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

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

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 445 out of 8,941

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VAERS ID: 1783758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF82222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Immunisation, Off label use, Product use issue
SMQs:, Hearing impairment (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101300838

Write-up: Deafness; Off label use; Booster; product use for unapproved combination; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109301144180580-8LNQZ, Safety Report Unique Identifier is GB-MHRA-ADR 26015471. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF82222), via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single (reported as dose 3a) for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken on 28Sep2021 for immunization. The patient experienced deafness on 28Sep2021, reported as serious per other medically important condition. Additionally, on 28Sep2021, the patient experienced off label use and booster as patient received the third dose of BNT162B2, and experienced product use for unapproved combination as influenza vaccine was given the same day as the BNT162B2. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event deafness was not recovered, while outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1783760 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Myalgia, Nausea, Off label use, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101300845

Write-up: Off label use; Booster; Swollen arm; Nausea; Fatigue; Muscle ache; High temperature; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109301146499320-SKK15, Safety Report Unique Identifier is GB-MHRA-ADR 26015469. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Sep2021 (Lot Number: FF2153 and expiry date not reported) as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced swollen arm on 28Sep2021 with outcome of not recovered, nausea on 28Sep2021 with outcome of not recovered, fatigue on 28Sep2021 with outcome of not recovered, muscle ache on 28Sep2021 with outcome of not recovered, high temperature on 28Sep2021 with outcome of recovered; off label use on an unspecified date and booster on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Sep2021 No - Negative COVID-19 test. The events swollen arm, nausea, fatigue, muscle ache, and high temperature were reported as serious, medically significant by the health authority, while the other events were assessed as non-serious. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1783762 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F 15782 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Joint injury, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), 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? 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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101300876

Write-up: vomiting; joint pain; fainting; muscle pain; fatigue; nausea; fever; Light headedness; Injury to knee as result of falling in faint; Fever chills; This is a spontaneous report from a contactable consumer, received from The regulatory authority report number is GB-MHRA-WEBCOVID-202109301222347090-THR9G, Safety Report Unique Identifier GB-MHRA-ADR 26015672. An 82-year-old female patient received BNT162B2, via an unspecified route of administration on 27Sep2001 (Batch/Lot Number: F 15782) as dose 3 (booster), single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vomiting, joint pain, fainting, muscle pain, fatigue, nausea, fever, light headedness and injury to knee as result of falling in faint on an unspecified date. The patient experienced fever chills on 28Sep2021. The seriousness criteria of the events was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the event fever chills was recovered on 30Sep2021, and outcome of the rest of the events was unknown. Additional information: Patient has not had symptoms associated with COVID-19. The clinical course was reported as follows: Subsequent reactions, fatigue, fever, joint pain, muscle pain, light- headedness, fainting, nausea and vomiting. Injury to knee as result of falling in faint. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1783763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Nausea, Pain in extremity, Paraesthesia, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms 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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101300898

Write-up: Numbness; Tingling; Leg pain; Headache; Fever; Rash was around the area of the injection; Nausea; This is a spontaneous report from a contactable other hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109301230484770-RMR7P, Safety Report Unique Identifier is GB-MHRA-ADR 26015665. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 28Sep2021 at dose 1, single for COVID-19 immunisation. Medical history included covid-19 from 05Jan2021 to 17Jan2021. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced numbness on 29Sep2021 with outcome of not recovered, tingling on 29Sep2021 with outcome of not recovered, leg pain on 29Sep2021 with outcome of not recovered, headache on 29Sep2021 with outcome of not recovered, fever on 29Sep2021 with outcome of not recovered , rash on 29Sep2021 with outcome of not recovered, nausea on 28Sep2021 with outcome of not recovered. Clinical course was the following the patient had numbness, tingling and pain below the knee in her left leg and foot and numbness and tingling in her left hand. Rash was around the area of the injection. Headache was a feeling of her head being squeezed. Patient has 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: 1783766 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101300766

Write-up: Headache NOS; Tiredness; Painful arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109301307038730-J7YVQ, Safety Report Unique Identifier is GB-MHRA-ADR 26015849. A 12-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on 28Sep2021 (at the age of 12-years-old), as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. It was stated that, on the same day, i.e., on 28Sep2021, the patient experienced painful arm. On 29Sep2021, she experienced headache nos and tiredness. All the events were reported as serious with seriousness criteria as other medically important condition. It was reported that the adverse reaction did not occur as a result of an exposure during pregnancy. On an unspecified date, the patient underwent COVID-19 virus test which resulted negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for the event headache nos was reported as recovered on 30Sep2021; outcome reported as recovering for tiredness and not recovered for painful arm, at the time of report. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1783854 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-09-28
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Fatigue, Headache, Night sweats, Pain in extremity, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; cough; tiredness; sweats; chills; wheezy; arm pain; Wheezing; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26032592) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (cough), FATIGUE (tiredness), NIGHT SWEATS (sweats), CHILLS (chills), WHEEZING (wheezy), PAIN IN EXTREMITY (arm pain) and WHEEZING (Wheezing) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant), FATIGUE (tiredness) (seriousness criterion medically significant), NIGHT SWEATS (sweats) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), WHEEZING (wheezy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (arm pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), COUGH (cough), FATIGUE (tiredness), NIGHT SWEATS (sweats), CHILLS (chills), WHEEZING (wheezy), PAIN IN EXTREMITY (arm pain) and WHEEZING (Wheezing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Most symptoms subsided by day 5 but it''s now one week later (monday to Monday) patient had tightness of chest. after second dose of vaccine. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Taking regular doses of cough medicine and have a tight upper chest No concomitant medication information was provided No treatment product information was provided This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected events of Headache, Cough, Fatigue, Night sweat, Chills, Wheezing, Pain in extremity, Wheezing. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.; Sender''s Comments: This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected events of Headache, Cough, Fatigue, Night sweat, Chills, Wheezing, Pain in extremity, Wheezing. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.


VAERS ID: 1784242 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Food allergy; Shellfish allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101282029

Write-up: Urticaria; cough; wheezing; This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority. A non-pregnant 14-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 28Sep2021 16:00 (Batch/Lot Number: FH0151; Expiration Date: 31Dec2021) as single dose (at the age of 14) for covid-19 immunisation. 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. Medical history included food allergy, asthma, allergies to crustacean. The patient''s concomitant medications were not reported. On 28Sep2021 at 16:15 (15 minutes after vaccination), the patient experienced urticaria, cough, wheezing. The outcome of the events was recovered with treatment including antihistamine, PREDONINE inhalation. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events wheezing, cough and urticaria and the suspect drug 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: 1784277 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Body temperature, C-reactive protein, C-reactive protein increased, Gamma-glutamyltransferase, Liver disorder, Liver function test increased, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: AST; Result Unstructured Data: Test Result:250; Test Date: 20210929; Test Name: pyrexia; Result Unstructured Data: Test Result:changing from 38-39 Centigrade; Test Name: CRP; Result Unstructured Data: Test Result:13; Test Name: gamma-gtp; Result Unstructured Data: Test Result:70
CDC Split Type: JPPFIZER INC202101288728

Write-up: Liver function test increased/gamma GTP 70; AST 250; Liver disorder; CRP 13; Pyrexia; This is a spontaneous report from a contactable physician via a sales representative. A 13-year-old male patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 25Sep2021 (at the age of 13 years old, Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced liver function test increased, liver disorder on an unspecified date, pyrexia on 28Sep2021. Clinical course: On 25Sep2021, the patient received Comirnaty. On 29Sep2021, now the pyrexia was changing from 38-39 degrees centigrade. The following laboratory values increased: gamma GTP 70; AST 250; CRP 13. The reporter was asking the causal relationship between Comirnaty and Liver function test increased. The reporter would like to know the causal relationship of liver disorder with Comirnaty. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1784292 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatitis atopic (patient''s mother)
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101289375

Write-up: anaphylaxis (Brighton Classification level 3); dyspnoea on throat; itching limbs.; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128078. The patient was a 15-year and 9-month-old female. Body temperature before vaccination was 36.3 degrees centigrade. The patient had a family history of Dermatitis atopic (patient''s mother). 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): In outpatient after symptom onset, the patient said she had felt dyspnoea on throat after taking over-the-counter analgesics before. On 28Sep2021 at 09:48 (the day of vaccination), at the age of 15-year-old, the patient received the second dose of bnt162b2 (COMIRNATY solution of injection, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 28Sep2021 at 09:58 (the day of the vaccination), the patient experienced anaphylaxis (Brighton Classification level 3). The course of the event was as follows: About 10 minutes after the vaccination, the patient experienced dyspnoea on throat, itching limbs. Confucianism, vital was not abnormal. The patient laid in bed quietly and was given iv drip. d- Chlorpheniramine Maleate. The symptoms were recovering. On 28Sep2021 (the day of the vaccination), the outcome of the events was recovered. The reporter 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.


VAERS ID: 1784296 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic nasopharyngitis; Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101289515

Write-up: chest heaviness; Dyspnoea; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128105. A 43-year-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: FH0151; Expiration Date: 31Dec2021), via an unspecified route of administration on 28Sep2021 at 15:30 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. Medical history included chronic nasopharyngitis and rhinitis allergic. Body temperature before vaccination was 36.3 degrees Centigrade. The patient''s concomitant medications were not reported. The patient previously took pusofeki. The patient previously received the first dose of Comirnaty on 07Sep2021 for covid-19 immunisation. On 28Sep2021 15:30 the patient experienced chest heaviness and dyspnoea. The clinical course was as follows: the adverse event onset date was reported as on 28Sep2021 at 15:30(the day of vaccination). The patient received the COMIRNATY vaccine. 30 minutes after vaccination, the patient complained of chest heaviness. Dyspnoea was noted. BOSMIN 0.3 mg was intramuscularly injected. After the blood vessel was secured with SOLITA T3 300l, SOLU-CORTEF 100mg was injected. However, the symptoms did not improve. The patient was taken to Privacy Hospital by ambulance. On unspecific date, the outcome of the event was not provided. The reporting physician classified the event as serious (Medically significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1784320 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Depressed level of consciousness, Dyskinesia, Gaze palsy, Heart rate, Joint ankylosis, Oxygen saturation, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:120/63 mmHg; Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210928; Test Name: PR; Result Unstructured Data: Test Result:75; Test Date: 20210928; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101292126

Write-up: Consciousness decreased; eyeballs raise upward; Vasovagal reflex; flexion of limbs and ankylosis; flexion of limbs and ankylosis; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21128055. The patient was a 23-year-and-9-month-old male (age at the vaccination). Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28Sep2021 at 10:18 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot number FH0151, Expiration date 31Dec2021)via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Sep2021 at 10:33 (15 minutes after the vaccination), the patient experienced Vasovagal reflex. On 28Sep2021(the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: about 15 minutes after the vaccination, Consciousness decreased, eyeballs raised upward, flexion of limbs and ankylosis occurred. One minute later, the patient regained consciousness and was able to speak. BP 120/63; PR 75; SpO2 98%. The patient''s respiratory status was fine, with no rash or gastrointestinal symptoms. It was thought as Vasovagal reflex and was observed at bed rest. The patient recovered well and went home about an hour after the vaccination. The reporting physician classified the event as non serious and assessed that the causality between the event and bnt162b2 as un-assessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1784331 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Dysphoria, Feeling abnormal, Gaze palsy, Heart rate, Oxygen saturation, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:99/55; Comments: after vaccination; Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210928; Test Name: HR; Result Unstructured Data: Test Result:80; Comments: after vaccination; Test Date: 20210928; Test Name: SPO2; Result Unstructured Data: Test Result:98
CDC Split Type: JPPFIZER INC202101295449

Write-up: mild Eyeball elevation convulsions; Vasovagal reflex; Feels poorly; Pallor facial; Dysphoria; Dizziness; BP 99/55; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128122. An 18-year and 6-month-old male patient received the 1st dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number FF3622, Expiration date 30Nov2021) via an unspecified route of administration on 28Sep2021 at 14:35 at age of 18 years old as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade on 28Sep2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28Sep2021 at 14:15 (as reported, 10 minutes after the vaccination), the patient experienced Vasovagal reflex. On 28Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: About 15 minutes after vaccination, Feels poorly appeared gradually, the patient indicated Pallor facial, Dysphoria, Dizziness. For vital signs, BP 99/55, HR 80, SPO2 98. Then mild Eyeball elevation convulsions appeared. Went to stretcher, no Enanthema. No Dyspnoea. Added 30 minutes of observation, symptoms were recovering, the patient went back home. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Outcome of the events was recovered on 28Sep2021.


VAERS ID: 1785892 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31045 BF / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Lymph node pain, Lymphadenitis, Lymphadenopathy, Off label use
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101301917

Write-up: Ganglion enlargement in the lower part (armpit) of the left arm and in the neck on the side; Ganglion enlargement/causing a ball of fluid of inflammation, causing intense pain; Ganglion enlargement/causing a ball of fluid of inflammation, causing intense pain; 1st dose: Astrazeneca; Dose 2: Comirnaty; 1st dose: Astrazeneca; Dose 2: Comirnaty; This is a spontaneous report from a contactable consumer (patient) received through the COVAES portal. A 38-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: 31045 BF; Expiration date was not reported) on the left arm on 28Sep2021 (13:00) as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient had previously received the first dose of COVID-19 vaccine astrazeneca ("Fiocruz - AztraZeneca", Lot number: 215VcD168; Expiration date was not reported) on the left arm on 07Jul2021 (01:00) for COVID-19 immunization. On 28Sep2021 (13:00), the patient had received BNT162B2 as the second dose of vaccination, when the first dose was with COVID-19 vaccine astrazeneca ("Fiocruz - AztraZeneca"). On 29Sep2021 (06:00), the patient had ganglion enlargement in the lower part (armpit) of the left arm and in the neck on the side, causing a ball of fluid of inflammation, and causing intense pain. The events were assessed as serious (medically significant), and had resulted into a physician''s office visit and emergency room visit. Treatment was provided for the reported events, but the patient did not remember the medication taken. The outcome of the events was not recovered. The patient had no COVID-19 prior to vaccination, and had not been tested post-vaccination.


VAERS ID: 1786378 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Influenza, Myalgia, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101294580

Write-up: off label use; Headache; Nausea; Fever; Muscle ache; Flu symptoms; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109291808276810-URMOQ. Safety Report Unique Identifier GB-MHRA-ADR 26010862. A 27-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number FF8288) via an unspecified route of administration on 28Sep2021 (at the age of 27 years old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number was not reported) via an unspecified route of administration on 12Jan2021 as dose 1, single and 23Mar2021 as dose 2, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 28Sep2021, the patient had fever, muscle ache, flu symptoms. On 28Sep2021, the patient received booster dose which led to Off label use. On 29Sep2021, the patient experienced headache, nausea. The patient underwent lab tests and procedures which included COVID-19 virus test resulted as negative on an unspecified date (No - Negative COVID-19 test). The clinical outcome of the event headache, nausea, flu symptoms was not resolved, the events fever, muscle ache was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1786385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Immunisation, Off label use, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101300929

Write-up: Headache; Sore throat; Aching joints; Runny nose; Coldness; Tiredness; Received dose 3 (booster); Received dose 3 (booster); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109300852563770-YE7II, Safety Report Unique Identifier GB-MHRA-ADR 26014849. This is the first of two reports. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 (booster) via an unspecified route of administration on 28Sep2021 (Batch/Lot Number: FF8222) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on 09Jan2021 and the second one on 04Mar2021. The patient experienced headache (medically significant) on 30Sep2021 with outcome of not recovered , runny nose (medically significant) on 29Sep2021 with outcome of not recovered , coldness (medically significant) on 28Sep2021 with outcome of not recovered , tiredness (medically significant) on 28Sep2021 with outcome of not recovered , sore throat (medically significant) on 30Sep2021 with outcome of not recovered , aching joints (medically significant) on 30Sep2021 with outcome of not recovered , received the third dose (booster) considered an off label use (non-serious) on 28Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Sep2021. Caused me to take a day off work at least. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101367154 same patient, different dose/event


VAERS ID: 1786392 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Enlarged uvula, Feeling cold, Feeling hot, Hypersensitivity, Oropharyngeal pain, Pain, Pharyngeal swelling, Pyrexia, Rhinorrhoea, Vaccination site discomfort
SMQs:, Anaphylactic reaction (broad), Angioedema (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)

Life 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 INC202101300878

Write-up: Allergic reaction; Hot temperature; Fever; Cold like symptoms; Uvula swells; Aches; Extreme cold; Pain in throat; Throat swelling; Injection site was much more uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109301354551970-CSB9L, Safety Report Unique Identifier GB-MHRA-ADR 26016209. A 56-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF8222), via an unspecified route of administration on 27Sep2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included COVID-19 VACCINE ASTRAZENECA taken for covid-19 immunization on 26Feb2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. On 28Sep2021, the patient had throat swelling. On an unspecified date, the patient experienced hot temperature, allergic reaction, fever, cold like symptoms, uvula swells, aches, extreme cold, pain in throat, and injection site was much more uncomfortable. The reporter considered the events as serious (medically significant). Patient was received treatment for events. He experiences a severe allergic reaction to cats, where his throat, uvula swells, and swelling becomes difficult. He also experiences fever like aches, and extreme cold and hot temperature surges. He has experienced this reaction post-booster, but to a more serious form he had ever experienced. He came close to calling for medical support last night such was the extent of the pain and swelling in his throat. He had managed the symptoms using over the counter pain-relief and NSAID. The symptoms have alleviated slightly but not resolved. He has not been near or in contact with cats prior to or since his booster. His initial COVID vaccines were both AstraZeneca and he had very mild cold like symptoms after the first and no symptoms at all after the second. He had no reaction such as this whatsoever. Additionally, the pain at the injection site was non-existent or very mild indeed after his initial two doses whereas the injection site was much more uncomfortable for 48 hours after the booster. He could not think of any other trigger/exposure that would explain this reaction, save for the booster jab. If his symptoms do not resolve themselves or worsen in the coming 24 hours, he would seek advice from a healthcare professional. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of event throat swelling was recovering, injection site was much more uncomfortable was recovered on an unspecified date in 2021 and other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1786405 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain lower, Diarrhoea, Gastroenteritis, Immunisation, Off label use, Pyrexia, Rectal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEMOSTON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopausal
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101311397

Write-up: Griping; lower abdo pain; Pyrexia; Bleeding PR; Gastroenteritis; Vomiting; Diarrhea; Off label use; Booster; This is a spontaneous report from a contactable other health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110011310362860-XQWIT, Safety Report Unique Identifier GB-MHRA-ADR 26026276. A 55-years-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF8222), via an unspecified route of administration on 28Sep2021 (at the age of 55-years-old) (off label use) as dose 3 (booster), single for covid-19 immunization. Medical history included menopausal from an unknown date and unknown if ongoing. Concomitant medications included dydrogesterone, estradiol (FEMOSTON) taken for menopausal, start and stop date were not reported and influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 28Sep2021 to 28Sep2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 12Jan2021 as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 30Mar2021 as dose 2, single for covid-19 immunization. On an unspecified date, the patient experienced bleeding PR, pyrexia, griping and lower abdo pain. On 28Sep2021 had diarrhea, vomiting and gastroenteritis. The reporter considered the events as non-serious. Vomiting and Diarrhoea commenced just over 3 hours post booster 28Sep2021 vaccine and had flu vaccine at same time. Griping and continuous lower abdo pain resolving to intermittent, pyrexia type symptoms, bleeding PR post initial diarrhoea. No side effects dose 1 or 2. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report does not relate to possible blood clots or low platelet counts. The outcome of events diarrhea, vomiting, pyrexia, griping and lower abdo pain was recovering, gastroenteritis was resolved on 29Sep2021, and bleeding PR was unknown. No follow up attempts are needed. No further information is expected.


VAERS ID: 1786436 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Fatigue, Immunisation, Nausea, Off label use, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101311118

Write-up: upper abdominal pain; Vomiting; Abdominal pain; Joint pain; Fever; Fatigue; Nausea; off-label use; booster; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110021004041200-IYWQE.Safety Report Unique Identifier is GB-MHRA-ADR 26027423. A 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 28Sep2021 (at the age of 81-years-old), as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On an unspecified date, the patient experienced upper abdominal pain. On 30Sep2021, had vomiting, abdominal pain, joint pain, fever, fatigue, nausea. It was reported that ambulance called due to severe upper abdominal pain and continuous vomiting. Nausea and fatigue with joint pain currently ongoing, 2 relatives of his that had the same booster vaccine have had similar issues following this jab, metocloperamide to control ongoing vomiting. The clinical outcome of the event upper abdominal pain, joint pain, fatigue, nausea was not resolved, the event vomiting, abdominal pain was resolving and the event fever was resolved on an unspecified date in 2021, outcome of Off label use and booster is unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1786454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Dyspnoea at rest, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (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 INC202101311286

Write-up: shortness of breath; rest; fatigue; Chest pain; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202110021724041890-QE80T], Safety Report Unique Identifier [GB-MHRA-ADR 26027675]. A 40-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 27Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 28Sep2021, the patient experienced chest pain. On an unspecified date, the patient experienced shortness of breath, rest and fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No- Negative COVID-19 test. Chest pain on exertion and in rest. Shortness of breath on exertion. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. When asked if patient''s report relate to possible blood clots or low platelet counts, he replied no. The outcome of the event chest pain was not recovered, and that of other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1786458 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Dizziness, Headache, Lethargy, Pain, Pyrexia, Swelling, Vaccination site inflammation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular 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 Name: Body temperature; Result Unstructured Data: Test Result:slight temperature
CDC Split Type: GBPFIZER INC202101311070

Write-up: feverish; shivering; Fever; Lethargy; Headache; Dizziness; Swelling; localised inflammation; Ache; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110021830460140-ZXEXR. Safety Report Unique Identifier GB-MHRA-ADR 26027743. A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 28Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. The patient previously received first dose of BNT162B2 as dose 1, single for COVID-19 immunization. The patient experienced localised inflammation and ache on 28Sep2021, feverish and shivering on an unspecified date, fever, lethargy, headache, dizziness and swelling on 01Oct2021. The patient underwent lab tests and procedures which included body temperature: slight temperature on an unspecified date. Additional Information: Vaccine occurred on the Tuesday, 2hrs post vaccine localised inflammation and aches begun. Thursday - Lethargy begins. Friday morning she awoke to a slight temperature and feverish feeling. Saturday - High fever, shivering, headache and dizziness kicks in. Majority of the swelling and aching had gone. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of fever(LLT: Fever), lethargy, headache, dizziness and swelling was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1786462 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Dyspnoea, Fatigue, Headache, Immunisation, Lymphadenopathy, Off label use, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: ATORVASTATIN; CITALOPRAM; FELODIPINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Blood pressure high; Cholesterol; Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20200505; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101311107

Write-up: Shooting pain; Breathlessness; Swollen glands; Fatigue; Fever chills; General body pain; Stomach cramps; Dizziness; Weakness; Headache; off label use; Booster; chills; fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110022038306490-BXYBP, Safety Report Unique Identifier GB-MHRA-ADR 26028210. A 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 28Sep2021 (At the age of 53-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included suspected covid-19 from 05May2020 and ongoing, clinical trial participant from an unknown date and unknown if ongoing, blood cholesterol from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Patient was not currently breastfeeding. Concomitant medications included ATORVASTATIN taken for blood cholesterol from 01Oct2018 to an unspecified stop date; CITALOPRAM taken for depression from 01Sep2020 to an unspecified stop date; FELODIPINE taken for hypertension from 01Apr2018 to an unspecified stop date. On 28Sep2021, patient experienced off label use, booster, headache, weakness. On 29Sep2021, patient experienced swollen glands, fatigue, fever chills, general body pain, stomach cramps, dizziness, breathlessness. On 30Sep2021, patient experienced shooting pain. On an unspecified date in 2021, patient experienced chills, fever. Case narrative: First had headaches and fatigue, then fever and chills, body pain then shooting pains down my legs as well as fever, chills, breathlessness, fatigue. Still weak and very tired. Took paracetamol regularly. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2020, Yes - Positive COVID-19 test. Therapeutic measures were taken because of chills, fever, fever chills, general body pain, stomach cramps, shooting pain included paracetamol. The case was reported as serious. The outcome of the event chills, fever, swollen glands, general body pain, weakness, breathlessness was recovering. Fatigue was not recovered. Fever chills, dizziness, shooting pain was recovered on 01Oct2021, headache, stomach cramps were recovered on an unspecified date in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1786499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Echocardiogram, Inflammation, Inflammatory marker test, Multisystem inflammatory syndrome in children, SARS-CoV-2 test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Baby premature (Ex premature infant, otherwise fit and well.); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:impaired cardiac function; Comments: Consistent with PIMS-TS; Test Date: 2021; Test Name: inflammatory markers; Result Unstructured Data: Test Result:Raised; Test Date: 20211002; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101310936

Write-up: SARS-CoV-2 infection; Inflammatory recation; suspected pims-ts reaction; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110031902367390-NMKL8, Safety Report Unique Identifier GB-MHRA-ADR 26031014. A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included suspected covid-19 from an unknown date and unknown if ongoing (unsure when symptoms started, unsure when symptoms stopped), Ex premature infant, otherwise fit and well. Concomitant medications were not reported. Patient was not enrolled in clinical trial. On 28Sep2021, patient experienced inflammatory reaction. On 02Oct2021, patient experienced sars-cov-2 infection. On an unspecified date in 2021, patient had suspected pims-ts reaction. As per additional information and clinical course, it was stated that, patient had a positive COVID 19 result 6 weeks earlier, subsequently had the first dose of Pfizer vaccine. Ten days later developed a PIMS TS reaction. The events covid-19, suspected pims-ts reaction, inflammatory reaction resulted in hospitalization (2021). The patient underwent lab tests and procedures on unspecified date in 2021, which included echocardiogram which showed impaired cardiac function and consistent with PIMS-TS and inflammatory marker test which were raised and also underwent COVID-19 virus test on 02Oct2021, which was positive (Yes - Positive COVID-19 test). This report did not relate to possible blood clots or low platelet counts. The outcome of the event inflammatory reaction was not recovered and the outcome of suspected pims-ts reaction and covid-19 was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1786529 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Pain in extremity, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle soreness; Fever; Fatigue; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 26037889) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness), FATIGUE (Fatigue), PAIN IN EXTREMITY (Painful arm) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 29-Sep-2021, the patient experienced MYALGIA (Muscle soreness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 30-Sep-2021, PYREXIA (Fever) had resolved. On 02-Oct-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, MYALGIA (Muscle soreness) was resolving and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. In October 2021, Muscle soreness (Myalgia) was resolving. No concomitant medications was reported. No treatment medication was reported. Company Comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Myalgia, Fatigue, Pain in extremity, Pyrexia . The events occurred approximately on the same day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Myalgia, Fatigue, Pain in extremity, Pyrexia . The events occurred approximately on the same day of the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1786606 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20211024732

Write-up: BRUISING; This spontaneous report received from a consumer via a Regulatory Authority (regulatory authority, IE-HPRA-2021-085172) on 12-OCT-2021 and concerned a 44 year old male. The patient''s weight was 100 kilograms, and height was not reported. The patient''s pre-existing medical conditions included: none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2149-91 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-AUG-2021 for covid-19 immunisation. The Drug Start were 5 weeks . No concomitant medications were reported. On 28-SEP-2021, the patient experienced bruising (excessive bruising). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1786748 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dysphoria, Heart rate, Heart rate decreased, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Depression (excl suicide and self injury) (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:80s; Comments: after vaccination; Test Date: 20210928; Test Name: HR; Result Unstructured Data: Test Result:50s; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101302580

Write-up: Dysphoria; BP 80s; HR 50s; Vasovagal reflex/ vagal reflex; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21128453. The patient was a 25-year and 11-month-old male. 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 28Sep2021 at 16:19 (the day of vaccination), the patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: FF4204, Expiration date: 31Oct2021) via an unspecified route of administration, at the age of 25 years and 11 months, as dose 1, single, for COVID-19 immunisation. On 28Sep2021 at 16:28 (9 minutes after the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: 10 minutes after vaccination, indicated dysphoria, transported to First aid room. Raised two legs and instructed to rest. BP 80s and HR 50s, suspected as vagal reflex. There were no other symptoms. Symptoms of allergy was negative. Symptoms were improved, then patient went back home. On 28Sep2021 (day of the vaccination), the outcome of the events was recovering. The reporting physician classified the events non-serious. The causality between the event and bnt162b2 was unassessable/not provided.


VAERS ID: 1786754 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Fall, Insomnia, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result: 36.7 Centigrade; Comments: before the vaccination.
CDC Split Type: JPPFIZER INC202101302683

Write-up: short of sleep recently; Depressed level of consciousness; Vasovagal reflex; slid off the chair; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21128474. The patient was a 37-year and 5-month-old male (age at first vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire. On 28Sep2021 at 14:17 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FJ5790, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Sep2021 at 14:20 (3 minutes after the vaccination), the patient experienced Vasovagal reflex. On 28Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: After the vaccination, in sitting position, the course was observed. The patient slid off the chair, Depressed level of consciousness was confirmed. It was considered as Vasovagal reflex. With the help of wheelchair, the patient lied in supine position on bed, level of consciousness was soon improved, 1 hour follow-up observed, no aggravation of symptoms appeared, so the patient walked back home on his own. As a subsequent report, the patient was short of sleep recently. Seriousness was not provided. The reporting physician assessed that the event was related to bnt162b2. There were no other possible causes of the event such as any other diseases. The reporting physician commented as follows: It was considered that Vasovagal reflex strongly appeared due to short of sleep. The outcome of short of sleep recently was unknown while outcome of other events was recovered on 28Sep2021.


VAERS ID: 1786763 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Clubbing, General physical condition, Investigation, Loss of consciousness, Lung disorder, Oxygen saturation, Oxygen saturation decreased, Presyncope
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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (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: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210928; Test Name: vitals; Result Unstructured Data: Test Result:WNL (within normal limits); Test Date: 20210928; Test Name: MMT (manual muscle test); Result Unstructured Data: Test Result:WNL (within normal limits); Test Date: 20210928; Test Name: Pupil; Result Unstructured Data: Test Result:WNL (within normal limits); Test Name: SpO2; Result Unstructured Data: Test Result:90~94 %; Test Date: 20210928; Test Name: SpO2; Result Unstructured Data: Test Result:89~94 %; Test Date: 20210928; Test Name: SpO2; Test Result: 98 %; Comments: kept off; Test Date: 20210928; Test Name: SpO2; Result Unstructured Data: Test Result:95~98 %
CDC Split Type: JPPFIZER INC202101303095

Write-up: Loss of consciousness; finger clubbing; potential lung disease; vasovagal reflex; SpO2 90-94%; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128456. A 49-year and 9-month-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Sep2021 16:19 (Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) (at the age of 49-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included had smoking history. It was reported that patient had no underlying disease and no allergies. The patient''s concomitant medications were not reported. On 28Sep2021 16:21 (2 minutes after the vaccination), the patient experienced loss of consciousness, finger clubbing, potential lung disease, vasovagal reflex, and SpO2 90-94%. The course of the event was as follows: Immediately loss of consciousness, SpO2 89%~94%, O2 1l started, 98% could be kept off, observation, improved to 95~98%. Had smoking history, Illegible=600. No subjective symptoms from the beginning, vitals, pupil, MMT (manual muscle test) was WNL (within normal limits). O2 attached, since finger clubbing, Suspected of the potential lung disease. The patient told that would take a rest tomorrow and have a respiratory consultation, then went home. Therapeutic measure was taken as a result of SpO2 90-94% includes O2 1l took about 10 minutes (as reported). The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2.; Sender''s Comments: Events represent intercurrent medical conditions and unrelated to bnt162b2 considering the history of smoking.


VAERS ID: 1786770 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Heart rate, Heart rate decreased, Loss of consciousness, Oxygen saturation, Presyncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:77/38 mmHg; Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210928; Test Name: HR; Result Unstructured Data: Test Result:53; Test Date: 20210928; Test Name: SaO2; Test Result: 100 %
CDC Split Type: JPPFIZER INC202101303227

Write-up: Loss of consciousness; Vasovagal reflex; Giddiness; Full black in front of eye; HR 53; BP 77/38; This is a spontaneous report from a contactable physician received from the regulatory authority Regulatory authority report number is v20108345. The patient was a 21-year and 6-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28Sep2021 at 11:28 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FJ5790, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Sep2021 at 11:35 (7 minutes after the vaccination), the patient experienced vasovagal reflex. On 28Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 28Sep2021 at 11:28, the patient received vaccination. At 11:35, the patient experienced giddiness, full black in front of eye, and loss of consciousness for several seconds. HR 53, BP 77/38, SaO2 100%, the symptoms was treated with intravenous injection and recovering, at 13:00, the patient returned home. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: recovering. The patient has recovered from the events on 28Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1786779 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular disorder, Loss of consciousness, Presyncope
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), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? 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: JPPFIZER INC202101303411

Write-up: Loss of consciousness; vasovagal reflex; cerebral blood flow decreased; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21128309. The patient was a 29-year-old (age at vaccination) male. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28Sep2021 at 18:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medication was not reported. On 28Sep2021 at 18:30 (30 minutes after the vaccination), the patent experienced vasovagal reflex, loss of consciousness, cerebral blood flow decreased. The outcome of the event was not provided. The course of the event was as follows: There was loss of consciousness during follow-up observation, and it was thought that cerebral blood flow decreased due to the vasovagal reflex. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1786790 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Flushing, Heart rate, Heart rate increased, Nausea, Oxygen saturation, Palpitations, Presyncope, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: Anaphylaxis; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: blood pressure; Result Unstructured Data: Test Result:130/57; Comments: at 10:20 (6 minutes after the vaccination),; Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20210928; Test Name: HR; Result Unstructured Data: Test Result:100; Comments: at 10:20 (6 minutes after the vaccination),; Test Date: 20210928; Test Name: HR; Result Unstructured Data: Test Result:110; Comments: 11:05(51minutes after the vaccination) unit: /min; Test Date: 20210928; Test Name: SaO2; Test Result: 100 %; Comments: at 10:20 (6 minutes after the vaccination),; Test Date: 20210928; Test Name: SaO2; Test Result: 100 %; Comments: 11:05(51minutes after the vaccination)
CDC Split Type: JPPFIZER INC202101303589

Write-up: breathing was slightly rapid; HR was 100/ HR was 110/min; Vasovagal reflex; Giddiness/Light-headed feeling; queasy; flushed face; Palpitations; This is a spontaneous report from a contactable physician received from the (RA). Regulatory authority report number is v21128343. The patient was a 35-year and 9-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had no family history. 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 urticaria, and anaphylaxis (Shrimp).On 28Sep2021 at 10:14, the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FJ5790, Expiration date 31Dec2021) via an unspecified route of administration at the age of 35-years-old and 9 months, as dose 1, single, for COVID-19 immunization.On 28Sep2021 at 10:20 (6 minutes after the vaccination), the patient experienced the vasovagal reflex. Clinical course of the events was reported as follows: On 28Sep2021 at 10:14, vaccination performed. On 28Sep2021 at 10:20 (6 minutes after the vaccination), Giddiness, Light-headed feeling, queasy, Flushed face and Palpitations appeared. BP was 130/57, HR was 100, SaO2 was 100% (r, a). On 28Sep2021 at 11:05 (51 minutes after the vaccination), HR was 110/min, breathing was slightly rapid, SaO2 was 100% (r, a). The intravenous drip was conducted. On 28Sep2021 at 11:45 (1 hour 31 minutes after the vaccination), the symptoms were improved, and the patient went home. Outcome of the events was recovering. The reporting physician classified the events non-serious and related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The symptoms improved.


VAERS ID: 1786938 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: Electrocardiogram; Result Unstructured Data: The negative T wave of V1 was noted in the electrocardiogram.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; Low-grade fever; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP104987) on 08-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This case, initially reported to the Regulatory Agency (RA) by a pharmacist, was received via the RA (Ref, v21129743). On an unknown date, the patient received the 1st dose of this vaccine. On 28-Sep-2021, the patient received the 2nd dose of this vaccine. Only on the same day, the patient had low-grade fever. On 01-Oct-2021, at 06:30, myocarditis developed. The patient felt pressure in the precordium after waking up. Because the symptoms persisted for about 1 hour and a half, the patient visited a medical institution. The symptoms had disappeared by the time the patient left home. The negative T wave of V1 was noted in the electrocardiogram. The patient had no medical or medication history and had no problems with other collagen diseases. The patient was hospitalized. On 05-Oct-2021, the symptoms were resolving, and the patient was discharged from the hospital. The outcome of low-grade fever was reported as recovered. The outcome of myocarditis 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 patient experienced chest pressure sensation on the 3rd day of the vaccination, and this event is considered as affected by adverse reactions to this vaccine. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case involves an 18-year-old male subject with no known history or concurrent medical condition who experienced the listed serious adverse event of myocarditis 4 days after his second vaccination and the non-serious listed adverse event of pyrexia 1 day after this vaccination. Pyrexia resolved and myocarditis was resolving. A relevant test result included an abnormal ECG (negative T wave in V1) 4 days after te vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1787059 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211025530

Write-up: COUGH; VOMITING; FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300109149] concerned an 81 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported,1 total, administered on 28-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced cough, vomiting (epigastric pain), fatigue (body weakness, COVID-19 probable). On an unspecified date, patient was hospitalized for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, vomiting, and fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20211025530-COVID-19 VACCINE AD26.COV2.S-cough. 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 20211025530-COVID-19 VACCINE AD26.COV2.S-vomiting, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1789252 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-09-28
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Fatigue, Headache, Lymphadenopathy, Myalgia, Pain, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Skin reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen arm; Slight temperature; Delayed skin reaction; Armpit pain; Painful arm; Exhaustion; Headache; Joint pain; Muscle ache; Shooting pain; Swollen glands; This case was received via Agency Regulatory Authority(Reference number: GB-MHRA-ADR 26044970) on 07-Oct-2021 and was forwarded to Moderna on 07-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle ache), PAIN (Shooting pain), LYMPHADENOPATHY (Swollen glands), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), FATIGUE (Exhaustion), PYREXIA (Slight temperature), AXILLARY PAIN (Armpit pain) and SKIN REACTION (Delayed skin reaction) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), PAIN (Shooting pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On 30-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PYREXIA (Slight temperature) (seriousness criterion medically significant) and SKIN REACTION (Delayed skin reaction) (seriousness criterion medically significant). On 30-Sep-2021, HEADACHE (Headache) was resolving, ARTHRALGIA (Joint pain), MYALGIA (Muscle ache) and FATIGUE (Exhaustion) had resolved. At the time of the report, PAIN (Shooting pain) was resolving, LYMPHADENOPATHY (Swollen glands), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), AXILLARY PAIN (Armpit pain) and SKIN REACTION (Delayed skin reaction) had not resolved and PYREXIA (Slight temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient developed events two hours post vaccination. Patient developed fever, pain all over the body, joint pain. Patient also developed shooting pains in fingers, thighs and arms. The outcome of the events was reported as recovering.After 36 hours patient developed red swollen patch under the injection site. Again after 12 hours there was an increase in size and sore to touch. The events armpit gland swollen, painfull was reported as increasing. It was reported that patient had no symptoms associated with COVID-19.Patient was not pregnant and was not breastfeeding at the time of reporting.Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. Company Comment: This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of Headache, Arthralgia, Myalgia, Pain , Lymphadenopathy, Peripheral swelling, Pain in extremity, Fatigue, Pyrexia, Axillary pain, and Skin reaction. The events of Headache, Arthralgia, Myalgia, Lymphadenopathy, Fatigue and Pyrexia are unexpected as they are retained as serious per the RA source document. The events occurred approximately 19-21 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. This is also a case of Inappropriate schedule of vaccine administration as the interval between doses was 85 days.; Sender''s Comments: This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of Headache, Arthralgia, Myalgia, Pain , Lymphadenopathy, Peripheral swelling, Pain in extremity, Fatigue, Pyrexia, Axillary pain, and Skin reaction. The events of Headache, Arthralgia, Myalgia, Lymphadenopathy, Fatigue and Pyrexia are unexpected as they are retained as serious per the RA source document. The events occurred approximately 19-21 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. This is also a case of Inappropriate schedule of vaccine administration as the interval between doses was 85 days.


VAERS ID: 1789264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lethargy, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis (Adalimubab injections for Ankylosing Spondylitis); COVID-19; Rheumatoid arthritis (Taking regular medicine for rheumatoid arthritis (or other types of arthritis except osteoarthritis))
Allergies:
Diagnostic Lab Data: Test Date: 20200622; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101311350

Write-up: Lethargy; Muscle soreness; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110011737003480-JVQKG and Safety Report Unique Identifier GB-MHRA-ADR 26025791. A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 28Sep2021 (Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included ankylosing spondylitis (Adalimubab injections for Ankylosing Spondylitis), rheumatoid arthritis - taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis) and COVID-19 on 22Jun2020. The patient''s concomitant medications were not reported. The patient previously took adalimumab. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced headache on 28Sep2021 and lethargy and muscle soreness 29Sep2021. Events were assessed as serious (Medically Significant) by reporter. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 22Jun2020 (Yes - Positive COVID-19 test). The outcome of the events lethargy, headache and muscle soreness was resolved on 01Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1789268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Chest pain, Diarrhoea, Electrocardiogram, Extra dose administered, Gastrooesophageal reflux disease, Joint stiffness, Migraine, Off label use, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome type III
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:1st irregular 2nd normal; Comments: ECG x 2; Test Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101311403

Write-up: Off label; Extra dose administered; back pain; cramping pain; Migraine; Chest pain; Abdominal cramp; Oesophageal reflux; Jaw stiffness; Acute back pain; Loose stools; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority(UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110012118195040-RBFS3, Safety Report Unique Identification Numbhosper: GB-MHRA-ADR 26027230 A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: FG3712) via an unspecified route of administration at Dose 3 (Booster), Single on 28Sep2021 (at the age of 36 year-old) for COVID-19 immunization. Medical history included Ehlers-danlos syndrome from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced off label,Extra dose administered, back pain, cramping pain. On 28Sep2021, the patient experienced chest pain, abdominal cramp, oesophageal reflux, jaw stiffness, acute back pain, loose stools.On 30Sep2021, the patient experienced migraine. Seriousness for the events was reported as hospitalization, medically significant.The patient underwent lab tests and procedures which included electrocardiogram: 1st irregular 2nd normal on ECG x 2, SARS-CoV-2 test: no - negative COVID-19 test on 22Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Outcome of the events off label use, Extra dose administered was unknown while the outcome of the event abdominal pain was recovering and the outcome of the event joint stiffness recovered on unspecified date of 2021 and the outcome of the events migraine was recovered on 30Sep2021, while the outcome of the other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1789307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Headache, Malaise, Nausea, Neuropathy peripheral, Skin burning sensation, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101311195

Write-up: burning sensation; headache; unwell; burning sensation in hands/ burning sensation in neck/ burning sensation in face; burning sensation in scalp; nausea; vomiting; Neuropathy; 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-202110030004597660-5VK2F, Safety Report Unique Identifier GB-MHRA-ADR 26028526. A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (Lot Number: FF2153)), dose 1 via an unspecified route of administration on 26Sep2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. On 28Sep2021, the patient experienced nausea, vomiting, neuropathy. On an unspecified date burning sensation, headache, unwell, burning sensation in hands/ burning sensation in neck/ burning sensation in face, burning sensation in scalp. Became unwell with nausea and vomiting 48 hours after vaccine. Then developed right sided tension headache and painful, burning sensation on both feet which would last for several seconds to minutes at a time. This burning painful burning sensation would subsequently migrate to affect the skin on other areas of the body including hands, neck, face and scalp but to a less intense degree and shorter duration. Patient had no underlying neurological conditions and this was the first time she was experiencing such symptoms. The events assessed as serious medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of burning sensation in hands/ burning sensation in neck/ burning sensation in face, burning sensation in scalp was unknown and for all other events it was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1789336 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood urine present, Body temperature increased, Cystitis, Dysuria, Fatigue, Headache, Immunisation, Influenza like illness, Malaise, Myalgia, Nausea, Off label use, Pelvic pain, Pyrexia, Urinary hesitation, Urine analysis, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: mild fever; Result Unstructured Data: Test Result:37.5 -37.8; Comments: 37.5 -37.8; Test Date: 20210930; Test Name: Urinalysis; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results
CDC Split Type: GBPFIZER INC202101311460

Write-up: blood in my urine; difficulty urinating; fever (37.5 -37.8); nausea; headache; muscle ache; malaise; tiredness; Cystitis; mild flu-type symptoms; pain in lower pelvic region; unusual sensation urinating; pain at injection site; Off label use; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110030902560800-8O2WY, safety report unique identifier is GB-MHRA-ADR 26029978. A 60-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: Not reported) dose 3 via an unspecified route of administration on 28Sep2021 at the age of (at the age of 60-years-old) as dose 3 (booster) single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. It was reported that after vaccinated 28Sep2021 the patient experienced usual range of side-effects experienced including pain at injection site that night, and mild flu type symptoms (muscle ache, nausea, headache, mild fever 37.5 -37.8), tiredness and malaise the following day (29Sep2021). The patient further reported that in the evening of 29Sep2021 developed cystitis symptoms (pain in lower pelvic region, and unusual sensation urinating) and at around 3.30am on 30Sep2021 these symptoms increased with some difficulty urinating. By the morning there was blood in patient urine. The patient was contacted the GP (General practitioner) and antibiotics started with good effect. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 28Sep2021 the patient underwent lab tests and procedures which included mild fever which was showed as 37.5 -37.8. On 30Sep2021 the patient underwent lab tests and procedures which included Urinalysis which was reported as unknown results. The outcome of the events was unknown for (pain at injection site, mild flu type symptoms, pain in lower pelvic region, unusual sensation urinating, difficulty urinating, blood in my urine). The patient was recovering from the event of (fever, nausea, headache, muscle ache, malaise, tiredness). The patient was recovered from the event of cystitis on 30Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1789373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101316678

Write-up: Heavy periods; painful periods; heavy bleed; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110041349311760-8HP7U, Safety Report Unique Identifier GB-MHRA-ADR 26033171. A 21-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Concomitant medication included ethinylestradiol, levonorgestrel (LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for birth control pill from 01Jul2020. The patient experienced heavy bleed on an unspecified date, heavy periods on 28Sep2021 and painful periods on 28Sep2021. The clinical course was as follows: The night after patient got the vaccine, it triggered a period. She did not get her period due to the birth control she took. This period was incredibly heavy and significantly more painful than any she has experienced before. It also showed no signs of stopping more than a full week later. She remained at a heavy bleed consistently for the duration of this time. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 26Sep2021 (No - Negative COVID-19 test). Heavy bleed was recovering, Heavy periods was not resolved, and the outcome of painful periods was unknown. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1789392 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Neuralgia, Pain in extremity, Product use issue
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101351631

Write-up: Nerve pain; Tight chested; Shortness of breath/short of breath; offered the flu vaccine at the same time injection; Tingling pain in left elbow and hand; Pain in left leg; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory Authority report number is GB-MHRA-WEBCOVID-202110100842240760-IW2MT with Safety Report Unique Identifier GB-MHRA-ADR 26057658. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Sep2021 as a dose 3, single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient had not had a COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) for immunisation on 28Sep2021. On 30Sep2021, 2 days after the vaccination, the patient experienced shortness of breath/short of breath and tight chested. On 03Oct2021, 5 days after the vaccination, the patient experienced nerve pain and on an unknown date in 2021, the patient experienced tingling pain in left elbow and hand and pain in left leg. The events shortness of breath/short of breath, tingling pain in left elbow and hand and nerve pain were assessed as serious for being medically significant. The clinical course was reported as follows: The patient reported that she was offered the flu vaccine at the same time injection and was given in the left arm. After 2 days of vaccination, the patient experienced short of breath and tight chested which lasted for 3 days and then she had tingling pain in left elbow, hand and had pain in left leg until now. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events shortness of breath/short of breath and tight chested was recovered 03Oct2021 while that of nerve pain was recovering at the time of this report. The clinical outcome of the event pain in left leg was not recovered while that of tingling pain in left elbow and hand was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1789400 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Nausea, Palpitations, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nauseous; Vaginal bleeding; Heart pounding; Headache; Dizziness; Light-headed; Nausea; Tiredness; Chest discomfort; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26057616) on 10-Oct-2021 and was forwarded to Moderna on 10-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), CHEST DISCOMFORT (Chest discomfort), PALPITATIONS (Heart pounding), HEADACHE (Headache), NAUSEA (Nauseous), FATIGUE (Tiredness), DIZZINESS (Dizziness), NAUSEA (Nausea) and DIZZINESS (Light-headed) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization), FATIGUE (Tiredness) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On 30-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and DIZZINESS (Light-headed) (seriousness criterion hospitalization). On 10-Oct-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous) (seriousness criterion hospitalization). On 07-Oct-2021, DIZZINESS (Light-headed) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding), CHEST DISCOMFORT (Chest discomfort), PALPITATIONS (Heart pounding), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Tiredness) had not resolved, DIZZINESS (Dizziness) was resolving and NAUSEA (Nausea) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported 20 minutes after the vaccine patient started to feel extremely nauseous, 2 days after that all the other symptoms started and lasted nearly 2 weeks, only a few remain. 2 weeks later were experiencing abnormal vaginal bleeding. Patient has not tested positive for COVID-19 since having the vaccine. No treatment information was provided. This case concerns a 37 year old female patient with no relevant medical history,who experienced the serious unexpected events of Vaginal haemorrhage, Chest discomfort, Palpitations, Headache, Nausea, Fatigue and Dizziness.The event Vaginal haemorrhage occurred after 12 days,Palpitations, Headache and Dizziness after 2 days and Chest discomfort,Nausea, Fatigue on the same day following administration of first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report; Sender''s Comments: This case concerns a 37 year old female patient with no relevant medical history,who experienced the serious unexpected events of Vaginal haemorrhage, Chest discomfort, Palpitations, Headache, Nausea, Fatigue and Dizziness.The event Vaginal haemorrhage occurred after 12 days,Palpitations, Headache and Dizziness after 2 days and Chest discomfort,Nausea, Fatigue on the same day following administration of first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) The rechallenge was not applicable since only information about the first dose was disclosed.The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report


VAERS ID: 1789511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-09-28
   Days after vaccination:238
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Familial hypercholesterolaemia; Hypertensive end-organ damage
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101305999

Write-up: positive molecular buffer in vaccine. Asymptomatic; positive molecular buffer in vaccine. Asymptomatic; This is a spontaneous report received from a contactable other health professional downloaded from the The regulatory authority report number is IT-MINISAL02-793075. An 87-years-old female patient received second and first doses of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EK9788 (dose 2), EL1484 (dose 1); Expiration Date: 31May2021 (dose 2), 30Apr2021(dose 1)) both via intramuscular route, in arm left (left shoulder) on 02Feb2021 as dose 2, 0.3ml single and on 12Jan2021 as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included diabetes mellitus from 29Nov2001 to an unknown date, type familial hypercholesterolaemia from 05Jul2001 to an unknown date and hypertensive end-organ damage from 05Jul2001 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced positive molecular buffer in vaccine, asymptomatic on 28Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test positive (sars-cov-2 test): positive on 28Sep2021. The events were serious (Medically Significant). Product Quality Complaint source: Conclusion for LOT EL1484: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1484. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root were identified as the complaint was not confirmed. Conclusion for LOT EK9788: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root were identified as the complaint was not confirmed. The outcome of the event asymptomatic COVID-19 was recovering and for the rest was unknown.


VAERS ID: 1789563 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Epilepsy, Fall, Loss of consciousness, Muscle twitching
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 (The patient had medical history of convulsion for 2 to 3 years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101303284

Write-up: Loss of consciousness; suspected epilepsy; fall from right side of chair; right facial bruise; Generalised twitches; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129082. A 24-years-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 28Sep2021 at 15:30 (the day of vaccination) at the age of 24 years old (Batch/Lot Number: FJ7489; Expiration Date: 31Jan2022) as single dose for covid-19 immunisation. Medical history included convulsion from an unknown date for 2 to 3 years ago. The patient''s concomitant medications were not reported. Event onset date was 28Sep2021 at 15:40 (10 minutes after the vaccination). On 28Sep2021 (the same day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: At around 15:30, the patient received vaccination. After 10 minutes, the patient experienced loss of consciousness, fell from right side of chair and right facial bruise. Generalised twitches improved for 1 minute. The patient was recovering from the events. The reporting physician classified the event as serious (risk of disability) and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were medical history of convulsion and had suspected epilepsy. No follow-up attempts are completed. No further inforamtion is expected.


VAERS ID: 1789665 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 - 42 Centigrade; Comments: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLPFIZER INC202101309762

Write-up: Chills; Pain in the joints; Myalgia; Fatigue; Headache; Fever: 40.5 to 42 degrees Celsius; not feeling well; This is a spontaneous report from a contactable consumer downloaded from the regulatory agency-WEB. The regulatory authority number NL-LRB-00690814. This is the first of two reports for the second dose. A 33-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Sep2021 (Batch/Lot Number: FF2834) as DOSE 2, SINGLE (at the age of 33 years) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no previous Covid-19 infection. The patient previously took BioNTech/Pfizer vaccine (Comirnaty) on 27Sep2021 for covid-19 immunisation and experienced painful arm. On 28Sep2021 2 hours after the start of vaccine, patient was not feeling well. On 29Sep2021, the patient experienced fever: 40.5 to 42, chills, pain in the joints, myalgia, fatigue and headache. The event chills was treated with paracetamol, generalized joint pain is treated with Pcm, headache treated with Pcm, hyperpyrexia treated with paracetamol and myalgia was treated with Pcm. The outcome of the event chills was recovered on 30Sep2021, not recovered from pain in the joints and headache, and recovering from all the other events. No follow-up attempts possible. No further information expected. Information about batch/lot already obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No only painful arm Date: 07Sep2021 COVID-19 Previous COVID-19 infection: No; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101335417 the same reporter/patient, different event after 1st dose


VAERS ID: 1794392 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-28
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hyperuricaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: 37
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; Headache; Pyrexia; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 48-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperlipidaemia and Hyperuricaemia. In August 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), HEADACHE (Headache) and PYREXIA (Pyrexia). At the time of the report, MYOCARDITIS (Myocarditis), HEADACHE (Headache) and PYREXIA (Pyrexia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Body temperature: 37 (normal) 37. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis), HEADACHE (Headache) and PYREXIA (Pyrexia) to be possibly related. The lot number and vaccination center are unknown because the patient did not receive this vaccine in the reporting hospital. The symptoms were not serious but considered to be moderate or severe. This case concerns a 48 year-old male patient with no relevant medical history who experienced the expected serious event of myocarditis, an AESI. The event occurred approximately 1 to 2 months after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be given.The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 48 year-old male patient with no relevant medical history who experienced the expected serious event of myocarditis, an AESI. The event occurred approximately 1 to 2 months after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be given.The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1796310 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Off label use
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101317127

Write-up: Numbness in face; third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00262278. Safety Report Unique Identifier GB-MHRA-ADR 26026533. A 33-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via parenteral on 28Sep2021 (Batch/Lot Number: Ff8222) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness in face (medically significant) on 28Sep2021 with outcome of not recovered. The patient had lost the feeling in her left cheek and she was unable to smile. It''s not Bells palsy or a stroke. The patient had been checked for both. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1796314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Hypopnoea, Immunisation, Off label use, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; OMEPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101316716

Write-up: Hypopnoea; off label use; Booster; severe urticaria/angiodema; severe urticaria/angiodema; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-EYC 00262375 and Safety Report Unique Identifier is GB-MHRA-ADR 26030837. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: unknown), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication''s included bisoprolol fumarate; omeprazole; and paracetamol. The patient previously took naproxen and experienced urticaria. The patient experienced severe urticaria/angioedema on 28Sep2021 and hypopnoea on an unspecified date. The patient''s hospitalization was prolonged as a result of severe urticaria/angiodema and hypopnoea. It was reported that on Sunday morning patient was given a booster injection of Pfizer vaccine having had no significant side effects to previous doses early in the year (sore arm). Having had a mild migraine headache for about a week that was not responding to paracetamol on Tuesday she took 1 ibuprofen 400mg tablet in the morning with no ill effects (she had taken ibuprofen on a number of occasions over 30 plus years). She took another at 10.30 that evening and just over an hour later she experienced itching on her back which then quickly erupted into a severe raised painful and itchy rash covering her whole body. She took a piriton tablet which calmed it slightly for a while but breathing was shallow and felt unwell an ambulance was called and she was taken to accident and emergency. Intravenous chlorpheniramine and hydrocortisone was given along with 2L Intravenous fluids. After monitoring she was discharged from hospital later Wednesday morning and advised to seek allergy testing to determine the cause. This has yet to be organised. The patient was taking ibucalm ibuprofen 400mg tablets for migraine headache. Outcome of severe urticaria/angioedema was resolved with sequel on 29Sep2021 and was unknown for hypopnoea. No follow-up attempts are possible, information about lot/batch number cannot be obtained, No further information is expected.


VAERS ID: 1796420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymph node pain, Off label use, Pain, Vaccination site pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pain; Result Unstructured Data: Test Result:6/10; Test Name: pain; Result Unstructured Data: Test Result:2/10
CDC Split Type: GBPFIZER INC202101316896

Write-up: localised pain at injection site; Lymph node pain; off label use; booster; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202110041322363850-ZEWM5, Safety Report Unique Identifier GB-MHRA-ADR 26033077. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Sep2021 (Lot number was not reported) as single dose (booster) for COVID-19 immunization. Historic vaccine included patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on unspecified date (Lot number was not reported) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not had symptoms associated with COVID-19. Patient was not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included pain: 6/10 on, pain: 2/10 on. On 28Sep2021, the patient experienced lymph node pain, off label use, booster. On an unspecified date, the patient experienced localised pain at injection site. Events were considered as medical significant. The outcome of event lymph node pain was resolved on 02Oct2021. The outcome of rest all events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1796433 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222L951 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Fungal test, Immunisation, Off label use, SARS-CoV-2 test, Ulcer, Viral test, Vulval ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Gastrointestinal ulceration (narrow), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease
Allergies:
Diagnostic Lab Data: Test Name: Bacterial; Result Unstructured Data: Test Result:Negative; Test Name: Fungal; Result Unstructured Data: Test Result:Negative; Test Date: 20210929; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test; Test Name: Viral; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC202101316747

Write-up: Vulval ulceration; Off label use; Booster; Ulceration; Ulcers; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110041501413310-HEC8G, Safety Report Unique Identifier GB-MHRA-ADR 26033483. A 23-years-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF8222-L951), via an unspecified route of administration on 28Sep2021 (at the age of 23-years-old) (off label use) as dose 3 (booster), single for covid-19 immunization. Medical history included Hashimoto''s disease from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took Thyroxine. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EJ1688), via an unspecified route of administration on 08Jan2021 as dose 2, single for covid-19 immunization and experienced vulval ulceration for second dose. On an unspecified date in 2021, the patient experienced ulceration and ulcers. On 01Oct2021 had vulval ulceration. The patient underwent lab tests and procedures which included bacterial test, fungal test, viral test: negative on an unspecified date and Covid-19 virus test: negative (No - Negative COVID-19 test) on 29Sep2021. She had no unusual reactions to her first dose. She developed ulcers 2-3 days after her second dose of Pfizer vaccine. She had her booster dose recently, and again developed ulceration 2-3 days after. This was when she realised that the ulceration was linked to the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Viral, fungal, bacterial swabs were all negative. The outcome of events vulval ulceration was not recovered, and other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1796456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Lymph node pain, Lymphadenopathy, Malaise, Off label use, Physical examination
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain bladder
Allergies:
Diagnostic Lab Data: Test Name: GP examination manually; Result Unstructured Data: Test Result:swollen lymph nodes in the underarm area; Comments: GP diagnosis
CDC Split Type: GBPFIZER INC202101317099

Write-up: unwell; fatigue; off label use; booster; swollen lymph nodes/swelling of under arm/armpit (same side as vaccination); Lymph node pain/pain down arm and into breast area (same side as vaccination); This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110041910274730-WFSN2, Safety Report Unique Identifier GB-MHRA-ADR 26034545. A 60-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2153), via an unspecified route of administration on 26Sep2021 as dose 3 (booster), single for COVID-19 immunisation. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Medical history included pain bladder. Concomitant medication included amitriptyline taken for pain bladder. No previous side effects with vaccine one and two apart from soreness at vaccination site. The patient previously received the first dose of BNT162B2 (Lot Number: unknown) on 02Jan2021 at single dose for COVID-19 immunisation and experienced soreness at vaccination site. The patient previously received the second dose of BNT162B2 (Lot Number: unknown) on 13Mar2021 at single dose for COVID-19 immunisation and experienced soreness at vaccination site and inappropriate schedule of vaccine administered. The patient experienced swelling of under arm/armpit with lymph node pain/pain down arm and into breast area 2 days after booster vaccination (same side as vaccination) on 28Sep2021. General practitioner (GP) diagnosis of swollen lymph nodes in the underarm area. The patient felt unwell and fatigue for 5 days. Seriousness criteria was reported as other medically important condition. Patient was not tested for COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included GP examination manually: GP diagnosis of swollen lymph nodes in the underarm area. Outcome of event lymph node pain was recovering. Outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1796691 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101313583

Write-up: After 5 minutes from the administration of the vaccine, convulsive syncope with falling to the ground from sitting.; After 5 minutes from the administration of the vaccine, convulsive syncope with falling to the ground from sitting.; head injury; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-793087. A 26-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 28Sep2021 09:30 at age of 26-years-old (Batch/Lot Number: FG6270; Expiration Date: 31Dec2021) as DOSE 1, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. after 5 minutes from the administration of the vaccine, convulsive syncope with falling to the ground from sitting, head injury on 28Sep2021 09:35 with outcome of recovered on 28Sep2021. Seriousness criteria reported as medical significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1796873 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005685 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Presyncope
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: Test Name: Body temperature; Result Unstructured Data: 36.2 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vasovagal reflex; This case was received (Reference number: 2021TJP105239) on 09-Oct-2021 and was forwarded to Moderna on 17-Oct-2021. This case, reported by an administrator of a clinic, (Ref, v21129066). Loss of consciousness was assessed as serious. On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 28-Sep-2021, at 14:28, the patient received the 1st dose of the vaccine. At 14:35, while waiting on a chair for 15 minutes, the patient experienced vasovagal reflex. The patient was found to fall with loss of consciousness. JCS was 2-20. Excessive cold sweat was noted in the whole body. Blood pressure was unmeasurable. The patient recovered to JCS of 1-1 when moving in a wheelchair. After moving to a bed, the patient had decreased blood pressure, and legs were elevated. The patient was awake and alert without any problems in responses. At 15:00, the patient recovered and returned home. The outcome of vasovagal reflex and loss of consciousness was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of loss of consciousness and presyncope. The events occurred the same day after the first dose of Spikevax. The rechallenge was assessed as not applicable, but as per Medical review, should be unknown as the patient experienced AEs after the first dose at the time of report but no information about second dose is available. The benefit -risk relationship of mRNA-1273 (Spikevax) is not affected by this report. The event loss of consciousness is assessed as serious. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event should not be considered as serious.


VAERS ID: 1797043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Fatigue, Hyperhidrosis, Hypoaesthesia, Lymphadenopathy, Malaise, Myalgia, Pain in extremity, Peripheral coldness, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101351279

Write-up: This is a spontaneous report from a contactable consumer or other non-HCP, downloaded via the regulatory authority (SE-MPA-2021-087307). A 33-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# FF2382), via an unspecified route of administration, on Sep 28, 2021, single dose, for COVID-19 immunization. The patient''s medical history not reported. Concomitant medication included escitalopram oxalate 10 mg, 1X/day (in the morning) for an unspecified indication (start and stop date not reported). On Sep 28, 2021, patient experienced a burning sensation in the area around the elbow of the arm where the syringe injected the vaccine. This then turned into a pain down the fingers. Gradually, she also developed pain in other joints, pain in the hands, ankles, pain in the foot joint and toes and severe pain in the knees (mainly left). On Sep 29, 2021, patient experienced pain at the vaccination site, muscle pain, heavy sweating, general malaise and tiredness. On Sep 30, 2021, patient experienced numbness in the arm, opposite arm from where the syringe injected the vaccine. On Oct 1, 2021, patient experienced swollen lymph nodes and fever. On Oct 3, 2021, patient experienced cold feeling in the legs and feet. She has been sweating cold at night. Since the vaccination, she experienced numbness in one arm for about 2 hours in connection with this. In the last 24 hours, she also experienced a "cold feeling" in the legs and feet. The case considered serious due to permanent disability. The outcome of cold feeling in the legs and feet, swollen lymph nodes, muscle pain, heavy sweating, burning sensation in the area around the elbow of the arm where the syringe injected the vaccine, pain in the hands, pain in the foot joint, pain in the joints and toes, severe pain in the knees (mainly left), fever, general malaise, tiredness: not recovered; and for events pain at the vaccination site, numbness in the arm, opposite arm from where the syringe injected the vaccine: resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1798677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Ear pain, Epistaxis, Facial paralysis, Fatigue, Headache, Oropharyngeal discomfort, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101318453

Write-up: Facial paralysis; Abdominal discomfort; Chills; Ear pain; Epistaxis; Fatigue; Headache; Oropharyngeal discomfort; Pain in extremity; This is a spontaneous report from a contactable health professional via the Regulatory Authority. The regulatory authority report number is 633724. A 50-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced facial paralysis, abdominal discomfort, chills, ear pain, epistaxis, fatigue, headache, oropharyngeal discomfort, and pain in extremity on 28Sep2021. The clinical outcome of facial paralysis, abdominal discomfort, chills, ear pain, epistaxis, fatigue, headache, oropharyngeal discomfort, and pain in extremity was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1798737 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-28
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101318682

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable healthcare professional received via the Regulatory Authority. The regulatory authority report number is 634176. A 35-year-old male patient received BNT162B2 (COMIRNATY solution for injection), first dose on 30Aug2021 (batch/lot number not reported) at dose 1, single, then second dose on an unspecified date in 2021 (batch/lot number not reported) at dose 2, single; both via an unspecified route of administration at an unspecified age for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, 29 days after the first dose vaccination, and on an unspecified date in 2021, 3 days after the second dose vaccination, the patient experienced pulmonary embolism. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1798748 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101318834

Write-up: Syncope; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number 634751. A 13-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number was unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced syncope on 28Sep2021. Outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1798755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness bilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101318900

Write-up: Deafness bilateral; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 634879. A 77-years-old female patient received BNT162B2 (COMIRNATY Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced deafness bilateral. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1798773 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
CDC Split Type: AUPFIZER INC202101318770

Write-up: Loss of consciousness; Headache; Pyrexia; Vomiting; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number is 634430. A 29-year-old male patient BNT162b2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced loss of consciousness, headache, pyrexia, and vomiting. The clinical outcomes of the loss of consciousness, headache, pyrexia, and vomiting were not recovered. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1799455 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar ataxia, Condition aggravated, Headache, Interchange of vaccine products, Limb discomfort, Nausea, Off label use, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebellar ataxia (idiopathic)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101325210

Write-up: Painful arm; Heaviness in arm; Nausea; Headache; idiopathic cerebellar ataxia and my muscle control was much worse; idiopathic cerebellar ataxia and my muscle control was much worse; First two jabs were AstraZeneca and the booster given on 28Sep2021 was Pfizer; First two jabs were AstraZeneca and the booster given on 28Sep2021 was Pfizer; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number is GB-MHRA-ADR 26033373. Safety Report Unique Identifier GB-MHRA-ADR 26033373. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Sep2021 (Batch/Lot Number: FF2153) as dose 3 (booster), single (at the age of 78-year-old) for COVID-19 vaccination. Medical history included ongoing idiopathic cerebellar ataxia. Historical vaccine includes dose 1 and dose 2 of Covid-19 Vaccine Astrazeneca (COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19)) received in 2021 for COVID-19 vaccination. The patient''s concomitant medications were not reported. The patient experienced nausea, headache and idiopathic cerebellar ataxia and my muscle control was much worse on 28Sep2021 and painful arm and heaviness in arm on an unspecified date. The events were reported as serious (medically significant). The clinical course was reported as follows: First two jabs were AstraZeneca and the booster given on 28Sep2021 was Pfizer FF2153 at a Pharmacy. The patient experienced a heavy painful arm for between 24 and 48 hours but it didn''t disturb sleep. The patient felt slight nausea during first 12 hours and bursting headache which was relieved by rest. The patient had a diagnosis of idiopathic cerebellar ataxia and her muscle control was much worse for 12 - 48 hours but returned to usual on third day. The outcome of painful arm and heaviness in arm was recovered on an unspecified date, for the nausea and headache was recovered on 29Sep2021, for ''idiopathic cerebellar ataxia and my muscle control was much worse'' was recovered on 30Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1799594 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Blood fibrinogen, Blood lactate dehydrogenase, C-reactive protein increased, Computerised tomogram, Dysphagia, Headache, Hyperacusis, Investigation, Magnetic resonance imaging, Myalgia, Pain, Pyrexia, SARS-CoV-2 test, Slow speech
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; CANDESARTAN; FAMOTIDINE; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis; Hypertension; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: Fibrinogen; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Name: LDH; Result Unstructured Data: Test Result:High; Comments: High; Test Name: CT; Result Unstructured Data: Test Result:Normal, no clots; Comments: Normal, no clots; Test Name: CRP; Result Unstructured Data: Test Result:High; Comments: High; Test Name: D-Dimer; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20211004; Test Name: MRI; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:NEGATIVE; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101325250

Write-up: diffuse headaches; Hyperaccousis; Bell''''s palsy; Slow speech; Swallowing impaired; Pyrexia; Ache; Polymyalgia; Headache; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110051654523090-XPRPG, Safety Report Unique Identifier GB-MHRA-ADR 26039402. A 56-years-old female patient received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FH8469), via an unspecified route of administration on 27Sep2021 (Age at Vaccination: 56 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included hypertension from an unknown date, steroid therapy from an unknown date (Taking regular steroid treatment e.g. orally or rectally), gastritis from an unknown date. Concomitant medication included bisoprolol taken for hypertension; candesartan taken for hypertension; famotidine taken for gastritis; lansoprazole taken for gastritis, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 27Sep2021 patient experienced off label use, Booster dose administered. On an unspecified date the patient experienced diffuse headaches, (which was initially bilateral, then unilateral to right side with neck involvement and mastoid region), and hyperacusis. The patient experienced pyrexia, ache, polymyalgia and headache on 28Sep2021. The patient developed bell''s palsy, slow speech and was swallowing impaired on 30Sep2021. The patient reportedly had polymyalgia on multiple sites and had speech impaired due to muscular involvement, making it difficult to talk and swallow. The patient can''t blow her cheeks and right eye is difficult to close. The seriousness criteria of the events was disability. The patient underwent lab tests and procedures on unspecified dates, which included SARS-CoV-2 test: negative (no - negative COVID-19 test), D-Dimer investigation: normal, blood lactate dehydrogenase (LDH): high, c-reactive protein: high, blood fibrinogen: normal, computerised tomogram: normal, no clots; and magnetic resonance imaging: normal on 04Oct2021. The outcome of the event bell''s palsy was not recovered, outcome of events slow speech, swallowing impaired and hyperacusis is recovering, diffuse headaches was recovered on an unknown date and outcome of rest of the events were recovered on 29Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1799606 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Blood test, Diarrhoea, Helicobacter test, Immunisation, Lymphocyte count, Lymphocyte count abnormal, Mass, Off label use
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Bloods normal; Comments: Bloods normal; Test Name: H Pylori; Result Unstructured Data: Test Result:H Pylori neg; Comments: H Pylori neg; Test Name: lymphocytes; Result Unstructured Data: Test Result:abnormal
CDC Split Type: GBPFIZER INC202101325258

Write-up: Lump just under the sternum/lump middle of upper chest; upset stomach; Off label use; Booster; Diarrhoea; Lymphocyte count abnormal; Bloated feeling; This is a spontaneous report from a contactable other HCP received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110051814294030-PFFUW, Safety Report Unique Identifier GB-MHRA-ADR 26039704. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 27Sep2021 (Lot Number: FJ5782) as dose 3 (booster), single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On 28Sep2021, the patient experienced diarrhea, feeling bloated and lymphocyte abnormal. On an unknown date, the patient had lump just under the sternum, upset stomach and a lump middle of upper chest. The outcome of upset stomach, bloated feeling and lymphocyte abnormal was not recovered. The outcome of diarrhea was recovering. The outcome of lump was unknown. The events were considered medically significant. The patient underwent lab tests and procedures which included bloods normal and helicobacter pylori was negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1799608 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Fibromyalgia, Headache, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (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: CO-CODAMOL; NEXPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Pain joint
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101325356

Write-up: Inappropriate schedule of vaccine administered; fibromyalgia; headaches got a lot worse; headache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110051846493370-MEFXY. Safety Report Unique Identifier GB-MHRA-ADR 26039873. A 20-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FE8087), via an unspecified route of administration on 28Sep2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunisation. Medical history included arthralgia and contraception from an unknown date. Patient had not had symptoms associated with covid-19. Patient was not currently breastfeeding. Patient was not pregnant at the time of vaccination. Patient had not tested positive for covid-19 since vaccination. Patient was not enrolled in clinical trial. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) taken for arthralgia from 07Dec2019 to an unspecified stop date; etonogestrel (NEXPLANON) taken for contraception from 06May2021 to an unspecified stop date. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FE1510) via unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation and had headache dull. On an unspecified date in 2021, patient experienced fibromyalgia, headache and condition aggravated. Patient had inappropriate schedule of vaccine administered on 28Sep2021. Clinical course: Patient reported that, since having her first dose she had headaches but brushed it off and did not seek any doctor advice. After her second dose the headaches got a lot worse. Some days they are really unbearable, but she feel like everyday the headache was there just not as severe as other days. The patient seeked doctor advice and was given Amitriptyline Hydrochloride (10 mg) and was advised to take her cocodomol that she take if and when needed for fibromyalgia. The headaches was still continuing and her doctor was upping Amitriptyline to see if that helps. The case was assessed as serious (medically significant) by the health authority. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 05Sep2021. Therapeutic measures were taken as a result of headache included Amitriptyline Hydrochloride (10 mg). The outcome of events fibromyalgia, headache and condition aggravated was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1799652 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dysstasia, Immunisation, Monoplegia, Off label use, Pain in extremity
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101334651

Write-up: Pain in arm; Paralysis arm; Loose bowels; Off-label use; Booster; difficulty standing; 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-202110061443510490-CCB8B. Safety Report Unique Identifier is GB-MHRA-ADR 26043927. A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: unknown), dose 3 via an unspecified route of administration, administered in Arm on 28Sep2021 (at 89-years-old vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 with unknown lot number for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. On 28Sep2021, the patient experienced pain in arm, paralysis arm, loose bowels, off-label use, booster. On an unspecified date, the patient experienced difficulty standing. All events were reported as medically significant. It was reported that My Father received a flue jab and a booster for COVID one in each arm. Later that day he fell asleep but in waking had excruciating pain in both arms. He found both arms paralysed and could not move arms or fingers. He has difficulty standing and was unable to call for help. He spent 3 days without food or water. He managed to walk to his garden only to loose control of his bladder. Returning to the house he could only lay on his bed and wait to be discovered. After the third day the symptoms started to ease. So far he has not been seen by a doctor but his local GP is aware. He has had a call from an emergency GP to check his current symptoms only. Some six days after the jabs he has had some reoccurrence of pains in his lower arms. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of difficulty standing was resolving. The outcome of pain in arm and paralysis arm was recovered with sequelae on an unspecified date in 2021. The outcome of loose bowels was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1799798 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dizziness postural, Headache, Pyrexia
SMQs:, 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? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhea; Fever; Headache; Dizzy on standing; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26062881) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy on standing), DIARRHOEA (Diarrhea), PYREXIA (Fever) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 30-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 30-Sep-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 06-Oct-2021, DIZZINESS POSTURAL (Dizzy on standing) and DIARRHOEA (Diarrhea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. No treatment information was provided. Company comment : This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness postural, pyrexia, headache and diarrhea. The events occurred approximately on the same day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity; Sender''s Comments: This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness postural, pyrexia, headache and diarrhea. The events occurred approximately on the same day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity


VAERS ID: 1799856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Migraine
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101323238

Write-up: Severe abdominal pain and severe migraine.; Severe abdominal pain and severe migraine.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-794072. A 13-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FF2382) at 0.3 ml single dose intramuscular in left arm on 26Sep2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient experienced severe abdominal pain and severe migraine with onset date of 28Sep2021 and seriousness criteria of hospitalization. Patient received intravenous pain reliever in hospital. Lab data included impact on quality of life 8/10. Outcome of the events was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1799873 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-09-28
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101344173

Write-up: Molecular swab positive in vaccinated. Asymptomatic; Molecular swab positive in vaccinated. Asymptomatic; Molecular swab positive in vaccinated. Asymptomatic; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-795338. A 52-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: ER9470, expiration date: 31Jul2021), via intramuscular route in left arm on 29Mar2021 as DOSE 2, 0.3 ML SINGLE and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP9598, expiration date: 30Jun2021), via intramuscular route in left arm on 08Mar2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Sep2021, the patient had Molecular swab positive in vaccinated. Asymptomatic. The patient underwent lab tests and procedures on 28Sep2021 which included COVID-19 PCR test: positive. The outcome of the event was recovering.


VAERS ID: 1799874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive end-organ damage; Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:weakly positive
CDC Split Type: ITPFIZER INC202101343523

Write-up: drug ineffective; inappropriate schedule of vaccine administered; Brioni cluster. Molecular swab positive in vaccinated; Asthenia.; This is a spontaneous report received from a contactable othr healthcare professional downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-795339. A 94-year-old female patient received BNT162B2 (COMIRNATY; formulation: Solution for injection, Lot Number: Ek9788, Expiry date: 30Apr2021), via intramuscular administered in Arm Right on 02Feb2021 as dose 1, 0.3ml single and BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: EL1484, Expiry date: 29Sep2021), via intramuscular administered in Arm Left on 28Sep2021 as dose 2, 0.3ml single both for COVID-19 immunization. The patient''s medical history included hypertensive end-organ damage from 07Apr2020, neoplasm nos from 10Nov1999. The patient''s concomitant medication was not reported. The patient was tested positive with COVID post vaccination. On 28Sep2021, the patient had brioni cluster, molecular swab positive in vaccinate and asthenia. The patient received inappropriate schedule of vaccine. The outcome of the events Brioni cluster. Molecular swab positive in vaccinated and asthenia was not recovered and outcome of other events was unknown.


VAERS ID: 1799989 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20211034335

Write-up: HEMORRHAGE; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, LT-SMCA-6333N) on 19-OCT-2021 concerned a 47 year old female of unspecified race and ethnicity. The patient''s weight was 72 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-SEP-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced hemorrhage (very large). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hemorrhage (very large). This report was serious (Other Medically Important Condition).


VAERS ID: 1800155 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Fatigue, Headache, Hyperhidrosis, Insomnia, Malaise, Middle insomnia, Myalgia, Nausea, Pain, Pharyngeal swelling, Throat tightness, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: Hypometabolism; Multiple allergies; Penicillin allergy (drug - Kavepenin)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101356901

Write-up: Sweating; waking up at night; Throat swelling with tightness; Throat swelling with tightness; Breathing difficult; Difficulty sleeping; Muscle pain in calves; Abdominal cramps; General malaise; vaccination site swelling; Headache; Vaccination site pain; Dizziness; Radiating sensations in the right hand; Nausea; Tiredness; This is a spontaneous report from a contactable consumer downloaded from the regulatory agency-WEB, regulatory authority number SE-MPA-2021-087682. A 68-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Sep2021 (at the age of 68years) as dose 1, single for Covid-19 immunization. Medical history included ongoing hypometabolism (low metabolism), ongoing Penicillin allergy (Kavepenin), and ongoing multiple allergies. The patient''s concomitant medications were not reported. On 28Sep2021, the patient experienced vaccination site pain, dizziness, radiating sensations in the right hand, nausea, tiredness, general malaise. On 29Sep2021, the patient experienced vaccination site swelling and headache. On 30Sep2021, the patient experienced muscle pain in calves, abdominal cramps. On 01Oct2021, the patient experienced throat swelling with tightness, breathing difficult, difficulty sleeping, and waking up at night. On 04Oct2021, the patient experienced sweating. Clinical course details: Reported suspected side effects were nausea, vaccination site pain, dizziness, radiating sensations in the right hand and fatigue with onset of symptoms on the same day as the first vaccination dose. 1-6 days later onset of swelling at the vaccination site, headache, general malaise, stomach cramps, swelling in the throat with tightness and difficulty breathing, muscle pain in the calves, sweating and difficulty sleeping both when falling asleep and waking up at night. According to the description, the swelling in the throat occurred at night and eased after the woman sat up for three hours and drank cold water. The outcome of event throat swelling with tightness, breathing difficult was recovered on 01Oct2021; outcome of abdominal cramps was recovered on 04Oct2021; outcome of vaccination site swelling, and vaccination site pain was recovered on 06Oct2021; radiating sensations in the right hand was recovered on 29Sep2021; outcome of headache, general malaise, tiredness, nausea, and dizziness was recovering; outcome of other events was not recovered. The case was judged to be serious, life-threatening. It is not clear from the report''s description of the course of events in what way the suspected adverse events were life-threatening. No follow-up attempts are possible. No further information is expected. Lot number cannot be obtained.


VAERS ID: 1801933 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101319052

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 635607. A 29-years-old female patient received bnt162b2 (COMIRNATY COVID-19 mRNA vaccine, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced bell''s palsy. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1801949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-09-28
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Illness, Malaise, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101364911

Write-up: Vaccination failure; COVID-19 infection after vaccination; cough without sputum; Malaise; Fever; generally ill; This is a spontaneous report from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107492. An 81-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW6126), via an unspecified route of administration on 07May2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. After vaccination, the patient experienced COVID-19 infection, vaccination failure, cough without sputum, malaise, fever and generally ill on 28Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 28Sep2021. The outcome of the events COVID-19 infection, cough without sputum, malaise, fever and generally ill was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1802173 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G04PA / 2 - / -

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to bee sting; Allergy to animal; Hay fever; House dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101323043

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer (parent) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021185641 with safety unique identifier DE-PEI-202100199901. A 15-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Sep2021 (Batch/Lot Number: 1G04PA) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose on an unspecified date. Medical history included allergies to house dust, animal hair, hay fever, bee venom. The child was fit and very athletic before the vaccination. On 28Sep2021 the patient experienced myocarditis, and being treated for myocarditis in intensive care. The patient''s outcome was unknown for Myocarditis. This report is serious - hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1802594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Frostbite, Immunisation, Nasopharyngitis, Off label use, Raynaud's phenomenon, SARS-CoV-2 test
SMQs:, Accidents and injuries (broad), Immune-mediated/autoimmune disorders (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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Neutropenia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - COVID-19 test Negative
CDC Split Type: GBPFIZER INC202101334558

Write-up: raynaud; frostbite; my toes are cold all the time; Raynauds phenomenon; Condition Aggravated; Off label use; Booster; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The first report is a report downloaded from the Regulatory Agency [GB-MHRA-WEBCOVID-202109301549326840-MTGYY]. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109301549326840-MTGYY, Safety Report Unique Identifier GB-MHRA-ADR 26046411. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 28Sep2021 as dose 3 (Booster), single for COVID-19 immunization. Medical history included neutropenia, immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency)). Patient has a mild neutropenia but was not known to be otherwise immunosuppressed. Patient had no symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) from 18Sep2021 to 18Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received her first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and as dose 2, single both for COVID-19 immunisation. On an unspecified date, the patient experienced Raynaud, frostbite, my toes are cold all the time. On 28Sep2021, she experienced condition aggravated, off label use, booster and on 29Sep2021, she experienced Raynauds phenomenon. Has mild Raynaud but this was different as it usually affects hands but it was only her toes after first two doses covid vaccine but since her booster, her fingers were affected but not as bad as toes. After each vaccine her toes were cold all the time. It had improved after a few months during summer but was really bad after booster and started within 24 hours. She was having difficulty doing blood sugar monitoring as she cannot get much blood out and her toes were cold even when she was warm to the point of being uncomfortable. After her second dose, she got frostbite despite wearing suitable footwear. It takes ages to get the circulation back into her toes which look mottled and feel cold. The patient underwent lab tests which showed sars-cov-2 test negative (no- COVID-19 test negative) on an unspecified date. Outcome of the events Raynaud, frostbite was resolving, event Raynauds phenomenon was not resolved while for the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101348755 Due to same patient/Drug/Reporter, different dose number and event.


VAERS ID: 1802598 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334489

Write-up: Diarrhea; off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109301650287230-UQUEE. Safety Report Unique Identifier GB-MHRA-ADR 26044940. A 59-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FG3712), via an unspecified route of administration on 28Sep2021 (at the age of 59-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. The patient had off label use and booster dose administration on 28Sep2021. The patient experienced uncontrollable diarrhea on 30Sep2021. The case was assessed as serious (disability) by the health authority. 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: no - negative covid-19 test on an unspecified date. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1802603 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Musculoskeletal stiffness, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334415

Write-up: Headache dull; Neck stiff; Fever; Off label use; Booster; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109301946314670-W3J9P, Safety Report Unique Identifier GB-MHRA-ADR 26046463. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28Sep2021 as dose 3, (booster), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included influenza vaccine taken for an unspecified indication from 28Sep2021 to an unspecified stop date. Historical vaccine included dose 1 and dose 2 of BNT162b2 on an unknown date for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. On 29Sep2021, the patient experienced headache dull, neck stiff and fever on 28Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test was resulted negative on an unknown date. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of headache dull, neck stiff was not resolved, and fever was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1802621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334569

Write-up: Bruising; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109302206323220-YZRK0. Safety Report Unique Identifier is GB-MHRA-ADR 26046527. A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on 25Sep2021 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient reported that she was taking birth control pills. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient experienced bruising on 28Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests which included sars-cov-2 test: negative on 27Aug2021 No - Negative COVID-19 test. The outcome of the events was reported as not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1802629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Delirium, Night sweats, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101334248

Write-up: delirium; fever; night long; Dream delirium; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202110010210417470-HUKFQ, Safety Report Unique Identifier GB-MHRA-ADR 26046583. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Sep2021 as DOSE 1, 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. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced fever, night long, delirium. On an 28Sep2021 the patient experienced dream delirium. The events were assessed as medically significant. Outcome of Events fever, night long, delirium were unknown while Dream delirium recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1802637 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Diarrhoea, Limb discomfort, Migraine, Pain in extremity, SARS-CoV-2 test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tachyarrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; NAPROXEN
Current Illness: Pain
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 INC202101334335

Write-up: Heart fluttering; Arm discomfort; Diarrhea; Migraine; arm has been painful; This is a spontaneous report from a contactable consumer. This is report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110010631492120-LVBYC, Safety Report Unique Identifier number is (GB-MHRA-ADR 26046618). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 28Sep2021 (age at the vaccination was 30-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing pain from an unknown date. Patient was not enrolled in clinical trial. Unsure if patient had symptoms associated with COVID-19. Patient was not breastfeeding. Concomitant medications included codeine taken for pain, start and stop date were not reported; naproxen taken for pain, start and stop date were not reported. On 28Sep2021, from the time of vaccination, the patient experienced arm has been painful, arm discomfort, later migraine started on the same day of vaccination and on the evening after getting the vaccine diarrhea started. On 29Sep2021, heart fluttering started and comes and goes since vaccination. The patient lab test which included COVID-19 virus test was no-negative COVID-19 test on an unspecified date. Therapeutic measures were taken as a result of migraine with paracetamol had not responded. The outcome of the event diarrhea was resolved on 29Sep2021. The outcome of the other events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1802638 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Lymphadenopathy, Migraine, Off label use, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101334316

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202110010716451510-RDN8C; safety report unique identifier: GB-MHRA-ADR 26046621). A 39-year-old (non-pregnant) female patient received the third (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not known), at the age of 39, via an unspecified route of administration, on Sep 28, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient experienced off-label use and booster dose administration on Sep 28, 2021. The patient had swollen lymph nodes (Sep 29, 2021), migraine headache and diarrhea on Sep 30, 2021. The case assessed serious (medically significant). Patient not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: No - Negative COVID-19 test on an unspecified date. The outcome of events: not recovered. No follow-up attempts possible. Batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1802642 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation, Off label use, Palpitations, Vitamin B12 deficiency
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101334363

Write-up: palpitations; dizziness; Off label use; Booster; Vitamin B12 deficiency/Anaemia vitamin B12 deficiency; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110010826365100-BPHMP. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Not known) via an unspecified route of administration on 25Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Previously patient received first dose of historical vaccine COVID-19 VACCINE ASTRAZENECA on 11Feb2021 (Dose 1) and second dose of historical vaccine COVID-19 VACCINE ASTRAZENECA on 21May2021 (Dose 2). The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 25Sep2021 to an unspecified stop date. The patient experienced palpitations (medically significant), dizziness (medically significant), b12 deficiency (medically significant), off label use and booster on an unspecified date; vitamin b12 deficiency (medically significant) on 28Sep2021. It was reported that the patient suffers from well controlled B12 deficiency. She self-injects at a regular time. Within 2 days of receiving the COVID and Flu injections on the first day her B12 deficiency symptoms came back very strongly. The cognitive problems, dizziness and palpitations. As she knows her own body well, she immediately self-injected her cobalamin, thereby stopping further deterioration, and this has resolved the problem. She writes as it may be that those who are dependent on nurse appts for their B12 may be left struggling. Also, that if these injections deplete B12, it may also contribute to long COVID, which appears to have strong similarities to B12 deficiency/PA. Patient has not tested positive for COVID-19 since having the vaccine; Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19; Not had a COVID-19 test. Therapeutic measures were taken because of vitamin b12 deficiency and included treatment with cobalamin. The outcome of the events palpitations, dizziness and b12 deficiency was recovered, while event vitamin b12 deficiency recovered on 29Sep2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1802643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF-2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Off label use, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (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:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334365

Write-up: Itchy rash; off label use; Interchange of vaccine products; This is a spontaneous report from a contactable other HCP. This is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110010832056650-QNIXI. Safety Report Unique Identifier GB-MHRA-ADR 26046611. A 31-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF-2153), via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single (at the age of 31-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Patient was not currently breastfeeding. The patient previously took COVID-19 VACCINE ASTRAZENECA on 19Jan2021 as dose 1, single and COVID-19 VACCINE ASTRAZENECA on 21Mar2021 as dose 2, single for covid-19 immunisation. The patient had off label use and interchange of vaccine products on 28Sep2021. The patient experienced itchy rash to the face, neck, chest and back area on 30Sep2021. No rash at injection site. The case was assessed as serious (medically significant) by the health authority. 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 as no - negative covid-19 test on an unspecified date. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1802650 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dissociation, Dizziness, Fatigue, Feeling of body temperature change, Headache, Immunisation, Myalgia, Off label use, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular 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: VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101334281

Write-up: sore/swollen armpit; Headache; Light-headed/12 hours after vaccination felt light-headed; Tiredness; achy; off label use; Booster; Slight sore arm; feeling hot and cold/ hot/cold went to bed; Muscle ache; Feeling detached; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110011009549690-YYDM2, Safety Report Unique Identifier GB-MHRA-ADR 26046792. A 42-year-old non-pregnant female patient received third dose (booster) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 28Sep2021 (Lot number was not reported, at the age of 42-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 31Dec2020 (Lot number was not reported) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 21Jan2021 (Lot number was not reported) as dose 2, single; both for COVID-19 immunization. Concomitant medication''s included influenza vaccine (INFLUENZA VIRUS) from 28Sep2021; and colecalciferol (VITAMIN D) from 20Apr2019. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. On an unspecified date in 2021, the patient experienced feeling detached. On 28Sep2021, she experienced slight sore arm, feeling hot and cold/ hot/cold went to bed, muscle ache, headache, light-headed/12 hours after vaccination felt light-headed, tiredness, achy, and off label use due to booster dose was observed. On 01Oct2021, she had sore/swollen armpit. It was reported that she had Slight sore arm 3 hours after vaccination but able to keep up with normal activity. 12 hours after vaccination felt light-headed, achy, hot/cold went to bed. Next day initially felt better then hot/cold and achy again. Same next day. Then had sore/swollen armpit. Outcome was resolving for events Feeling detached, Muscle ache and Light-headed/12 hours after vaccination felt light-headed, was not resolved for sore/swollen armpit. Headache was resolved on 29Sep2021, tiredness was resolved on 30Sep2021, feeling hot and cold/ hot/cold went to bed was resolved on 01Oct2021 and outcome was unknown for rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1802671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Chest discomfort, Chills, Dyspnoea, Headache, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (severe); Heart failure; Rheumatoid arthritis (Taking regular medicines for RA (or other types of arthritis except osteoarthritis))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101334671

Write-up: Felt unwell; feverish; shivery; loss of balance; Chest tightness; Breathlessness; Headache; 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-202110011224526680-SATLH, Safety Report Unique Identifier GB-MHRA-ADR 26046815. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 28Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included cardiac failure, severe chronic obstructive pulmonary disease (COPD), and rheumatoid arthritis (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medications were not reported. On 28Sep2021, very soon after the vaccination, the patient felt unwell and as the evening progressed, the patient experienced feverish, shivery, loss of balance, chest tightness, breathlessness, and headache. After 3 days, the patient was starting to improve. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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: 1802686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Blood test, Embolism, Immunisation, Off label use, Peptic ulcer haemorrhage, Platelet count, Salivary hypersecretion, Urinary tract disorder, Urine abnormality
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Proteinuria (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: Bladder cancer; Neoplasm malignant (Patient has history of, or current, malignancy); Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:UNKNOWN RESULT; Comments: Unknown; Test Name: D-dimer; Result Unstructured Data: Test Result:UNKNOWN RESULT; Comments: Unknown; Test Date: 20210930; Test Name: Thromboembolic event; Result Unstructured Data: Test Result:Bleeding pu; Comments: Bleeding pu; Test Name: platelet count; Result Unstructured Data: Test Result:UNKNOWN RESULT; Comments: Unknown; Test Name: MSU; Test Result: Negative ; Comments: msu negative
CDC Split Type: GBPFIZER INC202101325268

Write-up: negative msu; Urine infection; Bleeding PU; Off label use; BOOSTER; This is a spontaneous report from a contactable physician received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110051001007620-WTJ0V. Safety Report Unique Identifier GB-MHRA-ADR 26037351. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported) via an unspecified route of administration on 28Sep2021 as dose 3 (booster) single for COVID-19 immunization. Medical history included bladder cancer, non-tobacco user, neoplasm malignant. The patient did not have a history of, or concurrent, intracranial malignancy. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications were not reported. Past drug event included heparin. Patient previously received bnt162b2 for COVID-19 immunization. On 28Sep2021, the patient received dose 3 (off label use and immunization). On 30Sep2021, the patient experienced bleeding pu (medically significant). On an unspecified date, the patient experienced negative msu, urine infection. The patient underwent lab tests and procedures which included antibody test: unknown result (Unknown); D-dimer: unknown result (Unknown); platelet count: unknown result (Unknown); urine abnormality: negative (msu negative) on unspecified dates and embolism: positive bleeding pu (Bleeding pu) on 30Sep2021. Therapeutic measures were taken as a result of urine infection with antibiotics. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient did not have any previous reactions to medications, especially heparin or anticoagulants. The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The outcome of the events bleeding pu was recovered on 05Oct2021 while for the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1802737 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Dizziness, Electrocardiogram, Hyperglycaemia, Palpitations, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: monitor blood sugar levels; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334379

Write-up: feeling light headed; Heart racing; Hyperglycemia; Felt faint; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110061235340440-K1L7L, Safety Report Unique Identifier GB-MHRA-ADR 26043324. A 36-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number was not reported) via an unspecified route of administration at single dose on 20Sep2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 28Sep2021 (after 8 days of vaccination), patient experienced hyperglycemia and felt faint. On an unspecified date, patient feeling light headed and heart racing (heart palpatations/ feels like heart was racing). Events were reported as medically significant. The patient underwent lab tests and procedures which included electrocardiogram: normal; blood sample taken to monitor blood sugar levels: unknown and COVID-19 virus test: negative (No - Negative COVID-19 test) all on unspecified date. The outcome of events was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1802801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-28
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Inappropriate schedule of product administration, Menstruation delayed, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), Fertility disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101334647

Write-up: not being able to hear; Late period; inappropriate schedule of vaccine administered; Tinnitus; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110061947533840-VRGBK, safety report unique identifier is GB-MHRA-ADR 26045634. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Sep2021 (Lot Number: FF8222) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jul2021 for COVID-19 immunization with late period and painful periods events. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. After second vaccine, the patient still have not started her period which was now 5 days late (late period). According to the patient, this was extremely unusual for her body as she had always had regular periods. On 28Sep2021, the patient experienced tinnitus which was extremely uncomfortable and affecting her every day life which has resulted in her not being able to hear properly and seeking treatment from the doctors. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of late period was recovering. The outcome of tinnitus was not recovered. The outcome of not being able to hear was unknown. The patient also had inappropriate schedule of vaccine administered. The patient underwent lab tests and procedures which included positive COVID-19 test on 09Jul2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101340738 Same patient/vaccine, different dose/ events


VAERS ID: 1803083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-09-28
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101344156

Write-up: Molecular swab positive in vaccinated. Asymptomatic; Vaccination failure; This is a spontaneous report from a contactable other healthcare professional and downloaded from the Agency Regulatory Authority-WEB Regulatory Authority. The Regulatory Authority Report Number is IT-MINISAL02-795336. A 55-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER9470; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in left arm on 29Mar2021 as DOSE 2, 0.3 ML SINGLE, and received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EP9598; Expiration Date: 30Jun2021), via intramuscular route of administration, administered in left arm on 08Mar2021 as DOSE 1, 0.3 ML SINGLE both doses taken for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Sep2021, the patient had molecular swab positive post vaccination, asymptomatic and vaccination failure. On 28Sep2021, the patient underwent lab tests and procedures which included COVID-19 PCR test positive. The outcome of the event COVID-19 was recovering at the time of report.


VAERS ID: 1803084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-09-28
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101344164

Write-up: Molecular swab positive in vaccinated. Asymptomatic; Molecular swab positive in vaccinated. Asymptomatic; Molecular swab positive in vaccinated. Asymptomatic; This is a spontaneous report from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-795337. A 31-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246, Expiration Date: 31Jul2021), intramuscularly administered in left arm on 08Apr2021 as dose 1, 0.3 ml single and dose 2, intramuscularly administered in left arm on 29Apr2021 (Lot Number: EX3599, Expiration Date: 31Aug2021) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced molecular swab positive in vaccinated. asymptomatic. On 28Sep2021, the patient underwent lab tests and procedures which included COVID-19 PCR test: positive. The outcome of the events was not resolved.


VAERS ID: 1803139 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Areflexia, Autoimmune disorder, Blood glucose, CSF protein, CSF white blood cell count, Cardiac electrophysiologic study, Full blood count, Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging, Magnetic resonance imaging head, Nerve conduction studies, Protein total, Sensory disturbance, Sjogren's syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Lacrimal disorders (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: Glucose; Result Unstructured Data: Test Result:70; Test Date: 20211001; Test Name: Electrophysiological study; Result Unstructured Data: Test Result:Not consistent with GBS; Test Date: 20211001; Test Name: cerebrospinal fluid protein level; Result Unstructured Data: Test Result:above the laboratory reference range; Test Date: 20211001; Test Name: cerebrospinal fluid white blood cell count; Result Unstructured Data: Test Result:below 50 cells/mcL; Test Date: 20211001; Test Name: Cell count; Result Unstructured Data: Test Result:1; Test Date: 20211001; Test Name: spinal-cord MRI; Test Result: Negative ; Test Date: 20211001; Test Name: head MRI; Test Result: Negative ; Test Date: 20211001; Test Name: nerve conduction test; Test Result: Negative ; Test Date: 20211001; Test Name: Protein; Result Unstructured Data: Test Result:41
CDC Split Type: JPPFIZER INC202101319983

Write-up: total loss of deep tendon reflex; decrease in position sensation and deep sensation/acute worsening of sensory disturbance in deep/pain and temperature sensation; unable to walk; difficulty in walking; Guillain-Barre syndrome; Sjogren''s syndrome; Autoimmune disease; numbness of upper extremities; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21128737. A 55-year and 10-month-old female patient received the first dose of bnt162b2 (Comirnaty, Lot number was reported as unknown) via an unspecified route of administration on 15Sep2021 at 10:00 (at the age of 55-year ) as a single dose for COVID-19 immunization. The patient had no family history. There were no points provided 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, etc.). On 15Sep2021 at 10:00 (the day of the vaccination), the patient received first dose of bnt162b2. On 28Sep2021 at 10:00 (13 days after the vaccination), the patient experienced Guillain-Barre syndrome and to be hospitalized on 01Oct2021(16 days after the vaccination) and still not discharged. The course of the event was as follows: On 15Sep2021, the patient received the first dose of COMIRNATY intramuscular injection for prevention of COVID-19 infection. Immediately after the dose, no major adverse events were noted. 28Sep2021, the event appeared with numbness of upper extremities. 29Sep2021, the patient had a difficulty in walking. On 30Sep2021, the patient became unable to walk. On 01Oct2021, the patient visited the hospital. On physical findings, total loss of deep tendon reflex and decrease in position sensation and deep sensation were noted. Negative results in head MRI, spinal-cord MRI and nerve conduction test were obtained. Considering the acute course and the symptoms, the possibility of Guillain-Barre syndrome was highly likely, and thus high dose immunoglobulin therapy was started. On 04Oct2021 (19 days after the vaccination), the outcome of the event was recovering tendency. The reporter concluded as follows: The event developed 13 days after the first dose of COMIRNATY, with an acute worsening of sensory disturbance in deep/pain and temperature sensation. The acute course was consistent with Guillain-Barre syndrome while differential diagnoses included Sjogren''s syndrome based on the symptoms. With a limited number of reported cases of Guillain-Barre syndrome in relation to the vaccine, it was difficult to assess the causality; however, it was meaningful to report this case for further accumulation of case data. GBS form reported as: The patient had clinical symptoms included: decreased or lost deep tendon reflex in the upper or lower limbs with muscular weakness and able to walk 5 meters with a walker or support. The course of disease was reported as disease showing a monophasic pathological pattern with the interval of 12 hours to 28 days between the onset of muscular weakness and the nadir, followed by clinically stable phase (This option should be selected based on the course until this report). On 01Oct2021, the patient received Electrophysiological study and the result was reported as Not consistent with GBS. On 01Oct2021, the patient received Cerebrospinal fluid test and the result was reported as Cell count 1, Glucose 70, Protein 41, Protein-cytological dissociation present (Increased cerebrospinal fluid protein level above the laboratory reference range and total cerebrospinal fluid white blood cell count below 50 cells/mcL) Other diseases are excluded. On 01Oct2021, the patient received Imaging examination (Magnetic resonance imaging (MRI)) On an unspecified date, the patient received autoantibody test, the result was still currently under examination. The patient had no preceding infection. The reporter classified the event as serious, hospitalization and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases were reported as Autoimmune disease. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1803142 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Body temperature, Feeling abnormal, Oropharyngeal discomfort, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101320580

Write-up: Anaphylaxis; Asthmatic attack; feels poorly; Pharynx strange sensation of; wheezing; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21128779. A 39-year-and-8-month-old female patient (age at the vaccination) on 28Sep2021 at 14:30 (the day of the vaccination), received the first dose of BNT162B2 (COMIRNATY, Lot number FF9942, Expiration date was 30Nov2021) via an unspecified route of administration at a single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade. 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) as follows: Asthma. On 28Sep2021 at 15:00 (30 minutes after the vaccination), the patient experienced Anaphylaxis. On 28Sep2021 (the day of the vaccination), the patient was admitted to the hospital and discharged on 29Sep2021. The course of the event was as follows: from after received the vaccination, feels poorly and Pharynx strange sensation of occurred. And wheezing occurred, then steroid and Antihistamine administration. After that, it was tend to improve gradually. On 29Sep2021 (the day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (caused hospitalization from 28Sep2021 to 29Sep2021) 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: It was thought that Asthmatic attack due to received the vaccination.


VAERS ID: 1803308 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8773 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101333622

Write-up: Fainting; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. The regulatory authority report number PH-PHFDA-300109071. A 34-year-old female patient received bnt162b2 (COMIRNATY) at the age of 34-year-old, intramuscular on 28Sep2021 (Batch/Lot Number: FH8773) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fainting on 28Sep2021 10:38 with outcome of recovered on 28Sep021 10:44. Seriousness criteria of the events was medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1803404 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 082F21B-CDC / 2 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Gait disturbance, Peripheral swelling, Pyrexia, Vein disorder
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Amyotrophic lateral sclerosis (patient had ALS, but with ability to walking with crutches)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: vein obstruction; Swelling in left foot; inability to walking; mild fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of VEIN DISORDER (vein obstruction) and PERIPHERAL SWELLING (Swelling in left foot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082F21B-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Amyotrophic lateral sclerosis (patient had ALS, but with ability to walking with crutches). On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 28-Sep-2021, the patient experienced PYREXIA (mild fever). On 29-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swelling in left foot) (seriousness criteria hospitalization and medically significant) and GAIT DISTURBANCE (inability to walking). On 02-Oct-2021, the patient experienced VEIN DISORDER (vein obstruction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 02-Oct-2021 due to PERIPHERAL SWELLING and VEIN DISORDER. At the time of the report, VEIN DISORDER (vein obstruction), PERIPHERAL SWELLING (Swelling in left foot), GAIT DISTURBANCE (inability to walking) and PYREXIA (mild fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment medication was not provided. On 02-Oct-2021, patient visited the outpatient for ALS and was admitted to the emergency department for examinations. It was initially showed that the patient developed vein obstruction and was recommended to receive surgery, 10/7 the patient was transferred to the Cardiology Department for treatment and also was recommended to receive surgery. Therefore, on 15-Oct-2021 the patient was expected to receive surgery.; Sender''s Comments: This case concerns a 74-year-old male patient with a history of amyotrophic lateral sclerosis, who experienced the unexpected, serious (medically significant) events of pyrexia, peripheral swelling, gait disturbance and vein disorder. The events occurred between 1-4 days after the second ose of mRNA-1273. The rechallenge was not applicable since information for the first dose was not disclosed. The medical history of amyotrophic lateral sclerosis is a confounder. ll the events'' seriousness assessments have been retained as per Regulatory Authority reporting. Pyrexia is an expected event but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1803739 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Discomfort, Dizziness, Dyspnoea, Hyperglycaemia, Hyperlipidaemia, Hypertension, Palpitations
SMQs:, Anaphylactic reaction (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (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 (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Lipodystrophy (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: TWMODERNATX, INC.MOD20213

Write-up: Chest pain/chest distress; Hypertension; Hyperglycemia; Hyperlipidemia; Discomfort; Hypertension; Difficulty breathing; Palpitations; Dizziness; This regulatory authority case was reported by a pharmacist and describes the occurrence of CHEST PAIN (Chest pain/chest distress) and the first episode of HYPERTENSION (Hypertension) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced CHEST PAIN (Chest pain/chest distress) (seriousness criterion hospitalization), the first episode of HYPERTENSION (Hypertension) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing), PALPITATIONS (Palpitations) and DIZZINESS (Dizziness). On 05-Oct-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycemia), HYPERLIPIDAEMIA (Hyperlipidemia), DISCOMFORT (Discomfort) and the second episode of HYPERTENSION (Hypertension). On 07-Oct-2021, last episode of HYPERTENSION (Hypertension) had resolved. At the time of the report, CHEST PAIN (Chest pain/chest distress) was resolving, DYSPNOEA (Difficulty breathing), PALPITATIONS (Palpitations) and DIZZINESS (Dizziness) outcome was unknown and HYPERGLYCAEMIA (Hyperglycemia), HYPERLIPIDAEMIA (Hyperlipidemia) and DISCOMFORT (Discomfort) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. On 28-Sep-2021, the patient developed hypertension and chest distress the day before and returned from the hospital this morning. Patient felt better after taking drugs. On 05-Oct-2021, the patient had discomfort due to hypertension, hyperglycemia and hyperlipidemia and had recovered after taking drugs. Company Comment: This is a regulatory case concerning a 79 year-old, female patient with no relevant history who experienced the unexpected serious events of CHEST PAIN and HYPERTENSION and other non-serious events. The events occurred the following day after the first dose of Spikevax The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 79 year-old, female patient with no relevant history who experienced the unexpected serious events of CHEST PAIN and HYPERTENSION and other non-serious events. The events occurred the following day after the first dose of Spikevax The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1803778 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood creatinine, Chest pain, Decreased appetite, Dizziness, Fatigue, Fibrin D dimer, Hypertension, Insomnia, Malaise, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: GPT; Result Unstructured Data: 29IU/L,; Test Date: 20211006; Test Name: Creatinine; Result Unstructured Data: 0.67mg/dL; Test Date: 20211006; Test Name: Fragment D dimer; Result Unstructured Data: 437.9ng/mL
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Loss of appetite; Malaise; chest pain; abnormal breathing; extreme fatigue; dizziness; sleeplessness; high blood pressure; This regulatory authority case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Malaise), CHEST PAIN (chest pain), RESPIRATION ABNORMAL (abnormal breathing), FATIGUE (extreme fatigue), DIZZINESS (dizziness), INSOMNIA (sleeplessness) and HYPERTENSION (high blood pressure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced DECREASED APPETITE (Loss of appetite) (seriousness criterion hospitalization prolonged), MALAISE (Malaise) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), RESPIRATION ABNORMAL (abnormal breathing) (seriousness criterion hospitalization prolonged), FATIGUE (extreme fatigue) (seriousness criterion hospitalization prolonged), DIZZINESS (dizziness) (seriousness criterion hospitalization prolonged), INSOMNIA (sleeplessness) (seriousness criterion hospitalization prolonged) and HYPERTENSION (high blood pressure) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 06-Oct-2021 due to CHEST PAIN, DECREASED APPETITE, DIZZINESS, FATIGUE, INSOMNIA, MALAISE and RESPIRATION ABNORMAL. At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Malaise), CHEST PAIN (chest pain), RESPIRATION ABNORMAL (abnormal breathing), FATIGUE (extreme fatigue), DIZZINESS (dizziness), INSOMNIA (sleeplessness) and HYPERTENSION (high blood pressure) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Alanine aminotransferase: 29 (normal) 29IU/L. On 06-Oct-2021, Blood creatinine: 0.67 (normal) 0.67mg/dL. On 06-Oct-2021, Fibrin D dimer: 437.9 (abnormal) 437.9ng/mL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 07-0ct-2021 patient remained developed general malaise, and high blood pressure, and received Antihypertensive drugs for treatment no treatment information were provided Company Comment : This case concerns a 71-year-old female patient with previous relevant medical history of Blood pressure high, who experienced the unexpected events of Decreased Appetite, Malaise, Chest Pain, Respiration Abnormal, Fatigue, Dizziness, Insomnia, and Hypertension. The event occurred on the same day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The medical history of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old female patient with previous relevant medical history of Blood pressure high, who experienced the unexpected events of Decreased Appetite, Malaise, Chest Pain, Respiration Abnormal, Fatigue, Dizziness, Insomnia, and Hypertension. The event occurred on the same day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The medical history of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1803782 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-28
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient said she had no chronic diseases before and had a 50-year history of smoking. She smoked a pack of cigarettes a day, and did not quit smoking.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Acute myocardial infraction; Chest pain; dyspnea; This regulatory authority case was reported by a pharmacist and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infraction), CHEST PAIN (Chest pain) and DYSPNOEA (dyspnea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Patient said she had no chronic diseases before and had a 50-year history of smoking. She smoked a pack of cigarettes a day, and did not quit smoking. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 28-Sep-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infraction) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and DYSPNOEA (dyspnea) (seriousness criterion hospitalization). At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infraction), CHEST PAIN (Chest pain) and DYSPNOEA (dyspnea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No, Concomitant medications were provided. On October 1, 2021, the chest pain lasted for a whole day and extended to the back and chin, and worsened when the patient took a deep breath or changed positions. The patient then consulted the thoracic medicine clinic. EKG showed 3 degree AV block and the patient was transferred to emergency department for treatment, where cardiac catheterization and TMP implantation were arranged. The patient was diagnosed with AMI and hospitalized. The follow-up care was as follows. Company comment -This case concerns a 71 year old female patient with history of smoking, who experienced the unexpected events of acute myocardial infarction, chest pain and dyspnoea. The events occurred on the same day after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. Patient''s history of smoking remains a confounder. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71 year old female patient with history of smoking, who experienced the unexpected events of acute myocardial infarction, chest pain and dyspnoea. The events occurred on the same day after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. Patient''s history of smoking remains a confounder. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1804935 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN CALCIUM; ASAFLOW; LANTUS; COVERSYL AM; EMCONCOR; NOVORAPID; SILDENON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101339408

Write-up: Drug ineffective; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107264. A 64-year-old male patient received bnt162b2 (COMIRNATY) on 11May2021 (Lot number was not reported) as dose 2, single, and on an unspecified date (Lot number was not reported) as dose 1, single both via an unspecified route of administration for covid-19 immunisation. The patient medical history included diabetes and hypertension. Concomitant medications included atorvastatin calcium; acetylsalicylic acid (ASAFLOW); insulin glargine (LANTUS); amlodipine besilate, perindopril erbumine (COVERSYL AM); bisoprolol fumarate (EMCONCOR); and insulin aspart (NOVORAPID); all were taken for an unspecified indication, start and stop date were not reported; and sildenafil citrate (SILDENON) taken for an unspecified indication from 11May2021 to 11May2021. On 28Sep2021, the patient experienced covid-19 and drug ineffective. Therapeutic measures were taken as a result of the events as the patient received O2 and dexamethasone. The patient was hospitalized due to the events. The outcome of the events was recovering. No follow up attempts are possible. Information about batch number cannot be obtained. No further information is expected.; Reporter''s Comments: ~~~


VAERS ID: 1806637 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Insomnia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101341824

Write-up: Difficulty breathing; insomnia; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110071257065460-B6ION, Safety Report Unique Identifier GB-MHRA-ADR 26048206. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF2153), via an unspecified route of administration on 28Sep2021 (at the age of 37-year-old) as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 01Jan2021 to 02Mar2021. The patient''s concomitant medications were not reported. On 28Sep2021, patient experienced difficulty breathing and on an unknown date in 2021, he had insomnia sought advice from 111 and GP (general practitioner). The case was assessed as serious (medically significant). 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 COVID-19 virus test: no - negative COVID-19 test on 08Aug2021. Outcome of the event insomnia was unknown and event difficulty breathing was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1806682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Illness, Insomnia, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20211005; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101341758

Write-up: Head pain/Severe head pain; sickness; chills; insomnia; nausea; pains in both legs; sweats; This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110071832356720-LDKXK, Safety Report Unique Identifier GB-MHRA-ADR 26050054. A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: FF8222, Expiration fate: Unknown), via an unspecified route of administration on 22Sep2021, as dose1 single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. On 28Sep2021, the patient experienced head pain/severe head pain. On unspecified dates in 2021, the patient experienced sickness, chills, insomnia, nausea, pains in both legs, sweats. Events were reported as serious, medically significant and led to hospitalization. The patient''s hospitalization was prolonged as a result of sickness, chills, insomnia, nausea, head pain/severe head pain and sweats. Patient experienced Severe head pain, sweats, chills, nausea, sickness, pains in both legs, insomnia. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 05Oct2021. The outcome of event Head pain/Severe head pain was not resolved and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1806916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Contusion, Ear pain, Eye pain, Hypoaesthesia, Insomnia, Jaw disorder, Migraine, Nausea, Swelling face, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Other ischaemic heart disease (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101327903

Write-up: heart pain; numbness arm hand; nausea; blocked jaw; migraine; left ear pain; vomiting; left eye pain; swollen cheek; bruising arm; insomnia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-794275. A female patient of an unspecified age received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 28Sep2021 (Batch/Lot Number: FG7387) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, immediately after vaccination, the patient had heart pain and numbness arm hand. On the same day after 1 hour of vaccination, the patient had nausea, blocked jaw, migraine, left ear pain, vomiting, left eye pain, and swollen cheek. In the evening on the same day, the patient had bruising arm and insomnia. The outcome of the events was recovering.


VAERS ID: 1807252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Dizziness postural, Gait disturbance, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211039104

Write-up: Orthostatic dizziness; Difficulty in walking; Chills; Tremor; Felt faint; This spontaneous report received from a consumer via Regulatory Authority (RO-NMA-2021-SPCOV12774) on 20-OCT-2021 and concerned a 31 year old female of an unspecified race and ethnic origin. The patient''s weight was 52 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, frequency 1 total, administered on 27-SEP-2021 for active immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-SEP-2021, the patient experienced orthostatic dizziness, difficulty in walking, chills, tremor and felt faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from orthostatic dizziness, difficulty in walking, chills, tremor, and felt faint on 29-SEP-2021. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1807300 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-09-28
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Neoplasm progression, Thyroid cancer metastatic
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (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: Neck mass (Benign tumor of the right neck 10 years ago)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Neck tumour had metastasized; Thyroid cancer / cervical tumor had metastasized to the lung; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Oct-2021 and was forwarded to Moderna on 13-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEOPLASM PROGRESSION (Neck tumour had metastasized) and THYROID CANCER METASTATIC (Thyroid cancer / cervical tumor had metastasized to the lung) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Neck mass (Benign tumor of the right neck 10 years ago). On 11-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced THYROID CANCER METASTATIC (Thyroid cancer / cervical tumor had metastasized to the lung) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NEOPLASM PROGRESSION (Neck tumour had metastasized) (seriousness criterion hospitalization). The patient was hospitalized until 30-Sep-2021 due to NEOPLASM PROGRESSION. At the time of the report, NEOPLASM PROGRESSION (Neck tumour had metastasized) and THYROID CANCER METASTATIC (Thyroid cancer / cervical tumor had metastasized to the lung) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This case concerns a 66-year-old female patient with a previous relevant medical history of Neck mass, who experienced the unexpected serious event of Thyroid cancer Metastasic and Neoplasm progression after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred approximately 2 months and 17 days after the dose of Spikevax, dose number unknown. Neck mass had been known for 10 years, and it was reported to be benign. Very limited information was provided regarding the mass clinical course, previous assessment, histologic diagnosis and treatment. The rechallenge is not applicable. Previous history of neck mass remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender''s Comments: This case concerns a 66-year-old female patient with a previous relevant medical history of Neck mass, who experienced the unexpected serious event of Thyroid cancer Metastasic and Neoplasm progression after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred approximately 2 months and 17 days after the dose of Spikevax, dose number unknown. Neck mass had been known for 10 years, and it was reported to be benign. Very limited information was provided regarding the mass clinical course, previous assessment, histologic diagnosis and treatment. The rechallenge is not applicable. Previous history of neck mass remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report


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