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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 354 out of 6,867

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VAERS ID: 1516692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial pain
SMQs:, Glaucoma (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 INC202100909443

Write-up: Pain in face; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161919247130-H6VML. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25666258 A 23-year-old female patient received bnt162b2 (BNT162B2), second dose, via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient was not pregnant at the time of vaccination. The patient''s concomitant medications were not reported. The patient experienced pain in face on 16Jul2021. Case was reported as medically significant condition. The outcome of the event was not recovered. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516695 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909341

Write-up: Ear pain; Headache; Myalgia; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161934237500-E62DS Safety Report Unique Identifier GB-MHRA-ADR 25666347. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: fd8813) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced ear pain (medically significant) on 16Jul2021 with outcome of not recovered, headache (medically significant) on 16Jul2021 with outcome of recovering, myalgia (medically significant) on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jul2021. 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: 1516718 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909138

Write-up: Vomiting; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107162111158130-YIUAX, Safety Report Unique Identifier is GB-MHRA-ADR 25666974. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 as DOSE 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not enrolled in clinical trial. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced vomiting on 16Jul2021 with outcome of not recovered, and headache on 16Jul2021 with outcome of not recovered. The events were reported as serious, medically significant by the health authority. Additional information: Narrative case summary and further information: Patient had 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: 1516760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-07-16
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Cardiac murmur, Chest pain, Joint swelling, Palpitations, SARS-CoV-2 antibody test, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Medical History/Concurrent Conditions: Autism spectrum disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Negative ; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202100908874

Write-up: burning sensation around injection site trailing down my arm; burning sensation around injection site trailing down my arm/ Injection site pain; heart murmur; Palpitations; Chest burning; swollen knee; This is a spontaneous report from a contactable consumer (patient). This report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162229597130-CJHH5. Safety Report Unique Identifier GB-MHRA-ADR 25667683. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA1027) via an unspecified route of administration on 20Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included autism spectrum disorder (on the autistic spectrum, high functioning and take no medication) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On an unspecified date in 2021, patient had swollen knee. On 16Jul2021 patient also had heart murmur, palpitations, chest burning and burning sensation around injection site trailing down his arm, injection site pain. Reportedly, until 16Jul2021 patient had no side effects but today had a concern, at 22:25 patient experienced burning sensation around injection site trailing down his arm then a large heart murmur followed by a series of minor palpitations over 5 minutes. It was stated that nothing precipitating the event, it had been over an hour since he had eaten, and he was lying on his sofa watching TV (television). The patient would be attending hospital tomorrow for a swollen knee (onset date unspecified) from a sports injury which he would present his symptoms. The patient underwent lab tests and procedures which included Covid-19 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of all the events were reported as recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516772 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Limb discomfort, Myalgia, Palpitations, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908916

Write-up: headache; palpitations; sweating; muscle pain; Arm discomfort; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107162354267830-FUCITGB-MHRA-ADR 25667722, Safety Report Unique Identifier GB-MHRA-ADR 25667722. A 32-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration on 16Jul2021 (at a age of 32 years old) as single dose for COVID-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. On an unspecified date, the patient experienced headache, palpitations, sweating, muscle pain and on 16Jul2021 had arm discomfort. Additional information included sweating heart palpitations headache neck and shoulder muscle pain. The events were reported as medically significant. On 12Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of arm discomfort was reported as not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908882

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107170057107270-0TW46, Safety Report Unique Identifier GB-MHRA-ADR 25667744. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FF3319), via an unspecified route of administration on 14Jul2021 as dose 2, single for covid-19 immunization.Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on unspecified date, as dose 1, single for COVID-19 immunization. On 16Jul2021, the patient experienced swollen lymph nodes. It was reported that armpit has swollen to the size of about half a grapefruit.The patient had not yet recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Hashimoto''s disease; Interstitial lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909334

Write-up: Palpitations; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107170247351610-PQAQ3. Safety Report Unique Identifier GB-MHRA-ADR 25667764.A female patient of an unspecified age had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection),(Lot Number: FD8813) via an unspecified route of administration on 16Jul2021 as dose1, single for covid-19 immunisation.The patient medical history included interstitial lung disease from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing.The patient concomitant medications were not reported.Hashimoto disease, anaemia ,Patient has not had symptoms associated with COVID-19,Patient has not tested positive for COVID-19 since having the vaccine,was not enrolled in clinical trial.On 16Jul2021,the patient had experienced palpitations (palpitations).This event was considered as medically significant. The clinical outcome of the event was not resolved.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Jul2021 (No - Negative COVID-19 test). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Jaw pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908990

Write-up: Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107170708106860-SEEQB, Safety Report Unique Identifier is GB-MHRA-ADR 25667932. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 as single dose for COVID-19 immunisation. Medical history included jaw pain. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medication included ibuprofen taken for jaw pain from 2021. The patient experienced enlarged lymph nodes (excl infective) on 16Jul2021 with outcome of not recovered. She has not tested positive for COVID-19 since having the vaccine. Case was reported as medically significant by health authority. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1516796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Lymphadenopathy, Pain
SMQs:, Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909093

Write-up: pain; Swollen lymph nodes; Aching joints; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107170809318630-AILWS, Safety Report Unique Identifier is GB-MHRA-ADR 25667986. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: Ff3319, Expiry date not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation and angioedema. Patient has not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Historical vaccine included BNT162B2 dose 1, single via an unspecified route of administration received for COVID-19 immunisation. Concomitant medication included fexofenadine taken for angioedema from 04May2021 to an unspecified stop date. The patient experienced pain on an unspecified date with outcome of unknown, swollen lymph nodes on 16Jul2021 with outcome of recovering, and aching joints on 16Jul2021 with outcome of recovered on 16Jul2021. Therapeutic measure was taken as a result of pain that included paracetamol. The events were reported as serious, medically significant by the health authority. Additional Information: Paracetamol taken for the pain, which helped. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral
SMQs:, Hearing impairment (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: PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909259

Write-up: sustained complete hearing loss in left ear; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202107170828188960-RD0LK. Safety Report Unique Identifier GB-MHRA-ADR 25668011. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF3319) (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased and anxiety, both from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included propranolol taken for anxiety, start and stop date were not reported. The patient experienced sustained complete hearing loss in left ear on 16Jul2021. The event was reported as serious (medically significant). The clinical course was reported as follows: sustained complete hearing loss in left ear around 10 hours after second vaccine. Hearing returned slowly over the following approximately 30 mins. Sought urgent medical advice from GP Out of Hours service and was advised to follow up further with GP. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was recovered on 16Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Heavy menstrual bleeding, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202100909242

Write-up: Headache; Vomited; Fever; Heavy periods; Dizziness; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107170834027050-61XDG. Safety Report Unique Identifier is GB-MHRA-ADR 25668022. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FD5613) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced headache, vomited, fever, heavy periods, and dizziness on 17Jul2021; tiredness on 16Jul2021. The events were reported as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1516803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Lymphadenopathy, Vomiting
SMQs:, Acute pancreatitis (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909119

Write-up: Vomiting; Diarrhoea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107170841178630-H1UUS, Safety Report Unique Identifier GB-MHRA-ADR 25668036. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (batch/Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included paracetamol taken for an unspecified indication, start and stop date were not reported. The patient experienced vomiting and diarrhoea on an unspecified date and swollen lymph nodes on 16Jul2021. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of diarrhoea and vomiting was recovered on an unspecified date and not recovered for swollen lymph nodes. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1516805 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD881 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Hyperhidrosis, Lethargy, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100909301

Write-up: Pain in left arm; weakness; sweating; lethargy; Pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107170856106780-49PTY, Safety Report Unique Identifier GB-MHRA-ADR 25668107. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Jul2021 at his 36-year-old (Lot Number: FD881) as dose 2, single for COVID-19 immunisation. Medical history included depression. Patient has not had symptoms associated with COVID-19. Concomitant medication included sertraline taken for depression, start and stop date were not reported. The patient experienced pain in left arm causing weakness, sweating and lethargy all on an unspecified date with outcome of unknown, pain on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 16Jul2021. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516808 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Nipple pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909289

Write-up: pain in his arm put and around his nipple; pain in his arm put and around his nipple; Armpit pain; This is a spontaneous report from a contactable consumer or other non hcp(patient) received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107170902176560-HRSHA. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25668114 A 23-years-old male patient received bnt162b2 (BNT162B2)(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient medical history and concomitant medications were not reported. The patient experienced armpit pain on 16Jul2021 with outcome of not recovered which was assessed as serious with medically significant, and also experienced pain in his arm put and around his nipple on an unspecified date with outcome of unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: NORTRIPTYLINE; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Penicillin allergy; Psychotic; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909315

Write-up: Headache; Knee pain/extreme pain in knees/pain in knees, shins, ankles, feet and hips; Aches & pains in legs/pain in knees, shins, ankles, feet and hips; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107170908530360-QGXPU, Safety Report Unique Identifier GB-MHRA-ADR 25668143. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. Medical history included suppressed lactation, Psychotic, schizophrenia. Allergic to Penicillin. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included nortriptyline taken for psychotic disorder from 11Jun2020 to an unspecified stop date; quetiapine taken for schizophrenia from 05Nov2019 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 on unspecified date for Covid-19 immunisation and no side effects. The patient experienced extreme pain in knees on an unspecified date with outcome of recovering, aches & pains in legs on 16Jul2021 with outcome of not recovered, headache on 17Jul2021 with outcome of not recovered, knee pain on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date No - Negative COVID-19 test. Extreme pain in knees, shins, ankles, feet and hips - can barely move because it''s all so painful. Paracetamol hasn''t helped at all. Started around 24 hours after her second dose. First dose she had no side effects. Patient is not enrolled in clinical trial. The seriousness was reported as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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? 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 INC202100909386

Write-up: dizzy/Light headed; Loss of consciousness/Blacked out; This is a spontaneous report from a contactable consumer. This report is received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107170931473750-2XJVK. Safety Report Unique Identifier is GB-MHRA-ADR 25668171. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced loss of consciousness/ Blacked out on 16Jul2021, dizzy/ Light headed on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event loss of consciousness was resolving and of the event dizzy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516816 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Heart rate, Insomnia, SARS-CoV-2 test, Sensory disturbance
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908971

Write-up: sensation; chest pain; Heart rate; Chest tightness; Insomnia; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202107170949528780-YFQ8T, Safety Report Unique Identifier is GB-MHRA-ADR 25668279. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: FF3319), dose 2 via an unspecified route of administration on 16Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mite allergy. The patient''s concomitant medications were not reported. Patient previously received bnt162b2 (Solution for injection; Batch/Lot Number: ET8885), via an unspecified route of administration on 12May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced sensation, chest pain on an unspecified date, heart rate, chest tightness, insomnia on 16Jul2021. On the day patient was vaccinated with 2nd dose, patient felt an unusually high heart rate and a very uncomfortable tightness on the left side of my chest that left patient unable to fall asleep until 6am. A way to describe the sensation was as if patient had 3 strong coffees before going to bed. The chest pain/tightness had continued to the next day but slightly less intense. Patient experienced similar side effects after 1st dose, but not as strong as for the 2nd one. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were assessed as serious. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 05May2021, No - Negative COVID-19 test. Outcome of other events sensation, chest pain was recovering, heart rate, chest tightness, insomnia was recovered on 17Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909060

Write-up: Swollen glands; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171017186990-4RE6J. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25668302. A 28-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: Ff3319) as dose 2, single for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced swollen glands on 16Jul2021. The medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516819 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909095

Write-up: Fever; Headache; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171028009710-TME3Y and Safety Report Unique Identifier is GB-MHRA-ADR 25668351. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: FD5613), via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced fever on 17Jul2021 with outcome of recovering, and headache on 16Jul2021 with outcome of recovered on 16Jul2021. The events were considered serious as other medically important condition. 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: 1516835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909011

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The Regulatory authority report number is GB-MHRA-WEBCOVID-202107171222480460-7N9VF, Safety Report Unique Identifier is GB-MHRA-ADR 25668619. A 41-year-old male patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot number: FD5613) as single dose for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. The patient experienced swollen lymph nodes on 16Jul2021 with outcome of not recovered. The event was considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516846 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909031

Write-up: Feeling unwell; Sore throat; Fatigue; Ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (UK-MHRA). Regulatory authority report number [GB-MHRA-WEBCOVID-202107171324444480-PCCKG], Safety Report Unique Identifier [GB-MHRA-ADR 25668725]. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FC9001), at the age of 37-years-old, as dose 2, single for COVID-19 immunisation. Medical history included steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) on an unknown date. The patient''s concomitant medications were not reported. The patient previously took mometasone (NASONEX, Steroid nasal spray) and methylprednisolone acetate (DEPO-MEDRONE). The patient experienced feeling unwell on an unspecified date; ache and fatigue on 16Jul2021; and sore throat on 17Jul2021. The events were assessed as serious (medically significant). The outcome of the events was not recovered. The clinical course was reported as follows: Whole body ache, general fatigue and feeling unwell, sore throat. No fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909015

Write-up: Swollen lymph nodes; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). Regulatory authority report number (GB-MHRA-WEBCOVID-202107171332464570-LOEUX), Safety Report Unique Identifier (GB-MHRA-ADR 25668727). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 15Jul2021 (Lot number: not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 16Jul2021, the patient experienced headache. On 17Jul2021, the patient experienced swollen lymph nodes. Outcome of the event swollen lymph nodes was not recovered. Outcome of the event headache was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Generalised anxiety disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909051

Write-up: Nausea; Fatigue; Stomach cramps; Pain in arm; Headache; This is a spontaneous report from a contactable consumer received from a regulatory authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jul2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included generalised anxiety disorder. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included escitalopram for generalised anxiety disorder from 01May2010. On 16Jul2021, the patient experienced headache and pain in arm. On 17Jul2021, the patient experienced nausea, fatigue and stomach cramps. Outcome of all the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908791

Write-up: Aches & pains in legs; Stomach cramps; Vomiting; Headache; Diarrhea; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171509162360-1GOV6, Safety Report Unique Identifier GB-MHRA-ADR 25668887. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Jul2021 (Batch/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. Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 16Jul2021, the patient aches & pains in legs, stomach cramps, vomiting, headache, diarrhea and fever. 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 13Jul2021. Outcome of the event aches & pains in legs, fever was recovering; other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Diarrhoea, Disease recurrence, Electrocardiogram, Pericarditis, Platelet count decreased, SARS-CoV-2 test
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Pericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Bloods; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Date: 20210717; Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Date: 20210717; Test Name: low platelet counts; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908958

Write-up: diarrhea; diarrhea; Pericarditis; Pericarditis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171618515600-FDKGI. Safety Report Unique Identifier: GB-MHRA-ADR 25668968. A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 02Jul2021 as DOSE 1, single for covid-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient medical history included pericarditis, diarrhea. The patient''s concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced diarrhea. On 16Jul2021, patient had pericarditis. Developed pericarditis 2 weeks after first COVID vaccine. Has also had diarrhea illness for the last week. On 17Jul2021, the patient underwent lab tests and procedures which included blood test was unknown, electrocardiogram was unknown (Unknown), platelet count decreased was unknown (unknown). On 17Jul2021, sars-cov-2 test was negative (No - Negative COVID-19 test). The outcome of event for diarrhea was recovered and for pericarditis was recovering. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516868 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908964

Write-up: Fever chills; Fever chills; First dose vaccination on 21May2021 and second dose vaccination on 16Jul2021; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107171628245620-EOCRA. Safety Report Unique Identifier is GB-MHRA-ADR 25668965. This is the first of two reports. A 37-year-old non-pregnant female patient received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jul2021 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. The patient previously received first dose of BNT162B2 on 21may2021 for COVID-19 immunization with local swelling. Concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. The patient experienced fever, chills on 17Jul2021, first dose vaccination on 21may2021 and second dose vaccination on 16jul2021. All events were reported as medically significant. The outcome of fever, chills was resolving. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Dizziness, Nasopharyngitis, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100909041

Write-up: cold; dizziness; upset stomach; Shivering/teeth chattering; Fever; Nausea; Injection site pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171724021120-TKONL, Safety Report Unique Identifier GB-MHRA-ADR 25669038. A 26-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 16Jul2021 as dose 2, single for Covid-19 immunization. Medical history included decreased lactation. The patient''s concomitant medication was not reported. The patient experienced injection site pain on 16Jul2021. She also informed that on 17Jul2021, she had cold, dizziness, upset stomach, shivering/teeth chattering, fever and nausea. The events were reported as serious medically significant. The patient took ibuprofen for cold, chills and fever. The patient underwent laboratory test test which included Sars-cov-2 test: negative on an unspecified date. The outcome of injection site pain, nausea was recovering; for chills, fever was recovered; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Lymphadenopathy, Neck pain, Pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; OMEPRAZOL; OXYBUTYNIN; PROPRANOLOL; VENLAFAXINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Depression; Excess sweating; Headache; Kidney cancer; Lactation decreased; Nephrectomy; Oesophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909228

Write-up: pain; Enlarged lymph nodes (excl infective); sore arm, neck and shoulder at the left side; sore arm, neck and shoulder at the left side; sore arm, neck and shoulder at the left side; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171837076630-WFKSB, Safety Report Unique Identifier GB-MHRA-ADR 25669171. A 39-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration in left arm on 15Jul2021 as dose 2, single for COVID-19 immunization. Medical history included kidney cancer, decreased lactation, nephrectomy, contraception, gastrooesophageal reflux disease , excess sweating, headache and depression. Concomitant medications included desogestrel (CERELLE) taken for contraception, start and stop date were not reported; omeprazole (OMEPRAZOL) taken for gastrooesophageal reflux disease, start and stop date were not reported; oxybutynin for hyperhidrosis, start and stop date were not reported; propranolol for headache, start and stop date were not reported; venlafaxine hydrochloride for depression, start and stop date were not reported. On 16Jul2021, she had a sore arm, neck and shoulder at the left side where she got her injection. On the second day 17Jul2021, she reported of pain (worse) and had enlarged lymph nodes along the collarbone on the left. The events were reported as serious medically significant. The outcome of lymphadenopathy was not recovered; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Peripheral swelling, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908917

Write-up: Rash; Nausea; Headache; Shivers; Swelling arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107172056135540-ZGNJZ, Safety Report Unique Identifier GB-MHRA-ADR 25669253. A 36-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FD8813) via an unspecified route of administration on 15Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On 16Jul2021, the patient experienced rash, nausea, headache, shivers and swelling arm. The patient underwent lab tests and procedures which included covid-19 virus test negative on 16Jul2021. Outcome of the events rash and swelling arm was not recovered. Outcome of the other events was recovered on 16Jul2021. The events are serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516928 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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 INC202100916782

Write-up: muscle aches; Vomiting; High temperature; Chills; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107180842512340-Y3ANC, Safety Report Unique Identifier is GB-MHRA-ADR 25669552. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 15Jul2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced muscle aches, headache on 16Jul2021, vomiting on 17Jul2021, chills on 16Jul2021, high temperature on 17Jul2021. The events were medically significant. Clinical course was reported as follows. Arm ache immediately after jab, getting worse during the day. This was the only symptom after first jab. However with second he felt chills, muscle aches and headaches during the first night and throughout the day after. Felt a bit better by the evening and then okay that night and following morning but then aches, chills, temperature, headache and vomiting occurring in afternoon. The following morning temperature came down but still aches and headache persisted. Myalgia and high temperature resolved, headache was not resolved, vomiting and chills were resolving as of 18Jul2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Headache, Lymphadenopathy, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100916791

Write-up: Swollen lymph nodes; Fever; Shivers; Generalised muscle aches; Headache; Generally unwell; armpit pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107180858164840-T0ZCI and Safety Report Unique Identifier GB-MHRA-ADR 25669564. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number Fd8813), via an unspecified route of administration, on 16Jul2021 at single dose for COVID-19 immunisation. Medical history included lactation decreased and fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Relevant concomitant medications included paracetamol from 16Jul2021 for fever. On 16Jul2021, the patient developed fever, shivers, generalised muscle aches, headache, generally unwell. On 17Jul2021, the patient had swollen lymph nodes. On unknown date in 2021, the patient had armpit pain. The events were reported serious as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. However, on 16Jul2021, the patient underwent a COVID-19 test which resulted negative. The patient had not recovered from the events ''swollen lymph nodes'' and ''armit pain'' while the outcome of the remaining events was recovered on 17Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916504

Write-up: Swelling arm; Pain; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190039123230-AZE0J and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25670229. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jul2021 (Lot Number: Not known) as single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On16Jul2021, the patient experienced swelling arm and pain; both the events were considered serious as medically significant. The patient experienced 4 inch swelling around injection area and pain in arm spreading up across top of shoulder as time goes on. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unknown date. The patient had not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923090

Write-up: Myopericarditis; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191532387770-Q5VNP. Safety Report Unique Identifier GB-MHRA-ADR 25673832. A19-years-old male patient (consumer) received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH solution for injection),(Batch/Lot Number: FA1027) dose 2 via an unspecified route of administration on 15Jul2021 with as dose 2,single, dose 1 via an unspecified route of administration on 13May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial.On 16Jul2021, the patient experienced myopericarditis (myocarditis).This events were assessed as medically significant. The outcome of the events were not resolved.The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative covid-19 test.Patient has not tested positive for COVID-19 since having the vaccine,Patient was not enrolled in clinical trial No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516988 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye symptom, Heart rate, Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: heart rate; Result Unstructured Data: Test Result:rested heart rate of 120; Comments: rested heart rate of 120 which lasted 2 days
CDC Split Type: GBPFIZER INC202100923229

Write-up: Tachycardia; Eye symptom; palpitations; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107200736422470-4Z8ON, Safety Report Unique Identifier GB-MHRA-ADR 25678407. A 41-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jul2021 (at the age of 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Concomitant medications were not reported. On 16Jul2021, the patient experienced tachycardia, eye symptom and palpitations. Case narrative included within 10 minutes of having the jab, she had palpitations and a rested heart rate of 120 which lasted 2 days. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome was unknown for event palpitations and resolving for rest of the events. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1516995 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Palpitations, Suspected COVID-19
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928942

Write-up: palpitations; Suspected COVID-19; Heart fluttering; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201251041230-HPGTF. Safety Report Unique Identifier GB-MHRA-ADR 25680163. A 21-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 16Jul2021 (at the age of 21-years-old) as a single dose for COVID-19 immunization. Medical history included suppressed lactation, suspected COVID-19 from 16Jul2021 and ongoing. The patient''s concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as dose 1, single for COVID-19 immunization. The patient did not have COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced heart fluttering on 16Jul2021, palpitations on an unspecified date, suspected COVID-19 on 16Jul2021. 111 said it was heart palpitations. The patient had this since the 16th, she was only 21 and have never had heart problems so this is worrying that the vaccine has caused this. The clinical outcome of the event heart fluttering was reported as not recovered and outcome of all the other events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1517000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH A1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Chest pain, Dizziness, Electrocardiogram, Heart rate, Palpitations, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928886

Write-up: Heart rate; Chest pain; Dizziness; atrial fibrillation; heart pounding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201749578710-Q5BDJ, Safety Report Unique Identifier GB-MHRA-ADR 25682208. A 29-years-old male patient received second dose BNT162B2 via an unspecified route of administration on 04Jul2021 (Lot Number: A1027) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Lot Number: ET8005) as dose 1, single for covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On unspecified date patient experienced heart pounding, atrial fibrillation, on 16Jul2021 patient experienced heart rate, chest pain and dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test: no-negative covid-19 test on 15Jul2021, electrocardiogram: normal. The outcome of the events heart rate, chest pain was not recovered, and other outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517072 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (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 INC202100960042

Write-up: Nausea; Breathlessness; first dose of BNT162B2 on 23May2021/ second dose of BNT162B2 on 16Jul2021; Fatigue; Headache; Muscle soreness; Light-headed; This is a solicited report from the regulatory authority from a contactable consumer. This is the second of two reports. The first report is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-YCVM-202105221527074750-DSRPO, Safety Report Unique Identifier GB-MHRA-ADR 25388546. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FD8813, at age of 37 years old) as single dose for COVID-19 vaccination. Unsure if patient had had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: EW4109) on 23May2021 for COVID-19 vaccination and experienced fatigue, headache and muscle soreness. The patient experienced fatigue, headache, muscle soreness, light-headed on 16Jul2021, nausea, breathlessness on 17Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events light-headed and breathlessness was not recovered, the outcome of events fatigue, muscle soreness and nausea was recovering, the outcome of event headache was recovered in Jul2021 The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported events are considered related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : GB-PFIZER INC-2021628796 same patient & drug, event, different dose


VAERS ID: 1517267 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100909884

Write-up: Consciousness disturbed; Vasovagal reflex; This is a spontaneous report from a contactable other healthcare professional received from the Agency. Regulatory authority report number is v21120088. A 21-year and 11-month-old female patient received BNT162B2 (COMIRNATY; Solution for injection ; Lot Number: FD0889; Expiration Date: 30Sep2021), via an unspecified route of administration on 16Jul2021 at 14:15 (the day of vaccination) (at the age of 21-year and 11-month-old) as first dose, single, for COVID-19 immunization. Body temperature before vaccination was 36.1 degrees Centigrade on 16Jul2021. The patient''s medical history and concomitant medications were not reported. The patient''s family history had Nothing special. On 16Jul2021 at 14:25 (10 minutes after the vaccination), the patient experienced Vasovagal reflex (as reported event terms) and developed sudden consciousness disturbed. The course of the event was as follows (as reported): about 10 minutes after vaccination, the patient developed sudden Consciousness disturbed. The patient recovered consciousness instantly. On 16Jul2021 (the day of vaccination), the outcome of the events was recovered. The reporting reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporter comment: Vasovagal reflex. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Vasovagal reflex


VAERS ID: 1517273 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cough, Investigation, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: chest examination; Result Unstructured Data: Test Result:Wheezing was audible
CDC Split Type: JPPFIZER INC202100909969

Write-up: Anaphylaxis; cough; Wheezing; This is a spontaneous report from a contactable physician. This is a report received from The regulatory authority report number is v21120090. A 29-year-old (also reported as 29-year and 3-month-old) female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 16Jul2021 14:30 (Batch/lot number: EW0207, Expiration date: 30Sep2021), at age 29 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history included asthma bronchial from an unknown date, not reported if ongoing or not. 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) included the patient had a medical history of asthma bronchial. On 16Jul2021 at 14:50 (20 minutes after the vaccination), the patient experienced anaphylaxis (as reported event terms). The course of the event was as follows (as reported): 20 minutes after the vaccination, cough developed and wheezing was audible at a chest examination. At 14:56, BOSMIN was administered. Afterwards, the patient was transported to a hospital (as reported). The outcome of the events was unknown. The reporting reporter classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was not provided.


VAERS ID: 1517287 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Computerised tomogram head, Dysphoria, Fall, Gaze palsy, Heart rate, Loss of consciousness, Oxygen saturation, Seizure
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), Depression (excl suicide and self injury) (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Gallbladder polyp; Hyperuricaemia; Lipids abnormal
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: Test Result:163/98; Test Date: 20210716; Test Name: blood test; Result Unstructured Data: Test Result:normal; Comments: no abnormalities; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210716; Test Name: Head CT; Result Unstructured Data: Test Result:normal; Comments: no abnormalities; Test Date: 20210716; Test Name: pulse; Result Unstructured Data: Test Result:56; Test Date: 20210716; Test Name: SPO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100910460

Write-up: got back the consciousness; Convulsion/Generalised rigid convulsion; left conjugate deviation; dysphoria; sudden fall; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the regulatory authority. Regulatory authority report number is v21120275. A 53-year and 8-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 16Jul2021 at 09:00 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. 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) included Hyperuricaemia, Lipids abnormal, Gallbladder polyp. Family history was unremarkable. The patient''s concomitant medications were not reported. Body temperature before the vaccination was 36.4 degrees Centigrade. On 16Jul2021 at 09:05 (5 minutes after the vaccination), the patient experienced Convulsion. On 16Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 16Jul2021 at 09:00 (the day of vaccination), the patient was vaccinated with COMIRNATY. On 16Jul2021 at 09:05 (the day of vaccination), the patient was aware of dysphoria and when standing up to report it to a receptionist, he experienced a sudden fall in front of the reception desk. Generalised rigid convulsion and left conjugate deviation were noted. The patient was transported to the operation room, and vital check was performed. BP 163/98, pulse 56, SpO2 98%. On 16Jul2021 at 09:10 (the day of vaccination), the patient got back the consciousness. No focal signs such as paralysis were noted. The patient was transported emergently to Privacy Hospital. A head CT and a blood collection showed no abnormalities, and the patient returned home. Brain MRI, electroencephalography, and echocardiography were scheduled in the future. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the events such as any other diseases was unknown. The reporter''s comments: The causal relationship between the events and vaccination was unknown. (A physician of the Privacy assumes the same opinion at this point.) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The causal relationship between the events and vaccination was unknown. (A physician of the Privacy assumes the same opinion at this point.)


VAERS ID: 1517290 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema, Haemorrhage, Nausea, Pruritus, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.9; Test Date: 20210716; Test Name: vital check; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202100910530

Write-up: redness, haemorrhage and itchy sensation in the left upper arm; redness, haemorrhage and itchy sensation in the left upper arm; redness, haemorrhage and itchy sensation in the left upper arm; Queasy; This is a spontaneous report from a contactable physician reported for a patient received from the Agency. Regulatory authority report number is V21120146. A 46-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 17:10 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation, age at vaccination 46 years old. The patient medical history and concomitant medications were not reported. The patient experienced redness, haemorrhage and itchy sensation in the left upper arm, and queasy on 16Jul2021 17:30. The patient underwent lab tests and procedures which included body temperature: 36.9 and vital check: no abnormality on 16Jul2021. Therapeutic measures were taken as a result of the events. Clinical course was reported as follows: The patient was a 46-year-old female. Body temperature before vaccination was 36.9 degrees Centigrade. Patient had no history according to the Vaccine Screening Questionnaire. On 16Jul2021 at 17:10 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of as a single dose for COVID-19 immunization. On 16Jul2021 at 17:30 (20 minutes after vaccination), the patient experienced adverse events. On 16Jun2021 (the same day of vaccination), the outcome of the events was recovered. The course of the events was as follows: After 20 minutes of observation, the patient had redness, haemorrhage and itchy sensation in the left upper arm. Queasy was also noted, but there was no vomiting. There was no difficulty breathing. PS 100 + Solu-cortef 250 mg DiV was administered. From 5 minutes after that, improvement of the symptom was noted. 30 minutes after the DiV, redness was erased. Outcome of the events recovered on 16Jul2021. Reporter''s additional information: This was a report on the person who had redness in the upper arm after the vaccination this day. There was no abnormality found by the vital check. This report on the person in the case that the symptom improved after starting IV drip of normal saline 100 ml and Solu-cortef 250 mg. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as related. There was no other possible cause of the event such as any other diseases.; Reporter''s Comments: This was a report on the person who had redness in the upper arm after the vaccination this day. There was no abnormality found by the vital check. This report on the person in the case that the symptom improved after starting IV drip of normal saline 100 ml and Solu-cortef 250 mg.


VAERS ID: 1517295 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Discomfort, Heart rate, Malaise, Oxygen saturation, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Arteriosclerosis; Autonomic nervous system imbalance; Cardiac valvulopathy; Cerebral haemorrhage; Fatigue (recently); Headache (every day); Hypertension; Osteoporosis; Pharyngodynia (body temperature 37.3 degree centigrade); Rash (caused by pyrine medicine)
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:171/82; Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:151/87; Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:150-190/90-100; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210716; Test Name: PR; Result Unstructured Data: Test Result:102; Test Date: 20210716; Test Name: PR; Result Unstructured Data: Test Result:81; Test Date: 20210716; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100910816

Write-up: blood pressure increased/BP 171/82; General malaise; body felt heavy; Palpitations; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120149. A 69-year and 3-month-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 14:15 (Batch/Lot Number: FC5295; Expiration Date: 30Sep2021) at the age of 69 years old as dose 1, single for COVID-19 immunisation. Medical history included patient felt fatigue recently, and headache every day. Within one month, the patient had pharyngodynia and body temperature 37.3 degree centigrade. The patient had medical history of hypertension, valvulopathy, angina pectoris, arteriosclerosis, cerebral haemorrhage has been followed up, autonomic nervous system imbalance, osteoporosis. Rash caused by pyrine medicine. After getting the influenza vaccine, cold sweat and chest distress appeared. There were no concomitant medications. Body temperature before vaccination was 36.7 degrees Centigrade. On 16Jul2021 at 14:42 (27 minutes after the vaccination), the patient experienced blood pressure increased and general malaise. The course of the event was as follows: About ten minutes after the vaccination, the patient''s body felt heavy, but the patient thought there is no problem. After 15 minutes of observation, the patient went home, then palpitations was noted in the parking lot and called a nearby nurse back to the hospital. blood pressure (BP) 171/82, pulse rate (PR) 102, SpO2 98%; Clear consciousness without Paralysis. Keep the line and follow the result of vital signs. Blood pressure kept high at 150-190/90-100. Oral Adalat-L 10mg, BP 151/87, PR 81. General malaise was recovering, then the patient went home. On 16Jul2021 (same day of the vaccination), the outcome of events were recovering. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was history of Autonomic nervous system imbalance.


VAERS ID: 1517299 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s encephalopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100910832

Write-up: Feels poorly; Queasy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120097. A 47-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Jul2021 13:45 (at the age of 47 years) (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as a single dose for COVID-19 immunization. Medical history included Hashimoto''s encephalopathy. The patient''s concomitant medications were not reported. The patient previously took Lamictal and experienced allergy. The patient was a 47-year and 9-month-old female. On 16Jul2021 at 13:50 (5 minutes after the vaccination), the patient experienced the following events. After the vaccination of COMIRNATY, the patient complained of feeling poorly. After that, patient was queasy. Blood pressure was immeasurable. Patient used EpiPen, secured a route, and was transferred to a nearby hospital. On 16Jul2021 (the day of vaccination), the outcome of the events was unknown. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was hashimoto''s encephalopathy.


VAERS ID: 1517305 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Oxygen saturation, Palpitations, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:no decreasing; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210716; Test Name: SPO2; Result Unstructured Data: Test Result:no decreasing
CDC Split Type: JPPFIZER INC202100911193

Write-up: Anaphylaxis; Dyspnoea; wheezing; Palpitations; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120144. A 40-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY0573; Expiration Date: 30Sep2021), dose 2 via an unspecified route of administration on 16Jul2021 15:40 (at the age of 40years) as dose 2, single for Covid-19 immunization. Medical history included asthma. The patient''s concomitant medications were not reported. The patient was a 40-year and 1-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had history of Asthma, and on an unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY). After that, the patient experienced numbness of feet, nausea, and tachycardia. On 16Jul2021 at 15:40 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 at 16:00(20 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: From 5 minutes after the vaccination, the patient experienced palpitations. After around 10 minutes, the patient stated dyspnoea. It could be heard that the patient had a wheezing. No decreasing of blood pressure or SpO2. On 16Jul2021 (the day of vaccination), the outcome of the events 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. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1517308 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dysphonia, Dyspnoea, Pruritus, Respiratory disorder
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria; Urticaria chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100911292

Write-up: the hoarseness was continued and dyspnoea was alleviated; Anaphylaxis; respiratory tract stenosis; itching on arm; Hoarseness; This is a spontaneous report from a contactable pharmacist received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21120488. A 39-year-old female received the first dose of (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration On 16Jul2021 at 14:35 (the day of vaccination), as dose 1, single (at the age of 39 years) for COVID-19 immunization. The patient''s medical history included urticaria, urticaria chronic. On 16Jul2021 at 15:05 (30 minutes after the vaccination), the patient experienced anaphylaxis. The patient''s body temperature before vaccination was 36.2 degrees Centigrade(16Jul2021).The course of the event was as follows: On 16Jul2021 at 14:35(the day of the vaccination), the vaccination of COMIRNATY. On 16Jul2021 at 15:05 (30 minutes after the vaccination),there were hoarseness, itching on arm and respiratory tract stenosis. Veen-D 500ml, Solu-Cortef 250mg was given. On 16Jul2021 at 15:25 (50 minutes after the vaccination), the hoarseness was continued and dyspnoea was alleviated. On 16Jul2021 at 15:30 (55 minutes after the vaccination), hoarseness was alleviated, dyspnoea was disappeared. On 16Jul2021 at 16:20 (1 hour and 45 minutes after the vaccination),no symptoms and the patient went to home. On 16Jul2021 at 16:20(the same day of the vaccination), outcome of the event was recovered. The reporting pharmacist classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was urticaria. The reporting pharmacist commented as follows: when the symptoms appeared, it was considered previous vaccination effect. No follow-up attempts are possible; information about batch number already obtained.


VAERS ID: 1517309 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Headache, Hypertension, Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Retinal 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Numbness of head; Vision blurred
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:226/93; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:170s; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100911297

Write-up: Hypertension/blood pressure 226; complained had tingling head; a feeling of Vision blurred; complained had tingling head/ling head was not strong headache like Thunderclap headache,; This is a spontaneous report from a contactable physician from the regulatory authority. Regulatory authority number was v21120147. The patient was an 84 years old female. On 16Jul2021 at 10:45 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC9880, expiration date 30Sep2021) via an unspecified route of administration as dose 2, single (at the age of 84 years) for COVID-19 immunization. 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) included hypertension and numbness in the head, a feeling of vision blurred. On 16Jul2021 at 11:15( 30 minutes after vaccination) , the patient experienced hypertension. Body temperature before vaccination was 36.2 degrees Centigrade.The course of the event was as follows:After observing for 30 minutes after the vaccination, confirmed that the patient''s physical condition did not change, and the patient complained had tingling head. The blood pressure was 226/93. tingling head was not strong headache like Thunderclap headache, no chest pain or Dyspnoea, no neurological abnormalities, no symptoms of hypertensive emergency suspect, and after followed-up, blood pressure recovering naturally to 170s. Numbness in the head has been a symptom appeared sometimes from long ago, and although there was a feeling of vision blurred, it was a symptom from long ago. It was recovering over time. Although it was not related to the vaccine, if there were any unusual symptoms, it was necessary to visit the physician. If there were something abnormal, consult with physician, the observation was completed. The patient was told to visit the physician if something happened. On 16Jul2021(the day of vaccination), the outcome of the events was recovered. The reporter classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unrelated. Other possible cause(s) of the event such as any other diseases was Excitement and Tension. The reporting physician commented as follows: Hypertension due to excitement and tension in the vaccination status of Hypertension patient, not related to the vaccine itself. The physician told the patient that there were no symptoms of hypertensive emergency and did not need emergency blood pressure reduction, but if the patient had unusual symptoms, needed to visit the physician. No follow-up attempts are possible; information about batch number already obtained.; Sender''s Comments: Based on strong temporal relationship the causal association between the events hypertension, paresthesia, headache and vision blurred and the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1517317 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood pressure measurement, Body temperature, Cough, Heart rate, Hypertension, Hypertonia, Insomnia, Investigation, Oxygen saturation, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Hypokalaemia (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: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:188/105; Comments: 10 minutes after second vaccination (15:23); Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:157/96; Comments: at 15:40; Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:140/88; Comments: at 16:00; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before second vaccination; Test Date: 20210716; Test Name: HR; Result Unstructured Data: Test Result:82; Comments: 10 minutes after second vaccination (15:23); Test Date: 20210716; Test Name: HR; Result Unstructured Data: Test Result:70; Comments: at 15:40; Test Date: 20210716; Test Name: HR; Result Unstructured Data: Test Result:66; Comments: at 16:00; Test Date: 20210716; Test Name: DL examination; Result Unstructured Data: Test Result:unknown; Comments: at 15:35 ; observation instruction; Test Date: 20210716; Test Name: DL examination; Result Unstructured Data: Test Result:unknown; Comments: at 16:00; permission to return home; Test Date: 20210716; Test Name: SpO2; Test Result: 99 %; Comments: 10 minutes after second vaccination (15:23)
CDC Split Type: JPPFIZER INC202100911843

Write-up: Had asthma-like symptoms at night; Hypertonicity; a little short of sleep; both hands tremor; BP188/105 / Blood pressure has been 150 increased for the past one week; had once cough/coughed about every 5 minutes; This is a spontaneous report from a contactable healthcare professional from the regulatory authority. Regulatory authority number was v21120127. The patient was a 51 years and 3 months old female. Body temperature before vaccination was 36.6 degrees Centigrade. 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) included Asthma bronchial. On 16Jul2021 at 15:13 (the day of second vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) at the age of 51 years old, via an unspecified route of administration as a single dose for COVID-19 immunization. Both hands tremor, the event onset date was reported as 16Jul2021 at 15:25 (12 minutes after second vaccination). On 16Jul2021 at 16:00 (47 minutes after the vaccination), the outcome of the event was recovered and the patient returned home. The course of the event was as follows: After the previous vaccination (first dose of Comirnaty), physical condition deteriorated (suspect of vagal reflex). Today (16Jul2021), lied down and received second vaccination. About 5 minutes after vaccination (15:18), had once cough. After that, the patient coughed about every 5 minutes. After 10 minutes (15:23), the cough was settled; from lying down to sitting position, BP188/105, HR 82, SPO2 99%. After 12 minutes at 15:25, both hands tremor. On 16Jul2021 at 15:25 (12 minutes after second vaccination), no Dyspnoea, lying down resting. Then, On 16Jul2021 at 15:35 (22 minutes after second vaccination), DL examination (as reported), observation instruction. On 16Jul2021 at 15:40 (27 minutes after second vaccination), sitting position again, BP157/96, HR 70, no tremor. On 16Jul2021 at 16:00 (47 minutes after second vaccination), DL examination (as reported), 50 minutes observation after vaccination, permission to return home. On 16Jul2021 at 16:00 (47 minutes after second vaccination), BP 140/88. HR 66, symptoms recovered, the patient returned home. The reporter classified the events as non-serious and assessed that the causality between the events and BNT162B2 as unrelated. Other possible cause of the event such as any other diseases was Hypertonicity. The reporting physician commented as follows: Blood pressure has been 150 increased for the past one week. Had asthma-like symptoms at night, coughed and someday could sleep well. The patient said had a little short of sleep. Outcome of the events ''BP188/105 / Blood pressure has been 150 increased for the past one week'', ''cough'', ''hand tremor '' was recovered on 16Jul2021 at 16:00. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1517416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902875

Write-up: Painful arm; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 15Jul2021 at dusk (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 15Jul2021 (reported as at dusk yesterday), the patient received the first dose of the BNT162B2 vaccine. On 16Jul2021 (reported as this morning), the patient experienced the adverse event of painful arm, so the patient went to the dentist and received a local anesthesia. The patient reported that it was said on the internet that it would be better to have anesthesia 3 days after vaccination or the effect of the vaccination would be decreased. The outcome of event painful arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1517438 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESALEX; MONTELUKAST; FLUTIFORM; ADOAIR; CARBOCISTEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021903437

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 62-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was unknown) via an intramuscular on an unspecified date (the day of vaccination) (at the age of 62-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had other medical history of asthma bronchial. Concomitant medication included desloratadine (DESALEX), montelukast, fluticasone propionate, formoterol fumarate (FLUTIFORM), fluticasone propionate, salmeterol xinafoate (ADOAIR) and carbocisteine taken for an unspecified indication, start and stop date were not reported. On 16Jul2021, the patient experienced anaphylaxis. The seriousness of the event was not provided. On 16Jul2021, the outcome of the event was recovering. The causality assessment was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event anaphylactic reaction and the administration of the vaccine cannot be excluded.


VAERS ID: 1517462 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Biliary colic, Body temperature, Gallbladder enlargement, Ultrasound abdomen
SMQs:, Gallbladder related disorders (narrow), Biliary tract disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer (on 2012, the patient received gastric cancer endoscopic therapy.)
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210716; Test Name: Abdominal US; Result Unstructured Data: Test Result:gallstone of 5.2 mm in diameter was found in the; Comments: enlarged gallbladder
CDC Split Type: JPPFIZER INC2021905766

Write-up: gallstone of 5.2 mm in diameter was found in the enlarged gallbladder; gallstone attack/gallstone/severe pain, and sweating of right hypochondrium/tenderness of right hypochondrium; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). This report was received from the regulatory authority report number is v21120018. The patient was 67-year and 7-month-old female. Body temperature before vaccination was 36.2 degrees Centigrade. On 13Jul2021 at 13:04 (the day of vaccination), a 67-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot number FC8736, and Expiration date 30Sep2021) via intramuscular injection on the left arm as a dose 2, single dose at age of 68-year-old for COVID-19 immunization. On 22Jun2021 at 13:00, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number FA4597, and Expiration date 31Aug2021) via an unspecified route of administration on the left arm as a dose 1, single dose at age of 67-year-old for COVID-19 immunization. Other medical history was on 2012, the patient received gastric cancer endoscopic therapy. The patient was not pregnant. The family history was not reported. There were no other 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, etc.). The patient had not received COVID vaccine prior to vaccination. The patient had not tested for COVID post vaccination. The patient had no known allergies. The patient''s concomitant medications were not reported. On 16Jul2021 at 10:40 (3 days after the vaccination), the patient experienced gallstone attack. The course of event was as follows: On 16Jul2021 (3 days after the vaccination), ate a normal breakfast and had no problems. Did not like greasy foods. At 10:40, went out with husband to take out the rubbish, and suddenly had severe pain, and sweating of right hypochondrium. At 11:33, managed to drive to the hospital. On examination, the abdominal skin was moist, and tenderness of right hypochondrium. Abdominal US: gallstone of 5.2 mm in diameter was found in the enlarged gallbladder. After that, the pain disappeared suddenly. Gave a referral to the ER and Gastroenterology Department of hospital. The fact that the primary organ of the gallbladder was embryologically derived from the intestinal tract makes it understandable that an adverse reaction of this form may occur. The reporter stated that Adverse event caused physician office visit and emergency room visit. The outcome of the events was unknown. The reporter classified the event as non-serious and assessed the causality between the event and the bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1517468 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Magnetic resonance imaging
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None.
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: MRI; Result Unstructured Data: Test Result: no abnormality found; Comments: The results were normal.; Test Date: 20210716; Test Name: MRI; Result Unstructured Data: Test Result: Embolism.
CDC Split Type: JPPFIZER INC2021905875

Write-up: Embolism; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 77-year-old female patient received her second dose of BNT162B2 (COMIRNATY, Solution for injection), intramuscularly in the left arm on 13Jul2021 at 16:00 (the day of vaccination), at the age of 77-year-old (Lot number EY0572, Expiration date 31Oct2021) as single dose for COVID-19 immunization. The patient was non-pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of BNT162B2 (COMIRNATY, Solution for injection), intramuscularly in the left arm on 16Jun2021 at 17:45 (the day of vaccination), at the age of 77-year-old (Lot number FA2453, Expiration date 31Aug2021) as single dose for COVID-19 immunization. On 16Jul2021 at 17:00 (3 days 1hr after vaccination), the patient experienced embolism. The course of the event was as follows, On the afternoon of 14Jul2021 (1 day after the vaccination), the patient didn''t feel well and went to doctor. The patient had forgetfulness. But the results of MRI showed that there was no abnormal index. On 16Jul2021, the patient had MRI examination again because of weird symptoms continued and was found embolism. Treatment including oral treatment for cerebral infarction. The reporter classified the event as serious (Disabling/Incapacitating) and stated the event results in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender''s Comments: Based on the current available information in the case provided, the causal association between the event embolism and the use of suspect product BNT162B2 cannot be fully assessed/excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1517692 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Neck pain, Pain, Pulmonary pain
SMQs:, Other ischaemic heart disease (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021908388

Write-up: ache on lungs and heart; ache on lungs and heart.; Strong body pain; joint ache, especially on neck shoulder underarm arm scapula area; joint ache, especially on neck shoulder underarm arm scapula area; This is a spontaneous report from a contactable consumer (patient) received via A 29-year-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot number: FE6029) via an unspecified route of administration at arm left on 15Jul2021 (at age of 29-year-old), as single dose for COVID-19 immunization at Hospital. Medical history of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not took concomitant medication (not received any other medications the patient received within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient previously received first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot number: FD0932) via an unspecified route of administration in left arm on 10Jun2021 (at age of 28-year-old), as single dose for COVID-19 immunization. On 16Jul2021 at 04:00, patient experienced strong body and joint ache, especially on neck shoulder underarm arm scapula area, ache on lungs and heart. Outcome of the events were unknown.


VAERS ID: 1517699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210760363

Write-up: UPPER BODY RASH; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-A202107-3312] concerned a 37 year old male. The patient''s weight was 70 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intravenous (not otherwise specified), batch number: 21C17-05) .5 ml, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-JUL-2021, the patient experienced upper body rash. The action taken with covid-19 vaccine was not applicable. The patient recovered from upper body rash on 18-JUL-2021. This report was serious (Other Medically Important Condition). Sender''s Comments: V0:20210760363-COVID-19 VACCINE -Upper body rash. This event(s) is labeled per Regulatory Authority and is therefore considered potentially related.


VAERS ID: 1517784 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea, Anovulatory cycle
SMQs:, Fertility disorders (broad), Sexual dysfunction (broad)

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

Write-up: HAR INTE F?TT MIN MENS; INTE F?TT OVULATION; This regulatory authority case was reported by a consumer and describes the occurrence of AMENORRHOEA (HAR INTE F?TT MIN MENS) and ANOVULATORY CYCLE (INTE F?TT OVULATION) in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In 2021, the patient experienced ANOVULATORY CYCLE (INTE F?TT OVULATION) (seriousness criterion disability). On 16-Jul-2021, the patient experienced AMENORRHOEA (HAR INTE F?TT MIN MENS) (seriousness criterion disability). At the time of the report, AMENORRHOEA (HAR INTE F?TT MIN MENS) and ANOVULATORY CYCLE (INTE F?TT OVULATION) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1519188 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Influenza like illness; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) in an 18-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Influenza like illness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medication have been reported. No treatment information has been provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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: 1519239 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210761393

Write-up: FEVER; This spontaneous report received from a consumer via a Regulatory Authority concerned a 42year old male of unspecified race and ethnicity. The patient''s weight was 82 kilograms, and height was 184 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Xd986 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 16-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-JUL-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210761393-Covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per Regulatory Authority and is therefore considered potentially related.


VAERS ID: 1520540 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: BRPFIZER INC202100942601

Write-up: contracted the Covid -19 virus after taking the first dose of the vaccine/ covid-19 test was positive; contracted the Covid -19 virus after taking the first dose of the vaccine/ covid-19 test was positive; This is a spontaneous report from a contactable consumer (the patient) received through portal. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number and expiry date were unknown), via an unspecified route of administration, in the right arm, on an unknown date at 04:00 (at the age of 35-year-old) and second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number and expiry date were unknown), via an unspecified route of administration, in the right arm, on 16Jul2021 04:00 (at the age of 35-year-old), both doses as single dose, for COVID 19 immunization. The patient''s medical history included the known allergies to nimesulide and paracetamol. The patient''s concomitant medications were not reported. On 16Jul2021 21:00, patient contracted the COVID 19 virus after taking the first dose of the vaccine. Adverse Events resulted in consultation or visit by a doctor or other health professional, gone to the emergency department. No COVID prior vaccination. Patient did not receive any treatment to the events. The patient underwent the lab tests and procedure which included COVID test post vaccination: Nasal swab test; DA-NCOV, test result was positive on 23Jul2021. Outcome of the events was not recovered. The lot number for the vaccine, COVID-19 vaccine, was not provided and will be requested during follow up.


VAERS ID: 1520768 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Joint noise, Myalgia, Pain in extremity, SARS-CoV-2 test, Sleep disorder due to general medical condition, insomnia type, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909108

Write-up: Chills; Joint pain; Muscle ache; Joint noise; Pain in arm; Insomnia due to organic factors; Injection site pain; Headache; Muscle pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-APPCOVID-202107170803537570-UBN6Y, Safety Report Unique Identifier is GB-MHRA-ADR 25668007. A 32 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 at the age of 32 years old (Batch/Lot Number: FE1510) as single dose for covid-19 immunization. Medical history included pain from an unknown date. Patient has not had symptoms associated with COVID-19. Concomitant medication included paracetamol (PARACETAMOL) taken for pain from 16Jul2021 to an unspecified stop date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced injection site pain, headache, muscle pain, joint pain, muscle ache, joint noise, pain in arm and insomnia due to organic factors all on 16Jul2021; chills on 17Jul2021. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test with no - negative covid-19 test on 15Jul2021. The patient was recovering from headache and insomnia due to organic factors while patient had not recovered from injection site pain, muscle pain, joint pain, chills, muscle ache, joint noise and pain in arm. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908865

Write-up: Vaccine exposure during pregnancy; Rash; Swelling; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162246562530-KLNVW. This consumer reported information for both mother and fetus/baby. A female patient of an unspecified age received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date: unknown), via an unspecified route of administration on 15Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SIN-GLE for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 16Jul2021, the patient experienced rash and swelling. The mother reported she became pregnant while taking bnt162b2. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520805 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain in extremity, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (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; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909201

Write-up: Skin peeling; cannot move my arm without pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171041024940-2K0L7, Safety Report Unique Identifier is GB-MHRA-ADR 25668386. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the arm on 15Jul2021 (Lot number was not reported) as single dose for covid-19 immunization. Medical history included lactation decreased and pain both from an unknown date. The patient''s concomitant medications were not reported. Patient was not taking any medicines, not even pain killers as she was trying to conceive. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, is not currently breastfeeding. The patient experienced swollen lymph nodes on 16Jul2021 and skin peeling on 17Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Swollen lymph nodes under the jabbed arm occurred the day after the jab, it was extremely uncomfortable and I cannot move my arm without pain. Woke up today (two days after jab) and the skin is peeling from the palms and fingers of my hands. I have no previous skin conditions. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. The patient had not recovered from the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Pruritus, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909232

Write-up: itching; Pins and needles in arm; Hives; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107171857004150-5DYFR, Safety Report Unique Identifier GB-MHRA-ADR 25669167. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased. Patient is not pregnant nor currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced itching and pins and needles in arm on an unknown date; and, hives on 16Jul2021. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative COVID-19 test on 17Jul2021. The patient has not recovered from the event, hives and outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Pain in extremity, Rash macular, Skin burning sensation, Skin warm, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (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: GBPFIZER INC202100916628

Write-up: Red blotches; Swelling; Muscle soreness; Skin warm; felt like area was burning; arm aching; This is a spontaneous report from a contactable consumer. This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107171907151780-HEKRO, Safety Report Unique Identifier GB-MHRA-ADR 25669613. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FD5613) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant nor currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced red blotches, swelling, muscle soreness, skin warm on 16Jul2021. Additional information was reported as follows: raised concern with doctor onsite, who said it was not warm, but felt like area was burning. Within 30 mins size of red area was noticeable (50p,) warm to touch, sore, arm aching. Patient has not tested positive for COVID-19 since having the vaccine. The events were considered medically significant. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520821 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916602

Write-up: Headache; Fatigue; Aching joints; Nausea; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107180750415660-EJ5UL, Safety Report Unique Identifier: GB-MHRA-ADR 25669520. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient experienced headache, fatigue, aching joints, and nausea on 16Jul2021. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Nausea recovered on 17Jul2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520832 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Decreased appetite, Fatigue, Headache, Myalgia, Pain, Pyrexia, SARS-CoV-2 test, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916342

Write-up: high temperature; pain; I slept on and off throughout that day; loss of appetite; Muscle ache; Fever; Taste loss; Headache; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is . A 34-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FE1510) via an unspecified route of administration on 16Jul2021 (at the age of 34-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) on unspecified date for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Concomitant medications included paracetamol taken for covid-19 immunisation, Period pains from 28Jun2021 to 17Jul2021. Patient had not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. On 16Jul2021, the patient experienced fatigue. On 17Jul2021, muscle ache, fever, taste loss, headache and loss of appetite. On unspecified date, the patient experienced high temperature, pain and reported that, i slept on and off throughout that day. It was stated that after receiving the vaccine at lunchtime patient was fine. That evening patient was very tired and went to sleep early. The following day patient was in bed the whole day with aches and pain, headache, loss of appetite and a high temperature. Patient slept on and off throughout that day. The next morning my body was recovered, but patient have noticed that my taste was not right yet, fruit taste bitter (papaya) even when my partner said it tastes sweet. The patient underwent lab tests and procedures which included covid-19 virus test negative on 20Dec2020. Outcome of the events high temperature and pain was recovered on unspecified date. Outcome of the event taste loss was recovering. Outcome of the events loss of appetite and I slept on and off throughout that day was unknown. Outcome of the other events was recovered on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520835 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916438

Write-up: Pain in foot/Pain in calf; Tingling sensation; Appetite lost; headache; tiredness; Aching; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181213149850-RNWSR, Safety Report Unique Identifier GB-MHRA-ADR 25669689. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FE1510), dose 2 via an unspecified route of administration on 16Jul2021 (at the age of 42 years old) as dose 2, single for COVID-19 immunization. The patient''s medical history included lactation decreased and suspected COVID-19 from 16Mar2020 to 01Apr2021 and was not ongoing. The patient has not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. On 16Jul2021, the patient experienced headache, tiredness, and aching. On 18Jul2021, the patient experienced tingling sensation, pain in foot/pain in calf, and appetite lost. The events were medically significant. Outcome of the events was not recovered. The clinical course was reported as follows: Aching, tiredness and slight headache on day 1. Fatigue, light headache, aching on day 2. Extreme fatigue, aching, shooting pains from bottom of foot up throughout calves, tingling sensation in big toe on both feet, no appetite on day 3. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No information is expected.


VAERS ID: 1520847 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916492

Write-up: Lymphadenopathy/painful swollen lymph node on left collarbone; bnt162b2 on 13May2021 as first dose/on 16Jul2021 as second dose; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181524447800-NWS0Z. Safety Report Unique Identifier (GB-MHRA-ADR 25669794). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot Number: FF3319), via an unspecified route of administration on 16Jul2021 (at the age of 32 years old) as second dose, single for covid-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (Lot Number: ET8885), via an unspecified route of administration on 13May2021 as first dose, single for covid-19 immunization. On 17Jul2021, the patient experienced lymphadenopathy with outcome of not recovered. The patient further reported painful swollen lymph node on left collarbone. 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 29Jan2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520870 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness postural, Syncope, Vital signs measurement
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: Test Date: 20210716; Test Name: vital signs; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100916686

Write-up: Dizziness postural; fainted; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181915349460-TERZ7 and Safety Report Unique Identifier GB-MHRA-ADR 25669952. A 20-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot Number: FF3319), via an unspecified route of administration on 16Jul2021, at the age of 20 years, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced dizziness postural and fainted on16Jul2021. Therapeutic measure given for the event fainted. The clinical course was reported as follows: Young man had vaccination and immediately afterwards he fainted and recovered within a minute. Feet were elevated and vital signs taken (16Jul2021, Unknown results). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for dizziness postural and fainted was recovered on 16Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Back pain, Body temperature, Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202100916618

Write-up: high temperature; chills; back pain; nausea; Abdominal bloating/distension; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107182015535350-PLVMN, Safety Report Unique Identifier: GB-MHRA-ADR 25669972. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Jul2021 (Lot Number: Fc9001) as dose 2, single for COVID-19 immunisation. Medical history reported as none. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced high temperature, chills, back pain, nausea, and distension on an unspecified date; and abdominal bloating on 16Jul2021. Clinical course reported: significant abdominal bloating, very distended. Feeling of nausea, chills & high temperature. Distension leading to back pain. Reduced after medication but only by 50%. 18th pm, bloating increased again. The outcome of the events abdominal bloating/distension was not recovered and for the rest of events was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520890 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Feeling abnormal, Headache, Illness, Myalgia, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (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: MERCILON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916453

Write-up: Fever; Sickness; Headache; Diarrhea; Nausea; sore arm; felt awful; Muscle ache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107182125219430-ILND2, Safety Report Unique Identifier is GB-MHRA-ADR 25670038. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jul2021 (age at vaccination was 36 years) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased), and oral contraception (birth control pill). Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included desogestrel, ethinylestradiol (MERCILON) taken for oral contraception, start and stop date were not reported. The patient experienced fever on 17Jul2021 with outcome of recovering, sickness on 17Jul2021 with outcome of recovered on 17Jul2021, headache on 17Jul2021 with outcome of recovering, diarrhea on 17Jul2021 with outcome of not recovered, felt awful on 16Jul2021 with outcome of recovering, muscle ache on 16Jul2021 with outcome of recovering, nausea on 17Jul2021 with outcome of recovering, and sore arm on 17Jul2021 with outcome of recovering. The events were reported as serious, medically significant by the health authority. Case narrative: I got a sore arm the first day. Woke up in the morning with a headache, nausea and muscle aches. This got a little better throughout the day. In the evening I felt awful with muscle aches, fever, headache, sickness and diarrhoea. Diarrhoea and nausea and slight headache continued into the next day and is still present. Patient had 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: 1520896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Dizziness, Feeling abnormal, Headache, Illness, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Date: 07/18/2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100916380

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107182153287730-VK1QS; safety report unique identifier: GB-MHRA-ADR 25670072). A 40-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# not known), via an unspecified route of administration, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation. Unsure if patient had symptoms associated with COVID-19. Patient is not pregnant, nor currently breastfeeding. The patient''s concomitant medications not reported. The patient experienced headache, dizziness, back pain on Jul 16, 2021; stomach cramps and diarrhea on Jul 18, 2021. Clinical course reported: On day 3 (Jul 16, 2021), she started to feel ill. On day 5 (Jul 18, 2021), she felt really bad. She was in bed all day and it was not getting better. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on Jul 18, 2021. The outcome of the events "ill" unknown; and for the rest of events was not recovered. The events assessed serious (medically significant). No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1520897 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916404

Write-up: Heavy periods; Irregular periods; patient received the 2nd dose of bnt162b2 on 16Jul2021 and the 1st dose on 13May202; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The consumer reported for 2 reports. This is the 1st of 2 reports. The regulatory authority report number for this 1st report is GB-MHRA-WEBCOVID-202107182205091710-ITE78 and Safety Report Unique Identifier: GB-MHRA-ADR 25670089. A 29-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021, at the age of 29 years, (Batch/Lot number: Unknown) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Historical vaccine includes 1st dose of bnt162b2 on 13May2021 for COVID-19 immunization and period was for 12 to 14 days. The patient''s concomitant medications were not reported. On 16Jul2021, the patient experienced heavy periods and irregular periods. The clinical course was reported as follow: The patient has always had regular periods but since the 1st jab in 13May2021, period has been on for 12 to 14 days. Second jab has made period very heavy and started 8 days early. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The patient had COVID-19 Virus test (Unknown date): No - Negative COVID-19 test. It was also reported that the patient received the 2nd dose of bnt162b2 on 16Jul2021 and the 1st dose on 13May2021 which was considered inappropriate schedule of vaccine administered. The outcome for heavy periods and irregular periods was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Low back pain (without radiation); Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916641

Write-up: Prolonged heavy periods/Heavy blood loss with large blood clots; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not known), dose 1 via an unspecified route of administration on 14Jul2021 as dose 1, single for COVID-19 immunization. Medical history included lactation decreased, diabetes 1, and low back pain (without radiation). Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medication included ibuprofen taken for low back pain (without radiation), start and stop date were not reported. The patient experienced prolonged heavy periods (Heavy blood loss with large blood clots) (assessed as medically significant) on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520917 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923306

Write-up: Enlarged lymph nodes (excl infective); Fatigue; Dizziness; Aching in limb; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190824439090-PO7I8. Safety Report Unique Identifier GB-MHRA-ADR 25671027. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 16Jul2021 at age of 33-year-old (Lot Number: FE1510) as single dose for COVID-19 immunization. Medical history included lactation decreased, pain. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain from 17Jul2021. The patient experienced enlarged lymph nodes (excl infective) (medically significant) on 17Jul2021, fatigue (medically significant) on 17Jul2021, dizziness (medically significant) on 17Jul2021, aching in limb (medically significant) on 16Jul2021. The patient underwent COVID-19 virus test on 19Jul2021 with negative result. The outcome of events was not recovered. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1520918 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decidual cast, Haemorrhage, Menstruation irregular, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923143

Write-up: bleeding; cramping; Decidual cast; period started about 3 days early; 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-202107190828248790-RYYHW. Safety Report Unique Identifier GB-MHRA-ADR 25671097. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. Patient received the first doe of BNT162B2 and experienced fatigue and aching arm. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced bleeding, cramping on an unspecified date, decidual cast on 18Jul2021. My period started about 3 days early, the evening after receiving the vaccine. That night I was woken by heavy cramping which is unusual for me. I bled normally the following day but the day after that, I vaginally passed a large piece of white flesh which was wrinkled but not bloody. Later that day, I passed a blot clot which was about the size of a two pound coin. Then the bleeding pretty much stopped entirely, two days earlier than usual. I believed this was a decidual cast, from looking online and because my bleeding has ended. Other than this, I have only experienced fatigue and an aching arm, which is how my body reacted when I had the first dose of the vaccine. Outcome of event decidual cast recovered on 18Jul2021, of period started about 3 days early was unknown, of others was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100928136 same patient/product, different event/dose.


VAERS ID: 1520947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-16
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Headache, Liver function test normal, Madarosis, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), Periorbital and eyelid disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Hay fever; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Bloods; Result Unstructured Data: Test Result:clear; Test Name: CT scan; Result Unstructured Data: Test Result:clear; Test Name: liver function; Result Unstructured Data: Test Result:clear; Test Date: 20210716; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative.
CDC Split Type: GBPFIZER INC202100923428

Write-up: head ache; loss of eye; Palsy Bells; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: FC8289) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased, acne and hayfever. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and she was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took fexofenadine 180mg for hayfever, spironolactone 100mg tablet for 3 months for acne and norgeston (daily contraceptive pill). The patient experienced head ache on an unspecified date, loss of eye (loss of eyelashes) on an unspecified date and palsy bells on 16Jul2021. The events required hospitalization. The clinical course was as follows: fit and healthy post normally, until 13Jul2021 head ache in RHS near of head started, and continued and got progressively worse till 17Jul2021. The on RHS Loss of eye control noticed on 16Jul2021, by 17Jul2021 noon, complete loss of control of side of face (eye, mouth, cheeks, jaw). Went to A&E and was prescribed Prednisolone steroids. 3 days taking steroids no improvements seen as yet. Still lack of control over RHS of face. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included Bloods, CT scan and liver function, all clears and COVID-19 virus test: negative (no - negative covid-19 test) on 16Jul2021. Palsy Bells was not recovered, the other events were recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520949 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201103; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100923427

Write-up: muscle aches; Ache; Headache; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107191052039690-QN7GV. Safety Report Unique Identifier: GB-MHRA-ADR 25672000. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FE1510) as single dose (at age of 33-years-old) for COVID-19 immunization. Medical history included Covid-19 from 03Nov2020. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not enrolled in clinical trial. On 16Jul2021 she experienced headache and on 17Jul2021 ache and muscle aches occurred. Events considered serious as medically significant. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 03Nov2020 Yes - Positive COVID-19 test. It was reported that patient woke up the day after the vaccine with full body and muscle aches. The headache had started the previous night. All symptoms eased as the day went on. Patient has not tested positive for COVID-19 since having the vaccine. Patient was recovering from myalgia and recovered on 17Jul2021 from headache and ache. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1521034 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: AMOXICILLIN; DULOXETINE; FOSTAIR; PREDNISONE; PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100923263

Write-up: Faint; Nausea; Fever; Shakiness; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107191609048210-B8PNB, Safety Report Unique Identifier GB-MHRA-ADR 25674077. A 30-year-old female patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration at single dose at age of 30 years on 16Jul2021 for COVID-19 immunization. Medical history included suppressed lactation. The patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), on unknown date .P atient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication(s) included amoxicillin (Manufacturer unknown) taken for an unspecified indication; duloxetine (Manufacturer unknown) taken for an unspecified indication; beclometasone dipropionate, formoterol fumarate (Manufacturer unknown) taken for an unspecified indication; prednisone (Manufacturer unknown) taken for an unspecified indication; pregabalin (Manufacturer unknown) taken for an unspecified indication. The patient experienced fever on 16Jul2021 with outcome of not recovered, shakiness on 16Jul2021 with outcome of not recovered, headache on 16Jul2021 with outcome of not recovered, faint on 19Jul2021 with outcome of not recovered, nausea on 16Jul2021 with outcome of not recovered. Seriousness criteria: medically significant.The patient underwent lab tests and procedures which included COVID-19 virus test: negative.Additional information.Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 9/21 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Fatigue, Nausea, Pericarditis
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; CITALOPRAM; EVENING PRIMROSE OIL [OENOTHERA BIENNIS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Familial risk factor (prolonged joint ache and shaking later followed by development of atrial fibrillation); Immune thrombocytopenia (during pregnancies only); Lactation decreased; Pericarditis; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202100922884

Write-up: Chest pain; pericarditis; nausea; tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number GB-RA-WEBCOVID-202107191720038360-X9DQB. A 38-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FC9001 9/21), dose 2 via an unspecified route of administration on 15Jul2021 as single dose for COVID-19 immunisation. Medical history included pericarditis, history of immune thrombocytopenia (during pregnancies only), atrial fibrillation, lactation decreased, hay fever, anxiety reaction, and breast pain. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Family history included Patient''s mother had severe reaction to Pfizer vaccine (unspecified): prolonged joint ache and shaking later followed by development of atrial fibrillation. Concomitant medication included cetirizine taken for hay fever, citalopram taken for anxiety reaction from Oct2020, and evening primrose oil (OENOTHERA BIENNIS) taken for breast pain from 2020. The patient previously took first single dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) on an unspecified date for COVID-19 immunisation. On 16Jul2021, the day following vaccination, the patient experienced mild nausea and tiredness as expected. On the 19Jul2021, she experienced sudden, sharp chest pain over the sternum. This was worse on inhalation and persisted after resting. After consulting GP, she was advised to go to A&E as the GP was full and her symptoms involved chest pain. She had an ECG on an unspecified date which was normal, but chest pain intermittently over the day. She was informed she presented similar to pericarditis, but with the exception that she had a normal ECG. She was also informed she was a mild presentation of this. She had been advised to take ibuprofen for 1 week and to return if further symptoms arise/worsen. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of chest pain was unknown while other events had not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521068 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, Nausea, Rhinorrhoea
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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923082

Write-up: Nausea; Runny nose; leg cramps/Leg cramp was quite severe and painful; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191852023300-90RAW, Safety Report Unique Identification Number: GB-MHRA-ADR 25675383. A 26-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: FD5613) via an unspecified route of administration at single dose on 16Jul2021 (at the age of 26-year-old) for COVID-19 immunization. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced leg cramps on 16Jul2021, nausea on 18Jul2021, runny nose on 17Jul2021; all medically significant. Leg cramp was quite severe and painful, lasting 30+ seconds. Not dehydration related. Patient is not enrolled in clinical trial. The outcome of the event leg cramps was recovered on 17Jul2021, nausea was recovering, runny nose was recovered on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521114 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Back pain, Headache, Lymphadenopathy, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922879

Write-up: rash; pain/pain under my left armpit (the side I had the injection in); my shoulder was very painful; Back ache; Painful arm; Swollen lymph nodes; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107192244379520-V5DA3. Safety Report Unique Identifier is GB-MHRA-ADR 25677026. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased and contraception. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medication included medroxyprogesterone acetate (DEPO-PROVERA) taken for contraception from 23Jun2021. The patient previously received DOSE 1 of BNT162B2 on an unspecified date for COVID-19 immunization. The patient started to get a headache a short while after she received the vaccine and the following day (17Jul2021) had a pain under her left armpit (the side she had the injection in) and shoulder was very painful and felt very achy in her head and down the back. The patient also experienced painful arm and swollen lymph nodes on 17Jul2021. On an unspecified date, noted that the injection site was a lot higher than her first dose to which she developed a rash on her trunk. The events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events headache, pain under left armpit , back ache, painful arm, rash was recovering; swollen lymph nodes was not recovered; while unknown for shoulder pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521151 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928978

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107200850375080-8Y1JS, Safety Report Unique Identifier is GB-MHRA-ADR 25678865. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not known), via an unspecified route of administration on 14Jul2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced heavy periods (medically significant) on 16Jul2021 and further informed extremely heavy period, socking through both super tampons and super sanitary towels at the same time within minutes and constantly nearly every hour. The patient underwent laboratory test which included Sars-cov-2 test: negative on 05Jul2021. The outcome event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521199 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928534

Write-up: bleeding; Menstrual irregularity; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107202249346350-XKWMF, Safety Report Unique Identifier GB-MHRA-ADR 25683697. A 34-year-old female patient (non-pregnant and not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: FA1027) via an unspecified route of administration on 14Jul2021 at dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, suspected covid-19 from an unknown date and unknown if ongoing Unsure when symptoms started and stopped, anxiety from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE) taken for anxiety from 10May2021 to an unspecified stop date. The patient previously took Mirena IUD. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced bleeding (medically significant) and on 16Jul2021 menstrual irregularity (medically significant). She does not normally menstruate due to Mirena IUD so any bleeding was unusual. The patient underwent lab tests and procedures which included sars-cov-2 test results negative for COVID-19 test, on an unspecified date. Outcome of the event bleeding was unknown and menstrual irregularity was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521298 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pharyngeal mass, Swelling face, Wound
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal neoplasms (narrow), Accidents and injuries (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100928316

Write-up: Forehead skin started to swell; small wound; throat lump; A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient experienced some side effects on the day after the first dose, however, the reported was not sure if its related or not with the vaccine. The reporter stated reporting the situation because the effects have started one day right after the vaccine was taken so they not sure how to proceed. It was further reported that the patient was now admitted to hospital and was told by the doctors that the effects are not related with the vaccine. The first side effect noticed: small wound on the skin close to the hair line, Friday: throat lump; Saturday and Sunday: Forehead skin started to swell and are getting worst each day. The patient was hospitalized on an unspecified date in response to the events. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender''s Comments: The events of pharyngeal mass, forehead swelling and wound are not related to the suspect drug BNT162B2 based on the long latent period for these events to occur and the vaccine was administered just a day ago.


VAERS ID: 1521401 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Asthenia, Blood pressure measurement, Blood pressure systolic increased, Body temperature, Eyelid function disorder, Feeling abnormal, Heart rate, Oropharyngeal spasm, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result: 150/80; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result: 35.4 Centigrade; Comments: Before vaccination; Test Date: 20210716; Test Name: Heart rate; Result Unstructured Data: Test Result: 90; Test Date: 20210716; Test Name: SpO2; Test Result: 99%.
CDC Split Type: JPPFIZER INC202100911817

Write-up: lose strength; feel not good; BP 150/80; convulsion around mouth; eyes couldn''t open; Consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120164. The patient was a 43-year-old female. On 16Jul2021 at 17:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) via an Intramuscular injection of administration as 0.3 mL, single dose for COVID-19 immunization. Body temperature before vaccination was 35.4 degrees Centigrade on 16Jul2021. Family history was not provided. The patient''s medical history and concomitant medications were not reported. The patient previously took ZITHROMAC and experienced Loss of consciousness for 4 hours. Event onset date was reported as 16Jul2021 at 17:00 (as reported). The course of the event was as follows: On 16Jul2021 at 5:00 PM, the patient received Comirnaty (0.3ml, Intramuscular injection). 10 minutes after that, the patient felt not good, suddenly lost strength. Immediately after that, convulsion around mouth appeared. The patient''s vitals were BP 150/80, HR 90, SpO2 99%. The patient could do the conversation like one or two sentences, but eyes couldn''t open. The patient received BOSMIN 50ml Intramuscular injection for Consciousness disturbed appeared. 10 minutes after that, the patient received another BOSMIN 50ml Intramuscular injection for symptom was not improving. Called the ambulance and the patient was transferred to the hospital with no change of condition. While in hospital, the symptoms were recovering, observed progress for 3 hours. The next day, the symptoms were improving and the patient backed to normal life. Therapeutic measures were taken as a result of consciousness disturbed, lose strength, convulsion around mouth, eyes couldn''t open and feel not good. On 16Jul2021, the outcome of event was recovering. The reporting physician classified the events as serious (for Medically Significant) and assessed that the events were related to bnt162b2. Other possible cause(s) of the event such as any other diseases was not provided. The reporting physician commented as follows: For the same symptom as what caused by ZITHROMAC appeared, it was considered as the side effect of Comirnaty this time.


VAERS ID: 1521408 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Malaise, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result: 116/71; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result: 78/50 mmHg; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result: 36.6 Centigrade; Comments: before the vaccination.
CDC Split Type: JPPFIZER INC202100914083

Write-up: Vasovagal reflex; felt sick; Blood pressure decreased to 78/50; Syncope when he stood up; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120159. The patient was a 55-year and 10-month-old male. Body temperature before vaccination on 16Jul2021 was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire. On 16Jul2021 at 09:40 (the day of vaccination), the patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration, at the age of 55-years-old, as dose 1, single, for COVID-19 immunisation. On 16Jul2021 at 09:56 (16 minutes after the vaccination), the patient experienced Vasovagal reflex. On 16Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 16Jul2021, around 9:40 COVID-19 vaccination. The patient was waiting in the hospital for observation after the vaccination. Around 09:56 the patient felt sick at and syncope when he stood up. Immediately sat down on a chair and recovered consciousness in about 15 seconds. Blood pressure decreased to 78/50 and move to bed, Lower limb elevation and keep supine position. Dealing with fluid replacement (Soldem 3A 200ul). The patient was conscious and had no problems talking and moving his limbs. Blood pressure recovered to 116/71, and after watching the situation in the outpatient clinic for about 2 hours, the patient returned home. Outcome of the events was recovered on 16Jul2021. The reporting physician classified the events as non-serious and related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Suspected vasovagal reflex to injection.


VAERS ID: 1521410 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site swelling
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: TRIQUILAR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: 1 day after the vaccination
CDC Split Type: JPPFIZER INC202100916089

Write-up: fist-sized Swelling at the vaccination site/ Swelling expanded to upper half of upper arm; pyrexia of 37.8 degrees centigrade; pain from the vaccination site to the entire upper arm; pain from the vaccination site to the entire upper arm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution. A 41-year-old female patient (non-pregnant) received the second dose of bnt162b2 (COMIRNATY) on 16Jul2021 at 10:15 (Lot number FC5947, Expiration date 30Sep2021) (at the age of 41-years-old) Intramuscularly administered in left arm at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ethinylestradiol, levonorgestrel (TRIQUILAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Triquilar 28 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jun2021 at 10:15, the patient previously received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EP9605, Expiration date 30Jun2021) for COVID-19 immunization. On 16Jul2021 at 10:15 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection) intramuscular route of administration in the left arm for COVID-19 immunization. Medical history was not reported. Concomitant medication included ethinylestradiol, levonorgestrel (TRIQUILAR). Patient experienced pain from the vaccination site to the entire upper arm on 16Jul2021 at 11:00; pyrexia of 37.8 degrees centigrade on 17Jul2021; fist-sized Swelling at the vaccination site/ Swelling expanded to upper half of upper arm on 18Jul2021. On 16Jul2021 at 11:00 (45 minutes after the vaccination), the patient experienced pain from the vaccination site to the entire upper arm. On 17Jul2021 (1 day after the vaccination), the patient had a pyrexia of 37.8 degrees centigrade, and it subsided the next day. On 18Jul2021 (2 days after the vaccination), fist-sized Swelling at the vaccination site. On 19Jul2021 (3 days after the vaccination), Swelling expanded to upper half of upper arm. The reporter classified the events as non-serious. The outcome of the event pyrexia of 37.8 degrees centigrade was recovered on 18Jul2021 without treatment. The outcome of other events was not recovered without treatment. No follow up attempts are possible. No further information is expected.


VAERS ID: 1521411 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100916165

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician received via Regulatory Authority The patient was a 90-year-old male. 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. On 17Jun2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and Expiration date Unknown) intramuscular (at the age of 90-years-old) for COVID-19 immunization. On 15Jul2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and Expiration date Unknown), intramuscular (at the age of 90-years-old) for COVID-19 immunization. On 16Jul2021 at 07:45 (about 1 day after the vaccination), the patient experienced Cerebral infarction. The patient received the second vaccine on 15Jul2021. On 16Jul2021, the patient sat quietly in the toilet, and the patient felt dyslalia. The patient was rushed to the hospital. Hospitalized for the diagnosis of cerebral infarction. The patient was hospitalized for the event Cerebral infarction from 16Jul2021 to an unspecified date. The outcome of the event was unknown with treatment including internal therapy. The reporter classified the events as serious (Disabling/Incapacitating, hospitalized). It was unknown since the vaccination, whether the patient has been tested for COVID-19 or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a causal association between the reported event cerebral infarction and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1521434 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cold sweat, Heart rate, Nausea, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:137/87; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: After vaccination.; Test Date: 20210716; Test Name: heart rate; Result Unstructured Data: Test Result:65; Test Date: 20210716; Test Name: SpO2; Test Result: 99 %; Test Date: 20210716; Test Name: respiratory rate; Result Unstructured Data: Test Result: 12.
CDC Split Type: JPPFIZER INC202100918187

Write-up: Anaphylaxis; Feeling queasy; Cold sweat; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120245. A 48-year-old (48-year and 11-month-old female) female patient received bnt162b2 (COMIRNATY), dose 1 at the age of 48-years-old via an unspecified route of administration on 16Jul2021 11:18 (Batch/Lot Number: FC9873; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 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 16Jul2021 at 11:18 (the moment of vaccination), the patient experienced anaphylaxis. On 16Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 17Jul2021 (1 day after the vaccination), the patient was discharged from hospital and the outcome of the event was recovered. The course of the event was as follows: The patient had digestive symptom. After the vaccination, the patient complained feeling queasy. Saline load test performed. Then the patient experienced cold sweat. After the administration of EPIPEN, the patient was carried to hospital in emergency. The blood pressure was 137/87, the heart rate was 65, the respiratory rate was 12, the body temperature was 36.5 degrees Centigrade, the SpO2 was 99% while stayed at the vaccination site. The vital signs were stable when the patient came to the hospital. The patient experienced a queasy feeling and was administrated the steroid and antihistamine. There was no any other abnormalities in circulation and breathing. No skin symptoms either. The reporting physician classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The patient recovered from the events on 17Jul2021.


VAERS ID: 1521454 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysphoria, Fall, Presyncope, Syncope, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result: 36.6 Centigrade; Test Date: 20210716; Test Name: vital signs; Result Unstructured Data: Test Result: settled down.
CDC Split Type: JPPFIZER INC202100918444

Write-up: Syncope; Vasovagal reflex; dysphoria; fell when stood up; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120247. A 43-year-old male patient (reported as 43-year and 10-month-old male) received 1st dose of BNT162B2 (COMIRNATY, lot number FC9873, expiration date 30Sep2021) at single dose on 16Jul2021 at 43-year-old for Covid-19 immunization. Medical history included rhinitis allergic. Concomitant drug was not provided. Body temperature before vaccination was 36.6 degrees Centigrade. On 16Jul2021 (the day of the vaccination), the patient experienced Vasovagal reflex. On 16Jul2021 (the day of the vaccination), the patient was admitted to the hospital. On 17Jul2021 (1 day after the vaccination), the outcome of the event was recovered. The clinical course was reported as follows: After the vaccination, dysphoria occurred during the observation. Syncope occurred and fell when stood up. Consciousness was recovered by lie down. It was suspected of Vasovagal reflex, and emergency transported. The vital signs have settled down but for observation the patient was admitted to the hospital. Outcome of the events was resolved on 17Jul2021. The reporting physician classified the event as serious (hospitalization from 16Jul2021 to 17Jul2021) and the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1521475 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia (taking medical treatment in hospital)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100918996

Write-up: Right occipital region Herpes zoster; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 52-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Oral prescription with VPA 800mg and APZ 24mg as the main ingredients 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 Schizophrenia and was taking medical treatment in hospital. On 08Jul2021 (the day of vaccination) at 13:45, the patient received the first single dose (COMIRNATY, Solution for injection, Lot number EY3860, expiration date 31Aug 2021) intramuscular in the left arm for COVID-19 immunization (52-year-old at vaccination). On 16Jul2021 (about 8 days after the day of vaccination), the patient experienced Right occipital region Herpes zoster. The reporter classified the event as serious (prolonged hospitalization) and stated the event result in Prolongation of existing hospitalization (vaccine received during existing hospitalization). The outcome of the event was unknown with treatment including orally taking VALACICLOVIR 3000mg / day for 7 days. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Herpes zoster cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1521498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100921001

Write-up: Herpes zoster; This is a spontaneous report from a contactable physician via medical information team. A 95 years old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number/ Expiration date: unknown) via an unspecified route of administration as a single dose on 29Jun2021 for COVID-19 immunization. The patient''s medical history and concomitant medications was not reported. The detail of the reaction was reported as follow: There was a patient in door-to-door consultation (physician office visit) who was not vaccinated in our hospital. The patient received the second dose of COMIRNATY on 29Jun2021 and developed herpes zoster symptoms on 16Jul2021. Herpes spread in a zoster, although in the use of internal and external medicine, but the condition was still worsening. There was no significant improvement. The outcome of event was not recovered. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of Herpes Zoster cannot be totally excluded/assessed. 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: 1521511 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100921661

Write-up: Asthmatic attack; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21120173. A non-pregnant 64-year and 4-month-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 15:00 (Batch/Lot Number: EY3860; Expiration Date: 31Aug2021), at the age of 64 years old, as dose 2, 0.3 ml single for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included underlying disease of asthma bronchial and asthma and currently was treated for this. On 25Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY). On 16Jul2021 at 15:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, 0.3mL, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 at 15:30 (30 minutes after the vaccination), the patient experienced asthmatic attack. On 16Jul2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: The patient received the vaccination at 15:00. Dyspnea occurred at 15:30. After using the bringing inhalant, dyspnea with wheezing occurred. Re-examination was taken at 16:00 and intravenous drip with Hydrocorton 100 mg was taken. Symptoms improved. The reporting physician non-serious and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1521533 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Dyspnoea, Pruritus
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100923798

Write-up: Depressed level of consciousness; dyspnoea; generalised itching; This is a spontaneous report from a contactable physician (vaccinator) received from the Regulatory Authority. Regulatory authority report number is v21120399 and v21120580. A 57-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, intramuscular injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration on 16Jul2021 at 17:58 at age of 57 years old as a single dose for COVID-19 immunization. Body temperature before the vaccination was 36.7 Centigrade on 16Jul2021. There were no points provided on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). On 16Jul2021 at 18:08 (10 minutes after the vaccination), events occurred. On 16Jul2021 (the same day of vaccination), the patient was hospitalised and the outcome of events were unknown. The reporter assessed the causality between the event and the vaccines as related. The seriousness was not provided. The course of the event was as follows: During the observation after the vaccination, dyspnoea and generalised itching occurred, after that, depressed level of consciousness was found but no rash. Requested an ambulance and was transported. Seriousness and causality of the events were not provided, but provided hospitalization period: from 16Jul2021 to 20Jul2021. On 20Jul2021 (4 days after vaccination), the outcome of the events was recovered.


VAERS ID: 1521567 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: MRI; Result Unstructured Data: Test Result:Cerebral infarction
CDC Split Type: JPPFIZER INC202100926767

Write-up: Cerebral infarction; This is a spontaneous report from a contactable nurse professional received from Medical Devices Agency. A 71-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jul2021, at the age of 71-years-old (Lot Number: FC5295; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EY0779, Expiration date 31Aug2021). On 16Jul2021, when the patient woke up, it was difficult to move the right half of the body. On the same day, emergency request at 17:45, arrived at the hospital at 18:25; and underwent MRI with Cerebral infarction as diagnosis. The patient was hospitalized due to the event the same day. The patient was hospitalized for cerebral infarction (cerebral infarction) from 16Jul2021. The outcome of the event was unknown. The reporting nurse classified the event as non-serious (as reported) and assessed that the causality between the event and bnt162b2 as unassessable. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1521598 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Computerised tomogram head, Electrocardiogram, Heart rate, Oxygen saturation, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Schizophrenia (On medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: BP 105/63; Test Name: Blood test; Result Unstructured Data: normal; Test Name: Body temperature; Result Unstructured Data: Body temperature 36.6 degrees Celsius.; Test Name: Computerised tomogram head; Result Unstructured Data: normal; Test Name: Electrocardiogram; Result Unstructured Data: normal; Test Name: Heart rate; Result Unstructured Data: HR 65; Test Name: SpO2; Result Unstructured Data: SpO2 94% (room air).
CDC Split Type: JPTAKEDA2021TJP063639

Write-up: Syncope convulsive; Vasovagal reaction; This case was received via the Regulatory Authority (Reference number: 2021TJP063639) on 22-Jul-2021 and was forwarded to Moderna on 31-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope convulsive) in a 37-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Schizophrenia (On medication). On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced SYNCOPE (Syncope convulsive) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reaction). On 19-Jul-2021, SYNCOPE (Syncope convulsive) and PRESYNCOPE (Vasovagal reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 105/63 (normal) BP 105/63. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Body temperature: 36.6 degrees Celsius. (normal) Body temperature 36.6 degrees Celsius.. On an unknown date, Computerised tomogram head: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate: 65 (Low) HR 65. On an unknown date, Oxygen saturation: 94% (Low) SpO2 94% (room air).. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SYNCOPE (Syncope convulsive) and PRESYNCOPE (Vasovagal reaction) to be possibly related. Concomitant medication use information was not provided by reporter. On 16-Jul-2021,the patient received the 1st dose of this vaccine. the patient complained of "feeling of losing consciousness" and then lost consciousness. Convulsive seizure occurred within 1 minute. On unknown date the laboratory exams performed to further understand the event included were blood test, head CT, UCG, and ECG and the results were unknown. Treatment medication use information was not provided by reporter.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1521601 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP064289

Write-up: Peripheral nerve disorder (numbness at the site of vaccination and in the ipsilateral forearm); This regulatory authority case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness at the site of vaccination and in the ipsilateral forearm)) in a 19-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021 at 3:47 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021 at 3:47 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness at the site of vaccination and in the ipsilateral forearm)) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness at the site of vaccination and in the ipsilateral forearm)) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness at the site of vaccination and in the ipsilateral forearm)) to be possibly related. Concomitant product was not provided by the reporter.Lab data was not provided. Treatment product was not provided by the reporter. On an unknown date, body temperature before vaccination: Unknown. It was reported that the patient experienced numbness at the site of vaccination and in the ipsilateral forearm, the symptom of peripheral nerve disorder developed. 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: 1522353 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Malaise, Pyrexia, SARS-CoV-2 test
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: ISOTRETINOIN
Current Illness: Acne
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains
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: feeling sick; fever; Period pains; This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains), MALAISE (feeling sick) and PYREXIA (fever) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Period pains. Concurrent medical conditions included Acne. Concomitant products included ISOTRETINOIN from 01-Jan-2021 to 15-Jun-2021 for Acne. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (feeling sick) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Period pains) had not resolved and MALAISE (feeling sick) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The patient had one day of intense fever and feeling sick. She had on and off really intense period pains. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient reports having an intrauterine contraceptive device for the last three years. 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. However, the patient reports using an intrauterine contraceptive device, which could be a confounder to the event DYSMENORRHOEA.; 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. However, the patient reports using an intrauterine contraceptive device, which could be a confounder to the event DYSMENORRHOEA


VAERS ID: 1522396 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C1603 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Cyanosis, Dyspnoea, Hyperhidrosis, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: O2 saturation; Result Unstructured Data: 98 %
CDC Split Type: ITJNJFOC20210765670

Write-up: 20 MINUTES AFTER THE VACCINATION- PRESSURE DROP, EXCESSIVE SWEATING, SYNCOPE, RESPIRATORY CRISIS RESOLVED BY ADMINISTRATION OF ADRENALINE.; 20 MINUTES AFTER THE VACCINATION- PRESSURE DROP, EXCESSIVE SWEATING, SYNCOPE, RESPIRATORY CRISIS RESOLVED BY ADMINISTRATION OF ADRENALINE.; 20 MINUTES AFTER THE VACCINATION- PRESSURE DROP, EXCESSIVE SWEATING, SYNCOPE, RESPIRATORY CRISIS RESOLVED BY ADMINISTRATION OF ADRENALINE.; 20 MINUTES AFTER THE VACCINATION- PRESSURE DROP, EXCESSIVE SWEATING, SYNCOPE, RESPIRATORY CRISIS RESOLVED BY ADMINISTRATION OF ADRENALINE.; 20 MINUTES AFTER THE VACCINATION- PRESSURE DROP, EXCESSIVE SWEATING, SYNCOPE, RESPIRATORY CRISIS RESOLVED BY ADMINISTRATION OF ADRENALINE.; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-761744] concerned a 49 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C1603, expiry: unknown) 1 dosage forms, 1 total administered on 16-JUL-2021 for sars-cov-2 vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced 20 minutes after the vaccination- pressure drop, excessive sweating, syncope, respiratory crisis resolved by administration of adrenaline. Laboratory data included: Oxygen saturation (NR: not provided) 98 percentage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 20 minutes after the vaccination- pressure drop, excessive sweating, syncope, respiratory crisis resolved by administration of adrenaline was not reported. This report was serious (Life Threatening).; Sender''s Comments: V0: 20210765670-covid-19 vaccine ad26.cov2.s -breathing difficult, blood pressure drop, excessive sweating, syncope, cyanosis. This event(s) is considered un-assessable. 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: 1523554 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100933246

Write-up: The 2nd dose, my first symptoms were headache and tiredness; The 2nd dose, my first symptoms were headache and tiredness; eczema in elbows, wrists, ankles as the days have passed, more, arms, legs, buttocks, back armpits; This is a spontaneous report from a contactable patient received. This is the first of two reports reflecting events after 2nd dose of COMIRNATY. A 43-years-old female (non-pregnant) patient received second dose of BNT162B2 ((COMIRNATY, solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 14Jul2021 (at the age of 43-Years-old) as dose 2, single for COVID-19 immunisation. Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. Medical history included Hashimoto from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had earlier received first dose of ((COMIRNATY, solution for injection; Batch/Lot Number: Unknown), and experienced "pain in my arm and shivers". Patient stated "the 2nd dose, my first symptoms were headache and tiredness (on unspecified dates). 48 hours later, the eczemas began on my elbows, wrists, ankles, as the days go by, its more, legs, glutes, back part of the armpits. Today I went to the physician''s office and got a corticosteroids shot but it did not ease. The doctor did not know either. What should I do if it got worse?". The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the event eczema in elbows, wrists, ankles as the days have passed, more, arms, legs, buttocks, back armpits which included corticosteroids in injection and polaramine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was reported as not recovered at the time of the report. Device Date was 21Jul2021. Follow-up attempts possible, further information is expected.


VAERS ID: 1523855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923410

Write-up: Rash; Lip swelling; Sickness; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Agency (RA).The regulatory authority report number is -MHRA-WEBCOVID-202107191245565700-KVCBE, Safety Report Unique Identifier is -MHRA-ADR 25672621 A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FD8813), via an unspecified route of administration on 15Jul2021 as single dose for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial .On 16Jul2021 patient experienced rash, lip swelling and sickness, all serious as medically significant. Events were also described as follows: rash - whole body, nettle like, with sickness and lip swelling, lasting 2/3 hours then resolving. Final outcome of the events was reported as recovered on 16Jul2021.Report did not relate to possible blood clots or low platelet counts.No follow-up attempts are possible. No further information is expected.


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