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From the 10/8/2021 release of VAERS data:

Found 781,870 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 425 out of 7,819

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VAERS ID: 1695899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101124737

Write-up: Herpes zoster; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-042193. A 35-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced herpes zoster on 17Aug2021 with outcome of not recovered. Seriousness criteria reported as hospitalization. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1697088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139228

Write-up: Bell''s palsy; headache; This is a spontaneous report from a contactable other Health Care Professional via the Agency Regulatory Authority. Regulatory authority report number is 609492. A 48-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 17Aug2021 the patient experienced bell''s palsy, headache. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Based upon of the product bnt162b2, the causal association between the event Bells palsy and headache and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1697105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Malaise, Myalgia, Neuralgia, Paraesthesia, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hearing impairment (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101139425

Write-up: Facial paralysis; Hypoaesthesia; Malaise; Myalgia; Neuralgia; Paraesthesia; Swelling face; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 610312. A 50-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial paralysis, hypoaesthesia, malaise, myalgia, neuralgia, paraesthesia and swelling face on 17Aug2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1697141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Pruritus, Rash, Rash erythematous, Respiratory disorder, Respiratory distress, Skin disorder, Suffocation feeling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101124307

Write-up: Anaphylaxis; with breathing difficulties; hives migrating all over the body; Choking sensation / Suffocation feeling; Itching; Brutal rash leaving little healthy skin; Rash erythematous; Respiratory disorder; Skin problem; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105506. A 12-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 10Aug2021 (Lot Number: FE7053) as dose 1, single for COVID-19 immunisation. Medical history was reported as None. The patient''s concomitant medications were not reported. On 17Aug2021, patient experienced hives (urticaria) migrating all over the body with breathing difficulty (respiratory distress), choking sensation (suffocation feeling), itching ++ and brutal rash leaving little healthy skin, anaphylaxis, rash erythematous, respiratory disorder and skin problem. Patient was put on methylprednisolone (MEDROL) and rupatadine (RUPATALL) twice a day, however, symptoms remained. Development: after 2 days of Medrol, erythematous rash but less relief. There is no change in lifestyle, diet or exposure to allergens. Healthy patient with no history. All the events were reported as serious, disability. The outcome of the events was recovering. Reporter''s comment: Treatment - No Development of the adverse drug reaction - Improving Adverse drug reaction description - Urticaria migrating all over the body with breathing difficulty. Choking sensation. Itching ++ Brutal rash leaving little healthy skin. Increased during the day. Put on Medrol and Rupatall twice a day, however, symptoms remained. Development: after 2 days of Medrol: erythematous rash but less relief. There is no change in lifestyle, diet or exposure to allergens. Healthy patient with no history No follow-up attempts are possible. No further information is expected.


VAERS ID: 1697306 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7205 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness unilateral, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101133645

Write-up: woke up without seeing with his left eye (feeling of having a black spot covering his vision); woke up without seeing with his left eye (feeling of having a black spot covering his vision); This is a spontaneous case from a contactable consumer (patient) received. A 25-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via unspecified route in arm left on 14Aug2021 at 12:15 AM at patient age of 25-year-old, as single dose (Lot Number: FD7205) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history was no. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 3 days (17Aug2021 at 06:00 AM) after taking the first dose of Pfizer''s Covid-19 vaccine, he woke up without seeing with his left eye (feeling of having a black spot covering his vision). The event resulted in consultation or visit by a doctor or other health professional, disability or permanent damage. The patient received antibiotic and steroid treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.


VAERS ID: 1697546 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, CSF test, Magnetic resonance imaging
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cerebrospinal fluid; Result Unstructured Data: Test Result:mild pleocytosis; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC202101125187

Write-up: Acute disseminated encephalomyelitis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number is DE-PEI-202100175560. A 21-year-old female patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN) (lot number: FF0900), intramuscularly on 02Aug2021 (21-year-old at vaccination) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced acute disseminated encephalomyelitis on 17Aug2021 with outcome of not recovered. Cerebrospinal fluid: mild pleocytosis, Magnetic resonance imaging with unknown results. This report was serious with seriousness criteria of hospitalization. Result of assessment of Comirnaty with event(s): Acute disseminated encephalomyelitis by PEI was B. Indeterminate. No follow-up attempts possible. No further information expected.


VAERS ID: 1697661 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Artery dissection, Ultrasound scan
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use; Tobacco user
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: computed tomography angiography; Result Unstructured Data: Test Result:dissection of the superior mesenteric artery; Comments: Spontaneous dissection of the superior mesenteric artery. Genesis unclear.; Test Date: 20210817; Test Name: sonography; Result Unstructured Data: Test Result:dissection of the superior mesenteric artery; Comments: Spontaneous dissection of the superior mesenteric artery. Genesis unclear.
CDC Split Type: DEPFIZER INC202101125016

Write-up: Spontaneous dissection of the superior mesenteric artery; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority EudraVigilance-WEB, regulatory authority number DE-PEI-202100176540. A 39-year-old male patient received second dose of BNT162B2 (COMIRNATY), intramuscularly on 14Aug2021 at the age of 39 years old as single dose for COVID-19 immunization. Medical history included cannabis use, nicotine user. Concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 03Jul2021 for COVID-19 immunization. On 17Aug2021, the patient suffered from spontaneous dissection of the superior mesenteric artery. Supported by sonography and computed tomography angiography. Genesis unclear. Differential diagnosis considerations are cannabis use, nicotine, and gender. This report was serious - hospitalization. The outcome of the event was not resolved. No follow-up attempts possible. No further information expected. Information about LOT/Batch number can not be obtained.


VAERS ID: 1697851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar infarction, Magnetic resonance imaging
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (Condition after Apoplexy 2017 with residual tinnitus and attacks of dizziness); Dizziness; Obstructive sleep apnoea syndrome; Tinnitus
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Magnetic resonance-tomographic; Result Unstructured Data: Test Result:acute infarction in the right cerebellar; Comments: evidence of acute infarction in the right cerebellar
CDC Split Type: DEPFIZER INC202101125047

Write-up: Cerebellar infarction; This is a spontaneous report received from a non-contactable consumer downloaded from the Agency WEB. The regulatory authority report number is DE-PEI-CADR2021168213, Safety report unique identifier DE-PEI-202100173958. A 58-year-old male patient received bnt162b2 (COMIRNATY, Strength 0.3ml), dose 2 via an unspecified route of administration on 10Aug2021 (Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient took the first dose of bnt162b2 (COMIRNATY) on an unknown date for covid-19 immunization. Medical history included ongoing arterial hypertension, rheumatism from 2017 and ongoing, apoplexy from 2017, not ongoing, condition after Apoplexy 2017 with residual tinnitus and attacks of dizziness, sleep apnoea syndrome. The patient''s concomitant medications were not reported. The patient experienced cerebellar infarction (hospitalization) on 17Aug2021 with outcome of recovered with sequelae on 23Aug2021. Admission of the patient to hospital due to acute vertigo and repeated vomiting. Magnetic resonance-tomographic evidence of acute infarction in the right cerebellar in 2021. Stationary exclusion of other genesis. Relatedness of drug to event; Source of assessment: RA; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1697861 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: ; This case was received via the regulatory authority (Reference number: DE-PEI-202100174955) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS in a 32-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). On 20-Aug-2021, MYOCARDITIS had resolved. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.. Further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Translated document received on 07-Sep-2021 contain no new information; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.. Further information is expected.


VAERS ID: 1697983 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Pulmonary embolism, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: ELOCON; SILDENAFIL ACCORD
Current Illness: Eczema; Impotence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Computerised tomogram thorax; Result Unstructured Data: Detected thrombosis in lowest lobe of right lung; Test Date: 202108; Test Name: Ultrasound scan; Result Unstructured Data: of left leg, that showed thrombosis in one vein.
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: DVT of calf; Lung embolism; This case was received via Regulatory Authority (Reference number: DK-DKMA-ADR 25817227) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (DVT of calf) and PULMONARY EMBOLISM (Lung embolism) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 vaccination. Concurrent medical conditions included Eczema and Impotence. Concomitant products included MOMETASONE FUROATE (ELOCON) from 29-Sep-2016 to an unknown date for Eczema, SILDENAFIL CITRATE (SILDENAFIL ACCORD) from 28-Nov-2014 to an unknown date for Impotence. On 26-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT of calf) (seriousness criteria disability and medically significant) and PULMONARY EMBOLISM (Lung embolism) (seriousness criteria disability and medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DVT of calf) and PULMONARY EMBOLISM (Lung embolism) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram thorax: abnormal (abnormal) Detected thrombosis in lowest lobe of right lung. In August 2021, Ultrasound scan: abnormal (abnormal) of left leg, that showed thrombosis in one vein.. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. It was reported that the patient was healthy and without risk factors for thrombosis i legs and lungs. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1697999 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:Result unknown; Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: Test Result:Perimyocarditis found; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result:Increased
CDC Split Type: DKPFIZER INC202101131240

Write-up: Chest pain; Perimyocarditis; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0086240 and Safety Report Unique Identifier DK-DKMA-ADR 25840961. A 22-year-old male patient received bnt162b2 (COMIRNATY (tozinameran), Solution for injection, Batch/Lot Number: FD0932, Expiry date: unknown), dose 1 intramuscular on 23Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, 25 days after first vaccination, the patient developed perimyocarditis and fever. On 19Aug2021, 27 days after first vaccination, the patient developed chest pain. The patient was hospitalized for perimyocarditis, chest pain and fever from 19Aug2021 to an unknown date. The ADRs were by the reporter reported resulting in hospitalization (19Aug2021). No treatment or medical procedure due to the ADRs was reported. The perimyocarditis was recovered on an unknown date in Aug2021. The patient underwent lab tests and procedures which included blood test: result unknown, echocardiogram showed perimyocarditis and troponin was increased in Aug2021. The outcome of fever and chest pain are unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1698014 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEPFIZER INC202101141294

Write-up: Fainted; Vaccination site pain; Abdominal pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient''s relative) downloaded from the regulatory authority-WEB. This consumer or other non hcp reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. The regulatory authority report number for the first, serious report is EE-SAM-484821081720. A 12-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: Unknown), via intramuscularly on 17Aug2021 (12-years-old at the time of vaccination) at a dose of 0.3 ml as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: Unknown) on an unspecified date for COVID-19 immunisation and experienced syncope. Patient has no concomitant diseases, medicines, or allergies. On 17Aug2021, 10 minutes after vaccination patient fainted. After vaccination patient also experienced abdominal pain and vaccination site pain. Fainting was resolved on 17Aug2021 and outcome was not resolved for rest of the events. Sender''s Comment: Non-serious psychogenic reactions. Vaccination site pain is non-serious, known side effect of the vaccine. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101180215 the same patient, different doses and events


VAERS ID: 1698056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Coma scale, Electrocardiogram, Headache, Neurological examination, Physical examination, Seizure, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:anodyne; Test Date: 2021; Test Name: GCS Result Unstructured Data: Test Result:15; Comments: conscious and oriented by answering orders; Test Date: 2021; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Unaltered; Test Date: 2021; Test Name: neurological examination; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: physical examination; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: urine; Result Unstructured Data: Test Result:toxic in urine
CDC Split Type: ESPFIZER INC202101125334

Write-up: headache in the retroocular area; Convulsive seizure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (regulatory authority number: ES-AEMPS-978537). A 12-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Aug2021 (Lot Number: FE8405) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced convulsive seizure on 17Aug2021 and headache in the retroocular area on an unspecified date. A 12-year-old boy went to the emergency room for a seizure episode. Upon arrival GCS 15 (2021) he was conscious and oriented by answering orders. Normal complete neurological and physical examination (2021). He reported headache in the retroocular area and in both temples. He denied alteration of vision. Blood tests, toxic in urine and Electrocardiography were requested (2021). Blood tests were anodyne. Unaltered Electrocardiography. Upon reappraisal improvement of the headache, he falls asleep. On suspicion of atonic seizure versus syncope, admission was submitted for clinical control. Normal complete neurological examination (2021). Electrocardiography was requested which was normal (2021). Outcome of convulsive seizure was recovered on 17Aug2021, while outcome of headache in the retroocular was unknown. The adverse events resulted into a visit to the emergency room. The patient was hospitalized for the events. No follow-up attempts are possible. No further information expected.


VAERS ID: 1698122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-08-17
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Ageusia, Asthenia, COVID-19 pneumonia, Chest X-ray, Cough, Dizziness, Drug ineffective, Headache, Hypoxia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADIRO; ATACAND; AMERIDE [AMILORIDE HYDROCHLORIDE;HYDROCHLOROTHIAZIDE]; DOBUPAL; PREVENCOR [ATORVASTATIN CALCIUM]; TRANKIMAZIN; EUTIROX; OMEPRAZOL; DOLOCATIL; REPAGLINIDA; SERC [BETAHISTINE HYDROCHLORIDE]; EXXIV
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: chest x-ray; Result Unstructured Data: Test Result:Normal; Comments: Normal cardio thoracic index. Thickened right hilum already known. Mild bilateral Infiltrate
CDC Split Type: ESPFIZER INC202101131374

Write-up: Drug ineffective; COVID-19 pneumonia; hypoxia/Secondary hypoxemia; headache/headache of moderate intensity; ageusia; cough; fever; asthenia; abdominal discomfort; dizziness/dizziness with ambulation; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. regulatory authority number ES-AEMPS-985948. A 79-years-old female patient received BNT162B2 (COMIRNATY) via intramuscular for COVID-19 immunisation, first dose on 08Apr2021 (lot number: EW2243) as dose 1, single and second dose on 29Apr2021 (lot number: EY3014) as dose 2, single. The patient medical history was not reported. She was not pregnant on the administration of the vaccine. Concomitant medications included acetylsalicylic acid (ADIRO); candesartan cilexetil (ATACAND); amiloride hydrochloride, hydrochlorothiazide (AMERIDE); venlafaxine hydrochloride (DOBUPAL); atorvastatin calcium (PREVENCOR); alprazolam (TRANKIMAZIN); levothyroxine sodium (EUTIROX); omeprazole (OMEPRAZOL); paracetamol (DOLOCATIL); repaglinida; betahistine hydrochloride (SERC); etoricoxib (EXXIV). The patient experienced drug ineffective (hospitalization) on 17Aug2021 with outcome of recovering; COVID-19 pneumonia (hospitalization) on 17Aug2021 with outcome of recovering; headache on 17Aug2021 with outcome of recovering; ageusia on 17Aug2021 with outcome of recovering; cough on 17Aug2021 with outcome of recovering; fever on 17Aug2021 with outcome of recovering; asthenia on 17Aug2021 with outcome of recovering; abdominal discomfort on 17Aug2021 with outcome of recovered; dizziness on 17Aug2021 with outcome of recovering; hypoxia on 17Aug2021 with outcome of recovering. The patient came being COVID positive and vaccinated with double dose of, with symptoms of 6 days duration, consisting of, headache of moderate intensity, without nuchal stiffness, ageusia, without anosmia, cough, fever and asthenia, digestive symptoms (resolved), without referring dyspnea, no chest pain, but dizziness with ambulation, without peripheral or central clinic that may relate to hypoxia. Chest- X-ray (RXTX): Normal cardio thoracic index (ICT). Thickened right hilum already known. Mild bilateral Infiltrate. Clinical judgment: Mild COVID pneumonia. Brescia 1. SEIMC score 10. Secondary hypoxemia. Investigation results: A sample was not sent to the QC-lab 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 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 EY3014. 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. Regulatory authority 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 needed. No additional information is expected.


VAERS ID: 1698143 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Facial paralysis, Headache, Odynophagia, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: Antigen tests; Result Unstructured Data: Test Result:positive; Comments: all were positive
CDC Split Type: ESPFIZER INC202101135933

Write-up: fever; headache; odynophagia; cough; infection by the same SARS-CoV-2 virus; Facial paralysis; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-987316. A 13-years-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection; Lot Number: FG4442) via intramuscular route of administration in Left Deltoid on 12Aug2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021 the patient experienced facial paralysis; on 18Aug2021 the patient experienced fever, headache, odynophagia, cough, infection by the same SARS-COV-2 virus. The patient underwent lab tests and procedures which included Antigen test: positive on 18Aug2021. Therapeutic measures were taken as a result of the adverse events; the patient was treated with corticosteroids and ocular lubricant was prescribed. The clinical outcome of the events was unknown. Follow-up attempts are not possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-202101176530 Same drug, reporter. Different event, patient.;ES-PFIZER INC-202101176529 Same drug, reporter. Different event, patient.


VAERS ID: 1698146 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-08-17
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: COVID-19 pneumonia; Drug ineffective; This case was received via Medicines Agency (Reference number: ES-AEMPS-987568) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) and DRUG INEFFECTIVE (Drug ineffective) in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3002183 and 3001532) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (Drug ineffective) (seriousness criterion hospitalization). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) and DRUG INEFFECTIVE (Drug ineffective) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: positive (Positive) positive. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 19-Apr-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment : This is a case of lack of efficacy of the vaccine, therefore causal association between the event is assessed as possible. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation document received on 08-Sep-2021 and does not contain any new information.; Sender''s Comments: This is a case of lack of efficacy of the vaccine, therefore causal association between the event is assessed as possible. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.


VAERS ID: 1698188 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Temperature; Result Unstructured Data: Test Result:over 39
CDC Split Type: FIPFIZER INC202101131185

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority WEB [FI-FIMEA-20214167]? A 13-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular at single dose on 16Aug2021 for covid-19 immunisation. Medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced allergic rash/allergic eczema on the back, chest, and face and pyrexia/ high temperature (over 39). High temperature (over 39) for the 5 days prior. In addition, on the fifth day, development of allergic eczema on the back, chest, and face. The seriousness criteria for the events were hospitalization. The outcome of events was not recovered. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1698236 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Electrocardiogram, Face oedema, Heart rate, Hyperthermia, Odynophagia, Oxygen saturation, Physical examination, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness: Hypercholesteremia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: C-reactive protein; Result Unstructured Data: Test Result:14; Test Name: electrocardiography; Result Unstructured Data: Test Result:sinus tachycardia; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Comments: Beats per minute(BPM); Test Date: 20210817; Test Name: Heart rate; Result Unstructured Data: Test Result:140-150; Comments: Beats per minute(BPM); Test Name: oxygen saturation; Test Result: 98 %; Test Name: Physical examination; Result Unstructured Data: Test Result:slight oedema in the cheeks; Comments: no skin lesions,no oedema of the uvula
CDC Split Type: FRPFIZER INC202101131098

Write-up: Face edema; Tachycardia; Hyperthermia/at 39 Centigrade; odynophagia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BS20211665 with Safety Report Unique Identifier FR-AFSSAPS-2021118558. This physician reported events for both doses of Comirnaty for this patient. This is the first of two reports for the second dose. A 54-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 17Aug2021 (Batch/Lot Number: FE8244) at 54-year-old, as dose 2, single for covid-19 immunisation. Medical history included ongoing Hypercholesteremia. no Medical history of COVID-19. Not had the person been tested. Concomitant medication included atorvastatin. The patient previously took ibuprofen and experienced drug hypersensitivity (ongoing), took first dose of comirnaty intramuscular on 27Jul2021 at 54-year-old for COVID-19 immunisation and she presented with urticaria of the lower limbs, forearms and abdomen and swelling of the face. The patient experienced face edema, tachycardia, hyperthermia, odynophagia, all on 17Aug2021. Clinical course as follows: Second injection of COMIRNATY on 17Aug2021 (batch FE8244), left arm. On the evening of the injection, despite taking 2 INORIAL, onset of facial oedema with hyperthermia at 39 Centigrade and tachycardia at 140-150 bpm. No notion of skin rash. The female patient was hospitalized. At ongoing medical care: fever at 38.9 Centigrade, heart rate at 120 bpm, sat at 98%, slight oedema in the cheeks, no skin lesions, odynophagia, no oedema of the uvula. Clinical examination otherwise unremarkable. On the blood test: C-reactive protein at 14, electrocardiography: sinus tachycardia. Ongoing medical care: antipyretics and monitoring in hospital. Favorable outcome and discharged from hospital on 20Aug2021. An angioedema assessment will be carried out later. In conclusion: facial oedema, tachycardia and fever after Dose 2. Treatment received for the events. Patient was recovered from the events. The patient was hospitalized for the events from an unknown date to 20Aug2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101182797 Same drug/patient, different dose/event


VAERS ID: 1698313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-08-17
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (high blood pressure); Insulin-requiring type 2 diabetes mellitus; Renal colic (with a placement of a double J catheter); Ureteral stent insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown result; Test Date: 20210818; Test Name: sars-cov-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101124986

Write-up: Vaccination failure; COVID-19/cough, fever/polymerase chain reaction was positive; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-LL20215893. A 86-year-old female patient received bnt162b2, dose 1 via intramuscular in right arm on 12Apr2021 at 14:22 PM (Batch/Lot number EW2246, Expiration Date 31Jul2021) as single dose, dose 2 via intramuscular in left arm on 10May2021 at 16: 18 PM (Batch/Lot number FA5831, Expiration Date 31Aug2021) as single dose for COVID-19 immunisation. The patient medical history included hypertension arterial/ high blood pressure, Insulin-requiring type 2 diabetes mellitus, renal colic with a placement of a double J catheter. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and COVID-19 on 17Aug2021. On 18Aug2021, the patient came to the emergency department then hospitalization for cough, fever since the day before (17Aug2021). On 18Aug2021, polymerase chain reaction was positive and chest X-ray performed with unknown result. The outcome of the events was not resolved. 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 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. Regulatory Authority 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. 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 FA5831. 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. Regulatory Authority 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. Note: Accountability without prejudice to the elements of investigation which could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698411 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101124173

Write-up: drug ineffective/Sars-Cov-2 test positive/CVOID-19; drug ineffective/Sars-Cov-2 test positive/CVOID-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20213401. A 23-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly, administered in Arm Left on an unspecified date (Lot Number and expiration date were unknown) as a single dose, 2nd dose intramuscularly, administered in Arm Left on 08Jul2021 (also reported as 17Aug2021) (Lot Number: FE1573; Expiration Date: 31Oct2021) as a single dose for covid-19 immunisation. The patient''s medical history in cluded COVID-19. Concomitant medications were not reported. The patient experienced drug ineffective/Sars-Cov-2 test positive/CVOID-19 on 17Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021. The outcome of the event was resolving. Description of adverse event: Vaccine failure (as reported) at Day 40 (D40) of the 2nd injection of COMIRNATY. Symptoms Covid without further details. Positive antigenic test. Investigation result for BNT162B2 (COMIRNATY, Lot Number: FE1573; Expiration Date: 31Oct2021) was as follow: The investigation included reviewing the involved batch records, deviation investigation, 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 FE1573. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA 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 lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1698506 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Rash, SARS-CoV-2 test, Skin swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cetirizine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic respiratory disease; Allergic to dogs; COVID-19; House dust mite allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: sars-cov-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101124802

Write-up: Skin eruption; skin reaction with swelling on the left chest and back; skin reaction with redness; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RN20212571. A 46-year-old female patient received bnt162b2 (COMIRNATY Batch/Lot Number: FG4493) intramuscular, administered in Arm Left on 17Aug2021 (at 46-year-old) as dose 1, single for covid-19 immunisation. Medical history included allergy included respiratory (mites, pollens, dogs) treated with CETIRIZINE, covid-19 from 03May2021. Concomitant medication included cetirizine for hypersensitivity. The patient experienced skin eruption (medically significant) on 17Aug2021 with outcome of not recovered. The patient experienced a skin reaction with redness and swelling on the left chest and back 2 hours after vaccine injection on 17Aug2021. No itching. No burns. Summary: 46-year-old patient with a history of allergies and Covid-19, vaccinated with dose 1 of COMIRNATY on 17Aug2021, presented a rash 2 hours after the injection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03May2021. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1698523 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Vaccination site joint pain
SMQs:, Tendinopathies and ligament disorders (broad)

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

Write-up: Aching in limb; Vaccination site joint pain; This case was received via regulatory authority(Reference number: FR-AFSSAPS-SE20212249) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching in limb) in a 21-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Tachycardia and Joint disorder. Concurrent medical conditions included Allergy. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant) and VACCINATION SITE JOINT PAIN (Vaccination site joint pain). At the time of the report, PAIN IN EXTREMITY (Aching in limb) and VACCINATION SITE JOINT PAIN (Vaccination site joint pain) had not resolved. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority. SD states that re-challenge was done, outcome unknown although it is unclear whether this means that the dose resulting in the events was the second dose as it would be too soon for a second dose to have been administered if the first dose occurred on 17-aug-2021.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority. SD states that re-challenge was done, outcome unknown although it is unclear whether this means that the dose resulting in the events was the second dose as it would be too soon for a second dose to have been administered if the first dose occurred on 17-aug-2021


VAERS ID: 1698542 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Eczema
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy multiple; Asthma; Corneal graft
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101130955

Write-up: Generalised eczematous reaction; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-ST20213195 A 52-year-old female patient received bnt162b2 (COMIRNATY) on 17Aug2021 10:00 at age of 52-year-old Intramuscular Arm Left (Lot Number: FE8235) as dose 1, 0.3 mL singlefor covid-19 immunisation. Medical history included asthma, corneal graft, Allergy multiple. On 17Aug2021 15:00, Onset after 5 hours of a generalized eczema flare which was Medically Significant. Outcome of the event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1698560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:revealed a 70% impairment; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:around 90 %
CDC Split Type: FRPFIZER INC202101125285

Write-up: Vaccination failure/respiratory COVID-19 infection; respiratory COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-TO20217030. A 90-year-old female patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose, 2nd dose intramuscularly, administered in Arm Right on 08Feb2021 (Lot Number: EK9788; Expiration Date: 31May2021) as a single dose for covid-19 immunisation. Medical history included overweight. The patient''s concomitant medications were not reported. The patient experienced vaccination failure/respiratory covid-19 infection on 17Aug2021. The patient underwent lab tests and procedures which included CT scan: revealed a 70% impairment, oxygen saturation: around 90 %, both on an unspecified date. Therapeutic measures were taken as a result of event. The outcome of the event was not recovered. Clinical course: Onset on 17Aug2021 of a severe respiratory COVID-19 infection: computed tomography revealed a 70% impairment, hospitalisation in the medical ward, currently on antibiotic therapy, corticosteroid therapy and high concentration mask oxygen therapy, no improvement, oxygen saturation around 90%. Investigation result BNT162B2 (COMIRNATY, Lot Number: EK9788; Expiration Date: 31May2021): 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698594 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004788 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Retinal vein occlusion
SMQs:, Embolic and thrombotic events, venous (narrow), Retinal disorders (narrow)

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

Write-up: Central retinal vein occlusion; This case was received via regulatory authority (Reference number: FR-AFSSAPS-TS20213728) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of RETINAL VEIN OCCLUSION (Central retinal vein occlusion) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004788) for COVID-19 vaccination. The patient''s past medical history included Transient ischaemic attack in 2005. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced RETINAL VEIN OCCLUSION (Central retinal vein occlusion) (seriousness criterion medically significant). At the time of the report, RETINAL VEIN OCCLUSION (Central retinal vein occlusion) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided. Company comments:Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Translation Document received on 3-Sep-2021 contains no new Information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.


VAERS ID: 1698643 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Illness, Kidney infection, Renal pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138227

Write-up: Renal pain; Illness; Dizziness; Kidney infection; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00259344. Safety Report Unique Identifier GB-MHRA-ADR 25858743. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot number was not reported) via parenteral route of administration on 17Aug2021 (at the age of 19 year) as unknown dose, single for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient experienced kidney infection on 17Aug2021, renal pain, illness and dizziness on an unspecified date. The outcome of the events kidney infection was resolved on 21Aug2021 and for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126217

Write-up: Bruise; Sweating fever; Headache; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291717283240-KRVBC, Safety Report Unique Identifier GB-MHRA-ADR 25865795. A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319), via an unspecified route of administration on 16Aug2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had no symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced sweating fever, and headache on 17Aug2021, bruise on 21Aug2021. The bruise - a strange bruise appeared on the back of her upper thigh 5 days after receiving the vaccine, and she had not bumped it anything or fallen over. The bruise grown in size. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted: "Contacted GP about bruise and they concluded it wasn''t a blood clot." The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 22Aug2021. This case was reported as serious due to medical significant. The outcome of event sweating fever was recovered on 19Aug2021, headache was recovered 18Aug2021, bruise was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1699018 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Anxiety, Crying, Depression, Enuresis, Erectile dysfunction, Fatigue, Hyperaesthesia teeth, Menstruation irregular, Mood swings, Panic attack, Suicidal ideation
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Depression (excl suicide and self injury) (narrow), Fertility disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Medical History/Concurrent Conditions: Anxiety; Depression; Lactation decreased; Panic attacks
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138010

Write-up: get; suicidal thoughts; anxiety; bed; mood swings; high sensitivity; tiredness; depression; crying; periods; panic attacks; Irregular periods; This is a spontaneous report from a contactable consumer received from the (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108311637328980-RFGDX. Safety Report Unique Identifier GB-MHRA-ADR 25875293. A female patient of 19-year-old age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FF3319 ), via an unspecified route of administration on 10Aug2021 at DOSE 2, SINGLE for COVID-19 immunization. She was not pregnant. She is not currently breastfeeding. Medical history included panic attack from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced anxiety, mood swings, get, bed, unable to get out of bed, high sensitivity, tiredness with suicidal thoughts, depression, crying, periods and panic attacks on an unspecified date, irregular periods on 17Aug2021. Patient have not had a period for 2 years as have contraceptive implant. Patient had severe period pains and bleeding for 4 days. Patient have periods of anxiety and depression with my periods and these have improved with the implant. Patient 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. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Extra dose administered, Herpes virus infection, Herpes zoster, Interchange of vaccine products, Listless, Malaise, Off label use
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Medication errors (narrow), Hypoglycaemia (broad), Opportunistic infections (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: VALSACOR; RIVOTRIL
Current Illness: Hypertension (started approximatelly since 2010); Stone urinary bladder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101131988

Write-up: herpesvirus infection NOS; he received Pfizer as his third vaccine on Tuesday last week (he received 2 doses of Sinopharm at spring); shingles; weak; listless; malaise; he received Pfizer as his third vaccine on Tuesday last week (he received 2 doses of Sinopharm at spring); he received Pfizer as his third vaccine on Tuesday last week (he received 2 doses of Sinopharm at spring); This is a spontaneous report from a contactable consumer (patient''s son). A 77-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: FF0680), Dose 3 intramuscular, administered in the right arm on 17Aug2021 at 08:30 as a single dose for COVID-19 immunisation. Medical history included hypertension from 2010 and ongoing (started approximately since 2010), ongoing calculus bladder started for about 1.5 years (Surgery is scheduled for 07Sep2021. They will decide on Monday whether keep it or postpone due to shingles). Concomitant medications included valsartan (VALSACOR) for hypertension from 2018 and ongoing; clonazepam (RIVOTRIL) for insomnia from 2020 and ongoing. The patient previously received 2 doses of Sinopharm COVID-19 vaccine in the spring of 2021, without side effects for 4 months. Then the patient received bnt162b2 as his third vaccine on Tuesday last week, on 17Aug2021. The patient experienced malaise and weakness on Thursday night, on 19Aug2021. A few days later, he had strong point-like pains at the right side of his abdomen. Then, a few days later (within 8 days after vaccination), spots appeared in a row, firstly in front of his back and then on his abdomen. The son reported, "as it was already very peak on Saturday, I took him to the duty in name of the city (28Aug2021, at 15:20), where the doctor examined it only visually, he did not admit him to the laboratory. Telviran 800 mg tablets for the diagnosis of herpesvirus infection NOS (B0090) (4x1 daily). We triggered it immediately and he started taking it, he has been taking it ever since, but there are still wounds. His well-being has not recovered either, and a special problem is that his urinary bladder stone surgery scheduled for Tuesday (missed so far due to the pandemic) is not certain to happen either. But what worries everyone more is that his well-being and strength did not come back to him". The son also reported that the patient experienced shingles on 19Aug2021. It was reported that the doctor on duty visually determined the shingles. There was no laboratory test. Since 1.5 weeks, however, he is weak, listless next to the above symptoms. The planned bladder stone surgery was done on Tuesday (the doctor who performed the surgery examined him on Monday and decided to have surgery because the wound was nicer), The patient had not recovered from the events, herpesvirus infection, weak, and shingles. Outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1699421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Chest pain, Chills, Headache, Myalgia, Pain, Palpitations, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101131168

Write-up: ALL OVER BODY PAIN IN LEGS ARMS EVERYWHERE; SHIVERING; PAIN IN THE CHEST / SQUEEZING FEELING / PAIN OVER THE HEART AREA WAS EXTREMELY WORRYING; MUSCLE PAIN ALL OVER BODY; PAIN OVER THE HEART AREA WAS EXTREMELY WORRYING; TEMPERATURE SPIKING; THE FEELING THAT MY HEART WAS RACING AND WAS BURSTING WAS SO SCARY; PAIN IN THE CHEST / SQUEEZING FEELING; HEADACHE EXTREMELY PAINFUL; This is a spontaneous report from a contactable consumer. downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-083159. Sender''s (Case) Safety Report Unique Identifier-IE-HPRA-2021-083159. A 21-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE7053, Expiry date was not reported), via an unspecified route of administration on 17Aug2021 as dose 2, first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number, Expiry date was not reported), via an unspecified route of administration on 27Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, patient experienced all over body pain in legs arms everywhere, shivering, pain in the chest / squeezing feeling / pain over the heart area was extremely worrying, muscle pain all over body, pain over the heart area was extremely worrying, temperature spiking, the feeling that my heart was racing and was bursting was so scary, pain in the chest / squeezing feeling, headache extremely painful. Eight hours later on 17/Aug/2021, the patient experienced muscle pain all over her body, headache, extremely painful pain in the chest, squeezing feeling, shivering, and temperature spiking. The patient took Panadol. The reporter stated that it was an extremely worrying time as so many things were going on particularly in the first 24 hours. The feeling that heart was racing, and bursting was scary. The events caused medically significant. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-08-17
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: echocardiography; Result Unstructured Data: Test Result:absence of alterations or coronary stenosis; Test Date: 20210817; Test Name: electrocardiogram; Result Unstructured Data: Test Result:absence of alterations or coronary stenosis; Test Date: 20210817; Test Name: Troponin; Test Result: Positive
CDC Split Type: ITPFIZER INC202101120592

Write-up: Myocarditis after Covid Pfizer vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-775315. A 34-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left (administration site: left shoulder) on 24Jun2021 12:00 (Batch/Lot Number: FD4555) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received 1st dose of COMIRNATY (Batch/Lot Number: FA4597), administered in left shoulder on 14May2021 15:00. On 17Aug2021, the patient experienced myocarditis after COVID Pfizer vaccination (medically significant). The patient underwent lab tests and procedures (17Aug2021) which included positivity of troponin in the absence of electrocardiogram or echocardiography alterations or coronary stenosis. Therapeutic measures taken included ibuprophen and bisoprolol therapy. The outcome of the event was not recovered. Reporter Comment: Cardiac Magnetic Resonance Imaging is expected for confirmation of the diagnosis and antivirus bodies known by etiological definition Sender Comment: 27Aug2021 severity changed on the basis of the IME list (Medical Event Terms) from not severe to severe. Other clinically relevant condition lot 1st dose Comirnaty FA4597 on 14May2021. I dose administration area: left shoulder. Approximate time of administration 15:00 No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Cardiac Magnetic Resonance Imaging is expected for confirmation of the diagnosis and antivirus bodies known by etiological definition


VAERS ID: 1699526 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Dyspnoea, Eye pruritus, Vaccination site pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathlessness; Bronchial asthma; Seasonal allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101125501

Write-up: feeling of breathlessness; feeling of breathlessness; ocular itching; itching at the injection site; This is a spontaneous report from a contactable physician downloaded from the RA: IT-MINISAL02-775686. A 40-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FG4493; Expiration Date: 30Nov2021), intramuscular, administered in left arm on 17Aug2021 15:31 (at 40-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included feeling of breathlessness for seasonal allergic bronchial asthma. Concomitant medications were not reported. The patient experienced itching at the injection site, ocular itching, feeling of breathlessness as usual for the seasonal allergic bronchial asthma from which patient suffered (medically significant) on 17Aug2021. Therapeutic measures were taken as a result of the events included actions taken (Aerosol with clenil 1 vial + atem 1 vial + broncovaleas 10 drops). The outcome of the events was recovering.


VAERS ID: 1699575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101129463

Write-up: Vaccine response impaired; SARS-CoV-2 molecular test positive; FEVER; FARMAVIGITER This is a non-interventional study report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-776097. A 25-year-old male patient received bnt162b2 (COMIRNATY), second dose intramuscular, administered in left deltoid on 27Jul2021 (Batch/Lot Number: FF2752; Expiration Date: 30Nov2021) as single dose, first dose intramuscular, administered in left deltoid on 20Jun2021 (Batch/Lot Number: FC5089; Expiration Date: 10Oct2021) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccine response impaired, COVID-19 molecular test positive on 17Aug2021, fever on 17Aug2021. The patient underwent lab tests and procedures which included COVID-19 molecular test: positive on 17Aug2021. The outcome of events was resolving. The reporter''s assessment of the causal relationship of all 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.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Vaccination Failure, COVID-19, Pyrexia and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1699584 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Blood thyroid stimulating hormone, Hypothyroidism, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid dysfunction in pregnancy
Allergies:
Diagnostic Lab Data: Test Name: hematochemical test; Result Unstructured Data: Test Result:unknown results; Test Name: TSH; Result Unstructured Data: Test Result:186; Comments: mU/l
CDC Split Type: ITPFIZER INC202101131489

Write-up: SEVERE HYPOTHYROIDISM (TSH 186 mU/L and suppression of thyroid hormones); PERSISTENT SLEEPING; WITH SYMPTOMS OF IMPORTANT ASTHENIA; This is a spontaneous report from a contactable physician downloaded from the RA, regulatory authority number IT-MINISAL02-776278. A 26-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FF7481), intramuscular, administered in left arm on 09Aug2021 14:00 as dose 1, single for COVID-19 immunization. Medical history included previous hypothyroidism in pregnancy from an unknown date. There were no concomitant medications. On 17Aug2021 09:00, the patient experienced severe hypothyroidism (TSH 186 mu/l and suppression of thyroid hormones), persistent sleeping (somnolence), and with symptoms of important asthenia. The patient underwent lab tests and procedures which included hematochemical test: unknown results on an unknown date, thyroid stimulating hormone (TSH): 186 mU/l on an unknown date. Therapeutic measures including monitoring of haematochemical tests, referral to endocrinological examination in the short term, and start of thyroxine therapy were taken as a result of the events. The outcome of the events was not recovered. The events were assessed as serious (medically significant) by the regulatory authority. Reporter comment: Reaction time: 09:00 am - Posted from report Sender comment: 26Aug2021, Pharmacovigilance Centre: This report sheet was updated from NON-SERIOUS to SERIOUS as the suspected adverse reaction described is a clinically relevant event on the Important Medical Event list. 03Sep2021 Pharmacovigilance Center: the clinical documentation provided by the reporter is attached. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reaction time: 09:00 am - Posted from report


VAERS ID: 1699648 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 21401Y / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Loss of consciousness, Muscle rigidity
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), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AERIUS [EBASTINE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Blood pressure; Result Unstructured Data: 120/90
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS and MUSCLE RIGIDITY in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 21401Y) for Vaccination. Concomitant products included EBASTINE (AERIUS [EBASTINE]) for an unknown indication. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 17-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant) and MUSCLE RIGIDITY (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS and MUSCLE RIGIDITY had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Blood pressure measurement: 120/90 (High) 120/90. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Lab data also included Heart rate and oxygen saturation without result. No treatment medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow up document received contains no new information (NNI).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1699665 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Episodio sincopale con emorragia cerebrale; Episodio sincopale con emorragia cerebrale; This case was received via (Reference number: IT-MINISAL02-777710) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE and SYNCOPE in a 26-year-old female patient who received mRNA-1273 (batch no. 3004499) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria hospitalization and medically significant) and SYNCOPE (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBRAL HAEMORRHAGE and SYNCOPE outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Unknown) was unknown. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. Lab data :On 17-Aug-2021,blood test,whole body CAT and patient had Otorhinolaryngologist consultation. On 18-Aug-2021,head CT was done. Results of lab data were not provided. No concomitant medication details were reported. No treatment medication details was reported. Company comment: This is a report of serious events in a 26-years old female whose medical history was not provided, after receiving an unknown dose number of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Translation pending.; Sender''s Comments: This is a report of serious events in a 26-years old female whose medical history was not provided, after receiving an unknown dose number of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Translation pending.


VAERS ID: 1699708 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, COVID-19, Drug ineffective, Mechanical ventilation, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: Anti-N Antibodies; Test Result: Negative ; Test Date: 20210818; Test Name: anti-S antibodies; Result Unstructured Data: Test Result:not reported; Comments: Anti-S Antibodies: 1990; Test Name: Mechanical ventilation; Result Unstructured Data: Test Result:needed; Test Date: 20210817; Test Name: First swab test; Test Result: Positive ; Comments: First swab positive (gene cycle): 15 - 16 - 15
CDC Split Type: ITPFIZER INC202101175523

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician, who reported similar events for six patients. This is the fourth of six reports. A 84-years-old patient of an unspecified gender received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and received first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that 6 patients hospitalized for COVID-19, all after a complete course of Pfizer vaccination. As you can see, for 4 of these the anti-S BAU (Diasorin) titre was high (column X). In any case, it was a delta variant. The patient was hospitalized for covid-19 confirmed by positive covid-19 test from 25Aug2021 to an unknown date. The patient underwent lab tests and procedures which included mechanical ventilation needed on unspecified date, first swab test with result first swab positive (gene cycle): 15-16-15 on 17Aug2021 and Anti-N Antibodies test result negative and Anti-S Antibodies result 1990 variant delta on 18Aug2021. The outcome of the event unknown.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and drug ineffective and Covid 19 cannot be completely excluded.,Linked Report(s) : IT-PFIZER INC-202101150614 same event same reporter, diffferent patient


VAERS ID: 1699783 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN K
Current Illness: Asplenia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial septal defect; Food allergy; Partial anomalous pulmonary venous connection (from Upper right pulmonary vein to superior vena cava); Pulmonary artery stenosis; Univentricular heart
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:there was no symptom of cerebral haemorrhage or in; Comments: there was no symptom of cerebral haemorrhage or infarction area; Test Date: 20210817; Test Name: echocardiogram; Result Unstructured Data: Test Result:no thrombus was observed
CDC Split Type: JPPFIZER INC202101129846

Write-up: Convulsion; Eczema; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21125641. A 16-years and 10-month-old male patient received BNT162B2 (COMIRNATY; Lot Number: FF4204; Expiration Date: 31Oct2021), via an unspecified route of administration on 10Aug2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. The patient had primary disease history of Right side homology /heterotaxy syndrome /asplenia (I.D.D), right univentricular heart, fontan surgery, pulmonary artery stenosis, atrial septal defect, Partial anomalous pulmonary venous connection correction surgery (from right superior pulmonary vein to superior vena cava). The patient had allergy to melon, allergy to raw potato, allergy to raw cucumber, allergy to raw avocado, allergy to kiwi fruit, allergy to peach. The patient was orally taking WARFARIN K 0.2% (YD) 1g a day (= 2mg a day) once a day. On 10Aug2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 17Aug2021 at 23:00 (7 days after the vaccination), the patient experienced convulsion and eczema. On 18Aug2021 (8 days after the vaccination), the patient was admitted to the hospital. On 19Aug2021 (9 days after the vaccination), the patient was discharged from hospital. On 18Aug2021 (8 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 17Aug2021 at about 23:00, the convulsion developed and was sustaining for about 1-2 minutes. The patient had first generalized convulsion. The patient asked for ambulance and was sent to the hospital. Consciousness was recovered to clear on the ambulance. Computerised tomogram head was taken and showed that there was no symptom of cerebral haemorrhage or infarction area. E Keppra was administered by intravenous injection Prophylactically. On 18Aug of the same year, the patient transferred to the hospital for further examination. Echocardiogram was taken and no thrombus was observed. Pulmonary valve had operation. After that, it was observed well. On 19Aug of the same year, the patient was discharged from hospital. On 30Aug of the same year, the patient planned to receive the second dose of the vaccination but skipped. On 11Sep of the same year, the patient planned to take MRI test. The reporting physician classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient did not have the history of seizure but it was diagnosed that the causality between the first vaccination and the afebrile convulsion could not be denied. Despite the patient received E Keppra Prophylactically in the last hospital, E Keppra was not administered in this hospital. After further examination both in last hospital and this hospital, there was no abnormality observed. The patient in good condition with following up and then was discharged from hospital. As the above diagnosis, it was considered that the second dose of vaccination was possible.


VAERS ID: 1699914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Mesenteric vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139142

Write-up: Intestinal ischaemia; Mesenteric vein thrombosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 608782. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (lot number and expiry date: unknown) as dose number unknown single, for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Aug2021, patient experienced intestinal ischaemia and mesenteric vein thrombosis. The events were considered serious medically significant. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood testosterone, Blood testosterone decreased, Dysuria, Erectile dysfunction
SMQs:, Sexual dysfunction (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: 08/17/2021; Test Name: Blood testosterone; Result Unstructured Data: Test Result: Decreased.
CDC Split Type: AUPFIZER INC202101139161

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 608940). A 39-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced erectile dysfunction, decreased testosterone and dysuria on Aug 17, 2021; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699920 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Hallucination, Paraesthesia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139163

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 608737). A 55-year-old male patient received BNT162B2 (Comirnaty), on unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant drugs: unknown. The patient experienced deep vein thrombosis; hallucination; paresthesia and swelling on Aug 17, 2021; with outcome of resolving. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699930 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139223

Write-up: Ventricular tachycardia; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. The regulatory authority report number is 609438. A 57-year-old male patient received BNT162B2 (COMIRNATY; Lot number was not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced ventricular tachycardia. The patient was recovering from the event. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.


VAERS ID: 1699931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Dizziness, Headache, Myalgia, Pain in extremity, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139230

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 608977). A 32-year-old female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Aug 16, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. On Aug 17, 2021, (1 day after vaccination), patient experienced spontaneous abortion (medically significant), abdominal pain, dizziness, headache, injection site pain, myalgia, pain in extremity and pyrexia; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? 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 INC202101139631

Write-up: Pericarditis; This is a spontaneous report from a contactable health professional via the Regulatory Authority. The regulatory authority report number is 611278. A 44-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced pericarditis. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700034 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? 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 INC202101140215

Write-up: Pericarditis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 613908. A 20-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced pericarditis. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701180 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-08-17
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute polyneuropathy
SMQs:, Peripheral neuropathy (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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Acute polyneuropathy; This case was received via Medicines Agency (Reference number: DE-PEI-202100180619) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ACUTE POLYNEUROPATHY (Acute polyneuropathy) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004217) for Prophylactic vaccination. Concurrent medical conditions included Arterial hypertension. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced ACUTE POLYNEUROPATHY (Acute polyneuropathy) (seriousness criteria hospitalization and medically significant). At the time of the report, ACUTE POLYNEUROPATHY (Acute polyneuropathy) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1701364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-17
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: PCR COVID; Test Result: Positive
CDC Split Type: FRPFIZER INC202101149393

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PP20211326. A 61-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EJ6788; Expiration Date: 30Apr2021), intramuscular, administered in left arm on 05Feb2021 as dose 2, single and (Lot Number: EJ 6796; Expiration Date: 30Apr2021) intramuscular, administered in left arm on 11Jan2021 as dose 1, single both for covid-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 17Aug2021, the patient experienced vaccination failure and covid-19 confirmed by positive covid-19 test. It was reported that, patient who presented with a Covid-19 infection without signs of severity after a complete vaccination regimen. Reportedly, non-severe Covid-19 infection approximately 6 months (PCR covid-19 positive on 17Aug2021) was reported after completion of a full vaccination schedule. On 17Aug2021, the patient underwent lab tests and procedures which included PCR COVID: positive. The outcome of the event was unknown. New information provided includes: 1. Reference PR ID 5574036 and PR ID 5674032. The complaint for fatal vaccine case of PFIZER-BIONTECH COVID-19 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EJ6796 and EJ6788. 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 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: 1701436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Nausea, SARS-CoV-2 test, Sinus tachycardia, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138109

Write-up: sinus tachycardia; vomiting; Felt unwell; Tachycardia; Nausea; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108311607438960-0NFKH and Safety Report Unique Identifier is GB-MHRA-ADR 25875267. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced sinus tachycardia and vomiting on an unspecified date, tachycardia and nausea on 17Aug2021. Felt unwell on an unknown date, the day after vaccine administered and had nausea and vomiting, also tachycardia. Ondansetron given but didn''t help but Cyclizine helped. Tachycardia not improved. No chest pain or SOB. ECG shows T inversion in lead3 and AVF. Sinus tachycardia at 124bpm. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 25Aug2021 No - Negative COVID-19 test. Relevant investigations or tests conducted: Bloods sent off on an unknown date with unknown results. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were reported as disabling and medically significant. The outcome of felt unwell was unknown while the other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101138169

Write-up: Pityriasis rosea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108311610528270-5YMZD, Safety Identifier Report Unique is GB-MHRA-ADR 25875135. A 16-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration as dose 1, single on 13Aug2021 for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant nor currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pityriasis rosea, medically significant on 17Aug2021. Event was described as: one appeared a couple days after getting the jab then later spread over the upper body. No treatment needed as per doctors advise. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative COVID-19 test on an unknown date. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701480 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; DESOGESTREL; FERROUS SULFATE; NAPROXEN; SERTRALINE; TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anxiety; Back injury; Contraception; Cyst breast; Endometriosis; Heavy periods; Iron supplementation; Nerve damage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145425

Write-up: Prolonged periods; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109011131257850-N2LHZ, Safety Report Unique Identifier GB-MHRA-ADR 25879357. A 41-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE8087) via an unspecified route of administration on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included endometriosis, cysts in left breast, anaemia, nerve damage, contraception, iron supplementation, back injury, anxiety and heavy periods all from an unknown date and unknown if ongoing. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included amitriptyline taken for nerve damage from 2018 to an unspecified stop date; desogestrel taken for contraception from 29Jun2021 to an unspecified stop date; ferrous sulfate taken for iron supplementation from Feb2020 to an unspecified stop date; naproxen taken for back injury from 2018 to an unspecified stop date; sertraline taken for anxiety from 2018 to an unspecified stop date; tranexamic acid taken for heavy periods from 2017 to an unspecified stop date. The patient had experienced prolonged periods on an unspecified date and headache on 17Aug2021. Patient started period on 15Aug. The events seriousness was assessed as medically significant. Paracetamol and ibuprofen not helping. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): no - negative covid-19 test on unspecified date, No - Negative COVID-19 test. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701597 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Fatigue; Breathlessness; This case was received via RA (Reference number: WEBCOVID-202109061751334330-RVTWC) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and DYSPNOEA (Breathlessness) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON) from 01-Feb-2006 to an unknown date for an unknown indication. On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and DYSPNOEA (Breathlessness) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) and DYSPNOEA (Breathlessness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information was mentioned by reporter. Patient was not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1701674 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E025A / 2 - / OT

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101189650

Write-up: PERIMYOCARDITIS; This is a spontaneous report from a non-contactable healthcare professional via department of health (Regulatory authority report number: DH/21/5383), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003354), license party for bnt162b2 (COMIRNATY). This is 1 of 112 reports. This is a spontaneous report received from a non-contactable HCP received via department of health(DH). The regulatory authority report number is DH/21/5383. Between 01-Aug-2021 and 31-Aug-2021, the DH received 40 reports of suspected myocarditis or pericarditis with history of COVID-19 vaccination. Having reviewed the available clinical data, four of the cases were considered not myocarditis or pericarditis, one case had insufficient information for assessment and 15 cases would require further clinical information before assessment could be concluded. The remaining 20 cases involved 14 males and 6 females aged between 12 and 63, among them, 19 received Comirnaty vaccine. This case was for 1 of remaining 19 Comirnaty cases. A 16-year-old male patient started to receive TOZINAMERAN (COMIRNATY, Formulation: Solution for injection, Batch number: 1E025A) on 14-Aug-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. The patient received first dose on an unknown date. Medical history, concomitant medication(s) and past product were not reported. The patient experienced perimyocarditis 3 days after vaccination with the second dose of Comirnaty (17-Aug-2021). Perimyocarditis met the seriousness criterion of hospitalization. The action taken for TOZINAMERAN (COMIRNATY) was not applicable. The event was resolved on an unknown date. Initial report was received on 03-Sep-2021. Follow-up(06-Sep-2021): New information reported from a non-contactable HCP received via the department of health. The regulatory authority report number is not applicable. New information includes: general myocarditis/pericarditis condition. Causality Assessment for COMIRNATY and Event Perimyocarditis as Per Reporter as Possible and as Per Company (BioNTech SE) as Possible. Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101189652 Same reporter, drug, different patient, event.


VAERS ID: 1701675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E025A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101189647

Write-up: MYOCARDITIS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: DH/21/5405), based on information received by Pfizer from RA (manufacturer control number: HK-Fosun-2021FOS003355), license party for bnt162b2 (COMIRNATY). This is 1 of 112 reports. Between 01Aug2021 and 31Aug2021, the RA received 40 reports of suspected myocarditis or pericarditis with history of COVID-19 vaccination. Having reviewed the available clinical data, four of the cases were considered not myocarditis or pericarditis, one case had insufficient information for assessment and 15 cases would require further clinical information before assessment could be concluded. The remaining 20 cases involved 14 males and 6 females aged between 12 and 63, among them, 19 received Comirnaty vaccine. This case was for 1 of remaining 19 Comirnaty cases. A 39-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: 1E025A) via unknown route of administration on 15Aug2021 as dose 2, single for COVID-19 immunization. The patient previously received COMIRNATY on an unknown date as dose 1, single for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. On 17Aug2021, the patient experienced myocarditis two days after vaccination with the second dose of Comirnaty. Myocarditis met the seriousness criterion of hospitalization. The outcome of the event was recovered on an unspecified date in 2021. All cases AER numbers are as follows: 2021FOS003313 (master case), 2021FOS003323, 2021FOS003324, 2021FOS003325, 2021FOS003340, 2021FOS003350, 2021FOS003351, 2021FOS003352, 2021FOS003353, 2021FOS003354, 2021FOS003355, 2021FOS003356, 2021FOS003378, 2021FOS003379, 2021FOS003385, 2021FOS003388, 2021FOS003389, 2021FOS003390, 2021FOS003408, 2021FOS003414, 2021FOS003415, 2021FOS003417, 2021FOS003420, 2021FOS003421, 2021FOS003426, 2021FOS003428, 2021FOS003437, 2021FOS003438, 2021FOS003439, 2021FOS003440, 2021FOS003441, 2021FOS003442, 2021FOS003443, 2021FOS003445, 2021FOS003446, 2021FOS003447, 2021FOS003448, 2021FOS003459, 2021FOS003460, 2021FOS003461, 2021FOS003462, 2021FOS003463, 2021FOS003464, 2021FOS003465, 2021FOS003466, 2021FOS003467, 2021FOS003468, 2021FOS003469, 2021FOS003470, 2021FOS003471, 2021FOS003472, 2021FOS003473, 2021FOS003474, 2021FOS003475, 2021FOS003476, 2021FOS003477, 2021FOS003478, 2021FOS003479, 2021FOS003480, 2021FOS003481, 2021FOS003482, 2021FOS003483, 2021FOS003484, 2021FOS003485, 2021FOS003486, 2021FOS003487, 2021FOS003488, 2021FOS003489, 2021FOS003490, 2021FOS003491, 2021FOS003492, 2021FOS003493, 2021FOS003494, 2021FOS003495, 2021FOS003496, 2021FOS003413, 2021FOS003514, 2021FOS003515, 2021FOS003418, 2021FOS003449, 2021FOS003453, 2021FOS003454, 2021FOS003455, 2021FOS003456, 2021FOS003457, 2021FOS003458, 2021FOS003497, 2021FOS003498, 2021FOS003499, 2021FOS003500, 2021FOS003501, 2021FOS003502, 2021FOS003503, 2021FOS003504, 2021FOS003505, 2021FOS003506, 2021FOS003507, 2021FOS003508, 2021FOS003509, 2021FOS003510, 2021FOS003512, 2021FOS003513, 2021FOS003516, 2021FOS003517, 2021FOS003518, 2021FOS003519, 2021FOS003520, 2021FOS003521, 2021FOS003522, 2021FOS003523, 2021FOS003524 and 2021FOS003525. Causality assessments as per Primary reporter and company (RA) was possible. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101195743 Same reporter, drug, different patient, event.


VAERS ID: 1701785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune-mediated adverse reaction, Product use issue, Rash erythematous, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101149872

Write-up: Drug used unapproved popullation; right cheek swelling; onset of red rash across neck extending to trunk and face; likely ige mediated reaction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-082962. Safety Report Unique Identifier IE-HPRA-2021-082962. A 15-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot Number: FE7053), via an unspecified route of administration on 17Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right cheek swelling, onset of red rash across neck extending to trunk and face, likely igE mediated reaction 30 minutes later on 17Aug2021, drug used unapproved popullation on an unspecified date. The patient was treated with Piriton (4mg x 3). It was outlined in the report that the patient did not experience any breathing difficulty, lightheadedness, syncope or pre-syncope, vomiting, lip swelling or eye swelling. The duration of the reaction was reported as 4 to 5 hours. According to the reporter it was likely an Immunoglobulin E (IgE)-mediated reaction. The outcome of the events right cheek swelling, onset of red rash across neck extending to trunk and face, likely igE mediated reaction was recovered on unspecified date, for event drug used unapproved population was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701835 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac discomfort, Heart rate irregular
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: FOLIDEX; LOETTE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101134982

Write-up: Arrhythmia; altered heart beat; heart discomfort; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority report number is [IT-MINISAL02-777001]. A 25-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Left Arm on 08Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included FOLIDEX and LOETTE, both were taken for an unspecified indication, start and stop date were not reported. On 17Aug2021, the patient experienced arrhythmia, altered heart beat, and heart discomfort. Impact on quality of life (9/10). The outcome of the events was recovering. No follow-up attempts are possible, information on batch number cannot be obtained. No pathology.


VAERS ID: 1701953 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neurosensory hypoacusis
SMQs:, Hearing impairment (narrow)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-778424) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEUROSENSORY HYPOACUSIS in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 17-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced NEUROSENSORY HYPOACUSIS (seriousness criterion hospitalization). At the time of the report, NEUROSENSORY HYPOACUSIS outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1702005 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101135945

Write-up: Convulsion; Generalized tonic seizures; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21125360. A 27-year- and 4-month old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Aug2021 14:22 (at the age of 27 years) (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) as a single dose for COVID-19 immunization. Medical history included cerebral palsy, epilepsy and had epilepsy seizure 2-3 times a month. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees Centigrade. On 16Aug2021 at 14:22 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY). On 17Aug2021 at 16:53 (1 day 2 hours 31 minutes after the vaccination), the patient experienced convulsion. On 17Aug2021 (same day of vaccination), the outcome of the event was recovered. The course of the event was reported as follows: On 17Aug at 16:53, patient experienced generalized tonic seizures. At 17:00, Diapp suppository 10 mg was used. Soon, the patient settled down and fell asleep in about 10 minutes. Outcome of the event was recovered on 17Aug2021. The reporting physician commented as follows: The causal relationship with vaccination was unknown due to convulsion seizures throbbed. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1702124 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral haemorrhage, Hemiplegia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Haemodialysis; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19NEAR test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC202101151313

Write-up: Cerebral haemorrhage; right sided paralysis; speech loss; This is a spontaneous report from a contactable physician received via regulatory authority. A 60-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) intramuscularly (at the age of 60-year-old) on 01Aug2021 (the day of 2nd dose of vaccination), as dose 2, single for COVID-19 immunization. The patient medical history included renal failure chronic, haemodialysis, diabetes mellitus. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) intramuscularly on 11Jul2021 (the day of 1st dose of vaccination) as dose 1, single for COVID-19 immunization. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Aug2021 at 09:00 (16 days 9 hrs after the vaccination), the patient experienced cerebral haemorrhage, right sided paralysis, and speech loss. The patient took hypotensive drug and outcome of the events were recovered with sequel. On the same day the patient had COVID-19 NEAR test by nasal swab, result of the test was negative. The patient underwent lab tests and procedures which included covid-19NEAR test: negative on 17Aug2021 Nasal Swab. Therapeutic measures were taken as a result of cerebral haemorrhage, right sided paralysis, speech loss. The outcome of the events was recovered with sequel on an unspecified date in 2021. The reporter classified the events as serious (hospitalization and disability) and stated the events result in emergency room/department or urgent care.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events cerebral haemorrhage, right sided paralysis, and speech loss.. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1702187 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004667 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Gastrointestinal oedema, Lymphadenopathy
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: Axillary and subclavian swollen lymph nodes; Intestinal oedema; Anaphylaxis; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP082472) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This case, initially reported to the regulatory authority by a person in charge of observation, was received via the RA (Ref, v21124256). Anaphylaxis and intestinal oedema were assessed as serious by the RA. On an unknown date, the patient received the 1st dose of this vaccine. After the vaccination, axillary and subclavian swollen lymph nodes developed. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 17-Aug-2021, at 16:30, the patient received the 2nd dose of this vaccine. Immediately after the vaccination, nausea and abdominal pain developed. Vital signs were normal. Anaphylaxis was considered. Although anaphylactic shock was not suspected, there was a possibility of intestinal oedema. Antihistamines and steroids were administered. The symptoms were subsequently resolving. The outcome of axillary and subclavian swollen lymph nodes was unknown. The outcome of anaphylaxis and intestinal oedema was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1702203 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004230 / 1 - / OT

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

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

Write-up: Loss of consciousness; Vasovagal reflex; Fall; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP083661) on 19-Aug-2021 and was forwarded to Moderna on 01-Sep-2021. This case, reported by a physician, was received by authority via Moderna''s adverse reaction reporting site (TASK0020983), and this case, initially reported to the regulatory authority by a physician, was received via the RA (Ref, v21124008). Loss of consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 17-Aug-2021, at 14:26, the patient received the 1st dose of this vaccine. At 14:35, loss of consciousness developed during follow-up in a decubitus position, and the patient fell from a chair. After the fall, the patient recovered consciousness immediately and returned to the chair on his/her own. The patient moved to a first-aid area and was followed up lying in bed. There was no abnormality in vital signs, paralysis, or trauma. At around 15:00, the patient returned home after follow-up. The patient was considered to have vasovagal reflex. The outcome of loss of consciousness, fall, and vasovagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1702208 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-17
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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: JPMODERNATX, INC.MOD20213

Write-up: Pyrexia; Convulsion from the left shoulder to near the ear; Pain; This case was received via regulatory authority (Reference number: 2021TJP084057) on 01-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This case was reported by a test subject via the regulatory authority. Convulsion was assessed as serious by the RA. On 20-Jul-2021, around 09:00, the patient received the 1st dose of this vaccine. On 17-Aug-2021, around 09:00, the patient received the 2nd dose of this vaccine. Around 20:00, Convulsion from the left shoulder to near the ear and pain developed. On 18-Aug-2021, pyrexia developed. At 13:00, the patient visited a medical institution and was prescribed loxoprofen sodium hydrate. On 20-Aug-2021, at 19:00, the fever went down. On an unknown date, the patient''s symptoms recovered. The outcome of convulsion from the left shoulder to near the ear, pain and pyrexia was reported as recovered. Follow-up investigation will not be possible due to lack of cooperation in the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1702252 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004734 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Contusion, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Loss of consciousness (Loss of consciousness (dental anesthesia))
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Normal before taking vaccine.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncopal attack; Head contusion; Vasovagal reflex; This case was received via regulatory authority(Reference number: 2021TJP088108) on 30-Aug-2021 and was forwarded to Moderna on 10-Sep-2021. This case, reported by a physician, was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK00201357). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 11-Aug-2021, at 10:58, the patient received the 1st dose of this vaccination. The patient experienced loss of consciousness while walking a few minutes after the vaccination, but recovered within less than one minute. On 17-Aug-2021, at 10:58, the patient experienced a head contusion and was transported to another hospital by ambulance. Since there were no apparent changes in vital signs, the patient was considered to have syncopal attack due to vasovagal reflex associated with this drug or intramuscular injection. Subsequently, it was confirmed that the symptoms were resolving. The outcome of head contusion, vasovagal reflex, and syncope attack was reported as recovering. No follow-up investigation is possible due to the reporters non-cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1702285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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: L-THYROXIN BERLIN-CHEMIE; DIGOXIN; SPIRIX; CARVEDILOL; TRIFAS [TORASEMIDE]; XARELTO
Current Illness: Atrial fibrillation; Autoimmune thyroiditis; Hypothyreosis; Overweight; Ventricular failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202101126098

Write-up: Herpes zoster (with no complications); This is a spontaneous report from a contactable consumer (patient) and physician downloaded from the regulatory authority-WEB, regulatory authority number LT-SMCA-4262. A 68-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jul2021 (Lot Number: FC1435) as dose 1, 30 ug single for COVID-19 immunisation. Medical history included ventricular failure, hypothyreosis, overweight, atrial fibrillation and autoimmune thyroiditis, all ongoing . Concomitant medications included levothyroxine sodium (L-THYROXIN BERLIN-CHEMIE) taken for autoimmune thyroiditis and hypothyreosis from 16Oct2020 to an unspecified stop date; digoxin taken for left ventricular failure and chronic atrial fibrillation from 21Oct2020 to an unspecified stop date; spironolactone (SPIRIX) taken for chronic atrial fibrillation and Left ventricular failure from 21Oct2020 to an unspecified stop date; carvedilol taken for chronic atrial fibrillation and Left ventricular failure from 21Oct2020 to an unspecified stop date; torasemide (TRIFAS) taken for an unspecified indication from 21Oct2020 to an unspecified stop date; rivaroxaban (XARELTO) taken for chronic atrial fibrillation and Left ventricular failure from 21Oct2020 to an unspecified stop date. The patient experienced herpes zoster (with no complications) on 17Aug2021. The event was assessed as serious (medically significant). Therapeutic measures were taken as a result of herpes zoster (with no complications) and included Acic 200 mg tablets, Acic 5% cream and Ultracod 500 mg/30 mg tablets were prescribed for treatment. On the reporting date, the patient has not recovered. On 18Aug2021, the second dose of Comirnaty 30 microgram concentrate for dispersion for injection was received (Batch: unknown). Additional information: Report was submitted by the patient herself on 20Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702296 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FQ2083 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Contusion, Hyperhidrosis, Lymph node pain, Lymphadenopathy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:not increased; Test Date: 20210820; Test Name: Body temperature; Result Unstructured Data: Test Result:not increased
CDC Split Type: LVPFIZER INC202101125560

Write-up: Bruising of leg/Bruising of hand; Lymph node pain; Swollen lymph nodes; Sweating; Chills; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number LV-SAM-2021086489. A 58-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 16Aug2021 (Lot number: FQ2083) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. Medical history included COVID-19 virus infection in Jan2021. There were no concomitant medications. On 17Aug2021 the patient experienced lymph node pain (all over the body ) and swollen lymph nodes, sweating and chills. Body temperature was not increased. On 23Aug2021 at 14:06 AM a second report was received from the patient. On 20Aug2021 (5 days after vaccination ) the patient experienced additionally bruising of hands and legs (bruises in size 2-3 cm). On 23Aug2021 the bruises begin to disappear. Sweating and chills are still intensified at night. The body temperature was not increased. The event bruising was assessed as serious (medically significant). The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1702591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dyspnoea, Syncope, Tinnitus, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210923219

Write-up: Syncope; Vision decreased; Tinnitus; Shortness of breath; Balance difficulty; This spontaneous report received from a consumer via Regulatory Authority (NL-LRB-00679353) on 13-SEP-2021 concerned a 37 year old male of an unspecified race and ethnic origin. The patient''s weight was 95 kilograms and height was 196 centimeters. The patient''s past medical history included that he had suspected covid-19. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) 1 dosage forms, frequency time 1 total administered on 11-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 17-AUG-2021, the patient experienced balance difficulty. On an unspecified date, the patient experienced syncope, vision decreased, tinnitus and shortness of breath. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vision decreased, and shortness of breath, and had not recovered from tinnitus, and balance difficulty. This report was serious (Other Medically Important Condition).


VAERS ID: 1702638 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Appendicitis
SMQs:

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

Write-up: APPENDICITIS; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00044990) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of APPENDICITIS (APPENDICITIS) in a 27-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021 at 11:53 AM, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced APPENDICITIS (APPENDICITIS) (seriousness criteria hospitalization and medically significant). On 18-Aug-2021, APPENDICITIS (APPENDICITIS) had resolved with sequelae. The action taken with mRNA-1273 (Intramuscular) was unknown. The Concomitant medications and the Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Translation received contains no new information.; Reporter''s Comments: Contact with healthcare professionals: Physician.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.


VAERS ID: 1702838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 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 Date: 20210817; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101155529

Write-up: eleven days after completing the Comirnaty vaccine schedule, the patient presented COVID-19; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB. This is a report received INFARMED regulatory authority report number PT-INFARMED-B202108-2842 with Safety Report Unique Identifier PT-INFARMED-B202108-2842. A 31-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number FE1573 (CAUL: 34721), Expiry date was not reported), intramuscular on 09Jul2021 (with modified nucleoside) concentrate for injectable dispersion) as dose 1, 0.3ml single and second dose intramuscular of bnt162b2 on 06Aug2021 (Batch/Lot Number: FG4442 (CAUL: 43221-A), Expiry date was not reported) as dose 2, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced eleven days after completing the Comirnaty vaccine schedule, the patient presented COVID-19 after vaccine failure, confirmed by a positive RT-PCR test for SARS-CoV-2 infection. The patient manifested symptoms associated with COVID-19, namely cough, headache and respiratory distress. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 Iu international units. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected; Reporter''s Comments: Further information- RT PCR test positive at 17Aug2021 Cough, headache and breathing difficulties


VAERS ID: 1702844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210920110

Write-up: PRURITIC RASH; This spontaneous report received from a physician via a Regulatory Authority (PT-INFARMED-B202108-3227) on 09-SEP-2021 concerned a 32 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: 21C19-02 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 16-AUG-2021 for covid-19 immunisation. Drug start period was 1 day. No concomitant medications were reported. On 17-AUG-2021, the patient experienced pruritic rash. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient recovered from pruritic rash on 24-AUG-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information: Vaccinated on 16-Aug-2021, single dose. The day after symptoms of pruritus and generalized skin rash, no improvement with topical treatment observed at medical facility on 23-Aug. administered Hydrocortisone 100 mg intramuscularly and Bilastine 20mg 1 time/day reports symptomatic improvement.


VAERS ID: 1702847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Dyspnoea, Fluid retention
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: PTJNJFOC20210922788

Write-up: Fluid retention; Cardiac arrhythmia; Dyspnoea; This spontaneous report received from a consumer via a Regulatory Authority (PT-INFARMED-B202108-3788) on 13-SEP-2021 and concerned a 95 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 0.5 ml, 1 total administered on 11-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Duration of drug administration was reported 0 day. No concomitant medications were reported. On 17-AUG-2021, the patient experienced fluid retention, cardiac arrhythmia, dyspnoea, and was hospitalized (date unspecified). The dose of covid-19 vaccine ad26.cov2.s was not changed. The outcome of the fluid retention, cardiac arrhythmia and dyspnoea was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1703023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: 20210817; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210916456

Write-up: MEDICATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (PT-INFARMED-T202108-2798) on 08-SEP-2021 concerned a 26 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-01 expiry: unknown) 0.5 ml, 1 total administered on 21-JUL-2021 for covid-19 immunisation (Drug start period - 27days). No concomitant medications were reported. On 17-AUG-2021, the patient experienced medication failure. Laboratory data included: Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from medication failure. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint: 90000192945. Version created to amend previously reported information on 08-SEP-2021. Upon review following information was amended: event ''medication failure'' was assessed as serious event considering it as vaccination failure.


VAERS ID: 1703102 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Migraine
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)

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

Write-up: This case was received via Regulatory Agency (Reference number: SE-MPA-2021-076282) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN, MIGRAINE and ARTHRALGIA in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005238) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced ARTHRALGIA (seriousness criterion hospitalization). On 18-Aug-2021, the patient experienced MIGRAINE (seriousness criterion hospitalization). On 19-Aug-2021, the patient experienced BACK PAIN (seriousness criterion hospitalization). On 18-Aug-2021, ARTHRALGIA had resolved. At the time of the report, BACK PAIN had not resolved and MIGRAINE was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant and treatment information were reported by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Translation received On 06-sep-2021 contains no new information; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1703154 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRINTELLIX; PAROXETIN HEXAL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101131597

Write-up: heart palpitations; Headache; Fever; first dose: 01Jul2021/second dose: 17Aug2021; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, authority number SE-MPA-2021-077953. A 43-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FE4728) at the age of 43-years-old as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included vortioxetine hydrobromide (BRINTELLIX) taken for an unspecified indication, start and stop date were not reported; paroxetine hydrochloride (PAROXETIN HEXAL) taken for an unspecified indication, start and stop date were not reported. The patient previousy received the first dose of bnt162b2 (COMIRNATY) on 01Jul2021 for covid-19 immunisation and experienced fatigue and Pyrexia. The patient experienced heart palpitations on 25Aug2021, headache on 18Aug2021, fever on 18Aug2021. The case was assessed as a serious, permanent physical impairment. The clinical course as following: suspected adverse reactions were fever, headache one day afterward and palpitations eight days after vaccination. Feeling feverish and moderate temperature rise come and go. The woman also had palpitations in connection with feeling feverish and headache. Palpitations were transient. Headaches are experienced more mildly than at the onset, but fever persists. The outcome of the event Heart pounding was recovered on 25Aug2021, the outcome of the event headache was recovering and the outcome of fever was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101131622 Same patient, different vaccine dose and events.


VAERS ID: 1703841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anti-thyroid antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood folate, Blood glucose, CSF glucose, CSF lymphocyte count, CSF protein, CSF red blood cell count, Coagulation factor, Complement factor C3, Complement factor C4, Computerised tomogram head, Cytomegalovirus test, DNA antibody, Demyelination, Enzyme level test, Epstein-Barr virus test, Folate deficiency, Fundoscopy, HIV antibody, Haemoglobin, Hepatitis C virus test, Herpes simplex, Investigation, Low density lipoprotein, Microbiology test, Neurological examination, Optic neuritis, Red blood cell sedimentation rate, Rheumatoid factor, Thyroid function test, Total cholesterol/HDL ratio, Varicella virus test, Visual acuity tests, Visual evoked potentials, Vitamin D
SMQs:, Guillain-Barre syndrome (broad), Optic nerve disorders (narrow), Demyelination (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Ocular infections (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NUVARING; ISOTRETINOINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Smoker (more than a year ago I smoked sporadically)
Allergies:
Diagnostic Lab Data: Test Name: ANCA; Result Unstructured Data: Test Result:Negative; Test Name: ANA; Result Unstructured Data: Test Result:Negative; Test Name: Antithyroid ac; Result Unstructured Data: Test Result:Negative; Test Name: Folic acid; Result Unstructured Data: Test Result:2.8; Test Name: Glucose; Result Unstructured Data: Test Result:126; Test Name: Basic coagulation; Result Unstructured Data: Test Result:Normal; Test Name: C3; Result Unstructured Data: Test Result:Normal; Test Name: C4; Result Unstructured Data: Test Result:Normal; Test Name: Craneal CT; Result Unstructured Data: Test Result:Tens hypodensity in the left parietal; Comments: Tens hypodensity in the left parietal radiated crown and to a lesser extent on the right side, to be assessed with programmed MRI for better characterization.; Test Name: CSF glucose; Result Unstructured Data: Test Result:70; Test Name: CSF Leukocytes; Result Unstructured Data: Test Result:8; Comments: Leukocytes: 8 cells / mm3: PMN (Neutrophils, eosinophils, and basophils): 12.5%, Mononuclear: 87.5%.; Test Name: CSF proteins; Result Unstructured Data: Test Result:45; Test Name: CSF red blood cells; Result Unstructured Data: Test Result:2500; Comments: cells / mm3; Test Name: CMV; Result Unstructured Data: Test Result:negative.; Test Name: Anti-DNA; Result Unstructured Data: Test Result:Negative; Test Name: Enzymes; Result Unstructured Data: Test Result:Normal; Test Name: EB (+) Ig G; Result Unstructured Data: Test Result:negative.; Test Name: eyeground; Result Unstructured Data: Test Result:without alterations.; Test Name: Hb; Result Unstructured Data: Test Result:11.5; Comments: Hb (hemoglobin) 11.5, N 76%.; Test Name: HBV; Result Unstructured Data: Test Result:negative.; Test Name: herpes simplex; Result Unstructured Data: Test Result:negative.; Test Name: HIV; Result Unstructured Data: Test Result:negative.; Test Name: AS; Result Unstructured Data: Test Result:unremarkable.; Test Name: Ions; Result Unstructured Data: Test Result:Normal; Test Name: LDL; Result Unstructured Data: Test Result:141; Test Name: Microbiology; Result Unstructured Data: Test Result:Negative; Test Name: Neurological examination; Result Unstructured Data: Test Result:preserved by anamnesis; Comments: FIS: preserved by anamnesis, fluent and coherent speech without blockages or dysarthria, no extinction or hemi negligence, confrontational campimetry in normal LE, in RE only hand movement (dilated pupils) PPCC: pharmacological dilated pupils, MOEs (Extrinsic Ocular Motility) without restriction or associated pain, normal sensory V, no facial asymmetry, low pairs preserved MOTOR: no claudication, normal muscular balance, no Hoffman, ROT ++ / ++++ in upper limbs and +++ / ++++ in lower limbs (patellae and achilles), without clonus. Bilateral flexor CPR (PLANTAR SKIN RESPONSE) SENSITIVITY: preserved and symmetric touch-pain in 4 extremities COORDINATION: no dysmetria in bilateral dn MARCH: stable, no increase in area, no Romberg, possible tandem- MRI brain and cervical spinal cord with and without intravenous gadolinium, in 3T equipment, with specific protocol for demyelinating disease, with pre-contrast cranial sequences 3D T1, 3D FLAIR, axial FLAIR, axial dual (DP and T2) and diffusion, and post-contrast 3D T1 iso and axial T1 sequences and pre-contrast sagittal T1 and T2 / DP and axial T2 spinal cord sequences and post-contrast sagittal and axial T1 sequences.; Test Name: VSG; Result Unstructured Data: Test Result:30; Test Name: Rheumatoid factor; Result Unstructured Data: Test Result:Negative; Test Name: Thyroid profile; Result Unstructured Data: Test Result:Normal; Test Name: CT; Result Unstructured Data: Test Result:202; Test Name: VHZ; Result Unstructured Data: Test Result:negative.; Test Name: visual acuity; Result Unstructured Data: Test Result:Relative afferent pupillary defect; Comments: RE (right eye) of 0.1 (car 0.2), and right DPAR (Relative afferent pupillary defect), the rest of the examination unremarkable; Test Name: Evoked potentials; Result Unstructured Data: Test Result:LEFT EYE STIMULUS/RIGHT EYE STIMULUS; Comments: RIGHT EYE STIMULUS N75: 79.4 ms P100: 163 ms N145: 215 ms Amplitude P100-N145: 5.55 uV LEFT EYE STIMULUS N75: 74.8 ms P100: 114 ms N145: 172 ms P100-N145 Amplitude: 8.8 uV; Test Name: Vitamin D; Result Unstructured Data: Test Result:20.4; Comments: sup 30
CDC Split Type: ESPFIZER INC202101149918

Write-up: Optic neuritis retrobulbar; Demyelinating disease of central nervous system, unspecified; Folic acid deficiency; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-988002. A 28-years-old female patient received bnt162b2 (COMIRNATY) second dose , intramuscular, administered in Arm Right on 12Aug2021 (Batch/Lot Number: FF2832) as single dose for covid-19 immunisation . Medical history included tobacco user (more than a year ago I smoked sporadically) , acne . Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) taken for contraception, start and stop date were not reported; isotretinoina (ISOTRETINOINA) taken for acne from Mar2021 to 18Aug2021. The patient experienced optic neuritis retrobulbar (hospitalization) on 17Aug2021 with outcome of recovering , demyelinating disease of central nervous system, unspecified (hospitalization) on 17Aug2021 with outcome of recovering , folic acid deficiency (non-serious) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included antineutrophil cytoplasmic antibody: negative, antinuclear antibody: negative, anti-thyroid antibody: negative, blood folate: 2.8, blood glucose: 126, coagulation factor: normal, complement factor c3: normal, complement factor c4: normal, computerized tomogram head: Tens hypodensity in the left parietal radiated crown and to a lesser extent on the right side, to be assessed with programmed magnetic resonance imaging (MRI) for better characterization , cerebrospinal fluid (csf) glucose: 70, csf lymphocyte count: 8 cells / mm3: Polymorphonuclear (PMN) (Neutrophils, eosinophils, and basophils): 12.5%, Mononuclear: 87.5% , csf protein: 45, csf red blood cell count: 2500cells / mm3 , cytomegalovirus test: negative, dna antibody: negative. Unknown therapeutic measures were taken as a result of difficulties of optic neuritis and demyelinating disease. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-202101182758 same pt, different drug dose /AE


VAERS ID: 1703853 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004952 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Erythema, Malaise, Sensation of foreign body, Vision blurred, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Wheezing; Localised erythema; Vision blurred; Asthenia; Lump feeling in throat; Dyspnoea; Malaise; This case was received via (Reference number: FI-FIMEA-20214214) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of WHEEZING (Wheezing), ERYTHEMA (Localised erythema), VISION BLURRED (Vision blurred), ASTHENIA (Asthenia), SENSATION OF FOREIGN BODY (Lump feeling in throat), DYSPNOEA (Dyspnoea) and MALAISE (Malaise) in a 15-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004952) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion life threatening), ERYTHEMA (Localised erythema) (seriousness criterion life threatening), VISION BLURRED (Vision blurred) (seriousness criterion life threatening), ASTHENIA (Asthenia) (seriousness criterion life threatening), SENSATION OF FOREIGN BODY (Lump feeling in throat) (seriousness criterion life threatening), DYSPNOEA (Dyspnoea) (seriousness criterion life threatening) and MALAISE (Malaise) (seriousness criterion life threatening). At the time of the report, WHEEZING (Wheezing), ERYTHEMA (Localised erythema), VISION BLURRED (Vision blurred), ASTHENIA (Asthenia), SENSATION OF FOREIGN BODY (Lump feeling in throat), DYSPNOEA (Dyspnoea) and MALAISE (Malaise) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.


VAERS ID: 1704911 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Dyspnoea, Fatigue, Feeling of body temperature change, Headache, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Allergy to grains (severe allergies to egg, dairy and wheat.); Dairy intolerance (severe allergies to egg, dairy and wheat.); Egg allergy (severe allergies to egg, dairy and wheat.)
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152968

Write-up: having hot and cold flushes; body was aching; after having the vaccine; SARS-CoV-2 infection; Breathing difficult; Aching joints; High temperature; Headache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109032336526940-LPUOO. Safety Report Unique Identifier GB-MHRA-ADR 25895504. A 19-years-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/ Lot Number: FE3380) via an unspecified route of administration on 17Aug2021 as single dose for COVID-19 immunisation. Medical history included severe allergies to egg, dairy and wheat. Concomitant medication was not reported. Patient previously took amoxycillin and had allergy. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 17Aug2021, patient had breathing difficult, aching joints, high temperature and headache. On 21Aug2021, patient had SARS-CoV-2 infection. On an unspecified date, patient after having the vaccine and having hot and cold flushes. All events were medically significant. After having the vaccine, patient was aching but assumed it was just a short reaction. However, that night was having severe breathing difficulties having to use inhalers, body was aching and was having hot and cold flushes and had a really bad headache that lasted days. Lab test on 21Jul2021, included COVID-19 virus test: Negative. Treatment received for breathing difficult. The outcome of events was high temperature was resolved on 21Aug2021, aching joints was resolved on 23Aug2021, breathing difficult, headache resolved on 24Aug2021, SARS-CoV-2 infection resolved on 27Aug2021, patient after having the vaccine was resolved on an unknown date and body was aching and having hot and cold flushes was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705120 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? 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 INC202101169948

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 613908. A 20-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 17Aug2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-17
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Skin haemorrhage, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (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:
CDC Split Type: DEPFIZER INC202101142621

Write-up: Skin bleeding; severe thrombocytopenia; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority report number is DE-PEI-CADR2021171128 with Safety Report Unique Identifier DE-PEI-202100178452. Additional reference number includes: DE-CADRPEI-2021171128. A 16-year-old female patient received bnt162b2 (COMIRNATY; strength: 0.3 mL, Batch/Lot Number: FD7958), via an unspecified route of administration, on 30Jun2021, as dose number unknown, 0.3 mL single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. On 17Aug2021, it was reported that the patient experienced severe thrombocytopenia, and skin haemorrhage (reported as skin bleeding) (hospitalization). The outcome of the events was not recovered. The regulatory authority assessed the events as serious (hospitalization). Sender''s comment: Do you or the person concerned have any known allergies? If so, what are they? None. Details of risk factors or previous illnesses. None/inpatient admission. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705373 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure diastolic increased, Blood pressure measurement, Dyspnoea, Fatigue, Heart rate, Heart rate increased, Malaise, Nausea, Oxygen saturation, Pharyngeal oedema, Respiratory rate increased, Sensation of foreign body, Use of accessory respiratory muscles
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:123-119/94-78; Test Name: pulse; Result Unstructured Data: Test Result:96-102/min; Test Name: Saturation; Test Result: 99 %
CDC Split Type: FIPFIZER INC202101142825

Write-up: nauseous; Dyspnoea; Malaise; Asthenia; Heart rate increased; Pharyngeal oedema; Lump feeling in throat; Use of accessory respiratory muscles; Respiratory rate increased; Fatigue; Blood pressure diastolic increased; This is a spontaneous report from a contactable physician downloaded from the FI-FIMEA-20214204. A 13-year-old male patient received BNT162B2 (COMIRNATY, lot number: FF2832) via intramuscular on 17Aug2021 at 10:15 a.m. at age of 13 years old as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced dyspnoea, malaise, asthenia, heart rate increased, pharyngeal oedema, lump feeling in throat, use of accessory respiratory muscles, respiratory rate increased, fatigue, blood pressure diastolic increased on 17Aug2021, with hospitalization. The patient was cycling to school when they suddenly became nauseous at around 12 p.m. Severe exhaustion, weakness, and shortness of breath. The patient''s throat felt swollen and they had difficulty swallowing. No rashes. When the first responders arrived, the patient was having difficulty breathing. The respiration rate was rapid and the accessory expiratory muscles were in use. Respiratory sounds clear, no wheezing. Blood pressure 123-119/94-78, pulse 96-102/min. Saturation 99%. The patient was not given any medication, as the shortness of breath subsided by itself. At the emergency room, the lungs were clear, blood pressure good, no swelling in the throat and the vaccination site appeared normal. The patient was in good health during monitoring. Outcome of the events was recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1705416 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Exercise adequate
Allergies:
Diagnostic Lab Data:
CDC Split Type: REPFIZER INC202101143077

Write-up: Stethalgia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BX20217815. A 35-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 13Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included former elite sportsman (cycling until 2012). The patient''s concomitant medications were not reported. No information on Dose 1, on any medical history of COVID, or on tests performed. On 17Aug2021 (also reported as "at Day 4 of Dose 2"), the patient experienced stethalgia - described as, presented with chest pain during exercise and new pain at rest at work. Moreover, he is a former elite sportsman (cycling until 2012). There is ongoing medical care - medical consultation with sick leave until stress test. Cardiological consultation planned for 30Aug2021. The event was considered medically significant. The outcome of the event was not recovered as of Day 11. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Body temperature, Fatigue, Gingivitis, Joint swelling, Lymphadenopathy, Odynophagia, Pain in extremity, Pyrexia, Swelling, Swelling face, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:rose to 40
CDC Split Type: FRPFIZER INC202101142811

Write-up: Fever/ Fever which rose to 40; Lymphadenopathy/ adenopathy; Acute gingivitis/ Infection which quickly reached the gums; Vaccination site pain; fatigue; swollen neck, cheek, up to the shoulder; swollen neck, cheek, up to the shoulder; swollen neck, cheek, up to the shoulder; discomfort when swallowing; abscess-like lump; pain in arm; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20217886. An 18-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 14Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute gingivitis/ infection which quickly reached the gums, fever, lymphadenopathy/ adenopathy, vaccination site pain, fatigue, swollen neck, cheek, up to the shoulder, discomfort when swallowing, abscess-like lump, and pain in arm and all on 17Aug2021 with outcome of not recovered. Lymphadenopathy and pyrexia were reported as medically significant. All events caused physician office visit. 3 days after vaccination, pain in arm but nothing serious. Then, discomfort when swallowing, adenopathy, swollen neck, cheek, up to the shoulder, Infection which quickly reached the gums with appearance of an abscess-like lump, fever which rose to 40, Fatigue. Treatment were paracetamol, and antibiotic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705434 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Headache, Herpes zoster, Ophthalmic herpes zoster, Oropharyngeal pain, Paraesthesia, SARS-CoV-2 test, Synovial cyst
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Ocular infections (narrow), Opportunistic infections (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: SEROPRAM [ESCITALOPRAM OXALATE]; TADENAN; AMLOR; ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101143102

Write-up: Herpes zoster ophthalmic; head aching on the right side; sensations of very brief needle-like pokes in the eye, the ear and towards the nose; sore throat; burning sensation on the upper right side of his face, in the hair and up to the right eyelid; more enlarged ganglion than normal; facial shingles; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority report number FR-AFSSAPS-DJ20213371. This report received via the Ministry of Health Reporting Portal (No. 20210824171336954). A 66-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Unknown, Expiration Date: Not reported), via intramuscular route of administration in left arm on 16Aug2021 as dose 2, single for covid-19 immunisation. Medical history included arterial hypertension. Concomitant medications included escitalopram oxalate (SEROPRAM [ESCITALOPRAM OXALATE]) taken for an unspecified indication, start and stop date were not reported; prunus africana extract (TADENAN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLOR) taken for an unspecified indication, start and stop date were not reported; atenolol taken for an unspecified indication, start and stop date were not reported. On 17Aug2021, the patient experienced herpes zoster ophthalmic. The occurrence of ophthalmic shingles in the right eye on 17Aug2021 was reported. On 17Aug2021, the patient stated that he started to feel his head aching on the right side with sensations of very brief needle-like pokes in the eye, the ear and towards the nose, with a sore throat also on the right side and a more enlarged ganglion than normal. Afterwards, the patient felt a burning sensation on the upper right side of his face, in the hair and up to the right eyelid. The patient consulted his GP, who immediately identified facial shingles. Referral to an ophthalmologist for ophthalmic shingles. Treatment in progress since 19Aug2021: VALACICLOVIR 500mg 6 tablets/day for 7 days; and BISEPTINE as a supplement for the eyes since 20Aug2021: EXOCIN Eye drops 0.3%; VIT A FAURE Eye drops. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jun2021. Therapeutic measures were taken as a result of herpes zoster ophthalmic. The outcome of the event Herpes zoster ophthalmic was recovering, and other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, C-reactive protein, Magnetic resonance imaging, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin, Troponin T
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Creatine kinase; Result Unstructured Data: Test Result:72 IU/l; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:40 mg/l; Test Date: 20210820; Test Name: Magnetic Resonance Imaging; Result Unstructured Data: Test Result:Left ventricular ejection fraction (LVEF); Comments: with diffuse hypokinesia without segmental predominance. No left ventricular hypertrophy.; Test Date: 2021; Test Name: NT-pro-brain natriuretic peptides; Result Unstructured Data: Test Result:327 pg/mL; Test Date: 2021; Test Name: positive troponin; Result Unstructured Data: Test Result:400 ng/L; Test Date: 2021; Test Name: Troponine THS; Result Unstructured Data: Test Result:55 ng/L
CDC Split Type: FRPFIZER INC202101149725

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20215990. A 16-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection) via intramuscularly on 05Aug2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY; solution for injection), via an unspecified route of administration on unspecified date in Jul2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. In the week of the 10th to the 15th onset of gastroenteritis, family contact. On 17Aug2021, chest pain at rest appeared in the evening. On 17Aug2021 the patient experienced myocarditis. On 18Aug2021 Patient was hospitalized for the event and the event was medically significant. The patient underwent lab tests and procedures which included Creatine kinase: 72 IU/L, C-reactive protein: 40 mg/l, N-terminal prohormone brain natriuretic peptide: 327 pg/ml, positive troponin: 400 ng/l, Troponine THS: 55 ng/l on an unspecified date in 2021. Magnetic Resonance Imaging which resulted left ventricular ejection fraction (LVEF) alteration with diffuse hypokinesia without segmental predominance. No left ventricular hypertrophy on 20Aug2021. Doubt about oedema of the myocardial apex. Small inferoapical subepicardial contrast compatible, but not correlated with normal T2 myocardial values opposite, remaining nevertheless compatible with a myocardial sequel. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-08-17
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood pressure measurement, Blood triglycerides, Dyslipidaemia, Echocardiogram, Haemodynamic test, Heart rate, High density lipoprotein, Low density lipoprotein, Magnetic resonance imaging, Myocarditis, Scan myocardial perfusion, Troponin
SMQs:, Dyslipidaemia (narrow), Cardiomyopathy (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Coronarography; Result Unstructured Data: Test Result: Suspicion of myo pericarditi; Comments: Left ventricular ejection fraction normal. Moderately atheromatous and slightly aneurysmal coronary network on the proximal left anterior descending artery without noticeable stenosis. Suspicion of myo pericarditis, post vaccine; Test Date: 20210817; Test Name: blood pressure; Result Unstructured Data: Test Result: 120/85; Test Name: triglycerides; Result Unstructured Data: Test Result: 1.8 g/l; Test Date: 20210817; Test Name: Echocardiogram; Result Unstructured Data: Test Result: No indirect signs of pulmonary hypertension; Comments: Size of left ventricle normal, no hypertrophy, conserved systolic function, with a left ventricular ejection fraction of 60%, without kinetic anomally, left ventricular filling pressures not elevated. No significant hemodynamic valve disease. No dilation of the right cavities, Left ventricle end, kinetic normal. Tricuspid annular plane systolic excursion 25mm. No indirect signs of pulmonary hypertension, ascending aorta not dilated. Dry pericardium. Non-dilated, breathable inferior vena cava; Test Date: 20210817; Test Name: Hemodynamics; Result Unstructured Data: Test Result: stable; Test Date: 20210817; Test Name: Heart rate; Result Unstructured Data: Test Result: 86 bpm; Test Name: high density lipoprotein; Result Unstructured Data: Test Result: 0.34 g/l; Test Name: low density lipoprotein; Result Unstructured Data: Test Result: 1.79 g/l; Test Name: Myocardial Magnetic Resonance Imaging; Result Unstructured Data: Test Result: No conductive or rhythmic problems; Comments: No conductive or rhythmic problems, except a salvo of non-sustained ventricular tachycardia, no cardiac insufficiency; Test Date: 2021; Test Name: myocardial scintigraphy; Result Unstructured Data: Test Result: normal; Test Name: Troponins; Result Unstructured Data: Test Result: 3780 ng/ml; Comments: significantly elevated; Test Date: 20210817; Test Name: Troponins; Result Unstructured Data: Test Result: largely positive ng/ml.
CDC Split Type: FRPFIZER INC202101142893

Write-up: dyslipidemia; Myocarditis; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-MP20216843. A 42-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 11Jun2021 (Batch/Lot Number: FC3143) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID-19. On 17Aug2021, the patient experienced significant chest pain (1:30 AM and of spontaneous onset) for which he was seen in the Emergency Room. Troponins largely positive, hospitalized for suspicion of Acute Coronary syndrome no ST troponin +. Hemodynamics stable, blood pressure 120/85 and a heart rate of 86 bpm. Regular heart sounds, no murmur, no sign of cardiac insufficiency on the right or left. Pulmonary auscultation clear and symmetrical. Echocardiogram: Size of left ventricle normal, no hypertrophy, conserved systolic function, with a left ventricular ejection fraction of 60%, without kinetic anomally, left ventricular filling pressures not elevated. No significant hemodynamic valve disease. No dilation of the right cavities, Left ventricle end, kinetic normal. Tricuspid annular plane systolic excursion 25mm. No indirect signs of pulmonary hypertension, ascending aorta not dilated. Dry pericardium. Non-dilated, breathable inferior vena cava,. Initial diagnosis: Acute Coronary syndrome no ST troponin +, as such treated with by Aspegic, Brilique And Arixtra. Coronarography: Left ventricular ejection fraction normal. Moderately atheromatous and slightly aneurysmal coronary network on the proximal left anterior descending artery without noticeable stenosis. Suspicion of myopericarditis, post vaccine. Myocardial Magnetic Resonance Imaging to be done. Troponin significantly elevated with the peak of troponin at 3780 ng/ml. Myocardial Magnetic Resonance Imaging, treat this aspect of acute myocarditis with Bisoprolol and coversyl for 36 + reevaluation of cardio program. No conductive or rhythmic problems, except a salvo of non-sustained ventricular tachycardia, no cardiac insufficiency. No infectious triggering factors including viral. Blood test was normal, except dyslipidemia with low density lipoprotein cholesterol at 1.79 g/l, triglycerides at 1.8 g/l and high density lipoprotein at 0.34 g/l. In summary Acute myocarditis inferior without a viral triggering factor found in the potentially post vaccination examination. The outcome of the events was not recovered 24Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Headache, Influenza like illness, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFIZINC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101142869

Write-up: Influenza like illness; Shortness of breath; headache; dizziness; nausea; extreme fatigue; Lack of concentration; This is a spontaneous report from a contactable consumer from the Regulatory Authority FR-AFSSAPS-NC20213783. A 30-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot and expiry were not reported), intramuscular in arm right on 16Aug2021 as dose 2, single for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included EFFIZINC. On 17Aug2021, the patient reported headache, dizziness, nausea, extreme fatigue, difficulty keeping her eyes open. Shortness of breath, two days sick leave from work and influenza like illness. Stopping sport for a week. Lack of concentration since returning to work. The outcome of the events influenza like illness and dyspnoea was recovering while for the rest of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1705588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cough, Dyspnoea, Headache, Liver function test, Pain, Polymerase chain reaction, Pulmonary pain, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECONASE; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coughing; Coughing blood; Fever; Hay fever; Rigors; Shaking; Suspected COVID-19 (later confirmed by a PCR)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: LFT; Test Result: Positive ; Test Date: 20210619; Test Name: PCR; Test Result: Positive ; Test Date: 20210619; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101145550

Write-up: Breathlessness; Throbbing headache; Chest pain - cardiac; Lung pain; pain; shaking; coughing; fever; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109010850519690-UITP9. Safety Report Unique Identifier is GB-MHRA-ADR 25878711. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 13Aug2021 as dose 1, single for COVID-19 immunization. Medical history included coughing, rigors, suspected covid-19 from 13Jun2021 to 24Jun2021, fever, shaking, and hay fever. The patient had COVID-19 very badly - testing positive on an LFT on 14Jun2021, which was later confirmed by a PCR. During the illness, the patient was coughing up blood and had extremely high fevers that often could not be controlled with paracetamol and ibuprofen. From the fever, he was also often shaking uncontrollably. He is a very fit, 21-year-old athlete who plays regular sport and has/had very high levels of cardiovascular fitness and strength prior to contracting the disease. Concomitant medications included beclometasone dipropionate (BECONASE) taken for hay fever from 01Apr2021; ibuprofen taken for fever from 14Jun2021 to 22Jun2021; paracetamol taken for fever from 14Jun2021 to 23Jun2021. On an unspecified date in 2021, the patient experienced pain, shaking, coughing, and fever; chest pain - cardiac and lung pain on 17Aug2021; and breathlessness and throbbing headache on 18Aug2021. The events were reported as serious per other medically important condition. The clinical course was reported as follows: From 17Aug2021, three days after his first vaccine dose (as reported), the patient started feeling frequent shooting pains in his chest, around his heart area and lungs. Once he was walking slowly doing shopping and one was sufficiently painful that he had to stop walking and bend over until the pain passed. On 18Aug2021, the pains still continued but he also felt very out of breath and was struggling to do very much at all. He also got a very bad headache that he treated with paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included LFT: positive on 14Jun2021; and on 19Jun2021, PCR: positive, and COVID-19 virus test: Yes - Positive COVID-19 test. The outcome of the events chest pain - cardiac and lung pain was recovered on 20Aug2021. The outcome of the events breathlessness and throbbing headache was recovered on 18Aug2021. The outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706052 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dizziness postural, Fall, Loss of consciousness, Nausea, Vagus nerve disorder
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), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: CT; Result Unstructured Data: Test Result: No abnormality
CDC Split Type: JPPFIZER INC202101152649

Write-up: she felt down due to dizziness on standing up and lost consciousness for about 20 seconds; Vagus nerve reflex (suspected); she felt down due to dizziness on standing up and lost consciousness for about 20 seconds; felt down; nausea; This is a spontaneous report from an uncontactable other HCP received via Regulatory Authority. The patient was a non-pregnant 45-year-old female adult. Medical history and concomitant medications were unknown. On 17Aug2021 (the day of vaccination), the patient received the single dose of BNT162B2 (COMIRNATY), Solution for injection, Lot number FF0843, Expiration date 31Oct2021, via an unspecified route of administration for COVID-19 immunization at the age of 45-year-old (dose number unknown). The details of the reaction were reported as follow: After the vaccination, the patient experienced nausea, she felt down due to dizziness on standing up and lost consciousness for about 20 seconds. No abnormal vitals. Suspected vagus nerve reflex. CT was performed, and there was no abnormality. On 17Aug2021 (the day of vaccination), the patient experienced loss of consciousness, vagus nerve reflex (suspected), nausea, dizziness on standing up and fall. The patient recovered from the events without treatment. The reporter classified the events as non-serious. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Loss of consciousness, Vagus nerve disorder and Dizziness postural cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1706064 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Oxygen saturation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion; Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: BP; Result Unstructured Data: Test Result:160s; Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210817; Test Name: Satc; Test Result: 96 %
CDC Split Type: JPPFIZER INC202101153916

Write-up: Consciousness clouding; BP 160s; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21125713. A 56-year and 7-month-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FF2782; expiration date: 30Nov2021), via an unspecified route of administration on 17Aug2021 15:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Medical history included psychosis and convulsion. The patient''s concomitant medications were not reported. The patient previously took gabapentin enacarbil (REGNITE). The clinical course of events was as follows: The patient''s body temperature before vaccination was 36.5 degrees Centigrade. On 17Aug2021 15:00 (the day of vaccination), the patient received the first dose of BNT162B2. On 17Aug2021 at 15:15 (15 minutes after vaccination), the patient experienced consciousness clouding and BP 160s. The patient''s oxygen saturation (sact) was at 96%, the consciousness always continued turbidity. There was no convulsion in particular, but there was a history of convulsion, psychosis. The outcome of the events was unknown. The reporting physician did not classify the event and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown.


VAERS ID: 1706119 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Body temperature increased, C-reactive protein, Chills, Electrocardiogram, Fatigue, Oedema peripheral, Pain, Palpitations, Panic attack, Pruritus, Superficial vein prominence, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PHLEBODIA
Current Illness: Radiculopathy (Radiculopathy due to spondylosis); Somatization disorder; Spondylosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:increased; Test Date: 20210823; Test Name: C-reactive protein; Result Unstructured Data: Test Result:2.8; Test Date: 20210820; Test Name: ECG; Result Unstructured Data: Test Result:no pathological changes found
CDC Split Type: LVPFIZER INC202101150035

Write-up: Pain in back and legs; Leg oedema; Chills; Urticaria; Generalized pruritus; Palpitations; Fatigue; Body temperature increased; Superficial vein prominence; panic attack; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number LV-SAM-2021086514. This is the first of two reports. A 34-years-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 17Aug2021 09:05 (Batch/Lot Number: FE2083), age at vaccination of 34-years-old, as 0.3 ml single for covid-19 immunisation. Medical history included ongoing radiculopathy (radiculopathy due to spondylosis), ongoing somatic symptom disorder, ongoing spinal osteoarthritis. The patient received received BNT162B2 (COMIRNATY), dose 1 on an unspecified date and experienced chills, pain and urticaria of lesser intensity after receiving 1st vaccination dose. Concomitant medication included diosmin (PHLEBODIA) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in back and legs (medically significant) on 17Aug2021, leg oedema (non-serious) on 17Aug2021, chills (non-serious) on 17Aug2021, urticaria (non-serious) on 17Aug2021, generalized pruritus (non-serious) on 17Aug2021, palpitations (non-serious) on 17Aug2021, fatigue (non-serious) on 17Aug2021, body temperature increased (non-serious) on 17Aug2021, superficial vein prominence (non-serious) on 17Aug2021. The patient underwent lab tests and procedures which included blood test: unknown results on 23Aug2021, body temperature increased on 17Aug2021, C-reactive protein: 2.8 on 23Aug2021, electrocardiogram: no pathological changes found on 20Aug2021. The clinical course was reported as follows: A physician (GP) reports regarding a patient - female, 34 years old. The patient received the 2nd vaccination dose with Comirnaty (BioNTech, batch No. FE2083) 0,3 ml intramuscularly on 17Aug2021 at 09:05. On 17Aug2021 the patient started to experience chills, body temperature increased, fatigue, pain (pain in back and legs), superficial vein prominence, generalized pruritus, urticaria, palpitations and leg oedema (both legs oedematous). On 20Aug2021 the patient had an ECG done - no pathological changes found. The patient experienced panic attack-like symptoms due to which the emergency medical services were called - the patient was not hospitalized. On 23Aug2021 the patient was still experiencing pain and fatigue. Patient had blood testing done - high sensitivity c-reactive protein 2.8 (units and reference interval not provided). The events recovered (date not specified). The patient is scheduled to have additional medical testing done. The events of chills, pain and urticaria were recurring (patient experienced chills, pain and urticaria of lesser intensity after receiving 1st vaccination dose). The patient''s medical history includes spondylosis, radiculopathy (due to spondylosis), somatization disorder. Concomitant medications: Phlebodia (diosmine) 600 mg tablets, dose not specified, indication not specified. The patient also uses NSAIDs (NOS), indication not specified. The reporter has been contacted in order to gather follow-up information. Follow-up information added on 06Sep2021: The patient was sent to the hospital emergency department due to the event of pain, but they were not admitted - the patient was not hospitalized. The patient is scheduled to have an echocardiogram. The patient recovered from the events on an unspecified date.; Sender''s Comments: Linked Report(s) : LV-PFIZER INC-202101181601 same patient/ vaccine, different dose/ events


VAERS ID: 1706306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-08-17
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 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? 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: 20210817; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101164378

Write-up: medication failure; medication failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received regulatory authority report number PT-INFARMED-T202108-2803 with Safety Report Unique Identifier PT-INFARMED-T202108-2803. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Feb2021 (Lot Number: EP2166) as DOSE 1, SINGLE, dose 2 intramuscular on 19Mar2021 (Lot Number: ER7812) as DOSE 2, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced medication failure on 17Aug2021 with outcome of recovered, COVID-19 on 17Aug2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021. The reporters assessment of the causal relationship of the [Vaccination failure, COVID-1] with the suspect product was [Source of assessment: reporter, Method of assessment was unknown, Result of Assessment was probable]. Case was not severe with PT-INFARMED-T202108-2803. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1706320 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bilirubin conjugated, Blood bilirubin, Body temperature, Eyelid oedema, Headache, Ocular discomfort, Pain, Periorbital swelling, Pruritus, Pyrexia, Urticaria, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis (When I was 13, I had appendicitis surgery.); Solar urticaria (had solar urticaria at sea in September 2018 due to my skin''s sensitivity to the sun.); Sun sensitivity
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Direct bilirubin; Result Unstructured Data: Test Result:7.5; Comments: increased; Test Date: 20210726; Test Name: total bilirubin; Result Unstructured Data: Test Result:28.4; Comments: increased; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade
CDC Split Type: RSPFIZER INC202101190207

Write-up: Eyelid oedema; a sensation of a small pillow when blinking; a swelling started to form under the left eye; mild stinging on various parts of the body; Urticaria; small red bite marks that itched mildly; the arm in which received the vaccine started to hurt; Pyrexia; headache; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number 515-00-02677-2021-2. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 (at the age of 28-year-old) as dose 2, single for COVID-19 immunisation. The patient hadn''t had any allergies so far, except that she had solar urticaria at sea in September 2018 due to her skin''s sensitivity to the sun. When she was 13 years old, she had appendicitis surgery. She tried to eat healthy and did not use any harmful substances, nor did she consume excessive alcohol. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 27Jul2021 (at the age of 28-year-old) at single dose for COVID-19 immunisation and had pain in the arm at the place where the vaccine was administered, and the following day she felt mild sleepiness. On Tuesday, August 17, 2021 in the morning, the patient received the second dose of the Pfizer vaccine. Few hours later, the arm in which received the vaccine started to hurt, and this pain passed in the evening of the following day. The same evening on 17Aug2021, the patient had a mild fever, 37.6 and a headache. The patient took Panadol on Wednesday, August 18 in the morning. The following days, temperature was 37.2 and 37. On Friday, August 20 at 5.30 p.m., the patient started to feel mild stinging on various parts of the body, and she saw something resembling small red bite marks that itched mildly. First they appeared around elbows. The patient applied Fenistil gel and took one Pressing tablet, which expired in February 2021. It all slowly withdrew, but the same night on 20Aug2021 at 3 a.m., hives appeared across the whole legs, arms, and shoulders and started to spread over the torso. The patient went to the Emergency Medical Service where she was given three injections (two intravenous and one intramuscular in the gluteal region), and was told to have one more Pressing (this time non-expired). She took one and approximately after an hour, the symptoms began to withdraw. They fully withdrew by morning and on Saturday (21Aug2021), everything was better all day. Nevertheless, on Sunday (22Aug2021) around 1 a.m., hives reappeared in the same areas, this time with a bit lower intensity. The spots were much paler in color and more sparsely distributed on the body. But, eyelids started to swell, as well as the area under the left eye. The patient took Pressing again, and by 7 a.m. hives receded on most of the body, but eyelids were more swollen, and a swelling started to form under the left eye, with a sensation of a small pillow when blinking. The patient stated this was why she went to the physician again and she was given the injections again. This time it was two injections (one intravenous, the second intramuscular in the gluteal region). After an hour, the swelling gradually receded. The patient had no reactions since then. Lab test performed on 26July2021: Value of total blood bilirubin and direct blood bilirubin increased (total 28.4 and direct 7.5). The outcome of the events "the arm in which received the vaccine started to hurt", "Pyrexia", "mild stinging on various parts of the body", "small red bite marks that itched mildly" and "headache" was recovered on 21Aug2021, of the other events was recovered on 22Aug2021. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1706369 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood pressure measurement, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram, Fibrin D dimer, Interchange of vaccine products, Off label use, Oxygen saturation, Pericarditis, Platelet count, Prothrombin time, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Medication errors (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myasthenia gravis (currently with no therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Creatinine; Result Unstructured Data: Test Result:65 umol/l; Test Date: 20210825; Test Name: Serum glucose; Result Unstructured Data: Test Result:7 mmol/L; Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:121/74 mmHg; Test Date: 20210825; Test Name: Chest X-ray; Result Unstructured Data: Test Result:normal; Comments: no special features; Test Date: 202108; Test Name: CRP; Result Unstructured Data: Test Result:INCREASED; Test Date: 20210825; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:left ventricle larger than right ventricle,; Comments: global left ventricular systolic function preserved, LVOT VTI ( Left ventricular outflow tract velocity time integral) 17 cm, TAPSE (Tricuspid annular plane systolic excursion) 1.3 cm, no clear segmental contraction disturbances, no significant valvular defects. Signal TR reg 2m / s, no signs of pulmonary hypertension. Hypoechoic pericardium posteriorly and inferolaterally along the left ventricle, without pericardial effusion. VCI (Vena Cava Inferior) 2 cm, collapses in the inspiration by less than 50%.; Test Date: 20210825; Test Name: EKG; Result Unstructured Data: Test Result:sinus rhythm with a frequency of 75/min,; Comments: normal cardiac axis, narrow QRS complexes, concave elevations of the ST segment by 1 mm in II, III, a VF; Test Date: 20210825; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:368; Test Date: 20210825; Test Name: oxygen saturation without added oxygen; Test Result: 100 %; Test Date: 20210825; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:148 x10 9/l; Test Date: 20210825; Test Name: Prothrombin time; Test Result: 0.73 s; Test Date: 202108; Test Name: Leucocyte count; Result Unstructured Data: Test Result:increased x10 9/l; Test Date: 20210825; Test Name: Leucocyte count; Result Unstructured Data: Test Result:14.2 x10 9/l
CDC Split Type: SIPFIZER INC202101143542

Write-up: pericarditis; first dose Vaxzevria, second dose Comirnaty; first dose Vaxzevria, second dose Comirnaty; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number SI-JAZMP-NCPHV-2021SI0866_0866. A 42-year-old female patient (also age at the time of vaccination) received bnt162b2 (COMIRNATY), intramuscular on 17Aug2021 (Lot Number: FE1573) dose 2 (initial Pfizer dose), single for COVID-19 immunisation. Medical history included myasthenia gravis from an unknown date and unknown if ongoing (currently with no therapy). The patient''s concomitant medications were not reported. The patient previously took methylprednisolone (MEDROL) for myasthenia gravis. The patient previously received dose 1 of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA, AstraZeneca, lot ABW2187) on 30Apr2021 for COVID-19 vaccination; after vaccination the patient had classic adverse reactions as than other people, perhaps a little more intense. The patient experienced pericarditis on 20Aug2021 with outcome of recovering. The event was described as follows: on Friday, 17Aug2021, patient received the second dose of the vaccine (Pfizer) against covid-19 vaccine. The first dose received was the vaccine from AstraZeneca. On Monday, patient experienced mild chest pain. As it aggravated in time, she visited internist first aid, where ECG and ultrasound revealed pericarditis. CRP and leukocytes were increased. Before vaccination felt very well and have never had similar problems, so this is why she believe the vaccine is the cause. Action taken: visit at emergency department, medical check, therapy with NSAID. The patient currently doesn''t have any regular therapy, in the past she was treated due to autoimmune disease myasthenia gravis (was taking biological drugs and Medrol). The problems started on day 3 in the evening, very gradually. The patient was not hospitalized, she is being treated at home with rest and NSAID therapy. Examination at the internal clinic on 25Aug2021: about 1 week ago, the patient received a vaccine against COVID-19, over the weekend she felt muscle pain (pain in her chest). The patient describes the pain as tightening, constant, intensifying with movement and bending, then it is of a stabbing nature. The patient denies fever, shortness of breath, palpitations, loss of consciousness, burning urination. The patient denied having a cold. The patient is without regular therapy, denied allergies and harmful habits. Status upon examination: blood pressure 121/74 mmHg, saturation without added oxygen 100%, breathing clean, head without special features. The heart action is rhythmic, the tone appropriately accentuated, with no obvious noises. Renal succussion painless, limbs without edema, pulses symmetrically tactile, afebrile, oriented, anicteric, cyanotic, skin warm and dry. ECG: sinus rhythm with a frequency of 75/min, normal cardiac axis, narrow QRS complexes, concave elevations of the ST segment by 1 mm in II, III, a VF. Chest X-ray: no special features. Cardiac ultrasound, orientation: left ventricle larger than right ventricle, global left ventricular systolic function preserved, LVOT VTI ( Left ventricular outflow tract velocity time integral) 17 cm, TAPSE (Tricuspid annular plane systolic excursion) 1.3 cm, no clear segmental contraction disturbances, no significant valvular defects. Signal TR reg 2m / s, no signs of pulmonary hypertension. Hypoechoic pericardium posteriorly and inferolaterally along the left ventricle, without pericardial effusion. VCI (Vena Cava Inferior) 2 cm, collapses in the inspiration by less than 50%. Opinion: The patient was examined due to chest pain. Clinically and ultrasound is most likely pericarditis. Prescribed ibuprofen (BRUFEN) 600 mg 1 tbl every 8h for 10 days. The patient will undergo an ultrasound check-up examination of the heart and an examination by a cardiologist. Other lab tests and procedures included blood creatinine: 65 umol/l on 25Aug2021, serum glucose: 7 mmol/l on 25Aug2021, chest x-ray: normal on 25Aug2021, C-reactive protein (CRP): increased in Aug2021, fibrin D dimer: 368 on 25Aug2021, thrombocyte count: 148 x10 9/l on 25Aug2021, prothrombin time: 0.73 seconds on 25Aug2021, leucocyte count: increased in Aug2021, leucocyte count: 14.2 x10 9/l on 25Aug2021. The patient experienced off label use and interchange of vaccine products on 17Aug2021 since first dose was Vaxzevria and second dose was Comirnaty.


VAERS ID: 1708058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Duodenal ulcer; Lung wedge resection; Pneumothorax spontaneous; Thoracic cavity drainage 23 years ago; Tonsillectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101155115

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-042957. A 62-year-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot Number: Unknown) intramuscularly on 31Jul2021 as single dose for COVID-19 immunisation. Medical history included duodenal ulcer from an unknown date and unknown if ongoing, tonsillectomy from an unknown date and unknown if ongoing, appendicectomy from an unknown date and unknown if ongoing, pneumothorax spontaneous from an unknown date and unknown if ongoing, pulmonary resection/lung wedge resection from an unknown date and unknown if ongoing, thoracic cavity drainage from 1998 to an unknown date. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 17Aug2021, the patient experienced pulmonary embolism [right main pulmonary artery embolism]. Event caused hospitalization. Therapeutic measures were taken as a result of pulmonary embolism which included initiation of therapeutic therapy with low molecular weight heparin. Outcome of the event was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.?


VAERS ID: 1709516 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Paraesthesia, Stomatitis, Tachycardia
SMQs:, Severe cutaneous adverse reactions (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Asthenia; Irritation roof of mouth; This case was received via regulatory authority (Reference number: ES-AEMPS-986468) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PARAESTHESIA in a 36-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINA C [ASCORBIC ACID] from 02-Mar-2015 to an unknown date for COVID-19 immunization. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant), PARAESTHESIA (seriousness criterion medically significant), ASTHENIA and STOMATITIS (Irritation roof of mouth). At the time of the report, TACHYCARDIA , PARAESTHESIA , ASTHENIA and STOMATITIS (Irritation roof of mouth) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 17-Aug-2021. No treatment information was provided. Vitamin C was taken once a day for many year for immune system. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Translation received on 09-Sep-2021 in which concomitant details were updated.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1709541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Dizziness, Immune system disorder, Malaise, Oropharyngeal pain, Pain in extremity, Peritonsillar abscess, Pharyngeal oedema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOJECT; HUMIRA; FOLIC ACID.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Iritis; Rheumatism.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101149792

Write-up: the vaccination may have caused a break in his immune defence; Throat oedema; Throat pain; Pain in arm; Axillary pain; Chills; Peritonsillar abscess; Pyrexia; Dizziness; Feeling sick; This is a spontaneous report from a non-contactable consumer (parent) downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214336. A 14-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 16Aug2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Pediatric rheumatism as an underlying disease with associated chronic iritis from an unknown date and unknown if ongoing. Concomitant medication included methotrexate sodium (METOJECT), adalimumab (HUMIRA) and folic acid (FOLIC ACID) taken for juvenile idiopathic arthritis (also reported as Pediatric rheumatism as an underlying disease with associated chronic iritis), start and stop date were not reported. The latest Humira injection before the vaccine was 2 weeks earlier and the Metotrexate less than a week earlier. The treatment of the disease has been good, symptom-free for years. The patient previously took ondansetron for anti-nausea and experienced allergic skin reaction. It was reported that the patient (son) got a corona vaccine on 16Aug2021. The next evening, 17Aug2021 he felt dizzy, had chills, fever, feeling sick. On 18Aug2021 a pain in the arm and armpit (also reported as axillary pain) started with a sore throat. Also on 18Aug2021 did not have fever. On 19Aug2021 throat ache got worse, throat swollen on one side (also reported as Throat oedema), went to the health centre to see a doctor, fever rose again. The doctor was considering a possibility of pharyngeal abscess. Was instructed to monitor the situation and sent home. On 20Aug2021 his throat was very sore, talking was difficult, from the health centre he was referred to the hospital, where in the evening of 20Aug2021 they operated on his pharyngeal abscess and tonsils (also reported as Peritonsillar abscess). Feeling better after surgery, discharged the next day. Now on a course of antibiotics, the hospital had intravenous antibiotics. According to the doctor it is possible that the vaccination may have caused a break in his immune defence that led to the development of a pharyngeal abscess. No medication was given after the vaccine as the symptoms appeared. This was the first vaccine dose. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1709611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210930640

Write-up: COVID-19 PNEUMONITIS; DRUG INEFFECTIVE; This spontaneous report received from a pharmacist by a Regulatory Authority (FR-AFSSAPS-MP20217343) on 15-SEP-2021 and concerned a 76 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: cerebrovascular accident and stroke, and concurrent conditions included: diabetes, and obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 27-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced covid-19 pneumonitis, and drug ineffective and was hospitalized (date unspecified) for unspecified duration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonitis, and drug ineffective. This report was serious (Hospitalization Caused / Prolonged). This case is associated with Product Quality Complaint.


VAERS ID: 1709688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Allergic hepatitis, Alpha-1 antitrypsin deficiency, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin, Blood gases, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Body temperature, Cardiovascular examination, Coagulation factor V level, Coma scale, Computerised tomogram, Cytomegalovirus test, Electrophoresis protein, Epstein-Barr virus test, Gamma-glutamyltransferase, HIV test, Haemoglobin, Heart rate, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Hepatitis E virus test, Herpes simplex test, Laboratory test, Oxygen saturation, Physical examination, Platelet count, Prothrombin time ratio, Respiratory rate, SARS-CoV-2 test, Smooth muscle antibody, Specialist consultation, Ultrasound scan, Varicella virus test negative, White blood cell count
SMQs:, Hepatitis, non-infectious (narrow), Congenital, familial and genetic disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pleurodesis; Pneumothorax
Allergies:
Diagnostic Lab Data: Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15; Comments: Conscious and oriented patient. Glasgow Coma Scale 15.; Test Name: computed tomography scan; Result Unstructured Data: Test Result:no evidence of Budd-Chiari; Comments: A computed tomography scan was performed to rule out hepatic vascular disorders, finding no evidence of Budd-Chiari, the hepatic artery appeared to be permeable. Homogeneous hepatosplenomegaly with periportal oedema. No vascular thrombosis; Test Date: 20210819; Test Name: Cytomegalovirus Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 20210819; Test Name: Cytomegalovirus serology; Test Result: Negative ; Test Name: Serum protein electrophoresis; Result Unstructured Data: Test Result:moderate hypoprotidaemia associated with a normal; Comments: moderate hypoprotidaemia associated with a normal looking electrophoretic profile; Test Name: Epstein-Barr virus; Test Result: Negative ; Test Date: 20210901; Test Name: Epstein-Barr virus; Test Result: Negative ; Comments: Absence of IgG and presence of anti-VCA IgM (no change compared to the serology of 22Aug2021).; Test Date: 20210819; Test Name: Epstein-Barr virus Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 20210818; Test Name: Gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:354; Comments: unit: IU/L; Test Date: 20210901; Test Name: Gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:158; Comments: unit: G/L; Test Date: 20210818; Test Name: haemoglobin; Result Unstructured Data: Test Result:15 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:50/min; Test Name: hepatitis A virus; Test Result: Negative ; Test Name: hepatitis B virus; Test Result: Negative ; Test Name: hepatitis C virus; Test Result: Negative ; Test Date: 20210819; Test Name: Hepatitis E Virus Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 20210819; Test Name: Hepatitis E Virus serology; Test Result: Negative ; Test Date: 20210819; Test Name: Herpes Simplex Virus Polymerase Chain Reaction test; Test Result: Negative ; Test Name: human immunodeficiency virus serologies; Test Result: Negative ; Test Date: 20210818; Test Name: human immunodeficiency virus serologies; Test Result: Negative ; Test Date: 20210819; Test Name: Human Immunodeficiency Virus serology; Test Result: Negative ; Test Name: Anti-endoplasmic reticulum antibodies; Test Result: Negative ; Test Name: Anti-liver cytosol 1 antibodies; Test Result: Negative ; Test Name: Anti-soluble liver antigen antibodies; Test Result: Negative ; Test Name: oxygen saturation; Test Result: 98 %; Comments: 98% (in room air); Test Name: Abdomen is soft, yielding and painless.; Result Unstructured Data: Test Result:Abdomen is soft, yielding and painless.; Comments: Abdomen is soft, yielding and painless. No signs of hepatocellular failure.; Test Date: 20210818; Test Name: platelets; Result Unstructured Data: Test Result:232 x10 9/l; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:lowered to 60%; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:55%; Test Date: 20210818; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:55%; Test Date: 20210819; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:49%; Test Date: 20210901; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:62; Test Name: respiratory rate; Result Unstructured Data: Test Result:16/min; Test Date: 20210818; Test Name: Sars-CoV-2 PCR (polymerase chain reaction) test; Test Result: Negative ; Test Name: Anti-smooth muscle antibodies; Test Result: Negative ; Test Name: Bilateral and symmetrical vesicular murmur; Result Unstructured Data: Test Result:Bilateral and symmetrical vesicular murmur.; Comments: Bilateral and symmetrical vesicular murmur. No functional respiratory signs.; Test Name: Ultrasound; Result Unstructured Data: Test Result:liver size at the upper limit of normal; Comments: liver size at the upper limit of normal. Permeability of the portal trunk. No dilation of the intra- and extra-hepatic bile ducts. Note a homogeneous splenomegaly (14 cm high).; Test Date: 20210819; Test Name: Varicella zoster virus Polymerase Chain Reaction test; Test Result: Negative ; Test Date: 202107; Test Name: Leukocytes; Result Unstructured Data: Test Result:15.57 x10 9/l; Test Date: 20210818; Test Name: Leukocytes; Result Unstructured Data: Test Result:8 x10 9/l; Test Date: 20210823; Test Name: Leukocytes; Result Unstructured Data: Test Result:21.24 x10 9/l; Test Date: 20210901; Test Name: Leukocytes; Result Unstructured Data: Test Result:25.54 x10 9/l; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:3400; Comments: unit: IU; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:67; Comments: unit: N; Test Date: 20210818; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:2920; Comments: unit: IU/L; Test Date: 20210819; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:1800; Comments: unit: IU/L; Test Date: 20210901; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:1884; Test Name: Alpha1 antitrypsin; Result Unstructured Data: Test Result:Normal; Test Name: Anti-mitochondrial antibodies; Test Result: Negative ; Test Name: Anti-nuclear antibodies; Test Result: Negative ; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:1967; Comments: unit: IU; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:33; Comments: unit: N; Test Date: 20210818; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:1402; Comments: unit: IU/L; Test Date: 20210819; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:1338/l; Comments: unit: /L; Test Date: 20210901; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:645; Comments: unit: IU/L; Test Name: Liver biopsy; Result Unstructured Data: Test Result:presence of eosinophilic infiltrate; Comments: presence of eosinophilic infiltrate, moderate intralobular hepatitis, interface hepatitis, no collapse necrosis. Acute hepatitis indicative of an immunoallergic origin; Test Date: 20210818; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:177; Comments: unit: IU/L; Test Name: Bilirubin; Result Unstructured Data: Test Result:157 umol/l; Test Name: hyperbilirubinemia; Result Unstructured Data: Test Result:hyperbilirubinemia at 197.7 ?mol/L; Test Date: 20210818; Test Name: Total bilirubin; Result Unstructured Data: Test Result:151 umol/l; Test Date: 20210819; Test Name: Total bilirubin; Result Unstructured Data: Test Result:178 umol/l; Test Date: 20210901; Test Name: Total bilirubin; Result Unstructured Data: Test Result:281 umol/l; Test Name: blood gas analysis; Result Unstructured Data: Test Result:No hyperlactataemia; Test Date: 20210820; Test Name: Immunoglobulin A; Result Unstructured Data: Test Result:1.41 g/l; Test Date: 20210820; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result:7.40 g/l; Test Date: 20210820; Test Name: Immunoglobulin G4 subclass; Result Unstructured Data: Test Result:<0.05 g/l; Test Date: 20210820; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result:0.95 g/l; Test Date: 20210818; Test Name: Potassium; Result Unstructured Data: Test Result:3.8 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:105/37 mmHg; Test Date: 20210818; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Test Name: Blood test; Result Unstructured Data: Test Result:revealed hepatic cytolysis; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Name: Regular heart sounds; Result Unstructured Data: Test Result:Regular heart sounds.; Comments: Regular heart sounds. No signs of right or left cardiac insufficiency.; Test Name: Factor V; Test Result: 115 %; Test Date: 20210819; Test Name: Factor V; Result Unstructured Data: Test Result:preserved at 124 %; Comments: preserved at 124%; Test Date: 20210901; Test Name: Factor V; Test Result: 162 %
CDC Split Type: FRPFIZER INC202101142848

Write-up: Severe immuno-allergic hepatitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number -AFSSAPS-NT20213485. A 16-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 16Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included pneumothorax from Jul2021 to an unknown date, pleurodesis from Jul2021 to an unknown date. Concomitant medications were not reported. The patient previously took the first dose of Comirnaty on 22Jul2021 intramuscular for covid-19 immunisation. On 17Aug2021, the patient was diagnosed with severe immuno-allergic hepatitis on Day 1 of Comirnaty vaccination with a 38% prothrombin ratio. The day after the injection, on 17Aug2021, onset of mucocutaneous jaundice, consultation with the general practitioner. Blood test carried out in the city revealed hepatic cytolysis (aspartate aminotransferase 1967 IU; alanine aminotransferase 3400 IU) with hyperbilirubinemia at 197.7 ?mol/L. Prothrombin ratio lowered to 60%. Given the clinical picture, admission to the emergency room. Clinically, the patient was haemodynamically stable. Afebrile. Blood test shows hepatic cytolysis (aspartate aminotransferase 33 N; alanine aminotransferase 67 N). Bilirubin 157 ?mol/L. Prothrombin ratio 55%. Factor V 115%. No hyperlactataemia on blood gas analysis. Ultrasound showed liver size at the upper limit of normal. Permeability of the portal trunk. No dilation of the intra- and extra-hepatic bile ducts. Note a homogeneous splenomegaly (14 cm high). The first samples taken in the laboratory showed Epstein-Barr virus, hepatitis A virus, hepatitis B virus, hepatitis C virus and human immunodeficiency virus serologies. All negative. The patient does not report any substance use. No hepatotoxic drugs. Paracetamol overdosage tested negative at 4 hours after intake. The patient was transferred on 18Aug2021 for further treatment. Heart rate: 50/min; blood pressure: 105/37 mmHg; respiratory rate: 16/min; oxygen saturation: 98% (in room air); temperature : 36.4 degree Celsius. Conscious and oriented patient. Glasgow Coma Scale 15. No signs of hepatic encephalopathy. Regular heart sounds. No signs of right or left cardiac insufficiency. Bilateral and symmetrical vesicular murmur. No functional respiratory signs. Abdomen was soft, yielding and painless. No signs of hepatocellular failure. Blood test on 18Aug2021, showed sodium 138 mmol/litre, potassium 3.8 mmol/litre, total bilirubin 151 micromoles/litre, aspartate aminotransferase 1402 IU/L, alanine aminotransferase 2920 IU/L, gamma-glutamyltranspeptidase 354 IU/L, alkaline phosphatase 177 IU/L, leukocytes 8 g/l, haemoglobin 15 g/dl, platelets 232 G/l, prothrombin ratio 55%. At the hepatic level, introduction of treatment on arrival with N-acetylcysteine, with close monitoring of the liver function with an initial decrease in prothrombin ratio to 49% on 19Aug2021, factor V preserved at 124%, associated initially with a decrease in cytolysis aspartate aminotransferase 1338/l, alanine aminotransferase 1800 IU/l but an increase in total bilirubin to 178 ?mol/l. A computed tomography scan was performed to rule out hepatic vascular disorders, finding no evidence of Budd-Chiari, the hepatic artery appeared to be permeable. Homogeneous hepatosplenomegaly with periportal oedema. No vascular thrombosis. Treatment with Cholurso was initiated on 19Aug2021. Infectious samples showed Human Immunodeficiency Virus negative on 18Aug2021 and also Sars-CoV-2 PCR (polymerase chain reaction) test negative. On 19Aug2021, Cytomegalovirus serology, Cytomegalovirus Polymerase Chain Reaction test, Hepatitis E Virus serology, Hepatitis E Virus Polymerase Chain Reaction test, Human Immunodeficiency Virus serology, Herpes Simplex Virus Polymerase Chain Reaction test, Varicella zoster virus Polymerase Chain Reaction test and Epstein-Barr virus Polymerase Chain Reaction test were all negative. Autoimmune assessment of Anti-nuclear antibodies, Anti-smooth muscle antibodies, Anti-mitochondrial antibodies, Anti-endoplasmic reticulum antibodies, Anti-soluble liver antigen antibodies and Anti-liver cytosol 1 antibodies were negative. Serum protein electrophoresis showed moderate hypoprotidaemia associated with a normal looking electrophoretic profile. Normal Alpha1 antitrypsin. On 20Aug2021, Immunoglobulin G 7.40 g/L, Immunoglobulin A 1.41 g/L, Immunoglobulin M 0.95 g/L, Immunoglobulin G4 subclass <0.05g/L (nomal value: 0.049-1.985). Liver biopsy showed presence of eosinophilic infiltrate, moderate intralobular hepatitis, interface hepatitis, no collapse necrosis. Acute hepatitis indicative of an immunoallergic origin. Initiation of treatment with Solumedrol IV 80 mg on 22Aug2021. Patient returned home on 01Sep2021. A recheck of EBV serology was carried out on 01Sep2021 due to a first serology showing the existence of an IgM but with two negative EBV PCRs: Absence of IgG and presence of anti-VCA IgM (no change compared to the serology of 22Aug2021). Assessment which is not in favor of a recent primary EBV infection. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected. Information about LOT/Batch number cannot be obtained.


VAERS ID: 1709714 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Dysstasia, Headache, Influenza like illness, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101149831

Write-up: Nausea; Myalgia; Drop of blood pressure/fall in blood pressure; Headache; Difficulty in standing/could not stand up; flu-like illness; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RS20212780. A 22-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FE8244, Expiry date was not reported), via intramuscular route of administration on 17Aug2021 (at the age of 22-years-old) in Arm Left, as dose 2, single for COVID-19 immunization .The patient medical history and concomitant medications was not reported. Patient had no history of COVID-19. On 17Aug2021, the day of vaccination (time not specified), the patient experienced nausea, myalgia, drop of blood pressure/fall in blood pressure, headache, difficulty in standing/could not stand up, 48 H work stoppage. On 2021,Patient experienced flu-like illness. Patient presented with a drop in blood pressure, nausea and flu-like illness requiring time off work on the day of the COMIRNATY (Dose 2) vaccination.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. The outcome for the events nausea, myalgia, drop of blood pressure/fall in blood pressure, headache, difficulty in standing/could not stand up was not recovered on 20Aug2021 and for the event flu-like illness was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1709725 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dyspnoea, Influenza like illness, Palpitations, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Palpitation; Shortness of breath; Influenza like illness; Abdominal pain; Vaccination site pain; This case was received via regulatory authority (Reference number: FR-AFSSAPS-ST20213263) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 18-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) and ABDOMINAL PAIN (Abdominal pain). On 20-Aug-2021, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (Palpitation) and DYSPNOEA (Shortness of breath) had not resolved, INFLUENZA LIKE ILLNESS (Influenza like illness) and ABDOMINAL PAIN (Abdominal pain) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant and treatment information was provided. Company comment- This case concerns a 28-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Palpitations and the non-serious unexpected events of Dyspnoea, Influenza like illness and Abdominal pain, in addition to, non-serious expected event of Vaccination site pain. The event Vaccination site pain occurred on the same day after the first dose of Spikevax whereas the events Influenza like illness and Abdominal pain occurred approximately 1 day after the first dose. The events Palpitations and Dyspnoea occurred three days following vaccination with the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation document received on 15-Sep-2021 as live follow up include dosage text updated; Sender''s Comments: This case concerns a 28-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Palpitations and the non-serious unexpected events of Dyspnoea, Influenza like illness and Abdominal pain, in addition to, non-serious expected event of Vaccination site pain. The event Vaccination site pain occurred on the same day after the first dose of Spikevax whereas the events Influenza like illness and Abdominal pain occurred approximately 1 day after the first dose. The events Palpitations and Dyspnoea occurred three days following vaccination with the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1709749 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Swollen lips; This case was received via Agency (Reference number: GB-MHRA-ADR 25916025) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced LIP SWELLING (Swollen lips) (seriousness criterion hospitalization). On 19-Aug-2021, LIP SWELLING (Swollen lips) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was reported that strong Anti-histamines are given for treatment of severely swollen lips. This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected event of lip swelling. The event occurred on an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected event of lip swelling. The event occurred on an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1709817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Anger, Anxiety, Bacterial infection, Chromaturia, Cough, Decreased appetite, Delusion, Depression, Distractibility, Dizziness, Encephalitis, Faeces discoloured, Fatigue, Feeling hot, Flushing, Fungal infection, Hunger, Hypersomnia, Insomnia, Irritability, Mood swings, Mutism, Neurotoxicity, Obsessive-compulsive personality disorder, Retching, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARIPIPRAZOLE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Bacterial infection; Catatonic reaction; Fungal dermatitis; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Paronychia; Sinus infection; Tooth abscess
Allergies:
Diagnostic Lab Data: Test Name: test for anti-neuronal encephalitis; Result Unstructured Data: Test Result:Unknown Results
CDC Split Type: GBPFIZER INC202101153145

Write-up: aggression; insomnia; flushing; retching; dizziness; irritability; encephalitis; rage; distractedness; loss of appetite; overheating (stripping off, spending hours in cold bath); compulsive behaviour; pale stools; dark urine; delusions of guilt; excess sleep; infections (bacterial, fungal, viral); infections (bacterial, fungal, viral); infections (bacterial, fungal, viral); depression; tiredness; anxiety; Neurotoxicity NOS; coughing; hunger; mood swings; mutism; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109031712361400-7SN9P Safety Report Unique Identifier GB-MHRA-ADR 25893848. A 30-year-old male patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported), dose 2 via an unspecified route of administration on 14Aug2021 as dose 2, single for COVID-19 immunization. Medical history included bacterial infection, fungal skin infection, sinusitis, tooth abscess, paronychia, immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response and I), catatonia, asthma from an unknown date and unknown if ongoing. The patient''s historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported), dose 1 via an unspecified route of administration for Covid-19 immunisation and the reactions were withdrawn/absent/spacy reaction on an unspecified date. In the past 19 years old our son has had similar reactions in the past to tooth abscess, sinus infection, fungal dermatitis, paronychia with extensive bacterial infection of digit and foot. These post-infectious reactions always take the same form and follow a similar course. Originally the symptoms were more severe, suggested to be toxic delirium. There would be resolution followed by approximately 3 weeks normality followed by recurrence. They have become milder and shorter over the 10 or so years he has been having them. The anorectic phase/cooling seems to be key in resolving the reaction spontaneously. Having the same response to the 2nd Pfizer Covid 19 vaccination confirms that they are the result of immune activation. Perhaps it has a similar mechanism to ICANS. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medications included aripiprazole (ARIPIPRAZOLE) 2.5 mg taken for catatonia from 06Jun2010 to an unspecified stop date, salbutamol (SALBUTAMOL) taken for asthma from 08Aug1997 to an unspecified stop date. The patient experienced aggression, insomnia, flushing, retching, dizziness, irritability, encephalitis, rage, depression, tiredness, anxiety, distractedness, loss of appetite, overheating (stripping off, spending hours in cold bath) (feeling hot), compulsive behavior (obsessive-compulsive personality disorder) on an unspecified date, mutism on 17Aug2021, coughing, mood swings, hunger on 18Aug2021, neurotoxicity nos on 19Aug2021. Depression (crying), distractedness and withdrawal (3 days) followed by mutism, loss of appetite and all normal activity, flushing and overheating (stripping off, spending hours in cold bath), (4 days) coughing and retching and dizziness,pale stools and dark urine, insomnia, anxiety and compulsive behaviour, delusions of guilt, rage, aggression and irritability, impulsive voracious hunger-(4 days) lastly mood swings, sudden tiredness and excess sleep, sudden hunger interspersed with longer phases of normality(4...days). This last was the current stage of recovery, so may be longer than 4 days. This was the same set of symptoms as experienced by his son in the past, to varying degrees and durations, after most infections (bacterial, fungal, viral). They have had no diagnosis for this repeated reaction to immune activation of all sorts (now including vaccination) but he takes a low dose of Aripiprazole (2.5mg) which we double during the phase (usually several days) with psychotic symptoms. It seems to be somewhat similar to Klein-Levin syndrome and he has had episodes where hypersomnolence, spaciness and hunger predominate. More frequently the reaction is as described with a mixture of all types of symptoms. Patient was not enrolled in clinical trial. Suspect Reactions: There have been no investigations nor tests as this was a recurrence of an existing reaction to immune activation. We wish there were some interest in researching the mechanism and preventing it. If this had been the first time this had happened, our son would likely have been admitted to hospital to test for anti-neuronal encephalitis or encephalitic reaction. The patient underwent lab tests and procedures which included encephalitis unknown results on an unspecified date. The patient was not enrolled in clinical trial. The outcome of the events neurotoxicity was recovering, neurotoxicity nos, distractedness, loss of appetite, overheating (stripping off, spending hours in cold bath) (feeling hot), compulsive behavior (obsessive-compulsive personality disorder) was unknown, retching, dizziness, irritability, encephalitis, rage, hunger, depression, tiredness, anxiety, coughing, mutism, aggression, insomnia, flushing, mood swings, was not recovered. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101161313 same patient same product different dosage and different event.


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