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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 363 out of 6,867

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VAERS ID: 1516516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906929

Write-up: Shivers; Muscle ache; Joint pain; Hand pain; Headache; Fatigue; 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-202107152026472120-JLBEH, Safety Report Unique Identifier GB-MHRA-ADR 25659457. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Lot Number: FA1027) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had 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. The patient''s concomitant medications were not reported. The patient experienced shivers, muscle ache, joint pain, hand pain, headache and fatigue on 15Jul2021. Reactions began approximate 12 hours after vaccine received. In addition to the reactions stated, her fingers would clench momentarily and then release when she shock her hands. The case was reported as serious due to other medically important condition. Outcome of events was recovering. 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: 1516571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Blood test, Cerebrovascular accident, Computerised tomogram, Hypoaesthesia, Nerve injury, Paraesthesia, Ultrasound Doppler
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown; Test Name: Ct scan; Result Unstructured Data: Test Result:Unknown; Test Name: Doppler; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC2021907103

Write-up: stroke; Nerve damage; face went tingly and numb; face went tingly and numb; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority, report number is GB-MHRA-WEBCOVID-202107152336240870-EZIHL, Safety Report Unique Identifier GB-MHRA-ADR 25660439. A 38-year-old non-pregnant female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number was not reported) via an unspecified route of administration on 15Jul2021 as dose 2, single for COVID-19 immunisation. The medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Patient did not have symptoms associated with COVID-19 and was not tested for COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced stroke and on 15Jul2021 the patient experienced nerve damage. It was reported that 30 minutes after vaccination face went tingly and numb, suspected mini stroke. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, Computerised tomogram: unknown on an unspecified date, ultrasound Doppler: unknown on an unspecified date. The outcome of the event stroke and face went tingly and numb was unknown and nerve damage was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516581 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907229

Write-up: Diarrhea; Nausea; 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-202107160654115430-NQ6ME, Safety Report Unique Identifier GB-MHRA-ADR 25661196. A 38-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) at 38-year-old, via an unspecified route of administration at single dose on 15Jul2021 for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced nausea on 15Jul2021, and diarrhea on 16Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lethargy, Lymphadenopathy, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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: CITALOPRAM; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill; Major depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909182

Write-up: Swollen lymph nodes; Headache; Nauseous; Lethargic; Muscle ache; 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-202107160815009150-U1E8V, safety report unique identifier is GB-MHRA-ADR 25661642. A female patient of an unspecified age received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot Number: Fe1510), via an unspecified route of administration on 14Jul2021, as dose 2, single for COVID-19 immunization. Medical history included use of birth control pill and major depression. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken as birth control pill; sertraline taken for major depression. On 15Jun2021, the patient experienced headache, nauseous, lethargic and muscle ache. On 16Jul2021, the patient experienced lymphadenopathy. 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. The outcome for the events headache, nauseous, lethargic, muscle ache and lymphadenopathy was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516586 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:negative; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908994

Write-up: Delayed period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107160823196010-Q8M22, and Safety Report Unique Identifier is GB-MHRA-ADR 25661672. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot/batch number was not reported), via an unspecified route of administration on 15Jul2021 as dose 1, single for COVID-19 immunisation. 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. Concomitant medications were not reported. The patient experienced delayed period on 15Jul2021 with outcome of not recovered. The event was considered serious as other medically important condition. Additional information: Patient was due to come on her period the day after her vaccine and her period has still not arrived. Her period is now a month late. She has always had regular periods and have never been on any kind of birth control. She had taken pregnancy test which have all been negative. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, 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: YASMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill; Ehlers-Danlos syndrome; Gallbladder inflammation; Gallbladder removal; 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 INC202100909210

Write-up: my period is heavier than normal; Menstrual cycle abnormal/but the blood is usually bright red, now it is almost black; This is a spontaneous report from a contactable consumer (patient) received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107160827216490-AE8QS, Safety Report Unique Identifier: GB-MHRA-ADR 25661686. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jul2021 (Lot Number: FD5613) as dose 1, single for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, lactation decreased, gallbladder inflammation, gallbladder removed, and birth control pill. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) taken for birth control pill from 14Apr2019. The patient experienced menstrual cycle abnormal on 15Jul2021. Clinical course reported: her period started on the day she expected it but the blood was usually bright red, now it was almost black and heavier than normal. 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 COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the events menstrual cycle abnormal was not recovered and her period was heavier than normal was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516589 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Arthralgia, Body temperature, Dizziness, Headache, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Arthritis (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202100909045

Write-up: headache; muscle weakness; joint pain; dizziness; High temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107160854309690-YDID2, Safety Report Unique Identifier is GB-MHRA-ADR 25661780. A 39-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: FD5613) as single dose for COVID-19 immunisation. Medical history included lactation decreased. 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. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on unspecified date for COVID-19 immunisation. The patient experienced high temperature on 15Jul2021. The patient also experienced sharp headache, muscle weakness, joint pain, and dizziness on unspecified dates. The outcome of high temperature was recovered on 16Jul2021, while for the other events was unknown. The events were considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-15
   Days after vaccination:4
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: 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative
CDC Split Type: GBPFIZER INC202100909344

Write-up: Myocarditis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107160923063950-ESODX. Safety Report Unique Identifier (GB-MHRA-ADR 25662140). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 11Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. The patient experienced myocarditis on 15Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative covid-19 test on an unspecified date. Patient was not enrolled in clinical trial. The outcome of the events was not resolved. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1516598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Hypoaesthesia, Pain, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (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: FERROUS SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; 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 INC202100909212

Write-up: Initial numb injection arm; Generalised aching, aching spread to right arm, right lower back, and pelvic area; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107160945144390-ZLSWD, Safety Report Unique Identifier is GB-MHRA-ADR 25662286. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm on 14Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased and anaemia. She has not had symptoms associated with COVID-19, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included ferrous sulfate taken for anaemia. The patient experienced generalised aching on 15Jul2021. Case narrative: Initial numb injection arm, aching spread to right arm, right lower back, and pelvic area. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The outcome of generalised aching was not recovered, while outcome of numbness of upper extremities was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-15
   Days after vaccination:6
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
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909381

Write-up: Shooting pain; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161010007090-8RN7V, Safety Report Unique Identifier GB-MHRA-ADR 25662418. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced shooting pain on 15Jul2021. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of the event was not resolved. The event was serious with medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Breast pain, Contusion, Headache, Hyperhidrosis, Lethargy, Localised infection, Lymphadenopathy, Myalgia, Nausea, Pain, Pain in extremity, Poor quality sleep, Swelling, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909221

Write-up: breast pain; headache; sweating; nausea; blurred vision; muscle pains; poor sleep; swollen; bruised; painful infection site; painful infection site; raised lymph node in left arm pit; pains down inside of left arm; Lethargy; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number: GB-MHRA- WEBCOVID- 202107161032593720-RK7CE and Safety Report Unique Identifier: GB-MHRA-ADR 25662519. A 44-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Fit and healthy. On no medication and no medical issues. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant; Patient is not currently breastfeeding. There were no concomitant medications. On 15Jul2021, the patient experienced lethargy. On an unspecified date, the patient experienced breast pain, headache, sweating, nausea, blurred vision, muscle pains, poor sleep, swollen, bruised, painful infection site, raised lymph node in left arm pit and pains down inside of left arm. The clinical course was reported as follows: The patient has experienced lethargy, muscle pains, sweating, headache, poor sleep, nausea, raised lymph node in left arm pit, left breast pain, pains down inside of left arm, swollen, bruised and painful infection site and blurred vision. 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 lethargy was not recovered; outcome for the events breast pain, headache, sweating, nausea, blurred vision, muscle pains, poor sleep, swollen, bruised, painful infection site, raised lymph node in left arm pit and pains down inside of left arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   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: Chest pain, Myocarditis, Pyrexia, SARS-CoV-2 test, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: Test Result:360 -$g 670
CDC Split Type: GBPFIZER INC202100908983

Write-up: Myopericarditis; chest pain; fevers; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161257169930-6YJLD, Safety Report Unique Identifier GB-MHRA-ADR 25663626. A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Jul2021 as dose 2, single for COVID-19 immunization. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient had 2ND COVID VACCINATION on the 12Jul21 and was admitted to hospital the night of the 15Jul21 with fevers and chest pain. Troponin was significantly raised and clinically this is in keeping with myopericarditis. On 15Jul2021, the patient experienced chest pain, myopericarditis, fevers. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 15Jul2021, No - Negative COVID-19 test, troponin: 360-$g 670 on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event fevers was unknown, Myopericarditis was not recovered, and chest pain 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 Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1516651 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Muscle spasms, Nausea, Neck pain
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: GBPFIZER INC202100909164

Write-up: Neck cramps; Neck pain; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number: GB-MHRA-WEBCOVID-202107161509130440-RDZGS; Safety Report Unique Identifier: GB-MHRA-ADR 25664508. A female patient of an unspecified age received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), 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 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced neck cramps, neck pain, and nausea on 15Jul2021. The events were considered serious: disability, and medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of nausea was recovering while other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516652 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Illness, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SUMATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908769

Write-up: Dizzy; Headache; Sickness; Tingling sensation; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202107161518377190-MZRVU), Safety Report Unique Identifier (GB-MHRA-ADR 25664536). A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), dose 1 via an unspecified route of administration on 15Jul2021 (at the age of 24 years old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical his-tory included lactation decreased and migraine. Concomitant medications included sumatriptan taken for migraine, start and stop date were not reported. Patient has not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. On 15Jul2021, the patient experienced tingling sensation. On 16Jul2021, the patient experienced dizzy, headache and sickness. Since the vaccination, the patient had not been tested positive for covid-19. The events were serious (medically significant). The patient underwent lab tests and procedures which included covid-19 virus test no- negative covid-19 test on unspecified date. Outcome of the event tingling sensation was recovering. Outcome of the other events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained


VAERS ID: 1516655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chillblains, Peripheral swelling, Pigmentation disorder, Pruritus, Rash macular, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908905

Write-up: Had facial spot on nose; very itchy/burn feeling in feet; blotches like chillblains; blotches like chillblains; swollen feet; Itchy skin; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161540239220-87FA7. Safety Report Unique Identifier GB-MHRA-ADR 25664622. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FE1510), via an unspecified route of administration on 09Jul2021, as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced swollen feet, had facial spot on nose, very itchy/burn feeling in feet, blotches like chilblains. On 15Jul2021, the patient had itchy skin. The outcome of the event swollen feet, very itchy/burn feeling in feet, blotches like chilblains was unknown. The outcome of the event Itchy skin was not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Jul2021 No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Arthralgia, Fatigue, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Hypermobility syndrome; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909350

Write-up: Joint pain; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107161653042010-TLNUD, Safety Report Unique Identifier -MHRA-ADR 25665139. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (at age of 33-year-old, Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, fibromyalgia, suspected covid-19 from 01Apr2020 (Unsure when symptoms stopped), hypermobility. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included naproxen (Manufacture Unknown) taken for fibromyalgia; sertraline (Manufacture Unknown) taken for fibromyalgia. Historical Vaccine include first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced joint pain (medically significant) on 15Jul2021 with outcome of not recovered, nausea (medically significant) on 15Jul2021 with outcome of recovered, headache (medically significant) on 15Jul2021 with outcome of recovered, fatigue (medically significant) on 15Jul2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516672 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FE5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
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: Blood tests; Result Unstructured Data: Test Result:clear; Test Name: ECG; Result Unstructured Data: Test Result:clear
CDC Split Type: GBPFIZER INC202100909355

Write-up: Passed out; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161659296740-6N4BU and Safety Report Unique Identifier is GB-MHRA-ADR 25665143. A 25-year-old female patient received bnt162b2 dose 2 via an unspecified route of administration on 15Jul2021 (at age of 25-year-old, Batch/Lot Number: FE5613) as 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''s concomitant medications were not reported. The patient experienced passed out (medically significant) on 15Jul2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Blood tests and ECG clear. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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: Lymph node pain, 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: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908819

Write-up: Lymph node under armpit swollen and painful; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107161849472090-LTURJ, Safety Report Unique Identifier GB-MHRA-ADR 25666043. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), dose 2 via an unspecified route of administration on 13Jul2021 as dose 2, single for covid-19 immunisation. Medical history included pregnancy. 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 is not enrolled in clinical trial. The patient experienced swollen lymph nodes on 15Jul2021, lymph node under armpit swollen and painful (Same side as injection site) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No - Negative COVID-19 test. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the event swollen lymph nodes was reported as not recovered and for the other event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516687 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Balance disorder, Dizziness, Nausea, SARS-CoV-2 test, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Date: 07/14/2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100909268

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107161857338570-9XSZ6; safety report unique identifier: GB-MHRA-ADR 25666065). A 40-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FC9001), via an unspecified route of administration on Jul 15, 2021, single dose, for COVID-19 immunisation. The patient''s concomitant medications were not reported. Medical history included decreased lactation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient experienced nausea, felt faint (on an unspecified date); and lightheaded (Jul 15, 2021). Clinical course reported: within 5 mins of receiving the jab (Jul 15, 2021), she started to feel nauseous. After another couple of mins, her vision started going funny and she felt faint. She stood up to go outside to get some air. She was very unsteady on her feet. Once she had some fresh air and water, she felt a bit 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 14, 2021. The outcome of the lightheaded event recovered on Jul 15, 2021; for other events recovering. Regulatory authority assessed the events serious (medically significant). No follow-up attempts possible. No further information expected.


VAERS ID: 1516688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Dizziness, Dyspnoea, Headache, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; 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 INC202100908781

Write-up: dizziness; headache; shortness of breath; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161858451000-KEUVI. A 21-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Jul2021 as DOSE 2, SINGLE for covid-19 immunisation.Medical history included Lactation decreased, anxiety disorder. Concomitant medications included fluoxetine taken for anxiety disorder,The patient experienced dizziness , headache, shortness of breath on an unspecified date , palpitations on 15Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No Negative COVID-19 test.Dizziness, headache, when I have palpitations I get shortness of breath. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial.The events were assessed as serious. The outcome of event for Palpitations was not recovered on unknown date .Outcome of other events was unknown on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Dysarthria, Haemorrhage urinary tract, Inflammation, Muscle spasms, Somnolence, Vaginal haemorrhage, Vertigo
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909255

Write-up: Vaginal bleeding; Blood clot in urine; Vertigo; Sore back; Inflammation; Slurred speech; Stomach cramps; Drowsy on awakening/Sleepy; Muscle cramps; This is a spontaneous report from a contactable consumer. received from a regulatory authority. A 25-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 15Jul2021 as dose 1, single for Covid-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. On 15Jul2021, the patient experienced inflammation, slurred speech, stomach cramps, felt drowsy on awakening/sleepy and had muscle cramps. She also had vertigo, vaginal bleeding, blood clot in urine and sore back on 16Jul2021. Events were serious disability. The outcome of events as not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot number cannot be obtained.


VAERS ID: 1516694 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Ear pain, Fatigue, Headache, Nausea, Pyrexia, Tearfulness
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), 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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909223

Write-up: Headache; Tearfulness; Stomach cramps; Tiredness; Nausea; Fever; Dizziness; Earache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107161923056470-JTOOT, Safety Report Unique Identifier is GB-MHRA-ADR 25666297. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FE1510), via an unspecified route of administration on 15Jul2021 (at the age of 35 years old) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 from 20Mar2020 to an unspecified date (unsure when symptoms stopped), and anxiety depression. Patent had not had a COVID-19 test. Concomitant medication included citalopram taken for anxiety depression from 01May2008. The patient experienced tearfulness on 16Jul2021, stomach cramps on 15Jul2021, headache on 16Jul2021, tiredness on 15Jul2021, nausea on 15Jul2021, fever on 15Jul2021, dizziness on 15Jul2021, and earache on 15Jul2021. The events were reported as serious per other medically important condition. Patient has 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 is expected.


VAERS ID: 1516753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Erythema, Fatigue, Headache, Off label use, Pain, Pain in extremity, Peripheral swelling, Product use issue, Swelling, Tension headache, Vaccination site pain, Vaccination site urticaria, Vaccination site warmth
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909274

Write-up: headache; swelling; ongoing breast feeding; ongoing breast feeding; Felt very drained; Redness; Swelling arm; Headache tension; Injection site hives; Pain; arm felt tender; injection site which was painful and hot to touch; injection site which was painful and hot to touch; 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-202107162137451600-D3DW6, Safety Report Unique GB-MHRA-ADR 25667159.This is a mother case. A 32-year-old female patient received 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. Medical history included pregnancy, ongoing breast feeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced headache on an unspecified date, swelling on an unspecified date, redness on 15Jul2021, swelling arm on 15Jul2021, headache tension on 15Jul2021, injection site hives on 15Jul2021, pain on 15Jul2021. Clinical course reported as: Day after the injection my arm felt tender and redness and swelling started. By the afternoon I had an angry red hive at the injection site which was painful and hot to touch. Headache started and got progressively worse. Struggled overnight to wake up properly to breastfeed by premature newborn baby (she was born 4 weeks after 1st jab and 34 weeks). Felt very drained all today (16th) similar to how i felt in pregnancy. Arm still has angry red hot to touch hive which has got larger throughout yie day. Outcome of headache, swelling, redness, swelling arm, injection site hives was not recovered, outcome of headache tension, pain was recovering, other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Case was reported as serious medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100927588 Mother-Baby case


VAERS ID: 1516767 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alexia, Depressed mood, Dizziness postural, Feeling abnormal, Headache, SARS-CoV-2 test, Tearfulness
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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 INC202100908987

Write-up: Alexia; Spacey; Depressed mood; Headache; Dizzy on standing; Tearfulness; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107162317306320-BC3XR, Safety Report Unique Identifier: GB-MHRA-ADR 25667702. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Jul2021 (Lot number was not known) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased. 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 alexia on an unspecified date; headache, dizzy on standing, and tearfulness on 15Jul2021; and depressed mood on 16Jul2021. Clinical course reported: she was a single mum, she struggled to provide care for her child today. She felt as if this should be more well documented. She had been around people who had caught COVID and never tested positive. She was annoyed at the level of reaction. She was spacey and not lucid. Other people had also described this reaction and it should be more well documented. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the events alexia and depressed mood was recovering; headache, dizzy on standing, and tearfulness was not recovered; and spacey was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-15
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Hot flush, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908977

Write-up: hot flushes; temperature; short breath; Hot flush; Nausea; Periodic fever; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID 202107162328325990-V9TTF, Safety Report Unique Identifier GB-MHRA-ADR 25667709. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EY5456),via an unspecified route of administration on 11Jun2021 as dose 1, single for covid-19 immunization. Medical history included suppressed lactation, suspected covid-19 from 20Feb2020 to an unknown date. Unsure when symptoms stopped. Concomitant medications were not reported. Patient was not currently breastfeeding. 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 hot flushes, temperature, short breath. On 15Jul2021, the patient experienced hot flush, nausea and periodic fever. It was reported that she had her vaccine on the 11Jun2021, period on the 15Jun2021. Nothing was wrong. Then after the 2 weeks period of the vaccine beginning to get into the system, the next period tried to start. Almost like a reaction, her body heated up and she had short breath, hot flushes, temperature and nausea. She never get this way on her period. When these symptoms started, her period immediately stopped and when they finished her period returned. Could not sleep or work efficiently the following day. The patient underwent lab tests which included sars-cov-2 test: negative on 15Jul2021. No - Negative COVID-19 test. The outcome of the events hot flush, nausea, periodic fever was recovered on 16Jul2021 and outcome of all the other events was reported as recovering. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1516776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Arthralgia, Fatigue, Headache, Hypoaesthesia, Hypoaesthesia oral, Oropharyngeal pain
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Arthritis (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 INC202100908875

Write-up: throat and facial went numb 20 mins after injection; Tiredness; Headache; Aching joints; Sore throat; Numbness facial; This is a spontaneous report from a contactable consumer. received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107170058477480-SN0QL. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25667748 A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Fd5613 and expiry date was not reported), via an unspecified route of administration, on 15Jul2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. On an unspecified date, the patient experienced throat and facial went numb 20 mins after injection, tenderness to injection site, body aching very tired for few days eyes and throat hurt flu like. On 15Jul2021, the patient experienced numbness facial. On 16Jul2021, the patient experienced tiredness, headache, aching joints, and sore throat. Outcome of the event throat and facial went numb 20 mins after injection was unknown, headache was recovered on an unspecified date. Outcome of the event numbness facial was recovered on 15Jul2021 and for all other events, it was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Arthralgia, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100908877

Write-up: Joint pain; This is a spontaneous report from a contactable consumer.This is a report received from the Agency Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202107170108099600-FP5UC,Safety Report Unique Identifier(GB-MHRA-ADR 25667749). A 38-year-old female patient had received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection),via an unspecified route of administration (at age of 38 years) on 15Jul2021 as dose 2, Single for COVID-19 immunisation.The patient medical history included suppressed lactation from an unknown date and unknown if ongoing.The patient''s concomitant medications were not reported.The joint pain stated in shoulders and as spread to every joint,knees and ankles are the worst at present but I can physically feel each joint in my body. The all hurt. Paracetamol and ibroprofen ease it slightly but not much. 2nd night if not sleeping due to the pain.Patient has not tested positive for COVID-19 since having the vaccine. On 15Jul2021,the patient experienced joint pain (arthralgia).This event was considered as medically significant. Therapeutic measures were taken as a result of joint pain (arthralgia).The patient underwent lab tests and procedures which included sars-cov-2 test was negative on unspecified date. The clinical outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516809 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: COVID-19, Chills, Cold sweat, Discomfort, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Malaise, Migraine, Myalgia, Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909319

Write-up: headache; SARS-CoV-2 infection; Chills; Migraine; Nausea; Muscle ache; Tiredness/exhausted; Injection site pain; Fever; arm pain; whole body felt heavy; feel sick; whole body aches; hot and cold sweats; hot and cold sweats; feel like she cannot function; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107170906594200-GBBC0, safety report unique identifier is GB-MHRA-ADR 25668141. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 15Jul2021 (at age of 26-year-old) as single dose 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 Patient is not pregnant, Patient is not currently breastfeeding. Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced sars-cov-2 infection, chills, migraine, nausea, muscle ache, tiredness/ exhausted, injection site pain, arm pain, fever, whole body felt heavy, feel sick, whole body aches, hot and cold sweats, feel like she cannot function, headache on 15Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 15Jul2021 No - Negative COVID-19 test. Started with arm pain within hours of the injection then approximately 10 hours later that evening whole body felt heavy and exhausted then she started to feel sick. During the night she kept waking up with chill and hot and cold sweats. Her whole body aches, she had the worst headache imaginable and feel like she cannot function. 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: 1516823 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FE1510 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest pain, Chills, Decreased appetite, Diarrhoea, Inappropriate schedule of product administration, Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908931

Write-up: Inappropriate schedule of vaccine administered; nausea; mild temperature; losing appetite; Swollen lymph nodes; Chest pain; High temperature; Chills; Weakness; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The first report is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171116065490-YZNCZ.Safety Report Unique Identifier GB-MHRA-ADR 25668499. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: fe1510) dose 2 via an unspecified route of administration, administered in Arm Left on 15Jul2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included Migraine. Concomitant medications included metoprolol taken for migraine and omeprazole. The patient received first dose of BNT162B2 (Batch/lot number:et8885) on 27May2021 for COVID-19 immunisation and experienced pain in the injection area. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On an unspecified date, the patient experienced nausea, mild temperature, losing appetite and Inappropriate schedule of vaccine administered. High temperature, chills, weakness on 15Jul2021; chest pain on 16Jul2021; swollen lymph on 17Jul2021. Reporter stated that, the first dose did not have any side effects other than a pain in the injection area. For the second dose on the day of injection, he felt mild temperature, chills, weakness, nausea, and losing appetite. The symptoms got worse overnight. He started to feel a throbbing pain in his chest (left side of his chest under his left arm). All these symptoms went away on the third day, but now on the morning of the third day, his left armpit was badly swollen. He received the vaccine in his left arm. The patient underwent lab tests and procedures which included temperature: high and COVID-19 virus test: negative on an unspecified date, No-Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events losing appetite was unknown, high temperature, chills, weakness, chest pain recovered on 17Jul2021, Swollen lymph nodes was not recovered and nausea, diarrhoea and other was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100921538 same patient,different dose,different event


VAERS ID: 1516825 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Pallor, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908829

Write-up: short moment of loss of vision which gradually came back; faint; drowsiness/Drowsy on awakening; pale; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107171132530410-ZXIPC. Safety Report Unique Identifier GB-MHRA-ADR 25668501. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: FA1027 and Expiration date was unknown), via an unspecified route of administration on 15Jul2021, as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Jul2021, as soon as patient received the vaccination, he became very pale and faint, sat down and had a short moment of loss of vision which gradually came back. Patient also experienced drowsiness and drowsiness on awakening with this. General observations where ok, and the patient observed for 45 minutes, he was able to see clearly, walk, talk and drink water. The patient was accompanied by parent. The events loss of vision and faint considered as medically significant. The outcome of the events was recovered on 15Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516847 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Fatigue, Headache, Lymphadenopathy, Pyrexia, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909021

Write-up: Swollen lymph nodes; Fever; Headache; Increased thirst; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107171329320180-DSDAQ, Safety Report Unique Identifier is GB-MHRA-ADR 25668728. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319, Expiry date not reported), via an unspecified route of administration on 15Jul2021 (age at vaccination was 24 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma. Concomitant medication included beclometasone dipropionate (CLENIL MODULITE) taken for asthma, start and stop date 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 swollen lymph nodes on 16Jul2021 with outcome of recovering, fatigue on 15Jul2021 with outcome of recovered on 17Jul2021, fever on 16Jul2021 with outcome of recovered on 17Jul2021, headache on 15Jul2021 with outcome of recovered on 17Jul2021, and increased thirst on 15Jul2021 with outcome of recovered on 17Jul2021. The events were reported as serious, medically significant by the health authority. Case narrative: 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: 1516885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Fatigue, Headache, Ocular hyperaemia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909231

Write-up: fatigue; headache; vomiting; Bloodshot eye; 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-202107171853387320-CV6DU], Safety Report Unique Identifier [GB-MHRA-ADR 25669168]. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced bloodshot eye on 15Jul2021 and fatigue, headache and vomiting on an unspecified date. The events were reported as serious (medically significant). The clinical course was reported as follows: fatigue headache vomiting very bloodshot eyes. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of bloodshot eye was not recovered and unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Maternal exposure during breast feeding, Off label use, Pain, Pain in extremity, Product use issue, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal insufficiency; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908748

Write-up: pain; Off label use; Drug use in unapproved population; Maternal exposure during breast feeding; Injection site redness; Injection site pain; Injection site lump; Injection site warmth; Pain in arm; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: solution for injection, batch/lot number: FA1027), via an unspecified route of administration on 14Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient was not enrolled in clinical trial. The patient''s medical history included adrenal insufficiency, ongoing breast feeding, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). The patient''s concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced pain, maternal exposure during breast feeding. On 15Jul2021, injection site redness, injection site pain, injection site lump, injection site warmth, pain in arm. pain, large red area, lump and heat all at the injection site. Difficulty lifting arm due to pain in arm. 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 was negative (No-Negative COVID-19 test). The outcome of event for pain, maternal exposure during breast feeding was unknown and for injection site redness, injection site pain, injection site lump, pain in arm was not recovered. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1516889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Chills, Fatigue, Headache, Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908755

Write-up: flu like symptoms; Extreme fatigue; sore throat; fever; chills; headache; Aches; Fever and chills; Skin rash; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107171927420100-MXC9E, Safety Report Unique Identifier GB-MHRA-ADR 25669197. A 35-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Fd5613) 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. Ona n unspecified date, patient experienced flu like symptoms, extreme fatigue, sore throat, fever, chills, headache, aches, fever and chills. On 15Jul2021, patient experienced skin rash. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event skin rash was recovering and outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516897 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Nausea, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100908915

Write-up: fever; nauseous; Fainting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107172112323080-SB3VI, Safety Report Unique Identifier GB-MHRA-ADR 25669268. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Jul2021 (at the age of 25-year-old), as dose 2, single for COVID-19 immunization. The patient''s medical history included lactation decreased. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was non-pregnant and was not currently breastfeeding. On an unspecified date, after the second dose of vaccine, the patient woke up in the night with a fever and was feeling nauseous. On 15Jul2021, around 16 hours after the second dose of vaccine, the patient fainted whilst walking to the bathroom, lasted for a duration of 1 day . Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted was reported as none. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 14Jul2021. The clinical outcome of the event fainting was reported as resolved on 16Jul2021 and clinical outcome of all other events was reported as unknown. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1516923 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Arthralgia, Fatigue, Feeling abnormal, Headache, Injection, Lymphadenopathy, Nausea, Pain, Pain in extremity, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916815

Write-up: pain; injection; still; hours; Swollen lymph nodes; Fever; Joint pain; Headache; Nausea; Fatigue; Painful arm; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107180832025720-O4LPZ. Safety Report Unique Identifier: GB-MHRA-ADR 25669543 A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Lot Number: FD5613) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation ,suspected Covid-19 and IBS (causing restricted diet and calorie intake). The patient''s concomitant medications were not reported. Age at vaccination was 37 years. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on unknown date. The patient experienced pain (pain) (medically significant) on an unspecified date with outcome of recovering, injection (medically significant) on an unspecified date with outcome of recovering, still (vaccination site pain) (medically significant) on an unspecified date with outcome of recovering, hours (Spaced out) (medically significant) on an unspecified date with outcome of recovering, swollen lymph nodes (medically significant) on 16Jul2021 with outcome of not recovered, fever (medically significant) on 16Jul2021 with outcome of recovered 17Jul2021, painful arm (medically significant) on 15Jul2021 with outcome of not recovered, joint pain (medically significant) on 16Jul2021 with outcome of recovering, headache ((medically significant) on 16Jul2021 with outcome of recovered on 17Jul2021, nausea (medically significant) on 16Jul2021 with outcome of recovered on 17Jul2021, fatigue (medically significant) on 16Jul2021 with outcome of recovering, Clinical course was : Pain and stiffness in the injection arm started first, roughly 12 hours after the injection. This was rapidly followed by the other side-effects. Effects #2,4,5,7 largely resolved within 24 hours after onset. Pain in the injection arm and swollen lymph nodes still present 72 hours after injection. Additional information : Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding.Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Abdominal pain upper, Diarrhoea, Feeling abnormal, Feeling cold, Feeling hot, Maternal exposure during breast feeding, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100916781

Write-up: Upper abdominal pain; Vomiting; stomach pain; hours; Maternal exposure during breast feeding; Vomited; Pain stomach; Diarrhea; Feeling hot; Feeling cold; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-202107180842073550-ICMJY, Safety Report Unique Identifier GB-MHRA-ADR 25669550. A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FC9001), via an unspecified route of administration, on 15Jul2021 at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, at single dose on unknown date for COVID-19 immunisation. Relevant medical history included lactation decreased. The patient is currently breastfeeding. Patient is not enrolled in clinical trial No relevant concomitant medications were provided. On an unspecified date, the patient had upper abdominal pain, vomiting, stomach pain, hours, and maternal exposure during breast feeding. On 15Jul2021, the patient had painful arm. On 17Jul2021, the patient vomited, had pain stomach, diarrhea, feeling hot and feeling cold. The events were assessed serious as medically significant by Health Authority. 111 was contacted. The clinical course was described as follows: Symptoms came on very quickly. Stomach pain was severe and was primarily upper abdominal pain lasting 5 hours. Vomiting and diarrhoea for 2-3 hours. Patient has not tested positive for COVID-19 since having the vaccine. However, on unknown date COVID-19 virus test was done and resulted negative. The patient had recovered from upper abdominal pain, vomiting, stomach pain, hours recovered on unknown date. The outcome of the event ''maternal exposure during breast feeding'' was unknown; the remaining events had recovered on 17Jul2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100925257


VAERS ID: 1516952 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100916364

Write-up: Neck pain; This is a spontaneous report from a contactable consumer (Patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107182155120830-IP27U Safety Report Unique Identifier GB-MHRA-ADR 25670064. A 26-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 13Jul2021 (Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient reported my neck was sore on the left side on 15Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jul2021.Therapeutic measures taken as result of neck pain included paracetamol. but didn''t help. The case was reported as serious of medically significant. 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, Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1516976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Feeling abnormal, Headache
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923170

Write-up: feel bloody awful; Headache; Heart fluttering; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107191220099590-JZG2O, Safety Report Unique Identifier GB-MHRA-ADR 25672388. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number:Unknown), dose 1 via an unspecified route of administration on 13Jul2021 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 heart fluttering now every 10 minutes, has gradually got worse on 15Jul2021, headache on 16Jul2021, feel bloody awful on an unspecified date. Patient was normally active and healthy. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event feel bloody awful was unknown, other events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1517043 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Fatigue, Headache, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909007

Write-up: Headache; Fatigue; Feverish; This is a solicited report from the (RA) Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number (GB-MHRA-YCVM-202106191057313580-JOHRM), Safety Report Unique Identifier (GB-MHRA-ADR 25668731). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FD8813) as DOSE 2, SINGLE at age of 25-year-old for COVID-19 vaccination. Medical history included steroid therapy from an unknown date (Taking regular steroid treatment (e.g. orally or rectally)). The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jun2021 (Lot number: FA1027) as dose 1, single dose at age of 25-year-old for COVID-19 vaccination. The patient experienced headache on 16Jul2021 with outcome of recovering, feverish on 15Jul2021 with outcome of recovered on 17Jul2021, fatigue on 16Jul2021 with outcome of recovered on 17Jul2021. The event was reported as serious for medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on 17Jun2021. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the events headache, feverish and fatigue 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.


VAERS ID: 1517053 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Inappropriate schedule of product administration, Influenza like illness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: ATORVASTATIN; LANSOPRAZOL; AMLODIPINE; KOLANTICON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal; Hypertension; Oesophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100917296

Write-up: Muscle pain; flu like symptoms; first dose of BNT162B2 on 12May2021/ second dose of BNT162B2 on 15Jul2021; 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-202103231409419490, Safety Report Unique Identifier GB-MHRA-ADR 25287693. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FD8813, at age of 52 years old) as single dose for COVID-19 vaccination. Medical history included hypertension, cholesterol abnormal, oesophageal reflux. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included atorvastatin taken for cholesterol abnormal from 08May2007 to an unspecified stop date; lansoprazol taken for oesophageal reflux from 06Mar2002 to an unspecified stop date; amlodipine taken for hypertension from 02Jul2021 to an unspecified stop date; aluminium hydroxide, dicycloverine hydrochloride, magnesium oxide, simeticone (KOLANTICON) from 15Apr2014 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12May2021 for COVID-19 Immunisation and experienced muscle ache, shivers, armpit pain, itchy, fatigue and felt a little rough. The patient experienced muscle pain and flu like symptoms 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 events was unknown. 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 events muscle pain and flu like symptoms 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.


VAERS ID: 1517057 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FD8513 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Inappropriate schedule of product administration, Migraine, Pregnancy test
SMQs:, 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: Medical History/Concurrent Conditions: Headache tension; Hormonal acne; Polycystic ovarian syndrome; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: pregnancy tests; Test Result: Negative
CDC Split Type: GBPFIZER INC202100918885

Write-up: Migraine headache; Migraine headache; first dose: 19May2021, second dose: 15Jul2021; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report downloaded from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171046497430-WCXP5, Safety Report Unique Identifier GB-MHRA-ADR 25668486. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FD8513) at the age of 39 years old, as single dose for COVID-19 immunization. Medical history included pregnancy, hormonal acne, polycystic ovaries. The patient had prone to tension headaches (not migraines) and hormonal headaches (day before period). No period was due near vaccine day. PCOS, but continuous regular periods for 18 months. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021 (Lot Number: EN4109) for COVID-19 immunization and experienced least/withdrawal reaction, vaccines/ tiredness, headache, phantom pregnancy, pcos (polycystic ovarian syndrome), migraine headache, delayed period. The patient''s, normally regular for the last year, period was due 2 weeks after the first vaccine. It didn''t come until July. The had hormonal changes enough to make her fear she was pregnant with a 4th child! She did pregnancy tests that were negative and got her period at the start of July. Could be a PCOS coincidence, but the phantom pregnancy type symptoms make me feel otherwise. The patient experienced migraine headache on 16Jul2021. Clinical course: Migraine like headache for 2 days at least for both vaccines. Starting the morning after the vaccine (both vaccines at same time of day). The patient would report again if this (delayed period) happened after the second vaccine. (Only had 2 days ago, still on the headache stage). Case was reported medically significant condition. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. The outcome of the event migraine headache 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. No further information is expected.


VAERS ID: 1517220 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Erythema, Headache, Hyperpyrexia, Nausea, Pain, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA, ERYTHEMA, CHILLS, ASTHENIA, HEADACHE, NAUSEA and VACCINATION SITE PAIN in a 46-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004499) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 15-Jul-2021, the patient experienced HYPERPYREXIA (IL(seriousness criteria hospitalization and medically significant), ERYTHEMA (seriousness criterion hospitalization), CHILLS (seriousness criterion hospitalization), PAIN ((seriousness criterion hospitalization), ASTHENIA (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization), NAUSEA (seriousness criterion hospitalization) and VACCINATION SITE PAIN (seriousness criterion hospitalization). At the time of the report, HYPERPYREXIA, ERYTHEMA, CHILLS, PAIN, HEADACHE, NAUSEA and VACCINATION SITE PAIN had resolved. No treatment information provided by the reporter and no concomitant medication reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1517258 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Dehydration, Hypophagia, Malaise, Pneumonia aspiration, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebellar infarction; Cerebral infarction; Disability; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade
CDC Split Type: JPPFIZER INC202100909780

Write-up: Pneumonia aspiration; General malaise; weakness; Low grade fever; state of poor oral intake; Dehydration; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120126. The patient was an 81-year old male (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade. The patient had the primary diseases with Cerebellar infarction, cerebral infarction, Hypertension. On 23Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number FA2453, Expiration date 31Aug2021). On 14Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was on 15Jul2021 at 15:50 (1 day after the vaccination). On 15Jul2021 (1 day after the vaccination), the patient was admitted to the hospital. On 16Jul2021 (2 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: No problem after the first vaccination. After the second vaccination, on 15Jul2021 the patient experienced General malaise, weakness and Low-grade fever (BT 36.8 degrees Centigrade). The patient was in a state of poor oral intake, the same day the patient was hospitalized. The patient experienced dehydration. The reporting physician classified the event as serious (caused hospitalization from 15Jul2021 to Jul2021) and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Pneumonia aspiration. The reporting physician commented as follows: Vaccinations for the elderly with disability need to be cautious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517262 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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, Body temperature, Muscle twitching, Oropharyngeal discomfort, Oxygen saturation, PO2, Respiratory rate, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:86/58; Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:104/89; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210715; Test Name: SAT; Result Unstructured Data: Test Result:98; Test Date: 20210715; Test Name: SAT; Result Unstructured Data: Test Result:98; Test Date: 20210715; Test Name: PA; Result Unstructured Data: Test Result:98; Test Date: 20210715; Test Name: PA; Result Unstructured Data: Test Result:88; Test Date: 20210715; Test Name: RR; Result Unstructured Data: Test Result:20
CDC Split Type: JPPFIZER INC202100909827

Write-up: Abnormal sensation; strange feeling in the throat; flickering in the eyes; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119862. A 36-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Jul2021 10:43 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) (at age 36-year-old) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced abnormal sensation, strange feeling in the throat, flickering in the eyes on 15Jul2021 10:59. Clinical course was as follows: Body temperature before vaccination was 36.4 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 15Jul2021 at 10:43 (the day of vaccination), the patient received the first dose of BNT162b2. On 15Jul2021 at 10:59 (16 minutes after the vaccination), the patient experienced Abnormal sensation. On 15Jul2021 (the day of vaccination), the outcome of the event was recovered on 15Jul2021. The course of the event was as follows: 15 minutes after the vaccination, the patient had tingling sensation from the lip to the neck. BP 86/58, PA 98, SAT 98. Few minutes later, the patient had strange feeling in the throat and flickering in the eyes. BP 104/89, PA 88, SAT 98, RR 20. At 11:08, normal saline 100 ml + Solu-Cortef 100 g DIV was given; At 11:20, all symptoms were erased. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There is the causality between events and the vaccine.


VAERS ID: 1517271 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Atrial fibrillation, Blood pressure measurement, Body temperature, Electrocardiogram, Heart rate, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPADEL [EICOSAPENTAENOIC ACID]; ALINAMIN-F [FURSULTIAMINE HYDROCHLORIDE]; HICEE [ASCORBIC ACID]; CANDESARTAN; AMLODIPINE; CILNIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Dyslipidaemia; Hypertension; Ventricular extrasystoles
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:120-140; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the vaccination; Test Date: 202107; Test Name: pulse rate; Result Unstructured Data: Test Result:90-100; Comments: beats/min; Test Date: 20210715; Test Name: pulse rate; Result Unstructured Data: Test Result:120-150; Comments: beats/min; Test Date: 20210715; Test Name: electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation paroxysmal
CDC Split Type: JPPFIZER INC202100909903

Write-up: Arrhythmia; atrial fibrillation paroxysmal/atrial fibrillation; palpitations; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority. Regulatory authority report number is v21120077. The patient was an 81-year and 6-month-old female. Body temperature before vaccination on 15Jul2021 was 36.4 degrees Centigrade. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included allergy to honey (anaphylaxis caused by honey), medial history of hypertension, dyslipidaemia and ventricular extrasystoles. On 24Jun2021, the patient received the first dose of COVID-19 vaccine, and there was no side reaction. Patient was under treatment of hypertension and dyslipidaemia at time of vaccination. Prescription content: epadel, alinamin-F, hicee, candesartan, amlodipine and cilnidipine. On 15Jul2021 at 12:30 (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 81-years-old and 6 months, as dose 2, single, for COVID-19 immunisation. On 15Jul2021 at 12:40 (10 minutes after the vaccination), the patient experienced arrhythmia (atrial fibrillation). On 16Jul2021 (1 day after the vaccination), the outcome of the events was recovered. The clinical course was reported as follows: 10 minutes after receiving the second dose of vaccination, the patient complained about palpitations. Blood pressure 120-140, pulse rate 120-150 beats/minute, atrial fibrillation paroxysmal was observed by electrocardiogram. Intravenous drip treatment was performed, the patient rested quietly. Pulse rate was improved to 90-100beats/minute, but the anomaly on electrocardiogram still existed. The reporting physician classified the event as serious (risk of disability) and assessed causality between the events and bnt162b2 as unassessable. The reporting physician commented as follows: It is possible that vaccination triggered atrial fibrillation paroxysmal. The plan was to continue with cardiac function tests in the future.


VAERS ID: 1517274 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Erythema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to grains; Allergy to metals; Appendicitis; Breast cancer; Hypertension; Pleurisy; Rheumatism; Rubber sensitivity
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100909976

Write-up: Itching; redness in both upper extremities; difficulty breathing; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120078. A 69-year-old female patient received BNT162B2 (COMIRNATY Intramuscular injection; lot number: FC8736 and expiration date: 30Sep2021), via an unspecified route of administration on 15Jul2021 at 23:12 (the day of vaccination), at the age of 69 years old as dose 2, single 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 pleurisy, appendicitis, left breast cancer, rheumatism and hypertension. The patient was allergic to medications such as anthracycline, fexofenadine (ALLEGRA) and calcium carbonate, magnesium carbonate and magnesium oxide (BUFFERIN) and was also allergic to buckwheat, metal and rubber. Body temperature before vaccination was 36.6 degrees centigrade on 15Jul2021. On 15Jul2021 at 23:40 (28 minutes after vaccination), the patient experienced the following events. The course of the events was as follows: On 15Jul2021, 30 minutes (as reported) after vaccination with BNT162B2 (COMINARTY), the patient experienced itching, redness in both upper extremities and difficulty breathing. The symptoms showed a tendency to improvement with oral administration of betamethasone and dexchlorphenamine maleate (BETASELEMIN). However, the patient was transferred to our hospital. As of 16Jul2021 (1 day after vaccination), the outcome of the events were recovering. The reporter classified the events as serious (hospitalization from 15Jul2021 to 16Jul2021) and assessed the causality between the events and the vaccine as unassessable. Other possible cause of the event such as any other diseases was none. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517322 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100912967

Write-up: Convulsion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120071. The patient was an 85-year-old male. Body temperature before vaccination was 36.0 degrees Centigrade. On 06Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Jul2021 at 00:00 (8 days and 10 hours after the vaccination), the patient experienced Convulsion. On 15Jul2021 (8 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: when the patient got up before dawn, the patient realized Convulsion of both upper limbs. The patient consulted the reporter''s hospital at 11:00 on 15Jul2021, and Convulsion without Loss of consciousness was found. Tegretol 100mg orally taken, Convulsion didn''t improved. CERCINE 5mg orally taken then the symptom disappeared. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: 9 days passed after the vaccination, but since no underlying disease causes Convulsion, it was suspected as an adverse reaction of the vaccine.


VAERS ID: 1517327 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LYRICA; TRAMAL; VESICARE; BELSOMRA; PAROXETINE [PAROXETINE HYDROCHLORIDE HEMIHYDRATE]; CELECOXIB; REBAMIPIDE; LIMAPROST ALFADEX; MAGNESIUM OXIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Lumbar spine compression fracture; Osteoporosis; Spondylolysis
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100917997

Write-up: Intra-cerebral haemorrhage; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120224. An 83-year and 3-month-old female received BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5765, Expiration date: 30Sep2021) on 06Jul2021 at 13:00 (at the age of 83-years and 3-months-old) via an unspecified route of administration as dose 2, single for COVID-19 immunisation. Medical history included dementia Alzheimer''s type, lumbar spondylolysis, lumbar spine compression fracture, and osteoporosis. Family history was not reported. Concomitant medications included pregabalin (LYRICA OD tablet 25 mg), tramadol hydrochloridE (TRAMAL OD tablet 25 mg), solifenacin succinate (VESICARE OD tablet 5 mg), suvorexant (BELSOMRA tablet 15 mg), paroxetine hydrochloride hemihydrate (PAROXETINE 20 mg), celecoxib tablet 100 mg, 2 tablets), rebamipide tablet 100 mg, 2 tablets, limaprost alfadex tablet 5 ug, 3 tablets), and magnesium oxide tablet 500 mg, 2 tablets. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) on an unknown date at unknown time, via unspecified route of administration for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees centigrade on 06Jul2021. On 15Jul2021 at 18:00 (9 days after the vaccination), the patient experienced intra-cerebral haemorrhage. On 15Jul2021 (9 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was unknown. The course of the event was as follows: On 15Jul2021 in the late afternoon, the patient''s response was poor. She had vaguely answered to name calling but became unresponsive, was foaming at the mouth, and had rightward deviation of both eyes. The patient was urgently transported and received a diagnosis of right intra-cerebral haemorrhage. The reporting physician classified the event as serious (life-threatening, risk of disability, hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Side effect was not conceivable but could not be completely denied.


VAERS ID: 1517341 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 EW0201 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100918396

Write-up: Vomiting; Queasy; giddiness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120185. An 85-year and 8-month-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Jul2021 at 15:00 (at the age of 85-year-old) (Lot Number: EW0201; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Relevant medical history was none. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unknown date (Lot number FA7338; Expiration date 30Sep2021) for COVID-19 immunisation. Body temperature on 15Jul2021 before vaccination was 36.2 Centigrade degrees. The patient had no family history. 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 15Jul2021 at 15:30, the patient experienced vomiting, queasy and giddiness. After vaccination, after observing the process, when standing up, the patient experienced giddiness, queasy and vomiting. Make observation for one hour, no improvement, so the patient was hospitalized on 15Jul2021. The symptoms were recovering the following day, so the patent was discharged from hospital on 16Jul2021. The patient was recovering from the events. The reporting physician classified the event as serious (caused hospitalization from 15Jul2021 to 16Jul2021). There was no other possible cause of the event such as any other diseases.


VAERS ID: 1517398 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 EW0201 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dysphagia, Laryngeal discomfort
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FASENRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure reading; Result Unstructured Data: Test Result:low (mild)
CDC Split Type: JPPFIZER INC2021898764

Write-up: blood pressure was low(mild); Laryngeal discomfort; Dysphagia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW0201; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in left arm on 15Jul2021 10:30 (the day of vaccination, at the age of 54-year-old) as dose 1, single for COVID-19 immunization. Medical history included asthma bronchial. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included benralizumab (FASENRA) taken for asthma bronchial. The patient previously took aspirin [acetylsalicylic acid] and experienced drug intolerance. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jul2021 at 10:30 (after the vaccination), the patient experienced blood pressure reading low (mild), Laryngeal discomfort and Dysphagia. The reporter stated the events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was recovered on unspecified date with treatment including intravenous injection of POLARAMINE and steroid. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The event of low blood pressure, laryngeal discomfort, dysphagia is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association.


VAERS ID: 1517403 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Anaphylactic reaction, Body temperature
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC2021898812

Write-up: Anaphylaxis; This is a spontaneous report from a contactable pharmacist received via COVID-19 Vaccine Adverse Event Reporting System and a contactable physician via the Regulatory Authority (regulatory authority report number: v21119858). A 58-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FC5295; Expiration Date: 30Sep2021), via an unspecified route of administration on 15Jul2021 12:50 (received at the age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included asthma, rheumatoid arthritis, depression. The patient was non-pregnant. Concomitant medications included unspecified oral treatment for asthma. The patient experienced anaphylaxis on 15Jul2021 13:00. Clinical course of the event was reported as follows: 10 minutes (as reported) after the vaccination, the patient experienced pharynx closed sensation of. Steroids and bronchodilators were administered. The outcome of the event was reported as recovered on 15Jul2021. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The reporting pharmacist did not provide seriousness assessment. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The reporting physician commented as follows: It was considered as a side reaction of the vaccine.; Sender''s Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.


VAERS ID: 1517446 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Feeling abnormal, Heart rate, Oxygen saturation, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none.
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:68/40; Comments: at 15:27; Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:112/60; Comments: at 15:45; Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:128/60; Comments: at 16:02; Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:120/60; Comments: at 16:18; Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:138/60; Comments: at 16:18; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the vaccination; Test Date: 20210715; Test Name: pulse rate; Result Unstructured Data: Test Result:44/minute; Comments: at 15:27; Test Date: 20210715; Test Name: pulse rate; Result Unstructured Data: Test Result:65/minute; Comments: at 15:45; Test Date: 20210715; Test Name: pulse rate; Result Unstructured Data: Test Result:74/minute; Comments: at 16:02; Test Date: 20210715; Test Name: oxygen saturation; Test Result: 98 %; Comments: at 15:45; Test Date: 20210715; Test Name: oxygen saturation; Test Result: 98 %; Comments: at 16:02.
CDC Split Type: JPPFIZER INC2021903601

Write-up: Shock; feels poorly; cold sweat; pallor facial; This is a spontaneous report from a contactable physician (vaccinator) received from the Regulatory Authority. Regulatory authority report number is v21119872. A 44-year and 8-month-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FC5947; Expiration Date: 30Sep2021) via an unspecified route of administration on 15Jul2021 at 15:15 (at 44 years) as single dose for Covid-19 immunisation. 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).Medical history was none. The patient''s concomitant medications were not reported. Body temperature before vaccination on 15Jul2021 was 36.7 degrees Centigrade. On 15Jul2021 at 15:27(12 minutes after the vaccination), the patient experienced shock.The course of the event was as follows: on 15Jul2021 at 15:15 (the day of vaccination), the patient received the first dose of COVID-19 vaccine. On 15Jul2021 at 15:27 (12 minutes after the vaccination), the patient complained about felt poorly, and experienced cold sweat and pallor facial, then was taken to emergency bed. The level of consciousness was clear. Since the patient experienced shock state with blood pressure 68/40, pulse rate 44/minute.On 15Jul2021 at 15:30 (15 minutes after the vaccination), bosmin 1 ampoule was injected intramuscularly to secure an intravenous drip route, intravenous drip of lactec 500cc mixed with injection of SOLU-CORTEF 100 2 ampoules was performed. Then symptoms gradually recovering.On 15Jul2021 at 15:45 (30 minutes after the vaccination), oxygen saturation 98%, pulse rate 65/minute, blood pressure 112/60.On 15Jul2021 at 16:02 (47 minutes after the vaccination), blood pressure 128/60, pulse rate 74/minute, oxygen saturation 98%.On 15Jul2021 at 16:18 (1 hour and 3 minutes after the vaccination), blood pressure 120/60 and 138/60. 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 suspected anxiety neurosis.The outcome of the event was recovering.The reporting physician commented as follows: Although it was first time to examine the patient, there was an anxiety neurosis-like impression, and it was considered to be a vagal reflex , the patient was in state of shock with blood pressure of 68/40, it was effectively after the injection of bosmin, the above report was reported. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular function test, Eczema, Hand dermatitis, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Extrasystoles
Allergies:
Diagnostic Lab Data: Test Name: heart examination; Result Unstructured Data: Test Result: the patient had Arrhythmia, Extrasystoles, and so; Comments: the patient had Arrhythmia, Extrasystoles, and so on.
CDC Split Type: JPPFIZER INC2021906133

Write-up: swelling; Eczema on knee and back hands yesterday and on tongue and buttocks since today; Eczema on knee and back hands; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number not confirmed, Expiration date not confirmed), via an unspecified route of administration on unspecified date at 13:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included arrhythmia, extrasystoles. Concomitant medications were not provided. The clinical course as follows: The patient received bnt162b2 vaccine on sunday at about 13:30. The patient started experiencing eczema on knee and back hands on 15Jul2021 (reported as yesterday, as of 16Jul2021) and on tongue and buttocks since today (16Jul2021). It seems that side reactions usually occurred within 2-3 days. The patient had an underlying illness and was postponed by her doctor. The patient had a doctor for the secondary emergency, but the doctor let her wait for a moment so did the heart examination for the tertiary emergency. And the doctor told that the patient had arrhythmia, extrasystoles, and so on. The patient received the vaccine due to there was a big risk if she did not receive bnt162b2 vaccine. It seemed that eczema, and the tongue also appeared. As searched, it seemed that it usually appeared after 2 or 3 days. The next day, the patient experienced swelling or something like that but yesterday eczema appeared on knee and back hands, since today it appeared on buttocks. It was about to ask what the patient should do and where should she ask for help. Were any reports of eczema on the back hand and buttocks? Events resulted in physician office visit. Lab data included heart examination on unspecified date with result of the patient had arrhythmia, extrasystoles, and so on. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1517475 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Body temperature, Dyspnoea, Feeling abnormal, Headache, Hypoxia, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: SPO2; Test Result: 89 %
CDC Split Type: JPPFIZER INC2021908128

Write-up: Hypoxaemia (SPO2: 89%); Dyspnoea; Feels poorly; maybe it was because the blood pressure increased rapidly; a little headache; This is a spontaneous report from a contactable pharmacist received via COVID-19 Vaccine and from a contactable physician received from the Agency Regulatory authority report number is 21120014. A 67-year and 1-month-old female patient received BNT162B2 (COMIRNATY; lot number: FA5765 and expiration date: 30Sep2021), via an unspecified route of administration on 15Jul2021 at 14:05 (the day of vaccination), at the age of 67-year and 1-month-old, dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.2 Centigrade on 15Jul2021. Medical history included allergy to antibiotic. The patient''s concomitant medications were not reported. The patient was unknown if she received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was unknown if she diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 15Jul2021 at 14:15 (10 minutes after the vaccination), the patient experienced dyspnoea, felt poorly, and hypoxaemia (SPO2: 89%). The clinical course of the event was as follows: 10 minutes after the vaccination (as reported), the patient experienced dyspnoea, feels poorly, and hypoxaemia (SPO2: 89%). The patient was given intramuscular injection of adrenaline 0.5 mg, oxygen administration, and normal saline was given to secure blood vessel. In addition, maybe it was because the blood pressure increased rapidly, a little headache was noted, but the patient could have meal. The events resulted in emergency room/department or urgent care. The patient was admitted to hospital on 15Jul2021 (the day of vaccination) and was discharged on 16Jul2021 (1 day after vaccination). The patient was unknown if she had been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: Based on strong temporal relationship the causal association of the events hypoxemia, dyspnea, feels poorly, blood pressure increased and headache with 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: 1517481 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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 FC5947 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021908264

Write-up: Erythema multiforme exudativum of whole body; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. The patient was a non-pregnant 81 years old female elderly. The patient had no other medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as yes but not provided. On 18Jun2021, patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration Date 30Sep2021) intramuscular in the arm left for COVID-19 immunization. On 13Jul2021(the day of vaccination), patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration Date 30Sep2021) intramuscular in the arm left at the age of 81 years for COVID-19 immunization. After the vaccination, the patient experienced erythema multiforme exudativum of whole body. The outcome of the event was unknown with treatment including under medical treatment after introduction of general hospital dermatology. The reporter 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.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event erythema multiforme and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1517485 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-15
   Days after vaccination:5
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: Alanine aminotransferase, Aspartate aminotransferase, Autoimmune pancreatitis, Body temperature, Computerised tomogram, Gastric ulcer, Gastritis, Haematuria, Headache, Movement disorder, Multiple organ dysfunction syndrome, Pain, Pain in extremity, Protein total, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific inflammation (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: ALT; Result Unstructured Data: Test Result:very high; Comments: these were abnormalities related to the liver; Test Date: 20210715; Test Name: AST; Result Unstructured Data: Test Result:very high; Comments: these were abnormalities related to the liver; Test Date: 20210715; Test Name: AIP; Result Unstructured Data: Test Result:very high; Comments: these were abnormalities related to the liver; Test Date: 20210716; Test Name: pyrexia; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210715; Test Name: CT scan; Result Unstructured Data: Test Result:symptomatically sever; Comments: The patient performed CT scan and blood test in the hospital. The doctor confirmed things like "floating something" and "changes related to gastric ulcer and gastritis" for stomach. The patient was told that what was seen on the CT scan was symptomatically sever.; Test Date: 20210715; Test Name: TP; Result Unstructured Data: Test Result:very high; Comments: these were abnormalities related to the liver
CDC Split Type: JPPFIZER INC2021908431

Write-up: Multi-organ failure; painful arm; Haematuria; pyrexia of 37.8 degree centigrade; headache / tightening-like headache; changes related to gastric ulcer and gastritis; pain which was like tightening the organs; the patient could not move; changes related to gastric ulcer and gastritis; This is a spontaneous report from a contactable consumer via medical information team. A 55-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Jul2021 (at the vaccination age of 55-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were not reported. The clinical course was as follows: on 10Jul2021, the patient received the first dose of Pfizer''s vaccine. In the 2-3 days after vaccination, the patient only experienced painful arm. However, on 15Jul2021, Thursday morning, the patient went to the hospital because the pain, which was like tightening the organs, and the patient could not move. The patient performed CT scan and blood test in the hospital. The doctor confirmed things like "floating something" and "changes related to gastric ulcer and gastritis" for stomach. The patient was told that what was seen on the CT scan was symptomatically sever. For blood tests, the values of "AST", "ALT", "LT", "AIP", "GP", and "TP" are very high, and these were abnormalities related to the liver. Haematuria occurred. The doctor wanted to proceed the medical examinations in the form of multi-organ failure, but she/he was not sure if these things related to vaccination. At that time, the patient experienced pyrexia of 37.8 degree centigrade and headache which started from 16th(16Jul2021). There was a medicine that the patient had received at that stage. The medicine that the patient received until 20Jul2021 was called "Nexium". The details for the tests was scheduled to be asked on 20Jul2021. It was unknown if it should be considered by the doctor as factors for vaccination. Neither patient nor the doctor knows what to look for and how to fix it. If it was considered as multi-organ failure, would wait till 20Jul2021 for clinical course observation. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1517522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-15
   Days after vaccination:34
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Sars-Cov-2 test; Test Result: Positive ; Comments: diagnosed with COVID
CDC Split Type: MXPFIZER INC202100942188

Write-up: today he is due for the second dose, but he is on the 8th day of COVID; today he is due for the second dose, but he is on the 8th day of COVID; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient) received from medical information team. A 44-years-old male patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on 11Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced covid-19 with drug ineffective. He scheduled to apply a 2nd dose of COVID-19 vaccine however, it is his eighth day after being diagnosed with COVID-19. He pointed out that he has no symptoms, but he wanted to know whether or not he should take the 2nd dose. Patient underwent lab tests on 15Jul2021 for Sars-Cov2 infection which results positive for covid-19. Outcome of the events was unknown. Lot number will be requested.


VAERS ID: 1519212 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Presyncope, 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), 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: 36.5 degrees Celsius
CDC Split Type: JPTAKEDA2021TJP062967

Write-up: Loss of consciousness; Vagal reflex; Convulsion; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP062967) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness), PRESYNCOPE (Vagal reflex) and SEIZURE (Convulsion) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria hospitalization and medically significant), PRESYNCOPE (Vagal reflex) (seriousness criterion hospitalization) and SEIZURE (Convulsion) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Jul-2021 to 15-Jul-2021 due to LOSS OF CONSCIOUSNESS, PRESYNCOPE and SEIZURE. On 15-Jul-2021, LOSS OF CONSCIOUSNESS (Loss of consciousness), PRESYNCOPE (Vagal reflex) and SEIZURE (Convulsion) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (normal) 36.5 degrees Celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness), PRESYNCOPE (Vagal reflex) and SEIZURE (Convulsion) to be not related. The patient lost consciousness for a short time after having blurred vision and a feeling of being hard of hearing. Per consumer people near by the patient saw that the patient had tonic convulsion for about 5 seconds. The patient was transported to hospital by ambulance, but on arrival, the patient was alert without abnormal vital signs or subjective symptoms. Vagal reflex was considered to be highly probable. The patient returned home without examination. No relevant concomitant medications were provided. No treatment information was provided. Sender''s comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company comment:: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Reporter''s Comments: Vagal reflex was considered to be highly probable.; 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: 1520781 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cough, Dysmenorrhoea, Insomnia, Menstruation irregular
SMQs:, Anaphylactic reaction (broad), Fertility disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECONASE; CETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Seasonal asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923214

Write-up: Painful periods; Early period by 7 ish days (from 34 to 28).; very sore joints especially hips and knees which prevented sleep; very sore joints especially hips and knees which prevented sleep; cough from seasonal asthma disappeared for 48 hours but returned, possibly due to taking an antihistamine; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), parenteral on 15Jul2021 (Lot number was not reported) (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included seasonal asthma and hay fever, both from an unknown date and unknown if ongoing. Concomitant medications included beclometasone dipropionate (BECONASE) taken for an unspecified indication and cetirizine hydrochloride taken for hay fever, both concomitants start and stop date were not reported. The patient experienced early period by 7ish days (from 34 to 28), very sore joints especially hips and knees which prevented sleep, cough from seasonal asthma disappeared for 48 hours but returned, possibly due to taking an antihistamine, all on 15Jul2021 with outcome of recovering; painful periods/period more painful overall on an unspecified date with outcome of unknown. The events were serious, medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909261

Write-up: Lymphadenopathy/Painful and inflamed lymph nodes; Flu like symptoms; sweats; Aching muscles; shivers; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107160801090510-JOWZG. Safety Report Unique Identifier GB-MHRA-ADR 25661615. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: FE1510) as dose 2, 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. On 15Jul2021, the patient experienced flu-like symptoms (shivers, sweats, aching muscles) 24 hours after vaccination, managed by paracetamol and rest. Also, painful and inflamed lymph nodes/lymphadenopathy around collar bone noticed 48 post-vaccination on 16Jul2021. The events were considered medically significant. The patient has not recovered from the event, lymphadenopathy/painful and inflamed lymph nodes and outcome of the remaining events was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1520826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-07-15
   Days after vaccination:65
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: Lymphadenopathy, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916574

Write-up: pain; swelling; Painful lymphadenopathy; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107181042413230-2CELG. Safety Report Unique Identifier GB-MHRA-ADR 25669638. A 39-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 11May2021 as dose 1, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pain and swelling on an unspecified date; had painful lymphadenopathy on 15Jul2021 which he further reported that it was very painful and had severe swelling in left under-arm lymph node possibly, pain and swelling increased on 18th of July further. The events were reported as serious disability. The outcome of lymphadenopathy was not recovered; for other events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1520841 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Chest pain, Headache, Heart rate abnormal, Hypoaesthesia, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916414

Write-up: Numbness; Fever; Pins and needles; Headache; Painful arm; Heart rate abnormal; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181314113490-UBAGD, Sender''s Safety Report Unique Identifier: GB-MHRA-ADR 25669739. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (at the age of 29 years), as dose 2, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant nor currently breastfeeding. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient experienced numbness, fever, pins and needles, headache, painful arm, heart rate abnormal, and chest pain on 15Jul2021. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient was recovering from the event, numbness; and recovered from the remaining events, fever, headache, and painful arm on 18Jul2021, and pins and needles, heart rate abnormal, and chest pain on 17Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cold sweat, Dyspnoea, Electrocardiogram, Heart rate increased, Nausea, Oxygen saturation, Oxygen saturation decreased, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ecg; Result Unstructured Data: Test Result:Unknown; Test Name: blood oxygen; Result Unstructured Data: Test Result:Unknown; Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916626

Write-up: nausea; palpitations; blood oxygen tests/Oxygen saturation decreased; shortness of breath; clammy; Tight chest; Heart rate/Raised heart rate; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number. Safety Report Unique Identifier. A 36-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FC9001), via an unspecified route of administration on 15Jul2021 as dose 2, 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 nausea, palpitations/heart palpitations, blood oxygen saturation tests decreased, shortness of breath, clammy/clammy skin and tight chest on unspecified date; raised heart rate on 15Jul2021. The events were reported as serious medically significant. Paramedics attended and conducted ECG and blood oxygen tests and patient was yet to have follow up testing with GP. The patient underwent laboratory tests and procedures which included electrocardiogram: unknown and oxygen saturation: unknown on unspecified date, Sars-cov-2 test: negative on 16Jul2021. The outcome of heart rate increased was recovering; for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520908 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Asthenia, Back pain, Body temperature, Chest pain, Headache, Heart rate, Myalgia, Neck pain, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOPHAGE; HYDROCORTISONE; IBUPROFEN; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s thyroiditis; Hypothyroidism; Lactation decreased; Pain; Rosacea; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9; Test Name: heart rate; Result Unstructured Data: Test Result:55-65; Test Date: 20210715; Test Name: heart rate; Result Unstructured Data: Test Result:115; Comments: resting heart rate up to 115; Test Date: 20200628; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916663

Write-up: leg muscle aches; Leg pain; Generalised muscle aches; aches in her neck and both arms; aches in her neck and both arms; felt weak; Chest ache; Back ache; low grade fever (around 37.9); tachycardia (resting heart rate up to 115); palpitations; headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190101038250-2IKME, and Safety Report Unique Identifier is GB-MHRA-ADR 25670246. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot/batch number not reported), via an unspecified route of administration on 15Jul2021 14:50 as dose 1, single for COVID-19 immunisation. Medical history included tachycardia, hypothyroidism, Hashimoto''s thyroiditis induced hypothyroidism, lactation decreased, rosacea, and pain. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included metformin hydrochloride (GLUCOPHAGE); hydrocortisone taken for rosacea from 09Aug2019; ibuprofen taken for pain; and levothyroxine taken for hypothyroidism from 20Jul2014. The patient experienced tachycardia (resting heart rate up to 115) on 15Jul2021 with outcome of recovered on 16Jul2021, palpitations on 15Jul2021 with outcome of not recovered, headache on 15Jul2021 with outcome of recovered on 16Jul2021, leg muscle aches on 19Jul2021 with outcome of not recovered, low grade fever (around 37.9) on 15Jul2021 with outcome of recovered on 17Jul2021, chest ache on 16Jul2021 with outcome of recovered on 19Jul2021, back ache on 16Jul2021 with outcome of recovered on 18Jul2021, leg pain on 18Jul2021 with outcome of recovering, generalised muscle aches on 16Jul2021 with outcome of recovering, aches in her neck and both arms on 16Jul2021 with outcome of unknown, and felt weak on 16Jul2021 with outcome of unknown. The events were considered serious as other medically important condition. Additional information: Patient received her vaccine on the 15Jul2021 at around 14:50pm. After 2 hours, significant headache, low grade fever (around 37.9), tachycardia (resting heart rate up to 115, her normal is 55-65). 1 day after on 16Jul2021, symptoms seemed to resolve, but in the evening of 16Jul2021, she begun getting aches in her chest, neck, back and both arms. She believed these were mostly muscle aches but she also felt weak if she moved around too much. 2 days after on 17Jul2021, the upper body aches continue and don''t appear to be better. 3 days after on 18Jul2021, upper body aches begin to subside and she feel less weak, but her thigh muscles are very painful and achy when moving around. 4 days after on 19Jul2021, leg muscle aches are still present. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included body temperature: 37.9 on 15Jul2021, heart rate: 115, resting heart rate up to 115 on 15Jul2021, heart rate: 55-65, COVID-19 virus test: No - Negative COVID-19 test on 28Jun2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-15
   Days after vaccination:5
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: Anxiety, Intermenstrual bleeding, Menstruation irregular, Palpitations, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Fertility 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: Acute thyroiditis; Hashimoto''s thyroiditis; Lactation decreased; Mood change; Palpitations
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100922959

Write-up: Period came 2 weeks early; Spotting menstrual; Palpitations; anxiety attacks; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107190903489510-QKETP. Safety Report Unique Identifier GB-MHRA-ADR 25671335. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included palpitations, thyroiditis acute, suppressed lactation, mood altered, Hashimoto''s thyroiditis. 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 previously took liothyronine (Take liothyronine Been well and healthy for 6 months). The patient experienced anxiety attacks on 15Jul2021 with outcome of not recovered, spotting menstrual on 17Jul2021 with outcome of not recovered, palpitations on 15Jul2021 with outcome of not recovered. Period came 2 weeks early, Heart palpitations and anxiety attacks started 5 days after the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests included Negative COVID-19 test on 08Jul2021. The outcome of Period came 2 weeks early was unknown. The report was considered as serious as medically significant from regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520927 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Body temperature, Chest pain, Cough, Decreased appetite, Fatigue, Headache, Intermenstrual bleeding, Menstruation irregular, Myalgia, Pain, Pain in extremity, Productive cough, Pyrexia, Rhinorrhoea, Sneezing, Sweating fever, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; LIOTHYRONINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: GBPFIZER INC202100922984

Write-up: phlegm; cough; Fever of 38 Centigrade; Sharp acute pains in hands and fingers; burning sensation up chest; not very hungry; Irregular periods; Spotting menstrual; Painful cough; Sweating fever; Headache/headache was dull frontal; Fatigue/Tiredness; Loss of taste; Loss of smell; Runny nose; Hand pain; Muscle ache; Productive cough; Sneezing; Injection site pain; This is a spontaneous report from a contactable consumer. This is a report received from The Regulatory authority report number is (GB-MHRA-WEBCOVID-202107190903531370-AASNP) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25671538). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (at the age of 41 years old) (lot number: Not Known) as single dose for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Medical history included Lactation decreased, Hypothyroidism. Concomitant medications included levothyroxine taken for hypothyroidism from 2014 to an unspecified stop date; liothyronine taken for hypothyroidism from 2016 to an unspecified stop date. The patient experienced phlegm on an unspecified date, cough on an unspecified date, sweating fever on 18Jul2021, headache/ headache was dull frontal on 18Jul2021, fatigue/ /Tiredness on 18Jul2021, loss of taste on 18Jul2021, loss of smell on 18Jul2021, muscle ache on 17Jul2021, productive cough on 17Jul2021, painful cough on 18Jul2021, injection site pain on 15Jul2021, irregular periods on 19Jul2021, spotting menstrual on 18Jul2021, sneezing on 17Jul2021, runny nose on 18Jul2021, hand pain on 18Jul2021, Fever of 38 Centigrade (C) on an unspecified date, sharp acute pains in hands and fingers on an unspecified date, burning sensation up chest on an unspecified date, not very hungry on an unspecified date. It was reported that: Fever of 38 Centigrade (C), Headache was dull frontal, Fatigue - drained when doing simple tasks like putting washing on, Loss of sense of taste and smell - and not very hungry, Sharp acute pains in hands and fingers, Mid-cycle period, having been regular for months, Cough - burning sensation up chest when coughing, producing phlegm. Ibuprofen and paracetamol taken regularly. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of phlegm, cough, Fever of 38 Centigrade, sharp acute pains in hands and fingers, burning sensation up chest and not very hungry was unknown; of Injection site pain was recovered on 17Jul2021; of Headache/headache was dull frontal was recovering; 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: 1520943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 EW4109 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Bradyphrenia, Fatigue, Feeling abnormal, Headache, Influenza like illness, Nasopharyngitis, Neck pain, SARS-CoV-2 test
SMQs:, Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Illness; Lactation decreased
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 INC202100923246

Write-up: head pain; cold; joint aches; fuzzy head; slow thinking; fatigue; Headache; Neck pain; flu-like symptoms; Pain in left armpit; Aching joints; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number , Safety Report Unique Identifier. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jul2021 (Lot Number: EW4109) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, illness. 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 head pain on an unspecified date with outcome of recovering, fuzzy head on 19Jul2021 with outcome of recovering, fatigue on 18Jul2021 with outcome of recovering, cold on an unspecified date with outcome of recovering, joint aches on an unspecified date with outcome of recovering, aching joints on 15Jul2021 with outcome of recovered on 16Jul2021, headache on 16Jul2021 with outcome of recovering, neck pain on 16Jul2021 with outcome of recovering, flu-like symptoms on 15Jul2021 with outcome of recovering, pain in left armpit on 15Jul2021 with outcome of recovering, slow thinking on 19Jul2021 with outcome of recovering. Events were serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 15Jul2021. Therapeutic measures were taken as a result of cold, headache. The clinical course was reported as follows: 14July: COVID vaccine (evening). 15July: flu-like symptoms, joint aches, felt cold helped with paracetamol. Pain in left armpit (vaccine received in left arm). 16July: flu-like symptoms, joint aches, felt cold helped with paracetamol started to get headache later on in the day. 17July: woke with severe headache, made worse with moving/turning head. Pain was all over head but particularly bad between temples and occipitally. Also neck pain on either side of spine (?glandular). Moving head and looking to the side or walking (due to impact of steps) causing worse head pain. Not helped by paracetamol. Fatigue. 18July: As 17July but head pain even worse and extreme fatigue and difficult to talk. Lasted all day. Helped by paracetamol a little. Slept most of the day. At around 6 pm, headache started to feel better and over about 2 hours improved considerably. Mild headache and less fatigued by night. 19July: Moderate headache all over head, fuzzy head, slow thinking, fatigue. Neck still painful to look to either side but less than at the weekend. Unable to work. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520994 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Fatigue, SARS-CoV-2 test, Somnolence, Tenderness, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923155

Write-up: Extremely drowsy/ wanting to sleep; Tenderness in the upper arm/site of injection continuing for 4+ days post administration; Tiredness/feeling tired/wanting to sleep within the first 15-24 hours; Tenderness/Tenderness in the upper arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191223042260-SLWUQ. Safety Report Unique Identifier GB-MHRA-ADR 25672401. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced tiredness/feeling tired/wanting to sleep within the first 15-24 hours on 16Jul2021, tenderness/tenderness in the upper arm on 15Jul2021, extremely drowsy on an unspecified date, tenderness in the upper arm/site of injection continuing for 4+ days post administration on an unspecified date. Extremely drowsy/ wanting to sleep within the first 15-24 hours post administration of the vaccination. Tenderness in the upper arm/site of injection continuing for 4+ days post administration of the vaccine, but gradually reducing in intensity. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 11Jul2021. Outcome of event tiredness was recovered on 17Jul2021, of tenderness, vaccination site tenderness was recovering, of other was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520999 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Cold sweat, Cystitis
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923407

Write-up: Cystitis; Stomach cramps; Cold sweat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191248266130-FPEW2, Safety Report Unique Identifier GB-MHRA-ADR 25672615. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications were not reported. On 15Jul2021 patient experienced cystitis, stomach cramps and cold sweat. Patient had not recovered from the events, at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521021 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Dizziness, Headache, Hypoacusis, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923097

Write-up: Muffled hearing in both ears; Enlarged lymph nodes (excl infective); Dizzy spells; Sore throat; Stiff neck; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107191416111620-AB2LR, Safety Report Unique Identifier GB-MHRA-ADR 25673594. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 25-year-old on 15Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped). Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache (medically significant) on 15Jul2021, enlarged lymph nodes (excl infective) (medically significant) on 17Jul2021, dizzy spells (medically significant) on 17Jul2021, sore throat (medically significant) on 17Jul2021, stiff neck (medically significant) on 17Jul2021, muffled hearing in both ears (medically significant) on 18Jul2021. Physician Office Visit for events.The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 01Jun2021. The outcome of events was not recovered. The clinical course was reported as follows: Patient phoned 111 on the Saturday after receiving patient''s first dose on the Thursday. Patient was told that none of patient''s symptoms could be due to the vaccine however patient was perfectly fine before the vaccine. Patient was also told that it would not cause enlarged lymph nodes as they only swell in response to certain areas, but patient''s inguinal nodes are the first to flare up with any infection. Patient felt the Health Agency did not assist patient at all during this phone call and did not make patient feel at ease in anyway. 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: 1521023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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 FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923316

Write-up: unwell; Fever; Sore throat; Headache; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191439053210-OKKSC, Safety Report Unique Identifier: GB-MHRA-ADR 25673659. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# FD8813) dose 1 via an unspecified route of administration on 13Jul2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient experienced unwell (medically significant) on an unspecified date, headache (medically significant) on 15Jul2021, sore throat (medically significant) on 16Jul2021, fever (medically significant) on 16Jul2021. The outcome of event unwell was unknown, outcome of other events was not recovered. The patient said he would not having a second vaccine of any kind. No follow-up attempts are possible; No information is expected.


VAERS ID: 1521049 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Migraine, Paraesthesia, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; DECAPEPTYL CR; FINASTERIDE; PROGYNOVA [ESTRADIOL VALERATE]; SOPROBEC; VENTOLINE [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression; Gender dysphoria; 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 INC202100923081

Write-up: headache; tingling; Fever; Chills; Migraine; Joint ache; Sensitive skin; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107191715460980-T9LTP, Safety Report Unique Identifier GB-MHRA-ADR 25674549. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (vaccination at age of 34 years old) (Lot Number: Fc9001) as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased, Depression from 2015 to an unknown date, Gender dysphoria from 04Aug2017 to an unknown date, Asthma from 1996 to an unknown date. Patient has not had symptoms associated with COVID-19, Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medication(s) included citalopram taken for depression from 2015 to an unspecified stop date; triptorelin acetate (DECAPEPTYL CR) taken for gender dysphoria from 08Jun2018 to an unspecified stop date; finasteride taken for gender dysphoria from 04Aug2017 to an unspecified stop date; estradiol valerate (PROGYNOVA) taken for an unspecified indication from 09Jun2018 to an unspecified stop date; beclometasone dipropionate (SOPROBEC) taken for asthma from 1996 to an unspecified stop date; salbutamol sulfate (VENTOLINE) taken for asthma from 1996 to an unspecified stop date. The patient experienced headache, tingling on an unspecified date with outcome of not recovered, fever, chills, migraine and sensitive skin on 15Jul2021 with outcome of recovered on 17Jul2021, joint ache on 15Jul2021 with outcome of recovered on 18Jul2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on unknown date (No - Negative COVID-19 test.) Clinical course as reported: A headache developed along with a feeling similar to mild heatstroke on the evening I had the jab, so I went to bed early to sleep it off. I woke up the next day with a fever around my head and shoulder and feet feeling like ice. My joints were aching/creaking when moved, and my skin became extremely sensitive through the morning as a migraine developed. Toward the evening of the second day it started to feel like tingling/pins and needles under the skin when touched. I could not settle to sleep, and was awake most of the night. I awoke on day 3 with none of the above. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100923011

Write-up: My bones in arms and legs ache it''s like tooth ache in my bones; My arms feel weak at the joints by the elbow.; Joint pain; 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-202107192129163610-MOJOP and the Safety Report Unique Identifier is GB-MHRA-ADR 25676310. A female patient of an unspecified age received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jul2021 as single dose COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. She has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced joint pain on 15Jul2021. Case narrative: Her bones in arms and legs ached, it''s like tooth ache in her bones. Her arms felt weak at the joints by the elbow. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The patient has not recovered from joint pain, while outcome of other events was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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: Chest discomfort, Chills, Pain in extremity, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Menstrual cramp
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923269

Write-up: Tight chest; Palpitations; Chills; Painful arm; 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-202107192225005640-BDNE8, Safety Report Unique Identifier GB-MHRA-ADR 25676771. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Lot Number: FD5613) as single dose for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date, dysmenorrhoea from an unknown date. 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(s) included paracetamol (PARACETS) taken for dysmenorrhoea, start and stop date were not reported. On 15Jul2021, approximatively 12 hours after vaccination, the patient experienced tight chest, palpitations, chills, painful arm. The event lasted between 1-2 hours. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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: Breast swelling, Contusion, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100923350

Write-up: swelling under left arm pit; swelling left breast; mild surface bruising left breast & left under arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107200527296610-5FFE4. Safety Report Unique Identifier GB-MHRA-ADR 25677510. A 60-years-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium taken for thyroid disorder, start and stop date were not reported. The patient experienced swelling under left arm pit, swelling left breast, mild surface bruising left breast & left under arm on 15Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test negative. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of all events was not resolved. All events were serious with medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521217 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-15
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / -

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

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

Write-up: pain; Tired out; Clot blood; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood), PAIN (pain) and FATIGUE (Tired out) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The patient''s past medical history included Rheumatoid factor increased. Concurrent medical conditions included Factor V Leiden homozygote (Homozygous Factor V Leiden). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant) and FATIGUE (Tired out) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). On 16-Jul-2021, FATIGUE (Tired out) had resolved. At the time of the report, THROMBOSIS (Clot blood) and PAIN (pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was provided. Patient had numbness in right ankle 30hrs (day 2) after 2nd jab, day 3 pain and redness in ankle, day 4 swelling of ankle with pain, investigations started day 6. Did not go deep vein but 5cm from ankle up calf. Patient had blood test and ultrasound done (Results not provided) Treatment included 6 week course of blood thinner. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. Further information can''t be requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. Further information can''t be requested.


VAERS ID: 1521407 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 EW0203 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dysphoria, Erythema, Heart rate, Heart rate decreased, Oedema peripheral, Oxygen saturation
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:194/98 mmHg; Comments: 10:00; Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:146/95 mmHg; Comments: 10:25; Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:154/87 mmHg; Comments: 10:40; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210715; Test Name: P; Result Unstructured Data: Test Result:72 times/min; Comments: 10:00; Test Date: 20210715; Test Name: P; Result Unstructured Data: Test Result:56 times/min; Comments: 10:25; Test Date: 20210715; Test Name: P; Result Unstructured Data: Test Result:51 times/min; Comments: 10:40; Test Date: 20210715; Test Name: SPO2; Test Result: 94 %; Comments: 10:00; Test Date: 20210715; Test Name: SPO2; Test Result: 93 %; Comments: 10:25; Test Date: 20210715; Test Name: SPO2; Test Result: 93 %; Comments: 10:40
CDC Split Type: JPPFIZER INC202100913246

Write-up: P72/P56/P51; Redness (+) on the inside of the forearm and chest; Oedema palmar; BP 194/98; Dysphoria; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120166. The patient was a 64-year-old female. Body temperature before vaccination was 36.2 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 allergies with foods such as eggs at the time of interview (although she did not fill in the pre-examination slip). Concomitant medication was not reported. On 15Jul2021 at 09:40(the day of vaccination), the patient received the first dose (at the age of 64-year-old) of bnt162b2 (COMIRNATY, Lot number EW0203, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: On 15Jul2021 10:00 (20 minutes after vaccination), there was a complaint of dysphoria, blood pressure (BP) of 194/98 Heart rate (P) of 72 times/min and oxygen saturation (SPO2) of 94%. At 10:07, redness (+) on the inside of the forearm and chest; and oedema palmar (+) noted. The patient received fexofenadine 60mg P.O. At 10:25, the redness, oedema, and dysphoria were improving. BP: 146/95, P: 56 times/min and SPO2 93% noted. At 10:40, the patient had BP: 154/87, P: 51 times/min and SPO2: 93%. Dysphoria had disappeared and the patient returned home. The patient recovered from the event of dysphoria on 15Jul2021 at 10:40, not recovered for BP increased and heart rate decreased while recovering for the remaining events. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. There was other possible cause(s) of the event such as any other diseases but the detail unknown.


VAERS ID: 1521409 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema, Hyperthermia, Neoplasm malignant, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (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: Chronic disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Hyperthermia/pyrexia; Result Unstructured Data: Test Result: 38.8 Centigrade.
CDC Split Type: JPPFIZER INC202100916077

Write-up: The patient received an anti-cancer drug the day after vaccination; Hyperthermia of 38.8 degrees centigrade; pyrexia of 38.8 degrees centigrade was noted when observed the situation; the arm was red and swollen.; the arm was red and swollen.; This is a spontaneous report received from a contactable consumer (patient). The patient gender and age were not confirmed, lot number was not confirmed. On 15Jul2021, the patient received the vaccination of bnt162b2 (COMIRNATY, Solution for injection, Lot number not confirmed) via an unspecified route of administration as a single dose (dose number unknown) for COVID-19 immunization. Medical history included ongoing chronic disease. Concomitant medication was not reported. Reaction was reported as follows: on 15Jul2021, the patient received the vaccination, currently having hyperthermia of 38.8 degrees centigrade. The patient took medicine, but the pyrexia was rising again. In addition, the arm was red and swollen. The patient was taking anti-cancer drug for the treatment of chronic disease. The patient received an anti-cancer drug the day after vaccination. after taking the medicine prescribed by the doctor at 13:30, pyrexia of 38.8 degrees centigrade was noted when observed the situation. The last outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1521442 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Eczema, Heart rate, Oxygen saturation, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatoid bronchitis
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result: 70/50; Test Date: 20210715; Test Name: body temprature; Result Unstructured Data: Test Result: 36.7 Centigrade; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:92; Test Date: 20210717; Test Name: sqo2; Test Result: 95%.
CDC Split Type: JPPFIZER INC202100918287

Write-up: Anaphylaxis; Eczema appeared on upper left limb; wheals with itching all over the body; wheals with itching all over the body; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120291. An 87-year-old female patient received bnt162b2 (COMIRNATY), the first dose via unspecified route of administration on 15Jul2021 at 12:37 (lot number: FA5765, expiration date: 30Sep2021) at single dose for COVID-19 immunisation. The relevant medical history included asthma bronchial from unspecified date. Concomitant medications were not reported. Body temperature before vaccination was 36.7 degrees Centigrade. On 15Jul2021 at 16:30 (the day of vaccination), the patient experienced anaphylaxis. On 15Jul2021(the day of the vaccination), the patient was admitted to the hospital. On 16Jul2021 (1 day after vaccination), the patient was discharged from the hospital. On 16Jul2021 (1 day after vaccination), the outcome of the event was recovered. The course of the event was as follows: On 17Jul2021(as reported) at 12:37 Vaccine was administered, after patient returned home, from about 14:00, Eczema appeared on upper left limb. Patient visited the hospital. There were wheals with itching all over the body at the time of examination. Blood pressure 70/50, pulse 92, Sq02 95%, judged as anaphylaxis. Treated with EPIPEN via intramuscular injection. Symptoms recovering promptly, but the patient was hospitalized for follow-up purposes. The reporting physician classified the event as serious (hospitalization, from 15Jul2021 to 16Jul2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. There was an impression that it was not a typical course of anaphylaxis, but it cannot be denied. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on 16Jul2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1521455 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Dizziness, Erythema, Headache, Heart rate, Heart rate increased, Nasal obstruction, Nausea, Oropharyngeal discomfort, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Mastectomy (breast cancer)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:170/107 mmHg; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:138/81 mmHg; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210715; Test Name: pulse; Result Unstructured Data: Test Result:103; Comments: /min; Test Date: 20210715; Test Name: pulse; Result Unstructured Data: Test Result:60s; Comments: /min; Test Date: 20210716; Test Name: pulse; Result Unstructured Data: Test Result:50s-60s; Comments: /min; Test Date: 20210715; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210715; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210716; Test Name: Oxygen saturation; Test Result: 97 %
CDC Split Type: JPPFIZER INC202100918457

Write-up: headache; dizziness; abdominal discomfort; blood pressure was 170/107; erythema; pulse was 103 times per minute; nasal obstruction; Chest discomfort; palpitations; Anaphylaxis; pharynx strange sensation of; feeling queasy; This is a spontaneous report from a contactable pharmacist received from the Agency. Regulatory authority report number v21120095. The patient was a 60-year-old female. The patient had an illnesses history of breast cancer after surgery and total left breast removal. The patient also had allergic history of palpitations due to Lidocaine and Xylocaine. On 15Jul2021 at 14:08, the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) at single dose for COVID-19 immunization (60-year-old at vaccination). On 15Jul2021 at 14:10 (2 minutes after the vaccination), the patient experienced anaphylaxis. On 15Jul2021 (the same day of the vaccination), the patient was admitted to the hospital. On 16Jul2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 15Jul2021 at 14:08, the patient received the first dose of COVID-19 vaccine. From 14:10, the patient was aware of palpitations, feeling queasy, and pharynx strange sensation of. At 14:44, emergency transportation while sodium chloride 500ml and solu-cortef 100mg were injected by DIV. At 15:24, There were appeal of the pharynx strange sensation of, dizziness, abdominal discomfort, and nasal obstruction; the body temperature was 37.1 degrees Centigrade; the pulse was 103 times per minute; the blood pressure was 170/107; SPO2 was 98%; erythema appeared from the head to the upper chest, but no pruritus. At 15:50, dexart 3.0mg 1A and sodium chloride 100ml by DIV were injected. At 16:12, polanamine 5mg was injected by IV. Chest discomfort was mild even after drip with Solu-Cortef and Dexart, heart rate was 60s sinus rhythm and no dyspnoea. SPO2 was 97%, have a headache, but self-controling. Loratadine OD 10mg was taken orally before sleep. On 16Jul2021 at 09:05, chest discomfort disappeared and no palpitations and dyspnoea, SPO2 was 98%, heart rate was 50s~60s sinus rhythm, blood pressure was 138/81 mmHg, erythema were observed from the right forearm to the upper arm, but no pain, pruritus and feeling hot, and the patient was discharged from the hospital with mild headaches but no other symptoms. The reporting physician classified the event as serious (hospitalization from 15Jul2021 to 16Jul2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Anaphylaxis symptoms after COVID-19 vaccination. Information on the lot/batch number has been requested.


VAERS ID: 1521478 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100919039

Write-up: Numbness in hand and feet; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. The patient was a 38-year-old female. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 14Jul2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) for COVID-19 immunization. On 15Jul2021(1 day after vaccination), the patient experienced Numbness in hand and feet. The course of the event was as follows: On 14Jul2021, the patient received the first vaccination. On 15Jul2021, the patient experienced Numbness in hand and feet. Since the symptoms did not subside, the patient went to privacy hospital, and changed to privacy hospital for a more detailed examination.Currently watching the situation at the hospital.(as reported) Information on the lot/batch number has been requested.; Sender''s Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1521507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder cancer stage III (The patient experienced Gallbladder cancer STAGE 3 8 years ago, and operated at a privacy hospital).
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100921315

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 68-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Jun2021 as single dose for covid-19 immunisation. Medical history included gallbladder cancer stage III 8 years ago (2013), and operated at a hospital; diabetes mellitus ongoing (currently). The patient''s concomitant medications were not reported. The patient previously received influenza vaccination last year (2020). The patient experienced cerebral haemorrhage on 15Jul2021. Clinical course: On 29Jun2021, the patient received the first dose. Second vaccination was scheduled for 3 weeks later, but the patient''s family contacted to cancel because of cerebral haemorrhage on 15Jul2021. The patient was only vaccinated this time. The patient only came to this hospital during the Influenza vaccination last year and the bnt162b2 vaccination this time. It was unknown which hospital the patient was currently in. Because the patient came to the hospital only with vaccination, the situation was completely unknown. The adverse events occurred after using the product. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the event cerebral haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1521571 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dysphonia, Heart rate, Oropharyngeal discomfort, PO2
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: BP; Result Unstructured Data: Test Result:148/82 mmHg; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Name: P; Result Unstructured Data: Test Result: 62; Comments: times/min; Test Name: SPO2; Test Result: 99 %.
CDC Split Type: JPPFIZER INC202100927327

Write-up: Anaphylaxis; Pharynx discomfort/pharynx strange sensation of; mild hoarseness; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21120620. A 65-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0889; Expiration Date: 30Sep2021), dose 2 via an unspecified route of administration on 15Jul2021 10:00 (at the age of 65years) as dose 2, single for Covid-19 immunization. The patient received the first dose of Comirnaty on an unspecified date and experienced pharynx discomfort. There was no medical history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.1 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 15Jul2021 at 10:00 (immediately after vaccination), the patient experienced anaphylaxis. The course of the event was as follows: Pharynx discomfort was noted. The discomfort increased as the observation time (15 minutes) ended. The same symptom occurred after the first vaccination of Comirnaty and disappeared after 15 minutes of observation. VS (vital signs) measurement: BP (blood pressure) 148/82 mmHg, P (pulse) 62times/min, SpO2: 99%. Polaramine (Antihistamine) 1ml was injected intravenously according to the prescription of the corresponding physician. Twenty minutes after inoculation, the symptoms were recovering with bedrest (mild hoarseness, pharynx strange sensation of) and clear consciousness. The physician directed the patient to visit a nearby physician on a later date; the patient was permitted to go home. On 15Jul2021 (the same day of the vaccination), the outcome of the event was recovering. The reporting other HCP classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1521713 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia, Nausea, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:40.5-42 Centigrade
CDC Split Type: NLPFIZER INC202100926187

Write-up: Headache; Not feeling well; Nausea; Fever: 40.5 to 42 degrees Celsius; Myalgia; Fatigue; Inflammatory reaction at the reaction site: redness, warmth, pain; Reaction at or around the injection site: redness; Reaction at or around the injection site: heat; Reaction at or around the injection site: pain; Generalized joint pain; Chills; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00629814. This is first of two reports, for the second does of vaccine. A 19-year-old female patient received second dose of BNT162B2 (COMIRANTY; Solution for injection; Lot number Unknown; expiration date: not reported) via an unspecified route of administration on 15Jul2021 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The previously received first dose of BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) via an unspecified route of administration on 10Jun2021 as dose 1 (injection fluid 0,3ml) for COVID-19 immunization and experienced pain at the site of vaccination. Extensive swelling of vaccinated limb was not there. Medical history included suspected covid-19 from 19Apr2020 to an unknown date. Concomitant medication(s) included ibuprofen (IBUPROFEN), 400 mg taken for an unspecified indication.On 16Jul2021, the patient experienced fever: 40.5 to 42 degrees Celsius, myalgia, fatigue, injection site erythema, injection site warmth, injection site pain, injection site inflammation on 15Jul2021, headache, not feeling well and nausea and on an unspecified date, the patient had generalized joint pain, chills It was reported that, chills: 12 hours after start, headache: 1 days after start, nausea: 1 days after start, generalized joint pain: 15 minutes after start, malaise: 1 days after start, fatigue: 6 hours after start, myalgia: 30 minutes after start, injection site erythema: within 1 day, injection site warmth: within 1 day, injection site pain: within 1 day, injection site inflammation: within 1 day, hyperpyrexia: within 1 day. The patient underwent lab tests which included body temperature: 40.5-42 centigrade on 16Jul2021. fever: 40.5 to 42 degrees Celsius was treated with Ibuprofen 400mg.The outcome of the events generalized joint pain, nausea, chills was resolved on an unspecified date in 2021 and injection site erythema, injection site warmth, injection site pain, injection site inflammation was recovered on 16Jul2021, the events fever: 40.5 to 42 degrees Celsius, myalgia was recovering and rest events were not resolved. No follow-up is possible, information about batch number cannot be obtained; Reporter''s Comments: Summary of Reporter Comment: ---------- BioNTech/Pfizer vaccine (Comirnaty) ---------------------- Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Pain at the site of vaccination Date: 10Jun2021 --------- Redness or Swelling ----------- Extensive swelling of vaccinated limb: no; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100955706 same patient, different doses of vaccine


VAERS ID: 1521804 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FF0680 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTPFIZER INC202100920666

Write-up: This is a spontaneous report from a contactable physician, downloaded via the regulatory authority (PT-INFARMED-V202107-3118). A 25-year-old patient, of an unspecified gender, received BNT162B2 (Comirnaty, lot# FF0680), at age of 25, intramuscularly, on Jul 15, 2021, 0.3mL, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced urticaria, maculopapular and erythematous skin lesions with mild itching on Jul 15, 2021. Adverse drug reactions appeared 2 hours after administration, lasting 8 hours. Outcome of events recovered. Therapeutic measures were taken as a result of the events included hydrocortisone 200mg IV + Clemastin 2mg IM. Case reported serious (medically significant). Reporter''s comment: About 2 hours after administration began to appear maculopapular and erythematous skin lesions with slight itching. No follow-up attempts possible. No further information expected.


VAERS ID: 1522339 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

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

Write-up: Palpitaciones cardiacas; This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitaciones cardiacas) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PALPITATIONS (Palpitaciones cardiacas) (seriousness criterion medically significant). On 18-Jul-2021, PALPITATIONS (Palpitaciones cardiacas) had resolved. Concomitant product use was not provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this event has been provided at this time. Further information is not expected; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.


VAERS ID: 1522358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
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: Asthenia, Dizziness, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

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

Write-up: Nauseous; Asthenia; Light headedness; Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant), ASTHENIA (Asthenia) and DIZZINESS (Light headedness). On 17-Jul-2021, VOMITING (Vomiting) had resolved. At the time of the report, NAUSEA (Nauseous), ASTHENIA (Asthenia) and DIZZINESS (Light headedness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Patient had felt very weak and light headed. patient not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1522421 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: SEMODERNATX, INC.MOD20212

Write-up: HUVUDV?RK; FROSSA; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (HUVUDV?RK) and CHILLS (FROSSA) in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (HUVUDV?RK) (seriousness criterion disability) and CHILLS (FROSSA) (seriousness criterion disability). On 17-Jul-2021, HEADACHE (HUVUDV?RK) had resolved. At the time of the report, CHILLS (FROSSA) had resolved. Concomitant medications were not provided. Treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1523551 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002921 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ESMODERNATX, INC.MOD20212

Write-up: Myocarditis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002921) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Endocervical) .5 milliliter. On 15-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. mRNA-1273 (COVID 19 Vaccine Moderna) (Endocervical) was withdrawn on 14-Jul-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Endocervical), the reporter did not provide any causality assessments. No concomitant medication was mentioned. No treatment medication was mentioned. 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: 1523616 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214009 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Comments: Medical History Not Reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: thrombophl?bite; This regulatory authority case was reported by a pharmacist and describes the occurrence of THROMBOPHLEBITIS (thrombophl?bite) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214009) for COVID-19 vaccination. Medical History Not Reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced THROMBOPHLEBITIS (thrombophl?bite) (seriousness criterion medically significant). At the time of the report, THROMBOPHLEBITIS (thrombophl?bite) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-LL20215033 No concomitant medications was provided by the reporter. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1523957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Malaise, Muscular weakness, Nausea, Pain in extremity, SARS-CoV-2 test, Swelling, Vaccination site mass, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (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: FEXOFENADINE; SINGULAIR; VENTOLINE [SALBUTAMOL SULFATE]; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypersensitivity
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928567

Write-up: swelling/Swelling and pain at the injection site was immediate.; Painful to move and lift arm for a few days.; Nausea; Dizziness; Fatigue; Malaise; Muscle weakness; Injection site pain/Swelling and pain at the injection site was immediate; Injection site lump; Headache; Leg pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is [-MHRA-WEBCOVID-202107201046444240-XYPKV], Safety Report Unique Identifier [-MHRA-ADR 25679582]. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 15Jul2021 as first dose, single for COVID-19 immunization. Medical history included allergy and allergic asthma. Concomitant medication included fexofenadine (FEXOFENADINE) taken for hypersensitivity; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (VENTOLINE [SALBUTAMOL SULFATE]) taken for asthma, ibuprofen (IBUPROFEN). On an unspecified date, the patient experienced swelling/swelling and pain at the injection site was immediate, painful to move and lift arm for a few days. On 15Jul2021, the patient experienced injection site pain/swelling and pain at the injection site was immediate, headache, leg pain and injection site lump. On 16Jul2021, the patient experienced dizziness, fatigue, malaise and muscle weakness. On 17Jul2021, the patient experienced nausea. It was reported that the headache started several hours after injection followed by dizziness and nausea. Ibuprofen and pare entomology taken along with rest, but still persisting with the medication having little effect. Fatigue and malaise along with the leg pain and muscle weakness in legs followed. The headache was still continuous with the nausea and dizziness becoming episode rather than continuous. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as a result of headache (headache) including treatment with Ibuprofen. The patient had no symptoms associated with COVID-19. The outcome of the event for injection site pain and injection site lump was recovered on 18Jul2021; for swelling/swelling and pain at the injection site was immediate was recovering; for headache, leg pain, dizziness, fatigue, malaise, muscle weakness, nausea was not recovered; while for painful to move and lift arm for a few days was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524081 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FO5763 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Inappropriate schedule of product administration, Libido decreased, Testicular pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929183

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107210050540230-2AEWT; safety report unique identifier: GB-MHRA-ADR 25683768). A 19-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FO5763), via an unspecified route of administration, on Jul 15, 2021, single dose, for COVID-19 immunisation. Medical history included anxiety from an unknown date. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Concomitant medication included sertraline for anxiety, start and stop date not reported. The patient previously received the first dose of BNT162B2 (lot# EW4109) on May 12, 2021, for COVID-19 immunisation. The patient experienced symptoms (unspecified date), testicular pain (Jul 20, 2021) and abdominal cramp (Jul 20, 2021). Case narrative: Woke up with the two symptoms: both strictly on the left-side (right testicle and right of abdomen felt normal). Left abdomen was tender when pressed about 10-15 cm from the top of the hips (in the crease of the groin). Left testicle ached and was tender. He had to sit with legs spread to prevent compression or pressure on it (to try and reduce symptoms). Patient has not tested positive for COVID-19 since the vaccination. Patient was not enrolled in a clinical trial. The events reported serious (medically significant). The outcome of the symptoms recovered on an unspecified date; for testicular pain and abdominal cramp not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1524184 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-07-15
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain, Fatigue, Haemorrhage, Heavy menstrual bleeding, Intermenstrual bleeding, Irritability, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Lipodystrophy (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: LEVOTHYROXINE
Current Illness: Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: bleeding; menstrual period; Spotting menstrual; Sore breasts; Irritable; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 038B21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE from 15-Aug-2015 to an unknown date for Hypothyroidism. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced FATIGUE (Tiredness). On 16-Jul-2021, the patient experienced BREAST PAIN (Sore breasts) and IRRITABILITY (Irritable). On 20-Jul-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting menstrual). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (menstrual period). At the time of the report, HAEMORRHAGE (bleeding), HEAVY MENSTRUAL BLEEDING (menstrual period), BREAST PAIN (Sore breasts), IRRITABILITY (Irritable) and FATIGUE (Tiredness) was resolving and INTERMENSTRUAL BLEEDING (Spotting menstrual) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, SARS-CoV-2 test: negative (Negative) Negative. No treatment information was provided. Patient was not post menopausal. Patient did not have a menstrual period about 4 years. Patient was not enough to have to use a menstrual pad, a panty liner was enough. Patient was on day 04 of spotting. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, all though event Hemorrhage is in IME list. Based on info available in source document. The event severity has been overridden.; 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. However, all though event Hemorrhage is in IME list. Based on info available in source document. The event severity has been overridden.


VAERS ID: 1524194 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
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: Contusion, Fatigue, Rash pruritic, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Itchy rash; Fatigue; Swelling; Bruising; This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), CONTUSION (Bruising), RASH PRURITIC (Itchy rash) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included SERTRALINE for an unknown indication. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and CONTUSION (Bruising) (seriousness criterion medically significant). On 16-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On 20-Jul-2021, SWELLING (Swelling) and RASH PRURITIC (Itchy rash) had resolved. At the time of the report, CONTUSION (Bruising) was resolving and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1524274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Chest pain, Heart rate, Palpitations, Scan
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (already had COVID twice, 1st during the first confinement and 2nd time in Dec2020, without symptoms).
Allergies:
Diagnostic Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result: strong/heart that beat hard; Test Name: scanner; Result Unstructured Data: Test Result: nothing abnormal.
CDC Split Type: GBPFIZER INC202100927574

Write-up: Anxiety; chest pain; chest pain with a feeling of tightness/ oppression; a strong heartbeat; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included COVID-19 (patient already had COVID twice, first during the first confinement and second time in Dec2020, without symptoms). The patient''s concomitant medications were not reported. Patient wished to know whether he should receive the second dose in view of the adverse reactions he had, he was very concerned. The patient experienced chest pain with a feeling of tightness/ oppression and a strong heartbeat (medically significant) on 15Jul2021, and anxiety on an unspecified date. It''s not sure if it''s because of the vaccine or if it was caused by the stress after reading the harsh information about the vaccine on the internet but it started to have a chest pain that was actually still present. The patient underwent lab tests and procedures which included heart rate showed strong/heart that beat hard on an unspecified date, scan was nothing abnormal on an unspecified date, he went to the emergency room where a scanner was done but found nothing abnormal, but it could be caused by his anxiety. The outcome of events "chest pain with a feeling of tightness and a strong heartbeat" was not recovered; of "anxiety" was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1524276 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Inappropriate schedule of product administration, Neck pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament 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: Suspected COVID-19 (unsure when symptoms started).
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Date: 07/19/2021; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100930847

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107190835275740-UW467; safety report unique identifier: GB-MHRA-ADR 25671085). A 25-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD5613), at the age of 25, via an unspecified route of administration, on Jul 15, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation and suspected COVID-19 (ongoing; unsure when symptoms started). Patient is not pregnant, nor currently breastfeeding. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The patient previously received B-12 injections. The patient also previously received dose 1 of BNT162B2 on May 21, 2021 (at the age of 25), for COVID-19 immunization; and experienced painful calf muscles (felt like pins and needles), and really heavy/sore/joint swelling. The patient had painful neck and joints on Jul 17, 2021 since her second jab. The patient also experienced leg pain on Jul 18, 2021. The events assessed serious (medically significant). Lab data included COVID-19 virus test: No - Negative COVID-19 test on Jul 19, 2021. The outcome of the leg pain and neck pain not recovered; painful joints unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1524277 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   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 FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endometriosis, Inappropriate schedule of product administration, Menstruation delayed, SARS-CoV-2 test
SMQs:, 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: AMITRIPTYLINE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenomyosis; Lactation decreased; Pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100936559

Write-up: endometriosis pain increased; Delayed period; dose 1 on 12May2021, dose 2 on 15Jul2021; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Agency (RA) [indicate MHRA regulatory authority number. The regulatory authority report number is GB-RA-WEBCOVID-202107201232441830-SDHTS, Safety Report Unique Identifier GB-RA-ADR 25680066. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FD5613) at single dose for COVID-19 immunisation (39-year-old at vaccination). Medical history included adenomyosis from an unknown date and unknown if ongoing , suppressed lactation from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. 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. Concomitant medication(s) included amitriptyline (AMITRIPTYLINE) taken for pain, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient received the first dose of BNT162B2 on 12May2021 for COVID-19 immunisation and experienced adenomyosis / Endometriosis pain increased scientifically, she had to increase my pain meds. The patient experienced endometriosis pain (endometriosis) (medically significant) on an unspecified date with outcome of recovered , delayed period (menstruation delayed) (medically significant) on 16Jul2021 with outcome of not recovered , dose 1 on 12May2021, dose 2 on 15Jul2021 (inappropriate schedule of product administration) with outcome of unknown. The patient underwent lab tests and procedures which included covid-19 virus test with negative result on unknown date. The patient stated since the second vaccine, the pain (endometriosis pain) had increased again and she was later than normal for her period. The patient would say both doses vaccines had affected her but no one actually warned that may happen. Patient had 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-202100928857 for same patient, different dose and different event


VAERS ID: 1524374 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/77 mmHg; Test Date: 20210715; Test Name: O2 saturation; Test Result: 97 %
CDC Split Type: ITPFIZER INC202100925929

Write-up: Lipothymic episode; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-758023. A 38-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FF0688; Expiration Date: 31Oct2021), via intramuscular, on 15Jul2021 (at the age of 38 years old) as dose 1, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Jul2021, it was reported that the patient experienced syncope (reported as lipothymic episode [medically significant]) immediately after the vaccination. Administration of physiological saline and observation for 1 hour. Symptoms regressed and the patient was sent home. The patient underwent laboratory tests and procedures which included on 15Jul2021 which showed blood pressure of 113/77 mmhg and oxygen saturation of 97 %. The outcome of the event was recovered on 15Jul2021. Reporter''s comments: Immediately after vaccine administration lipothymic episode. Administration of physiological saline and observation for 1 hour. Symptoms regressed and the patient was sent home. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Immediately after vaccine administration lipotimic episode. Administration of physiological saline and observation for 1 hour. Symptoms regressed and the patient was sent home.


VAERS ID: 1524435 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Chronic obstructive pulmonary disease, Computerised tomogram thorax, Dyspnoea, Hypercapnia, Hyperoxia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood gases; Result Unstructured Data: Test Result:Hyperoxia and Hypercapnia; Test Date: 20210716; Test Name: chest CT; Result Unstructured Data: Test Result:not seemed as Pneumonia
CDC Split Type: JPPFIZER INC202100924357

Write-up: Breathing diffcult; Hyperoxia; Hypercapnia; COPD exacerbation; pyrexia ( temperature not proved); This is a spontaneous report from a contactable other healthcare professional (infection control practitioner) received from the Regulatory authority. Regulatory authority report number is v21120569. An 81-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021, at the age of 81-years-old, (Lot Number: FC8736; Expiration Date: 30Sep2021) as DOSE 2, SINGLE COVID-19 immunisation. Medical history included hypertension, chronic obstructive pulmonary disease, and diabetes mellitus. The patient''s concomitant medications were not reported. On 15Jul2021 at 17:00 (the day of the vaccination), the patient experienced pyrexia. On 16Jul2021 (1 day after the vaccination), the patient experienced breathing difficult and was admitted to the hospital. The course of the event was as follows: On 15Jul2021 from the evening, the patient experienced pyrexia (temperature not provided). On 16Jul2021 in the morning, the patient experienced breathing difficult and was given emergency request. The patient took chest CT and it proved that it was not seemed as Pneumonia and she tested blood gas inspection and there were Hyperoxia and Hypercapnia. The patient was given steroid iv drip and inhale bronchodilator. It was diagnosed as COPD exacerbation, the patient hospitalized and was given further treatment now (the patient was given oxygen 0.5L). The outcome of the events was unknown. The reporter classified the event as serious (hospitalized in 16Jul2021) and assessed that the causality between the event and bnt162b2 as unassessable. The reporter commented as follows: The treatment was going on now and the outcome of recovered would be sent in second report. No follow-up attempts are needed. No further information is expected.


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