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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1937674 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness, Eye pain, Headache, Pruritus, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Convulsions; Hearing loss; Headache; Eye pain; Itching; High temperature; This case was received via Regulatory Authority-RA (Reference number: GB-MHRA-ADR 26263260) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DEAFNESS (Hearing loss), HEADACHE (Headache), EYE PAIN (Eye pain), PRURITUS (Itching) and PYREXIA (High temperature) in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), DEAFNESS (Hearing loss) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), EYE PAIN (Eye pain) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, SEIZURE (Convulsions) and PYREXIA (High temperature) was resolving and DEAFNESS (Hearing loss), HEADACHE (Headache), EYE PAIN (Eye pain) and PRURITUS (Itching) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. Company Comment: This case concerns a 39-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Seizure, Deafness, Headache, Eye pain, Pruritus and Pyrexia. The events occurred the day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 39-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Seizure, Deafness, Headache, Eye pain, Pruritus and Pyrexia. The events occurred the day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1938150 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: BLOOD PRESSURE; Result Unstructured Data: Test Result:140/100; Comments: High
CDC Split Type: PHPFIZER INC202101663254

Write-up: HIGH BLOOD PRESSURE(140/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120190 (RA). A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant) with onset 18Nov2021 10:59, outcome "recovered" (18Nov2021), described as "HIGH BLOOD PRESSURE(140/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 140/100, notes: High. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938153 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Fall, Heart rate, Loss of consciousness, Oxygen saturation, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:110/80 mmHg; Test Date: 20211118; Test Name: heart rate; Result Unstructured Data: Test Result:77; Comments: bpm; Test Date: 20211118; Test Name: Oxygen saturation; Test Result: 96 %
CDC Split Type: PHPFIZER INC202101663276

Write-up: Fainting; BLACKED OUT; Dizziness; Pain at injection site; fell on the floor; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120206. A 14 year-old female patient (unknown if pregnant) received bnt162b2, intramuscular, administration date 18Nov2021 10:33 (Lot number: 32025BD) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 10:38, outcome "recovered" (18Nov2021 12:00), described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant) with onset 18Nov2021 10:38, outcome "recovered" (18Nov2021 12:00), described as "BLACKED OUT"; DIZZINESS (non-serious) with onset 18Nov2021 10:38, outcome "recovered" (18Nov2021 12:00), described as "Dizziness"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2021 10:38, outcome "recovered" (18Nov2021 12:00), described as "Pain at injection site"; FALL (non-serious) with onset 18Nov2021 10:38, outcome "unknown", described as "fell on the floor". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 110/80 mmHg; heart rate: (18Nov2021) 77, notes: bpm; oxygen saturation: (18Nov2021) 96 %. Therapeutic measures were taken as a result of syncope, loss of consciousness, dizziness, vaccination site pain, fall. Clinical course: 5 minutes post inoculation, patient was sitting at the post vaccination monitoring area felt dizzy, blacked out and fell on the floor. Medical staff immediately attended to the patient and transferred for monitoring. patient was placed on high fowlers position. Patient was conscious already at the AEFI area and is slowly getting better. Cold compress was placed at the affected area. Paracetamol 500mg was given PO. Doctor on duty referred the patient hospital for further management. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1938155 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/100; Comments: 13:20
CDC Split Type: PHPFIZER INC202101663317

Write-up: "HIGH BLOOD PRESSURE(140/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120245 (PHFDA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 13:20, outcome "recovered" (18Nov2021), described as ""HIGH BLOOD PRESSURE(140/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 140/100, notes: 13:20. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938156 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0008 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663324

Write-up: Fainting; Diaphoresis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120262 (PHFDA). A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCA0008) at the age of 12 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 11:00, outcome "recovered" (18Nov2021 12:00), described as "Fainting"; HYPERHIDROSIS (non-serious) with onset 18Nov2021 11:00, outcome "recovered" (18Nov2021 12:00), described as "Diaphoresis". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938159 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:125/75 mmHg; Comments: PREVACCINATION; Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:180/158 mmHg; Comments: POST VACCINATION
CDC Split Type: PHPFIZER INC202101663367

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120309 (PHFDA). A 14 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: 32025BD) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 125/75 mmHg, notes: PREVACCINATION; (18Nov2021) 180/158 mmHg, notes: POST VACCINATION. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938160 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/100 mmHg; Comments: 14:56
CDC Split Type: PHPFIZER INC202101663397

Write-up: High blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120329 (PHFDA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 14:56, outcome "recovered" (18Nov2021), described as "High blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 140/100 mmHg, notes: 14:56. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938161 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: 14:18
CDC Split Type: PHPFIZER INC202101663406

Write-up: High blood pressure (160/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120316 (PHFDA). A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 14:18, outcome "recovered" (18Nov2021 14:18, as reported), described as "High blood pressure (160/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 160/100 mmHg, notes: 14:18. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938162 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:130/100 mmHg
CDC Split Type: PHPFIZER INC202101663410

Write-up: High blood pressure (130/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120331 (PHFDA). A 15 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 15:18, outcome "recovered" (18Nov2021), described as "High blood pressure (130/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 130/100 mmHg.


VAERS ID: 1938178 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-11-18
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG8643 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID; Test Result: Positive
CDC Split Type: PHPFIZER INC202101663710

Write-up: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: RA-300120848 (RA). A 49 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 07Sep2021 (Lot number: FG8643) at the age of 48 years as dose 2, single and intramuscular, administration date 17Aug2021 (Lot number: FF8671) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.


VAERS ID: 1939204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101698596

Write-up: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 669770 (RA ADR#). A 15 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Myocarditis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Malaise, Muscular weakness, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670606

Write-up: Booster; Diarrhoea; Muscular weakness; Malaise/illness; off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority (RA). Regulatory number: GB-MHRA-ADR 26243126 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Astra zeneca (Dose-1), administration date: 05Feb2021, for COVID-19 immunisation, reaction(s): "weakness in limbs", "sickness/generally feeling WELL below par", "diarrhoea"; Astra zeneca (Dose-2), administration date: 30Apr2021, for COVID-19 immunization, reaction(s): "weakness in limbs-milder", "feeling slightly unwell-milder", "diarrhoea-milder". The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DIARRHOEA (medically significant), outcome "recovered", described as "Diarrhoea"; MUSCULAR WEAKNESS (medically significant), outcome "unknown", described as "Muscular weakness"; MALAISE (medically significant), outcome "unknown", described as "Malaise/illness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest pain, Drug ineffective, Dyspnoea, Fatigue, Heart rate, Myocarditis, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia, Vaccination site bruising, Vaccination site mass, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hair loss; Nephrotic syndrome; Pregnancy (I gave birth to my son 6 months ago)
Allergies:
Diagnostic Lab Data: Test Name: resting heart rate; Result Unstructured Data: Test Result:feels like it''s gone faster as well; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101670599

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Racing heart (tachycardia); left arm where I was injected is very painful; there is a black bruise there along with a bump; there is a black bruise there along with a bump; report relates to possible inflammation of the heart (myocarditis or pericarditis); report relates to possible inflammation of the heart (myocarditis or pericarditis); COVID-19 virus test: Yes - Positive COVID-19 test; COVID-19 virus test: Yes - Positive COVID-19 test; breathlessness; Heart racing/ Heart palpitations; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111242157383510-BVRQQ (RA). Other Case identifier: GB-MHRA-ADR 26247008 (RA). A 25 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Nephrotic syndrome" (unspecified if ongoing); "Pregnancy" (unknown if ongoing), notes: I gave birth to my son 6 months ago; "Alopecia" (unknown if ongoing). Patient''s last menstrual period date was 20Oct2021. It''s been two months since I began losing a lot of hair, I have lost my right brow, I don''t know if that''s postpartum hair loss or something else, my father had an immune disorder at my age. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The following information was reported: DYSPNOEA (medically significant), outcome "recovering", described as "breathlessness"; PALPITATIONS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Heart racing/ Heart palpitations"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "left arm where I was injected is very painful"; VACCINATION SITE BRUISING (medically significant), VACCINATION SITE MASS (medically significant), outcome "unknown" and all described as "there is a black bruise there along with a bump"; MYOCARDITIS (medically significant), PERICARDITIS (medically significant), outcome "unknown" and all described as "report relates to possible inflammation of the heart (myocarditis or pericarditis)"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 virus test: Yes - Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: heart rate: feels like it''s gone faster as well; COVID-19 virus test: Yes - positive covid-19 test. Clinical course: Chest pain, fatigue/unusual tiredness, fever, heart racing, tachycardia. Heart palpitations and breathlessness. I don''t really go out much but when I am going and up and down the stairs, I feel very breathless or just doing a small task makes me very breathless along with my heart racing when I haven''t done anything much. My resting heart rate feels like it''s gone faster as well. My left arm where I was injected is very painful and there is a black bruise there along with a bump. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. There was no diagnosis made by a medical professional. If none of the above symptoms were experienced, can you confirm that there were no symptoms?: "No" (as reported). There were no imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940857 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Chest pain, Discomfort, Hypokinesia, Immunisation, Interchange of vaccine products, Off label use, Pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670480

Write-up: Booster; chest pain; Chest pain aggravated; Armpit pain; achey; felt heavy; left breast (injection was received in left arm); unable to move my arm; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111251104556940-U7VBO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26249148 (MHRA). A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Nov2021 11:55 (Lot number: FK0596) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 19Nov2021, stop date: 21Nov2021. Date of last menstrual period: 12Sep2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series complete but unknown manufacturer.), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; CHEST PAIN (medically significant), outcome "recovering", described as "chest pain"; CHEST PAIN (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Chest pain aggravated"; AXILLARY PAIN (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Armpit pain"; PAIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "achey"; DISCOMFORT (medically significant) with onset 19Nov2021, outcome "unknown", described as "felt heavy"; BREAST PAIN (medically significant) with onset 19Nov2021, outcome "unknown", described as "left breast (injection was received in left arm)"; HYPOKINESIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "unable to move my arm". Therapeutic measures were taken as a result of chest pain, chest pain, axillary pain, pain, discomfort, breast pain, hypokinesia. Clinical course: It was reported that on 19Nov2021, pain was too painful to sleep, took pain killers. Later that evening the pain moved to my left armpit, very achey. She was unable to move her arm in certain positions (she couldn''t squeeze her arm into her side, it hurt too much) and every now and then there was a shooting pain. This went on until the evening of Sunday 20Nov2021 around 18:00, when I felt better, less achey and less tired. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Follow-up attempts are completed. No further information is expected.


VAERS ID: 1940876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chills, Headache, Hypoaesthesia, Immunisation, Interchange of vaccine products, Muscle spasms, Musculoskeletal chest pain, Nausea, Neuralgia, Off label use, Pyrexia, Walking disability
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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? 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: 20211119; Test Name: Fever; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101670437

Write-up: numbness and pain including spasm in ribs; chills; Fever; Headache; Nausea; Shivers; Muscle spasm; Weakness; Nerve pain; Numbness; Morning after vaccine unable to walk for a day; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111251416533520-LMYSN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26252833 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; MUSCULOSKELETAL CHEST PAIN (medically significant), outcome "not recovered", described as "numbness and pain including spasm in ribs"; CHILLS (medically significant), outcome "not recovered", described as "chills"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "Fever"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Headache"; NAUSEA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Nausea"; CHILLS (medically significant) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Shivers"; MUSCLE SPASMS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Muscle spasm"; ASTHENIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Weakness"; NEURALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Nerve pain"; HYPOAESTHESIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Numbness"; WALKING DISABILITY (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Morning after vaccine unable to walk for a day". The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) unknown results. Clinical Information: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940877 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH 4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate increased, Pain, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670450

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111251428258240-JUN8R (MHRA). Other Case identifier(s): GB-MHRA-ADR 26252815 (MHRA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18 Nov 2021 (Lot number: FH 4751) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (medically significant) with onset 2021, outcome "recovering", described as "increased heart beat"; PAIN (medically significant) with onset 2021, outcome "recovering", described as "pain"; PALPITATIONS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Palpitations"; CHEST PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Chest pain". Patient was in touch with a doctor at that moment to investigate the issue further. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial and the report dose not relate to possible inflammation of the heart. No follow up attempts are possible. No further information is expected.


VAERS ID: 1940906 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Immunisation, Insomnia, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; NAPROXEN; Inhaler
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101670438

Write-up: Off label use; interchange of vaccine products; Booster; Insomnia; Backache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111251921080300-4GG8B. Other Case identifier(s): GB-MHRA-ADR 26253587. A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH4751) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation; NAPROXEN taken for arthritis; Inhaler taken for COPD, start date: 20Mar2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/lot number: PV46671), administration date: 12Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2, Batch/lot number: PV46693), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; INSOMNIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Insomnia"; BACK PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Backache". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (21Jan2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1940910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101670600

Write-up: Diarrhea; Urge incontinence; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111252112335410-UBJZF (RA). Other Case identifier(s): GB-MHRA-ADR 26253682 (RA). A 70 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK0112) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Primary Immunization series complete but unknown manufacturer), administration date: 12Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2, Primary Immunization series complete but unknown manufacturer), administration date: 29Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Diarrhea"; URGE INCONTINENCE (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Urge incontinence". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1940957 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Fatigue, Feeling abnormal, Hypersomnia, Immunisation, Interchange of vaccine products, Off label use, Post viral fatigue syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675051

Write-up: Off label use; Interchange of vaccine products; Booster; Fatigue aggravated; Falling asleep multiple times per day; Brain fog; Exacerbated symptoms of M.E; confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111260920435360-HJYWN. Other Case identifier(s): GB-MHRA-ADR 26256186. A 20-year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Covid-19 vaccine astrazeneca (Dose number unknown,), for COVID-19 immunisation; Covid-19 vaccine (Dose number unknown,), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 18Nov2021, outcome "unknown", described as "Booster"; CONFUSIONAL STATE (disability) with onset 2021, outcome "not recovered", described as "confusion"; FATIGUE (disability) with onset 18Nov2021, outcome "not recovered", described as "Fatigue aggravated"; HYPERSOMNIA (disability) with onset 2021, outcome "unknown", described as "Falling asleep multiple times per day"; FEELING ABNORMAL (disability) with onset 2021, outcome "unknown", described as "Brain fog"; POST VIRAL FATIGUE SYNDROME (disability) with onset 2021, outcome "unknown", described as "Exacerbated symptoms of M.E". The clinical course was as follows: Falling asleep multiple times per day Brain fog and confusion Exacerbated symptoms of M.E. significantly Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not 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: 1941001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Intermenstrual bleeding, Off label use
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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...); Shingles; SLE
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675044

Write-up: Shingles; Intermenstrual bleeding; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111261350513140-HXR3X (MHRA). Other Case identifier(s): GB-MHRA-ADR 26257090 (MHRA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "shingles", start date: Jun2020 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Mirena. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 IMMUNISATION; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Shingles"; INTERMENSTRUAL BLEEDING (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Intermenstrual bleeding". Therapeutic measures were taken as a result of herpes zoster. Clinical course: Patient last menstrual period date was 23Nov2021. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient had Mirena coil fitted. No bleeding for over a year. Sudden period-like bleeding this week. Had shingles in June 2020; had antivirals. Same symptoms started on Wednesday 24Nov2021. Antivirals given on 26Nov2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1941120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Contusion, Pain in extremity, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101675513

Write-up: After 15 days legs feel sore; Bruising of leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111271009124390-MGVIP (RA). Other Case identifier(s): GB-MHRA-ADR 26260547 (RA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Lot number: FH3220) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 . Lab data included sars-cov-2 test: negative. The following information was reported: CONTUSION (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Bruising of leg"; PAIN IN EXTREMITY (medically significant) with onset 25Nov2021, outcome "unknown", described as "After 15 days legs feel sore". Clinical course: After eight days bruises appeared on tops of legs moving down legs and to calf area. After 15 days legs feel sore. Advised by 111 to go to urgent care for advise. Doctor felt it was reaction to vaccine. Moniting condition. Several blood test were done.


VAERS ID: 1941212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: New daily persistent headache, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101675556

Write-up: Swelling arm; New daily persistent headache; Injection site redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111280730459050-H9NU7 (RA). Other Case identifier(s): GB-MHRA-ADR 26262690 (RA). A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Swelling arm"; NEW DAILY PERSISTENT HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered", described as "New daily persistent headache"; VACCINATION SITE ERYTHEMA (medically significant) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Injection site redness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Oct2021) positive, notes: Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter did not relate the event to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1941246 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: day 2 : local pain; headache; chills; fever; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26272958) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (day 2 : local pain), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and VOMITING (Vomiting) in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (day 2 : local pain) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). On 21-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (day 2 : local pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications available. Day 1: local pain, fever 38oC, headache, chills. Day 2: local pain, vomiting, fever 39oC, headache, chills. Day 3: local pain, headache, diarrhoea. Couldn''t go work during that time. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This is a regulatory case concerning a 52-year-old male patient with no relevant medical history, who experienced the expected events of vaccination site pain, headache, chills, pyrexia and vomiting. The event vomiting occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events occurred on an unknown date. Events were reported as medically significant and at the time of report all have not resolved except for vomiting. As per SD patient also experienced diarrhoea. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 52-year-old male patient with no relevant medical history, who experienced the expected events of vaccination site pain, headache, chills, pyrexia and vomiting. The event vomiting occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events occurred on an unknown date. Events were reported as medically significant and at the time of report all have not resolved except for vomiting. As per SD patient also experienced diarrhoea. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1941267 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FIASP; INSULIN DEGLUDEC; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Immunodeficiency; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: blood sugar; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101727194

Write-up: bad cramps; Heavy periods; Period pains; Booster; MHRA YELLOW CARD VACCINE MONITOR This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA) for a sponsored program. The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing); "Type 1 diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: FIASP taken for type 1 diabetes mellitus; INSULIN DEGLUDEC taken for type 1 diabetes mellitus, start date: 15May2016; LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (Dose 1, Lot number: er1741), administration date: 25Feb2021, for COVID-19 vaccination, reaction(s): "Chills", "Painful arm", "Nausea", "Generalised muscle aches", "Lost my appetite", "Discomfort"; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Heavy periods"; DYSMENORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Period pains"; MUSCLE SPASMS (medically significant), outcome "unknown", described as "bad cramps"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: blood glucose: unknown results. Clinical information: Some of the symptoms were sporadic. the first night after the jab were the worst. The nausea was bad the day following the jab, and had to rest for the day. The patient totally lost my appetite for 3 days. Zero effect on blood sugars from what could see and was able to carry on with normal activities 2 days after the jab with some discomfort. Booster jab: on 2 contraceptive methods - combination pill and mirena coil. The don''t have a period normally. Since the jab patient had heavy bleeding and bad cramps. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the close temporal association, the causal relationship between the events heavy menstrual bleeding, dysmenorrhea and muscle spasms with the administration of suspect product BNT162b2 cannot be completely excluded. The event immunization is assessed in context of the other true associated events. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021246105 same patient, same product, different events/dose.


VAERS ID: 1941287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ragweed allergy (Allergy to ambrosia); Sinus tachycardia (Sinus tachycardia)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211218724

Write-up: BLEEDING INTERMENSTRUAL; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, HR-HALMED-300052418] concerned a 35 year old female. The patient''s weight was 59 kilograms, and height was not reported. The patient''s concurrent conditions included: ragweed allergy (Allergy to ambrosia), and sinus tachycardia. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, intramuscular, batch number and expiry was not reported) 0.5 ml, 1 total administered on 06-NOV-2021 for covid-19 immunisation. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 18-NOV-2021, the patient experienced bleeding intermenstrual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding intermenstrual. This report was serious (Other Medically Important Condition).


VAERS ID: 1941439 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-THYROXIN BERLIN-CHEMIE
Current Illness: Autoimmune thyroiditis
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyreosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202101719264

Write-up: off label use; Interchange of vaccine products; Booster; Urticaria on the shins; Armpit lymph nodes enlarged; Rash on the arms, armpits and both thighs; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: LT-SMCA-4385 (RA). A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyreosis" (unspecified if ongoing); "Autoimmune thyroiditis" (ongoing). Concomitant medication(s) included: L-THYROXIN BERLIN-CHEMIE taken for autoimmune thyroiditis, hypothyroidism, start date: 19Oct2021. Vaccination history included: Vaxzevria covid-19 vaccine (chadox1-s [recombinant]) (2nd dose; Batch/lot number not reported), administration date: 2021, for COVID-19 immunization; Vaxzevria covid-19 vaccine (chadox1-s [recombinant]) (1st dose; Batch/lot number not reported), administration date: 2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant) with onset 18Nov2021, outcome "recovered" (22Nov2021), described as "Urticaria on the shins"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered" (22Nov2021), described as "Armpit lymph nodes enlarged"; RASH (non-serious) with onset 18Nov2021, outcome "recovered" (22Nov2021), described as "Rash on the arms, armpits and both thighs". Therapeutic measure was taken as a result of urticaria, lymphadenopathy, and rash included Zyrtec 10 mg daily for treatment. Clinical course: The patient did not inform her doctor. All symptoms lasted 5 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1944859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis, Myocarditis, Pericarditis, Petechiae, Pleuritic pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20211118; Test Name: body temperature; Result Unstructured Data: Test Result:pyrexia
CDC Split Type: AUPFIZER INC202101698430

Write-up: Haematemesis; Myocarditis; Pericarditis; Petechiae; Pleuritic pain; Pyrexia; Vomiting; This is a spontaneous report received from a contactable Other HCP from Regulatory Authority. Regulatory number: 669141 (TGA ADR number). A 20-year-old male patient received BNT162B2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATEMESIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Haematemesis"; MYOCARDITIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Myocarditis"; PERICARDITIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pericarditis"; PETECHIAE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Petechiae"; PLEURITIC PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Pleuritic pain"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Pyrexia"; VOMITING (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Vomiting". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) pyrexia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1945673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Eosinophil count, Full blood count, Haematocrit, Haematology test, Haemoglobin, Lymphocyte count, Mean cell volume, Neutrophil count, Pancytopenia, Platelet count, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthropathy; Hemochromatosis; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Polynuclear Basophils; Result Unstructured Data: Test Result:0 g/l; Test Date: 20211118; Test Name: Polynuclear eosinophils; Result Unstructured Data: Test Result:0.049 g/l; Test Date: 202110; Test Name: Complete blood count; Result Unstructured Data: Test Result:Normal; Test Date: 20211118; Test Name: Haematocrit; Test Result: 26.8 %; Test Date: 20211118; Test Name: Haematology; Result Unstructured Data: Test Result:2.58; Test Date: 20211118; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.1 g/l; Test Date: 20211118; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.878 g/l; Test Date: 20211118; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:104; Comments: fl; Test Date: 20211118; Test Name: Neutrophils; Result Unstructured Data: Test Result:0.339 g/l; Test Date: 20211118; Test Name: platelets; Result Unstructured Data: Test Result:78 g/l; Test Date: 20211118; Test Name: Leukocytes; Result Unstructured Data: Test Result:1.350 g/l
CDC Split Type: FRPFIZER INC202101695511

Write-up: Pancytopenia; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA. Regulatory number: FR-AFSSAPS-CN20213721 (RA). A 72-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 03Nov2021 (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hemochromatosis" (unspecified if ongoing); "HTA" (unspecified if ongoing); "Arthropathy" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PANCYTOPENIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Pancytopenia". The patient underwent the following laboratory tests and procedures: Polynuclear Basophils (normal high range 0.200): (18Nov2021) 0 g/l; Polynuclear eosinophils (0.04-0.8): (18Nov2021) 0.049 g/l; full blood count: (Oct2021) normal; haematocrit (40-50): (18Nov2021) 26.8 %; haematology test (1.5-5.8): (18Nov2021) 2.58; haemoglobin (13.5-17.5): (18Nov2021) 9.1 g/l; lymphocyte count (1-4.5): (18Nov2021) 0.878 g/l; Mean corpuscular volume: (18Nov2021) 104 fl; neutrophil count (1.8-7.5): (18Nov2021) 0.339 g/l; platelet count (150-450): (18Nov2021) 78 g/l; Leukocytes (4-10): (18Nov2021) 1.350 g/l. Patient had no associated symptoms, no myelogram, no other investigations and had no history of COVID-19 or test history The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1945780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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: Medical History/Concurrent Conditions: COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101628907

Write-up: the skin around my right eye was very swollen, especially around the inner eye; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111190959230990-2MQYQ (RA). Other Case identifier(s): GB-MHRA-ADR 26226356 (RA). A 49-year-old female patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: FK0596) via an unspecified route of administration on 18Nov2021 at 18:00 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history COVID-19 which was confirmed by the COVID-19 virus test on 25Aug 2021 and the result was positive. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient was not pregnant and was not currently breast feeding at the time of this report. Last menstrual date of the patient was on 24Oct2021. Concomitant medications included HEPATITIS B VACCINE from 13Oct2021 to 13Oct2021 and INFLUENZA VACCINE from 09Nov2021 to 09Nov2021. Previously, the patient previously took COVID-19 VACCINE ASTRAZENECA via an unspecified route of administration on unspecified dates as a single dose for COVID-19 immunisation. On 19Nov2021, 1 day after the vaccination, the patient experienced the skin around my right eye was very swollen, especially around the inner eye. It was reported that the patient had the Pfizer booster at 18:00 on 18th November. In the morning she woke up and the skin around right eye was very swollen, especially around the inner eye. This had not happened to her before. The patient had not had a previous Pfizer vaccine (Her other two were Aatrazeneca). The clinical outcome of the event eye swelling was recoveing at the time of this report. Therapeutic measures were taken as a result of eye swelling (piriton and put frozen peas). The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). Follow-up(30Nov2021): This is a spontaneous follow-up report received from the same contactable consumer. Updated Information: Concomitant drugs date and event eye swelling captured as serious No follow-up attempts are needed. No further information is expected.


VAERS ID: 1946138 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Gait inability, Immunisation, Pain, SARS-CoV-2 test, Scan
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Scan; Result Unstructured Data: Test Result:Unknown Result
CDC Split Type: GBPFIZER INC202101697807

Write-up: pain; Unable to walk; Deep vein thrombosis leg; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111300658582480-FBLAK. Other Case identifier: GB-MHRA-ADR 26267798. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK9413) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 01Feb2021, notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: dose 1 & 2 of Bnt162b2 for COVID-19 immunisation. The patient experienced deep vein thrombosis leg with onset 26Nov2021; severe pain and unable to walk on unknown date. The events were considered life threatening. Admitted to emergency hospital. The event, deep vein thrombosis was also considered medically significant. The patient has not recovered from the events. deep vein thrombosis leg and pain. Outcome of the event, unable to walk was unknown. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative; and scan: unknown result. Therapeutic measures were taken as a result of deep vein thrombosis (anticoagulants). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946196 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECOTIDE; PROSTAP; SALBUTAMOL; TIBOLONE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Early menopause; Endometriosis; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101721445

Write-up: Migraine; Nausea; Patient received booster dose of COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112021909491830-LL9WI. Other Case identifier(s): GB-MHRA-ADR 26282976. A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FKO596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Early menopause" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef... Concomitant medication(s) included: BECOTIDE taken for asthma; INFLUENZA VIRUS taken for influenza immunisation, administration date 17Nov2021; PROSTAP taken for endometriosis, start date: 12Jan2021; SALBUTAMOL taken for asthma; TIBOLONE taken for premature menopause, start date: 12Jan2021; TRAMADOL taken for endometriosis. Vaccination history included: Bnt162b2 (DOSE 2, SINGLELot number: UNKNOWN Route: Unspecified), administration date: 30Apr2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN Route: Unspecified), administration date: 22Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; MIGRAINE (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Migraine"; NAUSEA (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) no - negative covid-19 test. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101749020 Same patient/different dose/different events


VAERS ID: 1946531 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8279 / 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 INC202101663576

Write-up: Fainting; This is a spontaneous report received from a contactable Other Health Professional from Regulatory Authority. Regulatory number: PH-PHFDA-300120667. A 16 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FF8279) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 12:20, outcome "recovered", described as "Fainting". No follow-up attempts possible. No further information expected. Information about batch number has been obtained.


VAERS ID: 1946570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Haematoma, Immunisation, Off label use, Pain in extremity, Platelet count, Prothrombin time
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Low platelets
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: C-reactive protein; Test Result: 1.14 mg/dl; Test Date: 20211124; Test Name: Platelets; Result Unstructured Data: Test Result:119; Test Date: 20211124; Test Name: Prothrombin time; Test Result: 21.4 s
CDC Split Type: PTPFIZER INC202101684926

Write-up: haematoma in the right leg; strong pain in the right leg; off label use; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Low platelet values" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation; Covid-19 vaccine (Dose 2), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 18Nov2021, outcome "unknown", described as "off label use"; IMMUNISATION (disability, medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (disability) with onset 21Nov2021, outcome "unknown", described as "strong pain in the right leg"; HAEMATOMA (disability) with onset 22Nov2021, outcome "not recovered", described as "haematoma in the right leg". The patient underwent the following laboratory tests and procedures: c-reactive protein: (24Nov2021) 1.14 mg/dl; platelet count: (24Nov2021) 119; prothrombin time: (24Nov2021) 21.4 seconds. Therapeutic measures were taken as a result of pain in extremity, haematoma. Clinical course: On 21Nov2021, the patient felt a strong pain on the right leg. Refers that didn''t hit anywhere, was just walking and suddenly felt a very strong pain, which prevented her from walking. On the day after, on 22Nov2021, the patient''s son noticed that his mother had an extensive hematoma. The patient was brought to the hospital on 24Nov2021 and underwent analysis: platalets 119 (usually has low values), prothrombine time 21.4 seconds and C-reactive protein 1.14mg/dl. The patient received treatment for the events with apixaban (ELIQUIS) at 5mg 2x/day. On 29Nov2021 the hematoma remained extensive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1949128 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-21
Onset:2021-11-18
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1003A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101693455

Write-up: Facial paralysis left; This is a spontaneous report received from a contactable reporter (physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-MP20218693 (AFSSAPS). A 37-year-old female patient received BNT162b2 (COMIRNATY, solution for injection), intramuscular, administration date 21Oct2021 (lot number 1F1003A) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "facial paralysis left". The event "facial paralysis left" was evaluated at the physician office visit (a simple consultation on day 1 of the onset of the disorders). Therapeutic measures were taken as a result of facial paralysis which included corticosteroid treatment for 8 days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Fatigue, Pain in extremity, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101697643

Write-up: Fatigue/unusual tiredness; Racing heart (tachycardia); Palpitations; Leg pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111281717170730-QXUKY. Other Case identifier(s): GB-MHRA-ADR 26263161. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (Lot number: FH4751) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Leg pain"; PALPITATIONS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Palpitations"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: blood test: unknown results; electrocardiogram: unknown results; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. The patient was happy for us to contact your GP or treating physician. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dizziness postural, Immunisation, Interchange of vaccine products, Off label use, Photophobia, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200601; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101697858

Write-up: dizzy; bright lights; Dizziness postural; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111292122423740-DN0ZB (RA). Other Case identifier(s): GB-MHRA-ADR 26267183 (RA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 05Mar2020, stop date: 10Mar2020. Concomitant medication included: AMLODIPINE; RAMIPRIL. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 18May2021, for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant), outcome "recovered", described as "dizzy"; PHOTOPHOBIA (medically significant), outcome "recovered", described as "bright lights"; DIZZINESS POSTURAL (medically significant) with onset 20Nov2021, outcome "recovering", described as "Dizziness postural". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jun2020) positive. Clinical course: On the second day after the Pfizer booster jab, patient was walking along a shore road in low, very bright sunlight. She was dazzled and suddenly became dizzy, tumbling forward and bashing my face on a field gate. She was unsure whether or not she fainted. When recovered and back on her feet, she avoided the sun and all bright lights for a full week, wearing dark glasses and a peaked hat to protect myself. She began to become dizzy at the least amount of bright light. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1949863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-11-18
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Loss of personal independence in daily activities, Polymenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None reported by patient
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20211228636

Write-up: MENSTRUATION PROLONGED; MENSTRUAL CYCLE SHORTENED; ACTIVITIES OF DAILY LIVING IMPAIRED; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, IE-HPRA-2021-087481] concerned a 30 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: None reported by patient. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total, first dose, administered on 09-JUL-2021 for covid-19 immunisation. The drug start period was 132 days. No concomitant medications were reported. On 18-NOV-2021, the patient experienced menstruation prolonged, menstrual cycle shortened (prolonged menstrual cycle/ 5-6 weeks of menstruation, only 1-3 days in between cycle and activities of daily living impaired (disruption to day day life). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstruation prolonged, menstrual cycle shortened, and activities of daily living impaired. This report was serious (Other Medically Important Condition).


VAERS ID: 1949891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-11-18
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101692592

Write-up: vaccination failure; COVID-19 PCR test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority and product quality group. Regulatory number: IT-MINISAL02-813675 (MINISAL02). An 86-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 30Apr2021 (Lot number: EX3599, Expiration Date: 31Aug2021) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 09Apr2021 (Lot number: EW2246, Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "recovering", described as "vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering", described as "COVID-19 PCR test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. Conclusion: 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 EX3599 and EW2246. 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. PGS 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 reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-11-18
   Days after vaccination:272
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 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: 20211118; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101692627

Write-up: PRIVACY cluster. Molecular swab positive in vaccinated.; PRIVACY cluster. Molecular swab positive in vaccinated.; This is a spontaneous report received from a contactable reporter (other healthcare professional) from the regulatory authority-WEB and product quality group. Regulatory number: IT-MINISAL02-813679 (MINISAL02). An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Jan2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 1, 0.3 ml single, and intramuscular, administered in arm left, administration date 19Feb2021 (Lot number: EP9598, Expiration Date: 30Jun2021) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "recovering" and all described as "PRIVACY cluster. Molecular swab positive in vaccinated.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (18Nov2021) positive. Investigation conclusion for lot# EK9788 was reported as: 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. PGS Puurs 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 cause or CAPA were identified as the complaint was not confirmed. Investigation conclusion for lot# EP9598 was reported as: 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 EP9598. 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. PGS Puurs 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 cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1949902 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005887 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-813767) on 05-Dec-2021 and was forwarded to Moderna on 05-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA , ASTHENIA , PYREXIA and ARTHRALGIA in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005887) for COVID-19 immunisation. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 18-Nov-2021, the patient experienced MYALGIA (seriousness criterion medically significant), ASTHENIA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant) and ARTHRALGIA (seriousness criterion medically significant). At the time of the report, MYALGIA , ASTHENIA , PYREXIA and ARTHRALGIA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Company Comment - This case concerns a 74 year old female patient with no relevant medical history, who experienced the serious(medically significant) unexpected events of myalgia. asthenia, pyrexia and arthralgia. The events occurred on the same day after an unknown dose of mRNA-1273 vaccine. Arthralgia, pyrexia and myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.; Sender''s Comments: This case concerns a 74 year old female patient with no relevant medical history, who experienced the serious(medically significant) unexpected events of myalgia. asthenia, pyrexia and arthralgia. The events occurred on the same day after an unknown dose of mRNA-1273 vaccine. Arthralgia, pyrexia and myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1949905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-11-18
   Days after vaccination:287
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101692039

Write-up: Vaccination failure; COVID-19, Cinquestelle cluster. Positive molecular swab in vaccinated; This is a spontaneous report received from a contactable reporter (Other HCP) from the RA. Regulatory number: IT-MINISAL02-813788 (MINISAL02). A 97-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left deltoid, administration date 04Feb2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 2, 0.3 ml single and intramuscular, administered in left deltoid, administration date 14Jan2021 (Lot number: EL1484, Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering", described as "COVID-19, Cinquestelle cluster. Positive molecular swab in vaccinated". The patient underwent the following laboratory tests and procedures: COVID-19 PCR test: (18Nov2021) positive. Product Quality Group provided investigational results on 02Dec2021 for BNT162B2 (COMIRNATY, Lot number: EK9788, Expiration Date: 31May2021). Conclusion: 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. Testing 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 cause or CAPA were identified as the complaint was not confirmed. Product Quality Group provided investigational results on 02Dec2021 for BNT162B2 (COMIRNATY, Lot number: EL1484, Expiration Date: 30Apr2021). Conclusion: 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101691746

Write-up: Vaccination Failure; Covid-19; BOOSTER; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority (RA)-WEB and product quality group. Regulatory number: IT-RA-813877 (RA). A 99-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single, intramuscular, administered in arm left, administration date 29Jan2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 08Jan2021 (Lot number: EL1484, Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "BOOSTER"; VACCINATION FAILURE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Vaccination Failure"; COVID-19 (medically significant) with onset 22Nov2021, outcome "unknown", described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive. Product Quality Group provided investigational results. 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 associated lots 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. Site concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 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 associated lots 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. Site concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 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 associated lots of the reported lot FF2382. 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. Site concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-11-18
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, 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: 20211122; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101691750

Write-up: vaccination failure; Positive molecular swab after vaccine.; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: IT-MINISAL02-813878 (RA). A 100 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FF2382) as dose 3, 0.3 ml, single, intramuscular, administration date 27May2021 (Lot number: FC3558) as dose 2, 0.3 ml, single and intramuscular, administration date 06May2021 (Lot number: EX7389) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "vaccination failure"; COVID-19 (medically significant) with onset 22Nov2021, outcome "recovering", described as "Positive molecular swab after vaccine."; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (22Nov2021) positive. Conclusion: For this LOT adverse event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC tab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5966857, 6082912 (see file attachment in this investigation record). The complaint for Pfizer-Biontech Covid-19 Covid" was investigated. 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 EX7389, FC3558. 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. PGS 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 cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101691846

Write-up: cluster Villa Iris. Positive molecular swab in vaccinated patient; cluster Villa Iris. Positive molecular swab in vaccinated patient; booster; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: IT-MINISAL02-813889 (RA). A 79 year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3(booster) 0.3 ml, single, intramuscular, administered in arm left, administration date 29Jan2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 2, 0.3 ml, single and intramuscular, administered in arm right, administration date 08Jan2021 (Lot number: EL1484, Expiration Date: 30Mar2021) as dose 1, 0.3 ml, single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 22Nov2021, outcome "recovering" and all described as "cluster Villa Iris. Positive molecular swab in vaccinated patient"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive. Investigation result was received from Product Quality Complaint group which stated; Conclusion: 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. PGS 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 cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KISQALI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (skin); Breast lump (from Jul)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:High; Comments: cause of the cerebral hemorrhage
CDC Split Type: ITPFIZER INC202101696496

Write-up: My sister has a lump in her breast, from Jul until 14Nov she went through 4 cycles of 21 days each with KISQUALI (chemo). On 16Nov she had the 2nd dose of Pfizer, on 18Nov she had a brain haemorrhage.; Blood pressure measurement high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-814169 (RA). A 50 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 10:50 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "nickel allergy" (unspecified if ongoing), notes: skin; "breast lump" (unspecified if ongoing), notes: from Jul. Concomitant medication(s) included: KISQALI, start date: Jul2021. Vaccination history included: Comirnaty (at 16.55 lot FG6270 expiring lot 31Dec2021), administration date: 26Oct2021, for COVID-19 immunisation. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, disability) with onset 18Nov2021, outcome "recovering", described as "My sister has a lump in her breast, from Jul until 14Nov she went through 4 cycles of 21 days each with KISQUALI (chemo). On 16Nov she had the 2nd dose of Pfizer, on 18Nov she had a brain haemorrhage."; HYPERTENSION (medically significant), outcome "unknown", described as "Blood pressure measurement high". The patient was currently hospitalized in the hospital, emergency medicine department, since 18Nov2021. Her left side arms and leg are weak in movement. Impact on the quality of life (10/10). The patient underwent the following laboratory tests and procedures: blood pressure measurement: high, notes: cause of the cerebral hemorrhage. Sender comment: on 23, 24 and 29 Nov2021 the reporter was contacted to request the date of the administration, batch and expiry date of the 1st dose; the attachments of the blood and instrumental tests conducted and a medical report with a diagnosis of cerebral haemorrhage, update of the outcome. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1950022 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Computerised tomogram thorax, Immunisation, Pulmonary embolism, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dyslipidaemia; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: chest CT; Result Unstructured Data: Test Result:pulmonary embolism
CDC Split Type: ITPFIZER INC202101702801

Write-up: chest CT scan on 23Nov2021: pulmonary embolism; hospitalization for respiratory failure in exacerbated COPD; hospitalization for respiratory failure in exacerbated COPD; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-814690. A 81 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 18Nov2021 09:21 (Lot number: FH9951, Expiration Date: 31Mar2022) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unknown if ongoing); "Dyslipidaemia" (unknown if ongoing); "Obesity" (unknown if ongoing); "COPD" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 18Nov2021 09:21, outcome "unknown", described as "Booster"; RESPIRATORY FAILURE (hospitalization, medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) all with onset 20Nov2021, outcome "unknown" and all described as "hospitalization for respiratory failure in exacerbated COPD"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 23Nov2021, outcome "unknown", described as "chest CT scan on 23Nov2021: pulmonary embolism". The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (23Nov2021) pulmonary embolism. Therapeutic measures were taken as a result of respiratory failure, chronic obstructive pulmonary disease, pulmonary embolism. The patient took anticoagulant therapy as a treatment for adverse events. Reporter Comment: detection of pulmonary embolism in a subject at risk a few days after the administration of the 3 dose vaccine against covid Pfizer.


VAERS ID: 1950264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-11-18
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (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: 20211118; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive lu international unit(s)
CDC Split Type: PTJNJFOC20211224565

Write-up: Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, PT-INFARMED-T202112-303] concerned a 40-year-old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 0.5 ml, 1 total, administered on 21-JUL-2021 for covid-19 immunisation (Dose number in series 1). The drug start period was reported as 120 days. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive lu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1950280 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0020 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Erythema, Lip swelling, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101696523

Write-up: Swelling of lips; Itchy skin; Dizziness; Swelling of face; Skin erythema; Chills; This is a spontaneous report received from a contactable consumer from the regulatory authority-WEB. The reporter is the patient. Regulatory number: RO-NMA-2021-SPCOV15145 (regulatory authority). A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: PCA0020) at the age of 24 years as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose1; single; lot: PCB0003), administration date: 28Oct2021, for COVID-19 immunisation. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. The following information was reported: LIP SWELLING (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Swelling of lips"; PRURITUS (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Itchy skin"; DIZZINESS (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Dizziness"; SWELLING FACE (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Swelling of face"; ERYTHEMA (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Skin erythema"; CHILLS (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Chills". Reportedly, on 28-Oct-2021 the patient received 1st dose of Comirnaty, lot PCB0003. On 18-Nov-2021 the patient received 2nd dose of Comirnaty, lot PCA0020. On the same day the patient experienced skin erythema, itchy skin, swelling of face and lips, dizziness, chills. As a corrective therapy the patient received Famotidina, Calciu, Claritine, Clorfeniramin, Prednison. The Reporter considered that the adverse reactions resulted in a life threatening. At the time of reporting, the outcome was not recovered. No follow up attempts possible. No further information is expected.


VAERS ID: 1950281 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL5324 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101696600

Write-up: Skin rash; Allergic reaction; Swollen eyes; rash all over the body/facial rash/scalp rash; Pruritic rash; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: RO-NMA-2021-SPCOV15156 (NMA). A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FL5324) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single; batch/lot number: PCA0003), administration date: 28Oct2021, for COVID-19 immunization, reaction(s): "Malaise", "Vomiting", "Headache". The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. The following information was reported: RASH PRURITIC (life threatening) with onset 18Nov2021, outcome "not recovered", described as "Pruritic rash"; HYPERSENSITIVITY (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Allergic reaction"; EYE SWELLING (life threatening) with onset 19Nov2021, outcome "not recovered", described as "Swollen eyes"; RASH (life threatening) with onset 19Nov2021, outcome "not recovered", described as "rash all over the body/facial rash/scalp rash"; RASH (life threatening) with onset 21Nov2021, outcome "not recovered", described as "Skin rash". Reportedly, on 28-Oct-2021 the patient received the 1st dose of Comirnaty. On 18-Nov-2021 the patient received the 2nd dose of Comirnaty. On 18-Nov-2021 the patient experienced pruritic rash. On 19-Nov-2021 the patient experienced scalp rash, facial rash, rash all over, swollen eyes. On 21-Nov-2021 the patient experienced skin rash. As per patient statement she went to the emergency room twice (on 19-Nov-2021 and on 21-Nov-2021) and was diagnosed with an "Allergic Reaction to the Pfizer Vaccine." As a corrective therapy the patient received hydrocortisone hemisuccinate 200 mg, quamatel, dexamethasone, adrenaline intramuscular injection, adrenaline infusion and drug treatment. The Reporter considered that the adverse reactions resulted in a "Life threatening" situation. In the reporter''s opinion the events were related to Comirnaty, lot FL5324. Sender''s comment: No consent obtained for contacting the treating physician for obtaining additional information regarding this case. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : RO-PFIZER INC-202101693773 same product, same patient and different dose/events


VAERS ID: 1950372 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vitreous floaters
SMQs:, Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Sudden onset of floaters in left eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of VITREOUS FLOATERS (Sudden onset of floaters in left eye) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VITREOUS FLOATERS (Sudden onset of floaters in left eye) (seriousness criterion medically significant). At the time of the report, VITREOUS FLOATERS (Sudden onset of floaters in left eye) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment drugs were reported. This case concerns a 53-year-old female patient with no medical history, who experienced the unexpected serious event of Vitreous Floaters. The event, which was medically significant, occurred approximately 1 day after receiving an undisclosed dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old female patient with no medical history, who experienced the unexpected serious event of Vitreous Floaters. The event, which was medically significant, occurred approximately 1 day after receiving an undisclosed dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1950373 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Myocarditis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was reported to be given second dose of Moderna vaccine on 25-Nov-2021 and also had second dose of Moderna vaccine in afternoon on 15-Nov-2021. Patient started to have a fever of about 39 degrees, chills and general fatigue. The fever subsided the same night after the patient used antipyretics, and the symptoms of chills and general fatigue lasted for 1 day before recovery. On November 18, the patient suffered from chest tightness and wheezing after getting up in the morning and later the symptoms were improved. Patient also suffered from asthma and went to the clinic for X-ray and electrocardiographic examinations, where no abnormality was found. On November 20, 2021, the patient started to suffer from chest tightness in addition to wheezing. On November 25, 2021 patient went to hospital Abnormality was found in the electrocardiogram and a blood test was performed. Abnormal increase of myocardial enzymes were detected. The patient was diagnosed with vaccine-induced myocarditis and was hospitalized for treatment. On November 29, 2021, the patient was taken daily blood tests during hospitalization. The myocardial enzymes decreased slightly but the improvement was not obvious and electrocardiogram was found to be normal, and the patient was discharged on the same day and arranged a return visit. Relevant concomitant medications were not provided. Treatment information was not provided. This case concerns a 26-year-old male patient with no medical history, who experienced the unexpected serious adverse event of special interest Myocarditis. The event occurred 4 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 26-year-old male patient with no medical history, who experienced the unexpected serious adverse event of special interest Myocarditis. The event occurred 4 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1951079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1012A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Hypertension, Palpitations, Rash, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug intolerance (Anaphylaxis, allergic reaction to monofer and iron infusion.); Hypothyreosis (Underactive thyroid)
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (Anaphylaxis, allergic reaction to monofer and iron infusion.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101720075

Write-up: Rash; Hypertension; Palpitations; Orthostatic collapse; Allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: AT-BASGAGES-2021-062305. A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: 1F1012A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Drug intolerance" (ongoing), notes: Anaphylaxis, allergic reaction to monofer and iron infusion.; "Hypothyreosis" (ongoing), notes: Underactive thyroid; "Anaphylaxis" (not ongoing), notes: Anaphylaxis, allergic reaction to monofer and iron infusion. The patient''s concomitant medications were not reported. Past drug history included: Monofer, reaction(s): "Anaphylaxis", notes: Anaphylaxis, allergic reaction to monofer and iron infusion. The following information was reported: RASH (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Rash"; HYPERTENSION (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Hypertension"; PALPITATIONS (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Palpitations"; SYNCOPE (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Orthostatic collapse"; HYPERSENSITIVITY (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Allergic reaction". Therapeutic measures were taken as a result of rash, hypertension, palpitations, syncope, hypersensitivity. Clinical course: Allergic reaction, palpitations, collapse, high blood pressure, rash Treatment of side effect: Cortizone, Domicom, infusion. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101755712 same patient, different drug, different events


VAERS ID: 1951119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-11-18
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Electrocardiogram ST segment, Electrocardiogram ST segment depression, Troponin I, Troponin I increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Electrocardiogram ST segment; Result Unstructured Data: Test Result:depression; Test Date: 20211118; Test Name: Troponin I; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101698537

Write-up: Electrocardiogram ST segment depression; Chest discomfort; Chest pain; Troponin I increased; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 669620 (RA). A 13-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ELECTROCARDIOGRAM ST SEGMENT DEPRESSION (medically significant) with onset 18Nov2021 (also reported as 27 days after vaccination), outcome "not recovered", described as "Electrocardiogram ST segment depression"; CHEST DISCOMFORT (non-serious) with onset 18Nov2021 (also reported as 27 days after vaccination), outcome "not recovered", described as "Chest discomfort"; CHEST PAIN (non-serious) with onset 18Nov2021 (also reported as 27 days after vaccination), outcome "not recovered", described as "Chest pain"; TROPONIN I INCREASED (non-serious) with onset 18Nov2021 (also reported as 27 days after vaccination), outcome "not recovered", described as "Troponin I increased". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101699543

Write-up: deep vein thrombosis; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 672004 (TGA ADR#). A 47-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 18Nov2021, outcome "recovering", described as "deep vein thrombosis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Carditis, Disturbance in attention, Fatigue, Feeling abnormal
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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: LOXALATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101699873

Write-up: Carditis; Disturbance in attention; Fatigue; Feeling abnormal; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 672737. A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: LOXALATE. The following information was reported: CARDITIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Carditis"; DISTURBANCE IN ATTENTION (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Disturbance in attention"; FATIGUE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Fatigue"; FEELING ABNORMAL (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Feeling abnormal". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTJ2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: DEPFIZER INC202101702561

Write-up: She was very ill overall and didn''t want to get out of bed; My daughter collapsed the day after the vaccination. On the floor but then fell right back there. Please check if dosage should be divided according to weight.; Pyrexia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the parent. Regulatory number: DE-PEI-CADR2021205209 (RA). Other Case identifier(s): DE-CADRPEI-2021205209 (RA Webportal), DE-PEI-202100230907 (RA). A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: SCTJ2) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "My daughter collapsed the day after the vaccination. On the floor but then fell right back there. Please check if dosage should be divided according to weight."; PYREXIA (non-serious) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Pyrexia"; ILLNESS (non-serious), outcome "unknown", described as "She was very ill overall and didn''t want to get out of bed". Senders comment: She was very ill overall and didn''t want to get out of bed. She had not collapsed during a normal vaccination. Should the dosage be determined by weight / gender / ...? No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953130 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Facial pain, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Glaucoma (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: CARBAMAZEPINE; TOPIRAMATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Facial neuralgia (Have had facial neuralgia for over two years controlled by anti convulsant medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712315

Write-up: Facial pain; Off label use; interchange of vaccine product; booster; extreme facial pain /aggravation of an existing facial neuralgia condition.; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111301806235680-OQ1PV (MHRA). Other Case identifier(s): GB-MHRA-ADR 26273361 (MHRA). A 53 year-old patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Facial neuralgia" (unspecified if ongoing), notes: Have had facial neuralgia for over two years controlled by anti convulsant medication. Concomitant medication(s) included: CARBAMAZEPINE taken for trigeminal neuralgia; TOPIRAMATE taken for trigeminal neuralgia. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "interchange of vaccine product"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; FACIAL PAIN (medically significant) with onset 20Nov2021, outcome "recovering", described as "Facial pain"; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome "not recovered", described as "extreme facial pain /aggravation of an existing facial neuralgia condition." Clinical course: Extreme facial pain, caused by the aggravation of an existing facial neuralgia condition. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953357 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Confusional state, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Neuralgia; Paraplegic
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101721363

Write-up: horrendous headache; confused; nauseous; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; Stroke/bleed on the brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112020833403360-PBBXW. Other Case identifier(s): GB-MHRA-ADR 26279666. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 11:00 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Paraplegia" (unspecified if ongoing); "Clinical trial participant" (unspecified if ongoing); "neurological pain" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN taken for paralysis. Vaccination history included: COVID-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; COVID-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (hospitalization, life threatening), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening), IMMUNISATION (hospitalization, life threatening) all with onset 18Nov2021 11:00, outcome "unknown" and all described as "Patient received third dose of Comirnaty"; CEREBROVASCULAR ACCIDENT (hospitalization, life threatening) with onset 18Nov2021, outcome "not recovered", described as "Stroke/bleed on the brain"; HEADACHE (hospitalization, life threatening) with onset 18Nov2021 20:00, outcome "recovering", described as "horrendous headache"; CONFUSIONAL STATE (hospitalization, life threatening) with onset 18Nov2021 20:00, outcome "unknown", described as "confused"; NAUSEA (hospitalization, life threatening) with onset 18Nov2021 20:00, outcome "unknown", described as "nauseous". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, cerebrovascular accident, headache, confusional state, nausea (start date: 18Nov2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: He has been paraplegic after an illness 6 years ago but is generally in very good health he does take a lot of medication for neurological pain but has never had any issues with high blood pressure. Booster was given at 1100 hrs at 2000 hrs he became confused nauseous and had horrendous headache was taken to hospital by ambulance and had suffered a bleed on the brain and is currently still in hospital 2 weeks later. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Myocarditis, Pain, Postmenopausal haemorrhage, SARS-CoV-2 test, Vulval haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopause
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101732087

Write-up: myocarditis; pain; Vulval bleeding; Not had a period for 4.5 years; SARS-CoV-2 infection; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112051056412640-JB8SJ. Other Case identifier(s): GB-MHRA-ADR 26290302. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Not had a period for 4.5 years" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Lot number: Not known, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Lot number: Not known, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; VULVAL HAEMORRHAGE (medically significant) with onset 04Dec2021, outcome "not recovered", described as "Vulval bleeding"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 04Dec2021, outcome "unknown", described as "Not had a period for 4.5 years"; COVID-19 (non-serious) with onset 28Nov2021, outcome "recovering", described as "SARS-CoV-2 infection"; PAIN (non-serious), outcome "not recovered", described as "pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected. Clinical course: Patient was not had symptoms associated with COVID-19. She was now bleeding, and she had a period, along with associated pain. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953551 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Lethargy, Malaise, SARS-CoV-2 test, Vaccination site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Blood test (Patient had a blood test some time ago that came back, antibodies were attacking his B12. Although have a B12 check on a regular basis, patient feel they are not doing the right one.); Fatty liver (Have None alchohol related fatty liver desease, not severe.)
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Injection area still swollen and tender after 3 weeks; Headaches and no energy; Joint pain; Lethargic; Feeling unwell; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26290666) on 06-Dec-2021 and was forwarded to Moderna on 06-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection area still swollen and tender after 3 weeks), ASTHENIA (Headaches and no energy), ARTHRALGIA (Joint pain), LETHARGY (Lethargic) and MALAISE (Feeling unwell) in a 68-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for Corona virus infection. The patient''s past medical history included Fatty liver (Have None alchohol related fatty liver desease, not severe.) and Blood test (Patient had a blood test some time ago that came back, antibodies were attacking his B12. Although have a B12 check on a regular basis, patient feel they are not doing the right one.). Previously administered products included for Drug use for unknown indication: ZAPAIN (When required.). Past adverse reactions to the above products included No adverse event with ZAPAIN. Concurrent medical conditions included Suspected COVID-19 since 18-Nov-2021. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 milligram. On 18-Nov-2021, the patient experienced MALAISE (Feeling unwell) (seriousness criterion disability). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection area still swollen and tender after 3 weeks) (seriousness criterion disability), ASTHENIA (Headaches and no energy) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and LETHARGY (Lethargic) (seriousness criterion disability). At the time of the report, VACCINATION SITE BRUISING (Injection area still swollen and tender after 3 weeks), ASTHENIA (Headaches and no energy), ARTHRALGIA (Joint pain) and LETHARGY (Lethargic) was resolving and MALAISE (Feeling unwell) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Patient was Taking just Omaprazole and qeustran, not regular. No concomitant medications were reported. It was reported that 24 hrs after having injection patient developed feverish symptoms, muscle/joint pain, lethargic, pain in bottom of foot, tight chest. Injection area still swollen and tender after 3 weeks, and still feeling unwell. Headaches and no energy, still the patient was unwell after 3 weeks, off food although still eating if pushed. Patient is not enrolled in clinical trial. No treatment information was reported. Company Comment: This case concerns a 68-year-old male subject, with reported medical history of Fatty liver and Suspected COVID-19, who experienced the unexpected serious adverse events of Vaccination Site Bruising, Asthenia, Arthralgia, Lethargy and Malaise. The events Vaccination Site Bruising, Asthenia, Arthralgia and Lethargy occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The event Malaise occurred the same day of the administration of one dose of an unknown schedule of product administration of the mRNA-1273 and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is unknown as the events happened after one dose of the vaccine and since no information on schedule of administration is provided. The reported medical history of Suspected COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old male subject, with reported medical history of Fatty liver and Suspected COVID-19, who experienced the unexpected serious adverse events of Vaccination Site Bruising, Asthenia, Arthralgia, Lethargy and Malaise. The events Vaccination Site Bruising, Asthenia, Arthralgia and Lethargy occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The event Malaise occurred the same day of the administration of one dose of an unknown schedule of product administration of the mRNA-1273 and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is unknown as the events happened after one dose of the vaccine and since no information on schedule of administration is provided. The reported medical history of Suspected COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1953565 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Breast cancer, COVID-19, Decreased appetite, Drug ineffective, Headache, Immunisation, Insomnia, Interchange of vaccine products, Malaise, Migraine, Myocarditis, Nasopharyngitis, SARS-CoV-2 test, Somnolence
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Breast malignant tumours (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101731997

Write-up: Interchange of vaccine products; BOOSTER; breast cancer; myocarditis; drug ineffective; Fell ill a few days after the booster.Says she has never felt so poorly (even though she has survived breast cancer) and is really struggling.; SARS-CoV-2 infection; Cold; Head pain; Migraine; Appetite lost; Smell loss; Sleepiness; Sleeplessness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112051643050500-IZDVC. Other Case identifier(s): GB-MHRA-ADR 26292333. A 68 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 immunization; Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant), outcome "unknown", described as "BOOSTER"; BREAST CANCER (disability, medically significant), outcome "not recovered", described as "breast cancer"; MYOCARDITIS (disability, medically significant), outcome "not recovered", described as "myocarditis"; DRUG INEFFECTIVE (disability, medically significant), outcome "unknown", described as "drug ineffective"; COVID-19 (disability, medically significant) with onset 28Nov2021, outcome "not recovered", described as "SARS-CoV-2 infection"; NASOPHARYNGITIS (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Cold"; HEADACHE (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Head pain"; MIGRAINE (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Migraine"; DECREASED APPETITE (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Appetite lost"; ANOSMIA (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Smell loss"; SOMNOLENCE (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Sleepiness"; INSOMNIA (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Sleeplessness"; MALAISE (disability, medically significant), outcome "unknown", described as "Fell ill a few days after the booster.Says she has never felt so poorly (even though she has survived breast cancer) and is really struggling.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: yes - positive covid-19 test, notes: Yes - Positive COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 PCR test positive; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101691738

Write-up: vaccination failure; Molecular swab positive in vaccinated; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number IT-MINISAL02-813875. A 94 year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single, intramuscular, administered in arm left, administration date Jan2021 (Lot number: EP9598, Expiration Date: 30Jun2021) as dose 2, 0.3ml single, and intramuscular, administered in arm left, administration date Jan2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 1, 0.3ml single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 18Nov2021, outcome unknown; DRUG INEFFECTIVE (medically significant) with onset 22Nov2021, outcome recovering; COVID-19 (medically significant) with onset 22Nov2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test on 22Nov2021 positive. 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, FF2382, EP9598. 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 reference samples. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, 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: 20211122; Test Name: COVID-19 PCR test positive; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101691783

Write-up: vaccination failure; cluster PRIVACY. Positive molecular swab in vaccine.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number IT-MINISAL02-813884. A 86 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 18Nov2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3ml single, intramuscular, administered in arm right, administration date 19Mar2021 (Lot number: ET3620, Expiration Date: 30Jun2021) as dose 2, 0.3ml single and intramuscular, administered in arm right, administration date 26Feb2021 (Lot number: EP2166, Expiration Date: 31May2021) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 18Nov2021, outcome unknown; VACCINATION FAILURE (medically significant) with onset 22Nov2021, outcome recovering; COVID-19 (medically significant) with onset 22Nov2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive on 22Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953851 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure timing unspecified, Uterine contractions during pregnancy, Uterine spasm
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101711245

Write-up: CONTRACTION; UTERINE CONTRACTION; Patient was pregnant; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: -PHFDA-300120963 . This is the maternal case. A 37-year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (life threatening) with onset 18Nov2021, outcome "unknown", described as "Patient was pregnant"; UTERINE SPASM (life threatening) with onset 19Nov2021 02:00, outcome "recovered" (2021), described as "CONTRACTION"; UTERINE CONTRACTIONS DURING PREGNANCY (life threatening) with onset 19Nov2021 02:00, outcome "recovered" (2021), described as "UTERINE CONTRACTION". The baby was delivered premature. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953861 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320218D / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever (greater or equal to 38 deg Centigrade
CDC Split Type: PHPFIZER INC202101712496

Write-up: Fever (greater or equal to 38 deg centigrade); Cough; COLDS; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120952. A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: 320218D) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Fever (greater or equal to 38 deg centigrade)"; COUGH (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Cough"; NASOPHARYNGITIS (hospitalization) with onset 18Nov2021, outcome "recovering", described as "COLDS". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) fever (greater or equal to 38 deg Centigrade. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953862 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8773 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Nausea, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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 INC202101712500

Write-up: Fainting; Loss of consciousness; Headache; Nausea; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120992. A 16-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FH8773) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 16:15, outcome "recovered" (18Nov2021 17:00), described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant) with onset 18Nov2021 16:15, outcome "recovered" (18Nov2021 17:00), described as "Loss of consciousness"; HEADACHE (non-serious) with onset 18Nov2021 16:15, outcome "recovered" (18Nov2021 17:00), described as "Headache"; NAUSEA (non-serious) with onset 18Nov2021 16:15, outcome "recovered" (18Nov2021 17:00), described as "Nausea". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953863 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / 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 INC202101712502

Write-up: Fainting; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121029 (RA). A 12 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0002) at the age of 12 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 11:15, outcome "recovered", described as "Fainting". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953864 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8760 / 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 INC202101712507

Write-up: Fainting; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: PH-PHFDA-300121066 (PHFDA). A 14 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FJ8760) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 15:00, outcome "recovered" (18Nov2021 15:30), described as "Fainting". No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1953868 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5973 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101712530

Write-up: Fainting; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121041 (PHFDA). A 12 year-old female patient (unknown if pregnant) received BNT162B2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: FJ5973) at the age of 12 years as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 15:00, outcome "recovered", described as "Fainting"; DIZZINESS (non-serious) with onset 18Nov2021 13:00, outcome "recovered", described as "Dizziness". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953869 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8773 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, 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 INC202101712533

Write-up: Fainting; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121059. A 17 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FH8773) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 14:35, outcome "recovered" (18Nov2021 15:00), described as "Fainting"; HEADACHE (non-serious) with onset 18Nov2021 14:35, outcome "recovered" (18Nov2021 15:00), described as "Headache". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953893 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 321558A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/70 mmHg; Comments: at 11:45
CDC Split Type: PHPFIZER INC202101713143

Write-up: ELEVATED BP 160/70; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121499 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: 321558A) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 11:45, outcome "recovering", described as "ELEVATED BP 160/70". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 160/70 mmHg, notes: at 11:45. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953920 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 321258A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:190/100 mmHg; Comments: 14:40
CDC Split Type: PHPFIZER INC202101713422

Write-up: Increased blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300122013. A 43 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: 321258A) at the age of 43 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 14:40, outcome "recovered" (18Nov2021), described as "Increased blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 190/100 mmHg, notes: 14:40. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954011 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: IIIrd nerve paralysis
SMQs:, Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Ocular motility disorders (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Left oculomotor palsy; This regulatory authority case was reported by an other health care professional and describes the occurrence of IIIRD NERVE PARALYSIS (Left oculomotor palsy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced IIIRD NERVE PARALYSIS (Left oculomotor palsy) (seriousness criterion hospitalization). At the time of the report, IIIRD NERVE PARALYSIS (Left oculomotor palsy) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided by the reporter. The patient received the second dose of Moderna COVID-19 vaccine on 16 Nov 2021. On 20 Nov 2021 , the patient visited the emergency room of the hospital, and complained of left eyelid ptosis since Nov 18 , and said she had visited other hospitals.The patient was admitted to the hospital for treatment that day: The Patient had having history of vertigo. The patient reported that she had left eye ptosis 36 hours after Moderna vaccine injection. The patient went to Shin Kong Hospital and did Brain CT which revealed no obvious abnormality. After that, the patient came to ER for ptosis getting worse. She also reported had mild headache over left vertex area and left periorbital pain. During the stay in ER, ER doctor did blood sample and MRI for further evaluation. Lab data and MRI revealed no obvious abnormalities. Under the impression of had left oculomotor palsy, she was admitted to the ward . Company Comment: This case concerns a 49-year-old, female subject with unknown medical history, who experienced the serious (seriousness criterion= Caused/Prolonged Hospitalization) unexpected event of Left Third nerve paralysis. The event occurred 36 hrs after the second dose of mRNA 1273 Vaccine. The patient went to a hospital where Brain CT done revealed no obvious abnormality. After that, the patient went to the reporting ER for ptosis getting worse. She also mentioned having mild headache over left vertex area and left periorbital pain. Blood test and MRI done revealed no obvious abnormalities. Diagnosis of left oculomotor palsy was made followed by subsequent admission for further evaluation. At the time of the report, the outcome of the event was Recovering/Resolving. Rechallenge was not applicable as there is no available information regarding an additional dose. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old, female subject with unknown medical history, who experienced the serious (seriousness criterion= Caused/Prolonged Hospitalization) unexpected event of Left Third nerve paralysis. The event occurred 36 hrs after the second dose of mRNA 1273 Vaccine. The patient went to a hospital where Brain CT done revealed no obvious abnormality. After that, the patient went to the reporting ER for ptosis getting worse. She also mentioned having mild headache over left vertex area and left periorbital pain. Blood test and MRI done revealed no obvious abnormalities. Diagnosis of left oculomotor palsy was made followed by subsequent admission for further evaluation. At the time of the report, the outcome of the event was Recovering/Resolving. Rechallenge was not applicable as there is no available information regarding an additional dose. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report.


VAERS ID: 1956414 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38.3; Test Date: 20211123; Test Name: COVID test; Result Unstructured Data: Test Result:positive
CDC Split Type: FRPFIZER INC202101710105

Write-up: COVID-19; COVID-19; Booster; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 38.3; sars-cov-2 test: (23Nov2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on information in the case a possible causal association between the reported events Immunisation ,Drug ineffective, Covid-19 and the suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1956644 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, 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? 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: 20211201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101721209

Write-up: The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of COMIRNATY vaccine; The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of COMIRNATY vaccine; The patient received booster dose of COMIRNATY vaccine.; Swollen glands/large egg-shaped lump in armpit same side as jab; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112021319363700-SPZYU. Other Case identifier(s): GB-MHRA-ADR 26281145. A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: Fh4751) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE;Lot number: unknown: Route of administration: unspecified Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE;Lot number: unknown: Route of administration: unspecified Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "The patient received the primary immunization series with non-Pfizer vaccine and received a third dose of COMIRNATY vaccine"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "The patient received booster dose of COMIRNATY vaccine."; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "recovered" (22Nov2021), described as "Swollen glands/large egg-shaped lump in armpit same side as jab". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) no - negative covid-19 test. Addition information: The patient has not tested positive for COVID-19 since having the vaccine. 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: 1957084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendix disorder, Ascites, Blood test, COVID-19, Cyst, Menstrual disorder, Menstruation delayed, Myocarditis, Ovarian cyst, Pain, SARS-CoV-2 test, Scan, Surgery, Thrombosis, Ultrasound scan
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Polycystic ovaries
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:result unknown; Comments: result unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:ovaries were fine; Comments: ovaries were fine; Test Name: surgery; Result Unstructured Data: Test Result:result unknown; Comments: result unknown; Test Name: ultrasound; Result Unstructured Data: Test Result:result unknown; Comments: result unknown
CDC Split Type: GBPFIZER INC202101768766

Write-up: Cyst ovary; periods started to change; dont happen or happened late; with clots; pain came; haemorrhaging cyst; angry appendix; fluid in my abdomen; myocarditis; cysts; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112092102111810-THVCU Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26314409 Regulatory Authority. A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovaries" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, disability, medically significant), outcome "recovering", described as "myocarditis"; CYST (hospitalization, disability, medically significant), outcome "recovering", described as "cysts"; COVID-19 (hospitalization, disability, medically significant) with onset 18Nov2021, outcome "recovering", described as "SARS-CoV-2 infection"; OVARIAN CYST (hospitalization, disability, medically significant), outcome "recovering", described as "Cyst ovary"; MENSTRUAL DISORDER (hospitalization, disability, medically significant), outcome "unknown", described as "periods started to change"; MENSTRUATION DELAYED (hospitalization, disability, medically significant), outcome "unknown", described as "dont happen or happened late"; THROMBOSIS (hospitalization, disability, medically significant), outcome "unknown", described as "with clots"; PAIN (hospitalization, disability, medically significant), outcome "unknown", described as "pain came"; CYST (hospitalization, disability, medically significant), outcome "unknown", described as "haemorrhaging cyst"; APPENDIX DISORDER (hospitalization, disability, medically significant), outcome "unknown", described as "angry appendix"; ASCITES (hospitalization, disability, medically significant), outcome "unknown", described as "fluid in my abdomen". The patient underwent the following laboratory tests and procedures: blood test: result unknown, notes: result unknown; sars-cov-2 test: negative, notes: No - Negative COVID-19 test; scan: ovaries were fine, notes: ovaries were fine; surgery: result unknown, notes: result unknown; ultrasound scan: result unknown, notes: result unknown. Clinical Course: Patient had emergency surgery in November with a haemorrhaging cyst and at the same time patient also had an angry appendix and fluid in abdomen. All very strange. Patient had cysts before, but they always had fluid not blood in them. Patient wonder if this correlates to the jab. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had covid asymptomatic after surgery having acquired it in hospital. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957214 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023F21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bloody discharge, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid; In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid; This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-814146) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) and BLOODY DISCHARGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 023F21A) for SARS-CoV-2 immunisation. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced HAEMORRHAGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) (seriousness criterion hospitalization) and BLOODY DISCHARGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) and BLOODY DISCHARGE (In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) had not resolved. No concomitant medication were reported No treatment medication were reported Homozygous genetic pathology MTHFR c677t. Carried out first dose on 21/10/2021 with lot 023F21A,Follow-up required: waiting for feedback. Company Comment: This case concerns a 47-year-old female subject, with no relevant medical history reported in this case, who experienced the unexpected serious adverse events of Haemorrhage (reported as In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) and Bloody discharge (reported as In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid). The events occurred the same day after the administration of one dose of an unknown schedule of product administration of the mRNA-1273 and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is unknown as the events happened after one dose of the vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non-significant follow up received; Reporter''s Comments: Homozygous genetic pathology MTHFR c677t; Sender''s Comments: This case concerns a 47-year-old female subject, with no relevant medical history reported in this case, who experienced the unexpected serious adverse events of Haemorrhage (reported as In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid) and Bloody discharge (reported as In menopause for two years: Blood loss. Second dose Moderna 18/11 4-day hemorrhage. First aid). The events occurred the same day after the administration of one dose of an unknown schedule of product administration of the mRNA-1273 and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is unknown as the events happened after one dose of the vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Chills, Headache, Heart rate, Immunisation, Ischaemia, Pain in extremity, Presyncope, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (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 Name: heart rate; Result Unstructured Data: Test Result:unknown results; Comments: after dose 2; Test Date: 20211119; Test Name: heart rate; Result Unstructured Data: Test Result:unknown results; Comments: after dose 3
CDC Split Type: ITPFIZER INC202101702733

Write-up: Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs; lipothymia; booster; FARO This is a non-interventional study report from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-814650. A 45 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 18Nov2021 12:27 (Lot number: 1F1006A, Expiration Date: 31Mar2021) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; BURNING SENSATION (medically significant), CHILLS (medically significant), HEADACHE (medically significant), ISCHAEMIA (medically significant), TACHYCARDIA (medically significant), PAIN IN EXTREMITY (medically significant), outcome "recovered" (25Nov2021) and all described as "Adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs"; PRESYNCOPE (medically significant), outcome "recovered" (25Nov2021), described as "lipothymia". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) unknown results, notes: after dose 2; (19Nov2021) unknown results, notes: after dose 3. Therapeutic measures were taken as a result of burning sensation, chills, headache, ischaemia, tachycardia, pain in extremity, presyncope included paracetamol 10 mg / ml IV and subsequently with paracetamol 1000 mg cpr. Additional information: adverse effects after 3rd dose started on 19Nov2021. The reporter''s assessment of the causal relationship of the "booster", "adverse effects after administration of anticovid 19 vaccine 2nd and especially 3rd dose: shaking chills for 2 hours, transient ischemia of extremities, headache, heart rate, pain and burning in legs" and "lipothymia" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Reporter Comment: 3 dose Covid 19 vaccine administered 18Nov2021. Similar less intense episode during the second administration. Description: adverse effects after administration of 3rd dose of anti-Covid 19 Pfizer vaccine: shaking chills for hours, headache, lipothymia, transient ischemia of the limbs, burning pain in the legs. Complete resolution on 25Nov2021. No follow-up attempts are possible; information about lot/batch number for dose 2 cannot be obtained. No further information is expected.; Reporter''s Comments: 3 dose Covid 19 vaccine administered 18Nov2021. Similar less intense episode during the second administration. Description: adverse effects after administration of 3rd dose of anti-Covid 19 Pfizer vaccine: shaking chills for hours, headache, lipothymia, transient ischemia of the limbs, burning pain in the legs. Complete resolution on 25Nov2021.; Sender''s Comments: Considering the plausible drug-event temporal association, there is a reasonable possibility that reported events were related to BNT162B2 vaccine administration. 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: 1957395 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia, Pain in jaw, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Osteonecrosis (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: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: body temeprature; Result Unstructured Data: Test Result:Fever: 40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC202101718322

Write-up: Fever: 40.5 to 42 degrees Celsius; Fatigue; Generalized joint pain; Not feeling well; Cold shivers; Myalgia; Headache; Reaction at or around the injection site: pain; Pain between the vertebrae extends to jaw pain; Pain between the vertebrae extends to jaw pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: NL-LRB-00715738 . A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: Unknown) at the age of 43 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). Patient had no previous COVID-19 infection. The patient''s concomitant medications were not reported. The following information was reported: HYPERPYREXIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Fever: 40.5 to 42 degrees Celsius"; FATIGUE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Fatigue"; ARTHRALGIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Generalized joint pain"; MALAISE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Not feeling well"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Cold shivers"; MYALGIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Myalgia"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Reaction at or around the injection site: pain"; BACK PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "Pain between the vertebrae extends to jaw pain". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) fever: 40.5 to 42. Therapeutic measures with paracetamol were taken as a result of headache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957435 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ3438 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fall, Immunisation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Home care
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101719009

Write-up: Booster; she became heavy in her breath; fell on the floor; This is a spontaneous report received from a contactable reporter (Other HCP) Regulatory number: NO-NOMAADVRE-FHI-2021-U11med. Other Case identifier: NO-NOMAADVRE-E2B_00062028. An 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 10:10 (Lot number: FJ3438) at the age of 87 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Home care" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunization; Comirnaty (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "she became heavy in her breath"; FALL (hospitalization) with onset 18Nov2021, outcome "recovering", described as "fell on the floor". The patient worried about reactions related to the vaccine before vaccination. She was fine while she was waiting after the injection. After she got home she developed heavy breathing and after a while she fell down to the floor. She was sent to hospital by ambulance. She is stable, but still in hospital, on the following day. The reporter was informed about this event by the home care nurse. No more information is available regarding this case. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter Comment: Reporter''s qualification: Nurse No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter''s qualification: Nurse


VAERS ID: 1957480 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32128B9 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/130 mmHg; Comments: 11:00
CDC Split Type: PHPFIZER INC202101713449

Write-up: INCREASED BLOOD PRESSURE; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300122007. A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: 32128B9) at the age of 44 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 18Nov2021 11:00, outcome "recovered" (18Nov2021), described as "INCREASED BLOOD PRESSURE". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Nov2021) 200/130 mmHg, notes: 11:00. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1957657 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: Vital sign: BP- 216 / 122 mmHg HR-102 beats/min RR- 18 beats/min BT- 38.4? SpO2-95?GCS: E4V5M6 including lab data WBC- 9.63 x1000/uL, RBC- 4.78 x10^6/uL, Hgb- 14.5 g/dL, PLT -238 x1000/uL - Lipase- 31 U/L, Tropo-I -0.056 ng/mL, D-Dimer- 0.34�g/mL, Sugar -167 mg/dL, PT -37 IU/L, CRP -36.52 mg/L, Urea- N 19.1 mg/dL, Creatinine -0.71 mg/dL, Na- 136.0 m mol/L, K- 3.2 m mol/L.
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Fever; Abdominal pain; Chest pain; This case was received via an unknown source on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN (Abdominal pain) and CHEST PAIN (Chest pain) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 13-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant) and CHEST PAIN (Chest pain) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), ABDOMINAL PAIN (Abdominal pain) and CHEST PAIN (Chest pain) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Patient reported that on November 17, 2021 patient came to the emergency room Other medications reported were Propacetamol 1 Vial ST IVD 1 day, Pantoprazole 1 Vial ST IVD 1 day, Acetaminophen 1 Tab QID PO Chlorzoxazone 150mg + Acetaminophen 250mg. Patient experienced GERD. ischemic heart disease preesntes ER complaining of burning sensation of chest and abdomen, cold sweating noted for three days after Moderna injection, fever, and chest and abdomen burning sensation, epigastric and anterior chest pain (+), cold sweating noted this afternoon. Company comment: This case concerns a 60-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected events of Pyrexia, Abdominal pain and Chest pain. The events occurred approximately 6 days after the administration of an unknown dose of the mRNA-1273 vaccine and, at the time of the report, the outcome was Recovering/Resolving. All the events were reported with the seriousness criteria of Medically significant. The rechallenge is not applicable since the events occurred after an unknown dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 60-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected events of Pyrexia, Abdominal pain and Chest pain. The events occurred approximately 6 days after the administration of an unknown dose of the mRNA-1273 vaccine and, at the time of the report, the outcome was Recovering/Resolving. All the events were reported with the seriousness criteria of Medically significant. The rechallenge is not applicable since the events occurred after an unknown dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957659 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 072F21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Pruritus; Severe allergic reaction; Skin rashes (non-injection site); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PRURITUS (Pruritus), HYPERSENSITIVITY (Severe allergic reaction) and RASH (Skin rashes (non-injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072F21A_1101207-CDC) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Nov-2021, the patient experienced PRURITUS (Pruritus) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction) (seriousness criterion medically significant) and RASH (Skin rashes (non-injection site)) (seriousness criterion medically significant). At the time of the report, PRURITUS (Pruritus), HYPERSENSITIVITY (Severe allergic reaction) and RASH (Skin rashes (non-injection site)) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. It was reported that the rashes appeared on the face, hands, feet and trunk successively after the patient received the second dose of vaccine, with itch, and redness and swelling. 18 November 2021 As the symptoms didn''t improve, the patient came to this hospital and was diagnosed with urticaria, and was given anti-allergic drug for oral administration after examination. On 25 November 2021 the urticaria improved when he took the drug, the same occurred after receiving the first dose the other time, and only improved through TCM treatment until vaccination of the second dose. He felt much more improved by taking unknown medicine. Company comment: This case concerns a 37-year-old female patient, with no medical history reported who experienced the serious unexpected events of pruritus, rash and hypersensitivity after dose of mRNA-1273. As per RA case narrative the events occurred the same day after second dose of mRNA-1273 and it was reported that the same occurred after receiving the first dose the other time, however, since it did not clarify what vaccine it was, the re-challenge is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 37-year-old female patient, with no medical history reported who experienced the serious unexpected events of pruritus, rash and hypersensitivity after dose of mRNA-1273. As per RA case narrative the events occurred the same day after second dose of mRNA-1273 and it was reported that the same occurred after receiving the first dose the other time, however, since it does not clarify what vaccine it was, the re-challenge is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957660 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abscess, Cellulitis, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute renal failure (treatment on 2011/08); Constipation; Diabetes mellitus (10 year regular F/U); Diabetic nephropathy; Functional gastrointestinal disorder; Hyperlipidemia; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (Few); Cigarette smoker (1PPD about 30 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Swollen lymph nodes; Local abscess or suspected cellulitis; Suspected cellulitis; This regulatory authority case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), ABSCESS (Local abscess or suspected cellulitis) and CELLULITIS (Suspected cellulitis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient''s past medical history included Cigarette smoker (1PPD about 30 years) and Alcohol use (Few). Concurrent medical conditions included Diabetes mellitus (10 year regular F/U), Acute renal failure (treatment on 2011/08), Type 2 diabetes mellitus, Diabetic nephropathy, Hyperlipidemia, Functional gastrointestinal disorder and Constipation. On 17-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), ABSCESS (Local abscess or suspected cellulitis) (seriousness criterion medically significant) and CELLULITIS (Suspected cellulitis) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes), ABSCESS (Local abscess or suspected cellulitis) and CELLULITIS (Suspected cellulitis) was resolving. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided On 17 NOV 2021, at 18:00 received the second dose of Moderna COVID-19 vaccine. On 19 Nov 2021, at 08:56 was admitted to the emergency department. The patient complained that since yesterday he developed swelling extended from left chin to the neck with pain score of 7 points. Rx: Amoxicillin/Clavulanate 1g BID 3 days, Acetaminophen 500mg TID 3 days On 22 Nov 2021, visited ENT clinic, was admitted to the emergency department, was hospitalized On 26 Nov 2021, Amoxicillin 1g/Clavulanate 0.2g, 0.5vial Q12H, from 23 Nov to 25 Nov, Clindamycin 300mg Q6H, from 23 Nov to 26 Nov, received analgesics, gastrointestinal drugs, hypoglycemic drugs. AAD the patient was transferred for treatment. Company comment: This case concerns a 56-year-old male patient with relevant medical history of diabetes mellitus type 2, who experienced serious unexpected events of lymphadenopathy, abscess and cellulitis, reported as local abscess or suspected cellulitis. The events occurred approximately 1 day after the 2nd dose of the mRNA-1273 . The patient was admitted to the emergency department due to swelling that spread from left chin to the neck with the pain score of 7. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient''s concurrent condition of diabetes mellitus type 2 is a possible confounder for the events of abscess and cellulitis since patients with diabetes are more susceptible to infections. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 56-year-old male patient with relevant medical history of diabetes mellitus type 2, who experienced serious unexpected events of lymphadenopathy, abscess and cellulitis, reported as local abscess or suspected cellulitis. The events occurred approximately 1 day after the 2nd dose of the mRNA-1273 . The patient was admitted to the emergency department due to swelling that spread from left chin to the neck with the pain score of 7. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient''s concurrent condition of diabetes mellitus type 2 is a possible confounder for the events of abscess and cellulitis since patients with diabetes are more susceptible to infections. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1958226 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Chest pain/chest tightness; Chest pain/chest tightness; This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain/chest tightness) and CHEST DISCOMFORT (Chest pain/chest tightness) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Nov-2021, the patient experienced CHEST PAIN (Chest pain/chest tightness) (seriousness criterion hospitalization prolonged) and CHEST DISCOMFORT (Chest pain/chest tightness) (seriousness criterion hospitalization prolonged). At the time of the report, CHEST PAIN (Chest pain/chest tightness) and CHEST DISCOMFORT (Chest pain/chest tightness) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported. On November 13, 2021 patient received the first dose of Moderna vaccine. Then on November 18, 2021: The patient went to the emergency department of their hospital and complained of chest tightness since yesterday. November 13: The patient received the Moderna vaccine. During doctor examination, the patient complained of intermittent chest tightness since last afternoon which lasted for about 30 minutes, with no cold sweating, no nausea or vomiting. Vital signs included GCS: E4V5M6; BP: 95 / 63 mmHg; HR: 85 times/min; RR: 18 times/min; BT: 35�C; SpO2: 98%. After doctor examination, the patient was given (injected) Sodium Chloride 0.9% 500 ml ST IVD according to doctor advice, [Examination] WBC 12.04x1,000/uL. Tropo-I =6.6445 ng/mL; CRP (quantitative)= 26.09 mg/L; GOT(AST)= 69 IU/L; GPT(ALT)= 19 IU/L; Creatinine=0.78 mg/dL. COVID-19 PCR test Negative. After examination, the patient was transferred to ICU on the day of hospitalization and then transferred to the Division of Cardiology. As the relevance to an adverse reaction of the COVID-19 vaccine cannot be ruled out, the doctor reported a vaccine adverse reaction. When the follow-up care was done on November 30, 2021: The call was missed. Company Comment: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the unexpected events of Chest pain and Chest discomfort. The events occurred approximately 5 days after the first dose of mRNA-1273 Vaccine which resulted in hospitalization and subsequent ICU admission. At the time of report the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the unexpected events of Chest pain and Chest discomfort. The events occurred approximately 5 days after the first dose of mRNA-1273 Vaccine which resulted in hospitalization and subsequent ICU admission. At the time of report the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1959119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Hypertension, Hypertensive crisis, Immunisation
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal RR
CDC Split Type: ATPFIZER INC202101728222

Write-up: Hypertensive crisis with persistent hypertension, before that normal RR; Hypertensive crisis with persistent hypertension, before that normal RR; Booster; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-062884 (BASGAGES). A 83 year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FF2834) via unspecified route of administration on 18Nov2021 as dose 3 (booster), single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Patient previously received Covid-19 vaccine (Manufacturer unknown, Batch/lot number not reported) via unspecified route of administration on unspecified date as 1st dose and 2nd dose for covid-19 immunization. On 19Nov2021, Patient experienced Hypertensive crisis with persistent hypertension, before that normal RR and Booster. The patient underwent laboratory tests and procedures includes electrocardiogram with result normal RR. The outcome of the event Hypertensive crisis was recovered on an unspecified date in 2021. The outcome of the event hypertension was not recovered. No follow-up attempts are possible. No further information is expected. Additional information: The casual relationship of Comirnaty and both events assessed as Certain by Primary source.


VAERS ID: 1960404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Disorientation, Dizziness, Feeling abnormal, Immunisation, Insomnia, Memory impairment, SARS-CoV-2 test, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101731656

Write-up: disorientated; Chest ache; Difficulty sleeping; Stomach pain; Tinnitus; Memory disturbance (excl dementia); Foggy feeling in head; Light-headed; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112052147423210-OMNPP (RA). Other Case identifier(s): GB-MHRA-ADR 26293238 (RA). A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 23Jan2021, stop date: 11Jun2021. There were no concomitant medications. Past drug history included: Covid-19 mrna vaccine biontech. Vaccination history included: Bnt162b2 (Dose 1); Bnt162b2 (Dose 2). The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; DISORIENTATION (medically significant), outcome "recovering", described as "disorientated"; FEELING ABNORMAL (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Foggy feeling in head"; DIZZINESS (medically significant) with onset 18Nov2021, outcome "recovered" (23Nov2021), described as "Light-headed"; INSOMNIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Difficulty sleeping"; ABDOMINAL PAIN UPPER (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Stomach pain"; TINNITUS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Tinnitus"; MEMORY IMPAIRMENT (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Memory disturbance (excl dementia)"; CHEST PAIN (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Chest ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2021) yes - positive covid-19 test. Clinical course: Not taking any other medication. About 2 months after the first Pfizer vaccine, the patient began to feel normal again and about 10 weeks following the second jab the effects of the fogginess wored off. The symptoms now were worsened than that of the two previous jabs. All started together a few days after the booster. The patient had similar symptoms after the first and second Covid vaccines but at the time was struggling with lockdown and had not associated the symptoms with the vaccines. So the patient had expected that time. The main issue was the Fogginess. Losing concentration for a split second and forgetting why he was doing and at times felt a little disorientated. The patient tried to remain calm knowing that would pass. The patient would be seeking further advise from his GP. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Reaction: This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pruritus, Rash, 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: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stomach ache
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731566

Write-up: Off label use; Interchange of vaccine products; Booster; Itchy; Skin rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112052236074830-QYSRS (RA). Other Case identifier(s): GB-MHRA-ADR 26293364 (RA). A 76 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Stomach ache" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for abdominal pain upper. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), administration date: 27Apr2021, for COVID-19 immunisation, reaction(s): "Itchy rash"; Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PRURITUS (medically significant) with onset 2021, outcome "unknown", described as "Itchy"; RASH (medically significant) with onset 2021, outcome "unknown", described as "Skin rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No-Negative COVID-19 test. Therapeutic measures were taken as a result of pruritus, rash. Clinical course: Patient has not had symptoms associated with COVID-19. Initial itchy spots later developing into very itchy, sometimes sore, skin rash, some on the legs but mostly on the upper arms, shoulders and back. Treatment had included Emollients, Eumovate Cortisone cream, Briefly Daktarin and now Fexofenadine antihistamine tablets and emollient cream, All without success. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1015A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dyspnoea, Feeling hot, Heart rate, Heart rate increased, Hyperhidrosis, Hyperventilation, Loss of consciousness, Muscle spasms, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: Hashimoto''s thyroiditis (Hashimoto''s thyroiditis, recently started therapy.)
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Dad allergic to penicillin, experienced shock after vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: heartbeat; Result Unstructured Data: Test Result:rapid
CDC Split Type: HRPFIZER INC202101733999

Write-up: I was out of breath; I was disorientated / disorientation; Heart rate increased; My whole body was in cramps/my arms and legs/leg cramps/cramp in hand; Loss of consciousness; Pyrexia; Breathing accelerated; Sensation of heat/rush of heat; sweating; fainted; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: HR-HALMED-300052389. Other Case identifier(s): 11-569-554-357. A 44-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 1F1015A) as dose 1, 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s thyroiditis" (ongoing), notes: Hashimoto''s thyroiditis, recently started therapy; penicillin allergy. Family history included: "penicillin allergy" (unspecified if ongoing), notes: Dad allergic to penicillin, experienced shock after vaccination. The patient''s concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 18Nov2021, outcome "unknown", described as "I was out of breath"; DISORIENTATION (life threatening) with onset 18Nov2021, outcome "unknown", described as "I was disorientated / disorientation"; HEART RATE INCREASED (life threatening) with onset 18Nov2021, outcome "unknown", described as "Heart rate increased"; MUSCLE SPASMS (life threatening) with onset 18Nov2021, outcome "unknown", described as "My whole body was in cramps/my arms and legs/leg cramps/cramp in hand"; LOSS OF CONSCIOUSNESS (life threatening) with onset 18Nov2021, outcome "unknown", described as "Loss of consciousness"; PYREXIA (life threatening) with onset 18Nov2021, outcome "unknown", described as "Pyrexia"; HYPERVENTILATION (life threatening) with onset 18Nov2021, outcome "unknown", described as "Breathing accelerated"; FEELING HOT (life threatening) with onset 18Nov2021, outcome "unknown", described as "Sensation of heat/rush of heat"; HYPERHIDROSIS (life threatening) with onset 18Nov2021, outcome "unknown", described as "sweating"; SYNCOPE (life threatening) with onset 18Nov2021, outcome "unknown", described as "fainted". The patient underwent the following laboratory tests and procedures: heart rate: (18Nov2021) rapid. After the 1st dose of Pfizer Comirnaty, the patient fainted the next morning. When she came to herself, she was disoriented and didn''t recognize her housemates. Then there was a rush of heat, sweating, rapid heartbeat, and she was out of breath. Her whole body was in cramps, her arms, and legs. It all took about half an hour. When it calmed down, she got a fever in the afternoon. All events were reported with stop date 18Nov2021 with outcome unknown (as reported). A causal relationship between Comirnaty and all events was assessed as "possible" by Regulatory Authority via WHO-UMC Causality method of assessment.


VAERS ID: 1960742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Contusion, Fatigue, Immunisation, Impaired work ability, Interchange of vaccine products, Loss of personal independence in daily activities, Muscle spasms, Myalgia, Off label use, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101729070

Write-up: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from the Regulatory Authority. Regulatory number: IE-HPRA-2021-087113 (RA). Other case identifier(s): IE-HPRA-CVARR2021112122776 (RA). A 52-year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (AstraZeneca 27/Feb/21 1st vaccine reaction muscle ache swell and redness at site for 3 weeks., Dose number unknown), administration date: 27Feb2021, for COVID-19 immunisation, reaction(s): "Vaccination adverse reaction", "muscle ache", "swell", "redness at site"; Vaxzevria (Dose number unknown), for COVID-19 immunisation.The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "interchange of vaccine product"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; CONTUSION (medically significant) with onset 19Nov2021, outcome "unknown", described as "BRUSING ABOVE LEFT KNEE"; MUSCLE SPASMS (medically significant) with onset 19Nov2021, outcome "unknown", described as "MUSCLE SPASMS"; PERIPHERAL SWELLING (medically significant) with onset 19Nov2021, outcome "unknown", described as "SWELLING ON LOWER LEFT LEG"; MYALGIA (medically significant) with onset 19Nov2021, outcome "unknown", described as "MUSCLE ACHES"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), ASTHENIA (medically significant), FATIGUE (medically significant), IMPAIRED WORK ABILITY (medically significant), outcome "unknown" and all described as "LEFT ME WEAK, FATIGUE AND UNABLE TO LIFT AND GO TO WORK". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960806 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-11-18
   Days after vaccination:251
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ectopic pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Normal delivery (live child) (The subject had been pregnant once before and had one child.); Tobacco user (The subject had smoked during this pregnancy.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101781110

Write-up: This is a non-interventional study report for protocol C4591006 from a physician and other health professional. The subject was a 31-year-old female. The subject was 149 cm tall and weighed 48 kg. The subject''s last menstruation began on 03Oct2021. The estimated date of conception for the subject was 18Oct2021. Relevant medical history included tobacco use and normal delivery (live child). The subject smoked during this pregnancy but did not drink alcohol or use illegal drugs. The subject had been pregnant once in the past and had given birth to a live child, so she had one child. There were no concomitant medications. On 19Feb2021, the subject received the first dose of BNT162b2 (COMIRNATY, Lot number: EP2163, expiration date 31May2021) 0.3 mL at the age of 31 years as single dose for COVID-19 immunization. On 12Mar2021 at 13:30, the subject received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EP2163, expiration date 31May2021) 0.3 mL in arm left at the age of 31 years as a single dose for COVID-19 immunization. On 18Nov2021, the subject experienced ectopic pregnancy (pregnancy in the right fallopian tube). On 18Nov2021 the subject experienced an elective abortion. The number of weeks of pregnancy at that time was 5 weeks. The patient was hospitalized for ectopic pregnancy (start date: 2021). The pregnancy resulted in elective termination. Therapeutic measures were taken as a result of ectopic pregnancy. The outcome of the event was resolved with sequel on 03Dec2021. On 03Dec2021, the subject received the third dose of BNT162b2 (COMIRNATY, Lot number: FJ5929, expiration date 31Jan2022) 0.3 mL at the age of 32 years for COVID-19 immunization. The investigator classified the event as serious (life-threatening and hospitalization). The investigator considered there was not a reasonable possibility that the event "ectopic pregnancy (pregnancy in the right fallopian tube)" was related to bnt162b2.; Sender''s Comments: Due to implausible temporal association, the event of Ectopic Pregnancy is assessed as unrelated to suspected vaccine BNT162b2 (COMIRNATY). The patient has been taking the medication, before development of pregnancy, Linked Report(s): JP-PFIZER INC-202101783336 The case of the child''s father.


VAERS ID: 1960916 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020G21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20214

Write-up: Headache; Dizziness; This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 020G21A) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). At the time of the report, HEADACHE (Headache) and DIZZINESS (Dizziness) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a 66-year-old female patient with no medical history provided who experienced serious unexpected events of Headache and Dizziness. The events occurred one day prior to vaccination with the dose of mRNA-1273, however, as at the time of the report, outcome of the events was unknown, causal relationship of the suspect product cannot be excluded and, therefore, causality is assessed as related. The rechallenge was not applicable. Causality is confounded with patient''s advanced age. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 66-year-old female patient with no medical history provided who experienced serious unexpected events of Headache and Dizziness. The events occurred one day prior to vaccination with the dose of mRNA-1273, however, as at the time of the report, outcome of the events was unknown, causal relationship of the suspect product cannot be excluded and, therefore, causality is assessed as related. The rechallenge was not applicable. Causality is confounded with patient''s advanced age. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1961003 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5973 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure diastolic, Blood pressure systolic, Dyspnoea, Erythema, Headache, Heart rate, Heart rate increased, Hypertension, Oxygen saturation, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy multiple; Anxiety disorder; Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20211118; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:85 mmHg; Test Date: 20211118; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:180 mmHg; Test Date: 20211118; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:155 mmHg; Test Date: 20211118; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Comments: beats/min; Test Date: 20211118; Test Name: Heart rate; Result Unstructured Data: Test Result:58; Comments: beats/min; Test Date: 20211118; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20211118; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: ROPFIZER INC202101730856

Write-up: Anaphylactic reaction; Headache; Breathing difficult; Arterial hypertension; Facial erythrosis; Paresthesias in the lips, nose, forehead; Heart rate increased; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: RO-NMA-2021-SPCOV15127 . A 49 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FJ5973) at the age of 49 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "Allergy multiple" (unspecified if ongoing). Concomitant medication(s) included: AERIUS [DESLORATADINE], start date: 17Nov2021. The patient had previously undergone an allergy consultation and the physician recommended a prophylactic regimen: Rupatadine 10 mg, 1 tablet, 2 days before vaccination, 1 tablet one day before vaccination and 1 tablet 60 minutes before vaccination. The patient took Aerius 1 tablet- one day before vaccination and 1 tablet 3 hours before vaccination. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Anaphylactic reaction"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Headache"; DYSPNOEA (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Breathing difficult"; HYPERTENSION (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Arterial hypertension"; ERYTHEMA (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Facial erythrosis"; PARAESTHESIA (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Paresthesias in the lips, nose, forehead"; HEART RATE INCREASED (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Heart rate increased". The events "anaphylactic reaction", "headache", "breathing difficult", "arterial hypertension", "facial erythrosis", "paresthesias in the lips, nose, forehead" and "heart rate increased" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure diastolic: (18Nov2021) 90 mmHg; (18Nov2021) 85 mmHg; blood pressure systolic: (18Nov2021) 180 mmHg; (18Nov2021) 155 mmHg; heart rate: (18Nov2021) 90, notes: beats/min; (18Nov2021) 58, notes: beats/min; oxygen saturation: (18Nov2021) 98 %; (18Nov2021) 99 %. Therapeutic measures were taken as a result of anaphylactic reaction, headache, dyspnoea, hypertension, erythema, paraesthesia, heart rate increased. Clinical course: On 18-Nov-2021 the patient received Comirnaty. On the same day, 30 minutes post-vaccination the patient experienced anaphylactic reaction, paresthesias in the lips, nose, forehead, difficulty breathing, oxygen saturation = 99%, blood pressure = 180/90 mmHg, heart rate = 90 / min, rhythmic, facial erythrosis. The allergist was contacted (by phone) and Aerius 1 tablet was recommended, up to 4 tablets/ day. As a corrective therapy the patient received 1 tablet Aerius, Anxiar 1mg - 1 tablet. After 30 minutes paresthesias and facial erythrosis recovered, oxygen saturation = 98%, blood pressure = 155/85 mmHg, heart rate = 58 / min, rhythmic, the patient accuses headache. After another 20 minutes, the headache disappears, good general condition, without other accusations. In the reporter''s opinion the events were related to Comirnaty, lot FJ5973. According to the Reporter, the patient is known to have hypertension, anxiety disorder and multiple allergies. She had previously undergone an allergy consultation and the physician recommended a prophylactic regimen: Rupatadine 10 mg, 1 tablet, 2 days before vaccination, 1 tablet one day before vaccination and 1 tablet 60 minutes before vaccination. The patient took Aerius 1 tablet- one day before vaccination and 1 tablet 3 hours before vaccination. Sender Comment: This case was reported by a physician in the National Registry and received by the Competent Authority from the National Centre PRIVACY. The seriousness of the case was not provided by the Reporter. The case was considered serious (Other medically important) by the Sender based on IME List.


VAERS ID: 1962652 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Periarthritis
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Frozen shoulder; This case was received via regulatory authority-RA (Reference number: GB-MHRA-ADR 26306671) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PERIARTHRITIS (Frozen shoulder) (seriousness criteria disability and medically significant). At the time of the report, PERIARTHRITIS (Frozen shoulder) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications not provided by the reporter. Patient had experienced Frozen shoulder in both shoulders, it was started on day of vaccination and still ongoing after three weeks. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medications was not provided by the reporter.; Sender''s Comments: This case concerns a 63-year-old female patient with no medical history reported, who experienced the serious (medically significant and disabling or Incapacitating) unexpected event of Periarthritis. The event occurred on the same day after the third dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown because it was not reported whether the same/similar events had occurred after the first and second dose. The benefit-risk relationship of mRNA-1273, 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 Disabling or Incapacitating.


VAERS ID: 1963137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1012A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Immunisation, Tinnitus
SMQs:, Cardiomyopathy (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101734102

Write-up: Circulatory problems; Ringing in the ears, tinnitus; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: AT-BASGAGES-2021-063403 (RA). A 38 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: 1F1012A) as dose 3 (booster),single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; CARDIOVASCULAR DISORDER (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Circulatory problems"; TINNITUS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Ringing in the ears, tinnitus". Therapeutic measures were taken as a result of cardiovascular disorder, tinnitus. The patient received with Trental 400 mg film-coated tablets 2x1, Sirdalud 4mg 1x treatment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1963145 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3560 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood test, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Hyperhidrosis, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CTCA; Result Unstructured Data: Test Result:PENDING; Test Name: blood test; Result Unstructured Data: Test Result:PENDING; Test Name: Cardiac Ecco; Result Unstructured Data: Test Result:PENDING; Test Name: ECGs; Result Unstructured Data: Test Result:PENDING
CDC Split Type: AUPFIZER INC202101732671

Write-up: Intense stabbing chest pain radiating to scapular with profuse diaphoresis; Day Two: SOB; Intense stabbing chest pain radiating to scapular with profuse diaphoresis; Day one post vaccination: Fever and malaise; Day one post vaccination: Fever and malaise; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY, solution for injection), administered in arm left, administration date 17Nov2021 11:00 (Lot number: FL3560) at the age of 47 years as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer Comirnaty xm68m6 (COVID-19) (first dose, Batch/Lot No: FH3219, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 21Oct2021, for COVID-19 vaccination; Adt/tettox, reaction(s): "Allergy"; Flu vaccinations, reaction(s): "allergy". The following information was reported: PYREXIA (hospitalization), MALAISE (hospitalization) all with onset 18Nov2021 07:00, outcome "recovering" and all described as "Day one post vaccination: Fever and malaise"; CHEST PAIN (hospitalization) with onset 19Nov2021, outcome "recovering", HYPERHIDROSIS (hospitalization) with onset 22Nov2021, outcome "recovering" and all described as "Intense stabbing chest pain radiating to scapular with profuse diaphoresis"; DYSPNOEA (hospitalization) with onset 19Nov2021, outcome "recovering", described as "Day Two: SOB". The patient was hospitalized for pyrexia, malaise, chest pain, hyperhidrosis, dyspnoea (hospitalization duration: 4 day(s)). The events "day one post vaccination: fever and malaise", "day one post vaccination: fever and malaise", "intense stabbing chest pain radiating to scapular with profuse diaphoresis", "intense stabbing chest pain radiating to scapular with profuse diaphoresis" and "day two: sob" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: pending; blood test: pending; echocardiogram: pending; electrocardiogram: pending. Therapeutic measures were taken as a result of pyrexia, malaise, chest pain, hyperhidrosis, dyspnoea. Additional information: Day one post vaccination, the patient experienced fever and malaise. Day two post-vaccination, the patient experienced dull left sided chest pain, SOB, and general malaise. Day three post-vaccination, the patient experienced left sided chest pain increased and general malaise. Day four post-vaccination, the patient experienced left sided chest pain increased to stabbing pain with general malaise. Day five post-vaccination, the patient experienced intense stabbing chest pain radiating to scapular with profuse diaphoresis, SOB, and malaise. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2 cannot be ruled out. 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: 1964126 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Immunisation, Lymph node pain, Lymphadenopathy, Myalgia, Vaccination site erythema, Vaccination site irritation, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fruit allergy; Graves'' disease; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101733937

Write-up: Booster; Swollen and painful glands in the armpit; Swollen and painful glands in the armpit; Arthralgia; Myalgia; Injection site reaction; Injection site is irritated, red, swollen and itchy; Injection site is irritated, red, swollen and itchy; Injection site is irritated, red, swollen and itchy; Injection site is irritated, red, swollen and itchy; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory agency-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109612 (FAMHP). A 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH8469) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hay fever" (unspecified if ongoing); "Citrus fruit allergy" (unspecified if ongoing); "Graves'' disease" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 18Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (disability), LYMPH NODE PAIN (disability) all with onset 18Nov2021, outcome "recovering" and all described as "Swollen and painful glands in the armpit"; ARTHRALGIA (disability) with onset 18Nov2021, outcome "recovering", described as "Arthralgia"; MYALGIA (disability) with onset 18Nov2021, outcome "recovering", described as "Myalgia"; VACCINATION SITE REACTION (disability) with onset 18Nov2021, outcome "recovering", described as "Injection site reaction"; VACCINATION SITE IRRITATION (disability), VACCINATION SITE ERYTHEMA (disability), VACCINATION SITE SWELLING (disability), VACCINATION SITE PRURITUS (disability) all with onset 18Nov2021, outcome "recovering" and all described as "Injection site is irritated, red, swollen and itchy"; FATIGUE (disability) with onset 18Nov2021, outcome "recovering", described as "Fatigue". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, arthralgia, myalgia, vaccination site reaction, vaccination site irritation, vaccination site erythema, vaccination site swelling, vaccination site pruritus, fatigue which included paracetamol. Reporter Comment: Treatment - Yes With paracetamol Evolution of the ADR - Recovering Situations - Other: General Vaccine Response ADR description - Swollen and painful glands in armpit Injection site is irritated: red, swollen and itchy Sore muscles and joints No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes With paracetamol Evolution of the ADR - Recovering Situations - Other: General Vaccine Response ADR description - Swollen and painful glands in armpit Injection site is irritated: red, swollen and itchy Sore muscles and joints


VAERS ID: 1964206 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dyspnoea, Immunisation, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vertigo
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 (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM
Current Illness: Adenocarcinoma of prostate; Epilepsy; Sleep apnoea syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: amti-S IgG; Test Result: Positive ; Test Date: 20211121; Test Name: anti-N IgG; Test Result: Negative ; Test Date: 20211120; Test Name: Covid-19 smear; Test Result: Positive
CDC Split Type: CHPFIZER INC202101762729

Write-up: Feverish; Episodes of dyspnea; Balance disorder; Rotatory vertigo; Comirnaty dose 3; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-29078 A 83 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 83 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (ongoing); "Epilepsy" (ongoing); "Sleep apnoea syndrome" (ongoing). Concomitant medication(s) included: LEVETIRACETAM. Vaccination history included: Cormirnaty (dose 2, single, Batch/lot number not reported), administration date: 16Feb2021, for Covid-19 immunization; Cormirnaty (dose 1, single, Batch/lot number not reported), administration date: 19Jan2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Comirnaty dose 3"; PYREXIA (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Feverish"; DYSPNOEA (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Episodes of dyspnea"; BALANCE DISORDER (hospitalization, medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Balance disorder"; VERTIGO (hospitalization, medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Rotatory vertigo". The events "feverish", "episodes of dyspnea", "balance disorder" and "rotatory vertigo" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (21Nov2021) positive; (21Nov2021) negative; sars-cov-2 test: (20Nov2021) positive. The events episodes of dyspnea and Episodes of dyspnea onset latency was 10 months, Balance disorder and Rotatory vertigo for 9 months 30 days. Therapeutic measures were taken as a result of pyrexia, dyspnoea, balance disorder, vertigo. No organic cause was found in the hospital. In addition, in recent weeks, a slight intentional tremor has appeared, with deterioration on19Nov, motivating the patient to consult the emergency room for these reasons on 20Nov. The patient receives oxygen, two doses of tocilizumab and treatment with dexamethasone. Home treatment included: Levetiracetam 500 [mg] 2x / d. This patient therefore presented with dizziness after the 3rd dose of the COVID-19 vaccine Comirnaty. He also developed a SARS-CoV-2 infection with acute hypoxemic respiratory failure 9 months after the second injection and shortly after the third injection. 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) : CH-PFIZER INC-202101786947 LOE + other events after 3rd dose of vaccine


VAERS ID: 1964272 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CYPFIZER INC202101730727

Write-up: Loss of consciousness; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory number: CY-CYPPVPR-230921KK1 (CYPPVPR). A 32-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 09:15 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (congenital anomaly, medically significant) with onset 18Nov2021, outcome "unknown", described as "Loss of consciousness". The event "loss of consciousness" was evaluated at the emergency room visit. Onset latency for event was reported as 30 seconds. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDCC8 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Arthralgia, Chest pain, Dizziness, Fatigue, Hypoaesthesia, Myalgia, Myocarditis, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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:
CDC Split Type: FIPFIZER INC202101729239

Write-up: Arrhythmia; Myocarditis; Pain in arm; Chest pain; Numbness in hand; Dizziness; Arthralgia; Myalgia; Pyrexia; Fatigue; This is a spontaneous report received from a contactable Consumer from the regulatory authority-WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217157 (FIMEA). A 29 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: SDCC8) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Numbness in hand"; DIZZINESS (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Dizziness"; ARTHRALGIA (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Arthralgia"; MYALGIA (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Myalgia"; PYREXIA (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Pyrexia"; FATIGUE (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Fatigue"; ARRHYTHMIA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Arrhythmia"; MYOCARDITIS (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Myocarditis"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Pain in arm"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Chest pain". The events "numbness in hand", "dizziness", "arthralgia", "myalgia", "pyrexia", "fatigue", "arrhythmia", "myocarditis", "pain in arm" and "chest pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arrhythmia included self-medication with Propral was successful at regulating the pulse. The patient have contacted the health care centre, who instructed me to monitor the situation, take medication, and go to the emergency room if this gets worse. No follow-up attempts are possible. No further information is expected.


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