25763311. A 28-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (at the age of 28-year-old) as single dose for COVID-19 immunisation. Medical history included Lactation decreased and Positive COVID-19 test on 20Jun2021. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 03Aug2021, the patient experienced numbness all over entire body particularly in chest and face. Left side of face also now had less control. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included blood tests with unknown results on an unspecified date and COVID-19 virus test on 20Jun2021 indicated Yes - Positive COVID-19 test. The outcome of the event was not recovered. The report was reported as serious with the criteria of medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593054 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Headache, Lower respiratory tract infection, Musculoskeletal stiffness, Neck pain, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (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: AMOXYCILLIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection; Depression; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014558

Write-up: chest infection worsening; chest infection worsening; neck stiffness; The neck stiffness/pain is getting progressively worse as the days go on; Neck stiff; Painful arm; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060833160020-JMBBW, Safety Report Unique Identifier GB-MHRA-ADR 25763673. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation . Medical history included lower respiratory tract infection , suppressed lactation , depression. Concomitant medications included amoxicillin (AMOXYCILLIN) taken for lower respiratory tract infection from 30Jul2021 to 06Aug2021; sertraline (SERTRALINE) taken for depression from 05Jan2020 to an unspecified stop date. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding. The patient experienced chest infection worsening (medically significant) on an unspecified date with outcome of recovering , neck stiffness (medically significant) on an unspecified date with outcome of recovering , headache (medically significant) on 03Aug2021 with outcome of not recovered , neck stiff (medically significant) on 04Aug2021 with outcome of not recovered , painful arm (medically significant) on 03Aug2021 with outcome of not recovered , the neck stiffness/pain is getting progressively worse as the days go on (medically significant) on an unspecified date with outcome of unknown. Additional information: I was suffering from a chest infection when I received my 2nd vaccine. The headache started 24hrs after the vaccine and is still here 3 days later. The neck stiffness/pain is getting progressively worse as the days go on. 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: 1593069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Drug ineffective, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014840

Write-up: Really strong lower back pain left side, not painful while I walking, the worst pain is while I sitting on the sofa or laying in bed and I need to change position; Suspected COVID-19; Suspected COVID-19; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060919374400-S0HWD, Safety Report Unique Identifier GB-MHRA-ADR 25763865. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient experienced low back pain and suspected COVID-19 on 03Aug2021. Events resulted into hospitalization. Really strong lower back pain left side, not painful while the patient walking, the worst pain was while she sitting on the sofa or laying in bed and the patient need to change position. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593089 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dizziness, Electrocardiogram, Fatigue, Headache, Nausea, X-ray
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: Xray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101014838

Write-up: Chest pain; Headache; Nausea; Dizzy spells; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108061024246200-BLDHL, Safety Report Unique Identifier GB-MHRA-ADR 25764264. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 2 via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced chest pain, headache, nausea, dizzy spells, and fatigue on 03Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted: "X-ray, blood test, ECG". This case was reported as serious cue to hospitalization and medically significant. The outcome of events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle injury, Pain in extremity
SMQs:, Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014855

Write-up: Muscle injury; Serve pain in arm/Pain spread to shoulder and neck; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202108061028216680-ZXGT6; Safety Report Unique Identifier: GB-MHRA-ADR 25764269. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: Not Known; Expiry date: Not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced muscle injury and serve pain in arm on 03Aug2021. Serve pain in arm that started 24 hours after vaccination. Pain spread to shoulder and neck only on the side the vaccination was injected. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not recovered from muscle injury, serve pain in arm was unknown. Event muscle injury was considered as serious as medically significant from Regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593115 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014704

Write-up: Nausea; Fatigue; Pain; 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-202108061216278040-8PUAB, Safety Report Unique Identifier GB-MHRA-ADR 25765281. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) (at the age of 22-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased from an unknown date. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced pain and fatigue on 03Aug2021, nausea on 04Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test on an unspecified date. The outcome of the events was not resolved. The events were reported as serious due to medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, SARS-CoV-2 test
SMQs:, 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: Medical History/Concurrent Conditions: COVID-19 virus test positive; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes-Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101014428

Write-up: Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061403564990-MAUBG, safety report unique identifier is GB-MHRA-ADR 25765708. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date and unknown if ongoing and COVID-19 virus test positive on 06Jun2021. The patient''s concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 03Aug2021, the patient experienced painful periods. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Jun2021 Yes-Positive COVID-19 test. Outcome of the event was recovered on 06Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593140 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breast tenderness, Erythema, Mastitis, Off label use, Product use issue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Functional lactation disorders (narrow), Hypersensitivity (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:40.2
CDC Split Type: GBPFIZER INC202101014587

Write-up: redness; pyrexia (Temp of 40.2); tenderness of left breast (same left side vaccine was given); Mastitis female; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061602576820-KZ9EZ. This healthcare professional reported information for both mother and baby. This is the maternal report. Only this case is serious. A 36-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 03Aug2021, at the age of 36 years, as the second single dose, for COVID-19 immunisation. Medical history included ongoing breast feeding. The first dose of BNT162B2 vaccine was administered on an unspecified date. Patient has not had symptoms associated with COVID-19, had no COVID-19 test and was not pregnant. The patient''s concomitant medications were not reported. The patient experienced redness on an unspecified date with outcome of recovering, pyrexia on an unspecified date with outcome of recovering, maternal exposure during breast feeding on 03Aug2021 with outcome of unknown, mastitis female on 05Aug2021 with outcome of not recovered. The case was reported as non-serious. Additional information: Temp of 40.2, redness and tenderness of left breast (same left side vaccine was given). Pyrexia ongoing, taking regular paracetamol and Brufen. Commenced on 5 day course of flucloxacillin and being referred to the breast clinic. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible blood clots or low platelet counts. Relevant investigations or tests conducted: Breast clinic review pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101022024 mother/baby case


VAERS ID: 1593155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Pyrexia, SARS-CoV-2 test, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Noninfectious diarrhoea (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:
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 INC202101014725

Write-up: Diarrhea; Vomiting; Fever chills; Stomach ache; Blurry vision; Dizzy; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061758011830-CQLOP. Safety Report Unique Identifier GB-MHRA-ADR 25766998. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 03Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced diarrhea on 05Aug2021 with outcome of recovered with sequel in Aug2021, vomiting on 05Aug2021 with outcome of recovered on 06-AUG-2021, dizzy on 03Aug2021 with outcome of not recovered, fever chills on 05Aug2021 with outcome of recovering, stomach ache on 05Aug2021 with outcome of not recovered, blurry vision on 03Aug2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report is considered as serious due to medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-08-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Dizziness, Dyspnoea, Myocarditis, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: GBPFIZER INC202101014297

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency. A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: fa1027), via an unspecified route of administration on 10jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19, not had a covid-19 test. Patient has not tested positive for covid-19 since having the vaccine. Patient is not enrolled in clinical trial. On an unspecified date patient experienced shortness of breath, dizziness, feeling like gonna faint, very weak, strong rapid or abnormal heart rhythms and on 03Aug2021 myocarditis. Outcome of myocarditis was not recovered, and shortness of breath, dizziness, syncope, asthenia, arrhythmia and presyncope was unknown.No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, SARS-CoV-2 test
SMQs:, Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014771

Write-up: Chest pain - cardiac; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061939494350-ZXZK4, Safety Report Unique Identifier GB-MHRA-ADR 25767994. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Historical Vaccine was first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) 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 experienced chest pain - cardiac (medically significant) on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1593321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014247

Write-up: This is a spontaneous report from a contactable consumer and received from the Regulatory Agency. The patient medical history included PCOS (polycystic ovaries) from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test.The patient''s concomitant medications were not reported. On 03Aug2021 after the vaccination, the patient experienced fever and diarrhea. On an unspecified date the patient experienced bad stomach pains. The events were assessed as serious (disability, medically significant) it was reported Diarrhea causing to patient bad stomach pains. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event fever was recovered on 04Aug2021 and the outcome of diarrhea was not recovered. The outcome of bad stomach pains reported as unknown.No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1593351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eczema, SARS-CoV-2 test
SMQs:, Hypersensitivity (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: Eczema
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014351

Write-up: Eczema; Eczema flare up; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108072036260590-LWNMW, Safety Report Unique Identifier GB-MHRA-ADR 25770951. A 31-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FF3319) via an unspecified route of administration on 02Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing eczema and lactation decreased from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 03Aug2021, the patient experienced eczema and eczema flare up. It was reported that eczema flare up on backs of legs and inside elbows started the next day, first flare in 10 years. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (no- negative COVID-19 test) on 07Aug2021. The events outcome was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593385 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cluster headache, Dizziness, Fatigue, Headache, Irritability, Muscle fatigue, Pallor, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache (taken ibuprofen or paracetamol for short spells during the past year); Toothache (taken ibuprofen or paracetamol for short spells during the past year)
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014932

Write-up: headache; pale; feeling okish; Cluster headache; Muscle fatigue; Irritable; Fatigue; Generalised joint pains; aching joints; tiredness; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108080157057100-3IOSX, Safety Report Unique Identifier GB-RA-ADR 25771099. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history toothache and headache. Patient stated that he had only taken ibuprofen or paracetamol (past drug) for short spells during the past year (that would be for tooth ache or mild headaches). 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. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for toothache from 18May2021 to 20May2021. The patient experienced aching joints on 03Aug2021, tiredness on 03Aug2021, headache on an unspecified, pale on an unspecified date, feeling okish on an unspecified date, generalised joint pains on 04Aug2021, cluster headache on 05Aug2021, fatigue on 04Aug2021, muscle fatigue on 05Aug2021 Abd irritable on 05Aug2021. Patient stated that had the vaccination at 12 noon. Symptoms started about 6 hours later. General fluey feeling at first, aching joints and extreme tiredness. The next day when he woke up he had a terrible headache, plus he could hardly move due to the pains in his muscles and joints. He had to take 4 days off work due to the after effect of the Pfizer. Day 2 was definitely the worst day, he felt and looked awful. He had a hot bath with salts in it to try and relieve the pains in his muscles and joints. He took ibruprofen and paracetamol and spent the rest of the day in bed, he felt ghastly. Day 3 (Thursday) he woke up with pains in his joints and muscles and a slight headache, but still felt exhausted. Day 4 (Friday) he woke up with brain fog and his body was aching still. He found himself becoming very irritable and felt the need for sugary food. Day 5 (Saturday) patient had only just started feeling okish. He still felt very tired but the muscle and joint aches seem to have gone away. He look exhausted and pale. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 03Jan2021. Cluster headache was resolved on 07Aug2021, the other events were resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593558 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pericarditis, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLCHICINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Pericarditis 2017
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This case was received via Agency (Reference number: 767318) on 12-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDITIS in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pericarditis (2017) and Allergic asthma. Concomitant products included COLCHICINE for an unknown indication. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 03-Aug-2021, the patient experienced PERICARDITIS. (seriousness criterion medically significant), NAUSEA and PYREXIA. At the time of the report, PERICARDITIS, NAUSEA and PYREXIA had not resolved. mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged. Treatment information was not provided. 05.08.21 Upgrade Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up received by safety 12-Aug-2021 included significant follow up: Events upgraded to medically important and patient history information updated.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1593563 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Diarrhoea, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: 767758) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE in a 35-year-old male patient who received mRNA-1273 (Spike vax) (batch no. 3003605) for SARS-CoV-2 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 03-Aug-2021, the patient experienced SYNCOPE (seriousness criterion medically significant), CONFUSIONAL STATE, HYPERHIDROSIS and DIARRHOEA. At the time of the report, SYNCOPE, CONFUSIONAL STATE, HYPERHIDROSIS and DIARRHOEA was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1593570 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperpyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

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

Write-up: Iperpiressia, insufficienza respiratoria.; Iperpiressia, insufficienza respiratoria.; This case was received via regulatory authority (Reference number: 767996) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE (Iperpiressia, insufficienza respiratoria.) and HYPERPYREXIA (Iperpiressia, insufficienza respiratoria.) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced RESPIRATORY FAILURE (Iperpiressia, insufficienza respiratoria.) (seriousness criteria hospitalization and medically significant) and HYPERPYREXIA (Iperpiressia, insufficienza respiratoria.) (seriousness criteria hospitalization and medically significant). At the time of the report, RESPIRATORY FAILURE (Iperpiressia, insufficienza respiratoria.) and HYPERPYREXIA (Iperpiressia, insufficienza respiratoria.) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received on 12-AUG-2021 contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1593684 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling abnormal, Hyperhidrosis, Hyperventilation, Oxygen saturation, Presyncope, Visual impairment
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:100/80; Test Date: 20210803; Test Name: spO2; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101023954

Write-up: Vasovagal reflex; Feels poorly; vision disorder; sweaty; mild hyperpnoea; This is a spontaneous report from a contactable nurse received from the Agency Regulatory Authority. Regulatory authority report number is v21122743. A 52-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot: FC9873, Expiration date: 30Sep2021) at 52-year-old, via an unspecified route of administration on 03Aug2021 at 14:30 at single dose for COVID-19 immunization. Medical history was none. Body temperature before vaccination was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. On 03Aug2021 at 14:50 (the day of vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: After 20 minutes of receiving the vaccine, patient felt poorly, experienced vision disorder, sweaty, and mild hyperpnoea. Bood pressure (BP) was 100/80, Spo2 was 99%. Intravenous catheterized, and then injected with methylprednisolone sodium succinate (SOLU-MEDROL) 40 mg (IV) and dexchlorpheniramine maleate (POLARAMINE) (IV). One hour later, the patient was recovering. The reporting nurse classified the events as non-serious and the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. On 03Aug2021 (the day of vaccination), the outcome of the events was resolved.


VAERS ID: 1593736 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072308

Write-up: Bradycardia; Vasovagal reflex; This case was received via agency (Reference number: 2021TJP072308) on 09-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This case, reported by a physician, was received by via Modernas adverse reaction reporting site (TASK0020784). Bradycardia was assessed as serious by the . On 03-Aug-2021, at 10:10, the patient received the 1st dose of this vaccination. At 10:15, the patient was aware of queasy. The patient developed hypertension and thereafter hypotension and bradycardia. The patient recovered at bed rest. The outcome of vasovagal reflex and bradycardia was recovered. No follow-up investigation was possible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1593808 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-08-03
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTHYROX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT SCAN; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: blood test for d-dimer; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC202101062012

Write-up: Double-sided pulmonary embolism; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00660470. A 59-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 (Lot Number: FC3098) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not have a previous COVID-19 infection. Concomitant medication included levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (lot number unknown) on 11May2021, dose 1, single for COVID-19 immunization with no adverse event. Two months after the start of vaccination (as reported), the patient experienced double-sided pulmonary embolism on 03Aug2021. The patient was treated with rivaroxaban. The patient underwent diagnostic procedures including ECG, CT SCAN and blood test for d-dimer on an unknown date in 2021 with unknown results. The outcome of the events was unknown. The event was reported as life-threatening. No follow-up attempts possible. No further information expected.


VAERS ID: 1593849 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Decreased appetite, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839321

Write-up: DIFFICULTY OF BREATHING; COUGH; LOSS OF APPETITE; BODY WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098895] concerned a 92 year old female of an unspecified race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 08:00 the patient experienced difficulty of breathing, cough, loss of appetite and body weakness. On an unspecified date, the patient was hospitalized. The number of days hospitalized was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, loss of appetite, body weakness, and difficulty of breathing. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839321-Covid-19 vaccine ad26.cov2.s-Difficulty of breathing, Cough, Loss of appetite. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210839321-Covid-19 vaccine ad26.cov2.s-Body weakness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1593852 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Syncope, Vomiting
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? 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: PHJNJFOC20210839612

Write-up: FAINTING; DIZZINESS; VOMITING; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098499] concerned a 29 year old female, 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: 213C21A expiry: unknown) frequency 1 total, dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 13:32 the patient experienced fainting, dizziness, vomiting, nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, dizziness, vomiting, and nausea. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210839612-COVID-19 VACCINE AD26.COV2.S - Fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1594007 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: ADAMTS13 inhibitor screen assay, Anxiety, Blood creatinine, Cerebral microinfarction, Confusional state, Depressed level of consciousness, Fatigue, Haemolytic anaemia, Investigation, Magnetic resonance imaging, Malaise, Nausea, Platelet count, Thrombotic thrombocytopenic purpura, Vomiting
SMQs:, Haemolytic disorders (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: ADAMTS13; Result Unstructured Data: Test Result:clearly reduced level of 0.2%; Comments: clearly reduced level of 0.2% and a very high titer of autoantibodies against ADAMTS13; Test Date: 20210809; Test Name: creatinine; Result Unstructured Data: Test Result:normalized; Test Date: 20210809; Test Name: LD; Result Unstructured Data: Test Result:declining; Test Date: 20210805; Test Name: sammpling; Result Unstructured Data: Test Result:DAT-negative hemolytic anemia; Comments: DAT-negative hemolytic anemia and pronounced thrombocytopenia; Test Date: 20210809; Test Name: MRI; Result Unstructured Data: Test Result:approximately 4 mm large focus with diffusion; Comments: approximately 4 mm large focus with diffusion restriction in the cerebellum left side compatible with fresh microinfarction; Test Date: 20210809; Test Name: platelet; Result Unstructured Data: Test Result:normalized
CDC Split Type: SEPFIZER INC202101062052

Write-up: TTP (Thrombotic thrombocytopenic purpura); DAT-negative hemolytic anemia; fell ill/malaise; fatigue; confusion; nausea; vomiting; approximately 4 mm large focus with diffusion restriction in the cerebellum left side compatible with fresh microinfarction; decreased consciousness; motor anxiety; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is SE-MPA-2021-073108 with Safety Report Unique Identifier SE-VISMA-1628768623456. A 36-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 20Jul2021 (Batch/lot number: FF3318), as dose 1, single, for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications. On 03Aug2021, the patient experienced TTP (Thrombotic thrombocytopenic purpura). It was reported that the patient fell ill two weeks after the vaccination, on 03Aug2021, with malaise, fatigue, confusion, nausea and vomiting but no fever. There was increasing confusion two days later, on 05Aug2021. On the same day, 05Aug2021, the patient was admitted to the hospital where sampling showed DAT-negative hemolytic anemia and pronounced thrombocytopenia. On the same day, tests for ADAMTS13 were taken. On 06Aug2021, the patient worsened with decreased consciousness and motor anxiety. On the same day, 06Aug2021, the patient was intubated and was transferred for intensive care at another hospital. On clinical suspicion of TTP, initiation of daily plasmapheresis and steroids were done pending response to ADAMTS13 test. On 09Aug2021, test results for ADAMTS13 were received which showed clearly reduced level of 0.2% and a very high titer of autoantibodies against ADAMTS13. On the same day, normalized platelets, declining LD (as reported) and normalized creatinine were noted. MRI brain on the same day that showed an approximately 4 mm large focus with diffusion restriction in the cerebellum left side compatible with fresh microinfarction. Rituximab was given on 09Aug2021 and three days later. An additional dose of Rituximab was planned. The patient was successfully extubated on 10Aug2021 and plasmapheresis treatment was ended on 11Aug2021 (reported as one day later). The patient remained at the hospitalized until further notice for continued mobilization, steroid and MABTHERA treatment. The outcome of the event "approximately 4 mm large focus with diffusion restriction in the cerebellum left side compatible with fresh microinfarction" was unknown. The patient was recovering from the remaining events. The health authority assessed the event TTP (Thrombotic thrombocytopenic purpura) as serious (life-threatening). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1620328 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza, Myalgia, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: sore; muscles; fatigue; Headache; Fever; Flu symptoms; Pain in arm; This case was received via Regulatory Authority (Reference number: 25768584) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (sore), INFLUENZA (Flu symptoms), PAIN IN EXTREMITY (Pain in arm), MYALGIA (muscles), FATIGUE (fatigue), PYREXIA (Fever) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Polycystic ovary. Concomitant products included CYPROTERONE ACETATE and METFORMIN for Polycystic ovary. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (sore) (seriousness criterion medically significant), MYALGIA (muscles) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. On 04-Aug-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever) had resolved. On 05-Aug-2021, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (sore), MYALGIA (muscles) and FATIGUE (fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient had not had symptoms associated with COVID-19. On an unspecified date, COVID-19 virus test was negative. It was reported that approximately 12 hours after vaccine, patient began experiencing fever and flu symptoms (sore muscles, fatigue). Patient took paracetamol and the fever subsided. Flu symptoms continued for another 12 hours or so. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded


VAERS ID: 1622978 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-08-03
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Left ventricular dysfunction, Myocarditis, Pyrexia
SMQs:, Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072250AA

Write-up: Myocarditis; Left ventricular function decreased; Pyrexia; This case was received via a regulatory authority (Reference number: JP-TAKEDA-2021TJP072250AA) on 09-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This case, initially reported to a regulatory authority by a physician, was received via the PMDA (Ref, v21123170). On 05-Jul-2021, the patient received the 1st dose of this vaccination. ON 02-Aug-2021, the patient received the 2nd dose of this vaccination. On 03-Aug-2021, body temperature went up to 39 degrees Celsius. On 04-Aug-2021, body temperature fluctuated between 37 to 38 degrees Celsius. At night, the patient was aware of heavy feeling in left precordial region. On 05-Aug-2021, chest symptom was aggravated the most in the morning, and it was accompanied by short of breath on exertion. At around 17:00, the patient visited the hospital. Electrocardiogram showed sinus rhythm with heart rate of 70 beats/min and ST increased in lead V2-6, which may be an early repolarization. Although BNP was within the normal range (10 pg/mL), echocardiography revealed diffuse left ventricular hypokinesia and ejection fraction (EF) of 48%. No pericardial effusion. The possibility of myocarditis after the vaccination with SARS-Co-2 mRNA could not be ruled out, and the patient was referred to another hospital. There is the possibility of myocardial disease (cardiomyopathy, etc.) as other contributing factor. The outcomes of pyrexia and left ventricular function decreased and myopathy were unknown. Follow-up investigation will be made. Reporter comments continuation: Echocardiography revealed left ventricular hypokinesia (EF 48%). It was considered that the possibility of myocarditis after SARS-CoV-2 mRNA vaccination could not be ruled out based on the clinical course, but the facts that there was not pericardial effusion, CRP was mildly elevated at 1.1 mg/dL, and BNP was within the normal range were not considered classical. In this regard, although it is possible that the left ventricular hypokinesis observed in this case was accidentally detected, further observation of the events is considered essential. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Reporter''s Comments: 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 32-year-old male with serious unexpected events of myocarditis, left ventricular dysfunction, and pyrexia. Event onset 2 days after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1622995 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Dyspnoea, Electrocardiogram, Heart rate, Oxygen saturation, Pain assessment, Physical examination, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: C-reactive protein; Result Unstructured Data: 48; Test Date: 20210806; Test Name: ECG; Result Unstructured Data: Generalised ST-elevations consistent with perimyocarditis; Test Date: 20210806; Test Name: Pulse rate; Result Unstructured Data: 100, regulary; Test Date: 20210806; Test Name: Oxygen saturation; Result Unstructured Data: 99 %; Test Date: 20210806; Test Name: Pain scale; Result Unstructured Data: Chest pain. NRS (numeric rating scale) 8 in the morning and 5-6 later that day; Test Date: 20210806; Test Name: Physical examination; Result Unstructured Data: Cor and pulm. without remark.No friction rub sound. No palpation tenderness over thorax.; Test Date: 20210806; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Chest pain; Fever; Dyspnea; This case was received via regulatory authority (Reference number: E2B_00041927) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNEA (Dyspnea) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004494) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Allergy. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and DYSPNOEA (Dyspnea) (seriousness criterion hospitalization). On 03-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, CHEST PAIN (Chest pain) and DYSPNOEA (Dyspnea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, C-reactive protein: 48 (High) 48. On 06-Aug-2021, Electrocardiogram: abnormal (abnormal) Generalised ST-elevations consistent with perimyocarditis. On 06-Aug-2021, Heart rate: 100 (High) 100, regulary. On 06-Aug-2021, Oxygen saturation: 99 % (normal) 99 %. On 06-Aug-2021, Pain assessment: abnormal (abnormal) Chest pain. NRS (numeric rating scale) 8 in the morning and 5-6 later that day. On 06-Aug-2021, Physical examination: abnormal (abnormal) Cor and pulm. without remark.No friction rub sound. No palpation tenderness over thorax.. On 06-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1624715 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Injection site hypoaesthesia
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; SERETIDE
Current Illness: Asthma chronic
Preexisting Conditions: Medical History/Concurrent Conditions: IgA nephropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Chest tightness of; This case was received via a regulatory authority (Reference number: 970100) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA and CHEST DISCOMFORT (Chest tightness of) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214013) for COVID-19 vaccination. The patient''s past medical history included IgA nephropathy. Concurrent medical conditions included Asthma chronic. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) for Asthma chronic, ENALAPRIL from 01-Jan-2016 to an unknown date for Glomerulonephritis. On 03-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced INJECTION SITE HYPOAESTHESIA (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest tightness of) (seriousness criterion medically significant). At the time of the report, INJECTION SITE HYPOAESTHESIA and CHEST DISCOMFORT (Chest tightness of) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 03-Aug-2021. Concomitant medication note on Enalapril, .5 milligrams received at morning, and 10 mg at night. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Medical history of asthma and IgA nephropathy, could be confounding factors for the events. Events seriousness criteria was assessed as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Medical history of asthma and IgA nephropathy, could be confounding factors for the events. Events seriousness criteria was assessed as per regulatory authority report.


VAERS ID: 1624718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

Administered by: Other       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101062953

Write-up: Lymphadenopathy axillary; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (EMA) EudraVigilance-WEB (ES-AEMPS-965784). This is the second of two reports for same patient and it refers to the 2nd dose of the vaccine. A 39-years-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 01Aug2021 (Batch/Lot Number: FF2752) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st dose of BNT162B2 (COMIRNATY,Batch/Lot Number: FD7959), intramuscularly, administered in Arm Left on 06Jul2021 single for covid-19 immunization and experienced thrombophlebitis of the leg. On 03Aug2021 the patient woke up with a lump the size of a tennis ball in left armpit that is probably a swollen lymph node; the event was considered serious as medically significant. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-202101022207 same patient, different dose


VAERS ID: 1624747 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchospasm, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Tabaquism (aucun, tabagisme actif)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: SARS-CoV-2 test negative.
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Bronchial spasm; This case was received via regulatory authority (Reference number: BR20213001) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of BRONCHOSPASM (Bronchial spasm) in a 42-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Tabaquism (aucun, tabagisme actif). On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced BRONCHOSPASM (Bronchial spasm) (seriousness criterion hospitalization). At the time of the report, BRONCHOSPASM (Bronchial spasm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 test negative.. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-BR20213001 Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1624861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood cholesterol, Blood pressure measurement, Blood triglycerides, Body temperature, C-reactive protein, Echocardiogram, Electrocardiogram, Heart rate, High density lipoprotein, Laboratory test, Low density lipoprotein, Myocarditis, Non-high-density lipoprotein cholesterol, Oxygen saturation, Physical examination, Supraventricular tachycardia, Troponin I, White blood cell count, Wolff-Parkinson-White syndrome
SMQs:, Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIBILLA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Oil acne; Palpitations (similar to the current one, without syncope); Smoker (2-3 cig / day)
Allergies:
Diagnostic Lab Data: Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:Rhythmic heart sounds without murmurs; Test Name: Respiratory auscultation; Result Unstructured Data: Test Result:Vesicular murmur preserved without ...; Comments: ...added sounds. Not hissing, not crackling, not rhonchi.; Test Date: 20210726; Test Name: Cholesterol; Test Result: 149 mg/dl; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/93 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/122/60-93 mmHg; Test Date: 20210726; Test Name: Triglycerides; Result Unstructured Data: Test Result:132 ng/ml; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Name: CRP; Result Unstructured Data: Test Result:minimal elevation of CRP inflammation markers; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal left ventricular global ...; Comments: ...systolic function. Septum of paradoxical / intermediate movement. Right ventricle with normal function; Test Name: ECG; Result Unstructured Data: Test Result:wide QRS with LBBB morphology; Test Name: ECG; Result Unstructured Data: Test Result:showing supraventricular ...; Comments: ...tachycardia with slowing of tachycardia after adenosine and subsequent cessation after 3 VE, assessing ECG with wide QRS and short PR, suggestive of delta wave and accessory pathway; Test Name: Heart rate; Result Unstructured Data: Test Result:215; Comments: bmp; Test Name: Heart rate; Result Unstructured Data: Test Result:93-215; Comments: bpm; Test Date: 20210726; Test Name: HDL; Test Result: 47 mg/dl; Test Name: cardiac biomarkers; Result Unstructured Data: Test Result:elevation of cardiac biomarkers; Test Date: 20210726; Test Name: LDL; Test Result: 75 mg/dl; Test Date: 20210726; Test Name: non-HDL; Test Result: 102 mg/dl; Test Name: SatO2; Result Unstructured Data: Test Result:99-100 %; Test Name: Abdomen; Result Unstructured Data: Test Result:Soft and depressible, not...; Comments: ...painful on palpation, no signs of peritoneal irritation, no masses or megaly. Hydro-air noise present.; Test Name: Physical examination; Result Unstructured Data: Test Result:No edema in lower limbs; Comments: Not Ileojejunal. Non-hepatojugular. Pedios and radial pulses present and symmetrical; Test Name: initial Troponin I; Result Unstructured Data: Test Result:1100 ng/L; Test Name: leukocytosis; Result Unstructured Data: Test Result:leukocytosis and left deviation
CDC Split Type: ESPFIZER INC202101017213

Write-up: Myocarditis; paroxysmal supraventricular tachycardia; Wolff-Parkinson-White Syndrome; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-966781. A 16-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 02Aug2021 (Batch/Lot Number: FE8244) as dose number unknown, single for covid-19 immunisation. Patient had no known drug allergies, 2-3 cig / day smoker, no alcoholism or other toxins, no hypertension, no Diabetes mellitus, no known Dyslipidemia (26Jul21: Triglycerides 132 ng / ml, Cholesterol 149 mg / dl, LDL 75 mg / dL, HDL 47 mg / dL, non-HDL 102 mg / dl). No history of heart disease. Medical history also included oil acne. Concomitant medication included dienogest, ethinylestradiol (SIBILLA) taken for oil acne from 29Jun2021 and ongoing. Patient went to the emergency room on 03Aug for presenting an episode of chest pain that she describes as stabbing, centrothoracic, which worsens with inspiration and improves with sitting. She also reports a feeling of palpitations from the beginning of the picture. No cough, no sputum, no thermometered fever, no dysthermic sensation. She refers that yesterday she was vaccinated with the Pfizer vaccine for COVID, previously in Jan2021 she had a COVID infection that did not require hospital admission. She refers to two previous episodes of palpitations, similar to the current one, without syncope, with abrupt onset and end, for which she had not consulted. COURSE: with narrow QRS tachycardia at 215 bpm, and hemodynamic stability with BP 122/93 mmHg. Tachycardia is controlled with adenosine 6 mg (no reaction to vagal maneuvers), appreciating ECG with wide QRS with LBBB morphology. Laboratory tests with leukocytosis and left deviation, minimal elevation of CRP inflammation markers and elevation of cardiac biomarkers with initial Troponin I (TnI) of 1100 ng / l. ECG recordings are reviewed and repeated showing supraventricular tachycardia with slowing of tachycardia after adenosine and subsequent cessation after 3 VE, assessing ECG with wide QRS and short PR, suggestive of delta wave and accessory pathway. Given the patient''s symptoms (chest pain with pericarditic characteristics) and the result of complementary tests (elevation of TnI and paroxysmal supraventricular tachycardia), it is oriented as post-COVID vaccine myocarditis (Pfizer) and paroxysmal supraventricular tachycardia due to Wolff-Parkinson-White Syndrome (WPW). ) in the right anteroseptal route. PHYSICAL EXAMINATION: fever 37.3 C, HR 93-215 bpm, Blood pressure 116-122 / 60-93 mmHg, SatO2 99-100% Abdominal aorta (AA). Conscious and oriented. Cardiac auscultation: Rhythmic heart sounds without murmurs. No edema in lower limbs. Not Ileojejunal. Non-hepatojugular (RHY). Pedios and radial pulses present and symmetrical. Respiratory auscultation: Vesicular murmur preserved without added sounds. Not hissing, not crackling, not rhonchi. Abdomen: Soft and depressible, not painful on palpation, no signs of peritoneal irritation, no masses or megaly. Hydro-air noise present. Echocardiogram: normal left ventricular global systolic function. Septum of paradoxical / intermediate movement. Right ventricle with normal function. Currently hospitalized for monitoring and response to treatment. With clinical improvement. No further information is provided. Outcome of events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1624930 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Auscultation, Bradycardia, Discomfort, Heart rate, Malaise, Oxygen saturation, Oxygen saturation decreased, Pallor
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: auscultation; Result Unstructured Data: Test Result:Abnormal; Comments: arrhythmia and bradycardia on auscultation; Test Date: 2021; Test Name: Heart Rate; Result Unstructured Data: Test Result:44; Comments: Discomfort with pallor bradycardia at 44/min; Test Date: 2021; Test Name: Saturation; Result Unstructured Data: Test Result:88
CDC Split Type: FRPFIZER INC202101017393

Write-up: arrhythmia; Saturation at 88; discomfort; Pallor; Feeling sick; Bradycardia/Bradycardia at 44/min; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20216295. A 19-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 03Aug2021 (Batch/Lot Number: FE8244) as DOSE 1, SINGLE at the age of 19-years-old for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling sick on 03Aug2021, bradycardia on 03Aug2021, arrhythmia and saturation: 88 on an unspecified date. The patient underwent lab tests and procedures which included heart rate: 44 in 2021 Discomfort with pallor bradycardia at 44/min, oxygen saturation: 88 in 2021, auscultation: abnormal in 2021 arrhythmia and bradycardia on auscultation. These symptoms lasted for one hour at the vaccination center.The doctor recommended hospitalization but the patient returned home slept 12 hours and said that he was feeling better.Vaccination center doctor asked him to see his general practitioner in relation to the arrhythmia and bradycardia on auscultation.Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624935 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004738 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Vagal reaction; This case was received via The Regulatory Authority (Reference number: TS20213404) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of PRESYNCOPE (Vagal reaction) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004738) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced PRESYNCOPE (Vagal reaction) (seriousness criterion medically significant). On 03-Aug-2021, PRESYNCOPE (Vagal reaction) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Sender''s (Case) Safety Report Unique Identifier:FR-AFSSAPS-TS20213404 Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1624968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Headache, Lymphadenopathy, Malaise, Nasopharyngitis, Night sweats, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014617

Write-up: Swollen glands; Headache; Swollen eyes; Head cold; Night sweats; unwell; 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-202108061520563420-IUSOK. Safety Report Unique Identifier GB-MHRA-ADR 25766105. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On 03Aug2021, the patient felt unwell and experienced swollen glands, headache, swollen eyes, head cold and night sweats. The events were considered medically significant. The outcome of the events was not recovered. The patient had to take time off work and stay in bed. Been feeling very run down and ill. The patient underwent lab tests and procedures which included negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1625016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101021721

Write-up: Shingles; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108081158221710-ZNPYA, Safety Report Unique Identifier GB-MHRA-ADR 25771316. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced shingles (medically significant) on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1625624 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Physical deconditioning, SARS-CoV-2 test positive
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071935

Write-up: This case received via the regulatory authority (reference number: 2021TJP071935) on Aug 10, 2021 and forwarded to Moderna on Aug 23, 2021. This case reported by a pharmacist. Patient was COVID-19 positive (assessed serious) by the regulatory authority. On Jul 12, 2021, patient received the 1st dose of this vaccine. On Aug 3, 2021, patient experienced physical deconditioning. On an unknown date, at unknown time, patient underwent a test. On Aug 4, 2021, patient tested positive for COVID-19. The outcome of COVID-19 positive and physical deconditioning: unknown. Follow-up investigation will be impossible. Reporter''s comments: The events developed after the administration of COVID-19 vaccine mRNA 1273 (Moderna COVID-19 vaccine) and there is temporal relationship. Sender''s comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional factors to be considered: The patient received only one dose of vaccination. A complete protection from COVID-19 infection is not to be expected. The positive COVID-19 test result may indicate a true infection, which may be a confounding factor for physical deconditioning.


VAERS ID: 1625635 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Beta 2 microglobulin urine, Blood bilirubin, Blood creatinine, Blood lactate dehydrogenase, Haematuria, Haemolysis, Haptoglobin, Renal tubular disorder, Reticulocyte count
SMQs:, Acute renal failure (broad), Haemolytic disorders (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: urinary B2-microglobulin; Result Unstructured Data: 10,437 mcg/L; Test Name: indirect bilirubin; Result Unstructured Data: 1.8 mg/dL; Test Name: creatinine; Result Unstructured Data: 0.52 mg/dL; Test Name: LDH; Result Unstructured Data: 2,070 U/L; Test Name: haptoglobin; Result Unstructured Data: less than 10 mg/dL; Test Name: reticulocyte; Result Unstructured Data: 49
CDC Split Type: JPTAKEDA2021TJP076395

Write-up: Hemolysis; Acute renal tubular disorder; Hematuria; This case was received via Regulatory Authority (Reference number: 2021TJP076395) on 12-Aug-2021 and was forwarded to Moderna on 23-Aug-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the Regulatory Authority (Ref, v21123643). On an unknown date, body temperature before the vaccination: unknown. On 01-Aug-2021, the patient received the 1st dose of the vaccine. On 03-Aug-2021, asymptomatic macroscopic hematuria developed. On 05-Aug-2021, the patient visited a medical institution. Urine and blood tests were performed, and the patient was diagnosed with acute renal tubular disorder due to hemolysis (LDH 2,070 U/L, indirect bilirubin 1.8 mg/dL, reticulocyte 49, haptoglobin less than 10 mg/dL, creatinine 0.52 mg/dL, and urinary B2-microglobulin 10,437 mcg/L). On 07-Aug-2021, based on the result of blood test at return visit, acute renal tubular disorder was considered to tend to improve, but follow-up would be necessary. The outcome of hematuria, hemolysis, and acute renal tubular disorder was reported as resolving. Follow-up investigation will be made. Reporter comments continuation: Although the result of blood test at visit on 07-Aug-2021 showed improving tendency, a large number of cells derived from the renal tubule was found in the urine, and proteinuria was also noted. Therefore, it is necessary to follow the course of the events carefully considering the possibility of hepatic dysfunction in the future. The patient originally had no physical symptoms other than hematuria. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1625756 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838373

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300098343] concerned a 19 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, therapy start date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-AUG-2021 at 15:00, the patient had loss of consciousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210838373-Covid-19 vaccine ad26.cov2.s-Loss of consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1625769 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Rash
SMQs:, Anaphylactic reaction (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839294

Write-up: DIFFICULTY OF BREATHING; DIARRHEA; RASHES; ON AND OFF CHEST PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099277] concerned a 65 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: unknown) dose was not reported, frequency time 1 total was administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, 22:00 the patient had on and off chest pain, and was hospitalized (date unspecified). On 08-AUG-2021 at 10:00 the patient had diarrhea and at around 15:00, he had rashes. On 10-AUG-2021, at 09:00 (AM/PM not specified), he experienced difficulty of breathing. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the on and off chest pain, diarrhea, rashes and difficulty of breathing was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210839294- Covid-19 vaccine ad26.cov2.s-On and off chest pain and difficulty of breathing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210839294- Covid-19 vaccine ad26.cov2.s-Diarrhoea & rashes. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1628988 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101037250

Write-up: incomplete facial palsy on the left; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, company number DE-PEI-202100161523. An adult patient of an unspecified gender received BNT162B2 (COMIRNATY, Solution for injection, Lot number FE8405), intramuscularly on 26Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number-unknown), via unknown route on 21Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Aug2021, the patient developed incomplete facial palsy on the left. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1634332 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Inappropriate schedule of product administration, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101034142

Write-up: Fatigue; was 28 Weeks pregnant at time of second dose 03Aug2021; first dose on 07Jun2021, second dose on 03Aug2021; This is a solicited report from the regulatory authority program from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number [GB-MHRA-YCVM-202106071329213430-BHOQ2], Safety Report Unique Identifier [GB-MHRA-ADR 25781585]. A 34-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 (Lot Number: FF3319) as Dose 2, Single for COVID-19 immunisation at age of 34 years old. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 07Jun2021 (Batch/lot number: EW3143) for COVID-19 vaccination. The patient experienced fatigue on 03Aug2021. The event fatigue was serious per medically significant. The mother reported she became pregnant while taking bnt162b2. The mother was 20 weeks at time of first dose 07Jun2021, was 28 Weeks pregnant at time of second dose 03Aug2021 and at the onset of the event. The outcome of fatigue was resolving. Patient has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the event fatigue is considered related to BNT162B2. 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: 1634338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20220226)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scans or investigations; Result Unstructured Data: Test Result:missed; Comments: Missed miscarriage diagnosed; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101034132

Write-up: Early miscarriage; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108110730369300-YIMNS, Safety Report Unique Identifier GB-MHRA-ADR 25782987. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Jul2021 (Lot Number: FD5613) as single dose; dose 1 via an unspecified route of administration on 25May2021 (Lot Number: ET8885) as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (as reported) Estimated due date: 26Feb2022. Concomitant medications included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy (First pregnancy) and early miscarriage on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative, scans or investigations: Missed miscarriage diagnosed. Patient was not enrolled in clinical trial. The outcome of event was unknown. 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 possible. No further information is expected.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1634383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Muscle twitching, Myalgia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: 37.5, Celsius; Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: 39, Celsius
CDC Split Type: HRJNJFOC20210844271

Write-up: LOSS OF CONSCIOUSNESS; MUSCLE TWITCHES; VERTIGO; FEVER; HEADACHE; MUSCLE PAIN; This spontaneous report received from a consumer via a Regulatory Authority (HR-HALMED-300050333) concerned a female of unspecified age of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported expiry: unknown) 0.5 ml, 1 total, administered on 03-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-AUG-2021, the patient experienced loss of consciousness, muscle twitches, vertigo, fever, headache, muscle pain. Laboratory data included: Body temperature (NR: 36 - 37) 39 Celsius and 37.5 Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, loss of consciousness, headache, muscle twitches, vertigo and muscle pain was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210844271- COVID-19 VACCINE AD26.COV2.S -loss of consciousness, muscle twitches, vertigo. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210844271- COVID-19 VACCINE AD26.COV2.S ?fever, headache, muscle pain . This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1637588 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: creatine kinase; Result Unstructured Data: Test Result:Increased; Test Name: troponin T; Result Unstructured Data: Test Result:Increased
CDC Split Type: DEPFIZER INC202101045440

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100162750. A 17-year-old male patient received the second dose of BNT162B2 (COMIRNATY) at 17-year-old, intramuscularly on 30Jul2021 (Batch/Lot Number: 1D020A) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 at 17-year-old on 02Jul2021 (Batch/Lot Number: FE6475) at single dose for COVID-19 immunisation and no adverse event reported. The patient experienced myocarditis on 03Aug2021. Increased troponin T and creatine kinase. Virological evaluation was carried out. This report was serious - hospitalization. Outcome of event was not resolved. Relatedness of drug to reaction(s)/event(s): Myocarditis, Source of assessment: regulatory authority, Result of Assessment: Indeterminate. No follow-up attempts possible. No further information expected.


VAERS ID: 1638702 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Body temperature increased, Cardiac monitoring, Chest X-ray, Chills, Echocardiogram, Electrocardiogram, Myalgia, Myocarditis
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: Test Result:1542; Test Date: 20210805; Test Name: body temperature increased; Result Unstructured Data: Test Result:Fever: 37.5 to 38 degrees Celcius Centigrade; Test Name: cardiac monitoring; Result Unstructured Data: Test Result:no results reported; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no results reported; Test Name: echocardiografie; Result Unstructured Data: Test Result:mildly impaired left and right ventricular functio; Test Name: ECG; Result Unstructured Data: Test Result:no resluts raported
CDC Split Type: NLPFIZER INC202101045699

Write-up: perimyocarditis: stabbing pain in the chest that persisted and became more and more severe, in hospital it was turned out to be perimyocarditis; Fever: 37.5 to 38 degrees Celcius; Cold chills; Myalgia; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB NL-LRB-00658858. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Aug2021 (Lot Number: FF2752) at the age of 17-year-old, as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on an unknown date for covid-19 immunisation and had no adverse event. The patient experienced perimyocarditis: stabbing pain in the chest that persisted and became more and more severe, in hospital it was turned out to be perimyocarditis (serious as hospitalization) on 05Aug2021 with outcome of unknown, myalgia (non-serious) on 03Aug2021 with outcome of recovering, fever: 37.5 to 38 degrees celcius (non-serious) on 05Aug2021 with outcome of recovering, cold chills (non-serious) on 05Aug2021 with outcome of recovered on 06Aug2021. The patient was treated with paracetamol, and a high dose of ascal and colchicine. The patient was recovering from myalgia 3 days after onset, was recovering from body temperature increased 1 day after onset, recovered from chills after a duration of 1 day, and the outcome of perimyocarditis was unknown. At first, the patient experienced chills, myalgia and increased body temperature. Then, he started experiencing stinging chest pain that was continuous and worsened. In the hospital it turned out to be perimyocarditis. His creatine kinase level was 1542 and echocardiography showed mildly decreased left and right ventricular function. He was subjected to cardiac monitoring and treated with a high dose of ascal and colchicine. The next day he did not experience pain anymore. Relevant tests included: blood test (creatine kinase: 1542), echography (mildly decreased left and right ventricular function), cardiac monitoring (no results reported), ECG (no results reported), thorax X ray (no results reported). Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes, perimyocarditis Hospitalization information: severity of illness, rhythm monitoring Additional information adverse drug reaction: after having been sick for a day with chills, muscle aches and feverish feeling, stabbing chest pain developed which persisted and became more severe; at the hospital it turned out that there was perimyocarditis Creatine kinase 1542 and echocardiogram showed slightly impaired left and right ventricular function. followed by hospitalization on cardiac ward, high dose of ascal colchicine; pain free the day after COVID19. Previous COVID-19 infection: No. Other, diagnostic procedures: electrocardiogram, echocardiogram (2x), laboratory tests, chest x-ray. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: perimyocarditis Hospitalization:severity of illness,rhythm monitoring.after having been sick for a day with chills,muscle aches and feverish feeling,stabbing chest pain developed which persisted and became more severe;it turned out that there was perimyocarditis Creatine kinase 1542 and echocardiogram showed slightly impaired left and right ventricular function.followed by hospitalization on cardiac ward,high dose of ascal colchicine;pain free the day after COVID19.


VAERS ID: 1638716 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:low
CDC Split Type: NLPFIZER INC202101003668

Write-up: Fainted multiple times; low blood pressure; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 13Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) 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 03Aug2021 17:15, the patient experienced fainted multiple times and low blood pressure. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1642547 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lennox-Gastaut syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101048708

Write-up: Swelling face; Difficulty in breathing; This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority. A 14-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection), intramuscular, administered in arm left on 03Aug2021 at 01:00 (Lot Number: FD1945; Expiration Date: 31Oct2021) (at the age of 14-year-old) as single dose for COVID-19 immunisation. Medical history included Lennox-Gastaut syndrome from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antiepileptic drug (not specified) within 2 weeks of vaccination. On 03Aug2021 at 01:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY). On 03Aug2021 at 14:00 (13 hours after the vaccination), the patient experienced swelling face and difficulty in breathing. The outcome of the events was recovered with treatment of anti-allergic drug. The reporter stated the events resulted in emergency room/department or urgent care. The reporter did not provide seriousness assessment or causality. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: based on the available information the causality between the suspect vaccine comirnaty and the events sweeling of face and dyspnea cannot be ruled out completely . 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: 1663579 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 202108; Test Name: Echocardiography; Result Unstructured Data: Test Result:Normal; Comments: with normal EF; Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: Test Result:No arrhythmias or pericardial accumulation; Comments: No arrhythmias or pericardial accumulation; Test Date: 202108; Test Name: Troponin T; Result Unstructured Data: Test Result:Subsequently decreasing to 915; Comments: Subsequently decreasing to 915; Test Date: 202108; Test Name: Troponin T; Result Unstructured Data: Test Result:gradually increasing to 1512; Comments: gradually increasing to 1512
CDC Split Type: DKPFIZER INC202101067013

Write-up: Stinging chest pain, aggravation by forward bending. Resolved within two days; Myocarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0083369. A 15-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC5029; Expiration Date: 31Oct2021), via an unspecified route of administration on 03Aug2021 (at the age of 15 years), as a dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC1433; Expiration Date: 31Oct2021), via an unspecified route of administration on 06Jul2021, as a single dose for covid-19 immunisation. On 03Aug2021, the same day as the second vaccination was given, the patient developed Myocarditis. On 05Aug2021, 2 days after the second vaccination was given, the patient developed stinging chest pain, aggravation by forward bending, resolved within two days. The patient was hospitalized from 05Aug2021 to an unknown date in 2021.The patient underwent lab tests and procedures on Aug2021 which included echocardiogram: normal, (with normal ef), and no arrhythmias or pericardial accumulation troponin t: subsequently decreasing to 915, and gradually increasing to 1512 on Aug2021. The outcome of the events was recovered on Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664540 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Head injury, Loss of consciousness, Ophthalmological examination, Vital signs measurement
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Vital signs measurement; Result Unstructured Data: Test Result: Normal; Test Date: 20210803; Test Name: eye exam; Result Unstructured Data: Test Result: pupils were equal and reacting to light
CDC Split Type: IEPFIZER INC202101079030

Write-up: slipped off the chair onto the ground, awoke immediately on the ground; DIZZY; small bump was observed on her left temple under her hair line; This is a spontaneous report from a contactable healthcare professional downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority report number is IE-HPRA-2021-081563. A 17-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 (lot number: FC5029), at the age of 17 years old, as dose 1, single for COVID-19 immunisation. The patient medical history included fainting aside from that did not have any medical history nor concurrent conditions. Concomitant medications were reported as not taking any medications. On 03Aug2021, 10 minutes after vaccination, the patient felt dizzy and was observed slipping off the chair onto the ground. It was reported that she awoke immediately on the ground. The patient was supported onto a trolley, fully alert and orientated. A small bump was observed on her left temple under her hair line. An ice pack was applied. It was reported that the patient''s vital signs were normal and that her pupils were equal and reacting to light. According to the patient''s father, the patient had not eaten any breakfast and has fainted in the past. The patient was kept for 45 minutes. Her Father was told to observe for any signs of headache, drowsiness and vomiting over the next 24 hours and if there was a change in the patient''s neurological status to bring her to Accident and Emergency (A/E). It was outlined in the report that the patient departed fully alert and orientated. The patient did not have a headache and the bump on her left temple had subsided with the ice application. The event, "slipped off the chair onto the ground, awoke immediately on the ground" was considered medically significant and the remaining events was non serious. The patient recovered from the events the same day of 03Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1669101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 11935933 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Menstruation delayed, Myalgia, Nausea, Pregnancy test, Uterine spasm
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (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: Test Name: Pregnancy test; Test Result: Negative ; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101055308

Write-up: then miscarriage: Pregnancy test negative first, then positive. 2 days ago miscarriage.; Nausea; heavy legs/muscle pain; terrible cramps in the uterus; Fatigue; No period: 25 days late; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00658150. A 40-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Jul2021 (Lot Number: 11935933) as Dose 2, single for covid-19 immunisation. Medical history was unknown. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 21Jun2021 for COVID-19 immunization and experienced short menstruation and Maternal Exposure During Pregnancy, first trimester. The patient experienced then miscarriage: pregnancy test negative first, then positive. 2 days ago miscarriage on 04Aug2021, nausea on 04Aug2021, heavy legs/muscle pain on 04Aug2021, no period: 25 days late (menstruation delayed) on 03Aug2021, terrible cramps in the uterus on 04Aug2021, fatigue on 04Aug2021. Clinical course reported as: This patient had a delayed menstruation, after which the pregnancy test was positive. The second covid vaccination took place at a pregnancy duration of about 6 weeks, and a miscarriage occurred at a pregnancy duration of about 7+2 weeks. Outcome of Miscarriage was unknown, other events was recovering Event Miscarriage was reported as serious medically significant. Sender Comment: Since the nature of (some of) the reported reactions does imply seriousness according to one of the HA critera, the report was considered as serious by the regulatory authority. Reporter''s Comments - BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A shortened menstrual period Date: 21Jun2021 - Absence of menstruation and subsequent miscarriage Additional information ADR: 25 days late. Pregnancy test negative first, then positive. 2 days ago miscarriage. Tired, nauseous, heavy legs / muscle pain, terrible cramps in the uterus- confounding factors. COVID-19 vaccine exposure during pregnancy week: 1.5 months. - COVID-19. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: - BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A shortened menstrual period Date: 21Jun2021 - Absence of menstruation and subsequent miscarriage Additional information ADR: 25 days late. Pregnancy test negative first, then positive. 2 days ago miscarriage. Tired, nauseous, heavy legs / muscle pain, terrible cramps in the uterus- confounding factors. COVID-19 vaccine exposure during pregnancy week: 1.5 months. - COVID-19. Previous COVID-19 infection: No


VAERS ID: 1669263 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure diastolic, Blood pressure systolic, Diabetes mellitus management, Generalised tonic-clonic seizure, Heart rate, Heart rate increased, Hypotension, Oxygen saturation, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:60 mmHg; Test Date: 20210803; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210803; Test Name: Glycemia control; Test Result: 93 mg/dl; Test Date: 20210803; Test Name: Heart rate; Result Unstructured Data: Test Result:110; Comments: Units:/min; Test Date: 20210803; Test Name: Oxygen saturation; Test Result: 98 %
CDC Split Type: ROPFIZER INC202101087239

Write-up: Fainting; Arterial hypotension; Heart rate increased; Tonic-clonic crisis; Pallor; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number RO-NMA-2021-SPCOV12179. A 15-years-old male patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: FA8142), via an unspecified route of administration on 03Aug2021 (at the age of 15-year-old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 03Aug2021, the patient experienced fainting, arterial hypotension, heart rate increased, tonic-clonic crisis, pallor. The patient underwent lab tests and procedures which included blood pressure diastolic: 60 mmhg on 03Aug2021, blood pressure systolic: 100 mmhg on 03Aug2021, diabetes mellitus management: 93 mg/dl on 03Aug2021, heart rate: 110 on 03Aug2021 Units:/min, oxygen saturation: 98 % on 03Aug2021. The outcome of the events was reported as unknown. Sender Comment: This case was reported by a physician in the regulatory authority and received by regulatory authority. The case was considered serious (Other medically important) by the Sender (regulatory authority) based on regulatory authority List. No follow-up attempts are possible. No further information is expected.


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