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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 266 out of 8,010

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VAERS ID: 1703623 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
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: Dermatitis allergic, Dizziness, Headache, Migraine, Nausea, Vaccination site erythema
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE; PARACETAMOL
Current Illness: Asthmatic; Multiple allergies
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslexia (Exma Dyslexic Had reaction to first vaccines as a new born)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dizzy; Nauseated; Headache; Raised read patch on skin appeared after 1st and second dose near the injection area"; Migraine; Allergic rash; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25906521) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash), MIGRAINE (Migraine), DIZZINESS (Dizzy), NAUSEA (Nauseated) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Dyslexia (Exma Dyslexic Had reaction to first vaccines as a new born). Concurrent medical conditions included Multiple allergies and Asthmatic. Concomitant products included CETIRIZINE HYDROCHLORIDE for Hay fever, PARACETAMOL for Pain. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant), NAUSEA (Nauseated) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and VACCINATION SITE ERYTHEMA (Raised read patch on skin appeared after 1st and second dose near the injection area"). At the time of the report, DERMATITIS ALLERGIC (Allergic rash) and MIGRAINE (Migraine) had not resolved, DIZZINESS (Dizzy), NAUSEA (Nauseated) and HEADACHE (Headache) had resolved and VACCINATION SITE ERYTHEMA (Raised read patch on skin appeared after 1st and second dose near the injection area") outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Antihistamines are the treatment medication reported by reporter Patient stated that she experienced raised read patch on skin appeared after 1st and second dose near the injection area. And lasted even after taking anti histamines. Severe headache/migraine occurred after 3 days after second dose. Feeling nauseated and dizzy Patient has not had symptoms associated with COVID-19, is not currently breastfeeding, has not tested positive for COVID-19 since having the vaccine and is not enrolled in clinical trial. Had reaction to first vaccines as a new born . 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1703629 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Illness, Migraine, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhea; Migraine; Stomach pain; Light-headed; Dizziness; Sickness; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25907528) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DIARRHEA (Diarrhea), MIGRAINE (Migraine), ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Light-headed), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 on 01-Sep-2021. Concomitant products included IBUPROFEN from 05-Sep-2021 to 06-Sep-2021 for Pain. On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced DIARRHEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness), DIARRHEA (Diarrhea), MIGRAINE (Migraine), ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Light-headed), DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1703636 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea, Pyrexia, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: fever; Tinnitus; Light headedness; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25909525) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), TINNITUS (Tinnitus), DIZZINESS (Light headedness) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (fever) (seriousness criterion medically significant). 05-Sep-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant), DIZZINESS (Light headedness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 06-Sep-2021, TINNITUS (Tinnitus), DIZZINESS (Light headedness) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Patient had the vaccine on 04 SEP 2021, the next day, patient had fever and muscle aches but also light headedness, nausea and tinnitus when she was trying to sleep. 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. No further information is expected. Event seriousness captured per Regulatory Authority reporting.; 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. No further information is expected. Event seriousness captured per regulatory authority reporting.


VAERS ID: 1704558 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood pressure fluctuation, Dizziness, Electrocardiogram normal, Fatigue, Heart rate, Tremor, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: ECG readings normal (taken 2 weeks after the first shot)
CDC Split Type:

Write-up: Each time started 3 days after the shot and lasted for 2 weeks. The second shot was easier. Increased rested heart rate from 70 to 90, jumping blood pressure, fatigue, heart palpitations (after the first dose), sometimes dizzines Random muscle shivers first in the arm, then in the chest area, then in stomach


VAERS ID: 1704937 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
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: Fatigue, Feeling abnormal, Hypokinesia, Malaise, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Feeling sick; whole arm was extremely sore; could not lift it; head was cloudy; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25908964) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever) and MALAISE (Feeling sick) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant). 06-Sep-2021, the patient experienced PAIN IN EXTREMITY (whole arm was extremely sore), HYPOKINESIA (could not lift it) and FEELING ABNORMAL (head was cloudy). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (whole arm was extremely sore), HYPOKINESIA (could not lift it) and FEELING ABNORMAL (head was cloudy) outcome was unknown, PYREXIA (Fever) was resolving and MALAISE (Feeling sick) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. The patient experienced painful injection site, whole arm was extremely sore, could not lift arm, head was very cloudy, shivery at hot. 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: 1704970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   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 FG1248 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Extra dose administered, Fatigue, Feeling cold, Headache, Influenza like illness, Myalgia, Off label use, Presyncope, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Medication errors (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101156132

Write-up: Administered with third dose of Pfizer COVID-19 vaccine; Administered with third dose of Pfizer COVID-19 vaccine; flu like symptoms; weakness; chills/shivering all over the body; muscle pain; cold feeling; vaccination site pain; severe headache; fever like feeling; fatigue/tired; almost fainted; This is a spontaneous report received from a contactable pharmacist (Pfizer colleague) reporting on himself. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FG1248, Expiration date: Nov2021), via an unspecified route of administration, administered in arm left on 04Sep2021 16:00 as dose 3, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. In the night after the vaccination on 05Sep2021 at around 02:00 ? 03:00, began to feel flu like symptoms: weakness, chills, shivering all over the body, muscle pain, cold feeling and vaccination site pain. On 05Sep2021 morning woke up with a severe headache, extreme fatigue, weakness, intermittent chills, fever like feeling (patient did not check her temperature), at one point she almost fainted and had to lie down on the floor until the feeling passed. Timeframe between vaccination and starting of symptoms was 1 day. At around 13:00 she took Acamol and another one at around 16:00. All events are considered as non serious events, related to the vaccine. On an unspecified date at around 16:00, the outcome of all the events was recovered and for mild headache, fatigue/tired and weakness was not recovered. No further information is available, no consent to contact for further information. No follow-up attempts are possible, information about batch /lot number cannot be obtained.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1705392 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
SMQs:, 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: 20210905; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: FIPFIZER INC202101154224

Write-up: Positive COVID 19 test result; mild symptoms like fever; This is a spontaneous report from a contactable consumer via company representative. A female patient of unspecified age had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 04Sep the patient had no symptoms but on 05Sep the patient had experienced fever and Covid-19 . The patient had been tested for COVID-19 Since the vaccination. On 05 sep2021 the patient underwent lab test and procedures which included COVID -19 test and diagnosed as having positive result. The Clinical outcome of the events were unknown . No follow-up attempts are possible. No further information is expected


VAERS ID: 1705574 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FF2153 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: GBPFIZER INC202101182468

Write-up: DVT of calf; This is a spontaneous report from a contactable consumer (patient) received from the . The regulatory authority report number is GB-MHRA-APPCOVID-20210909073745. Safety Report Unique Identifier GB-MHRA-ADR 25916165. A 27-year-old female patient received bnt162b2 (Pfizer- BioNTech COVID-19 VACCINE), via an unspecified route of administration on 05Sep2021, at the age of 27 years, (Batch/Lot Number: FF2153) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient experienced DVT of calf on 05Sep2021. Patient is currently having to take CLEXANE injections twice a day and waiting for a scan which will then decide what the next treatment is going to entail. The event is serious (medically significant, life threatening). The outcome for the event DVT of calf was not recovered. No follow-up attempts are possible No further information is expected.


VAERS ID: 1705783 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   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 FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101160959

Write-up: Muscle ache; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202109051556346980-STKSR with Safety Report Unique Identifier of GB-MHRA-ADR 25897190. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8087) via an unspecified route of administration on 04Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient did not have a COVID-19 test. On 05Sep2021, the patient experienced muscle ache and tiredness; reported as serious for being medically significant. The patient had not tested positive for COVID-19 since the vaccination. The clinical outcomes of the muscle ache and tiredness were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1708017 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Loss of consciousness; Poorly feeling; Vagal reflex; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP088215) on 06-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21125926). Loss of consciousness was assessed as serious by the Regulatory Authority. On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 05-Sep-2021, at 14:00, the patient received the 1st dose of the vaccine. At 14:35, about 3-4 minutes after the intramuscular injection, the patient complained of poorly feeling while waiting. About 10 seconds after that, the patient lost consciousness. At 14:38, the patient was placed at bed rest with leg elevation, and BP: 134/75, P: 59 bpm, SpO2: 98% (room), and E4VSH6. The patient was examined by a physician. The patient regained consciousness and became able to talk. At 14:45, BP: 119/74, P: 69 bpm, and SpO2: 97% (room). At 15:00, BP: 109/65, P: 67 bpm, SpO2: 97% (room). The patient drank 50-80 mL of water. At 15:15, BP: 106/90, P: 76 bpm, and SpO2: 98% (room). At 15:30, BP: 120/73, P: 72 bpm, and SpO2: 98% (room). The vital signs returned to normal. The patient walked home without help. The outcome of poorly feeling, loss of consciousness, and vagal reflex 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: Vagal reflex was suspected.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case involves a 20-year-old female subject with no known medical history who experienced the unlisted serious AE of loss of consciousness following the first administration of mRNA-1273. The SAE was assessed by the reporter as possibly related to the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1709728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   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 FG7387 / 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101194584

Write-up: Acute myocarditis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213372. A 16-year-old male patient received BNT162B2 (COMIRNATY; strength 0.3 ml), intramuscular on 02Sep2021 (Lot Number: FG7387, unknown expiration) as dose 2, 0.3ml, single for COVID-19 immunisation. Medical history included asthma. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY (lot number: FE8235) on 12Aug2021 for COVID-19 vaccination. The patient experienced acute myocarditis on 05Sep2021. The patient has not yet recovered from the event. The event was assessed as serious (hospitalization and life-threatening condition). Reporter''s comment: Report for a teenager. History of cardiovascular disease (ATCD) COVID-19: no. D1 COMIRNATY on 12Aug2021, lot: FE8235. D2 COMIRNATY on 02Sep2021, lot: FG7387. Onset of acute myocarditis 72 hours after the 2nd injection of COMIRNATY. Patient still hospitalized on 08Sep2021, no other information available. Reaction/event assessed: Acute myocarditis. Time interval between beginning of drug administration and start of reaction/event: 4 days. Time interval between last dose of drug and start of reaction/event: 4 days. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1709923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARIPIPRAZOLE; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism; Depression; Hypermobility syndrome; Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: Lateral flow test; Result Unstructured Data: Test Result:positive for covid-19
CDC Split Type: GBPFIZER INC202101160878

Write-up: SARS-CoV-2 infection/ COVID-19; Tiredness; Migraine; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109050959160370-QZ9NG with Safety Report Unique Identifier of GB-MHRA-ADR 25897003. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 28Aug2021 as a single dose for COVID-19 immunisation. Medical history included autism and hypermobility; depression which was diagnosed in 2018 (reported as three years ago), but was now taking meds. Patient reported that he has been undiagnosed and was said that it was not a depressive disorder. Medical history also included COVID-19 from an unspecified date (unsure when symptoms started) to 30Aug2021. The patient was not enrolled in clinical trial. Concomitant medications included aripiprazole (MANUFACTURER UNKNOWN) for depression from an unknown date and bisoprolol (MANUFACTURER UNKNOWN) for palpitations from an unknown date in Jun2021 and both unknown if ongoing. On 05Sep2021, the patient had SARS-CoV-2 infection/COVID-19. On an unknown date in 2021, the patient experienced tiredness and migraine. All the events were reported as serious for being medically significant. Patient reported that he has been self isolating. Patient had been having really bad migraine and it got worst. Patient took a lateral flow and it was positive for covid-19 on an unspecified date. On 05Sep2021, the patient underwent COVID-19 virus test and the result was positive (Yes - Positive COVID-19 test). The clinical outcome of the events tiredness and migraine were recovered on unspecified date in 2021, while the outcome of SARS-CoV-2 infection/ COVID-19 were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1715236 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SC

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Clot retraction normal, Fatigue, Musculoskeletal pain, Pyrexia, Ultrasound Doppler normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I have heart disease, I take VERAPAMIL 80mg, half in the morning and 1/4 of it at night. Also, 100mg Amiodarone in the morning for the thyroid I take Levothyroxine 100mg 3 times a week.
Current Illness: Supraventricular arrhythmia, awaiting ablation. Hypothyroidism in control.
Preexisting Conditions: Hypothyroidism; Cardiac disease
Allergies: No
Diagnostic Lab Data: Ultrasound Doppler, without any type of thrombosis. Totally normal clotting blood test.
CDC Split Type:

Write-up: With the first dose I had a lot of joint pain, temperature and exhaustion for the first 3 days. Second dose, fever and fatigue, after 5 days the pain in the ankle area of the right leg, after a few days it got worse, now the pain is very intense and it is up to the gluteus. It hurts to sit and lay down and walk.


VAERS ID: 1716792 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Initial insomnia, Insomnia, SARS-CoV-2 test
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161054

Write-up: cannot fall asleep; Insomnia; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-APPCOVID-202109060732599010-9ZGDH, Safety Report Unique Identifier GB-MHRA-ADR 25898260. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Sep2021 (at the age of 29-year-old) (Lot Number: FE3380) as single dose for COVID-19 immunisation. Medical history included fall. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced cannot fall asleep (medically significant) on an unspecified date, insomnia (medically significant) on 05Sep2021, suspected covid-19 from 06Sep2021 and ongoing. Clinical course: Cannot fall asleep easily or stay asleep for long periods. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on 06Sep2021. The outcome of the event insomnia was not recovered, of the other event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716793 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Middle insomnia, Migraine, Pain of skin, Pyrexia, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Chills; Migraine; Pain; Sleep disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168383

Write-up: Joint pain; Skin tenderness; Migraine; High temperature; Lymph nodes enlarged; Swelling; felt tired; Chills; had a good nights sleep; Rolling onto the injected arm which caused pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-202109060903084340-PSQA6, Safety Report Unique Identifier GB-MHRA-ADR 25898705. A 26-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 05Sep2021 10:30 (Batch/Lot Number: FF2153) (at the age of 26-year-old) as single dose for COVID-19 immunization. Medical history included asthma, migraine, chills, sleep disorder and pain, all from an unknown date and unknown if ongoing. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) and salbutamol sulfate (VENTOLIN), both taken for asthma from 01Sep2018. The patient has not had symptoms associated with COVID-19, she had not a COVID-19 test, she was not pregnant and was not currently breastfeeding. On 05Sep2021 around 18:00 the patient felt tired, she had a nap and woke up with the chills. She could not get warm at all however her partner was a comfortable temperature next to her in T-shirt and shorts. She had a good nights sleep, waking a few times due to being too warm and also rolling onto the injected arm which caused pain. She woke up the next morning and skin was very tender and painful to get dressed, even drying her hands and face with a towel was sore. Migraine developed and temperature kept coming and going so she would attempt to sleep it off. On 06Sep2021 she also experienced lymph nodes enlarged and swelling. The outcome of the event "felt tired" was unknown, the events chills, skin tenderness and migraine resolved on 06Sep2021 and the other reported events had not resolved yet at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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: GBPFIZER INC202101168559

Write-up: Serious dead arm, fever; Serious dead arm, fever; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-EYC 00259879, and Safety Report Unique Identifier is GB-MHRA-ADR 25897063 A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number was not reported), dose 1 via parenteral on 04Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced serious dead arm and fever (medically significant). The outcome of both 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: 1716841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Menstrual disorder, Polymenorrhoea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood; Cramp
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101160918

Write-up: Vaginal bleeding/ bright red bleeding from vagina with blood clots; Early for regular period; Cramping in stomach; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109050920405520-ZIH7D with Safety Report Unique Identifier GB-MHRA-ADR 25896987. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Sep2021 at 14:30 as dose 2, single for COVID-19 immunisation. Medical history included clot blood and cramp. The patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. The patient did not have a COVID-19 test. Patient was not pregnant and not breastfeeding at the time of this report. Concomitant medications were not reported. On 05Sep2021 at 08:00, the patient experienced vaginal bleeding. The clinical course was reported as follows: had vaccine at 2.30pm yesterday (04Sep2021). Woken this morning (05Sep2021) at 8am with cramping in stomach. Went to toilet and noticed bright red bleeding from vagina with blood clots. Early for regular period. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as serious (medically significant). The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event vaginal bleeding/ bright red bleeding from vagina with blood clots was not resolved while unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716865 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101160965

Write-up: Palpitations; Headache dull; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109051640044190-S3JCE with Safety Report Unique Identifier GB-MHRA-ADR 25897206. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/Lot Number: not known), via an unspecified route of administration on 04Sep2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 05Sep2021, the patient experienced palpitations, headache dull and tiredness; all the events were reported as serious for hospitalization and for being medically significant. Patient has not tested positive for COVID-19 since having the vaccine. It was reported that the patient''s relevant investigations or tests were ongoing. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The clinical outcome of the events palpitations and tiredness were not recovered; outcome of event headache dull was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210830; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161023

Write-up: Fatigue; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202109051659098470-WDZPG; Safety Report Unique Identifier: GB-MHRA-ADR 25897214. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Sep2021 (Batch/Lot Number: Not known; Expiry date: Not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced fatigue and nausea on 05Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 30Aug2021. Patient had not recovered from both events. The events were assessed as serious medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716913 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Faeces pale, Feeling cold, Feeling hot, Headache, Loss of consciousness, Nausea, SARS-CoV-2 test
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), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to grains; Allergy to nuts; Anaphylactic reaction; Asthma; Cold; Eczema; Fish allergy; Nausea
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161117

Write-up: nauseous; feeling hot; Blackout; feeling cold; she lost the colour in her face; head hurting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109052213450730-XRIB2. Safety Report Unique Identifier GB-MHRA-ADR 25897470. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 17-years, on 05Sep2021 (Lot Number: FE8087) as dose 1, single for COVID-19 immunisation. Medical history included that the patient had allergy to nuts, seeds and fish which can cause an anaphylactic reaction. She also had mild eczema and asthma. And nausea and cold. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced nauseous, feeling hot and blackout on 05Sep2021. Events was reported as serious as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test on an unspecified date: No - Negative COVID-19 test. The outcome of event blackout was recovered on 05Sep2021; of remains events was unknown. The clinical course was reported as follows: A few minutes after having the jab, she complained of feeling hot and cold. Ten minutes after having the jab, she lost the colour in her face and complained of her head hurting and feeling nauseous. She then blacked out for a few minutes. The nurses brought her round, gave her some water and laid her down for 30 minutes. She was fine after that. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Diarrhea
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101161058

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109060035040530-T33RV, Safety Report Unique Identifier GB-MHRA-ADR 25897508 A male patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date (Lot Number: fe3380) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included the first dose of BNT162B2 on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included diarrhea. Patient had not symptoms associated with COVID-19 or had not a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced diarrhea (Since having the vaccine yesterday patient had repeated diarrhea 8 times today. Patient knew the food he had eaten was safe as he had consumed exactly what his family had for a week and none of them have any side effects) on 05Sep2021. Event was reported as serious as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Event outcome was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716955 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168525

Write-up: Muscle pain; Nauseous; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109060851386540-QCXTW. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25898508 A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Sep2021 (at the age of 37-years-old) as dose 2, single for covid-19 immunization. The Patient was not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On 05Sep2021 the patient experienced muscle pain, nauseous. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1716961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Diarrhoea, Generalised tonic-clonic seizure, Inappropriate schedule of product administration, Insomnia, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA XR; PARACETAMOL; TEGRETOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Grand mal seizure; Headache
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168500

Write-up: loss of sleep; grand mal seizure (lack of sleep was a known trigger for me); grand mal seizure (lack of sleep was a known trigger for me); Dose 1: 07Jul2021 Dose 2: 04Sep2021 Inappropriate schedule of vaccination administered; Diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109061017547690-HTVKA. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FE3380) via an unspecified route of administration on 04Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FE3380) via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included generalised tonic-clonic seizure, epilepsy and headache from an unknown date and unknown if ongoing. Patient had not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Concomitant medications included levetiracetam (KEPPRA XR) for epilepsy, paracetamol for headache and carbamazepine (TEGRETOL) for epilepsy start and stop date were not reported. On 05Sep2021, the patient experienced diarrhea and inappropriate schedule of vaccination administered. She was taking keppra and tegretol for epilepsy. On an unspecified date, she had grand mal seizure (lack of sleep was a known trigger for me), the side effect she was reporting caused loss of sleep which in turn caused a grand mal seizure (lack of sleep was a known trigger for me). The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date (No-Negative COVID-19 test). This case was classified as serious (medically significant). The outcome of the events was recovered on 06Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716970 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN [SERTRALINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168503

Write-up: Fever; Ache; Flu; Shivers; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109061144487210-0FJUB, Safety Report Unique Identifier GB-MHRA-ADR 25899635. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 05Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation (at the age of 24 years). Medical history included immunodeficiency from an unknown date and unknown if ongoing Has an illness or condition, not listed above, which reduces the immune response (eg. immunodef), anxiety from an unknown date and unknown if ongoing. The patient previously received BNT162B2, dose 1 on an unspecified date for COVID-19 immunisation. Concomitant medication included sertraline (SERTRALIN [SERTRALINE]) taken for anxiety, start and stop date were not reported. Patient was not enrolled in clinical trial. The patient experienced flu on 05Sep2021, shivers on 05Sep2021, fever on an unspecified date, ache on an unspecified date. All events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1716988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168273

Write-up: headache/ headache fullness/ headache worsens upon standing; Red rash; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109061520189660-GH6VY with Safety Report Unique Identifier of GB-MHRA-ADR 25900933. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 04Sep2021 as a single dose for COVID-19 immunisation. Medical history included headache. The patient did not have symptoms associated with COVID-19. The patient was not pregnant and was not breastfeeding at the time of the report. The patient was not enrolled in the clinical trial. Concomitant medications were not reported. On 05Sep2021, 1 day after vaccination, the patient experienced headache/ headache fullness/ headache worsens upon standing and red rash; all reported as serious for being medically significant. On 06Sep2021, the patient underwent a COVID-19 virus test and the result was negative. The clinical outcome of the events headache/ headache fullness/ headache worsens upon standing and the red rash was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1716998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Dysmenorrhoea, Frequent bowel movements, Heavy menstrual bleeding, Limb discomfort, Pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Clot blood; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168254

Write-up: Painful periods; Lots of period blood clots which was very unusual; unusually bloated; 5 small bowel movements; pain; feeling heavy/Heavy feeling in arms & legs; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109061737329110-M7QAS with Safety Report Unique Identifier of GB-MHRA-ADR 25901828. A 37-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 22Aug2021, as a single dose for COVID-19 immunisation. Medical history included clot blood and pain. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and not breastfeeding at the time of this report. The patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced pain, feeling heavy on an unspecified date in 2021, painful periods on 05Sep2021. The events pain, feeling heavy and painful periods were reported as medically significant. Lots of period blood clots which was very unusual in 2021. The pain was similar to her first ever period and never had period pains since. Patient also unusually bloated and feeling heavy since her period started which was very unusual. This can happen pre-menstruation but had never happened during. She had 5 small bowel movements on the second day of her period in 2021, again this had never happened before. The clinical outcome of the events pain, feeling heavy, painful periods were recovering. The clinical outcome of the events lots of period blood clots which was very unusual, unusually bloated and 5 small bowel movements were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1717027 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, Muscle tightness
SMQs:, Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168461

Write-up: Muscle spasm; neck felt extremely ''tight''; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109070732462330-NVXJX Safety Report Unique Identifier GB-MHRA-ADR 25904919. A 31-year-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 03Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. On 05Sep2021, the patient experienced neck felt extremely ''tight''. On 07Sep2021 the patient experienced muscle spasm. Both the events were assessed as medically significant. It was reported that on both occasions of receiving the vaccine, 2 days after receipt his neck felt extremely ''tight''. Then last night (3rd day) his neck went in to spasm which was extremely painful and uncomfortable. He suspected it will subside in a few days as before. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of muscle spasm was not recovered, neck felt extremely ''tight'' was unknown. No follow-up attempts are possible, Information about lot/batch number can not be obtained. No further information is expected.


VAERS ID: 1717028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tooth pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test (COVID lateral flow); Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168287

Write-up: Fever, High temperature; Fatigue; Body ache; Loss of energy; Painful arm; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority; report number GB-MHRA-WEBCOVID-202109070734348160-ODMYO, Safety Report Unique Identifier GB-MHRA-ADR 25904999. A male patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8087) via an unspecified route of administration on 05Sep2021 as a single dose for COVID-19 immunisation. Medical history included tooth pain from an unknown date and unknown if ongoing. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications included paracetamol (MANUFACTURER UNKNOWN) taken for tooth pain from 05Aug2021 to 25Aug2021. On 05Sep2021, approximately 10 hours after vaccination, the patient experienced painful arm; on 06Sep2021, the patient experienced fever, fatigue, loss of energy and body ache. The clinical course was reported as follows: it was reported that the patient''s painful arm began approximately 10 hours after the vaccine was administered. The events fever, body ache, and fatigue all were started around 24 hours and lasted for approximately 24 hours, this was severe enough that the patient was confined to bed for six hours at the height of the fever. On an unknown date, the patient underwent COVID-19 virus test (COVID lateral flow) and the result was negative. The clinical outcome of the events painful arm was resolving (also reported with a stop date of 07Sep2021, 2 days duration), of the other events was resolving. The events painful arm, fever, fatigue, fever and loss of energy were reported as serious for being medically significant. No follow-up attempts are needed. No further information is expected


VAERS ID: 1717032 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Pain, Presyncope
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypermobility syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176199

Write-up: Numbness; Near fainting; pain; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is the [first] of [2] reports. The first report is a report downloaded from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109070933130820-ULNPQ, Safety Report Unique Identifier GB-MHRA-ADR 25905572. A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 05Sep2021 (at the age of 22-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypermobility syndrome (diagnosed as a child) from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding. The patient concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 26May2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced Joint pain. Patient stated pain started whenever she stood up and got so intense, she was almost passing out when she stands. Numbness was from her elbow to halfway across her back and chest including her boob. It gradually decreased the affected area when she took painkillers. On 05Sep2021, the patient experienced numbness, near fainting. Therapeutic measures were taken as a result of numbness. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of event numbness was recovering, event near fainting was not recovered, while event pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101182836 Same patient/drug and different dose/event


VAERS ID: 1717034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176230

Write-up: Pain in fingers; Back pain; Joint pain; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071013426770-H3EKR, Safety Report Unique Identifier is GB-MHRA-ADR 25905768. A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date was not reported) via an unspecified route of administration on 04Sep2021 as dose 2 single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Not known) via an unspecified route of administration on unspecified date dose 1 single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 05Sep2021 (after 1 day of vaccination), patient experienced pain in finger, back pain and joint pain. events reported as medically significant. The outcome of events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1717040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Circulatory collapse, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging, Myocarditis, SARS-CoV-2 test, Troponin increased
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:CT Aorta NAD, coronaries as seen on CT Aorta look; Comments: CT Aorta NAD, coronaries as seen on CT Aorta look OK (non-gated); Test Name: ECG; Result Unstructured Data: Test Result:non-diagnostic; Comments: non-diagnostic; Test Name: MRI; Result Unstructured Data: Test Result:unknown; Comments: unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: troponin rise; Result Unstructured Data: Test Result:rise to 70s; Comments: rise to 70s
CDC Split Type: GBPFIZER INC202101176194

Write-up: chest pain; collapse; Ongoing atypical left chest pain; Myocarditis; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109071057351390-G2CGF. Safety Report Unique Identifier GB-MHRA-ADR 25906081. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date 2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced chest pain, ongoing atypical left chest pain and collapse on an unspecified date with outcome of unknown. On 05Sep2021, the patient experienced myocarditis. About 7 weeks since second COVID vaccine. Presents with collapse and chest pain with troponin rise to 70s. Working diagnosis of myocarditis. On an unspecified dated, the patient lab test included computerised tomogram (CT): CT Aorta NAD, coronaries as seen on CT Aorta look OK (non-gated), magnetic resonance imaging (MRI): unknown, electrocardiogram (ECG): non-diagnostic, COVID-19 virus test was no - negative COVID-19 test, troponin increased was rise to 70s. The patient reported that no possible blood clots or low platelet counts. Since vaccination, the patient was not tested with COVID-19. The patient started on colchicine and betablocker for the events. The outcome of the event myocarditis was resolving. The outcome of the events chest pain and collapse was unknown. The outcome of the event ongoing atypical left chest pain was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176253

Write-up: Tachycardia; Chest ache; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109072306047600-PGXFJ. Safety Report Unique Identifier GB-MHRA-ADR 25909811. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunization. Patient previously received the first dose of BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient medical history and concomitant medications were not reported. The patient experienced chest ache on 05Sep2021 and tachycardia on 06Sep2021. Unusual chest ache/pain which could not be explained. Decided to delay exercise activities as a result. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event chest ache was recovering, and the event tachycardia was recovered on 07Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717072 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Electrocardiogram, Fatigue, Lethargy, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result: Unknown; Test Name: ECG; Result Unstructured Data: Test Result: Unknown; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176189

Write-up: lethargy; fatigue; stomach cramps; Terrible diarrhoea; Racing heart; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109080704585000-JSRRN, Safety Report Unique Identifier GB-MHRA-ADR 25910313. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Sep2021 as (at the age of 16-year-old) dose 1, single for COVID-19 immunization. Medical history included suspected COVID-19 from 17Mar2020 to 21Mar2020, pyrexia. Concomitant medication(s) included paracetamol (MANUFACTURER UNKNOWN) taken for pyrexia from 05Sep2021 to an unspecified stop date. The Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. On an unspecified date the patient experienced lethargy, fatigue, stomach cramps, terrible diarrhea, racing heart. On 05Sep2021 the patient experienced Fevers up to 39. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included blood test: unknown on unspecified date, electrocardiogram: unknown on unspecified date, sars-cov-2 test: negative on unspecified date. The outcome of the events Fever was recovering and lethargy, fatigue, stomach cramps was not recovered, Terrible diarrhea, Racing heart was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1717405 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Body temperature, Fall, Heart rate, Heart rate decreased, Loss of consciousness, PO2
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/59; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: pulse; Result Unstructured Data: Test Result:59; Comments: times/min; Test Date: 20210905; Test Name: PaO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101162152

Write-up: It was considered to be an Anaphylactic shock.; Loss of consciousness; fell down; pulse 59 times/ minute; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125917. A 27-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 05Sep2021 at 13:20 (Lot Number: FF2782; Expiration Date: 30Nov2021) at the age of 27-year-old as single dose for COVID-19 immunization. Medical history was none. Body temperature before vaccination was 36.8 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication was not reported. The clinical course was as follows: On 05Sep2021 at 13:29 (the day of vaccination), the patient experienced Loss of consciousness and fell down. Blood pressure 120/59, pulse 59 times/ minute, PaO2 97%. After infusion of saline, Adrenaline 0.5 ml was injected intramuscularly. The patient was transported to hospital in emergency. The events resulted in emergency room visit. The event of heart rate decreased was unknown. The outcome of other events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered to be an Anaphylactic shock. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717406 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Contusion, Heart rate, Heart rate decreased, Loss of consciousness, Mouth haemorrhage, Oxygen saturation, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result: 117/43; Comments: at 11:15; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result: 121/66; Comments: at 11:52; Test Date: 20210905; Test Name: P; Result Unstructured Data: Test Result: 48; Comments: at 11:15; Test Date: 20210905; Test Name: P; Result Unstructured Data: Test Result: 40; Comments: at 11:52; Test Date: 20210905; Test Name: spo2; Test Result: 98 %; Comments: at 11:15; Test Date: 20210905; Test Name: spo2; Test Result: 100 %; Comments: at 11:52
CDC Split Type: JPPFIZER INC202101162161

Write-up: Loss of consciousness; Transient Convulsion; BP 117/43; There was Contusion in Left forehead; small amount of Mouth haemorrhage; P48/P40; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the Devices Agency (DA). Regulatory authority report number is v21125919. A 17-year-old male patient received first dose of BNT162B2 (Pfizer), via an unspecified route of administration on 05Sep2021 11:09 (Lot Number: FF2782; Expiration Date: 30Nov2021, at the age of 17-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Sep2021 at 11:15 (the day of vaccination), the patient experienced loss of consciousness, transient convulsion, blood pressure (BP) 117/43, there was contusion in left forehead, small amount of mouth haemorrhage and pulse rate (P)48/P40. The course of the event was as follows: At 11:15 after inoculation, the patient experienced loss of consciousness and transient convulsion. BP 117/43, P48, SPO2 98%. There was contusion in left forehead, small amount of mouth haemorrhage. At 11:52, BP 121/66, SPO2 100%, P40, and the patient was transported to hospital. The outcome of the events was unknown. The reporting other HCP classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717407 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:dropped to 49/19 mmHg; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:recovered to 112/60 mmHg; Comments: After the treatment; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101162165

Write-up: Anaphylactic shock; Anaphylaxis; Blood pressure dropped to 49/19 mmHg; the patient had obviouse Giddiness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125950. The patient was a 27-year and 2-month-old female(age at vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Sep2021 at 11:50 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose at the age of 27-year-old for COVID-19 immunization. On 05Sep2021 at 11:59 (the day of vaccination), the patient experienced Anaphylaxis. On 05Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: Anaphylactic shock.Blood pressure dropped to 49/19 mmHg and the patient had obviouse Giddiness.BOSMIN 0.5mg Subcutaneous injection and Solu-Cortef 100mg Intramuscular injection and SOLDEM 3 infusion 500 ml were performed.After the treatment, the blood pressure recovered to 112/60 mmHg and the patient returned home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717415 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Erythema, Heart rate, Oxygen saturation, Paraesthesia, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (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: Medical History/Concurrent Conditions: Shellfish allergy (allergy to crabs, redness, was allergy to shrimps for the second time, redness.)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:169/106 mmHg; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:138/91s mmHg; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20210905; Test Name: P; Result Unstructured Data: Test Result:69; Test Date: 20210905; Test Name: P; Result Unstructured Data: Test Result:61; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Test Date: 20210905; Test Name: SpO2; Test Result: 100 %
CDC Split Type: JPPFIZER INC202101162333

Write-up: BP 169/106; Redness of wrist and hand back; Itching both hands; Tingling sensation of eye; Rash; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125920.The patient was a 49-year and 4-month-old female. (age at first dose of vaccination) Body temperature before vaccination was 36.3 centigrade. The patient had no family history. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: allergy to crabs in the first grade of middle school, redness, was allergy to shrimps for the second time, redness. And have not eaten them since then.On 05Sep2021 at 12:35 (the day of vaccination), the patient received the first dose of bnt162b2 (comirnaty, solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration at the age of 49-year-old as a single dose for COVID-19 immunization.The adverse event onset date was reported as on 05Sep2021 at 12:50(the day of the vaccination).On 05Sep2021 (the day of the vaccination), the outcome of the event was recovering.The course of the event was as follows: After inject the comirnaty (15 min), the patient felt Redness of wrist and hand back, Itching both hands, and bed rest Induction. BP: 169/106, P: 69, SpO2:99%.Pharynx strange sensation of(-), Abdominal pain(-), Dyspnoea(-). Itching and rash disappeared.The patient felt Tingling sensation of eyes, continue Keep lying in bed quietly. At 13:50(After 1hour), BP: 138/91, P: 61, SpO2:100%, Tingling sensation of eyes disappeared. After getting fluid infusion, the patient returned home.The reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not provided. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717418 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101162762

Write-up: it looked like internal haemorrhage along the bandage and on the upper part of the bandage.; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received dose 2 of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 03Sep2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the second dose on 03Sep2021, Friday evening. The patient did not take off bandage until the second day. When the patient looked at the arm on Sunday (05Sep2021), it looked like internal haemorrhage along the bandage and on the upper part of the bandage. But not on the part under the bandage where the patient was injected. When the patient asked the hospital about it, they said it could happen. The outcome of internal hemorrhage along the bandage was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717442 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram head, Epilepsy, Generalised tonic-clonic seizure, Insomnia, Magnetic resonance imaging, Polymicrogyria, Stertor
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 202109; Test Name: brain CT; Result Unstructured Data: Test Result:unknown results; Test Date: 202109; Test Name: MRI; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202101169713

Write-up: generalised tonic-clonic seizure; Polymicrogyria; Epilepsy; a breathing like a stertor; lack of sleep; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126038. A 41-year and 0-month-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration on 05Sep2021 14:00, at 41 years of age, (Batch/Lot Number: FF9942; Expiration Date: 30Nov2021) as single dose for COVID-19 immunization. Medical history was none: there were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s family history was reported as unknown. The patient''s concomitant medications were not reported. On 05Sep2021 14:12 (12 minutes after the vaccination) Generalized tonic clonic seizure (GTC) started with adverse seizure toward left. There was a breathing like a stertor, started with the left-facing repulsion work, and the eyeball was initially gazing to the left, and then there was no laterality of the upper limbs. There was a lack of sleep, the symptom developed when watching the smartphone, intervals were made at about the time, two times of seizure were noted, and it was diagnosed as epilepsy. It was inferred as the cause of the suspect Polymicrogyria. The patient was admitted to the hospital on the same day and Brain CT and MRI were carried out. Body temperature before vaccination was 36.1 degrees Centigrade. As of 06Sep2021 the reported events were resolving The patient was discharged from hospital on 06Sep2021. The reporting physician classified the event as serious (hospitalized from 05Sep2021 to 06Sep2021) and assessed the causality between the events and bnt162b2 as unassessable. Other possible cause of the events such as any other diseases was Polymicrogyria.


VAERS ID: 1717443 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
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, Erythema, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:180/92 mmHg; Comments: at 11:23; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:188/103 mmHg; Comments: at 11:44; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 97 %; Comments: at 11:23; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 98 %; Comments: at 11:44
CDC Split Type: JPPFIZER INC202101169775

Write-up: redness appeared on the right forearm; BP 180/92; This is a spontaneous report from a contactable other HCP received from the Regulatory authority report number is v21126042. A 53-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration, on 05Sep2021 (Lot number FF2782, Expiration date 30Nov2021), at the age of 53 years old, as first single dose, for COVID-19 immunization. The patient''s medical history included hypertension and hyperlipidaemia. The patient had never had any severe allergic reactions or anaphylaxis. The patient was not pregnant or breastfeeding. The patient had not received any other vaccines in two weeks prior to the BNT162b2 vaccination. The patient''s concomitant drugs were not provided. On 05Sep2021, at 11:23 (the day of vaccination), redness appeared on the right forearm. There was no feeling hot nor itching. SpO2 was 97% and blood pressure (BP) was 180/92 mmHg. The symptoms were reported to the doctor and starting from 11:24 the patient was told to standby for 15 minutes. At 11:44, the physician''s visit showed SpO2 at 98%, and BP at 188/103 mmHg. It was the ordinary state. The patient said that she could consult with her primary physician if something happened to her, and she went home. There was no staggering. The reported events were blood pressure increase and redness, both non-serious per reporter. The outcome of the events was not provided.


VAERS ID: 1717479 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Depression; Mechanical urticaria (Mechanical urticaria); Vascular malformation cerebral (Cerebral artery malformation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Vagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP082108) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This case, initially reported to the Regulatory Authority by a pharmacist, was received via the Regulatory Authority(Ref, v21125934). On 05-Sep-2021, at 11:15, the patient received the 1st dose of the vaccine. At 11:20, the patient complained of dimmed vision and feeling of growing pallor. The patient was transported to the emergency outpatient department. The patient was diagnosed with vagal reflex, and the symptoms improved only with follow-up. The patient returned home. The outcome of vagal reflex was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This case concerns a 44-year-old, female patient with no relevant medical history who experienced the unexpected event of presyncope (vagal reaction). The event occurred on the same day, five minutes after the administration of the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1717483 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Presyncope; This case was received via Pharmaceuticals (Reference number: 2021TJP087654) on 06-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This case was reported by a physician via a medical representative. Presyncope was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 05-Sep-2021, at 09:26, the patient received the 1st dose of this vaccine. At 09:37, the patient complained of presyncope. Blood pressure 119/66 mmHg, pulse rate 57, and SPO2 96%. The patient recovered consciousness after resting in bed and was instructed to return home. Blood pressure 117/59 mmHg, pulse rate 66, and SPO2 97%. The outcome of presyncope was reported as recovered. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported; Sender''s Comments: This case involves a 17-year-old female subject with an unknown medical history who experienced the unlisted serious adverse event of consciousness decreased on the day of her first vaccination with mRNA-1273. The event is considered related per the reporter?s assessment.. Because of the temporal association of the SAE with the administration of the drug, a causal relationship cannot be excluded. The benefit risk relationship of mRNA-1273 is not impacted by this report.


VAERS ID: 1717490 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Loss of consciousness; Vasovagal reaction; This case was received Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP091218) on 07-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 17-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reaction). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reaction) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reaction) to be possibly related. No concomitant medications were reported. No treatment information was provided. This case concerns a 17 year old female who experienced the unlisted events of Loss of consciousness and presyncope immediately after the first dose of Moderna COVID-19 vaccine. No re-challenge was done and the events resolved within the hour. The causality of the event of Loss of consciousness was reported as Possible. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 17 year old female who experienced the unlisted events of Loss of consciousness and presyncope immediately after the first dose of Moderna COVID-19 vaccine. No re-challenge was done and the events resolved within the hour. The causality of the event of Loss of consciousness was reported as Possible. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1718585 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cough, Dizziness, Headache, Hypertension, Palpitations, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure (underwent a heart transplant in 2020 due to progressing CHF); CVA (had a procedure to evacuate a parietal haematoma in the brain due to a CVA); Dilated cardiomyopathy; Heart transplant (underwent a heart transplant in 2020 due to progressing CHF); Pacemaker insertion (cardiac); Subdural hematoma (had a procedure to evacuate a parietal haematoma in the brain due to a CVA)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:163/84
CDC Split Type: AUPFIZER INC202101162253

Write-up: cough and a fair amount of mucus; BP at 163/84 which was considered to be high; nearly collapsed; heart racing; headache; was feeling quite dizzy; This is a spontaneous report from a contactable consumer received via a Pfizer colleague. A 57-year-old male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 04Sep2021 (Batch/Lot number and expiration date were not reported) at age of 57 years old as a single dose for covid-19 immunisation. Medical history included dilated cardiomyopathy, pacemaker inserted, underwent a heart transplant in 2020 due to progressing CHF, had a procedure to evacuate a parietal haematoma in the brain due to a CVA. The patient''s concomitant medications were not reported. The patient experienced BP at 163/84 which was considered to be high, nearly collapsed, heart racing, headache, was feeling quite dizzy, all on 05Sep2021 02:00, cough and a fair amount of mucus on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: 163/84 on 05Sep2021. The outcome of cough and a fair amount of mucus was not recovered, the rest events was unknown. The events '' BP at 163/84 which was considered to be high, nearly collapsed, heart racing, headache, was feeling quite dizzy'' were resulted in emergency room visit. Clinical course: after receiving the 1st dose of the Comirnaty vaccine on 04 Sept 2021, he awoke on 05 Sept 2021 at approx. 2am and describes having "heart racing, headache, was feeling quite dizzy and nearly collapsed". He measured his BP at 163/84 which was considered to be high based on pre-existing conditions. He rang an ambulance and was subsequently presented to ER (it was unclear as to whether he was admitted as an inpatient or was seen only through ER. Medical history includes: dilated cardiomyopathy and subsequently had a pacemaker inserted (dates unknown). The reporter states that he underwent a heart transplant in 2020 due to progressing CHF. Had also had a procedure to evacuate a parietal haematoma in the brain due to a CVA (no dates provided). The reporter stated that as of today he was still experiencing a "cough and a fair amount of mucus". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1718605 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOMED [DEXPANTHENOL]; COVERSYL; SYMBICORT
Current Illness:
Preexisting Conditions: Comments: not a smoker, no excessive alcohol consumption, suffers from chronic bronchitis, suffers from reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210936184

Write-up: PULMONARY EMBOLISM; FEELING UNWELL; This spontaneous report received from a consumer via a Regulatory Authority (BE-FAMHP-DHH-N2021-106479) on 17-SEP-2021 and concerned a 52 year old male of unspecified race and ethnic origin. The patient''s weight was 115 kilograms, and height was 179 centimeters. The patient''s pre-existing medical conditions included: not a smoker, no excessive alcohol consumption, suffers from chronic bronchitis, suffers from reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: xd 955 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAY-2021 for covid-19 immunisation. Concomitant medications included budesonide/formoterol fumarate, dexpanthenol, and perindopril. On 05-SEP-2021, the patient experienced pulmonary embolism and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, and feeling unwell. This report was serious (Life Threatening).; Reporter''s Comments: Unknown Evolution of the ADR- Recovering Situations - Other: no idea. Examinations - Blood test have been done, bowel movement test, ultrasounds of legs and heart, CT scan, EKGs....ADR description - Dear, I was admitted to the hospital last Sunday night on 15-Sep with pulmonary embolisms in both lungs. Test have shown that there is no concrete cause but the number of cases with pulmonary embolism here in the hospital is ten times higher than normal. In addition, six people have been admitted here alone this week who have also been fully vaccinated for more than three months and also have embolisms. At the request of the treating physician, I am therefore creating this report.


VAERS ID: 1720653 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dysmenorrhoea, Heavy menstrual bleeding, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEFENAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bleeding; Cramps; Menstrual cramp; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168310

Write-up: severe period bleeding; pain; Menstrual cramps/Severe period cramps; Menstrual cramps/Severe period cramps; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-202109052141248010-XGRJI and Safety Report Unique Identifier GB-MHRA-ADR 25903342. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Aug2021 (Batch/Lot number: Unknown) as dose 1, single for COVID-19 immunization. Medical history included bleeding, cramps, pain and menstrual cramps. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included mefenamic acid menstrual cramps from 06Jun2021 to 06Sep2021. On 05Sep2021, the patient received menstrual cramps/severe period cramps. On an unspecified date, the patient experienced severe period bleeding and pain. The clinical course was reported as follows: Severe period cramps and bleeding at the end of cycle which has never happened before. Pain suddenly came on a day after no bleeding. Lasted about 90 mins at an intense rate and then died down with some tablets (pain killers). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the events menstrual cramps/severe period cramps was recovered on 06Sep2021; outcome for the event severe period bleeding was unknown; outcome for pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720736 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101168221

Write-up: Joint pain; Headache dull; Chills; Ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109061601552110-CWDKD with Safety Report Unique Identifier GB-MHRA-ADR 25901131. A 28-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Sep2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 12Jul2021 (not ongoing) and was unsure when the symptoms stopped. On an unknown date, the patient underwent a COVID-19 test and the result was positive. The patient was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications included desogestrel (CERELLE) taken for birth control from an unknown date and unknown if ongoing. On 05Sep2021 the patient experienced ache; on 06Sep2021 joint pain, headache dull and chills; all were reported as serious for being medically significant. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the events ache, joint pain, headache dull and chills were not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Chills, Delirium, Headache, Hyperacusis, Limb discomfort, Mobility decreased, Nausea, Pain in extremity, Photophobia, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: High temperature; Result Unstructured Data: Test Result:High; Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168436

Write-up: arm is currently not usable; Couldn''t bear sounds; Arm is currently not usable, heavy and aching; Arm is currently not usable, heavy and aching; Arm is currently not usable, heavy and aching; Fever; High temperature; Shivering; Headache; Light sensitivity to eye; Nausea; Delirium; Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109062143119020-JHETB, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25903459. A 24-year-old female non pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not reported) dose 2 via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced arm currently not usable, heavy and aching, couldnt bear sounds. On 05Sep2021, the patient experienced fever, high temperature, shivering, headache, light sensitivity to eye, nausea, delirium and armpit pain. Case narrative as reported: Really poorly. Spent a day and a half in bed, couldn''t bear sounds or light. Arm is currently not usable, heavy and aching. On 01Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, on 05Sep2021, body temperature: high. The outcome of Arm currently not usable was not recovered. The outcome of heavy and aching arm, couldnt bear sounds was unknown.The outcome of other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720754 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Movement disorder, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168297

Write-up: headache; sore arm; cant move arm; Swollen lymph nodes; Fatigue; Pain injection site; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109070738450340-EPMZF, Safety Report Unique Identifier number is GB-MHRA-ADR 25905000. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 05Sep2021 (age at vaccination was 23 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced headache on an unspecified date with outcome of unknown, sore arm on an unspecified date with outcome of unknown, cant move arm on an unspecified date with outcome of unknown, swollen lymph nodes on 06Sep2021 with outcome of not recovered, fatigue on 05Sep2021 with outcome of recovering, pain injection site on 05Sep2021 with outcome of recovering, and fever on 05Sep2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Case Narrative: Headache and sore arm hit me first and then fatigue and fever for whole day and then now my lymph nodes are swollen in armpit and cant move my arm. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1720765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176050

Write-up: Migraine; Blurry vision; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202109071841175540-3HFML with Safety Report Unique Identifier GB-MHRA-ADR 25908246. A 28-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and not breast feeding at the time of this report. The patient had no symptoms associated with COVID-19, and was not enrolled in the clinical trial. The patient did not undergo a COVID-19 test. Concomitant medications were not reported. On 05Sep2021, the patient experienced migraine and blurry vision; both were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event migraine was not resolved; while that of blurry vision was resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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: PROPRANOLOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101182474

Write-up: Breathlessness; Vaginal bleeding; This is a spontaneous report from a contactable consumer or other non HCP received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109081108212050-F055P. Safety Report Unique Identifier GB-MHRA-ADR 25911301. A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included clinical trial participant from an unknown date and unknown if ongoing. Concomitant medication(s) included propranolol and paracetamol both taken for an unspecified indication, start and stop date were not reported. Patient had no symptoms associated with COVID-19, patient was not pregnant, patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine clinical trial participant. On 05Sep2021, the patient experienced vaginal bleeding. on 08Sep2021 patient experienced breathlessness. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - negative covid-19 test) on an unspecified date. The outcome of events was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1720865 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Headache, Panic attack, Presyncope, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: backache; panic attack; shivering; vision blurred; close to passing out; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25923619) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (backache), PANIC ATTACK (panic attack), CHILLS (shivering) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (backache) (seriousness criterion medically significant), PANIC ATTACK (panic attack) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), VISION BLURRED (vision blurred) and PRESYNCOPE (close to passing out). On 10-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (backache), PANIC ATTACK (panic attack) and CHILLS (shivering) had resolved and VISION BLURRED (vision blurred) and PRESYNCOPE (close to passing out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided Company comment This case concerns a 27 year old female patient with no relevant medical history who experienced unexpected serious events of headache, back pain, chills, panic attack and non-serious events of pre-syncope, blurred vision. The events occurred on the same day after vaccination with second dose of mRNA-1273. The re-challenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. The most intense throbbing pain I''ve ever experienced and had a panic attack because my vision was blurred and I was close to passing out every time I stood. Patient has not tested positive for COVID-19 since having the vaccine patient is not enrolled in clinic al trial.; Sender''s Comments: This case concerns a 27 year old female patient with no relevant medical history who experienced unexpected serious events of headache, back pain, chills, panic attack and non-serious events of pre-syncope, blurred vision. The events occurred on the same day after vaccination with second dose of mRNA-1273. The re-challenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1720888 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune thyroiditis, Dizziness, Ear pain, Fatigue, Hypotension, Lethargy, Migraine, Myalgia, Pharyngeal swelling, Presyncope, SARS-CoV-2 test, Swelling, Swollen tongue
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute thyroiditis; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
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: Hashimoto''s thyroiditis; Neck swelling; Tongue swelling non-specific; Migraine; Tiredness; Lethargic; Ear ache; Throat swelling; Near fainting; Low blood pressure; Dizziness; Muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimoto''s thyroiditis), SWELLING (Neck swelling), SWOLLEN TONGUE (Tongue swelling non-specific), MIGRAINE (Migraine), FATIGUE (Tiredness), LETHARGY (Lethargic), EAR PAIN (Ear ache), PHARYNGEAL SWELLING (Throat swelling), PRESYNCOPE (Near fainting), HYPOTENSION (Low blood pressure), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Acute thyroiditis. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimoto''s thyroiditis) (seriousness criteria disability and medically significant), SWELLING (Neck swelling) (seriousness criterion disability), SWOLLEN TONGUE (Tongue swelling non-specific) (seriousness criterion disability), MIGRAINE (Migraine) (seriousness criterion disability), FATIGUE (Tiredness) (seriousness criterion disability), LETHARGY (Lethargic) (seriousness criterion disability), EAR PAIN (Ear ache) (seriousness criterion disability), PHARYNGEAL SWELLING (Throat swelling) (seriousness criterion disability), PRESYNCOPE (Near fainting) (seriousness criterion disability), HYPOTENSION (Low blood pressure) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimoto''s thyroiditis), SWELLING (Neck swelling), SWOLLEN TONGUE (Tongue swelling non-specific), LETHARGY (Lethargic), EAR PAIN (Ear ache), PHARYNGEAL SWELLING (Throat swelling), PRESYNCOPE (Near fainting), HYPOTENSION (Low blood pressure), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) had not resolved, MIGRAINE (Migraine) was resolving and FATIGUE (Tiredness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter Treatment information was not provided. After 48 hours from receiving my vaccine. My neck swelled up as well as my tongue and my thyroid. I have been in bed ever since Monday and been diagnosed with Hashimoto thyroiditis which is an auto immune disease that I will never recover from. I had a thyroid test a week before my vaccine which proves there was no problem before the jab. Company comment- This case concerns a 23-year-old, female patient with medical history of acute thyroiditis who experienced serious unexpected events of autoimmune thyroiditis, swelling, swollen tongue, migraine, fatigue, lethargy, ear pain, pharyngeal swelling, presyncope, hypotension, dizziness and myalgia. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. Medical history of acute thyroiditis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Onset dates captured per SD Authority reporting and differ from what is described on the narrative.; Sender''s Comments: This case concerns a 23-year-old, female patient with medical history of acute thyroiditis who experienced serious unexpected events of autoimmune thyroiditis, swelling, swollen tongue, migraine, fatigue, lethargy, ear pain, pharyngeal swelling, presyncope, hypotension, dizziness and myalgia. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. Medical history of acute thyroiditis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Onset dates captured per SD Authority reporting and differ from what is described on the narrative.


VAERS ID: 1720904 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-05
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Migraine with aura, Palpitations, SARS-CoV-2 test, Ultrasound scan
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20220313)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test Negative; Test Name: ultrasoud scan; Result Unstructured Data: normal, healthy at 12 weeks scan
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; Palpitations; Migraine with aura; Inappropriate schedule of vaccine administered; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25929308) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MIGRAINE WITH AURA (Migraine with aura) and PALPITATIONS (Palpitations) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pregnancy (Estimated due date: 20220313). Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient''s last menstrual period was on 06-Jun-2021 and the estimated date of delivery was 13-Mar-2022. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 06-Sep-2021, the patient experienced MIGRAINE WITH AURA (Migraine with aura) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the first week of the pregnancy. On 05-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 08-Sep-2021, MIGRAINE WITH AURA (Migraine with aura) and PALPITATIONS (Palpitations) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. On an unknown date, Ultrasound scan: normal, healthy at 12 weeks scan (normal) normal, healthy at 12 weeks scan. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. This is a case of maternal exposure during pregnancy and inappropriate schedule of vaccination with associated unexpected events of Migraine with aura and Palpitations for this 27-year-old female patient. The patient received the first dose of vaccine -RNA 1273 (Moderna COVID-19 Vaccine) at approximately the first week of gestation. The second vaccination dose was administered approximately 80 days after the first one. The onset of the event Migraine with aura occurred approximately one day after the second vaccination dose and the event Palpitations 3 days after the second dose. The benefit-risk relationship of vaccine -RNA 1273 is not affected by this report. There is a discrepancy in SD narrative, since it states that the patient was exposed to the vaccine Second-trimester (13-28 weeks) and differs from reported patient last menstrual period date.; Sender''s Comments: This is a case of maternal exposure during pregnancy and inappropriate schedule of vaccination with associated unexpected events of Migraine with aura and Palpitations for this 27-year-old female patient. The patient received the first dose of vaccine -RNA 1273 (Moderna COVID-19 Vaccine) at approximately the first week of gestation. The second vaccination dose was administered approximately 80 days after the first one. The onset of the event Migraine with aura occurred approximately one day after the second vaccination dose and the event Palpitations 3 days after the second dose. The benefit-risk relationship of vaccine -RNA 1273 is not affected by this report. There is a discrepancy in SD narrative, since it states that the patient was exposed to the vaccine Second-trimester (13-28 weeks) and differs from reported patient last menstrual period date.


VAERS ID: 1721023 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7416 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Drug ineffective, Illness, Musculoskeletal pain, Pain in extremity, Rash, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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:
CDC Split Type: ILPFIZER INC202101119080

Write-up: Sick with corona; pain in the left arm radiating to lower back and the shoulder blades.; rash comes out in the legs; pain in the left arm radiating to lower back and the shoulder blades.; pain in the left arm radiating to lower back and the shoulder blades.; She discovered today that she is positive for corona after the third vaccine; She discovered today that she is positive for corona after the third vaccine; This is a spontaneous report from a contactable consumer (patient) via a colleague. A 40-years-old female patient received third dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: FF7416 and Expiry date: 30Nov2021), dose 3 via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) via an unspecified route on an unspecified date for COVID-19 immunization. It was reported that patient received a third vaccine of Pfizer for Corona (2 first ones were also Pfizer) on Tuesday 24Aug2021. She experienced pain in the left arm radiating to lower back and the shoulder blades. From time to time a rash comes out in the legs that comes back and disappears since the vaccine. Upon follow up information received on 05Sep2021, patient stated that from the third corona vaccine, she became sick with corona and was discovered that on 05Sep2021, she was positive for corona after the third vaccine. As was said she was vaccinated with the third vaccine on 24Aug2021. Outcome of all events was unknown. Information regarding the lot/ batch number will be requested in follow-up activities. Follow-up (05Sep2021): New information received from same consumer and colleague that includes (Case upgraded to serious) New events (Sickness, COVID 19 and Drug ineffective) and its''s description was updated accordingly. Information on the lot/batch number has been requested. Follow-up (09Sep2021) New information received from QUALITY COMPLAINTS included: lot number, expiry date and case number: 6318178.


VAERS ID: 1721144 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Fall, Loss of consciousness, Oxygen saturation, Peripheral coldness, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Giddiness; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BS; Test Result: 109 mg/dl; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:136/77(65); Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Test Date: 20210905; Test Name: O2; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101163849

Write-up: Loss of consciousness; a high probability of Vasovagal reflex; a little giddiness; fell down; Cold sweat; Cold hands & feet; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21125940. The patient was a 44-year-old male (Age at Vaccination). Body temperature before vaccination was 35.8 degrees Centigrade on 05Sep2021. The patient''s family history was unknown. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included food (oysters) allergy (unsure). Concomitant medications were not reported. On 05Sep2021 at 15:25 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was reported as 05Sep2021 at 15:40 (15 minutes after vaccination). On 05Sep2021 (the same day of vaccination), the outcome of the event was recovered. The course of the event was as follows: after the vaccination, while standing continuously and waiting, the patient felt a little giddiness and then was considered of loss of consciousness. After that, he fell down. BP 136/77(65) (as reported), BS 109 mg/dl. There was cold sweat. Body temperature was 35.4 degrees Centigrade. Cold hands & feet. The patient had a history of slight giddiness at blood drawing. There was a high probability of Vasovagal reflex. O2 99%. The reporter classified the events as non-serious (as reported) and assessed that the events was unrelated to bnt162b2. The reporting physician commented as follows: it was necessary to lie down during the second dose of vaccination.


VAERS ID: 1721152 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cough, Heart rate, Hot flush, Oropharyngeal discomfort, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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: Empyema (Currently under treatment of empyema (oral intake unknown))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:110/73; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210905; Test Name: HR; Result Unstructured Data: Test Result:70s; Test Date: 20210905; Test Name: HR; Result Unstructured Data: Test Result:78; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Test Date: 20210905; Test Name: respiratory count; Result Unstructured Data: Test Result:12; Comments: times/min
CDC Split Type: JPPFIZER INC202101164541

Write-up: Anaphylaxis; continuous cough; mild hot flushes facial; pharynx strange sensation of; This is a spontaneous report from a contactable physician (vaccinator) received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21126059. A 56-year-old female patient (reported as 56-year and 7-month-old (age at second vaccination, as reported)) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05Sep2021 15:47 (Batch/Lot Number: FF9942; Expiration Date: 30Nov2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing empyema (Currently under treatment of empyema (oral intake unknown)). Body temperature before vaccination was 36.1 degrees Centigrade. The family history was reported as unknown. The patient''s concomitant medications included treatment of empyema (oral intake unknown). The patient experienced anaphylaxis, continuous cough, mild hot flushes facial, all on 05Sep2021 16:00, pharynx strange sensation of, on 05Sep2021. On 05Sep2021 at 16:00 (13 minutes after the vaccination), the patient experienced Anaphylaxis. On 05Sep2021 (the day of vaccination), the outcome of the event was unknown. The course of the event was as follows: 13 minutes after vaccination, the patient experienced continuous cough and mild hot flushes facial. The level of consciousness was clear. HR was 70S. SpO2 97% (room air), HR 78, BP 110/73, respiratory count was 12 times/min, body temperature 36.6 degrees Centigrade. While observing the clinical course of the events, the cough disappeared within about 1 minute, but pharynx strange sensation of persisted. No other physical condition abnormality was noted. The patient visited the family hospital for the purpose of course observation. The reporting physician (vaccinator) classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of event cough was recovered on 05Sep2021, event pharynx strange sensation of was not recovered, while for other events was unknown. Therapeutic measures were taken as a result of events. The reporting physician (vaccinator) commented as follows: It was considered as anaphylaxis. After consultation, the course of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: It was considered as anaphylaxis. After consultation, the course of the events was unknown.


VAERS ID: 1721368 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

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

Write-up: Bell''s palsy of the right side; Facial palsy; This regulatory authority case was reported by a physician and describes the occurrence of FACIAL PARALYSIS (Facial palsy) and BELL''S PALSY (Bell''s palsy of the right side) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced BELL''S PALSY (Bell''s palsy of the right side) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial palsy) and BELL''S PALSY (Bell''s palsy of the right side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by the reporter. No treatment information was provided by the reporter. This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the expected event of Bell''s palsy and Facial paralysis. The event Bell''s Palsy occurred approximately 26 days after the first dose of Spikevax, and the event Facial paralysis occurred around 23 days after first dose. The rechallenge was unknown since only information about first dose was disclosed. The events were considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the expected event of Bell''s palsy and Facial paralysis. The event Bell''s Palsy occurred approximately 26 days after the first dose, and the event Facial paralysis occurred around 23 days after first dose. The rechallenge was unknown since only information about first dose was disclosed. The events were considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship is not affected by this report.


VAERS ID: 1722421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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: AUPFIZER INC202101174794

Write-up: Angioedema; This is a spontaneous report from a contactable other health professional via the Administration. Regulatory authority report number is 618058. A 27-year-old female patient 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 angioedema on 05Sep2021 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: 1724416 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-09-05
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101189661

Write-up: acute idiopathic pericarditis; chest pain; difficulty breathing; This is a spontaneous report received from a contactable consumer or other non Health Care Professional (mother-parent) via Medical information. A 34-year-old male patient received bnt162b2 (COMIRNATY, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 02Aug2021 as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient required to emergency room visit on 05Sep2021 because he had chest pain and difficulties respiratory. Physicians diagnosed him with acute idiopathic pericarditis on 05Sep2021. The outcome of all the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1724508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymph nodes enlarged
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168350

Write-up: very painful and swollen lymphnodes under the armpit and on the neck; very painful and swollen lymphnodes under the armpit and on the neck; Swollen lymph nodes; 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-202109061418449790-8CJXV, safety report unique identifier is GB-MHRA-ADR 25900609. A 19-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 04Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included lymphadenopathy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced ''very painful and swollen lymphnodes under the armpit and on the neck'' on an unspecified date; swollen lymph nodes on 05Sep2021. Patient''s clinical course is as follows: It was reported that patient had very painful and swollen lymphnodes under the armpit and on the neck, same side where vaccine was injected. The events were assessed as serious (medically significant). It was reported that it was ''ongoing, not sure how long will last''. The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-09-05
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain in extremity, Pruritus, Rash macular, Rash papular, SARS-CoV-2 test, Upper gastrointestinal haemorrhage, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176092

Write-up: Itching/itchy skin; raised rash; blotch / Erythromacular rash; red from vaccinated part of left upper arm; Arm pain joint from arm that had vaccine; Arm pain joint from arm that had vaccine; upper gastrointestinal bleeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202109072222469730-220P3 with Safety Report Unique Identifier of GB-MHRA-ADR 25909562. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW4109) via an unspecified route of administration in the left arm on 19Jun2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On an unknown date in 2021, the patient experienced upper gastrointestinal bleeding, raised rash, blotch (Erythromacular rash), red from vaccinated part of left upper arm, joint pain and arm pain joint. On 05Sep2021, the patient experienced itching/itchy skin. The clinical course was reported as follows: The patient experienced arm pain joint from arm that had vaccine. Itchy skin and raised blotch red from vaccinated part of left upper arm. Comes and goes. On 05Sep2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome for the events (upper gastrointestinal bleeding, raised rash, blotch / Erythromacular rash, arm pain joint, joint pain and red from vaccinated part of left upper arm) was unknown. The clinical outcome of the event itching/itchy skin was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724559 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Inappropriate schedule of product administration, Influenza, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough variant asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182335

Write-up: dry irritating cough; patient received the 2nd dose of bnt162b2 on 05Sep2021 and the 1st dose on 04Jul2021; sore throat; head cold; shortness of breath; felt fluey; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109081019476510-OQNBF, Safety Report Unique Identifier GB-MHRA-ADR 25911219. An 18-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FE8087) via an unspecified route of administration on 05Sep2021, at the age of 18 years, as a dose 2, single for COVID-19 immunization. Medical history included cough variant asthma when he was young but by the age of 11 years, the patient grew out of it. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: FD5613) via unspecified route of administration on 04Jul2021 as a single dose for COVID-19 immunizations. On 06Sep2021, 1 day after vaccination, the patient experienced dry, irritating cough. On an unknown date in 2021, the patient experienced sore throat, head cold, he felt fluey and experienced shortness of breath. Clinical course was reported as follows: The patient felt fluey and then started a dry, irritating cough which resulted in shortness of breath. The patient had symptoms of a head cold and sore throat. The case is serious (medically significant). It was also reported that the patient received the 2nd dose of bnt162b2 on 05Sep2021 and the 1st dose on 04Jul2021 which was considered inappropriate schedule of vaccine administered. On 07Sep2021, the patient underwent COVID-19 virus test and the result was No-Negative COVID-19 test. The clinical outcome of the event sore throat, head cold and dry irritating cough was recovering while the outcome of shortness of breath and felt fluey was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-05
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage urinary tract, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190771

Write-up: Blood clot in urine; This is a spontaneous report from a contactable consumer or other non hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202109092039520190-NCPTL, Safety Report GB-MHRA-ADR 25920369. A 31-year-old female (not pregnant) patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported), dose 2 via an unspecified route of administration on 07Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient Historical vaccine include BNT162B2 dose 1 for COVID-19 Immunization from Unknown dates to Unknown dates. The patient concomitant medications were not reported. The patient experienced blood clot in urine on 05Sep2021. The patient has not had symptoms associated with COVID-19. The patient is not pregnant. The patient is not currently breastfeeding. The patient was passing blood clots when no period due. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the event was recovered on 07Sep2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1724634 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Headache, Malaise, Muscle twitching, Palpitations, SARS-CoV-2 test, Tinnitus
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Cardiomyopathy (broad), Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191576

Write-up: Headache; Earache; Tinnitus; Palpitations; Fatigue; Feeling sick; Muscle twitch; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109100815116300-OYCRD. Safety Report Unique Identifier GB-MHRA-ADR 25922481. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: FE8087), via an unspecified route of administration on 04Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included clinical trial participant. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: FE3380) intramuscular on 10Aug2020 for COVID-19 immunisation. It was reported that on 05Sep2021, the patient experienced headache, earache, tinnitus, palpitations, fatigue, feeling sick, muscle twitch. No other illness or medication Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Clinical trial participant Study details were Oxford University study re COVID. On 05Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (No-Negative COVID-19 test). The events were considered as serious (medically significant) by health authority. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724685 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Malaise, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101191463

Write-up: feeling ill; headaches; Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109102345550030-BDSRL, Safety Report Unique Identifier GB-MHRA-ADR 25926918. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not known) via unspecified route of administration on 04Sep2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. No medical issues prior to vaccine. Patient had no symptoms associated with COVID-19. The patient experienced headaches and feeling ill on an unspecified date, chest pain on 05Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Additional Information: Headaches, chest pain, feeling ill since vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of chest pain was not recovered while for the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724893 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Ear discomfort, Headache, Hypoaesthesia, Muscular weakness, Nausea, Retinitis, Visual field defect
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Retinal disorders (narrow), Ocular infections (narrow), Noninfectious diarrhoea (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOCLOPRAMIDE; BIOFERMlN-R
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Queasy
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101167925

Write-up: weakness of lower extremities; Queasy; Diarrhoea; Headache; suspected left central retinitis; visual field defect in the center of the left eye; Pulling feeling in both earlobes; numbness from the outside of the upper arm to the neck on the vaccinated side; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 08Sep2021, this case now contains a serious adverse reaction. Information processed together. This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority. A 17-year and 1-month-old female patient received the first dose of BNT162B2(COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) intramuscular in the arm left on 05Sep2021 at 14:00 (at the age of 17 years old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Body temperature before vaccination was 36.6 degrees Centigrade. From 02Sep2021, queasy developed and the patient took metoclopramide and enterococcus faecalis (BIOFERMlN-R) orally at another hospital. From 03Sep2021, the symptom improved. On 05Sep2021 at 17:00 (3 hours after the vaccination), the patient experienced headache, queasy, diarrhoea, weakness of lower extremities and left eye visual field defect. Clinical course was reported as: Immediately after the vaccination on 05Sep2021, pulling feeling in both earlobes and numbness from the outside of the upper arm to the neck on the vaccinated side were observed, but the symptoms improved during 15 minutes of follow-up. After the patient returned home she experienced queasy, diarrhoea for 4 times, headache and visual field defect in the center of the left eye. From the morning of the following day (06Sep2021), With the addition of weakness of lower extremities, no improvement was observed, so the patient visited the hospital at 15:36 on 06Sep2021. Headache, queasy, and weakness of lower extremities persisted mildly. The patient was referred to ophthalmology for visual field defect and was under close examination for suspected left central retinitis. The reporter stated the events queasy, diarrhoea, headache, visual field defect, weakness of lower extremities and suspected left central retinitis result in doctor or other healthcare professional office/clinic visit. The outcome of the events pulling feeling in both earlobes and numbness from the outside of the upper arm to the neck on the vaccinated side recovered on 05Sep2021, for the rest of the events was unknown without treatment. The reporting physician assessed that the causality between the events and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are completed. No further information is expected.


VAERS ID: 1724896 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall, Fracture, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:about 39s Centigrade; Test Date: 20210906; Test Name: temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Test Date: 20210907; Test Name: temperature; Result Unstructured Data: Test Result:38s to 39s Centigrade; Test Date: 20210908; Test Name: temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210909; Test Name: temperature; Result Unstructured Data: Test Result:closing to 39 Centigrade; Test Date: 20210906; Test Name: SpO2; Test Result: 96 %; Test Date: 20210907; Test Name: SpO2; Test Result: 96 %; Test Date: 20210908; Test Name: SpO2; Test Result: 90 %; Test Name: antigen test/PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101169639

Write-up: it (SpO2) decreased to 90%; pyrexia with temperature of 39.8 Centigrade/ pyrexia continued with temperature of 38s to 39s Centigrade; fracture; fell from the bicycle; This is a spontaneous report from a contactable pharmacist via Medical Information team. A 60-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 05Sep2021 at the age of 60 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Sep2021, the patient fell from the bicycle on her way home and experienced fracture. On 06Sep2021, the patient was admitted to the reporter''s hospital. The patient had been experiencing pyrexia with temperature not reducing at all. When the patient came to the reporter''s hospital on 06Sep2021, the patient had pyrexia with temperature of 39.8 Centigrade. Antigen test was negative on an unspecified date. Being hospitalized, the patient was receiving rest treatment. On 07Sep2021, pyrexia continued with temperature of 38s to 39s Centigrade. Body temperature was 38.9 Centigrade in the morning at the time of the report (08Sep2021). The reporter was asking for the opinion on having pyrexia with temperature closing to 39 Centigrade on the fourth day (09Sep2021). On 06Sep2021 and 07Sep2021, oxygen saturation (SpO2) was 96% due to the vaccine''s side effect. At the time of the report (on 08Sep2021), in the morning, it (SpO2) decreased to 90%. The reporter asked if the reason for pyrexia was the fracture or vaccine. It was difficult to judge since the time coincided. Upon follow up on 09Sep2021, the same pharmacist reported that pyrexia persisted with body temperature about 39s Centigrade on an unspecified date. Polymerase chain reaction (PCR) test was negative on an unspecified date. The reporter was asking if it was possible that the vaccination made the patient''s reaction to COVID-19 slower. Many tests had been done, but they could not figure out the cause of the event. The reporter was also asking if it was possible that the patient was infected with the COVID-19, while the PCR test was negative. The reporter asked if the PCR test could be trusted. The patient was hospitalized for the events from 06Sep2021 to an unknown date. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected 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: 1724907 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Contusion, Fall, Heart rate, Insomnia, Loss of consciousness, Oxygen saturation, Physical deconditioning, Presyncope, Respiratory rate, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Syncope (happened when the patient was a primary school student)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:80; Comments: /minute Sinus rhythm; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210905; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: /minute
CDC Split Type: JPPFIZER INC202101170677

Write-up: lost consciousness; Syncope; temporary Convulsion; Vasovagal reflex; fell; right forehead Contusion pain; lack of sleep; Physical condition of the patient was not good; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126047. A 19-year-old male patient received BNT162B2 (COMIRNATY; lot number: FF4204, Expiration Date: 31Oct2021) via an unspecified route of administration on 05Sep2021 16:06 (at the age of 19-year-old) as dose 1, single for COVID-19 immunisation. Medical history included syncope (happened when the patient was a primary school student). Body temperature before vaccination was 36.9 degrees Centigrade. The patient''s concomitant medications were not reported. On 05Sep2021 at 16:10 (4 minutes after the vaccination), the patient experienced Vasovagal reflex (Syncope). The course of the event was as follows: After vaccination at 16:06, when the patient was about to stand up from chair during listening to the Instructions after vaccination at 16:10, lost consciousness and fell, the right forehead hit the corner of the chair. Temporary Convulsion occurred, about 30 seconds later, consciousness recovered. During the diagnosis, clear consciousness, blood pressure 130/80mmHg, according to Electrocardiogram, heart rate was 80/minute, Sinus rhythm. Oxygen saturation 98%, Respiratory rate 18/minute, no symptoms related to Anaphylaxis such as rash. Suspected to be Vasovagal reflex. Took Observation through Lifting lower limbs in a lying position, then because no symptoms relapsed and no blood pressure decreased in sit and stand position, the patient could return home at about 17:00. The right forehead Contusion pain remained only and without headache. No Neurological abnormalities. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: According to the patient himself and family, Syncope after vaccination happened when the patient was a primary school student. On the vaccination date the patient was lack of sleep, Physical condition of the patient was not good. On 05Sep2021 (the day of vaccination), the outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724914 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Heart rate increased, Hot flush, Oxygen saturation, Panic attack, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:144/105; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210905; Test Name: pulse rate; Result Unstructured Data: Test Result:114; Test Date: 20210905; Test Name: oxygen saturation; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101170999

Write-up: pulse was 114; It was considered as Panic attack; Blood pressure was 144/105; the patient complained tremulousness of both upper limbs, hot flush of face, and dyspnoea; the patient complained tremulousness of both upper limbs, hot flush of face, and dyspnoea; the patient complained tremulousness of both upper limbs, hot flush of face, and dyspnoea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126128. A 24-year and 1-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05Sep2021 14:18 (at age of 24 years old) (Lot Number: FD0349; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. Body temperature before vaccination was 36.3 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. The onset date of the event was reported as 05Sep2021 at 14:20 (2 minutes after the vaccination). On 05Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 05Sep2021 at 14:20 (2 minutes after the vaccination), from several minutes after the vaccination, the patient complained tremulousness of both upper limbs, hot flush of face, and dyspnoea. Blood pressure was 144/105, pulse was 114, oxygen saturation was 98% , body temperature was 36.3 degrees Centigrade. Just in case, secured blood vessels and Atarax-P 1A i.m. On 05Sep2021 at 16:00 (1 hours and 42 minutes after the vaccination), symptoms disappeared. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2.Other possible cause of the event such as any other diseases was Panic attack. The reporting physician commented as follows: It was considered as Panic attack.


VAERS ID: 1724917 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-05
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endoscopy, Haematemesis, Haemorrhage, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: Alcohol use; Hepatic cancer; Hepatic cirrhosis; Smoker
Allergies:
Diagnostic Lab Data: Test Name: Endoscope; Result Unstructured Data: Test Result:Obvious Haemorrhage couldn''t be confirmed
CDC Split Type: JPPFIZER INC202101171123

Write-up: Haematemesis; melena; chronic Haemorrhage; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21126050. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) (at age of 60-year-old) as DOSE 2, single for covid-19 immunisation. On 17Jul2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number was unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient medical history included Hepatic cirrhosis with alcohol, cigarettes and Hepatic cancer. Concomitant medications were not reported. The patient experienced haematemesis (hospitalization, Medically Significant) on 05Sep2021 15:30 with outcome of unknown, melena (hospitalization, Medically Significant) on 05Sep2021 15:30 with outcome of unknown, chronic haemorrhage (hospitalization, Medically Significant) on 05Sep2021 15:30 with outcome of unknown. The patient was hospitalized from 05Sep2021 (29 days after the vaccination). The patient was shocked by the symptoms of Haematemesis and melena and was taken to the hospital by ambulance. Obvious Haemorrhage couldn''t be confirmed by an Endoscope. Hepatic cirrhosis with alcohol, cigarettes and Hepatic cancer were suspected to be the reason. The patient was hospitalized due to suspicion of chronic Haemorrhage. The reporting physician classified the event as serious and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases was Hepatic cirrhosis. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1724931 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Depressed level of consciousness, Fall, Gaze palsy, Heart rate, Heart rate decreased, Oxygen saturation, Pallor, Presyncope, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:78/5 (as reported) mmHg; Comments: 15:50; Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/68 mmHg; Comments: 15:51; Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/70 mmHg; Comments: 15:56; Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:106/58 mmHg; Comments: 16:08; Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:108/62 mmHg; Comments: 16:16; Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before the vaccination; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: 11:00; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:50s; Comments: 15:49; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:65; Comments: 15:50; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:76; Comments: 15:51; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:79; Comments: 15:56; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:78; Comments: 16:08; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:74; Comments: 16:16; Test Date: 20210905; Test Name: SpO2; Test Result: 98 %; Comments: 15:50; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Comments: 15:51; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Comments: 15:56; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Comments: 16:08; Test Date: 20210905; Test Name: SpO2; Test Result: 99 %; Comments: 16:16
CDC Split Type: JPPFIZER INC202101171780

Write-up: KT 37.8 degrees Centigrade; Difficulty focusing eyes; Blood pressure 78/5 mmHg (as reported)/Blood pressure 106/58 mmHg; Consciousness clouding; Eyeballs raise upward; Cold sweat; Pallor facial; Pulse rate 50s; walked a few steps, but collapsed; strong vasovagal reflex; This is a spontaneous report from a contactable other health professional received from the regulatory authrity. Regulatory authority report number is v21126111. A 16-year-old (reported as "16-year and 8-month-old") male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Sep2021 15:38 (at the age of 16 years old, reported as "16-year and 8-month-old") (Lot Number: FG0978; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade on 05Sep2021. The patient''s family history was known. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced consciousness clouding (medically significant) on 05Sep2021 15:49; eyeballs raise upward (medically significant) on 05Sep2021 15:49; strong vasovagal reflex on 05Sep2021; cold sweat on 05Sep2021 15:49; pallor facial on 05Sep2021 15:49; pulse rate 50s on 05Sep2021 15:49; walked a few steps, but collapsed on 05Sep2021 15:49; difficulty focusing eyes on 05Sep2021 15:51; blood pressure 78/5 mmhg (as reported)/blood pressure 106/58 mmhg on 05Sep2021 15:50; KT 37.8 degrees centigrade on 06Sep2021 11:00. The course of the event was as follows: At 15:38, the patient received the first vaccination. (pre-examination without problems, 15 minutes follow-up observation was performed). At 15:49, the patient sat in a chair, and experienced Cold sweat, Pallor facial, Pulse rate 50s and Consciousness clouding. The patient walked a few steps, but collapsed and Eyeballs raise upward. At 15:50, there was Consciousness clouding. Pulse rate 65. Blood pressure 78/5 mmHg (as reported). SpO2 98%. At 15:51, there was Difficulty focusing eyes. Pulse rate 76. Blood pressure 110/68 mmHg. SpO2 99%. Saline 500 ml IV was administered. At 15:56, the eyes was gradually recovering. Pulse rate 79. Blood pressure 116/70 mmHg. SpO2 99%. At 16:08, consciousness was clear. Pulse rate 78. Blood pressure 106/58 mmHg. SpO2 99%. At 16:16, consciousness was clear. Pulse rate 74. Blood pressure 108/62 mmHg. SpO2 99%. Administration of Saline 500 ml IV was finished, and the needle was removed. (emergency treatment under the instruction of the doctor who was in charge of pre-examination). At 16:28, the patient was at sitting position. And sat in a chair in 38 minutes. At 16:50, the patient left the room and went home. On 06Sep2021 (the next day) at 11:00, the physical condition of the patient was checked with the patient''s mother. KT 37.8 degrees Centigrade. The patient was able to talk, and had an appetite. The reporting other HCP classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting other HCP commented as follows: From the doctor, it was strong vasovagal reflex. The outcome of the event "KT 37.8 degrees Centigrade" was unknown; of Consciousness clouding was recovered on 05Sep2021 16:08; of Pulse rate 50s was recovered on 05Sep2021 15:50; of Blood pressure 78/5 mmHg (as reported)/Blood pressure 106/58 mmHg was recovered on 05Sep2021 16:16; of the other events was recovered on 05Sep2021. No follow-up attempts are needed. No further information is expected.~


VAERS ID: 1724981 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Heart rate, Nausea, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:66/40; Comments: at 12:10; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:89/51; Comments: at 12:18; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:86/60; Comments: at 12:28; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:55; Comments: at 12:10; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:67; Comments: at 12:18; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:77; Comments: at 12:28; Test Date: 20210905; Test Name: SpO2; Test Result: 98 %; Comments: at 12:10
CDC Split Type: JPPFIZER INC202101183647

Write-up: Blood pressure decreased/66/40; Vasovagal reflex; cold sweat; Queasy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126270. This patient was a 15-year and 6-month-old female (age at vaccination). On 05Sep2021 at 12:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3622 Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.3 Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Sep2021 at 12:07 (7 minutes after the vaccination), the patient experienced Vasovagal reflex. The event course was reported as follows: On 05Sep2021 at 12:07 (7 minutes after the vaccination) there were cold sweat, Queasy. At 12:10 blood pressure was 66/40, heart rate was 55 SpO2 was 98%. The patient was lying on bed under observation. The symptoms recovering. At 12:18 blood pressure was 89/51, heart rate was 67, the test results was back to normal. At 12:28 the patient rested in bed, blood pressure was 86/60, heart rate was 77, the test results showed that symptoms improved , then the patient went home. On05Sep2021 the outcome of the event was recovered. The reporter classified the event as non-serious and the causality between the event and bn162b2 as related. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: Before receiving the second dose of the vaccine, the patient had blood pressure measurement, the patient was lying down while received the second dose, then stayed rest in 30 minutes on bed. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1726082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210940140

Write-up: FATIGUE; MALAISE; ARTHRALGIA; INJECTION SITE REACTION; MYALGIA; FEVER; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (BE-FAMHP-DHH-N2021-106587) on 21-SEP-2021 and concerned an adult male. The patient''s weight was 95 kilograms, and height was 186 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C16-05 expiry: UNKNOWN) dose was not reported,1 total, administered on 04-SEP-2021 for Covid-19 immunisation. No concomitant medications were reported. On 05-SEP-2021, the patient experienced fatigue, malaise (Feeling unwell), arthralgia (Joint pain), injection site reaction (Reaction at the injection site), myalgia, fever and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, malaise, arthralgia, injection site reaction, myalgia, fever, and headache. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - No. Evolution of the ADR - Recovering


VAERS ID: 1728675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Condition aggravated, Endometriosis, Muscle spasms, SARS-CoV-2 test, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191840

Write-up: Endometriosis; cramping; lower abdominal pain worse; Lower abdominal pain; Visual disturbances; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109100653164830-JS3OM and Safety Report Unique Identifier GB-MHRA-ADR 25923667. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FD7204), via an unspecified route of administration on an unknown date in Sep2021 as dose 1, single for COVID-19 immunization. Medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. It was reported that the patient have endometriosis and known uterine issues. All of those effects have not been present in over a year, then she got the vaccine and two days later she experienced awful cramping and lower abdominal pain worse than she ever have. Patient has not tested positive for COVID-19, since having the vaccine Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced endometriosis, on 05Sep2021, the patient had lower abdominal pain, visual disturbances, cramping, lower abdominal pain worse. On 08Sep2021, the patient underwent lab tests and procedures which included SARS-COV-2 test negative No - Negative COVID-19 test. The outcome of the event endometriosis, visual impairment was recovering, abdominal pain was not recovered and muscle spasms, lower abdominal pain worse was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1728999 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190627

Write-up: Lymph nodes enlarged; Underarm pain/large lump had formed where the pain was under arm; started with arm pain / ache on day of injection; Mild headache; Injection site pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-APPCOVID-20210909111147, Safety Report Unique Identifier GB-MHRA-ADR 25917326. A 25-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 05Sep2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 05Sep2021, the patient experienced ache on day of injection /started with arm pain, mild headache and injection site pain; on 06Sep2021, 1 day after vaccination, the patient experienced underarm pain; on 08Sep2021, 3 days after vaccination, the patient experienced lymph nodes enlarged; all events were reported as serious for being medically significant. The clinical course was reported as follows: the patient started with arm pain/ache on day of injection, with mild headache. Next day had pain underarm still occurring but slightly milder that day and noticed a large lump had formed where the pain was under arm and were attending doctors. On 05Sep2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events injection site pain and mild headache was resolved on 07Sep2021, after the duration of 2 days. The clinical outcome of the event ache on day of injection /started with arm pain was resolving, while that of underarm pain and lymph nodes enlarged was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729108 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chills, Headache, Hyperhidrosis, Hypersensitivity, Pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash pruritic, SARS-CoV-2 test, Spinal pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191522

Write-up: chills; upper arm swelled up; developed an itchy red rash; arm is still sore/numb; sweats; headache; Back pain; spinal pain; Fainting; Allergy; Pain; Feverish; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109101313521350-YU5GD, Safety Report Unique Identifier GB-MHRA-ADR 25923825. A 35-year-old non-pregnant female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FE3380), via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient not had symptoms associated with COVID-19. Patient was not breastfeeding. Patient was not enrolled in clinical trial. Since the vaccination, the patient was not tested positive for COVID-19. The patient experienced chills, upper arm swelled up, developed an itchy red rash, arm is still sore/numb, sweats, headache, back pain and spinal pain on an unspecified date. On 05Sep2021, patient experienced allergy, pain, feverish on 05Sep2021. On 06Sep2021 patient experienced fainting. Clinical course site of jab and most of upper arm swelled up the day after the jab and developed an itchy red rash which was hot to the touch. This continued for several days and had only now eased. The arm was still sore/numb. Patient fainted two days (06sep2021) after the jab and Patient had experienced feverish symptoms for several days including sweats/chills and headaches. The patient body was aching, more so on the side of the jab with significant back/spinal pain. Patient was still suffering these effects. The patient lab tests and procedures which included COVID-19 virus test was no-negative COVID-19 test. The outcome of the event chills was resolving. The outcome of the event allergy was resolved with Sequel on 08Sep2021, fainting was resolved on an unknown date 2021 The outcome of the event pain, feverish was not resolved. The outcome of the event upper arm swelled up, developed an itchy red rash, arm is still sore/numb, sweats, headache, back pain and spinal pain was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729109 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Neck pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Poor sleep
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191816

Write-up: Chest pain; had local pain at injection site; pain on upper back/neck region; pain on upper back/neck region; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101431223890-L2IUT, Safety Report Unique Identifier GB-MHRA-ADR 25924276. A 31-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FF2153), via an unspecified route of administration on 05Sep2021 (at the age of 31-year-old) as dose 1, single for COVID-19 immunization. Medical history included poor quality sleep from an unknown date and unknown if ongoing. It was unsure if patient had symptoms associated with COVID-19. Concomitant medication included melatonin taken for poor quality sleep from 01Feb2021 to an unspecified stop date. The patient reported that, he had the vaccine shot on Sunday 05Sep2021 and on the same day, had local pain at injection site and pain on upper back/neck region. He stated that, on 06Sep2021, he woke up with chest pain. It was sharp pain when breathing in, especially on deep breathed in. He told that, he had not done any chest exercise in over 7 day prior to vaccination and had no chest pain prior to vaccination. The event chest pain was reported as serious with seriousness criteria as other medically important condition (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result on an unspecified date (No - Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for the event chest pain was reported as not recovered at the time of report and the outcome for the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101196550

Write-up: Delayed period/ week late on period and still no period; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109122011422170-JHY0P. Safety Report Unique Identifier GB-MHRA-ADR 25929379. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing suspected COVID-19, unsure when symptoms started. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 05Sep2021, delayed period/ week late on period and still no period (at the time of report). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The case was assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 13Jan2021. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature labour, SARS-CoV-2 test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 2021; Test Name: Anomaly scan; Result Unstructured Data: Test Result:Anomly scan normal
CDC Split Type: GBPFIZER INC202101205356

Write-up: Preterm labor; Maternal exposure during pregnancy Third-trimester (29-40 weeks).; This is a spontaneous report from a contactable Other Health Professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131347079490-WBLYP. Safety Report Unique Identifier of GB-MHRA-ADR 25932190. A 32-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included folic acid supplementation from an unknown date and unknown if ongoing. Concomitant medication included folic acid (MANUFACTURER UNKNOWN) taken for folic acid supplementation from an unspecified date. The patient was no longer pregnant at the time of reporting. The patient was not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On 05Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 05Sep2021, the patient experienced pre-term labor; on an unknown date in 2021, the patient was exposed to the medicine in third-trimester (29-40 weeks); both the events were reported as serious for being medically significant. The patient had her first pregnancy and it was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Relevant investigations included anomaly scan which was normal. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event pre-term labor was recovered on 05Sep2021 while that of the event patient was exposed to the medicine in third-trimester (29-40 weeks) was unknown at the time of this report. 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-202101216641 Mother/child case


VAERS ID: 1729190 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Illness, Influenza, Influenza like illness, Irritability, Maternal exposure during breast feeding, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXPLANON; SERTRALIN
Current Illness: Anxiety; Birth control; Breast feeding
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: Cough; Sneezing; Flu like symptoms; Irritable; Maternal exposure during breast feeding; Flu; Sickness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25940972) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), SNEEZING (Sneezing), INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritable) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Birth control since an unknown date. Concurrent medical conditions included Breast feeding and Anxiety. Concomitant products included SERTRALIN for Anxiety, ETONOGESTREL (NEXPLANON) for Birth control. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced ILLNESS (Sickness). On 06-Sep-2021, the patient experienced INFLUENZA (Flu). On an unknown date, the patient experienced COUGH (Cough), SNEEZING (Sneezing), INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritable) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 05-Sep-2021, ILLNESS (Sickness) had resolved. On 08-Sep-2021, INFLUENZA (Flu) had resolved. At the time of the report, COUGH (Cough), SNEEZING (Sneezing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and IRRITABILITY (Irritable) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. 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. The patient also experienced tired, unsettled, clingy and off her food. The patients daughter experienced similar side effects after vaccine exposure via breastmilk. Treatment information was not provided. Company comment: This case concerns a 29 year-old, female subject with no significant medical history, who experienced the unexpected events cough, sneezing, flu like symptoms, irritable and maternal exposure during pregnancy. The event occurred approximately on the day after the second dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 29 year-old, female subject with no significant medical history, who experienced the unexpected events cough, sneezing, flu like symptoms, irritable and maternal exposure during pregnancy. The event occurred approximately on the day after the second dose of Moderna Covid-19 vaccine. The event was considered related to the study drug. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1729625 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Decreased appetite, Feeling abnormal, Heart rate, Oxygen saturation, Palpitations, Peripheral coldness, Physical deconditioning, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:40/84 mmHg; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: after vaccination; Test Date: 20210905; Test Name: pulse test; Result Unstructured Data: Test Result:100; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 100 %
CDC Split Type: JPPFIZER INC202101184978

Write-up: Palpitations; Inappetence; feels poorly/ different state compared usually; blood pressure 40/84; peripheral coldness; tremulousness; physical deconditioning; This is a spontaneous report from a contactable other HCP received from the Agency Regulatory Authority. Regulatory authority report number is v21126383. The patient was a 41-year and 3month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had a family history of husband, first son, second son, first daughter, father-in-law, and mother-in-law. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Sep 2021 at 16:15 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization.Age at vaccination :41 years old. On 05Sep 2021 at 16:15 ((the day of vaccination), the patient experienced palpitations, Inappetence, and feels poorly The outcome of the event was not provided. The course of the event was as follows: After receiving the vaccination, the patient complained of palpitations and moved to the lounge. Pulse rate, 100/min; SpO2, 100%; blood pressure, 40/84; and body temperature, 35.6 degrees Centigrade. The patient laid in bed with observation. The symptoms has alleviated temporarily ; however, she experienced palpitations, peripheral coldness, and tremulousness again. At 17:35, she was transferred to a medical office by an ambulance. She received a intravenous drip. On 05Sep around 20:00, the patient went home. Afterwards the symptoms subsided; however, palpitations appeared repeatedly. On 07Sep at 10:52, the patient was transferred by an ambulance and was hospitalized. Symptom: palpitations, physical deconditioning, and unusual condition The reporting other HCP classified the event as serious and 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: 1729636 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Oropharyngeal discomfort, Throat irritation, Throat tightness, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis (In the early days of August); Pyrexia (In the early days of August); Ventricular septal defect; Ventricular septal defect repair (At 9 months old)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: vital signs; Result Unstructured Data: Test Result:had no problem
CDC Split Type: JPPFIZER INC202101185961

Write-up: irritating feeling in a throat and pharynx closed sensation of;; irritating feeling in a throat and pharynx closed sensation of;; irritating feeling in a throat and pharynx closed sensation of;; Anaphylaxis; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126379. The patient was a 30-year-old female (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade. The patient''s history according to vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included as below: Three to four years before, the patient experienced pharyngeal oedema and anaphylaxis owing to BUFFERIN. At 9 months old, the patient underwent surgery for ventricular septal defect. In the early days of August, pyrexia due to gastritis developed. On 05Sep2021 at 09:43 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: On 05Sep2021 at 09:43, the patient received vaccination. At about 10:20 (the day of vaccination) also reported as thirty minutes later when the patient went out of the venue, she experienced irritating feeling in a throat and pharynx also closed sensation of; for which the patient was shown into the first-aid room. The vital signs had no problem; however, the patient had a history of anaphylaxis due to BUFFERIN. Hence, BOSMIN 0.3 mg was administered into the outside of the right thigh intramuscularly at the thought of anaphylaxis. The patient was carried on a stretcher to a Hospital (emergency room visit) Outcome of the events was unknown. The reporting physician classified the event as serious (Medically Significant) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There was a possibility of vaccine side effect.


VAERS ID: 1729665 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Feeling abnormal, Magnetic resonance imaging head, Muscle spasms, Pallor, Seizure, Vital signs measurement
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BLOOD TEST; Result Unstructured Data: Test Result:No abnormality; Test Date: 20210905; Test Name: HEAD MRI; Result Unstructured Data: Test Result:No abnormality; Test Date: 20210905; Test Name: vital signs; Result Unstructured Data: Test Result:No abnormality
CDC Split Type: JPPFIZER INC202101192195

Write-up: Convulsion; Cramp of limb (rigidity type); Complexion ill; Feels poorly; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126429. The patient was a 16-year and 11-month-old male. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. Other medical history was unknown. On 05Sep2021 (the day of vaccination) at age of 16-year-old, the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Sep2021 at 17:00 (the day of vaccination), cramp of limb (rigidity type) for a few seconds after vaccination. Even after the convulsions disappeared, the patient experienced complexion ill and Feels poorly and transferred to this hospital in emergency. The event resulted in Emergency room/department or urgent care. At the time of admission, there were no abnormalities with blood sampling, head MRI, consciousness, and vital signs, but the patient was admitted to the hospital for observation. On 05Sep2021, the outcome of the event was recovered without treatment. On the next day 06Sep2021, the patient was discharged from the hospital. The reporting physician classified the event as serious (hospitalized from 05Sep2021 to 06Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Reporter''s comment: convulsions appeared immediately after vaccination, considering it happened due to the vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Reporter''s comment: convulsions appeared immediately after vaccination, considering it happened due to the vaccine.


VAERS ID: 1729933 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101222354

Write-up: Severe pain in the heart area; Inability to breathe due to pain; left shoulder hurts as well; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the RA, regulatory authority number RO-NMA-2021-SPCOV12584. Sender''s (Case) Safety Report Unique Identifier: RO-NMA-2021-SPCOV12584-AM-16-SEP-2021. A 40-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via intramuscular on 22Aug2021 (Batch/Lot Number: FA4632) as single dose, at an unspecified age, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. The patient experienced severe pain in the heart area (life threatening) on 05Sep2021, inability to breathe due to pain (life threatening) on 05Sep2021, left shoulder hurts as well in 2021. Treatment received for the events. As a corrective therapy the patient received anti-inflammatory treatment. At the time of reporting, the outcome of the events was not recovered. In the reporter''s opinion the events were related to BNT162B2. Sender''s comments: No consent obtained for contacting the treating physician for obtaining additional information regarding this case.


VAERS ID: 1729957 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Nasal test; Test Result: Negative
CDC Split Type: SEPFIZER INC202101190848

Write-up: Muscle weakness/Muscle weakness in right leg; right arm tingling; This is a spontaneous report from a contactable consumer reporting about herself. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 30Aug2021 13:45 (Batch/Lot Number: UNKNOWN) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 34 years). Patient had no known allergies. Medical history included arthritis from an unknown date and unknown if ongoing. The patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had no concomitant medications. The patient experienced muscle weakness/muscle weakness in right leg and right arm tingling, both on 05Sep2021 11:00 with outcome of not recovered. Events required visit to [Emergency department, hospital accommodation]. The patient was hospitalized for 2 days. Patient received no treatment for the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Sep2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested negative for nasal test since the vaccination. No Follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732907 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-05
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Asthenia, Headache, Malaise, Pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182294

Write-up: Pain; feel sick; feel weak; taste buds are off; arm pain and tenderness in the exact spot; headache; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109090446518930-CHY3W with Safety Report Unique Identifier of GB-MHRA-ADR 25915419. A 36-year-old patient of an unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Aug2021 as dose 2, single dose for COVID-19 immunisation. Medical history included anemia. The patient was not enrolled in clinical trial. Concomitant medications included ferrous sulfate (MANUFACTURER UNKNOWN) from 01Apr2021 for anemia and unknown if ongoing. On 05Sep2021, the patient experienced pain and on an unknown date in 2021, the patient experienced headache. On an unknown date in 2021, the patient experienced arm pain and tenderness in the exact spot where the patient had jab, felt sick; weak and taste buds off. The clinical course was reported as follows: After the second vaccination, the patient felt like he had COVID for four days. Symptoms were severe but had resolved, then one month later, exact same symptoms had appeared, along with the arm pain and tenderness in the exact spot of COVID jab. The patient had severe headache, felt sick and weak, taste buds were off, and arm hurts. The patient felt strange how these symptoms had appeared and the spot of jab felt tender to even lightly touch but other arm was fine. The patient had suspected COVID-19 from 06Sep2021 which was reported as ongoing. On 07Sep2021, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The events were reported as serious for being medically significant. The clinical outcome of the event headache was recovered on an unknown date in 2021, event arm pain and tenderness in the exact spot, feel sick, feel weak and taste buds are off were unknown whereas that of the event pain was recovered on 06Sep2021 with a duration of 1 day. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1732935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, Menstruation delayed, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191488

Write-up: Delayed period; Heartburn aggravated/heartburn; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202109112002402840-MUKYX; Safety Report Unique Identifier: GB-MHRA-ADR 25928686.~ A 36-year-old female patient received Bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: Not known; Expiry date: Not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant,Patient was not currently breastfeeding. The patient experienced heartburn on an unspecified date, delayed period on 05Sep2021, heartburn aggravated on 05Sep2021. Her Period was now over a week late (not pregnant) and she was usually always regular and on the date. Heartburn on and off from eating spicy or rich in flavour foods, something that had never happened before but now a regular occurrence since having the vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on unknown date. Patient had not recovered from all events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed mood, Drug ineffective, Dyspnoea, Fatigue, Loss of personal independence in daily activities, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196549

Write-up: short of breath; Drug ineffective; low in mood; difficulty in functioning in daily activities; Fatigue; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109121045145060-ZPTX3. Safety Report Unique Identifier is GB-MHRA-ADR 25929011 A 47-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Fe3380), via an unspecified route of administration on 31Aug2021 as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Medical history included ongoing suspected covid-19 from 05Sep2021 and no significant pmh. The patient''s concomitant medications were not reported. The patient experienced short of breath, drug ineffective, low in mood on an unspecified date and fatigue on 05Sep2021. The adverse events were considered as serious with seriousness criteria of disability. Patient was unable to run, cycle or swim without becoming very short of breath and fatigued. Normally very fit and active so low in mood and difficulty in functioning in daily activities e.g communting by bike to work, taking part in training sessions. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the event fatigue was not recovered and events short of breath, drug ineffective, low in mood and difficulty in functioning in daily activities was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1732970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Inappropriate schedule of product administration, Menstruation delayed, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Fertility disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196575

Write-up: Late period; Painful periods; Skin rash; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer received from the Regulatory Authority The regulatory authority report number is GB-MHRA-WEBCOVID-202109121747124420-9U1BZ, Safety Report Unique Identifier GB-MHRA-ADR 25929277. A 37-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Fe8087) via an unspecified route of administration on 05Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Fe1510) on 09Jul2021 as dose 1, single for COVID-19 immunization. The patient concomitant medications were not reported. The patient experienced late period, painful periods, and skin rash on an unspecified date(s). inappropriate schedule of vaccine administered on 05Sep2021. On an unspecified date the patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test): No - Negative COVID-19 test. The events were reported as serious (Medically significant). The outcome of the events late period and painful periods was recovered on unspecified date(s) and skin rash was recovered with sequelae. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Biopsy bone marrow, Blood culture, Blood test, Body temperature, Computerised tomogram abdomen, Computerised tomogram pelvis, Headache, Inflammation, Joint stiffness, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia, Rash, SARS-CoV-2 test, Scan myocardial perfusion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: bone marrow biopsy; Result Unstructured Data: Test Result:Unknown Results; Comments: All tests carried out suspected PIMS-TS but not consistent with other recorded symptoms; Test Name: blood cultures; Result Unstructured Data: Test Result:Unknown Results; Comments: Several blood tests and cultures; Test Name: blood tests; Result Unstructured Data: Test Result:Unknown Results; Comments: Several blood tests and cultures; Test Date: 20210906; Test Name: Temperature; Result Unstructured Data: Test Result:High; Test Name: ct scan abdomen; Result Unstructured Data: Test Result:Unknown Results; Comments: All tests carried out suspected PIMS-TS but not consistent with other recorded symptoms; Test Name: ct scan pelvis; Result Unstructured Data: Test Result:Unknown Results; Comments: All tests carried out suspected PIMS-TS but not consistent with other recorded symptoms; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test; Test Name: Heart scan; Result Unstructured Data: Test Result:Unknown Results; Comments: All tests carried out suspected PIMS-TS but not consistent with other recorded symptoms
CDC Split Type: GBPFIZER INC202101226683

Write-up: Skin rash; High temperature; Painful joints; Stiffness joints; Sore throat; Stiff neck; Swollen lymph nodes; Inflammation; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171655271190-YX2V7, safety report unique identifier is GB-MHRA-ADR 25960375. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Fit and well until the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced sore throat on 05Sep2021, high temperature on 06Sep2021, painful joints on 06Sep2021, stiffness joints on 05Sep2021, skin rash on 06Sep2021, stiff neck on 05Sep2021, swollen lymph nodes on 05Sep2021, inflammation on 05Sep2021, headache on 05Sep2021. The case was reported as serious due to Life threatening and hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the events sore throat, Painful joints, Stiffness joints and Headache was recovering, High temperature, Swollen lymph nodes, Inflammation was not recovered, Skin rash was recovered with sequel, Stiff neck was recovered on 15Sep2021. The clinical course was reported as follows: "A&E on 9/9 PICU at the hospital 10Sep to 12Sep, another hospital, several tests and scans carried out still unable to lower inflammation markers with 3 antibiotics via IV. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: ''All tests carried out suspected PIMS-TS but not consistent with other recorded symptoms. Heart scan, ct scan pelvis and abdomen, bone marrow biopsy. Several blood tests and cultures.'' No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733378 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Vesicular murmurs; Result Unstructured Data: normal; Test Date: 20210906; Test Name: Head CT; Test Result: Inconclusive ; Result Unstructured Data: test results for Head CT were not provided
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-783791) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE , MALAISE , HEADACHE and PYREXIA in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 05-Sep-2021, the patient experienced SYNCOPE (seriousness criterion medically significant), MALAISE (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). At the time of the report, SYNCOPE , MALAISE , HEADACHE and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Computerised tomogram head: not provided (Inconclusive) test results for Head CT were not provided. On an unknown date, Cardiac murmur functional: normal (normal) normal. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. On general examination patient was alert, eupneic in well perfused ambient air, no rigor, no neurological deficits. Normal vesicular murmurs, RVT, abdomen not painful no edema or signs of DVT. Rechallenge with respect to events is Unknown Company comment: This case concerns a 21-year-old female patient with no relevant medical history who experienced serious unexpected events of Syncope, Malaise, Headache and Pyrexia. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown since it was not provided whether the patient received the first or the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. 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. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21-Sep-2021 and laboratory data and narrative updated.; Sender''s Comments: This case concerns a 21-year-old female patient with no relevant medical history who experienced serious unexpected events of Syncope, Malaise, Headache and Pyrexia. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown since it was not provided whether the patient received the first or the second dose. The events are consistent with the current understanding of the mechanism of action of the vaccine. 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. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1733425 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Electrocardiogram, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anticholinergic syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Comments: at 11:40; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:92/64 mmHg; Comments: at 11:46; Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:no abnormality mmHg; Test Date: 20210905; Test Name: blood test; Result Unstructured Data: Test Result:no allergic reaction was recognized; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210905; Test Name: pulse; Result Unstructured Data: Test Result:80; Comments: /min at 11:46; Test Date: 20210905; Test Name: oxygen saturation; Test Result: 97 %; Comments: at 11:46
CDC Split Type: JPPFIZER INC202101184539

Write-up: Vasovagal reflex/vagal reflex; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21126369. An 18-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 05Sep2021 at 11:30 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) (at the age of 18 years old) as dose 1, single for COVID-19 immunisation. Medical history included convulsion. The patient''s concomitant medications were not reported. On 05Sep2021 around 11:30 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 05Sep2021 at 11:40 (10 minutes after vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: On 05Sep2021 around 11:30 (the day of vaccination), the vaccination of COMIRNATY was performed at a privacy place. After the vaccination, light-headed feeling appeared. On 05Sep2021 at 11:40 (10 minutes after the vaccination), blood pressure was 80/50 mmHg min. Considering the situation, anaphylaxis was suspected, so EPIPEN was intramuscularly injected (on the left thigh). On 05Sep2021 at 11:46 (16 minutes after the vaccination), blood pressure was 92/64 mmHg. Pulse was 80/min. oxygen saturation (room) was 97%. The level of consciousness did not decline. The patient had never had a feels poorly caused by an injection. The patient said that the usual blood pressure was 100s mmHg. After confirming that the blood pressure increased, emergency transport was requested, and went to emergency department of a privacy hospital for treatment. The patient was examined in the hospital and there was no abnormality found in electrocardiogram or blood pressure and so on. And no allergic reaction was recognized in blood test as well. Therefore, it was thought that the symptoms were vagal reflex. Symptoms improved after the examination in the hospital and the patient went home. The patient underwent laboratory tests and procedures which included body temperature: 36.7 degrees on 05Sep2021 (before vaccination). On 05Sep2021(the day of vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. Reporter comment: Anaphylaxis was denied, so the second vaccination of COMIRNATY was considered as possible. But there was a high possibility that same symptoms would appear. Therefore, when the second vaccination performed at the vaccination venue, the physician thought that the patient should receive vaccination in a resting position. And when vaccination other than collective vaccination was required, instructed the patient to receive the vaccination in a hospital. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Anaphylaxis was denied, so the second vaccination of COMIRNATY was considered as possible. But there was a high possibility that same symptoms would appear. Therefore, when the second vaccination performed at the vaccination venue, the physician thought that the patient should receive vaccination in a resting position. And when vaccination other than collective vaccination was required, instructed the patient to receive the vaccination in a hospital.


VAERS ID: 1733432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101191333

Write-up: After that, she became unconscious for a moment and fell; After that, she became unconscious for a moment and fell; bruised from the upper left eyelid to the left cheek; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). The patient was an unknown pregnancy status female adult. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Concomitant medications were not reported. On 05Sep2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF3620, Expiration date: 30Nov2021) intramuscular in the left arm for COVID-19 immunization. On 05Sep2021, the patient experienced events as follows: the patient was sitting on sofa when administrated. After that, she became unconscious for a moment and fell, and when she noticed, she was bruised from the upper left eyelid to the left cheek. Her consciousness quickly recovered, she moved to bed in a wheelchair, and walked home as a follow-up until her condition settled down. The reporter stated the event result in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered without treatment in Sep2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between all the reported events and the suspect drug BNT162B2 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: 1733436 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Fall, Heart rate, Oxygen saturation, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:117/75; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210905; Test Name: P; Result Unstructured Data: Test Result:62; Test Date: 20210905; Test Name: SPO2; Result Unstructured Data: Test Result:99
CDC Split Type: JPPFIZER INC202101191950

Write-up: Syncope; slipped off the chair; vagal reflex; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126370. The patient was a 15-year and 4-month-old male (age at vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Sep2021 at about 13:35 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route as a single dose for COVID-19 immunization. Event onset date was reported as 05Sep2021 at 13:43 (the day of vaccination). On 05Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: About 10 minutes after the vaccination, the patient suddenly slipped off the chair and was in state of syncope at this time. Immediately after that, the patient had an immediate reaction to a call, and the patient was transported to emergency room on a stretcher. The patient was placed on the bed for observation, at this time, BP: 117/75, P:62, SPO2: 99. After 20 minutes, the symptoms improved, and after observation for 15 minutes, no abnormality were found, so the patient returned home. The reporting physician classified the event as serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered to be vagal reflex.


VAERS ID: 1733438 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Hypoaesthesia oral
SMQs:, Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache (Blood pressure 140s this morning, there was headache.); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:147/67; Comments: before vaccination; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:192/111; Comments: at 16:40; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:162/89; Comments: at 17:00; Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:140s; Comments: in the morning; Test Date: 20210905; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Comments: before vaccination; Test Date: 20210905; Test Name: PULSE RATE; Result Unstructured Data: Test Result:68; Comments: at 16:40; Test Date: 20210905; Test Name: PULSE RATE; Result Unstructured Data: Test Result:63; Comments: at 17:00
CDC Split Type: JPPFIZER INC202101192136

Write-up: BP192/111,BP162/89; Numbness lips; This is a spontaneous report from a contactable physician received from the regulatory agency. Regulatory authority report number is v21126331. A 60-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD0349; Expiration Date: 31Oct2021), via an unspecified route of administration on 05Sep2021 16:20 (at age of 60 years old) as single dose for COVID-19 immunisation. Medical history included Hypertension, headache (Blood pressure 140s this morning, there was headache). The patient''s concomitant medications were not reported. The patient was a 60-year old and 9-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included originally being treated for hypertension. Blood pressure 140s this morning, there was headache. Right before vaccination BP147/67. On 05Sep2021 at 16:20, the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FD0349, Expiration date: 31Oct2021), via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was 05Sep2021. The course of the event was as follows: On 05Sep2021 at 16:35 (15 minutes after vaccination), Numbness lips, clear consciousness appeared. On 05Sep2021 at 16:40 (20 minutes after vaccination), BP192/111, P68. The patient took a rest. On 05Sep2021 at 17:00 (40 minutes after vaccination), BP162/89, P63. The patient was recommended to rest at home because blood pressure improved slightly. The patient would consult with her family doctor. On 05Sep2021 (the day of vaccination), The outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2.; Sender''s Comments: Based on the information in the case report, the causal relationship between the event blood pressure increased and suspect drug BNT162B2 can 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: 1733474 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Cerebral thrombosis, Depressed level of consciousness, Dizziness, Eye movement disorder, Fall, Heart rate, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Quadriplegia, Seizure, Type I hypersensitivity, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:60 or so mmHg; Comments: It was difficult to palpate her blood pressure (BP 60 mmHg or so).; Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210905; Test Name: HR; Result Unstructured Data: Test Result:100 or so; Test Date: 20210905; Test Name: SpO2; Test Result: 90 %
CDC Split Type: JPPFIZER INC202101212330

Write-up: Anaphylaxis; light-headed feeling; Loss of consciousness; fell down backward; generalised convulsion-like; eyes were moved towards the right direction; extreme Depressed level of consciousness; It was difficult to palpate her blood pressure (BP 60 mmHg or so); SpO2 was bad at 90%; Vomiting (food leftover); quadriplegia was not clear; Immediate type (Type I); Anaphylactic shock; a possibility of cerebral thrombosis cannot be ruled out; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126821. The patient was a 62-year-old female (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Sep2021 at 13:55 (the day of vaccination), the patient received the second dose of bnt162b2 (Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Sep2021 at 13:55 (the day of vaccination), the patient experienced Anaphylaxis. Date of outcome and the outcome of the event was not provided. The course of the event was as follows: The patient presented no problems at the time of pre-screening and it was judged that vaccination could be performed. A few minutes after the vaccination, while the patient was chatting with the person in charge of the vaccination certificate, the symptom of light-headed feeling occurred. Immediately after that, the patient experienced Loss of consciousness, and she fell down backward presenting generalised convulsion-like symptom. At this time, it was observed that her eyes were moved towards the right direction, and she had extreme depressed level of consciousness. It was difficult to palpate her blood pressure (BP 60 mmHg or so). At first, her SpO2 was bad at 90%. With EPIPEN 1A (another 1A was added: 2As in total), her consciousness level was slightly improved (JCSC: 1-II level). During the course, the patient experienced Vomiting (food leftover). Her eyes being moved towards the right direction remained. Convulsion was subsided, and quadriplegia was not clear. HR 100 or so, no arrhythmia. The reporting physician classified the events as serious (Life-threatening) and assessed that the event was related to bnt162b2. It was unknown that there was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Immediate type (Type I), Anaphylactic shock, a possibility of cerebral thrombosis cannot be ruled out. It was considered to be unclear.


VAERS ID: 1733507 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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? 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: JPMODERNATX, INC.MOD20213

Write-up: Chest pain; This case was received via a regulatory authority (Reference number: 2021TJP092096) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported to a regulatory authority by a physician, was received via a regulatory authority (Ref,v21126104). On 04-Sep-2021, the patient received this vaccine (number of doses was unknown). On 05-Sep-2021, at 01:30, chest pain of unknown cause developed. ECG, blood test, and contrast CT showed no abnormalities. The patient was hospitalized. On 07-Sep-2021, the patient improved with follow-up alone. The symptoms resolved, and the patient was discharged from the hospital. The outcome of chest pain was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected event of Chest pain. The event occurred one day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1733512 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005286 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Weakness of upper limbs; Pyrexia; Malaise; This case was received via a regulatory authority (Reference number: 2021TJP092438) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, reported by a person in charge of the workplace vaccination, was received by a regulatory authority via Moderna''s adverse reaction reporting site (TASK0021598), and reported to a regulatory authority by a person in charge of the workplace vaccination, was received via a regulatory authority (Ref, v21126273). On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 05-Sep-2021, at 14:07, the patient received the 1st dose of this vaccine. After the vaccination, the patient was followed up in a sitting position, weakness of upper limbs developed. Blood pressure and Sp02 were within the normal range, but pyrexia of 38.0 degrees Celsius developed. The patient was raced to an emergency hospital because weakness persisted. On 06-Sep-2021, pyrexia of 37.5 developed. Malaise persisted. On 07-Sep-2021, pyrexia went down, but the patient had physical deconditioning. On 08-Sep-2021, pyrexia returned to normal, and malaise disappeared. The symptoms resolved. The outcome of weakness of upper limbs, pyrexia, and malaise 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.; Sender''s Comments: This case concerns a 22 year old male patient with medical history of seizure, who experienced the unexpected serious events of asthenia, pyrexia, and malaise, within same day after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1733571 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210905; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: Not specified, but the patient was diagnosed with perimyocarditis.; Test Date: 20210905; Test Name: Magnetic resonance imaging heart; Test Result: Inconclusive ; Result Unstructured Data: Results showed perimyocarditis.; Test Date: 20210905; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: Not specified other than that troponin showed "flat dynamics".
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via the Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00049839) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Echocardiogram: not specified (Inconclusive) Not specified, but the patient was diagnosed with perimyocarditis.. On 05-Sep-2021, Magnetic resonance imaging heart: perimyocarditiis (Inconclusive) Results showed perimyocarditis.. On 05-Sep-2021, Troponin: not specified (Inconclusive) Not specified other than that troponin showed "flat dynamics".. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information were provided. No treatment information were provided. Company comment: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. The events chest pain and myocarditis occurred 4 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Received on 20-SEP-2021 contains No New Information.; Sender''s Comments: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. The events chest pain and myocarditis occurred 4 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


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