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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 240 out of 5,069

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VAERS ID: 1397847 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Chills, Chromaturia, Headache, Lymphadenopathy, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vaccination site swelling, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Lactation decreased; Comments: Previous known allergies to short haired animals. Asthmatic. No other medical history. Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20200312; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Positive COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blister on injection site and swollen arm - recovering 48hours later; chills; sleepless first night; Fever chills; Swollen glands; Fever; Headache; Swollen arm; Blister; Brown urine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) (serious criterion - medically significant), BLISTER (Blister) (serious criterion - medically significant), CHROMATURIA (Brown urine) (serious criterion - medically significant), VACCINATION SITE SWELLING (blister on injection site and swollen arm - recovering 48hours later) (serious criterion - medically significant), and PYREXIA (Fever) (serious criterion - medically significant), in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional serious events is detailed below. Previous known allergies to short haired animals. Asthmatic. No other medical history. Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased and Suspected COVID-19 since 06-Mar-2020. Concurrent medical conditions included Asthmatic. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), (serious criterion - medically significant), BLISTER (Blister) (serious criterion - medically significant), CHROMATURIA (Brown urine) (serious criterion - medically significant), PYREXIA (Fever) (serious criterion - medically significant), HEADACHE (Headache) (serious criterion - medically significant), LYMPHADENOPATHY (Swollen glands) (serious criterion - medically significant), and PYREXIA (Fever chills) (serious criterion - medically significant). On an unknown date, the patient experienced VACCINATION SITE SWELLING (blister on injection site and swollen arm - recovering 48hours later) (serious criterion - medically significant), CHILLS (chills) (serious criterion - medically significant), and VOMITING (sleepless first night) (serious criterion - medically significant). On 05-Jun-2021, PYREXIA (Fever chills) had resolved. On 06-Jun-2021, HEADACHE (Headache) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), BLISTER (Blister), VACCINATION SITE SWELLING (blister on injection site and swollen arm - recovering 48hours later), CHILLS (chills), LYMPHADENOPATHY (Swollen glands) and VOMITING (sleepless first night) was resolving, CHROMATURIA (Brown urine) had not resolved and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2020, SARS-CoV-2 test: positive (Inconclusive) Positive COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397867 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Discomfort, Erythema, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swollen arm; Redness; mild discomfort; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Redness) in a 34-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 28-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Redness). 04-Jun-2021, the patient experienced DISCOMFORT (mild discomfort). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Redness) had not resolved and DISCOMFORT (mild discomfort) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced 7 days after infection, red swollen and hot patch (roughly 20 cm by 6 cm) which was causing mild discomfort. Relevant concomitant medications were not reported. Treatment medication was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.


VAERS ID: 1400800 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, SARS-CoV-2 test: (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant, Patient was not currently breastfeeding. No concomitant medication and treatment drug reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1400945 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MINOXIDIL; VITAMIN D
Current Illness: Hair loss; Vitamin D deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chills; felt feverish; Pain in arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and CHILLS (Chills) in a 35-year-old female patient 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. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 27-Mar-2020 to 12-Apr-2020. Concurrent medical conditions included Hair loss since 01-Jan-2015 and Vitamin D deficiency since 01-Jan-2018. Concomitant products included MINOXIDIL from 01-Jan-2015 to an unknown date for Hair loss, VITAMIN D from 01-Jan-2018 to an unknown date for Vitamin D deficiency. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 05-Jun-2021, the patient experienced CHILLS (Chills). 05-Jun-2021, the patient experienced PYREXIA (felt feverish). The patient was treated with PARACETAMOL for Pain in arm, Chills and Fever, at a dose of took 2 paracetamol 4 times a day to ease all reactions. On 06-Jun-2021, CHILLS (Chills) and PYREXIA (felt feverish) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced pain in arm at the injection site and in neck started and got worse during the day of the vaccine. After 24 hours also had chills and felt feverish. She took two paracetamol four times a day to ease all reactions, which helped for a few hours. Patient has not tested positive for COVID-19 since having the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1404117 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, SARS-CoV-2 test, Sleep disorder
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; sleep disturbance; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 30-year-old female patient 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. The patient''s past medical history included Lactation decreased. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and SLEEP DISORDER (sleep disturbance). At the time of the report, PAIN (Pain) had not resolved and SLEEP DISORDER (sleep disturbance) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient had non stop pain in her left arm (at the site of the injection) ever since the vaccination. A couple of hours after the vaccine the pain was so much that she could not really lift her arm . The only non-painful position was with it limp by her side, sitting/standing upright. The pain was about a 6 out of 10 and it stopped her from sleeping properly. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The patient was not currently breastfeeding. The patient did not tested positive for COVID-19 since having the vaccine. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1404366 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Choking, Dizziness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (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: EPIPEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antibiotic therapy (Patient had completed course of antibiotics 4 days ago but was not sure about name of antibiotic.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657591

Write-up: patient started feeling dizzy then she said she is choking; patient started feeling dizzy then she said she is choking; Anaphylaxis; This is a spontaneous report from a contactable pharmacist received from The Regulatory authority report number is [GB-MHRA-WEBCOVID-202106041048182580-JN5FU], Safety Report Unique Identifier [GB-MHRA-ADR 25419345]. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration at 1st dose, single on 04Jun2021 (Lot number: EW3143) for COVID-19 immunisation. The patient''s medical history included antibiotic therapy on an unknown date. Concomitant medications included epinephrine taken for an unspecified indication, start and stop date were not reported. The patient previously took adrenalin on an unknown date. The patient experienced patient started feeling dizzy then she said she is choking on an unspecified date and anaphylaxis on 04Jun2021. The clinical course was reported as follows: Patient started feeling dizzy then she said she is choking, at this point she was injected with Epipen and ambulance was called. She started feeling better but after 3-4 minute she said she is choking again. She was given another dose of adrenalin. She felt better and ambulance arrived. She was taken into hospital. Additional information: Patient had completed course of antibiotics 4 days ago but was not sure about name of antibiotic. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1404378 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, which reduces the immune response.); Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Increased shortness of breath; This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Increased shortness of breath) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. The patient''s past medical history included Immunodeficiency (Has an illness or condition, which reduces the immune response.). On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced DYSPNOEA (Increased shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Increased shortness of breath) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1404384 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT3002332 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vesicoureteral reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Rash; sore red rash painful to touch about 2 inches below the injection site; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) and VACCINATION SITE ERYTHEMA (sore red rash painful to touch about 2 inches below the injection site) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT3002332) for COVID-19 vaccination. The patient''s past medical history included Vesicoureteral reflux. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). 04-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (sore red rash painful to touch about 2 inches below the injection site) (seriousness criterion medically significant). At the time of the report, RASH (Rash) had not resolved and VACCINATION SITE ERYTHEMA (sore red rash painful to touch about 2 inches below the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided by the reporter. No treatment information was provided. Patient relevant medical history includes Long COVID investigations still going on. Patient stated that he had not tested positive for COVID-19 since having the vaccine. 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: 1404386 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Hypoaesthesia, Limb discomfort, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Patient has not had symptoms associated with COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Bruising; Arm discomfort; Numbness of upper arm; This regulatory authority case was reported by a consumer and describes the occurrence of CONTUSION (Bruising), LIMB DISCOMFORT (Arm discomfort) and HYPOAESTHESIA (Numbness of upper arm) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced CONTUSION (Bruising) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness of upper arm) (seriousness criterion medically significant). At the time of the report, CONTUSION (Bruising) and LIMB DISCOMFORT (Arm discomfort) had not resolved and HYPOAESTHESIA (Numbness of upper arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: covid-19 virus test-19 test (Negative) Patient has not had symptoms associated with COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned.Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial and was not breastfeeding No treatment medication information was mentioned For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. 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: 1404390 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Rash papular, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Generalized raised red spots trunk; Headache; Chills; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of RASH PAPULAR (Generalized raised red spots trunk), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle ache) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced RASH PAPULAR (Generalized raised red spots trunk) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, RASH PAPULAR (Generalized raised red spots trunk), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1404409 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Fatigue, Feeling abnormal, Nausea, Night sweats, Pain, SARS-CoV-2 antibody test
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Suspected COVID-19 (unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Spaced out), COLD SWEAT (Cold sweat), NIGHT SWEATS (Night sweat), PAIN (Ache), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (unsure when symptoms stopped) on 30-Jan-2021. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced COLD SWEAT (Cold sweat) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Spaced out) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (Spaced out), NAUSEA (Nausea) and FATIGUE (Tiredness) was resolving and COLD SWEAT (Cold sweat), NIGHT SWEATS (Night sweat) and PAIN (Ache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. It was reported that the patient felt tired the evening of the vaccine, had arm aches the next morning and as the day went on, patient had the flu like symptoms. Patient had full body ache, tiredness, the hot and cold sweats, the feeling of being sick. It took 2 days after the vaccine to feel ok. Patient had a feeling of spaced out now. Treatment information was unknown. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events cold sweat, night sweats, pain, nausea, fatigue, and feeling abnormal, 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 cold sweat, night sweats, pain, nausea, fatigue, and feeling abnormal, a causal relationship cannot be excluded.


VAERS ID: 1404416 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: Diarrhea; Nausea; Fever; Chills; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 33-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 Lactation decreased. On 04-Jun-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 06-Jun-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient not had symptoms associated with COVID-19 and was not enrolled in clinical trial. She was a very distressing 48 hrs and not something she wish to experience again. Patient was hesitant for her 2nd vaccine now. She had not tested positive for COVID-19 since having the vaccine Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1404430 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Limb discomfort, Monoparesis, Pain, Pain in extremity, Paresis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Paresis; Pain; Hives; Painful arm; Heaviness in arm; Left arm paresis; This regulatory authority case was reported by a consumer and describes the occurrence of PARESIS (Paresis), PAIN (Pain), PAIN IN EXTREMITY (Painful arm), LIMB DISCOMFORT (Heaviness in arm), MONOPARESIS (Left arm paresis) and URTICARIA (Hives) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and LIMB DISCOMFORT (Heaviness in arm) (seriousness criterion medically significant). 04-Jun-2021, the patient experienced MONOPARESIS (Left arm paresis) (seriousness criterion medically significant). On 07-Jun-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On an unknown date, the patient experienced PARESIS (Paresis) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). On 07-Jun-2021, MONOPARESIS (Left arm paresis) had resolved. At the time of the report, PARESIS (Paresis) and PAIN (Pain) had resolved, PAIN IN EXTREMITY (Painful arm) and LIMB DISCOMFORT (Heaviness in arm) was resolving and URTICARIA (Hives) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. The patient had sore arm then felt really heavy and painful to move even with painkillers it was started about 4 hours after injection. The patient right arm became very floppy for 2.5 days and to used his right arm to move left one. The patient was awake at night. The patient was unable to drive due to pain and arm not responding properly. The patient had hives on left thumb, spreading to the back of hands and up forearm. Settled after a few hours,12 hours later had the same thing but on right hand and forearm. The patient had not tested positive for COVID-19 since having the vaccine. Treatment medication included painkillers. 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: 1404451 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Muscular weakness, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 test-Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle weakness; Fever; Headache; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 on 18-Dec-2020. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 05-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), ARTHRALGIA (Joint pain) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2020, SARS-CoV-2 test: positive (Positive) COVID-19 test-Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Patient is not currently breastfeeding. 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: 1404501 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Dizziness, Eye pain, Headache, Pain in extremity, Rhinalgia, SARS-CoV-2 test, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain eye; Stinging of nose; Headache; Blurry vision; Dizzy; Painful arm; Confusion; This regulatory authority case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Painful arm), EYE PAIN (Pain eye), RHINALGIA (Stinging of nose) and HEADACHE (Headache) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No medical history was reported. Concomitant products included IBUPROFEN for Back pain. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced VISION BLURRED (Blurry vision) (seriousness criterion medically significant). On 07-Jun-2021, the patient experienced EYE PAIN (Pain eye) (seriousness criterion medically significant), RHINALGIA (Stinging of nose) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 05-Jun-2021, VISION BLURRED (Blurry vision) had resolved. On 06-Jun-2021, CONFUSIONAL STATE (Confusion) had resolved. At the time of the report, DIZZINESS (Dizzy) and PAIN IN EXTREMITY (Painful arm) was resolving and EYE PAIN (Pain eye), RHINALGIA (Stinging of nose) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, SARS-CoV-2 test: covid-19 virus test (Negative) COVID-19 virus test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1407422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: PCR test; Test Result: Positive
CDC Split Type: BRPFIZER INC2021655899

Write-up: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient''s father) from Pfizer medical information team. A female patient of unspecified age received bnt162b2 (COMIRNATY), unknown dose in May2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient''s father reported that his daughter took the pfizer vaccine last week and today she tested positive for Covid on 04Jun2021 and asked if it would be a false negative for PCR, since pfizer vaccine is from RNA. The outcome of the event was unknown. The batch number has been requested in follow-up-activities.


VAERS ID: 1407434 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002912 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Concussion, Dizziness, Fall, Headache, Loss of consciousness, Pain in extremity, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Increased; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Increased
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: suddenly fainted; lost consciousness for a few seconds; Fall; slight concussion; Light pain in the arm; Dizziness; Chills; Headache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (suddenly fainted) and LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) in a 26-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 in October 2020. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced SYNCOPE (suddenly fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) (seriousness criterion medically significant), FALL (Fall), CONCUSSION (slight concussion), PAIN IN EXTREMITY (Light pain in the arm), DIZZINESS (Dizziness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL from 04-Jun-2021 to 06-Jun-2021 for Fever, at a dose of 3 dosage form. On 04-Jun-2021, SYNCOPE (suddenly fainted) and LOSS OF CONSCIOUSNESS (lost consciousness for a few seconds) had resolved. On 07-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, FALL (Fall), CONCUSSION (slight concussion) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Light pain in the arm), DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 38 degree Celsius (High) Increased. On 05-Jun-2021, Body temperature: 37-38 degree Celsius (High) Increased. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. Patient states that he does not take any other medications and have no pre-existing medical conditions except that he wear glasses. Concomitant medications were not provided. Patient received the vaccine in the morning as an injection to the right arm, since the left arm is his dominant arm. patient was feeling good during the day, no fever, just light pain in the arm. In the evening, the patient visited his parent''s in-law and watched TV on the couch. the patient got up from the couch, walked about 10 meters and suddenly fainted. (patient was found half a meter away from the doorframe), he had lost consciousness for a few seconds, their relatives found the patient on the floor. (patient did not realize what was happening around him until he suddenly regained consciousness) then the patient had a fever (38 degree) and chills. patient waited for a while to feel better and then went to the emergency room on the same night. In the hospital, patient was diagnosed with slight concussion due to the fall. No treatment was prescribed. It was reported that the patient continued to have a light fever through Saturday (05-Jun-2021) and Sunday (06-Jun-2021) at around 37-38 Degree, so the patient took 1 tablet of paracetamol on Sunday evening. On 07-Jun-2021, patient fever is gone and there is still some feeling of dizziness, headache and light pain in the arm. 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. affiliate comment: This spontaneous report was received from a 26-year-old male consumer who received the first dose of Moderna''s COVID-19 Vaccine (mRNA1273) on 04-JUN-2021 in his right arm (Batch number: 3002912, exp date: unknown) for prophylaxis of COVID-19 infection. The reporter felt well during the day after the vaccination but experienced a slight pain in the vaccination arm which did not have any impact as his dominant arm was the left one. However, on the same day in the evening, when he was visiting his family and was watching TV, he got up from the couch, walked about 10 meters and suddenly fainted (verbatim: I found myself half a meter away from the doorframe). They had lost consciousness for a few seconds, his relatives found him on the floor (verbatim: I did not realize what was happening around me until I suddenly regained consciousness). After that, the reporter experienced fever (38?) and chills. He presented himself on the same evening to the local hospital for investigations in emergency. In the hospital, a slight concussion due to the fall was diagnosed, no treatment was prescribed. He applied self-treatment with 2 tablets of paracetamol for the reported fever. Over the next 2 days, the reporter continued to experience "slight fever" throughout Saturday, 05-JUN-2021 and Sunday, 06-JUN-2021 up to 37?-38?C; he applied an additional tablet of paracetamol on Sunday evening and the fever resolved by the next day 07-JUN-2021. At the moment of reporting on 07-JUN-2021, the fever was resolved but dizziness, headache and also a slight pain in the arm were still ongoing. The medical history did not include any relevant condition or comorbidity (except that the reporter had been wearing glasses) and no concomitant medication was used at the time of vaccination. The company assessed the case as serious. Company''s assessment: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Local assessment: Vaccination arm pain (onset latency: on the same day after the vaccination with the first dose, grade not reported ? described by the reporter as mild, unilateral, ipsilateral to the vaccination arm without impact on activities as the vaccination arm was the non-dominant one) [unlabeled / no additional risk minimization measures (aRMMs) necessary; episode of fainting with transitory loss of consciousness and fall leading to mild concussion (onset latency: in the evening of the vaccination day; assumed resolved by the moment of reporting with residual dizziness and headache; other physical signs or symptoms possibly associated with the reported concussion were not specified, possible late-onset symptoms following concussion not known at the moment of reporting; no symptoms which may have triggered the patient to get up from the coach were reported; possibly associated febrile state) [unlabeled / no aRMMs necessary for the general population; the patient was consulted in emergency by hospital physician; we assume vasovagal effects which did not require inpatient treatment, but specific tests to rule out other causes for fainting in this apparently healthy young man must be confirmed; the hospital report was not provided]; fever (up to 38?C) (onset latency: in the evening of the vaccination day, following fainting, resolved with paracetamol treatment over the next 2 days) [labeled / no aRMMs necessary for the general population; chills (onset latency: in the evening of the vaccination day, following fainting, resolved by the time of reporting) [labeled / no aRMMs necessary for the general population; headache and dizziness (onset latency: assumed after the reported fainting with concussion, grade not reported, ongoing at the time of reporting) [unlabeled in the context of fainting but headache alone is covered necessary for the general population. Action taken with the Moderna product in response to the reported events was not reported. The events reported on 07-JUN-2021 are assessed as possibly related to the vaccine, confounded by the ophthalmological condition and/or external visual triggers; pupillary pathways in triggering the event of fainting cannot be ruled out. The long-term outcome of the event is not known.; 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: 1408780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Atrophic vulvovaginitis, Chest pain, Loss of libido, Palpitations, Sensory loss
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
Previous Vaccinations:
Other Medications: BOOTS ALLERGY RELIEF ANTIHISTAMINE; MAEXENI; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021663807

Write-up: loss of sensation; Stomach pain; Lack of libido; Atrophy of vulva; Palpitations; Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106062104293270-6HRK8. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: FA1027), via an unspecified route of administration on an unspecified date as 1ST dose, Single Dose for COVID-19 immunisation. The patient''s medical history was not reported. The patient has not had symptoms associated with covid-19, has not had a covid-19 test, and is not enrolled in a clinical trial. Concomitant medications included chlorpheniramine maleate (BOOTS ALLERGY RELIEF ANTIHISTAMINE), ethinylestradiol, levonorgestrel (MAEXENI) taken from 01Jan2019, and paracetamol for unspecified indications (start and stop date were not reported). on an unspecified date the patient experienced loss of sensation. On 04Jun2021, the patient experienced stomach pain, lack of libido, atrophy of vulva, palpitations, and chest pain. The seriousness criteria of the events were considered to be other medically important condition. The patient reported that stomach pain and palpitations occurred during the night and caused her to wake up and intermittent dull chest pain followed on her right side. The patient also reported complete loss of sensation in clitoris. The outcome of the event loss of sensation was unknown. The outcome of the events palpitations, chest pain and stomach pain was on 05Jun2021. The outcome of the event lack of libido and atrophy of vulva was 06Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Hypoaesthesia, SARS-CoV-2 test, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hearing impairment (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: ARIPIPRAZOLE; MONTELUKAST
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Lactation decreased; Sciatica
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021708388

Write-up: atypical palsy; facial numbness; numbness facial; This is a spontaneous report from a contactable consumer received from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106130734234670-CMRTH, Safety Report Unique Identifier GB-MHRA-ADR 25466922. A 44-year-old female patient (non pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM4965) via an unspecified route of administration on 01May2021 as 2nd dose, single dose for covid-19 immunization. Medical history included suppressed lactation, sciatica, asthma, bipolar disorder. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient was not breastfeeding at the time of reporting. Concomitant medication included aripiprazole taken for bipolar disorder, start and stop date were not reported, montelukast taken for asthma, start and stop date were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER1741), via unspecified route of administration on 27Feb2021 as 1st dose, single dose for covid-19 immunization for the reaction sciatica. The patient experienced atypical palsy and facial numbness on an unspecified date. Facial numbness had started some weeks after second dose. Atypical palsy, cranial nerves test was ok. Nurse practitioner advised the patient to report here. The patient also experienced numbness facial on 04Jun2021. The patient had also registered that sciatica which was started sometime after first dose (atypical, numb but no pain). 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 (SARS-CoV-2 test): result negative on an unspecified date (No - Negative COVID-19 test). The outcome of events palsy and facial numbness was recovering, and numbness facial was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1408907 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994/ EX65 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021654767

Write-up: Faint post vaccination; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program. A 22-years-old non pregnant female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# PAA165994/ EX6537), via an unspecified route of administration on 04Jun2021 at 10:00 into arm left as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04Jun2021 at 10:30, the patient experienced faint post vaccination. Therapeutic measures were taken as a result of faint post vaccination. The outcome of the event was recovered.


VAERS ID: 1409227 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021673229

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable physician, received via a sales representative. The patient was a non-pregnant 82-year-old female. Relevant medical history included dementia. Allergic information was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant drugs prescribed at another hospital within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021 at 11:30 (the day of vaccination, at 82-year-old, not pregnant at the time of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 04Jun2021 at 11:45 (15 minutes after the vaccination), the patient experienced anaphylactic shock. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was resolved in Jun2021 with treatment including oxygen administration, adrenaline, and steroid. The reporting physician classified the event as serious (life threatening). Additional clinical course on 11Jun2021: After the vaccination, symptoms of anaphylactic shock such as blood pressure decreased, bradycardia, and wheezing appeared, for which the patient received the treatment including steroid. When an emergency service arrived, the symptoms settled down, but just to be safe, the patient was admitted to a hospital overnight where she was transferred.; Sender''s Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported event of anaphylactic shock, based on temporal relationship and the known product safety profile. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. Based on the information provided in the case, this individual report would not seem to modify the risk-benefit profile of the subject product.


VAERS ID: 1409842 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP037333

Write-up: Thrombus (blackened index finger); This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Thrombus (blackened index finger)) in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Hyperlipidaemia. On 01-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced THROMBOSIS (Thrombus (blackened index finger)) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Thrombus (blackened index finger)) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered THROMBOSIS (Thrombus (blackened index finger)) to be possibly related. The concomitant medications were not provided. The treatment information was not provided Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. further information has ben requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. further information has ben requested.


VAERS ID: 1410590 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Dizziness, Dyspnoea, Headache, Hyperhidrosis, Loss of consciousness, Muscle spasms, Palpitations, Speech disorder, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021665377

Write-up: loss of consciousness; confusion; difficult with elocution; heart palpitations; blurred vision; difficulty breathing; dizziness; headache; painful cramping in the calf; sweating; This is a spontaneous report from a contactable nurse (patient). This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 04Jun2021 14:45 (at the age of 34-year-old) (Lot Number: EW0221) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was not pregnant. On 04Jun2021 at 23:45, the patient experienced loss of consciousness, confusion, difficult with elocution, heart palpitations, blurred vision, difficulty breathing, dizziness, headache, painful cramping in the calf and sweating; the event loss of consciousness was considered serious as medically significant, all the other events were non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No hospitalization was required; the patient received oxygen mask as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.; Sender''s Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1410656 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Postmenopausal 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: Medical History/Concurrent Conditions: Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021659403

Write-up: Bleeding in the menopause; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 51-year-old on 01Jun2021 15:15 (Lot Number: 1D016A) as single dose for COVID-19 immunisation. Medical history included menopause. The patient was not pregnant. The patient''s concomitant medications were not reported. On 04Jun2021 the patient experienced bleeding in the menopause. The event was considered as serious as it was medically significant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was reported as recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
SMQs:, 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 202106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:not tested positive; Comments: since having the vaccine
CDC Split Type: GBPFIZER INC2021655437

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106040634485900-SEXV2, Safety Report Unique Identifier GB-MHRA-ADR 25417918. A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot number and expiry date were not reported) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 25Mar2021 to 04Apr2021. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes (medically significant) on 04Jun2021 with outcome of not recovered. The patient had positive COVID-19 virus test on 26Mar2021. Patient has not tested positive for COVID-19 in Jun2021 since having the vaccine. No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.


VAERS ID: 1411613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Nausea, Presyncope, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655512

Write-up: Blurring of vision; Period pains; Near fainting; Nausea; Fainting; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106040750499600-Y7XHU and Safety Report Unique Identifier GB-MHRA-ADR 25418332. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 as single dose for COVID-19 immunisation. Medical history included pregnancy. She was no longer pregnant at the time of reporting. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced nausea and fainting on an unspecified date; period pains and near fainting on 04Jun2021. Case narrative: Period started and was accompanied by extreme nausea, pains and fainting/temporary blurring of vision on an unspecified date. This lasted for around 40 minutes and was very different to normal period reactions. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from nausea and fainting on an unspecified date; recovering from period pains and near fainting; while outcome of blurring of vision was unknown. Case was reported as medically significant by health authority. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1411618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chillblains, SARS-CoV-2 test
SMQs:, Accidents and injuries (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657784

Write-up: Chilblains; This is a spontaneous report. A 38-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW3143), via an unspecified route of administration on 31May2021 as a 1st dose, single dose for COVID-19 immunization. The patient''s medical history included lactation decreased, hypothyroidism from an unknown date and unknown if ongoing. The patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medication included Levothyroxine taken for hypothyroidism from 05Sep1982 to an unspecified stop date. On an unknown date, the patient underwent lab test which included sars-cov-2 test which shown negative results for COVID-19. On 04Jun2021, the patient experienced chilblains as very painful swollen big toe on right foot which looked like a blood blister under the toenail and feels as if toenail was going to burst off. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411731 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021654698

Write-up: Fainted after vaccination; This is a spontaneous report from a contactable consumer (patient) received from Pfizer sponsored program. A 24-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in right arm, on 04Jun2021 at 13:30 (Lot number: EW6126, at the age of 24-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fainted after vaccination on 04Jun2021 13:30. There were no treatment for the event. The outcome of the event was recovered on unspecified date in Jun2021.


VAERS ID: 1411760 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994/EX653 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021654953

Write-up: Faint post vaccination; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 24-year-old male patient received bnt162b2 (COMIRNATY, Lot# Paa165994/EX6537), dose 1 via an unknown route of administration administered at the age of 24-year-old on arm left on 04Jun2021 14:00 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced faint post vaccination on 04Jun2021 14:00 with outcome of recovered. No treatment received.


VAERS ID: 1411887 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Auscultation, Blood pressure increased, Blood pressure measurement, Body temperature, Conjunctival hyperaemia, Dizziness, Feeling cold, Heart rate, Hypoaesthesia, Oropharyngeal discomfort, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYMBICORT; ALLEGRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (drugs used included Steroid inhalation drugs, symbicort and allegra, etc); Dermatitis atopic
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: chest auscultation; Result Unstructured Data: Test Result:no abnormality; Comments: 15:40; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:187/113; Comments: 13:40; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:168/105; Comments: 13:45; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:177/10; Comments: 13:55; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:106/102; Comments: 14:00; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:155/100; Comments: 14:10; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/122; Comments: 14:25; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:138/81; Comments: 14:50; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/86; Comments: 15:10; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/103; Comments: 15:15; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:148/108; Comments: 15:25; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:138/95; Comments: 15:35; Test Date: 20210604; Test Name: bodytempurature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: 14:30; Test Date: 20210604; Test Name: bodytempurature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: 15:00; Test Date: 20210604; Test Name: bodytempurature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before the vaccinations; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:100; Comments: 13:40; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:110, ranging from 99 to 112; Comments: 13:45; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:100; Comments: 13:55; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:100; Comments: 14:00; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:80; Comments: 14:10; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Comments: 14:25; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:80-95; Comments: 14:50; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:85; Comments: 15:10; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:86; Comments: 15:15; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:91; Comments: 15:25; Test Date: 20210604; Test Name: SPO2; Test Result: 96 %; Comments: 13:40; Test Date: 20210604; Test Name: SPO2; Test Result: 99 %; Comments: 13:45; Test Date: 20210604; Test Name: SPO2; Result Unstructured Data: Test Result:96-97 %; Comments: 13:55; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %; Comments: 14:00; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %; Comments: 14:10; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %; Comments: 14:25; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %; Comments: 14:50; Test Date: 20210604; Test Name: SPO2; Test Result: 97 %; Comments: 15:10; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %; Test Date: 20210604; Test Name: SPO2; Result Unstructured Data: Test Result:97-98 %; Comments: 15:25
CDC Split Type: JPPFIZER INC2021653908

Write-up: Chilliness; Light-headed feeling/Swaying feeling; Anaphylaxis; Blood Pressure 187/113; bulbar conjunctiva hyperaemia; throat discomfort; Palpitations; Numbness of both upper limbs; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and received via RA. The patient was a non-pregnant 42-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Symbicort and Allegra within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included Asthma bronchial and Dermatitis atopic. On 04Jun2021 at 13:30 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. Event onset date was reported as 04Jun2021 at 13:45 (as reported). Clinical course of events as follow: On 04Jun2021 13:30, the patient was vaccinated. 10 minutes after vaccination, the patient experienced bulbar conjunctiva hyperaemia, throat discomfort, Palpitations, Numbness of both upper limbs, Blood Pressure 187/113, Pulse rate 100, SpO2 96%. At 13:45, Blood Pressure 168/105, Pulse rate 110, SpO2 99% Pulse rate ranging from 99 to 112, Numbness in the left upper limb disappeared. At 13:55, blood pressure 177/10 (as reported), Pulse rate 100, SpO2 96-97%, Numbness in the right upper limb disappeared. At 14:00, Blood pressure 106/102, Pulse rate 100, SpO2 98%, Numbness in both upper limbs disappearedd. Bulbar conjunctiva hyperaemia was recovering. At 14:10, Blood pressure 155/100, Pulse rate 80, SpO2 98%. At 14:20, walking to the toilet with feeling of urination, and had chillness and Light-headed feeling when walking. At 14:25, Blood pressure 166/122, Pulse rate 67, SpO2 98%. At 14:30, Lactec 500ml was started via iv drip for 2 hours, body temperature 37.2 Centigrade. At 14:50, Blood pressure 138/81, Pulse rate 80-95, SpO2 98%. At 15:00, body temperature 37.1 Centigrade. At 15:10, Blood pressure 133/86, Pulse rate 85, SpO2 97%, walking to the toilet with a feeling of urination, and there was still Swaying feeling. At 15:15, Blood pressure 140/103, Pulse rate 86, SpO2 98%. At 15:25, Blood Pressure 148/108, Pulse rate 91, SpO2 97-98%. At 15:35, Blood pressure 138/95. At 15:40, there was no abnormality in chest auscultation, Bulbar conjunctiva hyperaemia was recovering, no redness and other symptoms. The patient was walking home. The patient was 42-year and 6-month-old female. Body temperature before the vaccinations was 36.1 degrees Centigrade. The patient''s family history was none. 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, etc.) included drugs used due to bronchial asthma included Steroid inhalation drugs, symbicort and allegra, etc. There was Dermatitis atopic. the patient self-stated that no asthma attack in this year. Since last Apr, there had been no job change due to asthma attack. No night shift. On 04Jun2021(the day of vaccination) at 13:40 (as reported), the patient experienced Anaphylaxis. On 04Jun2021 (the day of vaccination), the outcome of event was recovered. Clinical course of events as follow: 10 minutes after vaccination, the patient experienced Hyperemia of eyeball (as reported), Throat discomfort, Palpitations, Numbness of both upper limbs, Blood Pressure 187/113, Pulse rate 100, SpO2 96%. At 14:00, Blood pressure 106/102, Pulse rate 100, SpO2 98%, Numbness in both upper limbs disappeared. Hyperemia of eyeball (as reported) was recovering. At 15:40, there was no abnormality in chest auscultation, Bulbar conjunctiva hyperaemia (as reported) was recovering, no redness and other symptoms. The patient was walking home. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. Other possible cause of the event such as any other diseases was none. The outcome of the event was recovered on 04Jun2021, Numbness of both upper limbs was recovered on 04Jun2021 14:00 with treatment including observation and infusion. The reporter classified the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on a very close time of vaccine administration to onset (10 mins) of events (anaphylactic reaction, conjunctival hyperemia, throat discomfort, palpitations, hypoasthesia, blood pressure increased, dizziness and chilliness), causality secondary to the COVID 19 vaccine cannot be denied.


VAERS ID: 1411902 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cold sweat, Erythema, Nausea, Pallor, Pruritus, Pulse abnormal, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea; Food allergy (dyspnoea with peanut, almond and lotus root urticaria with beef and mackerel); Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021654100

Write-up: vomiting; cold sweat; pallor facial; Anaphylaxis; Systemic pruritus without rash; redness; Central pulse weakness; Pharynx closed sensation of; nausea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111754. A 35-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EY0779, expiration date: 31Aug2021) at the age of 35-years, via an unspecified route of administration on 04Jun2021 at 11:35 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade. Through the vaccine screening questionnaire, the patient had food allergy: experienced dyspnoea with peanut, almond and lotus root; experienced urticaria with beef and mackerel. The patient was taking fexofenadine hydrochloride (ALLEGRA) orally. The patient had no allergy to the vaccine. The onset of events was on 04Jun2021 at 11:50 (15 minutes after the vaccination), the patient experienced anaphylaxis, systemic pruritus without rash, redness, vomiting, cold sweat, pallor facial, central pulse weakness, pharynx closed sensation of and nausea. The course of the event was as follows: 11:35 vaccination; 11:50 itching, redness; 11:56 vomiting, cold sweat, pallor facial. No respiratory symptoms, no symptoms of blood pressure decreasing, no symptom of palpitation. The patient was diagnosed as anaphylaxis. In that, at 12:06, epinephrine (ADRENALINE) 0.3 ml was administrated through intramuscular injection. An intravenous line was secured, large amount of metoclopramide hydrochloride (PRIMPERAN) was administrated intravenously. Methylprednisolone sodium succinate (SOLU-MEDROL) was administrated through injection via iv drip. The symptoms were relieved (whole process within 1 hour). The ticked symptoms in classification were provided as attachment: Major symptoms: Central pulse weakness. Minor symptoms: systemic pruritus without rash, pharynx closed sensation of, nausea and vomiting. 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 reporter commented as follows: classification Level 3. Outcome of the events was recovering/resolving.


VAERS ID: 1411918 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021655935

Write-up: Dizziness; Nausea; This is a spontaneous report from a contactable nurse received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 77-year-old female. 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. Other medical history included hypertension and cardiac failure. On 02Jun2021at 12:45 (the day of vaccination), the patient received the first single dose (also reported as 6th dose, pending clarification) of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 04Jun2021 at 5:00 (1 day 16 hours 15 minutes after the vaccination), the patient experienced dizziness and nausea. The outcome of the event was recovered with treatment by drip infusion. The reporter stated the events results in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1411940 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Cough, Dyspnoea, Erythema, Heart rate, Heart rate increased, Nausea, Oxygen saturation, Pruritus, Respiratory rate, Respiratory rate increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:58; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:112; Test Date: 20210604; Test Name: SPO2; Result Unstructured Data: Test Result:98 to 99 %; Test Date: 20210604; Test Name: respiratory rate; Result Unstructured Data: Test Result:32
CDC Split Type: JPPFIZER INC2021656239

Write-up: Anaphylaxis; Dyspnoea; Redness around the neck/Redness with thigh; itching/itching with thigh; cough; Nausea; Respiratory rate was 32; Pulse rate was 112; blood pressure was 58; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21111866. A 49-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 04Jun2021 at 16:00 at age of 49 years old as single dose for COVID-19 immunization. Medical history included shrimp allergy. Concomitant medications were unknown. The patient previously received lidocaine (XYLOCAINE) and experienced drug allergy. The course of the event was as follows: On 04Jun2021 at 16:05 (5 minutes after the vaccination, as reported), the patient experienced Dyspnoea, Redness around the neck, Itching, Cough, Nausea, Redness with thigh and itching. And Pulse rate was 112, respiratory rate was 32, blood pressure was 58, SPO2 was 98 to 99 %.The patient began to inhale oxygen, BOSMIN 0.3mg, Atarax-P 25 mg Intramuscular, Meptin air 2 push was enforced. Secure the route and 100 ml of saline and Solu-Medrol 125mg was administration. The patient was hospitalized. This report meet the criteria of Anaphylaxis. The outcome of the events were unknown. The reporting physician classified the event as serious (Hospitalized) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411943 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Blood pressure measurement, Body temperature, Cough, Heart rate, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:160/86; Comments: 14:26; Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:157/71; Comments: 14:46; Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:94; Comments: 14:26; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:74; Comments: 14:30; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:74; Comments: 14:34; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:79; Comments: 14:37; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:78; Comments: 14:44; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:75; Comments: 14:46; Test Date: 20210604; Test Name: Spo2; Test Result: 91 %; Comments: 14:24; Test Date: 20210604; Test Name: Spo2; Test Result: 95 %; Comments: 14:26; Test Date: 20210604; Test Name: Spo2; Test Result: 92 %; Comments: 14:30; Test Date: 20210604; Test Name: Spo2; Test Result: 98 %; Comments: 14:34; Test Date: 20210604; Test Name: Spo2; Test Result: 97 %; Comments: 14:37; Test Date: 20210604; Test Name: Spo2; Test Result: 97 %; Comments: 14:44
CDC Split Type: JPPFIZER INC2021656255

Write-up: asthma; Spo2 decreased to 91%; Anaphylaxis; cough; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is. The patient was an 88-year and 3-month-old male. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jun2021 at 14:12, the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) at the age of 88-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. On 04Jun2021 at 14:23 , the patient experienced events. On 04Jun2021 , the outcome of the event was recovering. The course of the event was as follows: On 04Jun2021 at 14:23, cough occurred. On 04Jun2021 at 14:24, Spo2 decreased to 91% and the patient started wearing oxygen masks. On 04Jun2021 at 14:26, BP was 160/86, P94 Spo2 95%. On 04Jun2021 at 14:30, the patient developed asthma, Spo2 92% P74. On 04Jun2021 at 14:33, BOSMIN 0.3mg was given via intramuscular. On 04Jun2021 at 14:34, Spo2 was 98% P74, normal saline 500ml was given to establish infusion route. On 04Jun2021 at 14:37, solu-medrol 125mg+normal saline 100ml were administered, asthma disappeared. Spo2 was 97% P79. On 04Jun2021 at 14:43, nasal cannula 1 L/min. On 04Jun2021 at 14:44, Spo2 was 97%, P78. On 04Jun2021 at 14:46, BP was157/71, P75. On 04Jun2021 at 14:50, the first-aid team arrived. The reporting physician classified the event as serious(hospitalization from 04Jun2021 to 05Jun2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. This report meet the criteria of Anaphylaxis.


VAERS ID: 1411965 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TELMISARTAN; JANUVIA [SITAGLIPTIN PHOSPHATE]; MAGNESIUM OXIDE; BROTIZOLAM; S.M COMBINATION POWDER; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; PITAVASTATIN CA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malignant tumour excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021657073

Write-up: Queasy; Cough; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 28-year-old female. 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. Other medical history included resection of lung cancer. Concomitant medications included telmisartan, sitagliptin phosphate (JANUVIA), magnesium oxide, brotizolam, aluminium magnesium silicate, diastase, taka (S.M COMBINATION POWDER), esomeprazole magnesium (NEXIUM), pitavastatin calcium (PITAVASTATIN CA). On 04Jun2021 at 14:15 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021), at vaccination age of 28 years, intramuscular in the left arm for COVID-19 immunization. On 04Jun2021 at 14:30 (15 minutes after the vaccination), the patient experienced queasy and cough. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including injection of Hydrocortisone. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events queasy and cough. 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: 1411975 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cough, Depressed level of consciousness, Pruritus, Tachycardia
SMQs:, Anaphylactic reaction (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021658235

Write-up: Consciousness disturbed; Consciousness clouding; tachycardia; cough; itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111814. The patient was a 49-year and 8-month-old female. Body temperature before vaccination was not provided. The patient had relevant medical history of Asthma. On 04Jun2021 around 10:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. Event terms were reported as itching, cough, tachycardia and Consciousness disturbed. Event onset date was reported as 04Jun2021. The course of the event was as follows: On 04Jun2021 at 10:05 (5 minutes after the vaccination), the patient experienced itching. On 04Jun2021 at 10:10 (10 minutes after the vaccination), the patient experienced cough. On 04Jun2021 at 10:15 (15 minutes after the vaccination), the patient experienced tachycardia and administered EPIPEN. On 04Jun2021 at 10:30 (30 minutes after the vaccination), the patient''s symptoms didn''t improved and administered EPIPEN, and experienced Consciousness clouding, so she was sent to this hospital. On 04Jun2021 (the same day after the vaccination), the outcome of the event was recovered. 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: I thought that it was the allergic reaction of COVID-19 vaccination. And not the Anaphylaxis.


VAERS ID: 1411976 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: TOKISHAKUYAKUSAN [ALISMA PLANTAGO-AQUATICA VAR. ORIENT. TUBER;ANGELICA ACUTILOBA ROOT;ATRACTYLODES L; MAKYOYOKUKANTO; DICLOFENAC; REBAMIPIDE; PREGABALIN; MENDON; KUMIBINROTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lumbago
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021658262

Write-up: Dyspnoea; cough; mild wheezing; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111840. A 45-year and 2-month-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: FA2453; Expiration Date: 31Aug2021) via unspecified route single dose for COVID-19 immunisation on 04Jun2021 14:00, at 45-year-old. Medical history included asthma, lumbago. Body temperature before vaccination was 35.6 degrees Centigrade. Concomitant medications included: alisma plantago-aquatica var. orient. tuber, angelica acutiloba root, atractylodes lancea rhizome, cnidium officinale rhizome, paeonia lactiflora root, poria cocos sclerotium (TOKISHAKUYAKUSAN); coix lacryma-jobi subsp. ma-yuen seed, ephedra spp. herb, glycyrrhiza spp. root, prunus spp. seed (MAKYOYOKUKANTO); diclofenac; rebamipide; pregabalin; clorazepate dipotassium (MENDON); areca catechu seed, aucklandia costus root, cinnamomum cassia bark, citrus spp. fruit peel, glycyrrhiza spp. root, magnolia spp. bark, perilla frutescens var. crispa herb, poria cocos sclerotium, rheum spp. rhizome, tetradium ruticarpum fruit, zingiber officinale rhizome (KUMIBINROTO, reported as Kotaro KUMIBINROTO extract fine granules). The course of event was as follows: The event onset date was reported as 04Jun2021 at 14:00 (same day of vaccination). After the first inoculation of the BNT162B2, the patient experienced Dyspnoea. Although one tablet of Loratadine was took orally, and then the patient started to cough. Right chest auscultation, and there was a mild wheezing. Intravenous drip of hydrocortisone sodium succinate (SOLU-CORTEF), it recovered after using hydrocortisone sodium succinate. On 04Jun2021 (same day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed the causality between the event and BNT162B2 as unassessable. The reporting physician commented as follows: Originally the patient had asthma, relationship was unknown.


VAERS ID: 1411979 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Oxygen saturation, Palpitations, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (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: Medical History/Concurrent Conditions: Anaphylactic shock (unknown cause); Cerebral haemangioma; Cerebral haemorrhage; Skin eruption
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:171/94; Comments: At 10:00; Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:138/89; Comments: At 10:30; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:108; Comments: At 10:00; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:75; Comments: At 10:30; Test Date: 20210604; Test Name: SpO2; Result Unstructured Data: Test Result:99 (ROOM Air) %; Test Date: 20210604; Test Name: SpO2; Test Result: 100 %
CDC Split Type: JPPFIZER INC2021658352

Write-up: BP 171/94; P 108; Palpitations; Tremor finger; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111747. The patient was a 56-year-old female. Body temperature before vaccination was 35.6 Centigrade. On 31Jan2021, the patient had a past medical history of Anaphylactic shock of unknown cause. EPIPEN was prescribed. The patient had a history of cerebral haemorrhage caused by cavernous cerebral haemangioma. On 04Jun2021 at 09: 30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at 56-year-old female for COVID-19 immunization. On 04Jun2021 at 09: 40 (10 minutes after the vaccination), the patient experienced Palpitations and Tremor finger. The course of the event was as follows: After vaccination, there were Palpitations and Tremor finger. Symptoms would appear and disappear every 10 minutes or so. On 31Jan2021, there was a skin eruption during shock, but today there was no skin eruption. At 10:00, BP 171/94, P 108, SpO2 99% (ROOM Air). The patient rest in bed, and was observed the course of the disease. The patient was measured blood pressure every 5 minutes. At 10:30, BP 138/89, P 75, SpO2 100%. Symptoms almost disappeared and the patient went home on foot at 10:45. On 04Jun2021 (the same day of vaccination), the outcome of the event was recovered. The reporter classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. The reporter commented as follows: Since symptoms similar to the precursors of the shock on 31Jan2021 were observed, the course of the disease was observed, but the blood pressure did not decrease, but recovered. However, because it had not been found out the reason for the previous anaphylactic shock, so the reporter thought it was best not to get the second shot.


VAERS ID: 1411982 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Nausea, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/79; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: P; Result Unstructured Data: Test Result:61
CDC Split Type: JPPFIZER INC2021658438

Write-up: Vasovagal reflex; feels poorly (queasy); feels poorly (queasy); This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111839. The patient was a 26-year-old female. Body temperature before vaccination was 36.4 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). There was no medical history or On 04Jun2021 at 13: 30 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration at age of 26-years, as a single dose for COVID-19 immunization. On 04Jun2021 at 13: 45 (15 minutes after the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: The patient was vaccinated at 13:30 and had feels poorly (queasy) after 15 minutes. Blood pressure 113/79, P 61, No arrhythmia, No cyanosis. Because of persistent queasy, the intravenous drip started at 2:35 (SOLDEM 200ml and Primperan 1A). The symptom of feels poorly (queasy) disappeared at the end of the intravenous drip (as reported). After resting for a while, the patient went home. On 04Jun2021 (the same day of vaccination), the outcome of the event was recovering (as reported). The reporter classified the event as non-serious and assessed the causality between the event and bnt162b2 as un-assessable. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information expected.


VAERS ID: 1411985 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Body temperature, Cold sweat, Dyspnoea, Heart rate, Heart rate decreased, Hyporesponsive to stimuli, Oxygen saturation, Palpitations, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:140-90; Comments: 2 minutes after the vaccination; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:118-70; Comments: 10 minutes after the administration of drugs; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:45; Comments: 2 minutes after the vaccination; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:47; Comments: 10 minutes after the administration of drugs; Test Date: 20210604; Test Name: Oxygen saturation; Test Result: 98 %; Comments: 2 minutes after the vaccination; Test Date: 20210604; Test Name: Oxygen saturation; Test Result: 99 %; Comments: 10 minutes after the administration of drugs
CDC Split Type: JPPFIZER INC2021658633

Write-up: reacion to question was dull; cold sweat; Pulse rate low (45); dyspnoea; palpitations; rash on the chest; rash on the chest; blood pressure was 140-90; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111851. The patient was a 40-year-old female. 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 an unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021). On 04Jun2021, at 13:20 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was reported as 04Jun2021, at 13:25 (5 minutes after the vaccination). On 04Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 04Jun2021, at 13:22 (2 minutes after the vaccination), the patient experienced cold sweat, palpitations, dyspnoea, and rash on the chest. The blood pressure was 140-90. Heart rate was 45. Oxygen saturation was 98%. The patient could answer questions when being asked. But the reaction was dull. BICANATE was administered via intravenous drip. Adrenaline was administered via injection. After 10 minutes, the symptoms almost disappeared. The blood pressure was 118-70. Heart rate was 47. Oxygen saturation was 99%. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411986 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cosmetic allergy (details such as what ingredient the patient was allergic to was unknown)
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/89 (about 140 usually); Comments: around 14:05-14:10; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:142/97; Comments: at 14:15; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:146/69; Comments: at 14:55; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:102/54 (decreased); Comments: at 15:15; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/65; Comments: at 15:35; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:115/68; Comments: at 16:00; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination (before 14:00); Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: at 14:55; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 15:15; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: at 15:35; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: at 16:00; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:88; Comments: around 14:05-14:10 88/min, which was higher than usual (70/min usually).; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Comments: 90/min at 14:15; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: 100/min around 14:20; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:96; Comments: 96/min at 14:55; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:80; Comments: 80/min at 15:15; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:88; Comments: 88/min at 15:35; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:85; Comments: 85/min at 16:00; Test Date: 20210604; Test Name: SpO2; Result Unstructured Data: Test Result:98 (room air) %; Comments: around 14:05-14:10; Test Date: 20210604; Test Name: SpO2; Test Result: 98 %; Comments: at 14:15; Test Date: 20210604; Test Name: SpO2; Test Result: 99 %; Comments: at 14:55; Test Date: 20210604; Test Name: SpO2; Test Result: 98 %; Comments: at 15:35; Test Date: 20210604; Test Name: SpO2; Test Result: 98 %; Comments: at 16:00
CDC Split Type: JPPFIZER INC2021658677

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111914. The patient was a 55-year and 1-month-old female. Body temperature before vaccination was 35.8 degrees centigrade. Family history was not reported. Medical history included cosmetic allergy (details such as what ingredient the patient was allergic to was unknown). Concomitant medications were not reported. On 04Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly, at the left upper arm (limb), as a single dose, for COVID-19 immunisation. On 04Jun2021 around 14:05-14:10 (5 to 10 minutes after the vaccination), the patient experienced anaphylaxis. On 05Jun2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: Summary of the symptoms: On 04Jun2021 at 14:00 (the day of vaccination), the patient received BNT162b2 intramuscularly at the left upper arm (limb). After the intramuscular injection, because the patient had reported cosmetic allergy and her use of additive-free products (it was unknown whether polyethylene glycol or other ingredients caused the allergy), she was observed at the waiting area next to the vaccination area. Around 14:05-14:10 (about 5 to 10 minutes after the intramuscular injection), palpitations, giddiness, and precordial hot feeling developed. No wheezing, dyspnoea, or tachypnoea was noted. No dermatologic findings such as erythema were observed. Vomiting, diarrhoea, abdominal pain, and mucosal symptoms such as pain in the lips were absent. The blood pressure was 144/89 (about 140 usually), and the SpO2 was 98% (room air), but the heart rate was 88/min, which was higher than usual (70/min usually). At 14:15 (15 minutes after the vaccination), the blood pressure was 142/97, the heart rate 90/min, and the SpO2 98%. Considering that the heart rate was increasing without decreased blood pressure and that the onset of the symptoms was at least about 5 to 10 minutes after the intramuscular injection, the condition was suspected to be anaphylaxis rather than vasovagal reflex. Therefore, around 14:20 (20 minutes after the vaccination), adrenaline (BOSMIN) 0.3 ml was administered intramuscularly into the right upper limb, a vascular access was secured with SOLACET F 500 ml at the left upper limb, and steroid (DEXART) 3.3 mg was administered for an hour by drip infusion. Around the time of this treatment, sweating was noted in the bilateral lower limbs, and the heart rate was 100/min. At 14:55 (55 minutes after the vaccination), the blood pressure was 146/69, the heart rate 96/min, the SpO2 99%, and the body temperature 36.0 degrees centigrade. Generalized sweating and tremulousness of the fingers were noted. At 15:15 (1 hour and 15 minutes after the vaccination), tremulousness and sweating persisted, and the body temperature was 36.8 degrees centigrade, the blood pressure 102/54 (decreased), and the heart rate 80/min. At 15:35 (1 hour and 35 minutes after the vaccination), the patient said that she felt slightly better. The blood pressure was 113/65, the heart rate 88/min, the body temperature 36.6 degrees centigrade, and the SpO2 98%. At 16:00 (2 hours after the vaccination), tremulousness and sweating disappeared. The body temperature was 35.8 degrees centigrade, the blood pressure 115/68, the heart rate 85/min, and the SpO2 98%. Because the symptoms and vital signs were improving (but the blood pressure was still slightly lower than usual) and no aggravation was found during the observation of the course until 17:00, the drip infusion of SOLACET F was terminated and the needle was removed. The patient went home. On the following 05Jun2021 (1 day after the vaccination), the subsequent course was checked through the smartphone''s messenger app (LINE); the report on the same day around 00:00 said that a scratchy throat and nasal discharge developed at night, but the report on the same day at 07:30 said that the scratchy throat and nasal discharge disappeared. 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: because of the short time between the onset of the symptoms and the intramuscular injection of adrenaline and considering that the blood pressure did not decrease at that time but decreased later, that the heart rate was increasing, and that the onset was not within a minute but 2 minutes or longer after the intramuscular injection of the vaccine, not vasovagal reflex but anaphylaxis was considered. In addition, the onset of the scratchy throat at night after returning home was a delayed reaction of anaphylaxis and had presented with non-serious symptoms as a result of the prior administration of the steroid (DEXART). The outcome was assessed as recovered.


VAERS ID: 1411987 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Eating disorder, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021658711

Write-up: Anaphylaxis; swelling tongue (left side); swelling left face; she cannot eat or drink; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111924. The patient was a 72-year and 9-month-old female. Body temperature before vaccination was 35.9 degrees Centigrade. The patient''s family history was unknown. There was point 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).: Yes, asthma bronchial. The patient concomitant medications were not reported. On 04Jun2021 at 09:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021), at vaccination age of 72 years, via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jun2021 at 13:30 (4 hours after the vaccination), the patient experienced anaphylaxis, as swelling tongue (left side) and swelling left face. The patient can''t eat. The outcome of the event was recovering, and the outcome date was provided as 05Jun2021 (as reported). The course of the event was as follows: Tongue''s left side and left face were swelling, she cannot eat or drink. The reporting physician classified the event as serious (Can lead to disability) 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: These events had a lot relationship with the vaccination, the patient could not take the second dose.


VAERS ID: 1411990 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Computerised tomogram, Convulsions local, Dizziness, Heart rate
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Vestibular disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:187/83; Test Name: body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:no problem; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:65
CDC Split Type: JPPFIZER INC2021658783

Write-up: convulsion in the limbs; Light-headed feeling; blood pressure increased 187/83; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111890. The patient was a 83-year-old male. Body temperature before vaccination was 36.3 degrees Centigrade on 04Jun2021. The patient received a pneumococcal vaccine and had a pyrexia of 38.0 degrees Centigrade on an unspecified date.On 04Jun2021 at 12:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: Thirty minutes after the vaccination on 04Jun2021 (12:35), the patient experienced Light-headed feeling, so the patient took rest and look the condition even more. One hour later, (04Jun2021 at 13:05) the patient experienced convulsion in the limbs. It lasted for 15 minutes without any consciousness impairment. And blood pressure increased 187/83, pulse rate 65. Urgently deliveried to PRIVACY Hospital, no problem with CT. After the convulsion disappeared, the patient went home. The outcome of the events was recovered on 04Jun2021. 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: Because of the past history of pneumococcal vaccine caused pyrexia , the patient should pay attention to it in the future.


VAERS ID: 1411993 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Heart rate, Hyperhidrosis, Oxygen saturation, Pallor, Swelling of eyelid, Visual analogue scale
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:164/66 mmHg; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: Before vaccination; Test Date: 20210604; Test Name: Pulse rate; Result Unstructured Data: Test Result:90; Comments: bpm; Test Date: 20210604; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:97-98 %; Test Date: 20210604; Test Name: VAS; Result Unstructured Data: Test Result:decreased from 10 to 0; Comments: After intravenous treatment
CDC Split Type: JPPFIZER INC2021658879

Write-up: Cough; sweaty; poor complexion; Swelling of eyelid; Blood pressure 164/66 mmHg; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111844. The patient was a 79-year-old female. Body temperature before vaccination was 35.6 degrees Centigrade. The patient had a medical history of asthma bronchial and has been taken Adoair 100 microgram. On 04Jun2021 at 14:20 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was reported as 04Jun2021 at 14:40. On 04Jun2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: The patient experienced cough and sweaty. Blood pressure was 164/66 mmHg. Pulse rate was 90 bpm. Oxygen saturation was 97-98%. The patient was observed on Fowler''s position. The symptom was recovering, but the patient showed poor complexion. Solu-Medrol 40 mg + normal saline 100 ml was administered via intravenous drip. The symptom relieved. Swelling of eyelid also relieved. The VAS of the symptom decreased from 10 to 0. The patient went back home, then. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.


VAERS ID: 1412016 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbago
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:160/98; Comments: 15 minutes after the vaccination.; Test Date: 20210604; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:98; Comments: 10 minutes after the vaccination.
CDC Split Type: JPPFIZER INC2021660033

Write-up: Anaphylaxis/anaphylaxis symptom/ itching in both arms, itching that could hardly bear, redness in both arms/ dyspnoea/ had consciousness twilight/ Exanthema generalised, blood pressure 160/98 mmhg; This is a spontaneous report received from a contactable other health professional and a contactable physician via a Pfizer sales representative. The patient was a 49-year-old female. Primary disease and Complication included Lumbago. Past drug included Loxoprofen used from 21Apr2021 to 19May2021 orally for Lumbago. On 04Jun2021 (the day of vaccination), the patient received the unspecified dose of bnt162b2 (COMIRNATY, intramuscular injection, Lot number not provided) intramuscular as a single dose at the age of 49-year-old for COVID-19 immunization. On 04Jun2021 (the day of vaccination), the patient experienced anaphylaxis symptom, transported to PRIVACY hospital urgently. On 04Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: 5 minutes after the vaccination, there was itching in both arms, itching that could hardly bear, redness in both arms. There was no rash on the back. 10 minutes after the vaccination, the patient started to have dyspnoea, SPO2 was 98 at the moment. 15 minutes after the vaccination, the patient had consciousness twilight, the patient treated the patient with Epipen. At this moment there was Exanthema generalised, blood pressure 160/98. After the treatment of Epipen, the patient was temporary recovered. 20 minutes after the vaccination (5 minutes after Epipen was treated), the patient had dyspnoea again, therefore the second dose of Epipen performed. After that, the patient was in twilight state, transferred to privacy hospital in emergency and treated. The patient was recovered. The reporter classified the event as serious (Other important medical event) and assessed the causality between the event and bnt162b2 as probably related. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event anaphylaxis cannot be excluded.


VAERS ID: 1412018 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood pressure decreased, Blood pressure measurement, Blood test, Body temperature, Gamma-glutamyltransferase, Hepatic function abnormal, Liver function test increased, Pallor
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Right sided paralysis
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: GPT; Result Unstructured Data: Test Result:1530; Test Date: 20210604; Test Name: GOT; Result Unstructured Data: Test Result:2933; Test Date: 20210604; Test Name: ALP; Result Unstructured Data: Test Result:744; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:90s; Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:105; Test Date: 20210604; Test Name: blood test; Result Unstructured Data: Test Result:high hepatic function disorder.; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: ?-GTP; Result Unstructured Data: Test Result:433
CDC Split Type: JPPFIZER INC2021660764

Write-up: his face looked pale; blood pressure decreased (90s); High hepatic function disorder; Liver function test increased; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. The patient was an 84-year-old and 10-month-old male. The patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) was none. While it''s also reported medical history cerebral infarction (right paralysis). Body temperature was 35.4 C before vaccination. On 31May2021 at 16:00 (the day of vaccination, at 84-year-old), the patient received the first single dose of BNT162B2(COMIRNATY, intramuscular injection, Lot number: EY5420, expiration date: 31Aug2021) via unspecified route of administration for COVID-19 immunization. There were no adverse events until 04Jun2021. At 19:30 on 04Jun2021 (4 days after the vaccination), when the patient was eating in a nursing facility (dining hall), his face looked pale, the patient was moved in a wheelchair, blood pressure decreased (90s), so he was moved to the bed to lie down. The blood pressure was measured later, the blood pressure was recovered to 105. Also, blood test was performed and it showed that liver function test increased (GOT 2933, GPT1530, ALP 744, ?-GTP 433). Judging from the results of the blood test at that time, it was high hepatic function disorder. Prescription drugs included amlodipine 2.5mg, clopidogrel 75mg, lansoprazole. The patient did not received amlodipine, clopidogrel, lansoprazole as of initial report on 04Jun2021. The meal, the drip was stopped and other supplement was not received at present. The outcome of the event was reported as recovering. The reporter classified the event as serious (hospitalized from 21Feb2021) (the patient had already been hospitalized) and the causality between the event and the vaccines was not provided. Other possible cause of the event such as any other diseases was it might be related to internal medicine. The reporter comments as follows: Although it was considered as a side effect of the vaccine, it was still unknown.; Sender''s Comments: Based on the available information, the causal association between the reported events (liver function test increased, pallor facial, blood pressure decreased and hepatic function disorder) and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes 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: 1412105 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210604; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210623167

Write-up: FEELING UNWELL; FATIGUE; MUSCLE PAIN; FEVER: 40.5 TO 42 DEGREES CELSIUS; HEADACHE; COLD CHILLS; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00569703] concerned a 44-year-old female patient of unspecified race and ethnic origin. The patient''s weight was 98 kilograms, and height was 176 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: XD 985 and expiry: unknown) 0.5 ml, 1 total, administered on 04-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 04-JUN-2021, the patient experienced fever of 40.5 to 42 degrees Celsius (hyperpyrexia), cold chills and headache. On 05-JUN-2021, the patient experienced muscle pain, fatigue and felt unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 05-JUN-2021, and headache on 06-JUN-2021, was recovering from fatigue, muscle pain, and fever: 40.5 to 42 degrees Celsius, and had not recovered from feeling unwell. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210623167- covid-19 vaccine ad26.cov2.s- fever of 40.5 to 42 degrees Celsius. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1412173 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dysarthria, Dyspnoea, Influenza like illness, Mental impairment, Pain, Pain of skin, Pollakiuria
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLINE [SALBUTAMOL]; ALVEDON; DUORESP SPIROMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021656230

Write-up: urinated 10 times during the night; One day later, the side effects are like the flu; "gone in my head", misspelled when I wrote the first day; Difficulty breathing; dizziness; weak; pain in whole body including skin; pain in whole body including skin; Slurred speech; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (COMIRNATY), dose 1 administered in Arm Left on 03Jun2021 01:45 (Lot Number: FA5833) at the age of 54-years-old as single dose for covid-19 immunisation. Medical history included asthma. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine, has not been diagnosed with covid-19 prior vaccination. Patient was not pregnant, not pregnant at time of vaccination. Concomitant medications included salbutamol (VENTOLINE); paracetamol (ALVEDON); budesonide, formoterol fumarate (DUORESP SPIROMAX). The patient experienced difficulty breathing, dizziness, weak, pain in whole body including skin; ''gone in my head'', misspelled when wrote the first day, and slurred speech, all above on 04Jun2021 11:00. The patient took paracetamol (ALVEDON) and slept for 3 hours. The adverse events decreased a bit during the evening. The patient also urinated 10 times during the night of 05Jun2021 (no treatment received), one day later on 05Jun2021, the side effects were like the flu (no treatment received). All events were reported as non-serious by the consumer. Patient had not been tested for covid-19 post-vaccination. The outcome of the events was recovering. Follow-up attempts completed. No Further information expected.


VAERS ID: 1412174 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Erysipelas
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021661876

Write-up: something reminiscent of erysipelas; This is a spontaneous report from a non-contactable consumer (patient). A 47-years-old male patient received BNT162B2 (COMIRNATY) in left arm, on 01Jun2021 at 16:00 (at 47 years of age), as first single dose, for COVID-19 immunisation. Medical history included COVID-19 infection. Patient had no known allergies. Concomitant medication included tick-borne encephalitis vaccine (TICK-BORNE ENCEPHALITIS VACCINE) taken for immunisation on 19May2021. The patient experienced something reminiscent of erysipelas on 04Jun2021 at 16:45 with outcome of unknown. Patient received treatment for the event with penicillin. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1412177 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product use issue, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (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: ANAFRANIL; KETOGAN [KETOBEMIDONE HYDROCHLORIDE]; ALVEDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to drug
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021674239

Write-up: Small blood clot in left arm; First dose AstraZeneca covid 19 vaccine, second dose Comirnaty; First dose AstraZeneca covid 19 vaccine, second dose Comirnaty; This is a spontaneous report from a contactable other healthcare professional, reporting on herself. A 49-year-old female patient received first dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 04Jun2021 (Lot Number: FA5833) as single dose for covid-19 immunisation (age of vaccination 49 years); first dose of covid-19 vaccine AstraZeneca (COVID-19 VACCINE ASTRAZENECA), intramuscular on 11Mar2021 10:00 (Lot Number: Unknown), as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included dose 1 of hepatitis B vaccine HBsAg (yeast) (ENGERIX B) taken for an unspecified indication on 02Jun2021 in left arm; clomipramine hydrochloride (ANAFRANIL) taken for an unspecified indication, start and stop date were not reported; ketobemidone hydrochloride (KETOGAN) taken for an unspecified indication, start and stop date were not reported; paracetamol (ALVEDON) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had first dose ofcovid-19 vaccine AstraZeneca and when the second dose was administered, it was changed to Pfizer BNT162B2 vaccine. The patient experienced small blood clot in left arm on 05Jun2021 09:00 which resulted in a physician office visit. No treatment had been given. The patient was not diagnosed with covid-19 prior vaccination and has not been tested for covid-19 post-vaccination. The outcome of the blood clot was recovering. No follow-up attempts are possible, no further information expected.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported Thrombosis and the use of bnt162b2 cannot be fully excluded. However, there event occurred within the circumstance of having to have used a different Covid vaccine type or brand as a first dose. This then confounds that reported drug event pair. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1412618 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYPERPHEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Refractory hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:179/80; Test Date: 202106; Test Name: BP; Result Unstructured Data: Test Result:212/80; Test Date: 202106; Test Name: BP; Result Unstructured Data: Test Result:212/79
CDC Split Type: ZAPFIZER INC2021706425

Write-up: Increase in BP over the next few days. Varied from 179/80 to 212/80; Mild headache; Light-headed; racing heart; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FA7812), via an unspecified route of administration on 04Jun2021 at 14:16 (at the age of vaccination) as 1st single dose for COVID-19 immunisation. Patient medical history included refractory hypertension. Concomitant medication included hydralazine hydrochloride (HYPERPHEN, tablet, dose: 2 tablets, 20mg) taken for blood pressure (BP). On 04Jun2021, the patient felt lightheaded, mild headache and had a racing heart during the 30 minutes of recovery and patient took lunchtime dose of Hyperphen (2 tablets, 20mg). Hyperphen is one of 4 other BP tablets prescribed (concomitant medication). The patient BP continued to go up to 212/79, increase in bp over the next few days, varied from 179/80 to 212/80. Patient saw her GP (general physician) on Monday 07Jun2021 and GP increased Hyperphen to 3x3 times a day and had increased hypertension medications. It has now gone down considerably. On 04Jun2021, the patient underwent lab tests and procedures which included blood pressure as 179/80 and on an unspecified date in Jun2021, BP was 212/80, and 212/79. Patient received treatment Hyperphen to 3x3 times a day and had increased hypertension medications for event increased BP. Patient informed to note the effect of the Pfizer vaccine on blood pressure. The outcome of event light-headed and racing heart was resolved on an unspecified date in 2021 and rest all events was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1414801 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Aphonia, Asthma, Blood pressure increased, Blood pressure measurement, Cough, Electrocardiogram, Erythema, Fatigue, Headache, Human papilloma virus test, Magnetic resonance imaging, Muscle disorder, Paraesthesia, Swelling face, Swollen tongue
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CANDEBLO
Current Illness: Extrasystoles; Loss of smell
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic reaction to contrast agent (.); Asthma; COVID-19 (first symptoms on 28Oct2020 and was then also in hospital); Hypertension; Hypoacusis unilateral
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:increased; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: HPV; Result Unstructured Data: Test Result:titer elevated since then; Test Name: MRI; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ATPFIZER INC2021663424

Write-up: anaphylactic shock; 2 minutes after the vaccination tingling on the body; lost voice; tongue swollen; severe cough attack; lost tension of body; bronchies went close/ asthmatic flare; headache; red and swollen head; red and swollen head; blood pressure increased; very tired, especially in the afternoon; This is a spontaneous report from a contactable consumer. A 51 years old female patient received BNT162B2 (COMIRNATY; lot FC2473) on 04Jun2021 at 16:00 (at 51 years of age), as first single dose, in left upper arm, for COVID-19 immunisation. Medical history included asthma, COVID-19 from 28Oct2020 (first symptoms on 28Oct2020 and was then also in hospital with severe was on sick leave for a total of 3 months), she still had extrasystoles, still smelt nothing, could not hear on the right, she had an anaphylactic reaction to the contrast medium, hypertension. HPV titer elevated since then, since then also asthma. Concomitant medication included candesartan cilexetil (CANDEBLO; 8 mg) ongoing, for hypertension. On 04Jun2021 at 16:02 the patient experienced anaphylactic shock, tingling on the body, lost voice, tongue swollen, severe cough attack, lost tension of body, bronchies went close/ asthmatic flare, headache, red and swollen head, red and swollen head, blood pressure increased. She had an MRI contrast medium examination and had an anaphylactic reaction to the contrast medium which was the same as the reaction to Comirnaty. Now she was taken to hospital after the anaphylactic reaction. The solvent was suspected - the family doctor said no. Events clinical course include the following information: reaction after vaccination: after 2 minutes tingling in the whole body (just like after contrast medium), it got worse, then lost voice, tongue swollen and severe coughing, red and swollen head, then body tension gone, bronchial tubes closed/ asthma attack, her speech was impaired because the tongue felt weird, headache, blood pressure increased. All this had gone now, only the asthma was better but still not so good. The events required Emergency room. She got cortisone and acute antihistamine + infusions + ECG on the spot. She also received oxygen in the ambulance. In hospital: cortisone, infusions, oxygen with bronchodilator, then also adrenalin. Since Saturday (unspecified date) for a total of 5 days: desloratadin 5mg 1 tablet. Since the vaccination she still had a headache (that''s why she took Mexalen) and was very tired, especially in the afternoon. She had Epipen with her when she was vaccinated, but it was not used in the hospital, they used their own Epipen. She never fainted. The other events resolved on an unspecified date in Jun2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1414848 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0216 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dry mouth, Fatigue, Feeling abnormal, Headache, Injected limb mobility decreased, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021671928

Write-up: Significant arm pain immediately after receiving the vaccine for 24 hours, could not raise left arm; Significant arm pain immediately after receiving the vaccine for 24 hours, could not raise left arm; Dry mouth; mild nausea; headache; slight dizziness; exhaustion; overall feeling poorly; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04Jun2021 11:15 (batch/lot number: EW0216), as 1st dose, single, at age 38 years old, for COVID-19 immunisation, at a public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. There were no concomitant medications (the patient did not receive any other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Jun2021, the patient experienced significant arm pain immediately after receiving the vaccine for 24 hours, could not raise left arm, dry mouth, mild nausea, headache, slight dizziness, exhaustion, overall feeling poorly for 48 hours. No treatment was given for the events. The events did not require hospitalization. The outcome of the events was reported as recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1414857 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess oral, Hypersensitivity, Oropharyngeal pain
SMQs:, Angioedema (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Osteonecrosis (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: CLONAZEPAM; SERTRALINE; ALPRAZOLAM; SEDATIF PC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (To many things); COVID-19; Hysterectomy; Tonsillectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021658701

Write-up: Left side pain in the throat; Abscess on the palate; Allergy in the skin, neck and face; This is a spontaneous report from a non-contactable consumer (patient) from the COVAES portal. A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 administered in arm right on 02Jun2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included a hysterectomy and a tonsillectomy on an unknown date and known allergies (reported as "to many things"). The patient informed that she was diagnosed with COVID-19 Prior to vaccination. Concomitant medications received within 2 weeks of vaccination included clonazepam (unknown manufacturer), sertraline (unknown manufacturer), alprazolam (unknown manufacturer) and abrus precatorius, aconitum napellus, atropa belladonna, calendula officinalis, chelidonium majus, viburnum opulus (SEDA TIF PC); all of them taken for an unspecified indication, start and stop date were not reported. On 04Jun2021 18:30 the patient experienced left side pain in the throat, abscess on the palate, an allergy in the skin, neck and face; all this on 04Jun2021 and 06Jun2021 (reported as 2 and 4 days after the vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient indicated that therapeutic measures were taken in response to the events, she received an injected antiallergic (decadron duo). The outcome for the events was unknown. Information of the lot/batch number has been requested.


VAERS ID: 1415587 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Extrasystoles
SMQs:, Tachyarrhythmia terms, nonspecific (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROPRANOLOL
Current Illness: Ectopic heartbeats
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657255

Write-up: ectopic heart beats on a daily basis; considerably increased in frequency and strength since around 2 to 3 hours after having the vaccine; ectopic heart beats on a daily basis; considerably increased in frequency and strength since around 2 to 3 hours after having the vaccine; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210605103249. A 34-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 04Jun2021 (batch/lot number EW3143 and expiry date unknown) at 34 years of age as unknown, single for covid-19 immunization. Medical history included suppressed lactation, ongoing ectopic heartbeats (on a daily basis). The patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial, was not currently breastfeeding. Concomitant medications included propranolol taken for ectopic heartbeats from 19Dec2020. The patient experienced ectopic beats on 04Jun2021. The patient informed that she experienced ectopic heart beats on a daily basis. The patient informed that she normally suffered from ectopic heartbeats but these has considerably increased in frequency and strength since around 2 to 3 hours after having the vaccine. The event was reported serious as other medically important condition. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Dizziness, Fatigue, Headache, Nausea, SARS-CoV-2 test, Somnolence, Thrombosis, Vision blurred
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657598

Write-up: 111 suspected a potential blood clot due to some unexplained bruising; headache; bruising; Dizziness; nausea; blurred vision.; feeling very fatigued; slept mostly all day; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106040911393820-FODOX. Safety Report Unique Identifier GB-MHRA-ADR 25418887. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27May2021 (Batch/Lot Number: EY5456) as 1ST DOSE, SINGLE for COVID-19 vaccination. The patient''s medical history included suppressed lactation. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding. On an unspecified date, the patient experienced headache. On an unspecified date, the patient experienced bruising. On 04Jun2021, the patient experienced dizziness. The above mentioned events were provided as serious other medically important condition by the regulatory authority. Additional clinical course details was as follows: Woke up with severe dizziness when standing, nausea and blurred vision. Also feeling very fatigued and slept mostly all day. Symptoms got better if sitting or laying down and much better the following day. Discussed with GP about symptoms as 111 suspected a potential blood clot due to some unexplained bruising. GP advised potential late side effects from vaccine and to go to clinic if symptoms got worse or headache appeared. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 24Jan2021. The outcome of the events headache and bruising was recovered, for event dizziness was recovering, and for the rest of events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415636 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Musculoskeletal stiffness, SARS-CoV-2 test, Sedation
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataplexy; Lactation decreased; Narcolepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative
CDC Split Type: GBPFIZER INC2021657407

Write-up: spaced out; feel genuinely spaced out like I have been sedated; Stiffness; This is a spontaneous report from a contactable consumer (patient). This report was received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041032040950-VW8RK. Safety Report Unique Identifier is GB-MHRA-ADR 25419164. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included lactation decreased, narcolepsy, and cataplexy; from unknown dates and unknown if ongoing. Patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial, was not pregnant at time of vaccination, and not currently breastfeeding. The patient''s concomitant medications were not reported. On 04Jun2021, the patient experienced stiffness. On an unspecified date, the patient felt genuinely spaced out like she had been sedated. The events were considered serious due to disability. The patient underwent lab tests and procedures which included COVID-19 virus test: no- negative COVID-19 test on 03Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of stiffness was not recovered while outcome of feel genuinely spaced out like I have been sedated was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415652 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Dizziness, Headache, Insomnia, Nausea, Pyrexia, Restlessness, SARS-CoV-2 test, Vaccination site pain, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC2021657593

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041211190630-1KAGO. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (as reported) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included suppressed lactation, and suspected covid-19 from 03May2020 to 10Jun2020. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Day of vaccine- 03Jun2021 (as reported). The patient experienced small headache in evening (approx. 4 hours after), sleepless and restless, pain in site of injection, day after fever, hot nausea all day, stomach discomfort, dizzy/woozy, pressure headache and blurred eyesight. The patient experienced nausea on 04Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive test on an unspecified date. The outcome of events nausea, headache, dizziness and injection site pain was not recovered, of other events was unknown. This is a serious report received with serious criteria medically significant from . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415654 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-04
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Muscle spasms
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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cramps; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657340

Write-up: Menstrual cramp; cramps; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041220156360-FAN4A, Safety Report Unique Identifier is GB-MHRA-ADR 25419947. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 20May2021 as second dose, single for COVID-19 immunization. Medical history included pain and cramps. Patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, and was not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain. The patient experienced cramps on an unspecified date in 2021, and menstrual cramp on 04Jun2021. Both events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: Cramps were extremely severe, far worse than anything she had previously. Nearly made her call an ambulance. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event cramps was unknown, while outcome of menstrual cramp was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415656 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: NA Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657226

Write-up: Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041226009700-BAUM5. Safety Report Unique Identifier: GB-MHRA-ADR 25419998. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW3143), via an unspecified route of administration on 04Jun2021 (at the age of 31 years old) as first dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced chest pain on 04Jun2021 with outcome of recovering. The patient further described not unbearable but some sharp chest pain feels like from muscle or bones. Get worse when bending. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657514

Write-up: Fatigue; Dizzy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041347211170-S2G4M, Safety Report Unique Identifier GB-MHRA-ADR 25420599. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as first dose, single for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On 04Jun2021, the patient experienced fatigue with outcome of unknown and dizzy with outcome of recovered on 04Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657675

Write-up: Fainting; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041350201580-SAP3P, Safety Report Unique Identifier GB-MHRA-ADR 25420610. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jun2021 (Lot Number: EY5456) as single dose for COVID-19 immunisation. The patient medical history was not reported. 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 fainting on 04Jun2021. Event outcome was recovered on 04Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415697 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Craniocerebral injury, Generalised tonic-clonic seizure, Loss of consciousness, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting; Comments: No known PMH or history of fainting Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657844

Write-up: Loss of consciousness; Fainting; Penetrating head injury/injured her head with small occipital laceration on a cupboard door; Seizure; tonic clonic episode; This is a spontaneous report from a contactable physician . This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041511257120-QPIFG. Safety Report Unique Identifier GB-MHRA-ADR 25421375. An 18-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EY5456), via an unspecified route of administration at the age of 18-year-old on 04Jun2021 at single dose for covid-19 immunisation. Medical history included syncope. No known PMH or history of fainting. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced tonic clonic episode on unspecified date, fainting on 04Jun2021, penetrating head injury on 04Jun2021, seizure on 04Jun2021, loss of consciousness on unspecified date. She had a significant faint and injured her head with small occipital laceration on a cupboard door. She had a brief tonic clonic episode lasting about 20 secs. She had loss of consciousness (LOC) of 2-3 mins. There was no incontinence or tongue biting. Ambulance called and care handed over- transferred to A&E Reaction. The events were serious for being medical significant. There was no report relate to possible blood clots or low platelet counts. The outcome of events tonic clonic episode and loss of consciousness was recovered and other events was recovering. No follow-up attempts are possible. No further information is expected


VAERS ID: 1415722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Palpitations, Paraesthesia, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657322

Write-up: Heart racing; lightheadedness; Tingling/left arm tingling; nausea; shaking; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041534129100-EB8V1. Safety Report Unique Identifier GB-MHRA-ADR 25421478. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. On 04Jun2021, the patient experienced heart racing with some lightheadedness, left arm tingling, nausea and shaking. The events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events heart racing and left arm tingling was not recovered, while unknown for the rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415766 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), 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: IRON SULPHATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:dropped; Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:still very low; Test Date: 20210511; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657318

Write-up: blood pressure dropped; fainted; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041730221520-KACNP, and Sender Report Unique Identifier is GB-MHRA-ADR 25422581. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (batch/lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included lactation decreased, and anaemia. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medication included iron sulphate (IRON SULPHATE) taken for anaemia from 28Feb2021. The patient experienced blood pressure dropped on 04Jun2021 with outcome of not recovered and fainted on 04Jun2021 with outcome of unknown. The events were assessed as serious (medically significant) by the health authority. The patient underwent lab test which included COVID-19 virus test: no - negative COVID-19 test on 11May2021. Additional information: suffer from low blood pressure and suddenly after patient got vaccinated she fainted. Her blood pressure dropped dramatically and she was given first aid. Six hours after her vaccine and she still haven''t fully recovered. Her blood pressure is still very low. Patient has not tested positive for COVID-19 since having the vaccine. Blood pressure monitoring by a doctor. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415776 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Loss of consciousness, Malaise, SARS-CoV-2 test, Syncope, Vaccination site haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown Result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Result; Test Date: 20201019; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657854

Write-up: loss of consciousness; Fainting; felt sick; Bleeding a lot at site of vaccine; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041836507160-WYVGE, Safety Report Unique Identifier GB-MHRA-ADR 25422972. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported, at age of 32-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. No medical history. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took epinephrine adrenaline [ADRENALINE]. Instantly after having the vaccine on 04Jun2021, patient felt sick. Patient was bleeding a lot at site of vaccine too. After the patient went to sit down, within 10 seconds patient passed out. After he came back around instantly again, patient had loss of consciousness again and had to have adrenaline. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests included COVID-19 virus test: negative on 19Oct2020 No - Negative COVID-19 test, blood pressure: unknown result on an unspecified date, electrocardiogram (ECG): unknown result on an unspecified date. The outcome of the events was unknown. The seriousness was reported as hospitalization. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1415800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Autoscopy, Back pain, Dizziness, Dry mouth, Dry throat, Ear pain, Fatigue, Fluid retention, Headache, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021657872

Write-up: Dry mouth; Upper back pain; Weakness; Tiredness; Dizzy spells; Low back pain; Ear ache; Water retention; Abdominal bloating; Dry throat; Headache; Out of body experience; Bloating; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106042039343810-HE2KO, Safety Report Unique Identifier is GB-MHRA-ADR 25423961. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW3143) via an unspecified route of administration at single dose on 04Jun2021 for COVID-19 immunization. Medical history included suffer from hay-fever, smoke but no previous reactions to vaccines. Concomitant medications were not reported. The patient previously took vitamin E and beclomethasone. Only supplements taken were vitamins and antihistamines in the past. Patient had not had symptoms associated with COVID-19. COVID-19 virus test on 02Jun2021 was no - negative. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. On 04Jun2021, patient experienced dry mouth, upper back pain, weakness, tiredness, dizzy spells, low back pain, ear ache, water retention, abdominal bloating, dry throat, headache, out of body experience and bloating. All events was considered serious as other medically important condition. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415816 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Head discomfort, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657821

Write-up: Pulsatile tinnitus; felt pressure in her head; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106042223471030-NFDGS. Safety Report Unique Identifier GB-MHRA-ADR 25424544. A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW3143), via an unspecified route of administration on 04Jun2021 (37-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced pulsatile tinnitus on 04Jun2021. The event was assessed as serious with criteria of Other medically important condition. Additional Information: Had her vaccine. Went home to rest. Within one hour she felt pressure in her head, mainly on vaccination side, and pulsatile tinnitus started. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The outcome of pulsatile tinnitus was not recovered; outcome of "felt pressure in her head" was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1415823 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657641

Write-up: Painful arm; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042318512560-RZEML Safety Report Unique Identifier GB-MHRA-ADR 25424767. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) at age of 32-year-old as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced painful arm and headache on 04Jun2021 with outcome of not recovered. The events were serious as medically significant. Clinical course: Severe headache for 10 minutes somewhat immediately after, persistent headache again late in evening. Continual upper arm ache/pain since vaccination. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415824 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC2021657642

Write-up: 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-202106042322118810-IQPCV, Safety Report Unique Identifier GB-MHRA-ADR 25424768. A 30-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: EW3143), via an unspecified route of administration on 04Jun2021 at the age of 30-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced chest pain (medically significant) on 04Jun2021. Tight chest pains in centre of chest around heart area. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415839 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Mobility decreased, Pain, SARS-CoV-2 test
SMQs:, Parkinson-like events (broad), Arthritis (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; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021657281

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202106050734458730-MCVI; safety report unique identifier: GB-MHRA-ADR 25425076). A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, administered in arm, on Jun 4, 2021, single dose, for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in a clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain and shoulder pain on Jun 4, 2021. Additional information: injection was given too high on the arm, which has resulted in severe shoulder joint pain. Unable to lift arm above head. Mobility severely limited since Jun 4, 2021. Pain relief did not help. The patient underwent lab tests, which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. Outcome of the events: not recovered. The regulatory authority assessed the events as medically significant. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Myalgia, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201017; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Positive COVID-19 test.
CDC Split Type: GBPFIZER INC2021657378

Write-up: Fatigue; Tingling; Numbness; Headache; Tiredness; Shivers; Muscle ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050753179950-7QOUP, Safety Report Unique Identifier GB-MHRA-ADR 25425120. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Batch/Lot number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included suspected covid-19 from 17Oct2020 to an unknown date (Unsure when symptoms stopped). Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced fatigue, tingling, numbness, headache, tiredness, shivers, and muscle ache on 04Jun2021. The case is serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient had COVID-19 Virus test (17Oct2020): Positive COVID-19 test. The outcome for the events fatigue, tingling, numbness, headache, tiredness, shivers, and muscle ache was recovering. No follow-up attempts are possible. Information about Batch/Lot Number cannot be obtained.


VAERS ID: 1415845 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH Y29E8 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Blood test, Chest pain, Dyspnoea, Electrocardiogram, Hallucination, visual, Heart rate increased, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: BLOOD test; Result Unstructured Data: Test Result:unknown Results; Test Name: ECG; Result Unstructured Data: Test Result:No indication of issue on ECG; Comments: No indication of issue on ECG however heart sensation did not occur whilst on ECG, no reported issues with blood work from doctors; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657970

Write-up: onset of pain in chest; shortness of breath; aching pain in heart; active heart rate higher than normal/ notable increase in resting heart rate (pre vaccine 65-75bmp, post vaccine 90-110); onset of pain in chest; Palpitations; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106050807411950-IA6BR Safety Report Unique Identifier GB-MHRA-ADR 25425147. A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot Number: Y29e8) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 08Feb2020 (Unsure when symptoms stopped). Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced onset of pain in chest (hallucination, visual), shortness of breath on an unspecified date with outcome of not recovered, palpitations on 04Jun2021 with outcome of recovering, aching pain in heart, active heart rate higher than normal/ notable increase in resting heart rate (pre vaccine 65-75bmp, post vaccine 90-110) on an unspecified date with outcome of unknown, onset of pain in chest on an unspecified date with outcome of not recovered. The patient underwent lab COVID-19 virus test: No - Negative COVID-19 test on unknown date. Additional information: Onset of pain in chest, notable increase in resting heart rate (pre vaccine 65-75bmp, post vaccine 90-110) and active heart rate higher than normal whilst climbing stairs etc. Palpitations occurred frequently accompanied by aching pain in heart area and sometimes shortness of breath whilst palpitations occurred. Patient has not tested positive for COVID-19 since having the vaccine. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Contacted 111, advised seeking further care at A&E (Accident & Emergency). A&E attended, ECG and blood work performed. No indication of issue on ECG however heart sensation did not occur whilst on ECG, no reported issues with blood work from doctors. " No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Dysmenorrhoea, Muscle spasms, Pain
SMQs:, Acute pancreatitis (broad), Dystonia (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: Inflammatory bowel disease (Crohn disease, ulcerative colitis); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657463

Write-up: cramps; bloating; pain; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202106050857014410-GA5JY, Safety Report Unique Identifier GB-MHRA-ADR 25425239. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at 1st dose single on 03Jun2021 for COVID-19 immunization. Medical history included Lactation decreased, inflammatory bowel disease (Crohn disease, ulcerative colitis). Patient had not experienced any flare up symptoms from IBD since the vaccine and have been well controlled for around a year. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced cramps, bloating, pain on an unspecified date, painful periods on 04Jun2021. Events outcome were recovering. Clinical course reported as following: usually have painful periods, maybe some cramps or bloating but period was extremely painful after coincidentally coinciding with the vaccine. The pain woke her up in the night and although taken paracetamol, still quite uncomfortable. Patient has not tested positive for COVID-19 since having the vaccine. Case reported serious due to Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415857 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657420

Write-up: Fever; Painful arm; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050933276410-H3S8Y, Safety Report Unique Identifier GB-MHRA-ADR 25425350. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Jun2021 (at the age of 30 years old) as 1st dose, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing and suspected COVID-19 (unsure when symptoms stopped) from 26Feb2020 to an unknown date. The patient had not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced painful arm, fatigue on 04Jun2021 and fever on 05Jun2021. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the 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: 1415860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Breathlessness; COVID-19 (COVID-19 symptoms persisted for about 3 months; unsure when symptoms stopped); COVID-19 virus test positive; Fatigue; Foggy feeling in head; High temperature; Increased skin sensitivity; Lactation decreased; Muscle ache; Olfactory hallucination; Smell change; Taste changed
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657173

Write-up: sore arm; Breathlessness/ catch her breath/ felt a bit breathless; 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-202106050949340740-OJZJA and the Safety Report Unique Identifier is GB-MHRA-ADR 25425397. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jun2021 around 2:20 pm (batch/lot number was not reported) at 24 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date. The patient was initially suspected and was diagnosed of COVID-19 from 28Dec2020; patient tested yes - positive for COVID-19 test on 29Dec2020. She had symptoms such as fatigue, breathlessness, high temperature, changes to taste and smell, olfactory hallucination, muscle aches, increased skin sensitivity, foggy feeling in head (also reported as "brain fog"), etc. She was never admitted to hospital. The symptoms gradually got better but persisted for about 3 months. Patient was unsure when symptoms stopped. The patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding. Concomitant medications were not reported. The patient experienced breathlessness on 04Jun2021 and sore arm on an unspecified date. It was reported that by 8pm of 04Jun2021, patient was talking on the phone to someone and realized she needed to stop talking and catch her breath, which she would never normally need to do. The next morning (05Jun2021), she felt a bit breathless sitting down and when she was doing something like making her bed, it was really noticeable. She had COVID-19 in 28Dec2020 and one of her symptoms was breathlessness. Patient stated it was much worse than this at first which slowly got better but the symptom lingered for a couple of months. Although she has not experienced any breathless in about 2/3 months until she had the vaccine. Patient also reported having a sore arm on an unspecified date. The patient has not recovered from the event breathlessness. Outcome of the event sore arm was unknown. The events were reported as serious, medically significant. The patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1415861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Menstruation irregular, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multi-vitamin maintenance (in the morning with breakfast)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657189

Write-up: numbness; "8 days after I got my first vaccine of Pfizer" (irregular menstrual cycle); pins and needles; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106050958147510-OXTAD, Safety Report Unique Identifier GB-MHRA-ADR 25425419. A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 27May2021 (batch/lot number EW3143 and expiry date unknown) as 1st dose, single for covid-19 immunization. The patient''s medical history included was usually takes normal multivitamins in the morning with breakfast. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 04Jun2021, the patient experienced numbness "8 days after I got my first vaccine of Pfizer" (irregular menstrual cycle), pins and needles. The reporter informed that 8 days after he got his first vaccine of Pfizer, he felt very strange numbness feeling on his left hand (got the vaccine from the same arm). The pins and needles feeling continued through his arm and it was not going away. The patient informed that right now his two fingers were completely numb. The patient was referred to the hospital in (place) on 04Jun2021. The events were reported serious as hospitalization and other medically important condition. The patient informed that after some tests they mentioned that this can be a strong side effects of the vaccine which was happening right now inside his body. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415864 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Maternal exposure during pregnancy, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Immunodeficiency; Ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657299

Write-up: Faint; Vomited; Stomach cramps; patient was exposed to the medicine second-trimester (13-28 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051020264080-I3EW9 and Safety Report Unique Identifier GB-MHRA-ADR 25425444. A 34-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTtech COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Batch/Lot number: Unknown), at the age of 34 years, as 1st dose, single for COVID-19 immunization. Medical history included ulcerative colitis, ongoing pregnancy, immunodeficiency and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included folic acid taken for folic acid supplementation. On 05Jun2021, the patient experienced faint, vomited and stomach cramps. On 04Jun2021, the patient was exposed to the medicine second-trimester (13-28 weeks). Patient has not tested positive for COVID-19 since having the vaccine. The case is serious (medically significant). The outcome of the event faint was recovered on an unspecified date; events stomach cramps and vomited outcome was recovering. The outcome for patient was exposed to the medicine second-trimester (13-28 weeks) was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1415869 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: N/A Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657205

Write-up: Tiredness; Headache tension; Fever; This is a spontaneous report from a non-contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051053055900-NXXMR, Safety Report Unique Identifier GB-MHRA-ADR 25425490. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET8885), via an unspecified route of administration on 03Jun2021 as 1st dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced tiredness, headache tension and fever on 04Jun2021. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no/negative COVID-19 test on an unspecified date. The outcome of the event tiredness was recovering while the outcome of the events headache tension and fever was recovered on an unspecified date in Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (Blood clot in the left side of his brain, surgery was done.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657891

Write-up: Clot blood; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051110087220-NMRJT. Safety Report Unique Identifier GB-MHRA-ADR 25426106. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23May2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included, surgery from an unknown date and unknown if ongoing, Blood clot in the left side of his brain, surgery was done. The patient''s concomitant medications were not reported. The patient experienced clot blood (thrombosis) (hospitalization) on 04Jun2021 with outcome of recovering. The patient underwent lab test included COVID-19 virus test: negative on an unspecified date. Additional Information: Blood clot in the left side of his brain, surgery was done, all his vital signs were normal, patient in ICU, doctor asking information like they don''t have clear the what causes the problem. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Myalgia, Nausea, Occult blood positive, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Anorexia nervosa; Immunodeficiency; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Q Fit Test; Test Result: Positive ; Comments: very raised levels; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657461

Write-up: Painful swelling at the injection site; Painful swelling at the injection site; diarrhoea; chills; nausea; dizziness; Fever; Unilateral leg swelling; Vomiting; Muscle ache; Swollen arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority . The regulatory authority report number is GB-MHRA-WEBCOVID-202106051305595790-VHELY, Safety Report Unique Identifier GB-MHRA-ADR 25425788. A 27-year-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as 1st dose single for covid-19 immunisation. Medical history included anorexia nervosa, Lactation decreased, immunodeficiency. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced painful swelling at the injection site, diarrhoea, chills, nausea, dizziness all on an unspecified date, fever, unilateral leg swelling, vomiting, muscle ache, swollen arm all on 04Jun2021. The patient had positive Q Fit Test result: very raised levels, test conducted due to frequent diarrhoea and blood loss, COVID-19 virus tested negative on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of Fever was recovering, Unilateral leg swelling, Muscle ache, Swollen arm was not recovered, Vomiting was recovered, other events outcome were unknown. Case reported serious due to Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415889 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-06-04
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Feeling cold, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral, Muscle tightness, Paraesthesia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine headache
Allergies:
Diagnostic Lab Data: Test Date: 20201027; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657447

Write-up: Sore tightness of the back and front of neck; Numb tongue/Mouth/gums/lips; stomach pain; belly cramps; Tingling/cold sensation down neck and back/Tingling, fingers & legs; cold rush feeling up and down body; heart rate racing; Numbness Face/chest/arms; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051322448080-PGV8Y. Safety Report Unique Identifier GB-MHRA-ADR 25425835. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased and migraine headache. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant or currently breastfeeding. Concomitant medications included naproxen for migraine headache from 19Oct2019 to an unspecified stop date. The patient previously took beclomethasone. The patient experienced sore tightness of the back and front of neck, numb tongue/mouth/gums/lips, stomach pain, belly cramps, tingling/cold sensation down neck and back/tingling, fingers & legs, cold rush feeling up and down body, all on an unspecified date; numbness face/chest/arms on 04Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Oct2020. The patient had sore tightness of the back and front of neck. Opposite were from vaccine entry sore and tight. Tingling/cold sensation down neck and back. Belly cramps. Numb tongue so unable to speak properly. Numb mouth, gums, lips, face, chest, arms. Tingling, fingers & legs. Like a cold rush feeling up and down body. But arm where vaccine was given there was nothing. Hospital gave the patient antihistamines through a canular in patient''s wrist/hand, fluids and did two heart trace due to the patient''s heart rate racing and temps being high and stomach pain. Patient had not tested positive for COVID-19 since having the vaccine. Details of any relevant investigations or tests conducted: "At hospital they did a heart trace 2 times due to elevating heart & rate". Outcome of the event numbness face/chest/arms was recovering, of the other events was unknown. This report is serious with seriousness criteria-caused/prolonged hospitalization and other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415902 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Headache, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEMSIP MAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold; Common cold; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657563

Write-up: joint pain; High temperature; Injection site muscle pain; Generalized joint pain; Headache; Decreased appetite; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106051430043410-ENHLB, Safety Report Unique Identifier GB-MHRA-ADR 25425944.A 34-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included Lactation decreased, cold, Common cold. Had a cold ongoing for 3 weeks at time of vaccine being administered. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding.Concomitant medication(s) included paracetamol, phenylephrine hydrochloride (LEMSIP MAX) taken for nasopharyngitis from 16May2021 to an unspecified stop date. The patient experienced joint pain on an unspecified date with outcome of unknown, high temperature on 04Jun2021 with outcome of not recovered, injection site muscle pain on 04Jun2021 with outcome of not recovered, generalized joint pain on 04Jun2021 with outcome of not recovered, headache on 04Jun2021 with outcome of recovering, decreased appetite on 04Jun2021 with outcome of not recovered.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26May2021, No - Negative COVID-19 test. Case Narrative: The joint pain and headache are sufficient that she cannot move without significant difficulty. Patient has not tested positive for COVID-19 since having the vaccine. All events were marked as medically significant. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1415906 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Fatigue, Maternal exposure during breast feeding, Myalgia, Off label use, Product use issue, Pyrexia, Somnolence, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:37.7 Centigrade
CDC Split Type: GBPFIZER INC2021657370

Write-up: Fever; Muscle ache; Injection site pain; Tiredness; Drowsiness; Maternal exposure during breast feeding; breasfeeding; breastfeeding; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report downloaded from the regulatory authority report number is GB-MHRA-WEBCOVID-202106051517171690-KORRP, Safety Report Unique Identifier GB-MHRA-ADR 25426018. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (at the age of 35 years) as the 1st dose, single for COVID-19 immunisation. Medical history included ongoing breast feeding, suspected COVID-19 from 30Mar2020 to 03Apr2020. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced fever, muscle ache, injection site pain, tiredness, drowsiness, and maternal exposure during breast feeding on 04Jun2021. The events were considered medically significant. Patient was taking regular paracetamol. The patient has not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021668836 Fetus/baby case


VAERS ID: 1415914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-04
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Dysmenorrhoea; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657818

Write-up: pain; Heavy periods; blood clots; Painful periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency.The regulatory authority report number is GB-MHRA-WEBCOVID-202106051644007620-EZZ9T,Safety Report Unique Identifier GB-MHRA-ADR 25426130. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on 25May2021 (Batch/Lot Number: Et8885) as single dose for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date, suspected covid-19 from an unknown date (Unsure when symptoms started/ Unsure when symptoms stopped), dysmenorrhoea from an unknown date. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included paracetamol (Manufacturer unknown) taken for dysmenorrhoea from 04Jun2021 to an unspecified stop date. The patient experienced pain on an unspecified date, heavy periods on 05Jun2021, painful periods on 04Jun2021. Her period had been so heavy she hadn''t been able to be away from a toilet for more than 20 minutes. Her menstrual cup was filling and overflowing within 30 minutes and she was passing golf ball sized blood clots. Last night her period was causing her far more pain than usual. Patient had not tested positive for COVID-19 since having the vaccine. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative covid-19 test on an unspecified date. The outcome of the event pain was unknown, while the other events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415918 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657531

Write-up: Heart fluttering; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051713138000-K60YO. Safety Report Unique Identifier is GB-MHRA-ADR 25426173. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW3143), via an unspecified route of administration on 04Jun2021 (at the age of 30 years old) as first dose, single for COVID-19 immunization. Medical history included suspected COVID-19 from 18Mar2020 to 30Mar2020. The patient has not had a COVID-19 test and he was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced heart fluttering on 04Jun2021. The event was reported as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was recovered on Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657533

Write-up: Chills; Pain in arm; Headache; Tiredness; Injection site swelling; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Authorioty (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051724311280-UVZBX, Safety Report Unique Identifier GB-MHRA-ADR 25426197. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown dose via an unspecified route of administration on 03Jun2021 (Lot Number: Ew3143) as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced chills, pain in arm, headache, tiredness, injection site swelling, swollen lymph nodes, all on 04Jun2021 and reported as serious due to Medically significant. The patient underwent lab test and procedure which included sars-cov-2 test with the result of No - Negative COVID-19 test on 05Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event chills was recovering, of headache and swollen lymph nodes was recovered, of others was not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1415924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657543

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051732123980-TTOZJ, Safety Report Unique Identifier GB-MHRA-ADR 25426204. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW3143), via an unspecified route of administration on 04Jun2021 as 1st dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced heavy periods on 04Jun2021. The reporter assessed the event as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was recovering. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1415937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Headache, Loss of consciousness, Malaise, SARS-CoV-2 test, Tachycardia
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), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657643

Write-up: headache; feeling unwell; passed out (collapse); passed out (collapse); Tachycardia; This is a spontaneous report from a contactable other healthcare professional received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051921301090-OPVDJ Safety Report Unique Identifier GB-MHRA-ADR 25426351. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot Number: Ew3143) as single dose for COVID-19 immunisation. Medical history included lactation decreased, and migraine. Unsure if patient had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications included amtriptyline from 03Jun2021 for migraine. The patient experienced headache on an unspecified date, tachycardia on 04Jun2021. The patient feeling terrible she had tachycardia, headache, felling unwell and finally she passed out (collapse) on an unknown date. This case was reported as serious, serious criteria was hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 02Jun2021. The outcome of events headache, feeling unwell and passed out (collapse) was unknown, tachycardia was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657763

Write-up: Near fainting; Tiredness; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051936059390-F8EWZ, Safety Report Unique Identifier GB-MHRA-ADR 25426361. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 04Jun2021, near fainting on 05Jun2021, tiredness on 04Jun2021; all events seriousness criteria: medically significant. The event outcome for all events was not recovered. No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1416044 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Cold sweat, Hypoaesthesia, Somnolence, Tinnitus
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tinnitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657310

Write-up: On 05Jun2021; vision loss/vision loss; recovered on 05Jun2021; tinnitus; numbness of upper arm; cold sweat; drowsiness; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052350122640-Z1JMR. A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 04Jun2021 (batch/lot number EW3143 and expiry date unknown) at 35 years of age as 1st dose, single for covid-19 immunization. Medical history included tinnitus. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 04Jun2021, the patient experienced drowsiness. On 05Jun2021, the patient experienced vision loss (medically significant), tinnitus, cold sweat, numbness of upper arm. The patient informed that he received the 1st jab yesterday noon (04Jun2021) and this morning at 5 am (05Jun2021), he felt numbness with his arm, on the way to bathroom he lost vision, and tinnitus simultaneously for several minutes. The patient returned to bed immediately and lie down for another several minutes with cold sweat. The patient informed that after his vision resumed, he took a paracetamol tablet (500 mg) before return to sleep. The patient did not receive any other medical treatment. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events On 05Jun2021; vision loss/vision loss; recovered on 05Jun2021, tinnitus, cold sweat was recovered on 05Jun2021, while not recovered for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain
SMQs:, Lipodystrophy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Hospitalization (for chest pain); Kidney infection; Kidney stones; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657457

Write-up: Pain spreads across breast from armpit area; 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-202106060123278770-EF8PG, Safety Report Unique Identifier GB-MHRA-ADR 25426660. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 as single dose for COVID-19 immunisation. Medical history included kidney stones, lactation decreased, chest pain, suffered with kidney stones and recurrent kidney infections, had 3 previous admissions to hospital for chest pain. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not enrolled in clinical trial, not pregnant, and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced armpit pain on 04Jun2021. Case narrative: Pain spreads across breast from armpit area. She has not tested positive for COVID-19 since having the vaccine. The outcome of armpit pain was not recovered while outcome of breast pain was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1416055 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657314

Write-up: Chest pain; It felt like someone was sat on his/her chest; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202106060722526260-EBMA2], Safety Report Unique Identifier [GB-MHRA-ADR 25426747]. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot Number: Ew3143) as 1st dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced chest pain and It felt like someone was sat on his/her chest on 04Jun2021. The outcome of the events was recovered on 05Jun2021. The clinical course was reported as follows: the patient was fine until about 6/7 hours later and she/he had chest pain. It felt like someone was sat on his/her chest. It disappeared early morning of 05Jun2021 and then came back in the afternoon. The patient felt well otherwise. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416072 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Joint pain
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: joint pain; sleepy; Pain in arm; Joint ache; Headache; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (joint pain), ARTHRALGIA (Joint ache) and HEADACHE (Headache) in a 31-year-old male patient 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. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient''s past medical history included Joint pain, Pregnancy, Joint pain and Pregnancy. Concomitant products included PARACETAMOL from 02-May-2021 to 05-May-2021 for Cold. On 04-Jun-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) Dose 1. On 04-Jun-2021, the patient experienced FATIGUE (Fatigue). On 05-Jun-2021, the patient experienced ARTHRALGIA (Joint ache) and HEADACHE (Headache). On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced SOMNOLENCE (sleepy) and ARTHRALGIA (joint pain). On 07-Jun-2021, ARTHRALGIA (Joint ache), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (sleepy) and ARTHRALGIA (joint pain) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, SARS-CoV-2 test: no - negative covid-19 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Had really bad joint pain. Making it difficult to move from Saturday evening until mid afternoon Sunday when it start going away. Also felt very sleepy and had regular headaches. Arm ached and was very painful whenever someone touched it. Patient has not tested positive for COVID-19 since having the vaccine Adverse reaction did not occur as a result of an exposure during pregnancy; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event was classified as serious by the regulatory authority. However, there is no apparent rationale to deal it as serious.


VAERS ID: 1416077 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Muscle spasms, Musculoskeletal stiffness, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: CLARITHROMYCIN
Current Illness: Tonsillitis
Preexisting Conditions: Comments: No relevant medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Back muscle spasms; Back pain; Back stiffness; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back muscle spasms), BACK PAIN (Back pain) and MUSCULOSKELETAL STIFFNESS (Back stiffness) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No relevant medical history was provided by the reporter. Concurrent medical conditions included Tonsillitis. Concomitant products included CLARITHROMYCIN from 01-Jun-2021 to an unknown date for Tonsillitis. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Back stiffness) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced MUSCLE SPASMS (Back muscle spasms) (seriousness criterion medically significant) and BACK PAIN (Back pain) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Back muscle spasms), BACK PAIN (Back pain) and MUSCULOSKELETAL STIFFNESS (Back stiffness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported excruciating back spasms and pain. Patient had not tested positive for COVID-19 since having the vaccine. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The overall seriousness of events is based on the Regulatory Authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The overall seriousness of events is based on the Regulatory Authority report.


VAERS ID: 1416095 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Skin wound
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Nausea; Skin wound; Nausea aggravated; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea aggravated), SKIN WOUND (Skin wound) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced NAUSEA (Nausea aggravated) (seriousness criterion disability). On 05-Jun-2021, the patient experienced SKIN WOUND (Skin wound) (seriousness criterion disability). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion disability). At the time of the report, NAUSEA (Nausea aggravated) and NAUSEA (Nausea) had not resolved and SKIN WOUND (Skin wound) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported. The patient had large sores in the form of herpes in and around in face, lips, nose and the problem still did not improved. It hurts extreme nausea, the patient lost 1/2 weight. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time.


VAERS ID: 1416115 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5454 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657544

Write-up: Fatigue; regulatory authority This is a Non-Interventional Study report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-YCVM-202105302033418200-W0D1R, Safety Report Unique Identifier GB-MHRA-ADR 25422787. A 30-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot Number: EY5454) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant and not currently breastfeeding, last menstrual period was 23May2021. The patient medical history and concomitant medications were not reported. The patient experienced fatigue on 04Jun2021. The event was serious, medically significant. The patient outcome of the event was recovering. Additional Information: the patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event fatigue was related to suspect drug.


VAERS ID: 1416120 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657725

Write-up: Light-headed; YELLOW CARD VACCINE MONITOR This is received from a contactable consumer via the Regulatory Authority. The Regulatory Authority report number is GB-MHRA-YCVM-202106041720241730-4LW0Q, Safety Report Unique Identifier GB-MHRA-ADR 25422441. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 04Jun2021 (Batch/Lot Number: Et8885), as 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 was not enrolled in clinical trial. The patient experienced light-headed (dizziness) (medically significant) on 04Jun2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. No follow-up attempts are possible. No further information is expected. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, there is a reasonable possibility that event Light-headed was related to suspect drug.


VAERS ID: 1416215 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

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

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

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA and LYMPHADENOPATHY in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 04-Jun-2021, the patient experienced URTICARIA (seriousness criterion hospitalization). At the time of the report, URTICARIA and LYMPHADENOPATHY was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: .; 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: 1416224 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary spastic angina; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021658655

Write-up: Anaphylaxis; body mild rash; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21111935. The patient was a 73-year and 3-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had coronary spastic angina, mackerel allergy, and cocoa allergy. On 04Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: The event onset date was reported as 04Jun2021 15:15. On 04Jun2021 at 15:15 (the day of vaccination), 15 minutes after the vaccination, the patient experienced body mild rash. The patient did not have other abnormalities. On 04Jun2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. The reporting physician commented as follows: Transfer to hospital. This report meets the criteria of Anaphylaxis.


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