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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 364 out of 6,867

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VAERS ID: 1524445 (history)  
Form: Version 2.0  
Age: 27.0  
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 FC5295 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100924812

Write-up: Anaphylaxis; Vomiting; Abdominal pain; This is a spontaneous report from a non-contactable physician received. A 27-year-old female patient (non-pregnant) received bnt162b2 (COMIRNATY, solution for injection), intramuscular, administered in arm left on 15Jul2021 11:00 (lot: FC5295; expiry: 30Sep2021) (at the age of 27-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient''s medical history and concomitant medications were not reported. The patient previously took loxoprofen sodium (LOXONIN) and experienced drug allergy. On 15Jul2021 at 12:15 (around 1 hour and 30 minutes after the vaccination), the patient experienced anaphylaxis, vomiting and abdominal pain. The events resulted in Emergency room/department or urgent care, hospitalization. The clinical course was reported as follows: Around 1.5 hours after the vaccination, the patient experienced vomiting and abdominal pain. The patient was rushed to the emergency room on suspicion of anaphylaxis. The outcome of the events was unknown with treatment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information in the case, the causal association between the events anaphylactic reaction, vomiting, abdominal pain and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1524576 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-15
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Headache, Heart rate, Hypertension, Myalgia, Oropharyngeal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: results increased; Test Date: 20210720; Test Name: Blood pressure; Result Unstructured Data: results increased; Test Date: 20210716; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: beats per minute; Test Date: 20210720; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: beats per minute
CDC Split Type: JPTAKEDA2021TJP064100

Write-up: Anaphylaxis (dyspnoea); Blood pressure increased (H160); Throbbing pain; Headache; Myalgia; Pharyngodynia; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis (dyspnoea)) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Pharyngodynia) and MYALGIA (Myalgia). On 16-Jul-2021, the patient experienced HYPERTENSION (Blood pressure increased (H160)), PAIN (Throbbing pain) and HEADACHE (Headache). On 18-Jul-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis (dyspnoea)) (seriousness criterion medically significant). The patient was treated with TRANEXAMIC ACID at an unspecified dose and frequency. On 21-Jul-2021, ANAPHYLACTIC REACTION (Anaphylaxis (dyspnoea)), OROPHARYNGEAL PAIN (Pharyngodynia), HYPERTENSION (Blood pressure increased (H160)), PAIN (Throbbing pain), HEADACHE (Headache) and MYALGIA (Myalgia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Blood pressure measurement: 160 (High) results increased. On 16-Jul-2021, Heart rate: 98 (Inconclusive) beats per minute. On 20-Jul-2021, Blood pressure measurement: 160 (High) results increased. On 20-Jul-2021, Heart rate: 100 (Inconclusive) beats per minute. Concomitant product use was not provided by the reporter. Patient was visited the emergency department. 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. This case was linked to MOD-2021-273032 (Patient Link).; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1524666 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
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:
CDC Split Type: PHPFIZER INC202100935306

Write-up: COVID suspect (close contact); COVID suspect (close contact); This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory authority report number PH-PHFDA-300092210. A 32-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on an unspecified date (Batch/Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021 07:00, the patient experienced covid suspect (close contact). The clinical outcome of the events was recovering at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1525216 (history)  
Form: Version 2.0  
Age: 30.0  
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 (MODERNA)) / MODERNA 214001 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia, Pallor, Pollakiuria
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN, FATIGUE, CHILLS, HEADACHE, MYALGIA, POLLAKIURIA and PALLOR in a 30-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214001) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced INJECTION SITE PAIN (seriousness criterion disability), FATIGUE (seriousness criterion disability), CHILLS (seriousness criterion disability), HEADACHE (seriousness criterion disability), MYALGIA (seriousness criterion disability), POLLAKIURIA (seriousness criterion disability) and PALLOR (seriousness criterion disability). At the time of the report, INJECTION SITE PAIN, FATIGUE, CHILLS, HEADACHE, MYALGIA , POLLAKIURIA and PALLOR was resolving. Concomitant medications were not reported No treatment information was provided. Company''s 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: 1525409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial asthma
Preexisting Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100954836

Write-up: This is a spontaneous report from a contactable physician, downloaded via the regulatory authority (AT-BASGAGES-2021-36988). A 56-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# FD6840, expiration date not reported), intramuscularly, on Jul 6, 2021, single dose (1 dosage form), for COVID-19 immunisation. Medical history included ongoing bronchial asthma from unknown start date. Patient had no concomitant medications. The patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date not reported), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On Jul 15, 2021, patient experienced peripheral pulmonary embolism/peripheral pulmonary artery embolism, which led to hospitalization. Therapeutic measures taken as a result of peripheral pulmonary embolism and treatment included Novel oral anticoagulants (NOAC). The outcome of peripheral pulmonary embolism: recovered on unspecified date in Jul 2021. No follow-up activities possible. No further information expected.


VAERS ID: 1525413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100966869

Write-up: Deep vein thrombosis Lower leg left; This is a spontaneous report from a contactable physician downloaded from the s Agency regulatory authority number AT-BASGAGES-2021-37193. A 36-years-old female patient received BNT162B2 (COMIRNATY, formulation solution for injection, Lot number: FE6208, Expiration date: unknown) via an unspecified route of administration on 07Jul2021 as dose 2, single for covid-19 immunization. No relevant medical history of patient was reported. No concomitant medications were not reported. The patient previously received first dose bnt162b2 (COMIRNATY) on 02Jun2021 as dose 1 single for COVID-19 immunization On 15Jul2021 the patient experienced Deep vein thrombosis leg. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1526467 (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: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100949107

Write-up: This is a spontaneous report from a contactable physician, downloaded via the regulatory authority (ES-AEMPS-950833). A 44-year-old male patient received the 1st dose of BNT162B2 (Comirnaty; solution for injection; lot# FC1435; expiration date: not reported) via an unspecified route of administration, in arm, on Jul 13, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced venous thrombosis in leg/venous thrombosis located in the venous sinuses of the soleus muscle, which extends cranially until near its mouth in the popliteal. Permeable more proximal deep venous system on Jul 15, 2021. It was unknown if patient had COVID-19. The patient awaiting clinical evolution. He had an appointment on Jul 23, 2021 to repeat ECHO. The outcome of the event was unknown. Follow-up attempts not possible. No expected further information.


VAERS ID: 1526593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-15
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Brain natriuretic peptide, Deep vein thrombosis, Echocardiogram, Electrocardiogram, NYHA classification, Pulmonary embolism, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LODOZ; CRESTOR; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Gastritis; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: CT angiogram; Result Unstructured Data: Test Result:Bilateral multisegmental pulmonary embolism; Comments: Bilateral multisegmental pulmonary embolism of the 2 bases and right upper and middle lobe at low risk, with bronchitis syndrome; Test Date: 20210715; Test Name: bnp; Result Unstructured Data: Test Result:High; Comments: Blood test: BNP levels high; Test Date: 20210715; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Grade 1 tricuspid regurgitation; Comments: Grade 1 tricuspid regurgitation, interior vena cava collapsed; Test Date: 20210715; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Fragmented QRS; Test Date: 20210715; Test Name: nyha; Result Unstructured Data: Test Result:stage 2; Test Date: 20210715; Test Name: Venous Doppler ultrasound; Result Unstructured Data: Test Result:Venous Doppler ultrasound of the lower limbs; Comments: Venous Doppler ultrasound of the lower limbs: Left fibular DVT (2 veins) without popliteal extension (sural anterior varicose thrombosis)
CDC Split Type: FRPFIZER INC202100949322

Write-up: Thrombosis of leg deep venous; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-CF20212079. A 69-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC6984) via intramuscular route of administration, administered in Arm Left on 22Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Gastritis, dyslipidaemia and hypertension from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (LODOZ), rosuvastatin calcium (CRESTOR) and omeprazole taken for an unspecified indication, start and stop date were not reported. She had no Covid-19. On 15July2021, The patient experienced thrombosis of leg deep venous and pulmonary embolism. She was hospitalized (at cardiology service) for thrombosis of leg deep venous and pulmonary embolism from 16Jul2021 to 20Jul2021. She was taken Treatment with APIXABAN 10 mg in the morning and in the evening. The patient underwent lab tests and procedures which included angiogram: bilateral multisegmental pulmonary embolism on 15Jul2021 Bilateral multisegmental pulmonary embolism of the 2 bases and right upper and middle lobe at low risk, with bronchitis syndrome , brain natriuretic peptide: high on 15Jul2021 Blood test: BNP levels high , echocardiogram: grade 1 tricuspid regurgitation on 15Jul2021 Grade 1 tricuspid regurgitation, interior vena cava collapsed , electrocardiogram: fragmented qrs on 15Jul2021, nyha classification: stage 2 on 15Jul2021, ultrasound doppler: venous doppler ultrasound of the lower limbs on 15Jul2021 Venous Doppler ultrasound of the lower limbs: Left fibular DVT (2 veins) without popliteal extension (sural anterior varicose thrombosis). Therapeutic measures were taken as a result of thrombosis of leg deep venous, pulmonary embolism. The outcome of the events were recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1526606 (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: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immune thrombocytopenia, Inappropriate schedule of product administration, Platelet count, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Immune thrombocytopenic purpura ((basal platelet value: 80-100 G/l))
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Platelets; Result Unstructured Data: Test Result:99 g/l; Test Date: 20210604; Test Name: Platelets; Result Unstructured Data: Test Result:58 g/l; Test Date: 20210605; Test Name: Platelets; Result Unstructured Data: Test Result:63 g/l; Test Date: 20210608; Test Name: Platelets; Result Unstructured Data: Test Result:73 g/l; Test Date: 20210610; Test Name: Platelets; Result Unstructured Data: Test Result:89 g/l; Test Date: 20210715; Test Name: Platelets; Result Unstructured Data: Test Result:33 g/l; Test Date: 20210716; Test Name: Platelets; Result Unstructured Data: Test Result:4 g/l; Test Date: 20210717; Test Name: Platelets; Result Unstructured Data: Test Result:38 g/l
CDC Split Type: FRPFIZER INC202100954721

Write-up: fever; Inappropriate schedule of vaccine administered; Immune-mediated thrombocytopenic purpura; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-2021097352. A 54-years-old male patient received second dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route of administration on 13Jul2021 at a dose of 0.3 mL single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 01Jun2021 at a dose of 0.3 mL single dose for COVID-19 immunisation. Medical history included Immune thrombocytopenic purpura from 1995 to an unknown date (basal platelet value: 80-100 G/l). The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced fever. On 15Jul2021, the patient experienced Immune-mediated thrombocytopenic purpura. This case was considered as serious (Medically significant). The patient underwent lab tests and procedures which included platelet count: 99 g/l on 02Jun2021, platelet count: 58 g/l on 04Jun2021, platelet count: 63 g/l on 05Jun2021, platelet count: 73 g/l on 08Jun2021, platelet count: 89 g/l on 10Jun2021, platelet count: 33 g/l on 15Jul2021, platelet count: 4 g/l on 16Jul2021, platelet count: 38 g/l on 17Jul2021. Therapeutic measures were taken as a result of immune-mediated thrombocytopenic purpura (immune thrombocytopenia). Subsequently, onset of fever and recurrence of idiopathic thrombocytopenic purpura (ITP).No concomitant COVID-19 infection. No hemorrhagic syndrome, initiation of corticosteroid treatment at 80 mg/d. The outcome of the event was recovering for Immune-mediated thrombocytopenic purpura and unknown for other events. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1526815 (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: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Blood test, Cough, Exposure during pregnancy, Lethargy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result: unknown; Test Date: 20210715; Test Name: High temp; Result Unstructured Data: Test Result:40.1?; Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100928573

Write-up: lethargic; cough; vomiting; unresponsive for short periods and apneac periods; High temperature; Vaccine exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201311014120-QYTE0, Safety Report Unique Identifier GB-MHRA-ADR 25680298. This consumer reported information for both mother and fetus/baby. This is a baby report. A 1-years-old female patient, whose mother received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), dose 1 via administration on 14Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. On 15Jul2021, the patient experienced high temperature of 40.1 degree. On unspecified date, the patient experienced cough, vomiting, lethargic, unresponsive for short periods and apneac periods. The patient was breast fed and this happened hours after her mother received her first vaccine and was terrifying. Vaccine exposure during pregnancy. Adverse reaction did not occur as a result of an exposure during pregnancy. Since the vaccination, the patient had not been tested positive for covid-19. The patient was admitted to hospital by ambulance. The patient underwent lab tests and procedures which included high temp 40.1 degree on 15Jul2021, covid-19 virus test negative on 16Jul2021 and blood test unknown. Outcome of the event high temperature was recovered on 19Jul2021. Outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100936858 same drug, different patient, different event. GB-PFIZER INC-202100936858 Mother/baby case.


VAERS ID: 1527045 (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: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Joint swelling, Lymphadenopathy, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941362

Write-up: Leg pain; Swollen ankles; Fingers swollen feeling of; Swollen glands; Armpit pain; Swollen arm; Chest pain; Pain in fingers; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202107221640103260-CHH7Y, Safety Report Unique Identifier GB-MHRA-ADR 25694067. A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: Fc9001) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced swollen gland, armpit pain, swollen arm, chest pain, pain in fingers and fingers swollen feeling of on 15Jul2021, and leg pain and swollen ankles on 19Jul2021. All the events were reported as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unknown date. Leg pain and swollen ankles were resolved on 21Jul201, the other events were resolved on 20Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527050 (history)  
Form: Version 2.0  
Age: 45.0  
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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymph node pain, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941398

Write-up: swelling; intense pain in armpit and arm on the side of the injection site; intense pain in armpit and arm on the side of the injection site; Lymph node pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221920341660-NBMPV. Safety Report Unique Identifier GB-MHRA-ADR 25695049. A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FF3319) as single dose (at age of 45-years-old) for COVID-19 immunisation. Medical history included lactation decreased, blood pressure high. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included ramipril (RAMIPRIL) taken for blood pressure high from 2016. On an unspecified date patient experienced swelling and intense pain in armpit and arm on the side of the injection site, on 15Jul2021 she experienced lymph node pain. Events considered serious as medically significant. It was reported swelling and intense pain in armpit and arm on the side of the injection site. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was recovering from Lymph node pain, while outcome of the other mentioned events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527140 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chorioretinopathy, Serous retinopathy, Skin discolouration
SMQs:, Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad)

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

Write-up: serous retinopathy; darker vision; Central serous retinopathy; This regulatory authority case was reported by a consumer and describes the occurrence of SEROUS RETINOPATHY (serous retinopathy), CHORIORETINOPATHY (Central serous retinopathy) and SKIN DISCOLOURATION (darker vision) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-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 CHORIORETINOPATHY (Central serous retinopathy) (seriousness criterion medically significant). On an unknown date, the patient experienced SEROUS RETINOPATHY (serous retinopathy) (seriousness criterion medically significant) and SKIN DISCOLOURATION (darker vision) (seriousness criterion medically significant). At the time of the report, SEROUS RETINOPATHY (serous retinopathy) and SKIN DISCOLOURATION (darker vision) outcome was unknown and CHORIORETINOPATHY (Central serous retinopathy) had not resolved. Patient stated that Tests was done at Eye Hospital . Concomitant medications was not reported. Treatment history was not reported . Patient had not tested positive for COVID-19 since having the vaccine . Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Company Comment: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded


VAERS ID: 1527203 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu symptoms; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) and FATIGUE (Fatigue) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 12-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 FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. No concomitant medication information was provided. No treatment medication information was provided. It was reported that patient had mild flu symptoms for 3 days also had 2 weeks of fatigue. Had naps and day sleeps to get through the day and they don''t always help patient. When patient get active than get really hot and had low stamina levels. Based on the current available information and apparent temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority. Patient was not enrolled in clinical trial.; Sender''s Comments: Based on the current available information and apparent temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority.


VAERS ID: 1527262 (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: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Maternal exposure during pregnancy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (estimated due date: 04Feb2022; was 3/4 weeks pregnant at first vaccine)
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (baby had stopped developing at about 6 weeks); Suspected COVID-19 (unsure when symptoms stopped); Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20201103; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100957165

Write-up: Maternal exposure during pregnancy; chills; Feeling unwell; Headache; Feverish; Generalised muscle aches; This is a Non-Interventional Study report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-YCVM-202106021734434530-YAPSO. A pregnant 33-year-old female subject received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FD8813) as a single dose for COVID-19 immunisation. Date of Last Menstrual Period (LMP) 27Apr2021. Medical history included ongoing pregnancy (estimated due date: 04Feb2022; was 3/4 weeks pregnant at first vaccine), suspected COVID-19 from 01Nov2020 to an unknown date (unsure when symptoms stopped), vitamin supplementation from an unknown date and unknown if ongoing, miscarriage from an unknown date and unknown if ongoing (baby had stopped developing at about 6 weeks). Concomitant medications included folic acid (MANUFACTURER UNKNOWN) taken for folic acid supplementation, start and stop date were not reported. The subject previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunisation on 19May2021 (lot number: ET8885; Dose 1 was 3/4 weeks pregnant at first vaccine) and experienced miscarriage. As reported, the subject was 3/4 weeks pregnant at the first vaccine and about 11 at the second vaccine. The subject was not currently breastfeeding. The subject experienced maternal exposure during pregnancy (medically significant) on an unspecified date, feverish (medically significant) on 15Jul2021, generalised muscle aches (medically significant) on 15Jul2021, headache (medically significant) on 16Jul2021, chills (medically significant) on an unspecified date, feeling unwell (medically significant) on an unspecified date. The clinical course was reported as follows: After the second dose, the subject had about 18 hours of feeling unwell-mild fever, aches and chills, headache, which resolved quickly and within 24 hours of beginning to feel unwell. The subject was "back to normal." It was also reported that the subject found on her 12-week scan that her baby had stopped developing at about 6 weeks and the subject experienced a missed miscarriage. The subject had no idea if this was related to the first vaccine dose or not. The subject had not tested positive for COVID-19 since having the vaccine. The subject was not enrolled in clinical trial. The subject was unsure if the vaccination had an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: unaware she was pregnant when she had the first vaccine dose. The subject was exposed to the vaccine first-trimester (1-12 weeks). Details of scans or investigations: 12 weeks scan found the baby had stopped developing at 5 or 6 weeks. The subject underwent lab tests and procedures which included COVID-19 virus test: negative on 03Nov2020 (No - Negative COVID-19 test). The clinical outcome of the events: headache, generalised muscle aches, feverish, was recovered on 16Jul2021. The clinical outcome of the events: chills and feeling unwell, was recovered on an unspecified date. The clinical outcome of the event, maternal exposure during pregnancy, was unknown. The reporter''s assessment of the causal relationship of the events with the suspect vaccine 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 known drug safety profile, there is reasonable possibility of causal association between the events maternal exposure during pregnancy, pyrexia, myalgia, headache, chills and malaise and the suspect drug BNT162B2.


VAERS ID: 1527677 (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: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Monoclonal gammopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100967088

Write-up: Massive pulmonary thromboembolism; Thrombosis of the right lower limb and iliac artery; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number. A 41-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, batch/lot number was not reported) via intramuscular route of administration on 11May2021 as dose 2, single for COVID-19 immunisation. Medical history included monoclonal gammopathy. The patient''s concomitant medications were not reported. On 15Jul2021, the patient experienced massive pulmonary thromboembolism and thrombosis of the right lower limb and iliac artery. The patient was admitted and underwent surgery with placement of a caval umbrella as a large thrombotic flow remained in the internal and external floating iliac. The patient was receiving pharmacological treatment with low weight heparin 100 UI per kg every 12 hours. He would undergo body CT to assess the vessels affected by thrombosis and to exclude crypt carcinoma syndrome. The events of massive pulmonary thromboembolism and thrombosis of the right lower limb and iliac artery was considered as serious (life threatening) by health authority. The outcome of the events were unknown. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected.


VAERS ID: 1527710 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Hypertension, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:171/116; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination.; Test Date: 20210715; Test Name: pulse rate; Result Unstructured Data: Test Result:129; Comments: /m
CDC Split Type: JPPFIZER INC202100935637

Write-up: Tachycardia; blood pressure increased; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120779. A 61-years and 4-month-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on 15Jul2021 15:45, at 61 years of age, (Batch/Lot Number: EY0572; Expiration Date: 10Oct2021) as single dose for COVID-19 immunization. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 15Jul2021 16:00 (15 minutes after the vaccination) the patient experienced tachycardia (129/m) and blood pressure increased (171/116), both assessed as medically significant. Prednisolone (PREDONINE) 10 mg + saline 20 mg was immediately given by intravenous injection. After about 20-30 minutes, the value returned to normal. The patient underwent lab tests and procedures which included blood pressure measurement: 171/116 on 15Jul2021, body temperature: 36.5 degrees centigrade on 15Jul2021 before vaccination, heart rate: 129/m on 15Jul2021. The reported events resolved on 15Jul2021, the same day of vaccination. The reporting physician classified the events as non-serious and assessed them as related to BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine. There was no other possible cause of the event such as any other diseases.The reporting physician commented as follows: "Considered it was not serious adverse event, considered it was a transient adverse reaction". The Company assessed both the events as medically significant.


VAERS ID: 1527713 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100935664

Write-up: headache; Giddiness; Malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120818. The patient was a 72-year-old (also the age at vaccination) female. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history and concomitant medication not reported. On unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY lot/batch not provided) for COVID-19 immunization, and experienced adverse event after that. On 15Jul2021 at 09:13 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5947, 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 at 09:40 (27 minutes after vaccination also reported as about 15 minutes after vaccination), she began to experienced headache, giddiness, and malaise. The patient went to the internal medicine clinic for a check-up due to the symptoms continued since that. Outcome of the events were not recovered. The reporting physician classified the event as serious (Medically significant) 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: Adverse event had occurred after the first vaccination. The symptoms continued after that, so the case was considered that the second dose of vaccination should be put on hold.


VAERS ID: 1527729 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 17:00
CDC Split Type: JPPFIZER INC202100936202

Write-up: Anaphylaxis; pyrexia/38.3 degrees Centigrade; vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21120790. A 76-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 14:00 (Batch/Lot Number: EY5422; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. The patient''s concomitant medications were not reported. The patient was a 76-year and 4-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 15Jul2021 at 17:00 (1 day after the vaccination), the patient experienced anaphylaxis (medically significant), pyrexia, vomiting. On 16Jul2021 (2 days after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 15Jul2021 (1 day after the vaccination), vomiting, at 17:00, 38.3 degrees Centigrade. CALONAL(200) 2T orally. On 16Jul2021 (2 days after the vaccination), the pyrexia alleviated. Therapeutic measures were taken as a result of the events. The patient underwent lab data which includes body temperature of 36.7 Centigrade before vaccination on 14Jul2021, and 38.3 centigrade on 15Jul2021 at 17:00. 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 outcome of the events was recovered with sequel.


VAERS ID: 1527740 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
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: PCR; Test Result: Positive.
CDC Split Type: JPPFIZER INC202100949481

Write-up: This is a spontaneous report received from a contactable physician via the Regulatory Authority. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Detail of the reaction was as follows: This month, a patient was released from isolation due to coronavirus infection and released from isolation on 20Jul2021. The second vaccination of this patient would be carried out this weekend. Although I didn''t ask when the first dose (vaccine) was given, if the second dose (vaccine) would be given this weekend, I think the first dose (vaccine) was given three weeks ago. Because it was just infected (coronavirus), there was also the possibility of strong adverse reactions. On 11Jul2021, Symptoms appeared, and on 15Jul2021, came to our hospital for examination, and PCR was positive. The patient seemed to be recuperating in a hotel. I''m afraid when I was doing examination, the symptoms were almost under control, so I guess just took antipyretics. The outcome of the event COVID-19 was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Sender''s Comments: Based on available information, a possible contributory role of the subject product, Comirnaty vaccine, cannot be excluded for the reported events of Drug ineffective and COVID-19.


VAERS ID: 1527819 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP066654

Write-up: Delayed anaphylaxis (throat tightness, phonation difficulty, swallowing difficulty); This case was received via Regulatory Authority (Reference number: 2021TJP066654) on 27-Jul-2021 and was forwarded to Moderna on 04-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Delayed anaphylaxis (throat tightness, phonation difficulty, swallowing difficulty)) in a 28-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021 at 4:15 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Delayed anaphylaxis (throat tightness, phonation difficulty, swallowing difficulty)) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Delayed anaphylaxis (throat tightness, phonation difficulty, swallowing difficulty)) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Delayed anaphylaxis (throat tightness, phonation difficulty, swallowing difficulty)) to be possibly related. Concomitant product use was not provider by the reporter. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Company Comment Based on the current available information and temporal association between the use of the product and the start date of this 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 this event, a causal relationship cannot be excluded.


VAERS ID: 1527948 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Feeling abnormal, Generalised tonic-clonic seizure, Heart rate, Malaise, Oxygen saturation, Physical examination, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:134/82; Comments: Time 08:58: 134/82; Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:137/79; Comments: Time 09:25: 137/79; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:34.8 Centigrade; Comments: 34.8 degree Celsius; Test Date: 20210715; Test Name: Pulse rate; Result Unstructured Data: Test Result:76; Comments: Units: beats/min; Test Date: 20210715; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210715; Test Name: Physical examination; Result Unstructured Data: Test Result:The patient was pale, had cold sweat, and was col; Comments: The patient was pale, had cold sweat, and was cold in distal extremities
CDC Split Type: NOPFIZER INC202100932314

Write-up: COLD SWEAT; FEELING UNWELL; DIZZY; a short-lived syncope, lasting 5 seconds, clonic-tonic generalized seizure as accompanied by staring eye.; GENERALIZED TONIC-CLONIC SEIZURE; FOGGY FEELING IN HEAD; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umqja1. A 26-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FC5029), intramuscular, administered in left arm on 15Jul2021 08:42 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cold sweat, feeling unwell, dizzy, a short-lived syncope, lasting 5 seconds, clonic-tonic generalized seizure as accompanied by staring eye, generalized tonic-clonic seizure and foggy feeling in head, all on 15Jul2021. The patient underwent lab tests and procedures which included blood pressure: 134/82 (Time 08:58) and 137/79 (Time 09:25); body temperature: 34.8 Centigrade; pulse rate: 76 Units: beats/min; oxygen saturation: 98 %; physical examination: the patient was pale, had cold sweat, and was cold in distal extremities, all on 15Jul2021. The outcome of the events were recovered on 15Jul2021. The regulatory authority assessed this report as serious (medically significant). The clinical course was reported as follows: The patient, a 26-year-old previously healthy man (no medicines and no allergies), received the first dose of Comirnaty (batch no FC5029) 15Jul2021. After 10 minutes he got very dizzy and felt unwell, cold sweat and a bit foggy in his head. He was transported to the observation zone in wheelchair. When being transferred to a bed he had a short-lasted syncope (lasting 5 seconds) and generalized tonic-clonic seizures with staring gaze. No rhythmic seizure, no froth from his mouth nor involuntary urination. Examination: The patient was pale, had cold sweat, and was cold in distal extremities. 08:58 o clock: Blood pressure: 134/82, pulse rate: 76, temperature: 34.8. O2: 98% without oxygen. 09:25 o clock: blood pressure: 137/79, pulse rate: 79. The patient was awake after the incident, and had no amnesia. He has no history of epilepsy, nor has he experienced any reactions like this before. He had no fever, but reported having being a bit sore in throat the day before and the same morning. The patient was observed at the vaccination site for one hour, but as he quickly recovered and was fine after the observation period, he wanted to go home (with a 24-hour driving ban). He received no treatment. The reporter states that the clinical presentation and the situation indicates that the patient had a transient symptomatic POTS episode. Seizure possible of psychogen cause, but as other causes could not be ruled out he should be examined by his GP at a later time. The reporter is a physician (probably working at the vaccination center). The reactions are Serious and Recovered/Resolved. The causality assessment is Possible. Drug-reaction(s) / Event(s) Matrix: Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)(unit): 10 min. Relatedness of drug to reaction(s)/event(s). Source of assessment: Regulatory Authority. Result of Assessment Possible. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1528002 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003652 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Urticaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Immuno-allergology which showed no changes
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Urticaria; This regulatory authority case was reported by a physician and describes the occurrence of URTICARIA (Urticaria) in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003652) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Bilastine. Past adverse reactions to the above products included No adverse reaction with Bilastine. Concurrent medical conditions included Urticaria. On 13-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 15-Jul-2021, the patient experienced URTICARIA (Urticaria) (seriousness criterion medically significant). At the time of the report, URTICARIA (Urticaria) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Immuno-allergology which showed no changes. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered URTICARIA (Urticaria) to be probably related. No concomitant medications were reported. Patient had a follow-up in Immuno-allergology consultation for persistent non-atopic rhinitis, febrile urticaria (with myalgia and malaise since she was 18 years old, with improvement in AH SOS, very limiting when it occurs; without evidence of infection at this stage). Blood test by Immuno-allergology which showed no changes, monitoring to be continued in consultations. She was awaiting an appointment with Immunoallergology for a new dose recommendation. No treatment information was reported. 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. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Translated document added; relevant medical history, past drug and reporter causality updated; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1528003 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-15
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002921 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Oedema peripheral, Pruritus, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (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? 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: PTMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA, PRURITUS, FATIGUE, OEDEMA PERIPHERAL , MYALGIA, ARTHRALGIA, TREMOR and HEADACHE in a 45-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 214006 and 3002921) for COVID-19 vaccination. Previously administered products included for an unreported indication: Tromalyt. On 17-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 milliliter. On 15-Jul-2021, the patient experienced PYREXIA (seriousness criterion disability), OEDEMA PERIPHERAL (seriousness criterion disability), MYALGIA (seriousness criterion disability) and TREMOR (seriousness criterion disability). On 16-Jul-2021, the patient experienced PRURITUS (seriousness criterion disability), FATIGUE (seriousness criterion disability), ARTHRALGIA (seriousness criterion disability) and HEADACHE(seriousness criterion disability). On 16-Jul-2021, OEDEMA PERIPHERAL and TREMOR had resolved. On 17-Jul-2021, PYREXIA , MYALGIA and ARTHRALGIA had resolved. At the time of the report, PRURITUS had resolved and FATIGUE and HEADACHE was resolving. No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event. Company''s 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: 1529458 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEJNJFOC20210803174

Write-up: SYNCOPE; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, EE-SAM-44702107156] concerned a 30 year old male patient of unspecified race and ethnicity. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XR393 expiry: unknown) 0.5 ml, 1 total, administered on 15-JUL-2021 for active immunization. No concomitant medications were reported. On 15-JUL-2021, the patient experienced syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 15-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210803174-Covid-19 vaccine ad26.cov2.s- Syncope. This event(s) is considered unassessable.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1529519 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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? Yes
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: Hypercholesterolaemia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Tabaquism (15 cig.j depuis 40 ans)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Convulsions; This regulatory authority case was reported by a pharmacist and describes the occurrence of SEIZURE (Convulsions) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. The patient''s past medical history included Tabaquism (15 cig.j depuis 40 ans). Concurrent medical conditions included Hypercholesterolaemia and Hypertension arterial. On 15-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced SEIZURE (Convulsions) (seriousness criteria hospitalization, medically significant and life threatening). On 15-Jul-2021, SEIZURE (Convulsions) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1529676 (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: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Blood test, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram, Influenza like illness, Pain, Pain in extremity, Rash, SARS-CoV-2 test, Stress, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GALPHARM HAYFEVER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210717; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941413

Write-up: dizzy spells; sore; stress; flu like symptoms; shaking; arm; Rash; Breathlessness; Tachycardia; Weakness; Ache; This is a spontaneous report from a contactable consumer or other non hcp. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107221552386280-BJFOA, Safety Report Unique Identifier GB-MHRA-ADR 25693795. The 33-year-old non pregnant female patient received dose 2 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on 14Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (GALPHARM HAYFEVER) taken for hypersensitivity, start and stop date were not reported. The historical vaccine included dose 1 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. 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 dizzy spells, sore, stress, flu like symptoms, shaking, arm, dizziness, head, on 15Jul2021 weakness, ache, on 17Jul2021 tachycardia, breathlessness, on 21Jul2021 rash. The patient hospitalization was prolonged as a result of dizzy spells, sore, stress, flu like symptoms, shaking. Patient further reported that flu like symptoms started day after vaccination with sore arm, 3 days post vaccination heart started to race uncontrollably with breathlessness and dizzy spells and shaking plus pop feelings in head. Patient was hospitalized with tachycardia and showed signs of blood clotting in blood work. She was given intravenous fluids and blood thinner and monitored for 24 hours. She was discharged after 24 hours when heart rate stabilized and advised to fully rest avoid any stress or exercise and keep taking lots of fluids. Flu like symptoms occurred again 1 week post vaccination and severe weakness was present with dizziness throughout and slowly getting better. Rash occurred on both arms and upper back 1 week post vaccination of small bumps but not itchy. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results, blood test: unknown results, computerised tomogram: unknown results, electrocardiogram: unknown results, sars-cov-2 test: no - negative covid-19 test on 17Jul2021. The outcome of the event dizzy spells, sore, stress, flu like symptoms, shaking, arm, dizziness, head was recovered on unspecified date in 2021, tachycardia was recovered on 18Jul2021, weakness, ache, rash was recovering, breathlessness was recovered on 22Jul2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1529852 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Limb discomfort, Lymph node pain, Lymphadenopathy, Menstruation delayed, Myalgia, Peripheral swelling, Pyrexia, Rash pruritic, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Fertility disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness: Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210727; 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: Muscle pain; Armpit lymph nodes; Itchy rash; Muscle ache; Swelling arm; Arm discomfort; Fever; Lymph node pain; Delayed period; Headache; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), LYMPHADENOPATHY (Armpit lymph nodes), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle ache), PERIPHERAL SWELLING (Swelling arm), LIMB DISCOMFORT (Arm discomfort), RASH PRURITIC (Itchy rash), LYMPH NODE PAIN (Lymph node pain) and MENSTRUATION DELAYED (Delayed period) in a 33-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. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MENSTRUATION DELAYED (Delayed period) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). On 22-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant). On 26-Jul-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant) and LYMPHADENOPATHY (Armpit lymph nodes) (seriousness criterion medically significant). On 26-Jul-2021, PYREXIA (Fever), MYALGIA (Muscle ache) and LYMPH NODE PAIN (Lymph node pain) had resolved. On 27-Jul-2021, HEADACHE (Headache) had resolved. On 28-Jul-2021, FATIGUE (Fatigue) had resolved. On 29-Jul-2021, PERIPHERAL SWELLING (Swelling arm), LIMB DISCOMFORT (Arm discomfort) and MENSTRUATION DELAYED (Delayed period) had resolved. At the time of the report, MYALGIA (Muscle pain), LYMPHADENOPATHY (Armpit lymph nodes) and RASH PRURITIC (Itchy rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.


VAERS ID: 1530019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-15
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Migraine, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic 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? 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941551

Write-up: fatigue; headache; nausea; vomiting; Light headed; Migraine; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107220943342930-O2TAM, Safety Report Unique Identifier is GB-MHRA-ADR 25691407. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not Known), via unspecified route of administration at single dose on 26Jun2021 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. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced fatigue, headache, nausea, vomiting all on an unspecified date; migraine on 15Jul2021. It was reported that patient had unbearable headache worsening with bending, nausea, vomiting, fatigue and lightheaded. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with No - Negative COVID-19 test result on 15Jul2021. The patient was recovering from migraine while outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. NO further information is expected.


VAERS ID: 1530023 (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: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Gait disturbance, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre 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: Chronic back pain; Lactation decreased; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941671

Write-up: chronic pain; Low back pain; could hardly walk; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107221842176750-SPBZN, Safety Report Unique Identifier is GB-MHRA-ADR 25694824. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 (Lot Number: FE1510) as single dose for covid-19 immunisation. Medical history included chronic back pain, lactation decreased and steroid therapy (taking regular steroid treatment (e.g. orally or rectally)) all from an unknown date. The patient''s concomitant medications were not reported. The patient previously took Montelukast and Fostair. 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 experienced chronic pain on an unspecified date and low back pain on 15Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Unbearable pain in lower back the day after my 2nd vaccine I could hardly walk. Sitting or standing for more than an hour was really uncomfortable. This lasted about 4 days. It started to get better for half a day then I would have chronic back pain again that would last a day. Yesterday I was in chronic pain but this afternoon I am fine. Pain killers ease the pain sighting but not fully. Does not hurt more when lifting arms up, moving neck or twisting body from side to side. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient recovered from chronic pain on an unspecified date while patient was recovering from low back pain and could hardly walk. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1530226 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Body temperature, Cold sweat, Heart rate, Pain in extremity, Presyncope, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (Pletaal); Hyperlipidaemia (EPADEL, ATORVASTATIN); Hypertension (BENIDIPINE)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:161/100; Comments: increased; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210715; Test Name: tachycardia; Result Unstructured Data: Test Result:113/n
CDC Split Type: JPPFIZER INC202100944374

Write-up: Blood pressure increased; tachycardia; left arm became dull; cold sweat; vagal reflex/vasovagal reflex; could not put strength into the body; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120970. A 62-year and 4-month-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 15Jul2021 at 14:40 (Lot Number: FC5947; Expiration Date: 30Sep2021) (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history included cerebral infarction, hyperlipidemia and hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took PLETAAL for cerebral infarction, EPADEL and atorvastatin for hyperlipidaemia and benidipine for hypertension. Body temperature before vaccination was 36.1 degrees Centigrade. On 15Jul2021 at 14:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 15Jul2021 (the same day of the vaccination). Event onset date and time was reported as 15Jul2021 around 15:00 (the same day of the vaccination). The course of the event was as follows: around 15:00 (about 20 minutes of inoculation), the patient''s left arm became dull due to blood pressure increased, cold sweat, thought it was a vagal reflex, tachycardia, the patient complained that could not put strength into the body, so the patient was taken to the hospital just in case. The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. The reporting physician commented as follows: suspected vagal reflex, blood pressure increased 161/100, tachycardia 113/n, suspected some different mechanism.


VAERS ID: 1530317 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100967116

Write-up: Cerebral infarction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00630381. A 50-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Jul2021 (Lot Number: FE7010) as 0.3 ML single for covid-19 immunisation. The patient medical history was not reported. No previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 05Jun2021 for covid-19 immunisation. The patient experienced cerebral infarction on 15Jul2021. The event assessed as life threatening, caused or prolonged hospitalization. Cerebral infarction was treated with intravenous drip and medication. Outcome of the event was recovering. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1530402 (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: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chest scan, Off label use, Pleural disorder, Product use issue, Pulmonary embolism, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: diffusion tensor imaging of thorax; Result Unstructured Data: Test Result:pulmonary embolism peripherally; Comments: diffusion tensor imaging of thorax showed pulmonary embolism peripherally in the lower lobe on the right, minimally with pleural fluid on the same side.
CDC Split Type: SEPFIZER INC202100940042

Write-up: pleural fluid; Pulmonary embolism; had a sudden stabbing pain in the right side of his chest; Fever; Vaxzevria (Covid-19 vaccines) which was the first dose in the order and COMIRNATY (Covid-19 vaccines) which was the second dose in the order; Vaxzevria (Covid-19 vaccines) which was the first dose in the order and COMIRNATY (Covid-19 vaccines) which was the second dose in the order; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number SE-MPA-2021-063701. Safety Report Unique Identifier SE-VISMA-1626707871652. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FE6208) as DOSE 1, SINGLE for COVID-19 immunisation; and covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on 07May2021 (Batch/Lot Number: ABW0891) at DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever on 16Jul2021 with outcome of recovering; pulmonary embolism on 17Jul2021 with outcome of recovering; had a sudden stabbing pain in the right side of his chest on 17Jul2021 with outcome of recovering; and pleural fluid on 18Jul2021 with outcome of recovering. Further ADR description indicated that the reported suspected drugs were Vaxzevria (Covid-19 vaccines) which was the first dose in the order administered on 07May2021 and COMIRNATY (Covid-19 vaccines) which was the second dose in the order administered on 15Jul2021. Reported adverse reaction was pulmonary embolism, which onset 17Jul2021, that was, two days after vaccination of COMIRNATY and 71 days after vaccination of Vaxzevria. The report described that the patient was significantly healthy. It was further noted in the report that the patient developed a fever on 16Jul2021. On 17Jul2021, he had a sudden stabbing pain in the right side of his chest, which had been reported to worsen when taking deep breaths. On 18Jul2021, diffusion tensor imaging of thorax showed pulmonary embolism peripherally in the lower lobe on the right, minimally with pleural fluid on the same side. Course: Recovering/being resolved. The case was assessed as serious, hospital care. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1531379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Full blood count, Intestinal obstruction, Magnetic resonance imaging, Mumps, Pain, Peripheral swelling, Ultrasound Doppler, Viral test, White blood cell count increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Hemogram; Result Unstructured Data: Leukocytes were high in the hemogram; Test Date: 20210726; Test Name: Viral test; Result Unstructured Data: Unspecified; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: Unspecified; Test Name: Doppler ultrasound; Result Unstructured Data: Unspecified.
CDC Split Type: BRJNJFOC20210804207

Write-up: SUSPECTED OF MUMPS, SWELLING ON THE INFERIOR PART OF THE LEFT MANDIBLE; LEUKOCYTES WERE HIGH IN THE HEMOGRAM; TRAPPED BOWEL; SWELLING ON LEGS; BODY PAIN; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age, race and Ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number:1821288 and expiry: unknown) dose was not reported, 1 total administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, on the next day of vaccination, the patient experienced body pain and tiredness. On 17-JUL-2021, three days later, the patient experienced trapped bowel and swelling on legs. On 26-JUL-2021, twelve days later, the patient experienced swelling on the inferior part of the left mandible, as the physician suspected of mumps, and leukocytes were high in the hemogram. On the same date at the hospital, patient underwent laboratory test on an emergency basis, and it includes: Hemogram (NR: not provided) Leukocytes were high in the hemogram (units unspecified), and Viral test (NR: not provided) Unspecified (units unspecified). Laboratory data (dates unspecified) included: Doppler ultrasound (NR: not provided) Unspecified (units unspecified), and Nuclear magnetic resonance imaging (NR: not provided) Unspecified (units unspecified). After the Doppler ultrasound the patient visited the dentist for consultation and could not ascertain any diagnosis, the patient was advised to visit a specialist in Semiology. The patient visited to the emergency room (ER). The patient hoped for a feedback on the reported symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body pain, tiredness, swelling on legs, trapped bowel, suspected of mumps, swelling on the inferior part of the left mandible and leukocytes were high in the hemogram was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210804207-covid-19 vaccine ad26.cov2.s-trapped bowel. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1531381 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Chest X-ray
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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:
Current Illness:
Preexisting Conditions: Comments: denied allergies or comorbidities.
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: DIFFUSE PARENCHYMAL CONDENSATION
CDC Split Type: BRJNJFOC20210808288

Write-up: ACUTE RESPIRATORY SYNDROME SECONDARY TO COVID-19; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 45-year-old of unspecified sex, race and ethnicity. The patient''s height, and weight were not reported. The patient denied allergies or comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. From 15-JUL-2021 to 17-JUL-2021 patient experienced fever and 16-JUL-2021 to 17-JUL-2021 experience loss of smell. This symptoms were improved on 19-JUL-2021 and patient was hospitalized. In hospital patient attended course complaining of shortness of breath for 2 days. Patient also experienced runny nose and nasal obstruction. Patient was diagnosed with acute respiratory syndrome secondary to covid-19 and experienced covid-19 infection. Number was days hospitalized was unknown. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) diffuse parenchymal condensation (consolidation). Treatment medications (dates unspecified) included: azithromycin, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute respiratory syndrome secondary to covid-19 and covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210808288- Covid-19 vaccine ad26.cov2.s- Acute respiratory syndrome secondary to covid-19, covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE


VAERS ID: 1532364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-15
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase increased, Basophil count, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood pH, Blood potassium, Blood pressure increased, Blood pressure measurement, Blood sodium, Carbon dioxide, Deep vein thrombosis, Eosinophil count, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, Physical examination, Platelet count, Polymerase chain reaction, Prothrombin level, Red blood cell count, Red cell distribution width, Ultrasound Doppler, Venous oxygen saturation, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden carrier; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: APTT; Test Result: 27.3 s; Test Date: 20210715; Test Name: CONTROL APTT; Result Unstructured Data: Test Result:29.1; Test Date: 20210715; Test Name: RATIO APTT; Result Unstructured Data: Test Result:0.91; Test Date: 20210715; Test Name: ALT (GPT); Result Unstructured Data: Test Result:16; Test Date: 20210715; Test Name: BASOPHILS; Result Unstructured Data: Test Result:0.1 10E3/uL; Test Date: 20210715; Test Name: BASOPHILS; Test Result: 1.2 %; Test Date: 20210715; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:77 U/L; Test Date: 20210715; Test Name: Bicarbonate venous blood; Result Unstructured Data: Test Result:28 mmol/L; Test Date: 20210715; Test Name: Standard venous blood bicarbonate; Result Unstructured Data: Test Result:25 mmol/L; Test Date: 20210715; Test Name: Bilirubin; Test Result: 0.6 mg/dl; Test Date: 20210715; Test Name: Chloride; Result Unstructured Data: Test Result:105 mmol/L; Test Date: 20210715; Test Name: Creatinine; Test Result: 0.69 mg/dl; Test Date: 20210715; Test Name: Fibrinogen; Test Result: 741 mg/dl; Test Date: 20210715; Test Name: Glucose; Test Result: 124 mg/dl; Test Date: 20210715; Test Name: LDH; Result Unstructured Data: Test Result:222 U/L; Test Date: 20210715; Test Name: Venous blood lactate; Result Unstructured Data: Test Result:1.0 mmol/L; Test Date: 20210715; Test Name: venous blood pH; Result Unstructured Data: Test Result:7.40; Test Date: 20210715; Test Name: Potassium; Result Unstructured Data: Test Result:3.9 mmol/L; Test Date: 20210715; Test Name: blood pressure; Result Unstructured Data: Test Result:175.0/100.0 mmHg; Comments: Systolic Blood Pressure (mmHg) :175.0, Diastolic Blood Pressure (mmHg) :100.0; Test Date: 20210715; Test Name: Sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210715; Test Name: CO2 whole blood venous; Result Unstructured Data: Test Result:29 mmol/L; Test Date: 20210715; Test Name: EOSINOPHILS; Result Unstructured Data: Test Result:0.2 10E3/uL; Test Date: 20210715; Test Name: EOSINOPHILS; Test Result: 2.2 %; Test Date: 20210715; Test Name: D-dimer; Result Unstructured Data: Test Result:2986 ng/ml; Test Date: 20210715; Test Name: GGT; Result Unstructured Data: Test Result:16 U/L; Test Date: 20210715; Test Name: Glomerular Filter (CKD-EPI); Result Unstructured Data: Test Result:90 ml/min; Comments: 90 mL/min/1.73 m2; Test Date: 20210715; Test Name: HEMATOCRIT; Test Result: 40.2 %; Test Date: 20210715; Test Name: HEMOGLOBIN; Result Unstructured Data: Test Result:13.9 g/dl; Test Date: 20210715; Test Name: INR; Result Unstructured Data: Test Result:1.04; Test Date: 20210715; Test Name: LYMPHOCYTES; Result Unstructured Data: Test Result:1.5 10E3/uL; Test Date: 20210715; Test Name: LYMPHOCYTES; Test Result: 16.2 %; Test Date: 20210715; Test Name: MCH; Result Unstructured Data: Test Result:31.0 pg; Test Date: 20210715; Test Name: MCH; Result Unstructured Data: Test Result:34.7 g/dl; Test Date: 20210715; Test Name: MCV; Result Unstructured Data: Test Result:89.2; Test Date: 20210715; Test Name: MONOCYTES; Result Unstructured Data: Test Result:0.8 10E3/uL; Test Date: 20210715; Test Name: MONOCYTES; Test Result: 9.0 %; Test Date: 20210715; Test Name: NEUTROPHILS; Result Unstructured Data: Test Result:6.6 10E3/uL; Test Date: 20210715; Test Name: NEUTROPHILS; Test Result: 71.4 %; Test Date: 20210715; Test Name: O2 saturation; Test Result: 67 %; Test Date: 20210715; Test Name: PCO2; Result Unstructured Data: Test Result:45 mmHg; Test Date: 20210715; Test Name: physical examination; Result Unstructured Data: Test Result:Hemodynamically stable BEG, COC.; Comments: Hemodynamically stable BEG, COC. Well hydrated and perfused. Glasgow 15/15. Afebril and eupneic at rest.; Test Date: 20210715; Test Name: PLATELETS; Result Unstructured Data: Test Result:152 10E3/uL; Test Date: 20210715; Test Name: PCR; Test Result: 15.3 mg/dl; Test Date: 20210715; Test Name: T.PROTHROMBIN; Test Result: 12.4 s; Test Date: 20210715; Test Name: HEMATIES; Result Unstructured Data: Test Result:4.50 10E6/uL; Test Date: 20210715; Test Name: ADE; Test Result: 13.4 %; Test Date: 20210715; Test Name: Eco Doppler; Result Unstructured Data: Test Result:signs of acute deep vein thrombosis extensive; Test Date: 20210715; Test Name: BeB (excl. base blood) venous blood; Result Unstructured Data: Test Result:2.5 mmol/L; Test Date: 20210715; Test Name: BeeCF (excl. extracel base) venous blood; Result Unstructured Data: Test Result:3.1 mmol/L; Test Date: 20210715; Test Name: LEUKOCYTES; Result Unstructured Data: Test Result:9.20 10E3/uL
CDC Split Type: ESPFIZER INC202100948765

Write-up: Systolic Blood Pressure (mmHg) :175.0, Diastolic Blood Pressure (mmHg) :100.0; Deep vein thrombosis leg; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-950903. A 50-years-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FD8274), via intramuscular on 28Jun2021 as dose 2, single and dose 1 via intramuscular on 02Jun2021 (Batch/Lot Number: FA5833) as single for covid-19 immunisation. Medical history included factor v leiden carrier from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Patient with Heterozygous Leiden factor V AP who goes to the emergency room for present for 2-3 days ago pain in right MMII that began in lateral knee region right and which today presents in the right calf in the form of heaviness. Refer that your brother was diagnosed with DVT 7 months ago. Denies fever, chest pain, dyspnea, abdominal pain, diarrhea, nausea or vomiting. On 15Jul2021, the patient experienced deep vein thrombosis leg and systolic blood pressure (mmhg) :175.0, diastolic blood pressure (mmhg) :100.0. on an unspecified date. Evolution: A 50-year-old male with a relevant history of factor V leiden heterozygous who comes due to pain in Right Lower Extremity (RLE) of 3 days of evolution. No other symptomatology. Upon arrival good general condition, hemodynamically stable, painful RLE, edematous and distal erythematosus. Blood analytics were performed with D-dimer 2986, rest without relevant alterations. Given haematological and analytical history with high DD, it is requested that objective ecodopler. Extensive acute DVT of RLE. The patient is in good general condition, eupneic, SatO2 96% baseline without work respiratory. Anticoagulation with LMWH is started and given clinical and hemodynamic stability, is discharged by the emergency department, by appointment at the thromboembolism consultation. Primary diagnosis was given as deep vein thrombosis in the lower right limb in a patient with factor V leiden. The patient underwent lab tests and procedures which included Physical examination: Systolic Blood Pressure (mmHg) :175.0, Diastolic Blood Pressure (mmHg) :100.0, Frequency cardiac (lat/min) :98.0. Hemodynamically stable BEG, COC. Well hydrated and perfused. Glasgow 15/15. Afebril and eupneic at rest. Cardiac auscultation: Rhythmic tones without audible murmurs. Don''t extrate us. Pulmonary auscultation: MVC without overadded noises. MMII: Lower right limb more edematous than contralateral, with erythema and heat at the distal level on 15Jul2021, hematies: 4.50 10E6/uL (4.6 - 5.7), haemoglobin: 13.9 g/dL (13 - 17.5), haematocrit: 40.2 per cent (40 - 54), V.C.M. 89.2 fL (80 - 98), H.C.M. 31.0 pg (27 - 32), H.C.M. 34.7 g/dL (32 - 36), ADE 13.4% (11.5 - 15), platelets: 152 10E3/uL (140 - 400), leukocytes: 9.20 10E3/uL (4 - 10), neutrophils: 6.6 10E3/uL (1.8 - 7.5), neutrophils: % 71.4% (42 - 73), lymphocytes: 1.5 10E3/uL (1.3 - 3.5), lymphocytes: 16.2% (16 - 45), monocytes: 0.8 10E3/uL (0.2 - 1), monocytes: % 9.0% (2 - 12), eosinophils: 0.2 10E3/uL (0 - 0.5), eosinophils: 2.2 % (0 - 5), basophils: 0.1 10E3/uL (0 - 0.2), basophils: 1.2% (0 - 2), T. Prothrombin: 12.4 sec. (10.5 - 13.5), I.N.R. 1.04 (0.8 - 1.2), Fibrinogen *741 mg/dL (150 - 450), APTT 27.3 sec. (27 - 38), control A.P.T.T. 29.1 (27 - 38), ratio A.P.T.T. 0.91 (0.8 - 1.3), BeB (excl. base blood) venous blood 2.5 mmol/L (-2 - 3), BeeCF (excl. extracel base) venous blood 3.1 Mmol/L, Bicarbonate venous blood 28 mmol/L (22 - 30), Standard venous blood bicarbonate 25 mmol/L, Venous blood lactate 1.0 mmol/L (0.6 - 2.2), PCO2 (partial pressure CO2) blood venous 45 mm Hg (40 - 50), venous blood pH 7.40 (7.31 - 7.41), Po2 (partial pressure O2) venous blood *35 mm Hg (40 - 50), O2 saturation O2 venous blood 67%, CO2 whole blood venous 29 mmol/L, D-dimer *2986 ng/mL (0 - 250), Glucose *124 mg/dL (74 - 110), ALT (GPT) 16 U/L (5 - 41), Bilirubin 0.6 mg/dL (0.1 - 1.1), GGT 16 U/L (10 - 60), Alkaline Phosphatase 77 U/L (40 - 130), LDH 222 U/L (135 - 225), Creatinine *0.69 mg/dL (0.7 - 1.2), Sodium 140 mmol/L (135 - 145), Potassium 3.9 mmol/L (3.5 - 5.2), Chloride 105 mmol/L (95 - 110), Glomerular Filter (CKD-EPI) 90 mL/min/1.73 m2 (60 - 100), PCR *15.3 mg/dL (0 - 0.5) on 15Jul2021, Eco Doppler lower right limb (15Jul/21): The deep venous system of the right lower limb is explored, observing in the vein femoral superficial intraluminal hyperechogenic content, absence of compression when pressing with the probe and absence of flow in the Doppler study, as signs of acute deep vein thrombosis extensive, long all its way to at least the entrance to Hunter''s conduit. Therapeutic measures taken as a result of deep vein thrombosis included ENOXAPARIN 100MG. One subcutaneous injection every 12h. If pain, PARACETAMOL 1g 1 tablet every 8 hours. If more pain, METAMIZOL 575mg 1 tablet every 8 hours, alternating with acetaminophen. The outcome of the event deep vein thrombosis was recovering and the outcome of blood pressure increased was unknown. Follow-up attempt are not possible. No further information expected.


VAERS ID: 1532376 (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: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINA ALTER; EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anxiety; Thyroid cancer (Thyroid cancer (last treatment in 2017)); Thyroidectomy total
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100980708

Write-up: Menstrual flow excessive; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency WEB, regulatory authority number ES-AEMPS-954451. An adult female patient an unknown age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on 18Jun2021 as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on 09Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Medical history included anaemia, thyroid cancer Thyroid cancer (last treatment in 2017), anxiety, thyroidectomy total from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (SERTRALINA ALTER) taken for anxiety from 22Jul2021 to an unspecified stop date; levothyroxine sodium (EUTIROX) taken for thyroidectomy total from 12Nov2010 to an unspecified stop date. On 15Jul2021 the patient experienced menstrual flow excessive. The event was serious (medically significant). Outcome of event was not recovered. Follow-up attempt are not possible. Information about batch number cannot be obtained.


VAERS ID: 1532723 (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: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF319 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Joint swelling, Lymphadenopathy, Mobility decreased, Pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Seasonal allergy, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Backache; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943092

Write-up: pain; swelling/left side of chest was swollen; Hay fever; Joint swelling; axillary nodes swollen; Difficulty in moving arm due to swelling and pain; Difficulty in moving arm due to swelling and pain; Left arm (where vaccine administered) started swelling; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107221028283950-P6W9Y], Safety Report Unique Identifier [GB-MHRA-ADR 25700350]. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Jul2021 (Batch/Lot Number: FF319) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included suppressed lactation and backache. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included ibuprofen taken for back pain, start and stop date were not reported; paracetamol taken for back pain, start and stop date were not reported. The patient experienced pain on an unspecified date, axillary nodes swollen and joint swelling both on 16Jul2021, hay fever on 17Jul2021, swelling/left side of chest was swollen on 18Jul2021. Left arm (where vaccine administered) started swelling 2 hours post vaccine on 15Jul2021. Axillary nodes were swollen when patient awoke on 16Jul2021. Difficulty in moving arm due to swelling and pain. Awoke on 18Jul2021 and left side of chest was swollen. Ibuprofen and paracetamol taken for pain relief. Swelling started to subside by 19Jul2021. Hay fever symptoms still ongoing. Taking antihistamines (fexofenadine hydrochloride) to help alleviate symptoms. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 12Jul2021. The outcome of event pain and axillary nodes swollen, swelling/left side of chest was swollen was recovering, of Hay fever was not recovered, Joint swelling was recovered on 19Jul2021, of other events was unknown. This is a serious report received with serious criteria other medically important condition form MHRA. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1533157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Conversion disorder, Hallucination, Neck pain, Neuralgia, Pain in extremity, SARS-CoV-2 test, Spinal pain, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100943558

Write-up: Foot pain; Pain in spine; Hallucination; pain was slowly spreading from injection site to shoulder blade; pain was slowly spreading from injection site to shoulder blade; The pain was worse by neck; Feet nerve endings feel sore; hysteria; spinal pain; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107242039534990-IM1AQ, safety report unique identifier is GB-MHRA-ADR 25703415. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date of 2021 as single dose for covid-19 immunization. Medical history included lactation decreased. Patient did not have symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced hysteria, spinal pain on an unspecified date of 2021, pain in spine on 17Jul2021, foot pain on 18Jul2021, hallucination on 15Jul2021. Vaccine given at 9am (2021), by 5pm (2021) pain was slowly spreading from injection site to shoulder blade, over the course of 3 hours the pain spread to my spine. The pain was worse by neck and top of spine. Intense pain in spine and ibuprofen was not effective. Spinal pain still occurring. Feet nerve endings feel sore. Experienced hallucination, hysteria type experience. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. This case was reported as serious due to medical significant. The outcome of events hysteria, spinal pain was not recovered, pain in spine was recovered with sequelae, foot pain was recovering, hallucination was recovered on 15Jul2021, the rest of events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1533490 (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: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: BODY TEMPERATURE; Result Unstructured Data: Test Result:38.2 Centigrade
CDC Split Type: ITPFIZER INC202100949151

Write-up: localized pomphoid/wheal erythema in the forehead, nape, thorax, upper limbs and thigh root bilaterally; localized pomphoid/wheal erythema in the forehead, nape, thorax, upper limbs and thigh root bilaterally; feverish peak at 38.2; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IT-MINISAL02-757505. A 15-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Jul2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Jul2021 04:00, the patient experienced localized pomphoid/wheal erythema in the forehead, nape, thorax, upper limbs and thigh root bilaterally and patient was feverish peak at 38.2 after dose 2 vaccination. The events were assessed serious, medically significant. The outcome of the events was unknown. Information on the lot number has been requested.


VAERS ID: 1533596 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
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, Dysphoria
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Hospitalisation; Hypertension; Myocardial infarction; Rheumatism
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100944055

Write-up: Blood pressure increased; dysphoria; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120899. The patient was a 78-year-old and female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had history, details were as follows: after myocardial infarction, cardiac pacemaker insertion, rheumatism, hypertension and was taking clopidogrel tablet orally, ongoing. On 15Jul2021 at 15:15 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was 15Jul2021 at 15:30 (the same day of vaccination). On 21Jul2021, outcome of the event was unknown. The course of the event was as follows: The patient had history of hypertension, it was treated ongoing. After the vaccination, the patient complained dysphoria, blood pressure increased. The patient rested in vaccination location. The patient was carried to a privacy hospital by emergency ambulance due to blood pressure increased was no changed through observation. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. Other possible cause(s) of the event such as any other diseases was hypertension. The reporting physician commented as follows: the patient had hospital of hypertension originally, had blood pressure increased due the Comirnaty. The patient rested for decrease blood pressure, but could not decrease. So the patient went to hospital for treatment. Follow-up activities completed. No further information is expected.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "Blood pressure increased" and "dysphoria" cannot be completely excluded based on temporal association.


VAERS ID: 1533603 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Decreased appetite, Dehydration, Inflammation, Malaise, Pyrexia, White blood cell count, White blood cell count increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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? 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: 20210719; Test Name: CRP; Result Unstructured Data: Test Result:10.3; Comments: high Inflammation; Test Date: 20210719; Test Name: WBC; Result Unstructured Data: Test Result:11000 /mm3; Comments: high Inflammation
CDC Split Type: JPPFIZER INC202100944612

Write-up: Pyrexia; CRP 10.3; wbc 11000/mm^3; high Inflammation; Dehydration; Malaise; Appetite impaired; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120964. A 91-year and 8-month-old female patient received BNT162B2 (COMIRNATY; solution for injection; Lot Number: FC9909; Expiration Date: 30Sep2021), via an unspecified route of administration on 06Jul2021 at 15:30 (at the age of 91-year-old) (the day of vaccination), as first dose, single, for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 15Jun2021 at 06:00 (9 days after the vaccination), the patient experienced dehydration, malaise, appetite impaired. On 19Jul2021, (13 days after the vaccination), the patient experienced pyrexia, high Inflammation with CRP (C-reactive protein) 10.3 and WBC (white blood cell) 11000/mm3. The course of the event was as follows: On 06Jul2021, the patient received the first dose of vaccine. From 15Jul2021, the patient experienced malaise and appetite impaired. On 19Jul2021, the patient experienced pyrexia from morning. On 19Jul2021, the patient visited clinic, found high Inflammation with WBC 11000/mm^3 and CRP 10.3. Since the patient didn''t have pyrexia in normal days, it was suspected as related to vaccine. On 20Jul2021 (14 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as serious (for Medically Significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter comment: Not provided. No follow-up attempts are possible; no further information is expected.


VAERS ID: 1533604 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Body temperature, Cellulitis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bradycardia; Gout; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccinations
CDC Split Type: JPPFIZER INC202100944616

Write-up: Cellulitis; arthritis; This is a spontaneous report from a contactable physician received from the Agency (DA). Regulatory authority report number is v21120892. The patient was a 76-year-old male. Body temperature before the vaccinations was 36.5 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 gout, hypertension, atrial fibrillation and bradycardia. The patient received BNT162B2 (COMIRNATY; Lot Number: FA5765; Expiration Date: 30Sep2021), via an unspecified route of administration on 15Jul2021 10:28 (at the age of 76-years-old) as dose 1, single for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient previously took Allopurinol, Pursennid, Pilsicainide HCl capsule, Xarelto, bisoprolol fumarate tablets and kindavate ointment. The patient experienced cellulitis and arthritis on 15Jul2021. The course of the event was as follows: On 15Jul2021 at night (the day of vaccinations), the patient experienced pain on the already hurt left wrist increased. Then, the pain increased day by day and the pain spread to the left front arm. Bedding touching caused a pain in a surface of skin, and tingling pain developed. On 19Jul2021 (4 days after vaccination), the outcome of the event was not recovered. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. There is no other possible cause of the event such as any other diseases.


VAERS ID: 1533608 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, C-reactive protein, C-reactive protein decreased, Chest X-ray, Dizziness, Dysarthria, Incontinence, Magnetic resonance imaging head, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:82/51; Comments: On arrival at the hospital; Test Date: 20210715; Test Name: BP; Result Unstructured Data: Test Result:80s; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: On arrival at the hospital; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: pyrexia (max 37.8 centigrade); Test Date: 20210715; Test Name: Chest X-P; Result Unstructured Data: Test Result:No congestion; Comments: On arrival at the hospital; Test Date: 20210716; Test Name: CRP; Result Unstructured Data: Test Result:5.31; Comments: CRP max5.31; Test Date: 20210715; Test Name: HEAD MRI; Result Unstructured Data: Test Result:No abnormality; Comments: On arrival at the hospital
CDC Split Type: JPPFIZER INC202100944682

Write-up: pyrexia (max 37.8degrees Centigrade ); CRP decreased; BP reached 80s/BP 82/51/blood pressure decreased; Light-headed feeling when walking; articulation disorder; Incontinence; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120816. A 56-year and 0 month old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 14:30 (Lot number unknown) as dose 1, single (at the age of 56 years old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 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) were unknown. The event onset date and time was reported as on 15Jul2021 at about 19:00 (the same day of vaccination). The course of the event was as follows: On 15Jul2021 at 14:30, the patient received the first dose of COMIRNATY. On 15Jul2021 at about 19:00, 4 hours after vaccination, blood pressure (BP) reached 80s, and she was transported by emergently transferred to hospital due to the light-headed feeling when walking and articulation disorder and incontinence. On arrival at the hospital, BP 82/51, body temperature (BT) 36.5 degrees Centigrade, Chest X-P :no congestion, HEAD MRI: No abnormality (Only diffusion can be performed due to body movement). Although the causal relationship with the vaccine was unknown, she was hospitalized for follow-up because of low blood pressure. After admission, fluid replacement improved blood pressure, and the patient became able to take full lunch the day after admission. In addition, on 16Jul2021, pyrexia (max 37.8degrees Centigrade) with CRP max 5.31, which is considered to be a side reaction of the vaccine, appeared, but without treatment, CRP decreased and the pyrexia tended to disappear, and the patient was discharged from the hospital on 21Jul2021 (as reported). The causal relationship between blood pressure decreased and the vaccine was unknown. Therapeutic measures were taken as a result of bp reached 80s/bp 82/51/blood pressure decreased, light-headed feeling when walking, articulation disorder, incontinence, pyrexia (max 37.8degrees centigrade ), CRP decreased. On 16Jul2021 (1days after vaccination), the outcome of the events was recovered. The reporting physician commented as follows: Unclear causality; Reporter''s Comments: Unclear causality


VAERS ID: 1533636 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100951863

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 74-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EY0572; Expiration Date: 31Oct2021), via intramuscular, administered in left arm, on 07Jul2021 at 15:00 (at the age of 74 years old) as dose 1, single for COVID-19 immunisation. Medical history included cerebral infarction. The patient was not pregnant at the time if the report. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jul2021 (7 days 9 hours after the vaccination), it was reported that the patient experienced cerebral infarction. The outcome of the event was recovering without treatment. The reporter stated that the event result in Doctor or other healthcare professional office/clinic visit.; Sender''s Comments: The causal association between the reported event cerebral infarction and vaccine administered 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: 1533853 (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: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100932137

Write-up: DIZZINESS; NAUSEA; SEVERAL FAINTINGS; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. A 29-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FE6208), via an unspecified route of administration on 15Jul2021 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced several faintings, nausea, vomiting and dizziness on 15Jul2021. It was reported that patient became dizzy and nauseous 14 minutes after the vaccination and fainted. After around an hour, the patient walked a few hundred meters to the car and fainted again. It was described that the patient vomited and fainted several times during four hours after the vaccination. The patient was dizzy and nauseous, and it was reported that she could not get anywhere by herself. Later in the day, the patient came into the emergency central. The events were manageable if the patient was lying prone on her back. It appeared that the dizziness and nausea continued all day after, but not as extensively. The events caused hospitalization. Patient recovered without damage. Outcome of events several faintings and vomiting were resolved on 15Jul2021, dizziness and nausea were resolved on 16Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1534542 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood sodium, Blood urea, C-reactive protein, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Oxygen saturation, Platelet count, Red blood cell count, Red blood cell sedimentation rate, Red cell distribution width, Troponin T, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISONE; BUDESONIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Creatinine; Result Unstructured Data: Test Result:79 umol/l; Test Date: 20210715; Test Name: sodium; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210715; Test Name: Urea; Result Unstructured Data: Test Result:4.1 mmol/L; Test Date: 20210715; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:normal; Test Date: 20210715; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:6 mg/l; Test Date: 20210715; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210715; Test Name: D-Dimer Quantitative; Result Unstructured Data: Test Result:0.12 mg/l; Test Date: 20210715; Test Name: eGRF (CKD-EPI); Result Unstructured Data: Test Result:63 ml/min/1.73m2; Test Date: 20210715; Test Name: eGRF (MDRD); Result Unstructured Data: Test Result:$g60 ml/min/1.73m2; Test Date: 20210715; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.458 L/L; Test Date: 20210715; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.7 g/dl; Test Date: 20210715; Test Name: MCH; Test Result: 29.3 pg; Test Date: 20210715; Test Name: MCHC; Result Unstructured Data: Test Result:32.1 g/dl; Test Date: 20210715; Test Name: MCV; Result Unstructured Data: Test Result:91.4 fL; Test Date: 20210715; Test Name: MPV; Result Unstructured Data: Test Result:10.7 fL; Test Date: 20210715; Test Name: Oxygen Saturation; Test Result: 100 %; Test Date: 20210715; Test Name: Platelet count; Result Unstructured Data: Test Result:339 x10E9 /L; Test Date: 20210715; Test Name: Red cell count; Result Unstructured Data: Test Result:5.01 H; Test Date: 20210715; Test Name: ESR; Result Unstructured Data: Test Result:9 mm/hr; Test Date: 20210715; Test Name: Red cell distribution width; Test Result: 14 %; Test Date: 20210715; Test Name: High-Sensitivity Troponin T; Result Unstructured Data: Test Result:7 ng/L; Test Date: 20210715; Test Name: WBC; Result Unstructured Data: Test Result:12.81 H
CDC Split Type: ZAPFIZER INC202100947682

Write-up: Shortness of breath; Right sided Chest pain; This is a spontaneous report from a contactable other healthcare professional (HCP). A 75-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Jul2021 11:39 (Lot Number: FE3064; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included COPD. Concomitant medication(s) included prednisone taken for COPD; budesonide taken for COPD. The patient experienced shortness of breath (hospitalization) and right sided chest pain (chest pain) (hospitalization) on 15Jul2021 with outcome of recovered. The patient was hospitalized for shortness of breath (dyspnoea), for right sided chest pain (chest pain) from 15Jul2021 to 16Jul2021. The patient underwent lab tests and procedures which included on 15Jul2021, blood creatinine: 79 umol/l on 15Jul2021, blood sodium: 147 mmol/l on 15Jul2021, blood urea: 4.1 mmol/l on 15Jul2021, chest x-ray: normal , c-reactive protein: 6 mg/l, electrocardiogram: normal, fibrin d dimer: 0.12 mg/l on 15Jul2021, glomerular filtration rate: 63 ml/min/1.73m2 on 15Jul2021 , glomerular filtration rate: $g60 ml/min/1.73m2 on 15Jul2021, haematocrit: 0.458 l/l on 15Jul2021, haemoglobin: 14.7 g/dl on 15Jul2021, mean cell haemoglobin: 29.3 pg on 15Jul2021, mean cell haemoglobin concentration: 32.1 g/dl on 15Jul2021, mean cell volume: 91.4 fl on 15Jul2021. All available information has been reported. No further information expected.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "Shortness of breath" and "Right sided Chest pain" cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1534543 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Circulatory collapse, Oxygen saturation, Oxygen saturation decreased, Seizure, Shock symptom, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Desaturation; Test Result: 77 %
CDC Split Type: ZAPFIZER INC202100951372

Write-up: Collapse; Shock-like state; Weakness for two weeks prior to admission; seizures; episodes of syncope; Desaturation (77 %); This is a spontaneous report received from a contactable health care professional (HCP). A 77-year-old female patient received bnt162b2 (CORMINATY), on 01Jul2021 (batch/lot number: FC1436; Expiration Date: 31Oct2021) (at the age of 77-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included chronic obstructive pulmonary disease (COPD) and hypertension, both from unspecified date. The patient''s concomitant medications were not reported. It was reported that the patient experienced weakness for two weeks prior to admission (unspecified date in 2021), collapse, shock-like state and episodes of syncope, all on 22Jul2021 and seizures on 17Jul2021. It was also reported that patient experienced afebrile (as reported) on 22Jul2021. The events weakness for two weeks prior to admission, seizure, collapse and shock-like state were reported as serious with hospitalization criterion while the event episodes of syncope was reported as non-serious. The patient underwent lab tests and procedures which included desaturation (77%) on 15Jul2021. Therapeutic measures were taken as a result of seizures (seizure). The outcome of the events was unknown.; Sender''s Comments: A causal association between BNT162B2 and the reported serious unlisted events namely asthenia, seizure, syncope, shock-like state, oxygen saturation decreased and circulatory collapse cannot be excluded based on a compatible temporal relation. 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: 1535744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210807888

Write-up: THROMBOCYTOPENIA; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, -PEI-CADR2021143414] concerned a 56 year old female of unknown race and ethnicity. The patient''s weight was 90 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 15-JUL-2021, the patient experienced thrombocytopenia, and on unspecified date patient was hospitalized. The action taken with covid-19 vaccine was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210807888 -COVID-19 VACCINE - Thrombocytopenia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1537680 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Palpitations
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100954694

Write-up: Heart racing; Dyspnea; Allergic reaction; Lightheadedness; This is a spontaneous report from a contactable consumer or other non health care professional downloaded from the regulatory authority; number AT-BASGAGES-2021-37055. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot number: Unknown) via unspecified route of administration, on 15Jul2021 dose 1, single for COVID-19 immunization. The patient''s relevant medical history, concurrent conditions and concomitant medications were not reported. On 15Jul2021, the patient experienced allergic reaction, dyspnea, lightheadedness and heart racing. The patient was hospitalized for the events on an unknown date. Outcome of the events was unknown. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1537693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963905

Write-up: Deafness unilateral; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 590033. A 59-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced deafness unilateral on 15Jul2021. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1537881 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: computed tomography; Result Unstructured Data: Test Result:Exclusion of inflammatory genesis.
CDC Split Type: DEPFIZER INC202100982132

Write-up: Facial palsy; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-202100142623. A 64-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Jul2021 (at the age of 64 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial palsy on 15Jul2021. The patient underwent lab tests and procedures which included computerised tomogram: exclusion of inflammatory genesis on an unspecified date. The reporter assessed the case to be non serious. Outcome of the event was not recovered.Relatedness of drug to reactions/events.Source of assessment: regulatory authority and result of assessment was unclassifiable. Sender Comment: Alcohol, motor evoked potentials of the facial nerve, blink reflex, computed tomography. Exclusion of inflammatory genesis. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1537985 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Haemochromatosis (Type 1)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100954941

Write-up: Syncope vasovagal; Dizziness; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority. The regulatory authority number is ES-AEMPS-946992. A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (COMIRNATY; lot number and expiration date not reported), via an unspecified route of administration on 15Jul2021 (at an unspecified age) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included haemochromatosis (type 1). The patient was not pregnant at the time of vaccination. The patient has no COVID-19 infection. It was reported that the day before the patient was vaccinated, the patient''s period came. The patient''s concomitant medications were not reported. On 15Jul2021, the patient experienced syncope vasovagal and dizziness. It was reported that the events resulted in emergency room visit and the patient was hospitalized on Jul2021 due to the events. The patient was given Dogmatil and physiological saline, dispensed in the emergency department, as treatments for the events. Outcome of the event syncope vasovagal was recovered on 15Jul2021, and for dizziness was recovered on Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1537986 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Lymphadenopathy
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Spondylitis ankylosing
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100954947

Write-up: Chest pain with radiation to left arm; Fatigue aggravated; Lymphadenopathy; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory authority, regulatory authority number ES-AEMPS-947033. A 38-year-old male patient received BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration, administered in Arm Left on 14Jul2021 (Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. Medical history included ankylosing spondylitis from an unknown date and unknown if ongoing. No previous COVID-19. The patient''s concomitant medications were not reported. On 15Jul2021, the patient experienced chest pain with radiation to left arm, fatigue aggravated (fatigue) and lymphadenopathy. The events were reported as serious, medically significant. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1538110 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness
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: FRPFIZER INC202100954719

Write-up: Intense influenza-like syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20214836. A 21-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 14Jul2021 (Batch/Lot Number: FE2296) as dose number, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced Intense influenza-like syndrome, requiring work interruption on 15Jul2021. Outcome of the event was not recovered. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1538204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fibrin D dimer, Hypothermia, Loss of consciousness, Magnetic resonance imaging, Malaise, Pulmonary embolism, Visual impairment
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), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: D Dimer; Result Unstructured Data: Test Result:$g20000; Test Date: 20210715; Test Name: MRI; Result Unstructured Data: Test Result:bilateral pulmonary embolism
CDC Split Type: FRPFIZER INC202100949368

Write-up: loss of consciousness; malaise; Pulmonary embolism; chills; visual disturbance; Hypothermia; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number FR-AFSSAPS-TO20215633. A 27-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 30Jun2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 15Jul2021 which caused hospitalization, chills, loss of consciousness , malaise, visual disturbance, hypothermia on an unspecified date. Clinical course as follows: On 15Jul2021, management and hospitalisation for malaise with loss of consciousness. Hypothermia and low saturation with respiratory discomfort, chills, visual disturbance. The patient underwent lab tests and procedures which included fibrin d dimer: $g20000 on 15Jul2021, and magnetic resonance imaging: bilateral pulmonary embolism on 15Jul2021. Outcome of the event pulmonary embolism was recovering while for the remaining event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1538257 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100949240

Write-up: Very painful at point of getting injection; Headache; Menses painful; Heavy periods; Painful arm; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number is GB-RA-WEBCOVID-202107200420342270-CBYZ4, Safety Report Unique Identifier is GB-RA-ADR- 25677168. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jul2021 at the age of 32 years old (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. 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. Patient is not enrolled in clinical trial. The patient experienced painful arm on 15Jul2021, menses painful and heavy periods on 17Jul2021 and headache on 18Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Very painful at point of getting injection (more than first dose) and for longer after. Headache ongoing. Painful and heavy period - unusual for patient. Very worrying. 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 with No - Negative COVID-19 test result on an unknown date. The patient was recovering from painful arm while patient has not recovered from menses, headache and heavy periods. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1538536 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test
SMQs:, 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; Result Unstructured Data: Test Result: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100956761

Write-up: Headache; 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-202107261104458620-JSLXE, Safety Report Unique Identifier GB-MHRA-ADR 25706115. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced headache on 15Jul2021. Clinical course reported as: A lingering headache that with medication was eased but didn''t go away. Lasted more than 5 days. Woke up with it went to bed with it. Mainly radiating from the top of the head. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: no-negative COVID-19 test. Outcome of event was recovered on 21Jul2021. 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.


VAERS ID: 1538585 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative.
CDC Split Type: GBPFIZER INC202100957041

Write-up: Swollen lymph nodes; 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-202107261433160210-KGLL5, Safety Report Unique Identifier GB-MHRA-ADR 25707994. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2, via an unspecified route of administration, administered in Arm Left on 14Jul2021 (Lot number: FA1027, Expiration Date: not reported), as single dose for COVID-19 immunisation. Medical history included Lactation decreased. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding. On 15Jul2021 patient experienced swollen lymph nodes. Patient stated she had painful swollen lymph nodes in her left arm, where the vaccine was administered, the next day after the vaccine. It slowly returned to normal, but still exists, not painful anymore. The event was considered serious as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unknown date. The outcome of event was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1538611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-15
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Investigation, Postmenopausal haemorrhage, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome; Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Internal examination; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100957057

Write-up: Clot blood; breakthrough bleeding; heavy menstrual bleeding; bleeding 5 days after original bleeding had stopped; This is a spontaneous report from a contactable consumer, received from the United Kingdom''s Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202107261719417790-GVABT, Safety Report Unique Identifier GB-MHRA-ADR 25709040. A 20-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on 21Jun2021, as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome, suppressed lactation, and contraception. Concomitant medications included desogestrel. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. On an unknown date in 2021, the patient had heavy menstrual bleeding following a missed pill with contraception this followed with passive large blood clots on 15Jul2021, also further breakthrough bleeding 5 days after original bleeding had stopped in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No, Negative COVID-19 test) and investigation: unknown results on an unspecified date in 2021. The outcome of the event clot blood was not recovered, and the other events was recovered on an unknown date in 2021. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Internal examination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1538633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100956757

Write-up: heavy period; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202107262040582170-LU4UV. Safety Report Unique Identifier GB-MHRA-ADR 25710359. A 21-years-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 05Jul2021 (Batch/Lot Number: FD5613) as DOSE 1, SINGLE 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. The patient''s concomitant medications were not reported. The patient experienced heavy period on 15Jul2021 with outcome of recovered in 2021. The patient never got period but after receiving the vaccine, she had a very heavy period. This lasted for 2 weeks which is very unlike her. The event was serious due to medically significant. 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: 1538915 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Erythema, Hypoxia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100952254

Write-up: Anaphylaxis; hypoxic; wheezing; dyspnoea; redness on neck; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21121183. The patient was a 91-year old male. Body temperature before vaccination was 36.4 centigrade. On 15Jul2021 at 14:15, the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot# EW0203, Expiration date 31Sep 2021) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history included hypertension. The only medicines are blood pressure medicine and constipation medicine. On 24Jun2021 the patient received the first dose and no problem appeared. About 15 mins after the vaccination on 15Jul2021, wheezing, dyspnoea appeared. The redness on neck was also observed and epipen injection was performed. The patient was delivered emergency to private hospital. During the delivering, the patient became hypoxic and oxygen administration was performed. He was hospitalized overnight with the following diagnosis anaphylactic reaction. The causality of the vaccine and AE was unknown. And the privacy hospital replied that it was related. The event onset date was reported as 15Jul2021 at 14:30 (15mins after vaccination) and the event result in hospitalization from 15Jul2021 to 16Jul2021. Emergency visit required for the events. On 16Jul2021 (the day after the vaccination), the outcome of events were recovered. The reporter classified the events as serious (Hospitalized from 15Jul2021 to 16Jul2021) and assessed that the event was the causality between the event and bnt162b2 as related and unassessble. Other possible cause of the event such as any other diseases was unknown. ~ Reporter''s comment: Anaphylactic reaction caused by covid-19 vaccine.


VAERS ID: 1538921 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Cough, Dyspnoea, Erythema, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? 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: Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202100952525

Write-up: precordial redness/redness; Dry cough/Cough; Dyspnoea; Queasy; feeling bad in depths of chest; This is a spontaneous report from a contactable nurse received from the Regulatory authority report number is v21121135. A 34-years-old (reported as 34-year and 4-month-old) female patient received bnt162b2 (COMIRNATY, Intramuscular injection), dose 1 via an unspecified route of administration on 15Jul2021 (in the morning) (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) at 34-years-old as single dose for COVID-19 immunisation. Medical history included Type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included influenza vaccine for immunization and experienced urticaria. The patient experienced feeling bad in depths of chest (medically significant), queasy on 15Jul2021. On 15Jul2021 at 09:40 (the same day of vaccination), the patient experienced redness, dyspnoea, cough. The course of the event was as follows: About 20 minutes after vaccination, the patient experienced feeling bad in depths of chest, precordial redness, queasy, dry cough, dyspnoea. At 9:50, normal saline 500l was started, Solu-Medrol 40mg, NEORESTAR, Famotidine were used. Blood test was performed. At about 10:45, the symptoms were recovering. At 12:00, IV drip was removed, the patient was back to home. The patient was easy to experience allergy symptom due to vaccination originally. The patient underwent lab tests and procedures which included blood test: unknown results on 15Jul2021. Outcome of the events was recovered on 15Jul2021. The reporting nurse classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1538940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram thorax, Echocardiogram, Oxygen saturation, Oxygen saturation decreased, Pulmonary embolism, Right ventricular hypertrophy
SMQs:, Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:Pulmonary embolism; Test Date: 20210715; Test Name: Echocardiography; Result Unstructured Data: Test Result:right heart thickening; Test Date: 20210715; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: JPPFIZER INC202100953023

Write-up: Pulmonary embolism; chest pain; Oxygen saturation was low; right heart was thickening; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21121160. A 72-year-old female received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) as dose 1, single for an unspecified indication. The patient''s medical history and concomitant medications were not reported. It was not provided if there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 15Jul2021, 8 days after vaccination, the patient experienced pulmonary embolism, chest pain and oxygen saturation was low. The course of the event was as follows: On 07Jul2021, the patient received the first dose of vaccine. On 15Jul2021, the patient visited the doctor after experienced a strong chest pain while working. The Oxygen saturation was low and according to the echocardiography the right heart was thickening. The patient was diagnosed with pulmonary embolism according to the CT pulmonary angiogram. After the anticoagulant therapy, the patient was recovering and left the hospital on 24Jul2021. On 24Jul2021, (17 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the causality between the event and the unknown vaccine as unassessable. The reporting physician commented as follows: report just in case. The vaccination information was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1538957 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Diabetes mellitus; Hyperlipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202100955318

Write-up: Suspected pericarditis; Stinging pain in the middle of the chest; This is a spontaneous report from a contactable physician received via Agency Regulatory Authority. A 59-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FC5947; Expiration Date: 30Sep2021), via intramuscular, administered in left arm, on 14Jul2021 (at the age of 59 years old) as dose 1, single for COVID-19 immunisation. The patient was a non-pregnant 59 -year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drugs within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included diabetes mellitus and hyperlipidaemia. On 15Jul2021 at about 14:00 (1 day after the vaccination), it was reported that the patient experienced a stinging pain in the middle of the chest while sitting down, which lasted for about two hours. The symptom was recovering, so the patient was in follow up. Then, the patient decided not to receive the second dose. Pericarditis was also suspected. On 26Jul2021, electrocardiogram examination showed no abnormality. The outcome of the event was recovered without treatment. The reporter classified the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Pericarditis and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1538966 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase, Aspartate aminotransferase increased, Band neutrophil count, Band neutrophil count increased, Base excess, Basophil count, Bilirubin conjugated, Blood albumin, Blood albumin decreased, Blood bicarbonate, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood creatinine increased, Blood culture, Blood glucose, Blood glucose increased, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Blood methaemoglobin, Blood potassium, Blood potassium decreased, Blood sodium, Blood test, Blood thyroid stimulating hormone, Blood urea, Body height, Body temperature, C-reactive protein, C-reactive protein increased, Carbon dioxide, Carboxyhaemoglobin, Cardiac index, Chills, Fibrin D dimer, Fibrin D dimer increased, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Glomerular filtration rate, Glomerular filtration rate decreased, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Haemoglobin decreased, Haemolysis, International normalised ratio, Investigation, Lymphocyte count, Lymphocyte count decreased, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell haemoglobin decreased, Mean cell volume, Mean cell volume decreased, Mean platelet volume, Methaemoglobinaemia, Monoblast count, Monocyte count decreased, Myalgia, Neutrophil count, Neutrophil count increased, Oxygen saturation, PCO2, PO2, Pain, Platelet count, Platelet distribution width, Platelet distribution width decreased, Procalcitonin, Progesterone receptor assay, Protein total decreased, Protein total normal, Prothrombin level, Prothrombin time, Pyrexia, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Specific gravity urine, Specific gravity urine decreased, Thyroxine free, Urine analysis, Weight, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypokalaemia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TERAMURO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: ALT; Result Unstructured Data: Test Result:45; Comments: High; Test Date: 20210719; Test Name: Anion gap; Result Unstructured Data: Test Result:13.1; Test Date: 20210719; Test Name: AST; Result Unstructured Data: Test Result:37; Comments: High; Test Date: 20210719; Test Name: STAB; Result Unstructured Data: Test Result:9.0; Comments: High; Test Date: 20210719; Test Name: ABE; Result Unstructured Data: Test Result:-0.1; Test Date: 20210719; Test Name: SBE; Result Unstructured Data: Test Result:-2.7; Test Date: 20210719; Test Name: BASO; Result Unstructured Data: Test Result:1.0; Test Date: 20210719; Test Name: D-BIL; Result Unstructured Data: Test Result:0.1; Test Date: 20210719; Test Name: T-BIL; Result Unstructured Data: Test Result:0.5; Test Date: 20210719; Test Name: ALB; Result Unstructured Data: Test Result:3.3; Comments: low; Test Date: 20210719; Test Name: HCO3-(P; Result Unstructured Data: Test Result:24.4; Test Date: 20210719; Test Name: HCO3-(P; Result Unstructured Data: Test Result:18.1; Test Date: 20210719; Test Name: Ca2+; Result Unstructured Data: Test Result:1.04; Test Date: 20210719; Test Name: CI-; Result Unstructured Data: Test Result:105; Test Date: 20210719; Test Name: CK; Result Unstructured Data: Test Result:46; Test Date: 20210719; Test Name: CRE; Result Unstructured Data: Test Result:1.05; Comments: High; Test Date: 20210719; Test Name: blood culture; Test Result: Negative ; Test Date: 20210719; Test Name: FBS; Result Unstructured Data: Test Result:152; Comments: High; Test Date: 20210719; Test Name: Glu; Result Unstructured Data: Test Result:138; Test Date: 20210719; Test Name: LD; Result Unstructured Data: Test Result:294; Comments: High; Test Date: 20210719; Test Name: Methemoglobin; Result Unstructured Data: Test Result:1.3; Test Date: 20210719; Test Name: K; Result Unstructured Data: Test Result:3.3; Comments: low; Test Date: 20210719; Test Name: K+; Result Unstructured Data: Test Result:3.3; Test Date: 20210719; Test Name: Na; Result Unstructured Data: Test Result:136; Test Date: 20210719; Test Name: Na+; Result Unstructured Data: Test Result:133; Test Date: 20210719; Test Name: TRC test; Test Result: Negative ; Test Date: 20210719; Test Name: TSH; Result Unstructured Data: Test Result:0.60; Test Date: 20210719; Test Name: BUN; Result Unstructured Data: Test Result:9.2; Test Date: 20210719; Test Name: UA; Result Unstructured Data: Test Result:5.0; Test Date: 20210719; Test Name: height; Result Unstructured Data: Test Result:167.00; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210719; Test Name: cO2; Result Unstructured Data: Test Result:18.2; Test Date: 20210719; Test Name: tCO2(P); Result Unstructured Data: Test Result:41.6; Test Date: 20210719; Test Name: COHb; Result Unstructured Data: Test Result:1.1; Test Date: 20210719; Test Name: CI; Result Unstructured Data: Test Result:101; Test Date: 20210719; Test Name: CRP; Result Unstructured Data: Test Result:10.29; Comments: High; Test Date: 20210719; Test Name: D-dimer; Result Unstructured Data: Test Result:5.2; Comments: High; Test Date: 20210719; Test Name: G-GTP; Result Unstructured Data: Test Result:64; Comments: High; Test Date: 20210719; Test Name: eGFR; Result Unstructured Data: Test Result:59.6; Comments: low; Test Date: 20210719; Test Name: hba1c ngs; Result Unstructured Data: Test Result:5.5; Test Date: 20210719; Test Name: hct; Result Unstructured Data: Test Result:40.7; Test Date: 20210719; Test Name: hct; Result Unstructured Data: Test Result:38.8; Test Date: 20210719; Test Name: HGB; Result Unstructured Data: Test Result:12.9; Test Date: 20210719; Test Name: tHb; Result Unstructured Data: Test Result:13.2; Test Date: 20210719; Test Name: HHb; Result Unstructured Data: Test Result:0.5; Test Date: 20210719; Test Name: Haemolysis; Test Result: Negative ; Test Date: 20210719; Test Name: INR; Result Unstructured Data: Test Result:1.09; Test Date: 20210719; Test Name: Laboratory for Adaptive Optics; Result Unstructured Data: Test Result:27; Test Date: 20210719; Test Name: LYMPHO; Result Unstructured Data: Test Result:10.0; Comments: low; Test Date: 20210719; Test Name: MCH; Result Unstructured Data: Test Result:28.1; Comments: low; Test Date: 20210719; Test Name: MCHC; Result Unstructured Data: Test Result:33.2; Test Date: 20210719; Test Name: MCV; Result Unstructured Data: Test Result:84.5; Comments: low; Test Date: 20210719; Test Name: MPV; Result Unstructured Data: Test Result:9.1; Test Date: 20210719; Test Name: MPV; Result Unstructured Data: Test Result:9.1; Test Date: 20210719; Test Name: MetHb; Result Unstructured Data: Test Result:1.3; Test Date: 20210719; Test Name: MONO; Result Unstructured Data: Test Result:1.0; Comments: low; Test Date: 20210719; Test Name: SEG; Result Unstructured Data: Test Result:79.0; Comments: High; Test Date: 20210719; Test Name: O2Hb; Result Unstructured Data: Test Result:97.1; Test Date: 20210719; Test Name: sO2; Result Unstructured Data: Test Result:99.5; Test Date: 20210719; Test Name: pCO2; Result Unstructured Data: Test Result:15.1; Test Date: 20210719; Test Name: pH; Result Unstructured Data: Test Result:7.678; Test Date: 20210719; Test Name: PLT; Result Unstructured Data: Test Result:150; Test Date: 20210719; Test Name: PDW; Result Unstructured Data: Test Result:11.1; Comments: low; Test Date: 20210719; Test Name: pO2; Result Unstructured Data: Test Result:117.0; Test Date: 20210719; Test Name: PO2; Result Unstructured Data: Test Result:21; Test Date: 20210719; Test Name: pO2(a)/F; Result Unstructured Data: Test Result:559; Test Date: 20210719; Test Name: PCT; Result Unstructured Data: Test Result:0.150; Test Date: 20210719; Test Name: PR; Result Unstructured Data: Test Result:1.10; Test Date: 20210719; Test Name: TP; Result Unstructured Data: Test Result:6.4; Comments: low; Test Date: 20210719; Test Name: PT activation; Result Unstructured Data: Test Result:84.8; Test Date: 20210719; Test Name: PT Time; Result Unstructured Data: Test Result:14.2; Test Date: 20210719; Test Name: RBC; Result Unstructured Data: Test Result:4.59; Test Date: 20210719; Test Name: RDW; Result Unstructured Data: Test Result:12.6; Test Date: 20210719; Test Name: Corona rapid antigen test; Test Result: Negative ; Test Date: 20210719; Test Name: specific gravity; Result Unstructured Data: Test Result:1.053; Comments: low; Test Date: 20210719; Test Name: F-T4; Result Unstructured Data: Test Result:0.94; Test Date: 20210719; Test Name: urinometry; Test Result: Negative ; Test Date: 20210719; Test Name: weight; Result Unstructured Data: Test Result:84.60; Test Date: 20210719; Test Name: WBC; Result Unstructured Data: Test Result:6.7
CDC Split Type: JPPFIZER INC202100957977

Write-up: pyrexia of 40 degrees Centigrade; chills/shivering; myalgia; generalised aching; MCV (Mean Corpuscular Volume):84.5 L; MCH (Mean corpuscular hemoglobin): 28.1 L; PDW(Platelet distribution width): 11.1L; STAB(Stabs band cell): 9.0H; SEG(Segmented(neutrophil)): 79.0H; LYMPHO (Lymphocyte count): 10.0 L; MONO(Mononucleosis): 1.0L; D-dimer:5.2H; Urine specific gravity: 1.053L; FBS(Fasting blood sugar): 152H; TP(Total protein): 6.4L; ALB(Albumin): 3.3L; AST (aspartate aminotransferase): 37H; ALT (alanine aminotransferase): 45 H; LD(IFCC)(LACTATE DEHYDROGENASE): 294H; G-GTP(gamma-glutamyl transpeptidase): 64H; CRE(creatinine): 1.05H; K: 3.3L; CRP(C-reactive protein):10.29H; eGFR(Estimated glomerular filtration rate): 59.6L; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120962. A 49-year and 7-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) at the age of 49-years, via an unspecified route of administration on 15Jul2021 at 11:00 as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had no family history. 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 oral medication of amlodipine besilate, telmisartan (TERAMURO) combination tablet AP (Sawai). The patient previously received the first single dose of BNT162B2 (COMIRNATY, Lot number FA4597, Expiration date 31Aug2021) at the end of Jun2021 for COVID-19 immunization and experienced shoulder pain. On 15Jul2021 at 23:00 (12 hours after the vaccination), the patient experienced chills, shivering, myalgia, pyrexia of 40 degrees Centigrade. On 19Jul2021 (4 days after the vaccination), the patient was admitted to the hospital. On 27Jul2021(12 days after the vaccination), the patient was discharged from the hospital. Outcome of the events was recovering/resolving. The course of the event was as follows: At the end of June2021, the patient received the first dose of COMIRNATY. For few days after the vaccination, shoulder pain developed and disappeared naturally. On 15Jul2021 (the day of vaccination), the patient received the second dose of COMIRNATY. A few hours later, Generalised aching occurred, Pyrexia developed and body temperature increased gradually from 38 to 40 degrees Centigrade. There was a apparent generalized pain: strong pain as if run over by a truck (Included both eyeballs, both ears, mouth, urethra, two scrotums, anus). The patient barely could sit with a help, on 19Jul2021 at 09:30 (4 days after the vaccination), the patient was emergency delivered to their hospital. Corona rapid antigen test and TRC test and 2 set of blood culture were ''negative''. During hospitalization, turning over on bed was barely possible, and almost no mobility was observed. Although CARONAL 3600 mg was used, pain relief was impossible. From 21Jul2021 (6 days after the vaccination), CARONAL 3700 mg+ TRAMAL 150 mg+ LYRICA 150+NEUROTROPIN 4 mg were administered. Few hours after the administration, the patient started to walk watched by a person. From 22Jul2021 (7 days after the vaccination), generalised aching almost recovered, and recovered to the state which the patient could freely walk inside the hospital. On 27Jul2021 (12 days after the vaccination), the patient was discharged from the hospital and followed-up through outpatient visit to their hospital was carried out. Test detail information: On 19Jul2021 at 09:48 (4 days after the vaccination), WBC (White Blood Cell): 6.7; RBC (Red Blood Cell): 4.59; MCV (Mean Corpuscular Volume):84.5 L; MCH (Mean corpuscular hemoglobin): 28.1 L; MCHC(Mean corpuscular hemoglobin concentration): 33.2; RDW (Red cell distribution width): 12.6; HGB (Hemoglobin): 12.9; HCT (hematocrit): 38.8; PLT (Platelets): 150; PCT(Procalcitonin): 0.150; MPV(Mean platelet volume): 9.1; PDW(Platelet distribution width): 11.1L; STAB(Stabs band cell): 9.0H; SEG(Segmented(neutrophil)): 79.0H; BASO(Basophil count): 1.0; LYMPHO (Lymphocyte count): 10.0 L; MONO(monocyte): 1.0L; PT TIME(prothrombin time): 14.2; PT activation: 84.8; PR(Progesterone receptor assay):1.10; INR(International normalized ratio): 1.09; D-dimer:5.2H; Urine specific gravity: 1.053L; Hemoglobin A1c NGS: 5.5; FBS(Fasting blood sugar): 152H; TP(Total protein): 6.4L;ALB(Albumin): 3.3L; CK(Creatine kinase): 46; AST (aspartate aminotransferase): 37H; ALT (alanine aminotransferase): 45 H; LD(IFCC)(LACTATE DEHYDROGENASE): 294H; G-GTP(gamma-glutamyl transpeptidase): 64H; CRE(creatinine): 1.05H; UA(uric acid): 5.0; BUN(blood urea nitrogen): 9.2; Na: 136; K: 3.3L; CI: 101; T-BIL(total bilirubin): 0.5; D-BIL(Direct bilirubin):0.1; CRP(C-reactive protein):10.29H; eGFR(Estimated glomerular filtration rate): 59.6L; Lysemia:Negative; Urinometry:Negative; pH:7.678; pCO2(partial pressure of carbon dioxide):15.1; pO2(partial pressure of oxygen): 117.0; Hco3-(p: 24.4; Hco3-(p): 18.1; ABE(actual base excess): -0.1; SBE(standard base excess): -2.7; tCO2 (total carbon dioxide):41.6; THB(total hemoglobin):13.2; HCT(hematocrit test): 40.7; O2HB(oxygen-carrying hemoglobin): 97.1; COHB(Carboxyhemoglobin): 1.1; METHB(Methemoglobin): 1.3; HHB(Deoxyhemoglobin): 0.5; SO2 (Oxygen saturation): 99.5; CO2:18.2; Na+: 133; K+: 3.3; CI-:105; Ca2+: 1.04; AniGap(Anion gap): 13.1; Glu(glucose): 138; Lao (Laboratory for Adaptive Optics):27;Po2(a)/F(partial pressure of oxygen): 559; PO2(I): 21; Haemolysis: Negative. On 19Jul2021 at 10:05 (4 days after the vaccination), TSH (thyroid-stimulating hormone): 0.60; F-T4:0.94; Height:167.00; Weight :84.60. The reporting physician classified the event as serious (can lead to disability, hospitalized started from 19Jul2021 to 27Jul2021) 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: AE of Vaccine can be thought rather than Sepsis. Outcome of the other events was unknown.


VAERS ID: 1538997 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, 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), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Cerebral infarction; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100960002

Write-up: Recurrent cerebral infarction; unconscious; This is a spontaneous report from two contactable physicians via a Pfizer sales representative. A 82-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number FD0889 , expiration date 30Sep2021, on 14Jul2021 at 0.3 ml single intramuscular for COVID-19 immunisation. Medical history included cerebral infarction and renal failure (with dialysis treatment). Concomitant medication was not reported. On an unspecified date (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration for COVID-19 immunization. The patient did not have adverse event after the first vaccination. On 14Jul2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0889, Dosage was 0.3 ml) intramuscular for COVID-19 immunization. On 15Jul2021 (one day after vaccination), the patient experienced recurrent cerebral infarction which leaded to unconscious. Until 27Jul2021, the patient was still unconscious. The outcome of events was not recovered. The reporter classified the event as serious. The event ''Recurrent cerebral infarction'' was assessed as serious with disability. The reporter stated that the causality between the events and the BNT162B2 cannot be evaluated.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Cerebral infarction , Loss of consciousness and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1539059 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Injection site warmth, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: BP; Result Unstructured Data: Test Result:107/80 mmHg; Comments: BP during syncope was in normal range
CDC Split Type: LVPFIZER INC202100948896

Write-up: Syncope; Difficulty breathing; Injection site warmth; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number LV-SAM-2021076304. A 21-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on 15Jul2021 (lot number: FD9234) at 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced syncope, difficulty breathing, and injection site warmth on 15Jul2021. Syncope and difficulty breathing were reported as medically significant by health authority. Case narrative: A spontaneous report received from a consumer (non-HCP) regarding a patient - female, 21 years old. The patient received the 1st vaccination dose with Comirnaty (BioNTech, batch No. FD9234) 0,3 ml intramuscularly on 2021/07/15. On 2021/07/15 during vaccine administration the patient felt injection site warmth. On 2021/07/15 (4 minutes after vaccination) the patient experienced difficulty breathing and syncope. The event of injection site warmth resolved on 2021/07/15. The events of difficulty breathing and syncope resolved after 1.5 minutes. No medications were administered to the patient. The patient''s BP during syncope was in normal range (107/80 mmHg). The patient did not have a rash or pruritus. The patient was not hospitalized. The patient did not have any chronic conditions. The patient did not use any medications regularly - no concomitant medications were reported. All events resolved on 15Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1539946 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
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? 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: BEJNJFOC20210808658

Write-up: JOINT PAIN; ACHES AND PAIN IN THE HAND THAT RECEIVED THE VACCINE; CHILLS; MUSCLE PAIN; 4 HOURS AFTER MY VACCINATION I WAS EXHAUSTED OR FATIGUE; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [BE-FAMHP-DHH-N2021-101952] concerned a 46 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 21C17-05 expiry: Unknown) dose was not reported,1 total, administered on 15-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 15-JUL-2021, the patient experienced joint pain, aches and pain in the hand that received the vaccine, chills, muscle pain, 4 hours after vaccination patient was exhausted or fatigue, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, chills, joint pain, 4 hours after vaccination patient was exhausted or fatigue, fever, aches and pain in the hand that received the vaccine, headache, and nausea. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment. Sender''s Comments: V0: 20210808658-Covid-19 vaccine ad26.cov2.s-Joint pain, Aches and pain in the hand that received the vaccine, Chills, Muscle pain, 4 hours after vaccination patient was exhausted or fatigue, Fever, Headache, Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1539972 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vestibular neuronitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Dyslipidaemia; Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210814540

Write-up: VESTIBULAR NEURITIS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-BS20211406] concerned a 66 year old male. The patient''s weight was 69 kilograms, and height was 170 centimeters. The patient''s concurrent conditions included: hypertension arterial, and dyslipidaemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02 expiry: UNKNOWN) 1 dosage forms, 1 in total administered on 12-JUN-2021 for covid-19 vaccination (drug start period: 34 days; drug last period: 34 days and duration of drug administration: 1 day). No concomitant medications were reported. On 15-JUL-2021, the patient experienced vestibular neuritis. The patient was hospitalized (date and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vestibular neuritis. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0.20210814540-covid-19 vaccine ad26.cov2.s -vestibular neuritis.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1540197 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIENOBEL.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210808588

Write-up: PAIN AT THE LEVEL OF MY KIDNEYS; COLD CHILLS; FEELING UNWELL; FATIGUE; FEVER; MUSCLE PAIN; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-101907] concerned a 25 year old female with an unspecified race and ethnic origin. The patient''s weight was 54 kilograms, and height was 173 centimeters. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C13-03 expiry: Unknown) dose was not reported, frequency 1 total administered on 15-JUL-2021 for covid-19 immunisation. Concomitant medications included Dienobel (dienogest/ethinylestradiol) for drug used for unknown indication. On 15-JUL-2021, the patient developed pain at the level of my kidneys, cold chills, feeling unwell, fatigue, fever, muscle pain, headache. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold chills, fatigue, feeling unwell, fever, muscle pain, headache, and pain at the level of my kidneys. This report was serious (Disability Or Permanent Damage); Reporter''s Comments: Treatment - Nee Evolution of the ADR - Herstellende ADR description -Sender''s Comments: V0: 20210808588-covid-19 vaccine ad26.cov2.s- pain at the level of my kidneys. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210808588 -covid-19 vaccine ad26.cov2.s- cold chills, feeling unwell, fatigue, fever, muscle pain, headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1540307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-15
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210717; Test Name: sars-cov-2 test; Test Result: Positive.
CDC Split Type: ESPFIZER INC202100979352

Write-up: sars-cov-2 test positive; sars-cov-2 test positive; Congestion nasal; Heaviness of head; Febricula; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number ES-AEMPS-960101. A 70-year-old female patient received second dose of BNT162B2 (COMIRNATY; Solution for injection, Batch/Lot Number: FA7083), dose 2 intramuscular on 27May2021 as dose 2, 0.3 ML single, for COVID-19 immunization. Patient previously received first dose of BNT162B2 (COMIRNATY; Solution for injection, Batch/Lot Number: EY3014), dose 1 intramuscular on 06May2021 as dose 1, 0.3ML single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced sars-cov-2 test positive, on 15Jul2021 congestion nasal, heaviness of head and febricula. The patient underwent lab tests and procedures on 17Jul2021 which included sars-cov-2 test positive. The outcome of event COVID-19 was unknown and for all rest events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected. Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of drug ineffective and COVID-19 cannot be excluded/assessed. The case will be reassessed if additional information becomes available.


VAERS ID: 1541232 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal rigidity, Bacterial test, Campylobacter gastroenteritis, Diarrhoea, Fatigue, Haematochezia, Malaise, Microbiology test, Nausea, Overdose, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Drug abuse and dependence (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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 Name: Bacteria stool test; Result Unstructured Data: Test Result:Not provided; Test Date: 20210720; Test Name: Microbiology; Result Unstructured Data: Test Result:molecular enterics(RM184); Comments: Stool specimen test Campylobacter enteritis
CDC Split Type: GBPFIZER INC202100962201

Write-up: Nausea; Abdominal rigidity; Haematochezia; Campylobacter enteritis; Syncope; Acute diarrhoea; Fatigue; Malaise; Pain in extremity/sore arm; DOSE 2, 0.5ML SINGLE; his is a spontaneous report from a contactable pharmacist received from a regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00257052, Safety Report Unique Identifier GB-MHRA-ADR 25705296. A 29-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), intramuscular on 15Jul2021 (Batch/Lot number was not reported) as Dose 2, 0.5ML SINGLE at 29 years old for covid-19 immunisation .The patient medical history and patient''s concomitant medications were not reported. The patient experienced fatigue on 16Jul2021, malaise on 16Jul2021, pain in extremity on 16Jul2021, acute diarrhoea from 17Jul2021, nausea on unknown date, abdominal rigidity on unknown date, haematochezia on 20Jul2021, syncope on 18Jul2021, campylobacter enteritis on 20Jul2021. Telephone consultation on 20Jul2021 08:59: The patient had some tiredness and a sore arm - then, increasingly felt unwell on 16Jul2021. The patient developed diarrhea over weekend that has continued. The patient had some nausea and no vomiting, passed urine (PU) this morning on 20Jul2021, has managed to eat yesterday, belly felt tight, has used Imodium, fainted on trip back from toilet early hours of Sunday morning after diarrhea on 18Jul2021. Diarrhea continued a little today. Comment: reassured, common side effect (s/e) - will task pharmacy to complete yellow card. Drink - especially with sugars/salts, stay out of sun, use Imodium if needs to; if diaarhoea continues for 5/7, send for MCS, ensure PU every 4 hours at least, if feels worse, more episode of fainting, vomiting starts, not tolerating fluids let the physician known, at risk of dehydration, given heat. Telephone consultation on 20Jul2021 12:42 with comment stool for MCS please. Microbiology - Stool specimen test request. Now blood in diarrhea and could be campylobacter, advise sample today, keep drinking. On 20Jul2021 16:26, General practitioner (GP) Surgery, Sis PS. Comment: send to lab for stool MCS as per GP request. On 22Jul2021 16:10, externally entered, lab results included: molecular enterics on 20Jul2021 (RM184) which has been discussed with the patient. On 23Jul2021 09:22, Telephone consultation for problem Campylobacter enteritis (First) with comment: Diarrhea settled, the patient felt much better, advised of above, worsening advice given, family well. The patient underwent lab tests and procedures which included bacterial test with result not provided on an unknown date. Outcome of diarrhea recovered on 23Jul2021, of other events was unknown. advised - at risk of dehydration, given heat. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1541277 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-07-15
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Heavy menstrual bleeding, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100957030

Write-up: excessive clotting (numerous large clots) compared to expected period; feeling fatigued; Excessive menstruation; 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-202107261214222340-VZPYB. Safety Report Unique Identifier [GB-MHRA-ADR 25706625]. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20May2021 (Lot number was not reported) as first dose, single for covid-19 immunization. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. The patient experienced excessive menstruation on 15Jul2021. The patient further reported, "excessive menstrual bleeding for three days. Excessive clotting (numerous large clots) compared to expected period (unspecified date). Super plus tampons were changed every twenty minutes and I bled through to my clothes while out. Double maxi towels were required to absorb. Left feeling fatigued (unspecified date)." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event excessive menstruation was recovered on 18Jul2021. Outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1541333 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Depressed mood, Fatigue, Heavy menstrual bleeding, Menstrual disorder, Pallor, SARS-CoV-2 test, Weight decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (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: Headache (sometimes take paracetamol for treating headaches but rarely happens.); 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 INC202100961800

Write-up: menstrual bleeding/ prolonged menstrual bleeding; pale; low appetite; weight loss; low mood; felling tired; Menstrual flow altered; This is a spontaneous report from a contactable other HCP received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107271053569790-DBGRZ, Safety Report Unique Identifier GB-MHRA-ADR 25713210. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Lactation decreased, headache, sometimes take paracetamol for treating headaches but rarely happens. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient regular menstrual cycle takes 3 days. After 1st dose of her covid vaccine, she reported having a significant blood loss due to prolonged menstrual bleeding (12 consecutive days at the time of reporting). She mentioned felling tired and looked pale. Patient has been advised to see her GP to rule out anaemia due to excessive blood loss. Patient have reported low mood, low appetite and weight loss. The patient experienced menstrual flow altered on 15Jul2021, menstrual bleeding, pale, low appetite, weight loss, low mood. Events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: on No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. At the time of reporting patient was due to see her GP for potential blood tests. Outcome of the event Menstrual flow altered was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1541712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-07-15
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pH, Dyspnoea, Embolism, Fibrin D dimer, Fibrin D dimer increased, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZANTIPRES; XANAX; INHIXA; LEVOXACIN
Current Illness: Hypertensive heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease; Spinocellular carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Angiography-computed tomography of thorax; Result Unstructured Data: Test Result:thromboembolism; Comments: at the level of a segmental branch of the right lung alveolus for the lower lobe; Test Date: 20210715; Test Name: Venous blood pH; Result Unstructured Data: Test Result:7.44; Test Date: 20210715; Test Name: Ambient air D-Dimer; Result Unstructured Data: Test Result:10.87 mg/l; Comments: Fibrin D dimer high; Test Date: 20210715; Test Name: Oxygen saturation; Test Result: 84 %; Comments: Oxygen saturation low; Test Date: 20210715; Test Name: PCO2; Result Unstructured Data: Test Result:52 mmHg; Test Date: 20210715; Test Name: PO2; Result Unstructured Data: Test Result:38 mmHg; Test Date: 20210715; Test Name: Real Time reverse transcription polymerase chain reaction swab; Result Unstructured Data: Test Result:Target not detected
CDC Split Type: ITPFIZER INC202100960323

Write-up: Oxygen saturation: 84%; D-Dimero:10.87 mg/L; thromboembolism; worsening dyspnea; Febricula; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-760867. A 89-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246; Expiration Date: 31Jul2021), dose 2 intramuscularly, administered in Deltoid Left on 09Apr2021 at 16:56 as 0.3 mL single dose for COVID-19 immunization.Medical history included Parkinson''s disease, Spinocellular carcinoma and ongoing hypertensive heart disease.Concomitant medications included zofenopril calcium (ZANTIPRES) taken for hypertensive heart disease; alprazolam (XANAX); enoxaparin sodium (INHIXA) and levofloxacin (LEVOXACIN).On 15Jul2021, the patient experienced worsening dyspnea, febricula and on an unknown date patient experienced oxygen saturation: 84%, D-dimero:10.87 mg/l and thromboembolism. It was reported that, in lung parenchyma, bilateral diffuse confluent ground-glass areas associated with diffuse parenchymal thickening. On 15Jul2021, the patient underwent lab tests which included angiography-computed tomography of thorax: thromboembolism (at the level of a segmental branch of the right lung alveolus for the lower lobe), venous blood pH: 7.44, ambient air D-Dimer: 10.87 mg/l (Fibrin D dimer high), oxygen saturation: 84 % (Oxygen saturation low), pCO2: 52 mmHg, pO2: 38 mmHg, Real Time reverse transcription polymerase chain reaction swab: Target not detected. Therapeutic measures were taken with Oxygen Therapy, Inhixa 4000 UI x 2/day and Levoxacin 500mg) as a result of events. The patient was recovering from worsening dyspnea, febricula and outcome for rest all events was unknown. Reporter''s comment: Tests:(arterial blood gas: pH:7.44, pO2 (partial pressure of oxygen): 38mmHg, pCO2 (partial pressure of carbon dioxide): 52mmHg, oxygen saturation: 84% ambient air D-Dimer: 10.87 mg/L, angiography-computed tomography of thorax: thromboembolism at the level of a segmental branch of the right lung alveolus for the lower lobe. In lung parenchyma, bilateral diffuse confluent ground-glass areas associated with diffuse parenchymal thickening. Real Time reverse transcription polymerase chain reaction swab: Target not detected. Measures taken: Oxygen Therapy. Inhixa 4000 UI x 2/day. Levoxacin 500mg). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541713 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood homocysteine, Blood pressure measurement, Cardiac electrophysiologic study, Glycosylated haemoglobin, High density lipoprotein, Impaired fasting glucose, Ischaemic stroke, Low density lipoprotein
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Lipodystrophy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes mellitus maturity onset; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Cholesterol total; Result Unstructured Data: Test Result:unknown results; Test Date: 20210720; Test Name: Blood homocysteine; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: Blood pressure; Result Unstructured Data: Test Result:210/120 mmHg; Test Name: Ecocolordoppler of supra-aortic trunks; Result Unstructured Data: Test Result:no significant carotid stenosis; Test Date: 20210719; Test Name: Glycohaemoglobin; Result Unstructured Data: Test Result:unknown results; Test Date: 20210720; Test Name: HDL cholesterol; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: Impaired fasting glucose; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: LDL cholesterol; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202100960327

Write-up: Minor ischemic stroke; FARO This is a Non-Interventional Study report from a contactable pharmacist downloaded from the Agency EudraVigilance-WEB, regulatory authority number IT-MINISAL02-760963. A 50-years-old male subject received bnt162b2 (COMIRNATY), intramuscular, administered in left deltoid (also reported as "left shoulder") on 10Jul2021 (Lot Number: FE2707; Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included diabetes mellitus maturity onset, overweight and arterial hypertension, all from an unknown date and unknown if ongoing. Subject did not take home medications, independently discontinued diabetes therapy set in 2019. The concomitant medications were not reported. The subject experienced minor ischemic stroke on 15Jul2021 with outcome of unknown. The event was reported as serious (hospitalization). The reaction description included minor stroke in patient with multiple risk factors. Motion impediment in fine motor skills of the left hand. Mingazzini pronation to the left, Mingazzini elevation 10 cm to the left. Hypoesthesia tactile and pain sensitivity to the left hemiparesis. Plantar response extending to the left. Measures taken of the event included ecocolordoppler of supra-aortic trunks: no significant carotid stenosis on electrocardiography, glycemic profile, glycated haemoglobin, brain Magnetic Resonance Imaging. Set up rapid insulin at meals and slow insulin in the evening. Set up statin as well as B9 and B12 supplementation for hyperhomocysteinemia. The subject underwent lab tests and procedures which included Cholesterol total: unknown results on 20Jul2021, blood homocysteine: unknown results on 20Jul2021, blood pressure: 210/120 mmHg on 19Jul2021, Ecocolordoppler of supra-aortic trunks: no significant carotid stenosis on electrocardiography on an unspecified date, Glycohaemoglobin: unknown results on 19Jul2021, HDL cholesterol: unknown results on 20Jul2021, impaired fasting glucose: unknown results on 19Jul2021, LDL cholesterol: unknown results on 19Jul2021. 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 expected.; Sender''s Comments: The event minor ischemic stroke is considered not related to BNT162B2, but intercurrent medical condition for this patient with multiple risk factors. 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: 1541755 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Subarachnoid 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100964825

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121567. A 75-year and 8-month female patient received bnt162b2 (COMIRNATY Solution for injection), dose 1 via an unspecified route of administration on 05Jul2021 (the day of vaccination) (Batch/Lot Number: EY5422; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation at the age of 75-year old. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees Centigrade. On 15Jul2021 (10 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 15Jul2021 (10 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was unknown. The reporting physician classified the event as serious (hospitalized) and assessed that the event was unrelated to bnt162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: In agreement with the physician, the reported event subarachnoid haemorrhage was unrelated to bnt162b2 and attributed to intercurrent condition in this elderly patient. Case will be re-assessed upon the additional information provided.


VAERS ID: 1541778 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthenopia, Conjunctival oedema, Dyspnoea, Erythema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100967579

Write-up: Anaphylaxis; Dyspnoea; Conjunctival oedema of eyelids; Difficulty opening eyes; Skin redness of the upper left limb; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21121733. A 48-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FA4597; Expiration Date: 31Aug2021), via an unspecified route of administration on 15Jul2021 at 15:43 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 15Jul2021 the patient experienced anaphylaxis, dyspnoea, conjunctival oedema of eyelids, difficulty opening eyes and skin redness of the upper left limb. The patient was hospitalized for the events anaphylaxis from 15Jul2021 to 16Jul2021. The clinical course was as follows: On 15Jul2021 at 16:03 (the day of vaccination), the patient experienced anaphylaxis. Twenty minutes after vaccination, Dyspnoea appeared, and almost at the same time, Conjunctival oedema of eyelids and Difficulty opening eyes were observed. Symptom relief was obtained after two doses of BOSMIN, and skin redness of the upper left limb appeared. On 15Jul2021 (the day of vaccination), the patient was admitted to the hospital, and on 16Jul2021 the patient was discharged from the hospital. On 16Jul2021 (1 days after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (Hospitalization) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1545799 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: CSF cell count, Facial paralysis, Protein total
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: CSF cell count; Result Unstructured Data: Test Result:5 /ul; Test Name: total protein; Result Unstructured Data: Test Result:624
CDC Split Type: DEPFIZER INC202100989518

Write-up: peripheral facial palsy on the right; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number DE-PEI-202100142233. A 56-years-old male patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EC1436; Expiration date: unknown) via an unspecified route of administration on 09Jul2021 (at the age of 56-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included schizophrenia and hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 15Jul2021 the patient experienced peripheral facial palsy on the right. This report was serious as patient was hospitalized. Therapeutic measures were taken as a result of peripheral facial palsy on the right as patient had therapy with prednisolone. The patient underwent lab tests and procedures which included CSF cell count: 5 /ul and protein total: 624 on an unspecified date. The outcome of event was unknown. Sender Comment: CSF cell count 5 / ?l, total protein 624. CSF diagnostics are still incomplete, if necessary call PRIVACY. Therapy with prednisolone. Underlying disease schizophrenia, especially hypertension. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.


VAERS ID: 1545820 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-15
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: D-dimer; Result Unstructured Data: Test Result:elevation; Test Date: 2021; Test Name: Doppler/duplex; Result Unstructured Data: Test Result:Deep venous thrombosis; Comments: Deep venous thrombosis of the right lower leg
CDC Split Type: DEPFIZER INC202100989920

Write-up: Deep vein thrombosis leg; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the regulatory authority number DE-PEI-202100149449. A 51-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection, Lot Number: FD7958/Batch number was not reported), via an unspecified route of administration on 23Jun2021 (at the age of 51-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced deep vein thrombosis leg. The patient underwent lab tests and procedures which included fibrin d dimer: elevation and ultrasound doppler: deep venous thrombosis (Deep venous thrombosis of the right lower leg) on an unspecified date in 2021. Relatedness of Comirnaty to Deep vein thrombosis leg: Source of assessment: PEI, Result of Assessment: B. Indeterminate. The outcome of the event was not resolved. Health authority comment: Sender Comment: Deep venous thrombosis of the right lower leg supported by Doppler/duplex. D-dimer elevation. No follow-up attempts possible. No further information expected.


VAERS ID: 1546061 (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: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Otic examination, Otitis externa, Otoscopy
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: Test Date: 20210715; Test Name: External ear canal; Result Unstructured Data: Test Result:Edematous and hyperemic; Test Date: 20210718; Test Name: Otoscopy; Result Unstructured Data: Test Result:Hyperemia and purulent discharge
CDC Split Type: ESPFIZER INC202100960345

Write-up: Otitis externa/ ear canal was found edematous and hyperemic/ hyperemia and a purulent discharge/Decrease in the left ear hearing; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number ES-AEMPS-955553. A 38-year-old female patient received bnt162b2 (COMIRNATY) intramuscular on 15Jul2021 (Batch/Lot Number: FF0900), at the age of 38 years old, as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced otitis externa. Outcome of the event was unknown. Clinical course was reported as follows. 3 hours after the second dose of Comirnaty, the patient started with an important decrease in the left ear hearing. It was later assessed for this reason and the external ear canal was found edematous and hyperemic. She was prescribed ciprofloxacin hydrochloride/fluocinolone acetonide (CETRAXAL PLUS). On 18Jul2021 (3 days after), she was reassessed due to a worsening and a left otoscopy revealed hyperemia and a purulent discharge. Subsequently, ciprofloxacin hydrochloride/fluocinolone acetonide was discontinued and amoxicillin started. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546065 (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: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Physical examination, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: abdominal aorta; Result Unstructured Data: Test Result:18; Comments: normal size without ectasia (18 mm).; Test Name: gastrocnemius veins medials; Result Unstructured Data: Test Result:5.5; Comments: 5.5 mm; Test Name: gastrocnemius veins medials; Result Unstructured Data: Test Result:6; Comments: 6 mm; Test Name: lateral gastrocnemius veins; Result Unstructured Data: Test Result:2.5; Comments: 2.5 mm; Test Name: lateral gastrocnemius veins; Result Unstructured Data: Test Result:3; Comments: 3 mm; Test Name: Lower left member; Result Unstructured Data: Test Result:Feoropopliteo-sural venous thrombosis; Comments: Feoropopliteo-sural venous thrombosis of interest to veins:; Test Name: popliteal; Result Unstructured Data: Test Result:12; Comments: 12 mm; Test Name: posterior tibial veins; Result Unstructured Data: Test Result:6; Comments: 6 mm; Test Name: posterior tibial veins; Result Unstructured Data: Test Result:3; Comments: 3mm; Test Name: superficial femoral; Result Unstructured Data: Test Result:9.5; Comments: superficial femoral (9.5 mm) with the upper pole 12 cm downstream of the head femoral.; Test Name: veins fibular; Result Unstructured Data: Test Result:5; Comments: 5 mm; Test Name: veins fibular; Result Unstructured Data: Test Result:5.3; Comments: 5.3 mm; Test Name: venous tibioperoneal trunk; Result Unstructured Data: Test Result:6; Comments: 6 mm; Test Name: Echo-Doppler Review; Result Unstructured Data: Test Result:Veins of lower limbs
CDC Split Type: ESPFIZER INC202100987899

Write-up: Deep vein thrombosis leg; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the Regulatory Authority number ES-AEMPS-956097 A 48-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FD8274) via an Intramuscular route in arm left on 29Jun2021, as dose 1, single for Covid-19 immunization. Medical history and concomitant medication were not reported. The patient did not have COVID-19 in the past (pass). No personal or family history. Since 15Jul2021, the patient developed deep vein thrombosis leg. On 19Jul2021, a Review conducted due to Suspicion of deep venous thrombosis to the lower left limb in front of calf pains for 5 days, 6h long car journey 6 days ago. The patient underwent Echo-Doppler Review: Veins of lower limbs - Lower left member: Feoropopliteo-sural venous thrombosis of interest to veins:- superficial femoral (9.5 mm) with the upper pole 12 cm downstream of the head femoral, popliteal (12 mm), on the sural floor: venous tibioperoneal trunk (6 mm); two gastrocnemius veins medials (5.5 and 6 mm); two lateral gastrocnemius veins (2.5 and 3 mm), two veins fibular (5 and 5.3 mm), two posterior tibial veins (6 and 3 mm). Lower Right Member: Permeability of deep venous network (common femoral veins, deep femoral veins a proximity of the confluent, superficial femoral throughout the length of the leg, and popliteal), with spontaneous and provoked satisfactory flow and good compressibility un-der the probe. The proximal collector trunks are well modulated. On the surface floor, no evocative thrombosis image is detected, and the deep venous trunks are accessible well permeable and easily compressible. On the abdominal floor: The iliac vein axes and the inferior cava vein are permeable, with a flux physiological respiratory modulation. For information purposes, the abdominal aorta is of normal size without ectasia (18 mm). The leg arterial axes are permeable to distality with satisfactory flows. Conclusion: Propliteal femoral-popliteosural deep venous thrombosis of superficial femoral veins (9.5 mm), popliteal (12 mm), venous tibioperoneal trunk (6 mm); two medial gastrocnemius veins (5.5 and 6 mm); two lateral gastrocnemius veins (2.5 and 3 mm), two fibular veins (5 and 5.3 mm) and two posterior tibial veins (6 and 3 mm). Inferior vein cava (VCI) permeable. Indication for a curative dose anticoagulant treatment for a period of at least 3 months and wearing a class 111 venous retainer for at least 1 year. It was stated that the patient was provided with a prescription for a full-dose ELIQUIS treatment for 3 months, a pre-therapeutic biological assessment and compression stockings. On the day of this report (stated as Today) he was injected LOVENOX O.7 mi. Would be followed in another country where he lived, he was recommended that a complete etiological assessment be carried out in spite of the presence of minor triggers (ride of 6h and vaccination at COVID 19) including an injected thoracic abdominal scanner, colorectal cancer screening test, serum protein electrophoresis, corrected serum calcium, PSAus and thrombophilia assessment. Description of the treatment: Heparin, after the non-functioning of Eliquis. The event was medically significant and Life threatening, The outcome for the event was reported as resolving. No follow-up attempts possible. No further information expected


VAERS ID: 1546237 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Asthenia, Cough, Dyspnoea, Fatigue, Flushing, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NEO-MERCAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals; Drug allergy; Hypersensitivity; Hyperthyroidism; Iodine allergy; Latex allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100966832

Write-up: flushed face/face which feels flus; Asthenia; fatigue; difficulty breathing/shortness of breath; Throat irritation; Cough; Angio-edema; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-NY20212910. A 48-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 15Jul2021 (Lot Number: FE2707) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypersensitivity, allergic to penicillin, hyperthyroidism, allergy aspirin iodine metals and latex from an unknown date. Concomitant medications included carbimazole (NEO-MERCAZOLE) taken for hyperthyroidism, start and stop date were not reported. On 15Jul2021, 1 day after the administration of COMIRNATY, the patient developed dyspnea, throat irritation, cough and angioedema. On 16Jul2021, 2 Days after the administration of COMIRNATY, the patient developed asthenia and flushed face. All events were reported as serious condition from a medical standpoint. Allergy assessment strongly recommended. 20 minutes after the injection on 15Jul2021, the patient had irritation of the throat, cough and problem breathing. The patient was transferred to the emergency room due to angioedema. The next morning on 16Jul2021, shortness of breath, difficulty breathing, great fatigue and face which feels flushed. Prescription of anti-allergy drugs and cortisone for 15 days. As reported conclusion, a probable histamine angioedema, with throat irritation, cough, dyspnoea, asthenia and a feeling of a flushed face of the patient 20 minutes after the 1st injection of the COMIRNATY vaccine. The outcome of events was recovering. Reporter''s comment: Probable histamine angioedema, with throat irritation, cough, dyspnoea, asthenia and a feeling of flushed face in a 48-year-old woman 20 minutes after the 1st injection of the COMIRNATY vaccine (batch FE2707). Transfer to Emergency Room, prescription of an anti-allergy medication and cortisone for 15 days. In the process of recovery. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Probable histamine angioedema, with throat irritation, cough, dyspnoea, asthenia and a feeling of flushed face in a 48-year-old woman 20 minutes after the 1st injection of the COMIRNATY vaccine (batch FE2707). Transfer to Emergency Room, prescription of an anti-allergy medication and cortisone for 15 days. In the process of recovery. Allergy assessment strongly recommended.


VAERS ID: 1546473 (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: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100969263

Write-up: Shortness of breath; 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-202107281411519960-LDPSE and Safety Report Unique Identifier GB-MHRA-ADR 25720430. A 29-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number FD5613), via an unspecified route of administration at dose 1, single on 14Jul2021 for COVID-19 immunization. Medical history included suspected covid-19 from 15Jul2021 and ongoing. The patient''s concomitant medications were not reported. On 15Jul2021, the patient experienced shortness of breath. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (20Jul2021): No - Negative COVID-19 test. The case is serious (medically significant). The outcome of the event shortness of breath was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-07-15
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100969142

Write-up: Menstruation delayed; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority; report number GB-MHRA-WEBCOVID-202107281915274680-UCCKI and Safety Report Unique Identifier GB-MHRA-ADR 25722509. A 36-year-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration at dose 1, single on 05Jun2021 for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. The patient experienced menstruation delayed on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the event menstruation delayed was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1546750 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling cold, Hypoaesthesia, Muscle spasms, Pyrexia, Seizure
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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: Varicose vein operation (Patient had vein surgery.)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: 39.2 degree celcius
CDC Split Type: HRJNJFOC20210811443

Write-up: CONVULSION; WHOLE BODY CRAMPS AND FEET CRAMPS; MY HANDS WENT NUMB FROM FEELING COLD; I WAS VERY VERY COLD; HIGH FEVER; This spontaneous report received from a consumer via a Regulatory Authority [Regulatory Authority, HR-HALMED-300049881] concerned a 43 year old female. The patient''s weight was 70 kilograms, and height was not reported. The patient''s past medical history included varicose vein operation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml, administered on 15-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 15-JUL-2021, the patient experienced convulsion, whole body cramps and feet cramps, hands went numb from feeling cold, high fever and the patient was very very cold. The patient took paracetamol, but only after the worst part was over (the too high fever). Laboratory data included: Body temperature (NR: 36 - 37) 39.2 degree celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from convulsion, high fever, whole body cramps and feet cramps, very very cold, and hands went numb from feeling cold. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210811443-Covid-19 vaccine ad26.cov2.s-Convulsion, whole body cramps and feet cramps. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210811443-Covid-19 vaccine ad26.cov2.s-My hands went numb from feeling cold, I was very very cold, High fever. This event(s) is labeled per regulatory authority and is therefore considered potentially related


VAERS ID: 1547123 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Fatigue, Heart rate, Hypopnoea, Status epilepticus, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (Family History: false)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: heart rate; Result Unstructured Data: Test Result:low; Comments: he had a weak heartbeat
CDC Split Type: NLPFIZER INC202100987875

Write-up: Status epilepticus; Bradycardia/ low heart rate/ he had a weak heartbeat; After a few hours he became dull and sluggish/ after a few hours he was unreachable, fell further and further away, couldn''t wake him up anymore; Breathing shallow; Fatigue/ Tired after few hours; This is as spontaneous report received from a contactable other HCP downloaded from a regulatory authority-WEB. The regulatory authority report number is NL-LRB-00631100. A 13-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FE7010) via an unspecified route of administration on 15Jul2021 (age at vaccination was 13-years-old) as single dose for covid-19 immunization. Medical history included epilepsy from an unknown date and unknown if ongoing (Family History: false). The patient''s concomitant medications were not reported. Past drug therapy with BioNTech/Pfizer vaccine (Comirnaty) was reported as no. Previous COVID-19 infection and diagnostic procedures both were reported as no. It was reported on 15Jul2021, 5 hours after receiving the vaccine, patient experienced fatigue, unresponsive to verbal stimuli, bradycardia, breathing shallow and status epilepticus following administration of covid-19 vaccine Pfizer injection fluid. Patient was not known to have status epilepticus. It was reported that patient was tired after few hours not approachable low heart rate shallow breathing. Additional information ADR was reported as: "shortly after the vaccine he became tired and slept after a few hours he became dull and sluggish. We could not wake him up and tried everything, finally we called 112 and they said he had a weak heartbeat and shallow breathing. He is known to have epilepsy. This was a status epileptic. We do not know this about him". The events resulted in emergency room visit. The patient underwent lab tests and procedures which included heart rate which was low (he had a weak heartbeat) on 15Jul2021. Therapeutic measures were taken with midazolam as a result of the events. The events unresponsive to verbal stimuli, bradycardia, breathing shallow and status epilepticus were reported as life threatening. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1554833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy test
SMQs:, Termination of pregnancy and risk of abortion (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: Pregnant (3 weeks)
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202100973286

Write-up: Spontaneous abortion week 5; This is a spontaneous report from a non-contactable consumer downloaded from the WEB NO-NOMAADVRE-PASRAPP-2021-Uxprq1. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular, administered in arm left on 02Jul2021 09:28 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (3 weeks) from an unknown date. The patient''s concomitant medications were not reported. The patient reported to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The patient experienced spontaneous abortion week 5 on 15Jul2021. The reactions/case was considered to be serious due to [Other Serious (Important Medical Events)]. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 06Jul2021. The outcome of the event was recovered with sequelae. Reporter Comment: Contact with healthcare professionals: Physician. The patient reports to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The SPONTANEOUS ABORTION happened in week 5. Sender Comment: Upgraded to Serious due to (Other Serious (Important Medical Events)). Did not provide a causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient reports to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The SPONTANEOUS ABORTION happened in week 5.


VAERS ID: 1555672 (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: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP066780

Write-up: Anaphylaxis (itching, diffuse redness of upper extremity, coughing, dyspnea); This case was received via regulatory authority (Reference number: 2021TJP066780) on 29-Jul-2021 and was forwarded to Moderna on 05-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis (itching, diffuse redness of upper extremity, coughing, dyspnea)) in a 21-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. 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 ANAPHYLACTIC REACTION (Anaphylaxis (itching, diffuse redness of upper extremity, coughing, dyspnea)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 15-Jul-2021 due to ANAPHYLACTIC REACTION. The patient was treated with EPINEPHRINE (ADRENALIN GALEN) for Anaphylaxis, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis (itching, diffuse redness of upper extremity, coughing, dyspnea)) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis (itching, diffuse redness of upper extremity, coughing, dyspnea)) to be possibly related. The concomitant medications on use were not provided. On 28-Jul-2021, the patient visited to consult about the next vaccination. The patient had no problem with the physical condition.; 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: 1573789 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6040 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: CYPFIZER INC202100980857

Write-up: Epileptic seizure; This is a spontaneous report from a contactable physician downloaded from a regulatory authority, regulatory authority number CY-CYPPVPR-150721KK3. An 18-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD6040), via an intramuscular route on 15Jul2021 (at the age of 18 years) as a dose number unknown, 0.3mL single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced epileptic seizure on 15Jul2021 at 10:30 with outcome of unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1575287 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA [LEVETIRACETAM]
Current Illness: Hemiparesis (left)
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (caused by a non-functional short circuit)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202100996371

Write-up: epileptic seizure/epileptic fit; This is a spontaneous report received from a contactable consumer (patient) downloaded from a regulatory authority. The regulatory authority report number is CZ-CZSUKL-21008677. An 18-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 15Jul2021 (Lot Number: FF0680; unknown expiration; at the age of 18 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing hemiparesis (left) and epileptic seizure/ epileptic fit on 15Jan2021 (caused by a non-functional short circuit). Concomitant medication included levetiracetam (KEPPRA) for epileptic fit from 22Jan2020 to 15Jul2021. The patient experienced epileptic seizure/epileptic fit after being vaccinated with COMIRNATY vaccine on 15Jul2021. The attack lasted 8 minutes, Buccolam 10 mg orally was administered. The patient recovered from the event on 15Jul2021. The events were assessed as serious (medically significant and life-threatening condition). No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1583682 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:pulseless
CDC Split Type: DEPFIZER INC202100990417

Write-up: Severe anaphylactic shock 20 minutes after injection, beginning with shortness of breath (collapsed, unconscious, pulseless, briefly reanimated, adrenaline administration; Severe anaphylactic shock 20 minutes after injection, beginning with shortness of breath (collapsed, unconscious, pulseless, briefly reanimated, adrenaline administration; This is a spontaneous report received from a non-contactable consumer, downloaded from a regulatory authority. The regulatory authority report number is DE-PEI-202100151802. An 18-year-old female patient received dose 2 of BNT162B2 (COMIRNATY), intramuscular on 15Jul2021 (at the age of 18-years-old) (Batch/Lot Number: 1F030A) single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received dose 1 BNT162B2 (COMIRNATY) on 24Jun2021 (Lot number: FD7958). The patient experienced anaphylactic reaction and severe anaphylactic shock 20 minutes after injection, beginning with shortness of breath (collapsed, unconscious, pulseless, briefly reanimated, adrenaline administration on 15Jul2021. Outcome of the event was not recovered. Relatedness of drug (Comirnaty) to event: Unclassifiable. Sender Comment: Patient: PRIVACY (first name) PRIVACY (last name) born PRIVACY, 1st Comirnaty vaccination (FD7958) on 24Jun2021.


VAERS ID: 1589036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-07-15
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210703; Test Name: Ultrasound; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210715; Test Name: Ultrasound; Result Unstructured Data: Test Result:Cardiac arrest of the fetus; Comments: Cardiac arrest of the fetus at 10 weeks of pregnancy
CDC Split Type: FRPFIZER INC202101003844

Write-up: received the 1st injection of the COMIRNATY vaccine although she was pregnant; Fetal death in utero; Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-NY20213108. The consumer reported events for both mother and fetus. This is the mother case. A 34-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 12May2021 (Batch/Lot Number: EX7389) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient did not know she was pregnant but had a pregnancy plan. She received the 1st injection of COMIRNATY vaccine while she was a few days pregnant without knowing it. Date of last menstrual period was on 26Apr2021. On 03Jul2021, follow-up ultrasound showed no abnormality. On 15Jul2021, 53 Days after the beginning of drug administration, the patient developed Loss of pregnancy < 20 weeks of gestation (10 weeks)/ fetal death in utero which constituted a congenital anomaly / birth defect. On 15Jul2021, new ultrasound showed cardiac arrest of the fetus at 10 weeks of pregnancy. Patient had hospitalization for curettage. Patient recovered in Jul2021. SARS-COV 2 test negative on 16Jul2021. Note: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Therapie 1985; 40: 111-8.; Reporter''s comments: Death of the fetus in utero and miscarriage <20 weeks gestation (10 weeks) in a 34-year-old woman who received the 1st injection of the COMIRNATY vaccine (lot EX7389) although she was pregnant for a few days without knowing it. Patient recovered.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101046535 Foetus case


VAERS ID: 1589104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-15
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: WYSTAMM; FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101003949

Write-up: Spontaneous abortion / Miscarriage at 6 weeks of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20212951. A pregnant 32-year-old female patient received the second dose of BNT162b2 (COMIRNATY), intramuscular, administered in left arm on 14Jun2021 (Batch/Lot Number: FD4342) at 0.3mL single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included rupatadine fumarate (WYSTAMM, strength: 10mg) taken for an unspecified indication, start and stop date were not reported; folic acid, strength: 0.4mg taken for an unspecified indication, start and stop date were not reported. The patient experienced spontaneous abortion/miscarriage at 6 weeks of pregnancy on 15Jul2021. Clear egg, awaiting further information. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. Outcome of the events was recovered with sequelae on 15Jul2021. The regulatory authority assessed the events as medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1631947 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bronchial hyperreactivity, Chest pain, Musculoskeletal chest pain, Rales
SMQs:, Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (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: None to medications or supplements.
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intermittent rib and chest pain. Affecting left side of chest. Signs of bronchial hyperresponsiveness. Crackling sounds on aspiration in the upper left superior and less in the right.


VAERS ID: 1468389 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Injection site pain
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: White pepper, amoxicillin, lactose intolerance
Diagnostic Lab Data:
CDC Split Type:

Write-up: Weakness, dizziness and headache approximately 12 hours later. Injection site pain.


VAERS ID: 1468975 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Injection site inflammation, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies: Pollen
Diagnostic Lab Data:
CDC Split Type:

Write-up: Days after the vaccine, inflammation and pain in the area of the puncture. It went away after 3-4 days. However, a week after the administration of the vaccine I woke up with significant inflammation with pain in the same area.


VAERS ID: 1470104 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Microgestin FE, Vyvanse, Lyrica, Topamax, Cymbalta
Current Illness:
Preexisting Conditions: Fibromyalgia, plantar fasciitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen painful lymph nodes on right side of neck and and collar bone


VAERS ID: 1470141 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-14
Onset:2021-07-14
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Arthralgia, Asthma, Burning sensation, Condition aggravated, Fatigue, Pain in extremity, Paraesthesia, Post-acute COVID-19 syndrome, Rash, Skin discolouration, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Rashes and hives as well as fatigue, nausea, achy joints
Other Medications: None
Current Illness: Common cold
Preexisting Conditions: Joint pain, chronic back and neck and shoulder pain, frequent migraines and headaches, small joint pain
Allergies: Allergies to gluten, dairy, egg yolks, cashews, pistachios
Diagnostic Lab Data: Doctor looked at symptoms, rashes, hand, prescribes antihistamines and naproxen
CDC Split Type:

Write-up: Hives and rashes on both days of vaccination and for a few days later Painful arm and shoulder from day one, worsened and has yet to subside Asthma day 5-11 after first vaccine ?Covid arm? rash day 9-13 after first injection Very painful small joints and elbows ongoing Easily fatigued limbs Discoloration of left hand from time to time. Sometimes whiter, sometimes purple, specially in cold weather Tingling that turns into burning sensation/feels like I?ve been stung by stinging nettles when cold on top of left hand after second injection, ongoing


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