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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 322 out of 7,116

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VAERS ID: 1576025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling cold, Hot flush, Pain, SARS-CoV-2 test, Vaccination site movement impairment, Vaccination site pain
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100984739

Write-up: body aching; physically hurts to move the arm that had the injection/Can''t raise arm above 90 degrees forward and only about 45 degrees sideways; feeling cold; Tiredness; Hot flush; Muscle ache/Arm that had the vaccine injection started to ache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011946362570-07HVJ, Safety Report Unique Identifier GB-MHRA-ADR 25738346. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ff3319), via an unspecified route of administration, administered in arm on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 16Jun2020 (unsure when symptoms stopped) and period pains. Concomitant medication included desogestrel, ethinylestradiol (GEDAREL) taken for period pains from 2020. The patient experienced muscle ache/arm that had the vaccine injection started to ache on 31Jul2021; feeling cold, tiredness, hot flush, body aching, and physically hurts to move the arm that had the injection/can''t raise arm above 90 degrees forward and only about 45 degrees sideways all on 01Aug2021. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 21Jun2021. Outcome of the vaccination site pain and tiredness was not recovered, of the feeling cold and hot flush was recovering, while of the remaining events was unknown. The clinical course was reported as follows: Arm that had the vaccine injection started to ache the night i had it. Woke up the next morning with whole body aching and feeling cold and physically hurts to move the arm that had the injection. Can''t raise arm above 90 degrees forward and only about 45 degrees sideways which has made it difficult to carry out everyday activities. 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: 1576027 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-31
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Muscle ache; Painful arm; Swollen arm; Localized itching; Vaccination site burning; This case was received via Agency Regulatory Authority (Reference number: ADR 25738350) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Localized itching) and VACCINATION SITE PAIN (Vaccination site burning) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PRURITUS (Localized itching) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Vaccination site burning) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache) outcome was unknown and PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Localized itching) and VACCINATION SITE PAIN (Vaccination site burning) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications reported. Slow onset of whole arm heaviness on day 8, heat at vaccine site, arm muscle ache had not sought any treatment. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.


VAERS ID: 1576029 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cognitive disorder, Dizziness, Fatigue, Headache, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Arthritis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984448

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; Dizziness; Joint pain; Headache; Cognitive impairment; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012001028450-MWB7I. A 35-years-old female patient received second dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported),via an unspecified route of administration on 31Jul2021 (at age of 35-years-old) as dose 2, single for covid-19 immunisation.Medical history included ongoing breast feeding.The patient''s concomitant medications was not reported.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial.Patient has not had symptoms associated with COVID-19 Patient is not pregnant. The patient experienced maternal exposure during breast feeding ,maternal exposure during breast feeding on an unspecified date, fatigue on 31Jul2021 and dizziness, joint pain, headache,cognitive impairment on 01Aug2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No- Negative COVID-19 test.The events were assessed as serious. The outcome of event for Maternal exposure during breast feeding,Maternal exposure during breast feeding was unknown on unknown .Outcome of other events was not recovered on unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypersensitivity, Pyrexia
SMQs:, Angioedema (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Head cold; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Fever; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100984412

Write-up: Fever; Hypersensitivity; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012004077480-MKCNQ, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25738357. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 31Jul2021, as a dose 2, single for COVID-19 immunisation. The patient''s medical history included suspected COVID-19 (from 12Oct2020 to an unknown date) Unsure when symptoms stopped, nasopharyngitis (from an unknown date and unknown if ongoing). Patient was not enrolled in clinical trial. Not had a COVID-19 test. Concomitant medication(s) included dihydrocodeine tartrate, paracetamol (PARAMOL) taken for nasopharyngitis (from 30Jul2021 to an unspecified stop date). On 31Jul2021, the patient experienced fever and hypersensitivity. The patient underwent lab tests and procedures which included body temperature: unknown results on 31Jul2021. All the events were serious (medically significant). The outcome of the events was recovered 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; 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 INC202100984415

Write-up: armpit very sore on side of vaccine; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012006024830-DTLJS and Safety Report Unique Identifier is GB-MHRA-ADR 25738358. The 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation and Endometriosis. Concomitant medications included ibuprofen (IBUPROFEN) taken for endometriosis. Patient did not have symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 31Jul2021 the patient experienced swollen lymph nodes and on 01Aug2021, patient had armpit very sore on side of vaccine. It was reported that patient had very tired day after vaccine, went to sleep for a few hours, woke up and next was very swollen on side of vaccine, armpit very sore on side of vaccine. Day 2 after vaccine neck still swollen and now a lump can be felt, armpit very sore, pain also in shoulder on side of vaccine. On unknown date, the patient underwent lab tests which included sars-cov-2 test: negative. The patient had not yet recovered from swollen lymph nodes and outcome for armpit very sore on side of vaccine was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576038 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Chills, Illness, Influenza like illness, Insomnia, Intentional self-injury, Limb discomfort, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20200716; 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: self medicating; Migraine; Abdominal pain; Sickness; Flu-like aching; Insomnia; Chest pain; Arm discomfort; Fever; Chills; This case was received via RA (Reference number: 25738382) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTENTIONAL SELF-INJURY (self medicating), MIGRAINE (Migraine), ABDOMINAL PAIN (Abdominal pain), ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu-like aching), INSOMNIA (Insomnia), CHEST PAIN (Chest pain), LIMB DISCOMFORT (Arm discomfort), PYREXIA (Fever) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 31-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 31-Jul-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced INTENTIONAL SELF-INJURY (self medicating) (seriousness criterion medically significant). At the time of the report, INTENTIONAL SELF-INJURY (self medicating), MIGRAINE (Migraine), ABDOMINAL PAIN (Abdominal pain), ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu-like aching), INSOMNIA (Insomnia), CHEST PAIN (Chest pain), LIMB DISCOMFORT (Arm discomfort), PYREXIA (Fever) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Arm discomfort started couple of hours after vaccination. About 5 hours after vaccination all other symptoms hit at once and have still not improved. Self medicating is not helping. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576041 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site 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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984594

Write-up: Swollen glands; Myalgia; Fatigue; Feverish; Injection site pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108012047447200-VLD6V, Safety Report Unique Identifier GB-MHRA-ADR 25738388. A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased and suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped). She was not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced injection site pain on 31Jul2021; swollen glands, myalgia, fatigue, and feverish on 01Aug2021. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The outcome of the events was not recovered. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576054 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue, Pain in extremity, Palpitations, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Unknown Results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984386

Write-up: dull ache around my shoulder and arm pit; dull ache around my shoulder and arm pit; left arm pit has swollen; Palpitations; heavy breathing; Tight chest; worn out; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108012159477350-REZAZ, Safety Report Unique Identifier GB-MHRA-ADR 25738445. A 31-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. N/A was reported for fit and healthy. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. On 31Jul2021, patient experienced heavy breathing, tight chest, worn out, palpitations. On 01Aug2021, patient experienced dull ache around my shoulder and arm pit, left arm pit has swollen. Clinical information was reported as 6AM Saturday 31Jul palpitations started by 15:30 patient had 5 separate episodes along with heavy breathing and tight chest. Attended hospital. 01Aug left arm pit has swollen and a constant dull ache around my shoulder and arm pit. Issue still ongoing. Since the start of morning 31Jul I have felt worn out with no energy spending a day and half in bed. Now have energy to get out of bed but not enough to carry out large tasks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test, electrocardiogram: unknown results on an unspecified date, blood pressure measurement: unknown results on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events heavy breathing, tight chest was recovered on 01Aug2021, palpitations was recovered on 31Jul2021, outcome of the events worn out, left arm pit has swollen, dull ache around my shoulder and arm pit not recovered No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1576063 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; 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 INC202100984619

Write-up: Swollen lymph nodes; Painful arm; Bruising of arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012240551010-6BZ81. Safety Report Unique Identifier is GB-MHRA-ADR 25738464. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 31Jul2021 (at the age of 33 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and anxiety. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Concomitant medication included sertraline taken for anxiety. The patient experienced swollen lymph nodes on 01Aug2021, painful arm on 01Aug2021, and bruising of arm on 31Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the 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: 1576079 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984539

Write-up: Swollen lymph nodes; Chills; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108020233072760-HLQOX. Safety Report Unique Identifier: GB-MHRA-ADR 25738537. A 34-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (Age at vaccination 34 years) . Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced chills (medically significant) on 31Jul2021 with outcome of recovered on 01Aug2021, swollen lymph nodes (medically significant) on 01Aug2021 with outcome of not recovered. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial Adverse reaction did not occur as a result of an exposure during pregnancy Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1576090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984303

Write-up: Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020748523170-QH2RF; Safety Report Unique Identifier (GB-MHRA-ADR 25739176). A 37-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (BNT162B2) as dose 1, single for COVID-19 immunisation. The patient experienced enlarged lymph nodes (excl infective) on 31Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576091 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Feeling cold, Headache, Heart rate increased, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Chilliness; Appetite lost; Heart rate increased; Tingling skin; Headache; This case was received via Regulatory Authority (Reference number: 25739262) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FEELING COLD (Chilliness), DECREASED APPETITE (Appetite lost), HEART RATE INCREASED (Heart rate increased), PARAESTHESIA (Tingling skin) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-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 31-Jul-2021, the patient experienced FEELING COLD (Chilliness) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), HEART RATE INCREASED (Heart rate increased) (seriousness criterion medically significant), PARAESTHESIA (Tingling skin) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 31-Jul-2021, FEELING COLD (Chilliness), DECREASED APPETITE (Appetite lost), HEART RATE INCREASED (Heart rate increased), PARAESTHESIA (Tingling skin) and HEADACHE (Headache) had resolved. At the time of the report, PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576094 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pyrexia, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (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: Lactation decreased
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test negative
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chills; Swelling; Rash; Fever; Headache; This case was received via Regulatory Authority RA (Reference number: 25739431) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), RASH (Rash), PYREXIA (Fever) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 virus test negative on 22-Jun-2021. Concurrent medical conditions included Lactation decreased. On 31-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 31-Jul-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills). At the time of the report, SWELLING (Swelling), RASH (Rash), PYREXIA (Fever) and HEADACHE (Headache) had not resolved and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. Treatment information was not provided by reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1576098 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza like illness, Lymphadenopathy, Maternal exposure during breast feeding, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding; Hashimoto''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic skin reaction (Previously unknown allergic skin reaction in 2019); Hashimoto''s disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Red rash; Flu-like aching; Swollen glands; Headache; This case was received via regulatory authority (Reference number: ADR 25739608) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), INFLUENZA LIKE ILLNESS (Flu-like aching), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Allergic skin reaction (Previously unknown allergic skin reaction in 2019) in 2019 and Hashimoto''s disease. Previously administered products included for Product used for unknown indication: LEVOTHYROXINE. Concurrent medical conditions included Breast feeding and Hashimoto''s disease. On 31-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 31-Jul-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Flu-like aching, at an unspecified dose and frequency. On 02-Aug-2021, INFLUENZA LIKE ILLNESS (Flu-like aching) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash) and LYMPHADENOPATHY (Swollen glands) had not resolved, HEADACHE (Headache) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient experienced flu-like aching went away after 24 hours and treated was with paracetamol. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a case of product exposure during breastfeeding with the following AEs associated: rash, influenza like illness, lymphadenopathy and headache. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: This is a case of product exposure during breastfeeding with the following AEs associated: rash, influenza like illness, lymphadenopathy and headache. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1576105 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100992330

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020957363030-PJ8WJ, Safety Report Unique Identifier GB-MHRA-ADR 25739783. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: fd8813 and expiration date: not reported), via an unspecified route of administration on 27Jul2021 as dose 2, single for COVID-19 immunisation and then first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as dose 1 single for COVID-19 immunisation on an unspecified date. The patient medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): positive on 31Jul2021 Yes - Positive COVID-19 test. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576106 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-07-31
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Embolism venous, Fibrin D dimer, Palpitations, Platelet count, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Non-smoker; Palpitations
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: D-dimer was $g4000; Test Name: LowPlatelets; Result Unstructured Data: <150 x 109/L low platelets; Test Date: 20210731; 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: platelet count <150 x 109/L; chest pain; palpitations; Venous thromboembolism; This case was received via a regulatory authority (Reference number: ADR 25739828) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (platelet count <150 x 109/L), EMBOLISM VENOUS (Venous thromboembolism), CHEST PAIN (chest pain) and PALPITATIONS (palpitations) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ANTI-D IMMUNOGLOBULIN for an unknown indication. The patient''s past medical history included Palpitations, Chest pain and Non-smoker. Previously administered products included for an unreported indication: HEPARIN. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ANTI-D IMMUNOGLOBULIN (unknown route) at an unspecified dose. On 31-Jul-2021, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced THROMBOCYTOPENIA (platelet count <150 x 109/L) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization and life threatening) and PALPITATIONS (palpitations) (seriousness criteria hospitalization and life threatening). The patient was treated with PREDNISOLONE at a dose of 70 milligram once a day and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) at a dose of 0.5 mg/kg. At the time of the report, THROMBOCYTOPENIA (platelet count <150 x 109/L), CHEST PAIN (chest pain) and PALPITATIONS (palpitations) outcome was unknown and EMBOLISM VENOUS (Venous thromboembolism) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On an unknown date, Fibrin D dimer: d-dimer was $g4000 (abnormal) D-dimer was $g4000. On an unknown date, Platelet count: <150 ?? 109/l (Low) <150 x 109/L low platelets. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The treatment medication provided was prednisolone (70mg od) and IVIG (0.5mg/kg). The reporter reported that patient was admitted to hospital on 31-Jul-2021 with Chest pain and palpations(Massive bilateral PE with right heart strain).There was no history clothing disorder. On admission D dimer was 6075, fibrinogen was 4 and Low platelets (124). The reporter reported the related causality between events and Drug administered. The reporter reports that Anti platelet 4 for antibody testing was requested" On 31-Jul-2021 CTPA (CT Pulmonary angiogram) was done which shows Massive bilateral PE with right heart strain. No medical history was provided that relates to previous venous or arterial thromboses. The patient did not have any previous reactions to medications especially heparin or anticoagulants. The patient did not have any confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient did not have any history of current malignancy. On 31-JUL-2021 the lowest count of platelet after vaccine was measured as 124.On 01-Aug-2021 There was discussion with Hematologist review ongoing. The Hemorrhage was not identified. The patient did not have a history of concurrent intracranial malignancy and concurrent or recent intracranial infections. The patient do not had any recent surgical or medical interventions to the central nervous system including lumbar puncture. No history of Trauma or Head injury was reported. Activated Partial Thromboplastin Clotting Time (APTT) was reported as 23.9, PT 11.4, Fibrinogen 4.0. Thrombophilia screening was pending. Infectious screening (example HIV, hepatitis C/B, herpes zoster/ CMV) was pending. 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. Patients past medical history and drugs without more information is a confounder for the case. ANTI-D (Rho) IMMUNOGLOBULIN has been r; 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. Patients past medical history and drugs without more information is a confounder for the case. ANTI-D (Rho) IMMUNOGLOBULIN has been reported as co suspect by RA.


VAERS ID: 1576112 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Eye pain, Gastroenteritis viral, Headache, Impetigo, Myalgia, Nausea, Night sweats, Pyrexia, Rash, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Impetigo; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Patient tested positive for COVID-19.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: impetigo; night sweats; diarrhea; eye ache; nauseous; fever; vomited; Epidemic vomiting and diarrhoea; Joint ache; Chills; Headache; Muscle ache; Impetigo contagious; Rash; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of EYE PAIN (eye ache), IMPETIGO (impetigo), NIGHT SWEATS (night sweats), DIARRHOEA (diarrhea) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Impetigo. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced NAUSEA (Nausea). On 01-Aug-2021, the patient experienced GASTROENTERITIS VIRAL (Epidemic vomiting and diarrhoea), IMPETIGO (Impetigo contagious), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), CHILLS (Chills), RASH (Rash) and HEADACHE (Headache). On an unknown date, the patient experienced EYE PAIN (eye ache), IMPETIGO (impetigo), NIGHT SWEATS (night sweats), DIARRHOEA (diarrhea), NAUSEA (nauseous), PYREXIA (fever) and VOMITING (vomited). On 01-Aug-2021, CHILLS (Chills) had resolved. At the time of the report, EYE PAIN (eye ache), IMPETIGO (impetigo), NIGHT SWEATS (night sweats), DIARRHOEA (diarrhea), NAUSEA (nauseous), PYREXIA (fever) and VOMITING (vomited) was resolving and NAUSEA (Nausea), GASTROENTERITIS VIRAL (Epidemic vomiting and diarrhoea), IMPETIGO (Impetigo contagious), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), RASH (Rash) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No Treatment medication reported. Additional information provided was that the patient was prescribed with medications which were 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: 1576119 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Illness, Influenza like illness, Maternal exposure during pregnancy, Migraine, Pain in extremity, Pyrexia, SARS-CoV-2 test, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; XONVEA
Current Illness: Migraine (Suffer with migraines but not had one for 3 years); Pregnancy (Twin pregnancy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Findings: Twin pregnancy.
CDC Split Type: GBMHRAWEBCOVID20210802121

Write-up: Maternal exposure during pregnancy; Migraine; Flu like symptoms; Sickness; Aches & pains in legs; Exhaustion; Fever; Stomachache; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), ILLNESS (Sickness), PAIN IN EXTREMITY (Aches & pains in legs), FATIGUE (Exhaustion), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Twin pregnancy) and Migraine (Suffer with migraines but not had one for 3 years). Concomitant products included FOLIC ACID for Folic acid supplementation, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (XONVEA) for Hyperemesis gravidarum. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 02-Aug-2021, ILLNESS (Sickness) had resolved. At the time of the report, MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Exhaustion) and PYREXIA (Fever) had not resolved, ABDOMINAL PAIN UPPER (Stomachache) was resolving, PAIN IN EXTREMITY (Aches & pains in legs) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (normal) Findings: Twin pregnancy.. On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment medication was provided. Patient was exposed to the medicine Second-trimester (13-28 weeks). Suffered with migraines but not had one for 3 years until the vaccine. Gestation period was 13-28 weeks. Company Comment: This is a case of product exposure during pregnancy with associated adverse events of migraine, influenza like illness, abdominal pain upper, illness, pain in extremity, fatigue and pyrexia. 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. As this case was reported by regulatory authority, no further information is requested.; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse events of migraine, influenza like illness, abdominal pain upper, illness, pain in extremity, fatigue and pyrexia. 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. As this case was reported by regulatory authority, no further information is requested.


VAERS ID: 1576121 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-31
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Erythema multiforme; This regulatory authority case was reported by an other health care professional and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications provided by the reporter. It was reported that the patient experienced Erythema Multiforme rash across legs and arms. 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: 1576140 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Depressed mood, Fatigue, Injection site erythema, Injection site pain, Myalgia, SARS-CoV-2 test, Viral rash
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Viral rash; Injection site redness; Joint pain; Fatigue; Muscle ache; Low mood; Injection site pain; This case was received via Regulatory Authority (RA) (Reference number: ADR 25741872) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VIRAL RASH (Viral rash), MYALGIA (Muscle ache), DEPRESSED MOOD (Low mood), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pain, Fibromyalgia, Migraine and Depression. Concomitant products included SERTRALINE (SERTRALIN [SERTRALINE]) for Depression, PREGABALIN for Fibromyalgia, PROPRANOLOL for Migraine, PARACETAMOL for Pain. On 31-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 31-Jul-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), DEPRESSED MOOD (Low mood) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced VIRAL RASH (Viral rash) (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant). At the time of the report, VIRAL RASH (Viral rash), MYALGIA (Muscle ache), DEPRESSED MOOD (Low mood), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness) and ARTHRALGIA (Joint pain) had not resolved and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were 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.; 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: 1576144 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Thermal burn
SMQs:, Accidents and injuries (narrow), COVID-19 (broad)

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

Write-up: Burn; This regulatory authority case was reported by a consumer and describes the occurrence of THERMAL BURN (Burn) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Depression. Concomitant products included MIRTAZAPINE for Depression. On 31-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 31-Jul-2021, the patient experienced THERMAL BURN (Burn) (seriousness criterion medically significant). At the time of the report, THERMAL BURN (Burn) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information 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: 1576150 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Myalgia, Peripheral swelling, SARS-CoV-2 test, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: injection site is red; Swelling arm; Skin warm; Muscle soreness; This case was received via regulatory authority on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), SKIN WARM (Skin warm), MYALGIA (Muscle soreness) and INJECTION SITE ERYTHEMA (injection site is red) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PROPRANOLOL and VENLAFAXINE for Anxiety. On 31-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 31-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (injection site is red) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm), SKIN WARM (Skin warm) and MYALGIA (Muscle soreness) had not resolved and INJECTION SITE ERYTHEMA (injection site is red) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Low) No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not 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 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: 1576151 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nervousness, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Faint; Dizzy; Nervous; Felt faint; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25743198) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Faint) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced DIZZINESS (Felt faint). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DIZZINESS (Dizzy) and NERVOUSNESS (Nervous). On 31-Jul-2021, DIZZINESS (Felt faint) had resolved. At the time of the report, SYNCOPE (Faint), DIZZINESS (Dizzy) and NERVOUSNESS (Nervous) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient waas not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576167 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Sore throat; Swollen glands; Sweating; Fever chills; Headache; Muscle soreness; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), OROPHARYNGEAL PAIN (Sore throat), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache), MYALGIA (Muscle soreness), FATIGUE (Fatigue) and PYREXIA (Fever chills) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) for Contraception. On 31-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 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 02-Aug-2021, HYPERHIDROSIS (Sweating) and PYREXIA (Fever chills) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Swollen glands) had not resolved and HEADACHE (Headache), MYALGIA (Muscle soreness) and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576171 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza, Influenza like illness, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: hours; tiredness; nausea; headache; flu like symptoms; Flu; This case was received via Agency Regulatory Authority (Reference number: 25744907) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), INFLUENZA (Flu), FEELING ABNORMAL (hours), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-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 31-Jul-2021, the patient experienced INFLUENZA (Flu) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant), FEELING ABNORMAL (hours) (seriousness criterion medically significant), FATIGUE (tiredness) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 02-Aug-2021, INFLUENZA (Flu) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (hours), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were reported. No treatment medication details was reported. It reported that patient had experienced flu like symptoms for 48 hours, involving severe ache in back, shoulders and neck. Severe headache and sensitivity to light. Nausea and tiredness. Very sore arm. Patient had not tested positive for COVID 19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576198 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Migraine, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: headache; chills; 38 fever; Pain; Acute migraine; Fever; Fever chills; This case was received via a regulatory authority (Reference number: 25747917) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), MIGRAINE (Acute migraine), HEADACHE (headache), CHILLS (chills), PYREXIA (Fever), PYREXIA (Fever chills) and PYREXIA (38 fever) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DIENOGEST, ESTRADIOL VALERATE (QLAIRA) from 01-Sep-2013 to an unknown date for Birth control pill. On 31-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 31-Jul-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), MIGRAINE (Acute migraine) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and PYREXIA (38 fever) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) had not resolved, MIGRAINE (Acute migraine), HEADACHE (headache), CHILLS (chills), PYREXIA (Fever) and PYREXIA (38 fever) was resolving and PYREXIA (Fever chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 (High) High temperature. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not provided. Symptoms not relieved by max dose of paracetamol (1000 every 5 hours), 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: 1576199 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anger, Asthenia, Depressed mood, Dermatitis allergic, Dizziness, Gingival pain, Headache, Injection site pain, Irritability, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gingival disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Fever; Sore gums; Outburst of anger; Allergic rash; Headache; Dizziness; Weakness; Irritability; Depressed mood; Muscle soreness; Pain injection site; This case was received via RA (Reference number: GB-MHRA-ADR 25748080) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain injection site), DIZZINESS (Dizziness), ASTHENIA (Weakness), IRRITABILITY (Irritability), DEPRESSED MOOD (Depressed mood), MYALGIA (Muscle soreness), DERMATITIS ALLERGIC (Allergic rash), GINGIVAL PAIN (Sore gums), PYREXIA (Fever), HEADACHE (Headache) and ANGER (Outburst of anger) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Premenstrual syndrome and Hashimoto''s disease. Concomitant products included LEVOTHYROXINE for Hashimoto''s disease, CITALOPRAM and DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) for Premenstrual syndrome. On 31-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 31-Jul-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), IRRITABILITY (Irritability) (seriousness criterion medically significant), DEPRESSED MOOD (Depressed mood) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash) (seriousness criterion medically significant) and ANGER (Outburst of anger) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced GINGIVAL PAIN (Sore gums) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, INJECTION SITE PAIN (Pain injection site), DIZZINESS (Dizziness), ASTHENIA (Weakness), IRRITABILITY (Irritability), DEPRESSED MOOD (Depressed mood), MYALGIA (Muscle soreness), DERMATITIS ALLERGIC (Allergic rash), GINGIVAL PAIN (Sore gums) and PYREXIA (Fever) had not resolved and HEADACHE (Headache) and ANGER (Outburst of anger) was resolving. No treatment information was provided by the reporter. On an unknow date-Aug2021, the patient had Fever. 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: 1576237 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pyrexia, Swelling
SMQs:, 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), 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: LEVOTHYROXINE; YASMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: General body pain; Local swelling; Injection site itching; Fever; Injection site redness; This case was received via Regulatory Authority (Reference number: ADR 25750443) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (General body pain), SWELLING (Local swelling), PYREXIA (Fever) and INJECTION SITE ERYTHEMA (Injection site redness) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) for Contraception, LEVOTHYROXINE for Hypothyroidism. On 31-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 31-Jul-2021, the patient experienced PAIN (General body pain) (seriousness criterion medically significant), SWELLING (Local swelling) (seriousness criterion medically significant), INJECTION SITE PRURITUS (Injection site itching), PYREXIA (Fever) (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant). On 02-Aug-2021, PAIN (General body pain) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (Local swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. No treatment information was provided. Company comment; Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576256 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone swelling, Diarrhoea, Fatigue, Influenza, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: swelling; tiredness; Bone swelling; Flu; Diarrhea; Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), BONE SWELLING (Bone swelling), SWELLING (swelling), DIARRHOEA (Diarrhea), FATIGUE (tiredness) and VOMITING (Vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. No Medical History information was reported. On 31-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 31-Jul-2021, the patient experienced INFLUENZA (Flu) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced BONE SWELLING (Bone swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (swelling) (seriousness criterion medically significant) and FATIGUE (tiredness) (seriousness criterion medically significant). On 01-Aug-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. On 02-Aug-2021, INFLUENZA (Flu) had resolved. At the time of the report, BONE SWELLING (Bone swelling) was resolving and SWELLING (swelling) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant information was not provided. First night after vaccine patient had flu aches, headaches, vomiting, diarrhea and an aching arm including underarm and into neck. Second day tiredness and sweats during sleep. Third day swelling around collarbone. Had taken antibiotics for the swelling. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576280 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: showed minor inferior ST elevation; Test Name: Troponin; Result Unstructured Data: troponin value of 991
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: chest pain; Myocarditis; This case was received via Regulatory Authority (Reference number: ADR 25754505) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (chest pain) and MYOCARDITIS (Myocarditis) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-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 31-Jul-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (chest pain) outcome was unknown and MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) showed minor inferior ST elevation. On an unknown date, Troponin: 991 (High) troponin value of 991. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. Patient had not tested positive for COVID-19 since having the vaccine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576471 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Night sweats
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Night sweats; Flu symptoms; This case was received via regulatory authority (Reference number: ADR 25771101) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) and NIGHT SWEATS (Night sweats) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-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 31-Jul-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced NIGHT SWEATS (Night sweats) (seriousness criterion medically significant). On 02-Aug-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, NIGHT SWEATS (Night sweats) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were given by the reporter. No Treatment information were 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 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: 1576481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-31
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CILIQUE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976901

Write-up: This is a report received from the Agency. A 32-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: EW3143), dose 1 via an unspecified route of administration on 04Jun2021 as single dose for covid-19 vaccination. Medical history included contraception. Patient did not have symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient last menstrual period date was 19Jul2021. Concomitant medication included ethinylestradiol, norgestimate (CILIQUE) taken for contraception from 02Aug2018 to an unspecified stop date. The patient experienced low grade fever (medically significant) on 31Jul2021 with outcome of not recovered. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event "pyrexia" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1576484 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

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

Write-up: Fever chills; Flu symptoms; Tiredness; Headache; Painful arm; This case was initially received via Regulatory Authority (Reference number: ADR 25737345) on 01-Aug-2021. The most recent information was received on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), PYREXIA (Fever chills), INFLUENZA (Flu symptoms) and FATIGUE (Tiredness) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concomitant products included CLOMIFENE CITRATE (CLOMID) for Fertility increased. On 31-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 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever chills) had resolved. On 04-Aug-2021, PAIN IN EXTREMITY (Painful arm) had resolved. On 05-Aug-2021, HEADACHE (Headache) and INFLUENZA (Flu symptoms) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient''s last menstrual period date was 21 Jul 2021 Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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. Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Follow up information was received wherein additional events were added and event outcome was changed.; 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: 1576485 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN (E.C.); CITALOPRAM; ESOMEPRAZOLE; FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100984741

Write-up: Headache; Fever; pregnancy; This is a solilcited report from a contactable consumer. This is the first of two reports. The first report is a report received from the Regulatory authority report number { GB-MHRA-YCVM-202108010809315380-IJHYY }, Safety Report Unique Identifier GB-MHRA-ADR 25737819. This consumer reported information for both mother and fetus.This is a maternal report. A 29-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813) (at the age of 29-year-old ) as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication; citalopram taken for an unspecified indication, esomeprazole taken for an unspecified indication and folic acid taken for vitamin supplementation. On an unknown date the patient had a negative COVID-19 test. The patient was pregnant at the time of vaccination. Estimated due date: 10Oct2021. The patient experienced headache and fever on 31Jul2021. The events were reported as medically significant. The outcome of the events was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events headache and pyrexia cannot be excluded.,Linked Report(s) : GB-PFIZER INC-202100998181 Foetus Case


VAERS ID: 1576489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Muscle spasms, Myalgia, Paraesthesia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swollen arm; Pins and needles; Muscle spasms; Dizziness; Muscle ache; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PARAESTHESIA (Pins and needles), MUSCLE SPASMS (Muscle spasms), DIZZINESS (Dizziness), MYALGIA (Muscle ache) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), MUSCLE SPASMS (Muscle spasms) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), PARAESTHESIA (Pins and needles) and MUSCLE SPASMS (Muscle spasms) had resolved, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial No treatment information was provided. No relevant concomitant medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the onset 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 onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1576496 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal 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: ASPIRIN (E.C.); CITALOPRAM; ESOMEPRAZOLE; FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998181

Write-up: Maternal exposure during pregnancy; Fetal movements decreased; YELLOW CARD VACCINE MONITOR This is a solilcited report from the regulatory authority from a contactable consumer. This is the second of two reports.The first report was downloded from the regulatory authority. Regulatory authority report number { GB-MHRA-YCVM-202108010809315380-IJHYY }, Safety Report Unique Identifier GB-MHRA-ADR 25737819. This consumer reported information for both mother and fetus.This is a fetus report. A 29 year old pregnant consumer received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), on 31Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. The consumer''s concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, citalopram taken for an unspecified indication,; esomeprazole taken for an unspecified indication, and folic acid taken for vitamin supplementation. The pregnancy estimated due date is 21Oct2021. The consumer experienced fetal movements decreased on 31Jul2021. The event was consdered medically significant. The outcome was not recovered. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, No further information is expected.; Sender''s Comments: Based on the available information in the case, the causal association between the events foetal hypokinesia, maternal exposure during pregnancy 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 and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-202100984741 Maternal Case


VAERS ID: 1576726 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; TRIAZOLAM; LOXONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Insomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100978436

Write-up: Vomiting; dizziness; nausea; This is a spontaneous report from a contactable other healthcare professional. A 64-year-old female patient received BNT162B2 (COMIRNATY; lot number was unknown and expiration date was not reported), intramuscular in left arm on 31Jul2021 13:00 (at the age of 64-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension and insomnia. Concomitant medication included bisoprolol fumarate 2.5 mg tablet; triazolam tablet 0.125 mg; loxoprofen sodium (LOXONIN). Historical vaccine included BNT162B2 (COMIRNATY; Solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient had no allergies history. The patient experienced vomiting, dizziness, and nausea on 31Jul2021 23:00. After the vaccination, the patient experienced dizziness and vomiting at the midnight and had vomiting 10 times or more times one day, in small amounts, and raw spit is produced. The patient drunk only small amount of water, experienced 1-2 times a day urine. The dizziness seems to have subsided, but it was hard due to nausea and vomiting. The reporter stated the events resulted in Doctor or other healthcare professional office or clinic visit. Treatment for the events included injection and oral as follows: Soldem 3A200ml, Primperan Injection 0.5% 10mg/2ml, MEYLON Injection 7% 20ml and Primperan Tablets 5mg 3 Tablets daily 3 times oral for 3 days. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on temporal relationship and since it is part of the product safety profile. 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: 1576729 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100979755

Write-up: Anaphylaxis; a feeling of clogging of the throat; This is a spontaneous report from a contactable physician received from the regulatory authority (PMDA). Regulatory authority report number is v21119540. A 51-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FD1945; Expiration Date: 31Oct2021), via an unspecified route of administration on 31Jul2021 14:30 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included allergy. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.1 centigrade. On 31Jul2021 at 14:30 (the day of vaccination), the patient received the second dose of the vaccine. On 31Jul2021 at 14:50 (20 minutes after the vaccination), the patient experienced Anaphylaxis. Clinical course was reported as follows: Since the patient complained of "a feeling of clogging of the throat", Bosmin 0.3 mg im and Rinderon 4 mg DIV performed. It soon improved. On 31Jul2021 (after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non serious and that the event was related to BNT162B2. There were no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered to be an allergic reaction. No follow up attempts are possible. No further information is expected.


VAERS ID: 1576735 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Epilepsy, Loss of consciousness, Musculoskeletal stiffness, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100980796

Write-up: This is a spontaneous report from a contactable physician (vaccinator) received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21119518. A 28-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FF4204; Expiration Date: 31Oct2021), via an unspecified route of administration on 31Jul2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunization. Medical history included epilepsy. The patient was diagnosed with epilepsy in another hospital (the final Epilepsy seizure was at the end of year before reporting). The patient''s concomitant medications were not reported. On 31Jul2021 the patient experienced transient loss of consciousness, epilepsy simple seizures, incapable of dialogue, hand and foot tightness and disorientation. The clinical course was as follows: On 31Jul2021 (the day of vaccination), the patient visited our hospital and asked for the Covid-19 vaccination. 10 minutes after the vaccination, the patient experienced Incapable of dialogue and Transient loss of consciousness, after that, hand and foot tightness, blinking action and disorientation was confirmed. Vital was normal. Epilepsy simple seizures was suspected on the basis of the medical history, emergency transfer to primary doctor was carried out (passed information to physician who is in charge of emergency cases). The outcome of events was reported as transferred to another hospital. The reporting physician classified the event as non-serious.


VAERS ID: 1576738 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Dysphoria, Erythema, Haemodynamic test
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria (due to meals( details unknown).)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210731; Test Name: Hemodynamics; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202100981321

Write-up: Dysphoria; Skin red; weakness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119526. A 45-year-old male patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration on 31Jul2021 at 12:53 (at the age of 45 years old) as a dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had relevant med history of Urticaria due to meals (details unknown). The patient''s concomitant medications were not reported. Event onset date was reported as 31Jul2021 at 13:13. On 31Jul2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: 20 minutes after vaccination, dysphoria, skin red, weakness appeared. hemodynamics was stable. Steroids was given as treatment. Then, the symptoms were improved and the patient went home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Side Effects Effective with Steroids. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576758 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Erythema, Feeling abnormal, Heart rate, Heart rate increased, Hypersensitivity, Oxygen saturation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:190/102; Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:141/97; Comments: at 14:15; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination.; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Low grade fever.; Test Date: 20210731; Test Name: P; Result Unstructured Data: Test Result:132; Test Date: 20210731; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100986486

Write-up: low grade fever with 36.9 degrees Centigrade; P 132; Allergic reaction; Blood pressure increased, BP 190/102; The patient felt poorly; redness on the neck and face; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119577. A 73-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 13:50 at 73-years-old (Batch/Lot Number: EY0572; Expiration Date: 31Oct2021) as dose 2, single COVID-19 immunization. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees Centigrade. On 31Jul2021 at 13:50, the patient received vaccination. The event onset date was reported as 31Jul2021 at 13:55 (5 minutes after the vaccination). After the vaccination, the blood pressure increased. BP 190/102, P 132, SpO2 98%. The patient felt poorly. On 31Jul2021 at 14:15 (25 minutes after the vaccination), BP decreased to 141/97, the condition became stable, but redness on the neck and face developed. Allergic reaction (illegible), vital signs were stable. When the patient arrived at the hospital, the redness had almost disappeared. Blood pressure decreased to 140 range, she received anti-allergic drug for 2 days, and returned home. On 01Aug2021 (1 day after the vaccination), there was no change in physical condition except for low grade fever with 36.9 degrees Centigrade. The patient outcome of the events blood pressure increased, bp 190/102; the patient felt poorly; redness on the neck and face was recovered on 31Jul2021. The outcome of other events was unknown. Therapeutic measures were taken as a result of blood pressure increased, bp 190/102; the patient felt poorly; redness on the neck and face; allergic reaction. The reporting classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: When the patient arrived at the hospital, the redness had almost disappeared. Blood pressure decreased to 140 range, she received anti-allergic drug for 2 days, and returned home. On 01Aug2021 (1 day after the vaccination), there was no change in physical condition except for low grade fever with 36.9 degrees Centigrade.; Reporter''s Comments: When the patient arrived at the hospital, the redness had almost disappeared. Blood pressure decreased to 140 range, she received anti-allergic drug for 2 days, and returned home. On 01Aug2021 (1 day after the vaccination), there was no change in physical condition except for low grade fever with 36.9 degrees Centigrade.


VAERS ID: 1576771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood sugar level; Result Unstructured Data: Test Result:96; Comments: showing no significant problem
CDC Split Type: JPPFIZER INC202100987257

Write-up: nausea; Vomiting; This is a spontaneous report from a contactable nurse received from the regulatory authority. Regulatory authority report number is v21122112. A 60-year and 5-month-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FE8206, Expiration date: 31Oct2021), via an unspecified route of administration, on 30Jul2021 at 15:38 (the day of vaccination), as dose 2, single for covid-19 immunization. The patient medical history according to the vaccine screening questionnaire included type 1 diabetes mellitus. Concomitant medications were not reported. On 31Jul2021 at 19:48 (1 day after the vaccination), the patient experienced vomiting and two days after vaccination patient had nausea. For this each events patient was admitted to hospital on 01Aug2021. The course of the event was as follows: on the next day of the vaccination, the patient had vomiting. The blood sugar level was 96, showing no significant problem, and the patient was also able to take dinner although the amount was small. Two days after the vaccination, the patient had nausea and vomiting, for which the patient visited the reporter''s hospital. Antiemetic was used, but the symptoms did not improve. On 01Aug2021 (2 days after the vaccination), the patient was admitted to the hospital for observation. The reporting nurse classified the event as serious (hospitalization from 01Aug2021) and assessed that the causality between the event and BNT162B2 as unassessable. Outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576774 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dyspnoea, Hypoaesthesia, Tetany
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (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: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood Pressure; Result Unstructured Data: Test Result:90/60; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccine
CDC Split Type: JPPFIZER INC202100988566

Write-up: Dyspnoea; Numbness of both upper extremities; blood pressure decreased to 90/60; Tetany appeared at the left finger/Hyperventilation tetany; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21119573. A 17-years-old male (reported as a 17-year and 4-month-old) patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EY5420; Expiration Date: 31Aug2021), via an unspecified route of administration on 31Jul2021 15:36 (at the age of 17 years old) as dose 1, single for covid-19 immunisation. There a point to be considered on the vaccine screening questionnaire which was irritable bowel syndrome as medical history from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination on 31Jul2021 was 36.8 degrees centigrade. The patient reported events with onset date and time reported as on 31Jul2021 at 15:58 (22 minutes after the vaccination). The course of the events was as follows: dyspnoea and numbness of both upper extremities appeared (also reported as after one minute). The blood pressure decreased to 90/60 and was injected with EpiPen 0.3mg intramuscularly. The symptoms improved slightly, and tetany appeared at the left finger. An ambulance was requested to take the patient to the hospital. The reporting physician classified the events as non-serious and assessed that the causality between the events and bnt162b2 as unassessable. There was a possible cause of the events such as any other diseases: Hyperventilation tetany. Therapeutic measures were taken as a result of the events reported. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1577104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: 210/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824982

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA300095873] concerned a 76 year old male of unspecified 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 (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 11:54, the patient''s blood pressure was elevated to 210/110 mmHg. Treatment medications included clonidine at 12:20. The action taken with Covid-19 vaccine was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210824982 -COVID-19 VACCINE-Elevated blood pressure. 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: 1577335 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Lymphadenopathy, Muscle spasms, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (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: CLARITYN ALLERGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101004530

Write-up: heart arrhythmias; Fever; muscle aches; swollen lymph nodes in the left armpit; muscle cramps; This is a spontaneous report from a non-contactable consumer, patient herself. A 36-years-old female (non-pregnant) patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported; Lot Number: FF3318) via an unspecified route of administration, administered in Arm Left on 31Jul2021 11:30 (at the age of 36-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included grass pollen allergy. Concomitant medications included loratadine (CLARITYN ALLERGY) taken for seasonal allergy, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 31Jul2021 22:00, the patient experienced heart arrhythmias (Medically significant), fever, muscle aches, swollen lymph nodes in the left armpit, muscle cramps. Patient did not receive treatment for the events caused. Outcome of all the events was recovering. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1577689 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN/AMLODIPINE NOVARTIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100977594

Write-up: I have not had a period for over 5 years - 2 weeks after first dose I have light bleeding - third day now.; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old non pregnant female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 13Jul2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amlodipine besilate, valsartan (VALSARTAN/AMLODIPINE NOVARTIS). The patient previously took codeine and experienced allergy. 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 31Jul2021 10:00, the patient have not had a period for over 5 years - 2 weeks after first dose she has light bleeding - third day now. No treatment was received for the event. The outcome of the event was Unknown. No Follow up attempts are possible, no further information expected.


VAERS ID: 1579304 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984585

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011043550100-AT2EJ, Safety Report Unique Identifier is GB-MHRA-ADR 25737921. A 38-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 29Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), on unspecified date (lot number and expiry date were not reported) for COVID-19 immunisation. The patient experienced swollen lymph nodes (medically significant) on 31Jul2021 with outcome of not recovered. The patient had negative COVID-19 virus test on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579306 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Back pain, Body temperature, Discomfort, Eye pain, Fatigue, Headache, Hypopnoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Respiratory failure (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: MARVELON
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: 39.4 Celsius
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Weakness; Eye pain; Sensation of heaviness; Headache; Vomiting; High temperature; Tiredness; Sore back; Breathing shallow; This case was received via Regulatory Authority (Reference number: 25737948) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Sore back), HYPOPNOEA (Breathing shallow), ASTHENIA (Weakness), EYE PAIN (Eye pain), DISCOMFORT (Sensation of heaviness), HEADACHE (Headache), VOMITING (Vomiting), PYREXIA (High temperature) and FATIGUE (Tiredness) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Acne. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (MARVELON) for Acne. On 31-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 31-Jul-2021, the patient experienced BACK PAIN (Sore back) (seriousness criterion medically significant), HYPOPNOEA (Breathing shallow) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant), EYE PAIN (Eye pain) (seriousness criterion medically significant) and DISCOMFORT (Sensation of heaviness) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Sore back), HYPOPNOEA (Breathing shallow), HEADACHE (Headache), PYREXIA (High temperature) and FATIGUE (Tiredness) had not resolved, ASTHENIA (Weakness), EYE PAIN (Eye pain) and DISCOMFORT (Sensation of heaviness) outcome was unknown and VOMITING (Vomiting) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Body temperature: 39.4 celsius (High) 39.4 Celsius. No treatment information was provided. Headache, sore back, tiredness, vomiting. I can''t eat, I''m struggling with fluids as they''re turning my stomach. I feel like I''m a lead weight and every movement is exaggerated. I have a temperature of 39.4 Celsius. Everything is sore, blinking is sore, breathing shallow and I feel weak. 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: 1579308 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984799

Write-up: Nausea; Ache; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011217436140-AOKAZ, Safety Report Unique Identifier GB-MHRA-ADR 25737999. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced nausea and ache on 31Jul2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579314 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
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 INC202100984728

Write-up: This is a spontaneous report from a contactable consumer received from the Agency. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot Number: FF3319), at the age of 27 years old, as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced arm discomfort on 31Jul2021 with outcome of not recovered and swollen and painful lymph nodes left axilla on an unspecified date with outcome of unknown. The patient underwent lab test which included Covid-19 virus test: no - negative Covid-19 test, on an unspecified date. The events were assessed as serious and medically significant by regulatory authority. Additional information: Swollen and painful lymph nodes left axilla. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, 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: LANSOPRAZOLE; VITAMIN B12 & FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue; Oesophageal reflux; Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984777

Write-up: pain under armpit; swollen lymph nodes, painful, in collar bone region and chest; swollen lymph nodes, painful, in collar bone region and chest; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012312288790-JAGWH and Safety Report Unique Identifier is GB-MHRA-ADR 25738483 A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 30Jul2021 (Lot number and expiry date were unknown) as single dose for COVID-19 immunisation. Medical history included transplant (recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney)), oesophageal reflux, and fatigue. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included lansoprazole taken for oesophageal reflux from 17Mar2020 and cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for fatigue from 30Jul2021. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on unspecified date (Lot number and expiry date were unknown) for COVID-19 immunisation. On 31Jul2021, the patient experienced swollen lymph nodes, painful, in collar bone region and chest, on the same side the vaccine was administered. The patient also had pain under armpit, same side, on unspecified date. The outcome of pain under armpit was unknown, while for the other events was not recovered. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.


VAERS ID: 1579324 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Menstruation irregular, Myalgia, Nausea, 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), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:High temperature
CDC Split Type: GBPFIZER INC202100992098

Write-up: Irregular periods; Muscle ache; Headache; High temperature; Shivering; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021525285830-UTOQV. Safety Report Unique Identifier GB-MHRA-ADR 25741787. A 30-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FD8813) via an unspecified route of administration on 31Jul2021 as dose 2 single (at the age of 30-year-old) 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 Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 05Jun2021 as dose 1 single for COVID-19 immunization. On 31Jul2021, patient experienced muscle ache, headache, high temperature, shivering, nausea. On 02Aug2021, patient experienced irregular periods. A majority of side effects began 12 hours (1 day) after 2nd dose of vaccine. 48 hours (2 days) after vaccine irregular bleeding is occurring. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event headache was recovering, event irregular periods was not recovered and outcome of the other events was recovered on 01Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579328 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocardial infarction, Pruritus
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992463

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108022015325220-MZVYD; safety report unique identifier: GB-MHRA-ADR 25743440). A 35-year-old patient, of an unspecified gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# and expiry date: unknown), at the age 35, on Jul 31, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test, nor tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The patient experienced itching all over and chest pain on Jul 31, 2021. The ambulance was needed because patient could not breath and felt like they were having a heart attack. The patient has long-term chest pain now. The outcome of the events recovered with sequelae. Serious case due to hospitalization, disabling/incapacitating and other medically important condition. No follow-up attempts possible. Information about lot number cannot be obtained.


VAERS ID: 1579358 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: stomach pain; Fatigue; Painful arm; Stomachache; This case was received via regulatory authority (Reference number: ADR 25754721) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN UPPER (Stomachache), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Nasal congestion and Asthma. Concurrent medical conditions included Subclinical hypothyroidism and Perennial rhinitis. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion medically significant). The patient was treated with HYOSCINE BUTYLBROMIDE (BUSCOPAN) for Stomach pain, at an unspecified dose and frequency. On 03-Aug-2021, PAIN IN EXTREMITY (Painful arm) had resolved. On 04-Aug-2021, ABDOMINAL PAIN UPPER (Stomachache) was resolving, FATIGUE (Fatigue) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided for the event Fatigue and Painful arm. Company Comment:Based on the current available information and temporal association between the use of the product and the start date of the events Abdominal pain upper (stomachache), Pain in extremity and Fatigue, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the event Abdominal pain upper (stomach pain) was assessed as ''Unlikely'' related to the vaccine because the patient experienced ''debilitating constant stomach pain after eating''.; 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 Abdominal pain upper (stomachache), Pain in extremity and Fatigue, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the event Abdominal pain upper (stomach pain) was assessed as ''Unlikely'' related to the vaccine because the patient experienced ''debilitating constant stomach pain after eating''.


VAERS ID: 1579372 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cough, Maternal exposure during breast feeding, Neonatal insufficient breast milk syndrome, Periarthritis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Functional lactation disorders (narrow), Neonatal exposures via breast milk (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; High temperature
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: High
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Frozen breast; High temperature; Cough; Maternal exposure during breast feeding; Neonatal insufficient breast milk syndrome; This regulatory authority case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen breast), NEONATAL INSUFFICIENT BREAST MILK SYNDROME (Neonatal insufficient breast milk syndrome), PYREXIA (High temperature), COUGH (Cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included High temperature and Cough. Concurrent medical conditions included Breast feeding. Concomitant products included PARACETAMOL from 29-Jul-2021 to an unknown date for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced NEONATAL INSUFFICIENT BREAST MILK SYNDROME (Neonatal insufficient breast milk syndrome) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIARTHRITIS (Frozen breast) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, PERIARTHRITIS (Frozen breast), NEONATAL INSUFFICIENT BREAST MILK SYNDROME (Neonatal insufficient breast milk syndrome), PYREXIA (High temperature) and COUGH (Cough) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient mentioned that 36 hours post vaccination she noticed that 12 week old was still hungry post feeding. Her baby wanted to feed every hour. After hours of trying to pacify baby realized he was not getting enough milk when feeding. She attempted to express and supply had dropped by almost 50% so resorted to frozen breast milk supply and eventually formula.1 week on and supply was returning to normal but this achieved via extra pumping and lots of close contact. This is a case of product exposure during breastfeeding with associated AEs for this 44 -year old female. This case is linked to child case [MOD-2021-280545]. No further information is expected. 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-2021-280545 (Parent-Child Link). See case MOD-2021-280545 for details regarding the child case.; Sender''s Comments: This is a case of product exposure during breastfeeding with associated AEs for this 44 -year old female. This case is linked to child case [MOD-2021-280545]. No further information is expected. 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: 1579529 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia, Neck pain, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain, Vaccination site rash
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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 Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991889

Write-up: Headache; Injection site rash; Injection site lump; Arthralgia; Generalized muscle aches; Neck pain; Pain injection site; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108020806464250-53WBH, Safety Report Unique Identifier GB-RA-ADR 25739260. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), dose 2 via an unspecified route of administration on 31Jul2021 (at the age of 31 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache, injection site rash, and injection site lump on 02Aug2021; arthralgia on 01Aug2021; generalized muscle aches, neck pain, and pain injection site on 31Jul2021. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 31Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the arthralgia and generalized muscle aches was recovering, of the neck pain was recovered on 02Aug2021, while of the remaining 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: 1579541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Dizziness, Hypertension, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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: SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data: Test Name: systolic blood pressure; Result Unstructured Data: Test Result:140 to 150; Comments: Several spikes in systolic blood pressure (140 to 150 over 70) - normally 110 over 70.; Test Date: 20210409; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992464

Write-up: Hypertension/Several spikes in systolic blood pressure; Dizziness; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021501520470-2N7AN. Safety Report Unique Identifier GB-MHRA-ADR 25741651. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: not known) as dose 2, single for COVID-19 immunization. Medical history included asthma. Concomitant medication included salbutamol (SALBUTAMOL) taken for asthma, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced dizzy spells/dizziness and nausea on 31Jul2021. The patient had hypertension/several spikes in systolic blood pressure (140 to 150 over 70) - normally 110 over 70 on 02Aug22021. The outcome of the events was not recovered. The events were medically significant. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included Negative COVID-19 test on 09Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1579805 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-31
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Eye movement disorder, Hemiplegia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (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 Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100987222

Write-up: Cerebral infarction; paralysis on left half body; conjugate deviation; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21122099. An 89-year and 11-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EY2173, Expiration Date: 31Aug2021), via an unspecified route of administration on 28Jun2021 14:00 at the age of 89 years old as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire. The patient previously received the first dose of BNT162B2 (COMIRNATY, Batch/Lot Number EY2173, Expiration date 31Aug2021) on 07Jun2021. Body temperature before vaccination (on 28Jun2021) was 36.6 degrees Centigrade. On 31Jul2021 at 09:30 (33 days after the vaccination), the patient experienced cerebral infarction. The course of the event was as follows: On 31Jul2021 (09:30), when the patient got up, paralysis on left half body and conjugate deviation were recognized, so ambulance was called. On an unspecified date, the patient was admitted to the hospital. Outcome of the events was unknown. The reporting physician classified the event as serious (life threatening and hospitalization) and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1579869 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pollinosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: High; Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: normal; Test Date: 20210731; Test Name: oxygen saturation; Result Unstructured Data: change in percutaneous oxygen saturation (SpO2) from 87 to 99; Test Date: 20210731; Test Name: oxygen saturation; Result Unstructured Data: Low
CDC Split Type: JPTAKEDA2021TJP071894

Write-up: Loss of consciousness; Bleeding from the back of the head; Vagal reflex; Fall; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case, initially reported to the Agency by a physician, was received via the RA (Ref, v21122105). On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 31-Jul-2021, at 17:58, the patient received the 1st dose of the vaccine. At 18:17, the patient left the room after observation. Immediately after that, the patient lost consciousness and fell, having bleeding from the back of the head. Administration of 10 L of oxygen was started. Adrenalin 0.3 mg was administered. The patient had spontaneous breathing. There was a change in percutaneous oxygen saturation (SpO2) from 87 to 99 and in blood pressure (BP) from 191/104 to 140/77. The patient was able to talk and was transported by ambulance. The symptoms were considered as vagal reflex. The outcome of vagal reflex, loss of consciousness, fall, and bleeding from the back of the head was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.


VAERS ID: 1579871 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Feeling abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Hypertension (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: JPTAKEDA2021TJP071897

Write-up: Increased blood pressure; Feels poorly; This case, initially reported to Regulatory Authority by a medical processor, was received via Moderna''s adverse reaction reporting site (TASK0020694). On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 02-Jul-2021, at 17:20, the patient received the 1st dose of this vaccine. At 17:24, feels poorly, cold sweat, and sensation of pressure developed. Thereafter, loss of consciousness (several seconds by about 3 times), lightheadedness, numbness of the upper body, weakness of hands, rapidly decreased blood pressure, breathlessness, and chills developed, and the patient was raced to a hospital. Anaphylaxis developed suddenly. The outcome of anaphylaxis (feels poorly, cold sweat, sensation of pressure, lightheadedness, numbness of the upper body, weakness of hands, rapidly decreased blood pressure, breathlessness, and chills) and loss of consciousness was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: 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: 1579889 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-31
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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: JPTAKEDA2021TJP072163

Write-up: Neurally mediated syncope; Vasovagal reaction; Dyspnoea; This case was received via agency(Reference number: 2021TJP072163) on 31-Jul-2021 and was forwarded to Moderna on 13-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Neurally mediated syncope) in a 25-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004229) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced SYNCOPE (Neurally mediated syncope) (seriousness criterion medically significant), PRESYNCOPE (Vasovagal reaction) and DYSPNOEA (Dyspnoea). On 31-Jul-2021, SYNCOPE (Neurally mediated syncope), PRESYNCOPE (Vasovagal reaction) and DYSPNOEA (Dyspnoea) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SYNCOPE (Neurally mediated syncope) and PRESYNCOPE (Vasovagal reaction) to be possibly related. No further causality assessment was provided for DYSPNOEA (Dyspnoea). No concomitant medications were reported by the reporter. On an unknown date, the patient''s body temperature before the vaccination was 36.4 degrees Celsius. It was reported that, ten minutes after receiving the second dose, the patient had vasovagal reaction. When the patient was in a sitting position, he seemed to be losing consciousness. He also felt dyspnoea. The patient was placed in a supine position in the first-aid room and after drinking a sports drink, the symptoms stabilized. No Treatment medication 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 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: 1579890 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (Poorly controlled)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.7 degrees Celsius.; Test Name: Body temperature; Result Unstructured Data: stable in supine position
CDC Split Type: JPTAKEDA2021TJP072175

Write-up: Neurally mediated syncope; Dizzy spells; This case was received via The Regulatory Authority (Reference number: 2021TJP072175) on 31-Jul-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician, was received by The Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020640). Neurally mediated syncope was assessed as serious by The Regulatory Authority. Poorly controlled hypertension. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 31-Jul-2021, at 19:29, the patient received the 1st dose of the vaccine. At 20:00, several minutes after the vaccination, the patient experienced lightheadedness and dizziness. The symptoms did not improve after 30 minutes, and the patient visited the first-aid room. The vital signs were stable in a supine position. The symptoms improved 15 minutes later. The patient was considered to experience nerally mediated syncope or dizzy spell. Dizziness may have been another possible contributing factor. The outcome of neurally mediated syncope and dizzy spell was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1579892 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072213

Write-up: Syncope; Vasovagal reflex (facial pallor, blood pressure decreased); Fall; This case was received via Regulatory Agency (Reference number: 2021TJP072213) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the Regulatory Agency by a physician, was received via the Regulatory Agency (Ref, v21122697). Syncope was assessed as serious. On an unknown date, body temperature before the vaccination: unknown. On 31-Jul-2021, at 17:59, the patient received the 1st dose of this vaccine. At 18:02, the patient had facial pallor. The patient had syncope and then fell. Consciousness improved immediately. At the onset of syncope, HR was 41, and BP was 56/41. At 18:12, HR was 41, and BP improved to 137/77. The symptoms disappeared. There were no skin, digestive, or respiratory symptoms. The patient was diagnosed with vasovagal reflex. The outcome of vasovagal reflex (facial pallor, blood pressure decreased), syncope, and fall was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: 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: 1579901 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Foreign body sensation in eyes, Heart rate, Hyperhidrosis, Oxygen saturation, Respiration abnormal, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (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: MONTELUKAST SODIUM
Current Illness: Allergy to insect sting (Bee allergy (carry adrenaline))
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (The patient''s mother had anaphylaxis after the 2nd dose of the Pfizer coronavirus vaccine.); Bronchial asthma (No regular inhalation, undertreatment only montelukast sodium, final attack in 3 years ago)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: blood pressure (BP) 160/114; Test Name: Pulse rate; Result Unstructured Data: pulse rate (PR) 94; Test Name: oxygen saturation; Test Result: 98 %; Result Unstructured Data: percutaneous oxygen saturation (SpO2) 98%
CDC Split Type: JPTAKEDA2021TJP073393

Write-up: Feeling of stuck in eye; Difficulty in breathing; Wheezing; Sweaty; This case was received via Pharmaceuticals (Reference number: 2021TJP073393) on 04-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case, initially reported by a physician, was received (Ref, v21122181). As a family history, the patient''s mother had anaphylaxis after the 2nd dose of the Pfizer coronavirus vaccine. On an unknown date, the patient received the 1st dose of this vaccination. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 31-Jul-2021, at 10:19, the patient received the 2nd dose of this vaccination. At 10:30, the patient noticed difficulty in breathing. At 10:40, the main complaint was appealed to the staff. At the time of medical examination, the patient had a wheezing by forced exhalation. There were no abdominal pain or skin eruption. Coma Scale (CS) 0, percutaneous oxygen saturation (SpO2) 98%, blood pressure (BP) 160/114, and pulse rate (PR) 94, and monitoring of vital signs was started in a supine position every 3 minutes. At 11:07, the patient noticed a feeling of stuck in the eyes; thus, d-chlorpheniramine maleate 5 mg was administrated intramuscularly. The patient also experienced sweaty. Though vital signs were maintained, an emergency request was made. Bronchial asthma was considered as other contributing factor. The outcomes of difficulty in breathing, wheezing, feeling of stuck on eye, and sweaty were resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1579905 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-31
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002181 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP073409

Write-up: Acute myocarditis (queasy, vomiting, chest pain); This case was received via regulatory authority on 04-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case reported by a physician, was received by regulatory authority via Modernas adverse reaction reporting site (TASK0020708) On 30-Jun-2021, the patient received the 1st dose of this vaccine. On 28-Jul-2021, the patient received the 2nd dose of this vaccine. On 30-Jul-2021, at 21:00, the patient experienced queasy. On 31-Jul-2021, around 00:00, the patient had aggravated queasy and vomiting. Thereafter, the patient experienced squeezing chest pain and requested an ambulance. An electrocardiogram showed extensive elevated ST at visit. The patient underwent cardiac catheterization, but there were no abnormalities in the coronary arteries. The patient was diagnosed with myocarditis and was hospitalized. The outcome of acute myocarditis (queasy, vomiting, chest pain) was reported as resolving. Follow-up investigation will be made.; 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: 1580056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic 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: Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIJNJFOC20210829783

Write-up: HEMORRHAGIC STROKE; This spontaneous report received from a consumer via a Regulatory Authority [SI-JAZMP-NCPHV-2021SI0812_0812] concerned a 53 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-05 expiry: UNKNOWN) 1 dosage forms, one total, administered on 21-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced hemorrhagic stroke, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhagic stroke was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210829783- Covid-19 vaccine ad26.cov2.s-hemorrhagic stroke. This event is considered unassessable. The event 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.


VAERS ID: 1582193 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210830147

Write-up: ARTHRALGIA; CHILLS; VOMITING; HEADACHE; PYREXIA; This spontaneous report received from a consumer via a Regulatory Authority [AT-BASGAGES-2021-40068] concerned a 17 year old female. 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, and batch number were not reported) dose was not reported, 1 total, administered on 31-JUL-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 31-JUL-2021, the patient experienced arthralgia, chills, vomiting, headache and pyrexia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pyrexia, had not recovered from arthralgia, and headache, and the outcome of chills and vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210830147-covid-19 vaccine ad26.cov2.s-arthralgia, chills, vomiting, headache, pyrexia.. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1583200 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Oropharyngeal discomfort, Pneumonia, SARS-CoV-2 antibody test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified (on medications); Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID test; Result Unstructured Data: Test Result:Negative
CDC Split Type: AUPFIZER INC202100994456

Write-up: pneumonia with shortness of breath and fever; Really bad headache, severe; throat felt prickly; unwell; This is a spontaneous report from a contactable consumer (patient''s wife) received via medical information team. A 58-year-old male patient received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), via an unspecified route of administration on 30Jul2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing heart disease (on medications) and he is also supposedly immunocompromised. The patient''s concomitant medications were not reported. The patient experienced unwell on 31Jul2021, but got really bad on 01Aug2021, pneumonia with shortness of breath and fever, really bad headache, severe and throat felt prickly on 01Aug2021. The patient was hospitalized for the events. As of the day of this report, patient was still in hospital, but condition has improved. Enquirer would like to know if this is from the vaccine and what the side effects of the vaccine include. The reporter believes there was a lack of duty of care, and these nurses were rushing the vaccination process and not considering each patient''s individual medical history appropriately. Outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1583551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-07-31
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, International normalised ratio, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL; COUMADIN.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: INR; Result Unstructured Data: Test Result:big INR increase; Test Date: 20210803; Test Name: INR; Result Unstructured Data: Test Result:4.8
CDC Split Type: CAPFIZER INC202101013590

Write-up: first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21May2021 as dose 1and second dose 31Jul2021; INR increased; This is a spontaneous report received from a contactable pharmacist from the medical information team. This pharmacist reported similar events for 2 patients. This is the second of 2 reports. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21May2021 (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced INR increased on an unspecified date in 2021. It was reported that after first dose on 21May2021 patient had big INR increase, had not found why, and came on 03Aug2021 and her INR was 4.8. Had second dose on 31Jul2021 then saw a link, and in addition said was unbalanced which decreased INR, took 2 Tylenol but under 2g so that''s not what has effect on INR (as reported). The outcome of event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event INR increased and the administration of the vaccine 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: 1585138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: End stage renal disease (ESRD); Haemodialysis; Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Morbid obesity; Psoriasis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210830510

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-PO20214154] concerned a 57 year old female, unspecified race and ethnicity. The patient''s weight was 114.5 kilograms, and height was 163 centimeters. The patient''s concurrent conditions included: haemodialysis, psoriasis, insulin-requiring type 2 diabetes mellitus, end stage renal disease (ESRD), hypertension arterial, and morbid obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-03 expiry: UNKNOWN) 0.5 ml, 01 total, administered on 02-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced vaccination failure, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210830510-covid-19 vaccine ad26.cov2.s-vaccination failure. 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: SPECIAL SITUATIONS


VAERS ID: 1585241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / OT

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

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: Chronic fatigue syndrome; Polycystic ovary (awaiting consultation but was flagged by a doctor because of symptom consistency.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992432

Write-up: Excruciatingly painful period on first occurrence after vaccine; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00257559. Safety Report Unique Identifier GB-MHRA-ADR 25737503. A 23-year-old female patient received the first dose of BNT162B2, dose 1 parenteral on 17Jul2021 (Lot Number: Fe1510) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing, polycystic ovary syndrome (awaiting consultation but was flagged by a doctor because of symptom consistency). The patient''s concomitant medications were not reported. The patient experienced excruciatingly painful period on first occurrence after vaccine on 31Jul2021. The event was medical significant and caused disability. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585301 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-31
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Hypoaesthesia, Pain in extremity, SARS-CoV-2 test, Thrombosis, X-ray
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (Product Name : SERTRALINE drug start date: 01Aug2015); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood markers; Result Unstructured Data: Test Result:signs of a clot; Comments: Went to hospital and blood markers had signs of a clot; Test Name: Ecg bloods; Result Unstructured Data: Test Result:Unknown Result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown Result
CDC Split Type: GBPFIZER INC202101017271

Write-up: chest pain; dead arm; Left arm pain; Thrombus; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202108020944409980-2VWUQ, Safety Report Unique Identifier: GB-MHRA-ADR 25739814. A 32-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FE1510; Expiration Date: unknown), dose 1 via an unspecified route of administration on 07Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation (unknown if ongoing or not) and anxiety. Concomitant medications included sertraline taken for anxiety from 01Aug2015. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at the time of vaccination, patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 31Jul2021, the patient experienced thrombus; on an unspecified date, the patient experienced chest pain, dead arm and left arm pain. The clinical course of the events was as follows: 8 days after taking vaccine I had severe chest pain on left side. Left arm pain and dead arm. Went to hospital and blood markers had signs of a clot. Was put on blood thinners and I''m waiting to return in 3 days for a scan. The patient underwent lab tests and procedures which included sars-cov-2 test: negative No -Negative COVID-19 test, blood test: signs of a clot Went to hospital and blood markers had signs of a clot, electrocardiogram: unknown result, x-ray: unknown result. Therapeutic measures were taken as a result of thrombus. The clinical outcome of the events thrombus was not resolved; chest pain, dead arm and Left arm pain was unknown. No follow-up attempts are possible; No information is expected.


VAERS ID: 1585303 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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: 20210731; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100992084

Write-up: COVID-19/positive COVID-19 virus test; COVID-19/positive COVID-19 virus test; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020959325270-0XOJH, Safety Report Unique Identifier GB-MHRA-ADR 25739786. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (lot number was not reported) on unspecified date and second dose on 23Mar2021 (Lot Number: er1741); bot via unspecified route of administration as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced COVID-19 with positive COVID-19 virus test on 31Jul2021. The outcome of the event was not recovered. No follow-up attempts are possible; information about the lot number of first dose cannot be obtained. No further information is expected.


VAERS ID: 1585308 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Herpes zoster, Photophobia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991912

Write-up: Vaccination site pain; Fatigue; within; Shingles; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108021023090330-XWKSS], Safety Report Unique Identifier [GB-MHRA-ADR 25739962]. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on 17Jul2021 (Lot Number: FC9001) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination site pain, fatigue and photophobia on an unspecified date; shingles on 31Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the events was unknown. The clinical course was reported as follows: Shingles starting within 2 weeks of vaccine administration. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Otherwise fit and well, no regular meds. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Fatigue, Lower respiratory tract infection, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications: BUDESONIDE; DOXYCYCLINE; LIDOCAINE; PREDNISONE; TRAMADOL
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Hip bursitis; Lactation decreased; Lung scarring (11 years old); Osteoarthritis; Pneumonia; Steroid therapy
Allergies:
Diagnostic Lab Data: Test Date: 20200504; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100992074

Write-up: tiredness; chest infection; vaccine was given to left arm. Painful to touch; no energy; Swollen lymph nodes; Breathlessness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021109068300-S87HR. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25740237 A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on the left arm, on 30Jul2021 (Batch/Lot number was not reported) as dose 2, single, both for Covid-19 immunisation. Medical history included lactation decreased, asthma ongoing, and has been admitted to hospital for asthma to be put on nebuliser, pneumonia, and scarring to lung (when 11-years-old), osteoarthritis, hip bursitis, steroid therapy from an unknown date and unknown if ongoing. 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. Concomitant medications included budesonide taken for asthma from 06Dec2020 to an unspecified stop date; doxycycline taken for chest infection from 18May2021 to 24May2021; lidocaine taken for hip bursitis from 24Jun2021 to 24Jun2021; prednisone taken for chest infection from 18May2021 to 22May2021; tramadol taken for osteoarthritis from 02Jul2010 to an unspecified stop date. The patient experienced tiredness on an unspecified date with outcome of recovering, chest infection on an unspecified date with outcome of recovering, swollen lymph nodes on 01Aug2021 with outcome of not recovered, breathlessness on 31Jul2021 with outcome of not recovered, vaccine was given to left arm. Painful to touch on an unspecified date with outcome of unknown and no energy on an unspecified date with outcome of unknown. The patient underwent lab test which included Covid-19 virus test: Negative COVID-19 test n 04May2020. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. Swollen lump near left collarbone, vaccine was given to left arm. Painful to touch and can move with touch. Also breathlessness, extreme tiredness and no energy. This happened after first dose and was given steroids for chest infection and has happened again after second dose. No steroids given as yet. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; LEVOTHYROXINE; LIOTHYRONINE; ZAPAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Nerve damage; Thyroid cancer
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100992036

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021152062100-C4NIZ, GB-MHRA-ADR 25740377. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: Not known) as dose 2, single for covid-19 immunisation. Medical history included thyroid cancer from the yrs ago (new node being monitored), nerve injury, and fibromyalgia from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at time of vaccination. Concomitant medications included AMITRIPTYLIN taken for nerve injury, start and stop date were not reported; levothyroxine taken for thyroid cancer, start and stop date were not reported; liothyronine taken for thyroid cancer, start and stop date were not reported; and ZAPAIN taken for fibromyalgia, start and stop date were not reported. The patient experienced swollen lymph nodes on 31Jul2021. Swollen lymphs 2 x neck I x groin 2 x armpit. The event was reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test negative on an unknown date, Negative COVID-19 test. Patient is not enrolled in clinical trial. The outcome of the event was not recovered. No follow-up attempts are possible, information on the batch/lot number could not be obtained. No further information was expected.


VAERS ID: 1585345 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Inappropriate schedule of product administration, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Oral contraception; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992045

Write-up: difficulty breathing; throat feeling tight; tight pain in chest; Acute anaphylaxis; Dosage text: 2, Date of start of drug: 31Jul2021, Dosage text: 1, Date of start of drug: 26May2021; This is a spontaneous report from a contactable consumer received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108021315041470-0ZKXC, Safety Report Unique Identifier is GB-MHRA-ADR 25741061. An 18-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FE3380, Expiry date not reported), via an unspecified route of administration as DOSE 2, SINGLE on 31Jul2021 (age at vaccination was 18 years) for COVID-19 immunization. Medical history included oral contraception. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Concomitant medication included ethinylestradiol, levonorgestrel (LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for oral contraception, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: FA5643 and expiry date not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced acute anaphylaxis on 02Aug2021 with outcome of recovering, difficulty breathing on an unspecified date with outcome of not recovered, throat feeling tight on an unspecified date with outcome of not recovered, and tight pain in chest with outcome of not recovered and dosage text: 2, date of start of drug: 31Jul2021, dosage text: 1, date of start of drug: 26May2021 on 31Jul2021 with outcome of unknown. The event anaphylactic reaction was reported as serious, medically significant by the health authority, while the other events were non-serious. Narrative case summary and further information: Throat feeling tight, difficulty breathing, tight pain in chest, lasted 3-4 hours. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585360 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Back pain, Breast pain, Chills, Dizziness, Fatigue, Hypersomnia, Malaise, Pain, Pain in extremity, Paraesthesia, Poor quality sleep, Speech disorder, Swelling, Tremor, Vaccination site pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992038

Write-up: slept for 18 hours; felt sick; Pain under armpit; Shaking; restricted pains in thighs; Shivers; Dizzy spells; Vomiting; Swelling under armpit; Joint pain; pain spread across back; pain into left breast; pins and needles in hands; felt like I''d been hit by a truck; couldn''t speak properly; restless nights sleep; Exhaustion; pain to the injection site area; 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-202108021436078070-9ITCG, Safety Report Unique Identifier GB-MHRA-ADR 25742153. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF3319), dose 2 via an unspecified route of administration on 31Jul2021 15:00 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 from 14Feb2020 and unsure when symptoms stopped. The patient had not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 in left arm for COVID-19 immunisation and experienced pain in arm and couldn''t lift arm. On 31Jul2021, the patient experienced exhaustion and pain to the injection site area. On 01Aug2021, the patient experienced felt sick, pain under armpit, shaking, restricted pains in thighs, shivers, dizzy spells, vomiting, swelling under armpit, joint pain, pain spread across back, pain into left breast, pins and needles in hands, felt like i''d been hit by a truck, couldn''t speak properly, and restless nights sleep. On 02Aug2021, the patient slept for 18 hours. The events were medically significant. Therapeutic measures were taken as a result of exhaustion and included treatment with sleep and felt sick and included treatment with water. Outcome of the dizzy spells and vomiting was recovered on 01Aug2021, of the exhaustion, shivers, and shaking was recovered on 02Aug2021, of the felt sick and pain in thigh was recovering, of the armpit pain, local swelling, and joint pain was not recovered, while of the remaining events was unknown. The clinical course was reported as follows: This box does not seem to be refreshing for each symptom. So will summarize all. I had both jabs in my left arm. After the first I had severe pain in my arm for 2 days and couldn''t lift my arm. I had the second around 3pm on 31Jul21. By evening I started to feel tired and pain to the injection site area. However by the next morning I had swelling and pain under my armpit. Which worsened throughout the day at work. I kept going dizzy. By 7pm 01Aug21 I was in agony with the pain to my arm, armpit, which felt swollen, had to hold it away from my ribcage. The pain spread across my back and into my left breast. I got cold chills, started shaking badly, felt sick and threw up several times from the pain. I got joint pain and pins and needles in hands. I got restricted pains in my thighs. Then suddenly felt like I''d been hit by a truck, exhausted and when I rang my mum worried, I couldn''t speak properly. I just needed to sleep. I fell asleep after the call, for a couple of hours. I woke feeling terrible, drank water and had a restless nights sleep. Was woken by my 5am work alarm, but was still in agony, so notified them and went straight back to sleep. Slept until 2pm. So I slept for 18 hours! Now feel shattered, feels like a knife in my armpit, swollen and very painful. Have joint pain and tingling in my hands. So I thought I should report this to you. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Please provide details of any relevant investigations or tests conducted: "None, I can''t get through to emergency services or my gp". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585368 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Pruritus, Rash macular, Skin warm, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; DULOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Pain relief
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992371

Write-up: itching; Skin warm; Red blotches; Injection site itching; Pain in arm; Injection site lump; Swelling arm; Localized muscle weakness; Injection site redness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021514359730-2GNTR, Safety Report Unique Identifier GB-MHRA-ADR 25741867. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (at the age of 37-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Lactation decreased, contraception, Pain relief. 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. Concomitant medications included desogestrel (CERELLE) taken for contraception from 04Jul2016 to an unspecified stop date; duloxetine taken for Pain relief, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for COVID-19 immunisation. It started in the evening of having the injection. The muscle in arm is pretty swollen with redness at the injection site. She now have a red, warm and painful blotch of skin approximately 10cm under the injection site and muscle is itching, painful and weak. The patient experienced itching on an unspecified date with outcome of recovering, swelling arm on 31Jul2021 with outcome of not recovered, skin warm on 02Aug2021 with outcome of not recovered , injection site itching on 01Aug2021 with outcome of recovering , localized muscle weakness on 31Jul2021 with outcome of not recovered , injection site redness on 31Jul2021 with outcome of not recovered, pain in arm on 01Aug2021 with outcome of not recovered , injection site lump on 01Aug2021 with outcome of not recovered , red blotches on 02Aug2021 with outcome of not recovered. Events were medically significant. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585398 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CILIQUE; FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992091

Write-up: Ache; Chills; Sweating; Painful arm; This is a spontaneous report from a contactable consumer or other non hcp Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021703421330-NMNKH. Safety Report Unique Identifier GB-MHRA-ADR 25742434. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and on 31Jul2021 (Batch/Lot Number: Fe3380) as DOSE 2, SINGLE; at the age of 32 years via unspecified routes of administration for covid-19 immunisation. Medical history included lactation decreased, contraception and depression. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included ethinylestradiol, norgestimate (CILIQUE) taken for contraception from 01Dec2011 to an unspecified stop date; fluoxetine taken for depression from 10Feb2010 to an unspecified stop date. The patient experienced painful arm on 31Jul2021; ache, chills and sweating on 01Aug2021. It was reported that "More intense and longer-lasting than first jab". The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 27Jul2021. The outcome of the events was not recovered. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1585406 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Headache, Hypersomnia, Pain
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992017

Write-up: Sleep a lot slept; Headache; Ache/ body aching; Tiredness; Pain back; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108021806138810-4UBVU, Safety Report Unique Identifier is GB-MHRA-ADR 25742697. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 31Jul2021 (at the age of 39 years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Concomitant medications were not reported. The patient experienced headache on 31Jul2021 with outcome of not recovered, ache/ body aching on 31Jul2021 with outcome of recovering, tiredness on 31Jul2021 with outcome of not recovered, pain back on 31Jul2021 with outcome of recovering and sleep a lot from 31Jul2021 18:30 with outcome of recovered on 01Aug2021 05:45. Therapeutic measures were taken as a result of headache that included paracetamol. The events were reported as serious, medically significant. Case narrative: Constant headache since jab paracetamol only helps for an hour before pain back. 20 hours after jab, woke up still body aching stopped 8 hours later then started again 6 hours later. Tired since jab can sleep a lot slept from 18:30 until 05:45 on 1st aug, slept hour and half at 13:06 until 14.30 this afternoon. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1585415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992028

Write-up: Fever; Tiredness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021943212220-ITJXE.[Safety Report Unique Identifier: GB-MHRA-ADR 25743257]. A 33-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number was not provided), via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation and hypothyroidism. Concomitant medication included levothyroxine for hypothyroidism from 2013 to an unspecified stop date. The patient experienced fever on 02Aug2021; had tiredness on 31Jul2021. The events were reported as serious medically significant. The outcome of event fever as recovering; for tiredness was recovered on 31Jul2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1585416 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hot flush, Lymphadenopathy, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; 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 INC202100992417

Write-up: This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202108021952561730-P1WGV, Safety Report Unique Identifier GB-MHRA-ADR 25743278. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (at the age of 31-year-old) (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, depression. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for depression. The patient experienced chills on 01Aug2021, swollen lymph nodes on 02Aug2021, hot flushes facial on 31Jul2021, armpit swollen in 2021; all medically significant. Armpit swollen on side where she had the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. The outcome of the event swollen lymph nodes was not recovered, armpit swollen was unknown, others was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Fatigue, Illness, Neck pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991946

Write-up: Neck pain; Sickness; Constipation; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108022041136530-DUS3F, Safety Report Unique Identifier GB-MHRA-ADR 25743571. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation.The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at time of vaccination. Concomitant medication included citalopram (Manufacture Unknown) taken for an unspecified indication from 21Dec2018 to an unspecified stop date. The patient experienced tiredness on 31Jul2021, neck pain, sickness, and constipation on 01Aug2021. The events were reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on unspecified date (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
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 INC202100992127

Write-up: heart fluttering; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108022107355320-6FK9Q. Safety Report Unique Identifier GB-MHRA-ADR 25743666. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced heart fluttering on an unspecified date and palpitations on 31Jul2021 which was reported as uncontrollable. The events were assessed as serious (medically significant). The outcome of the event palpitations was recovered with sequel and heart fluttering was unknown. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1585447 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Headache, Insomnia, Nausea, Poor quality sleep, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Lipodystrophy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992114

Write-up: poor sleep; Breast pain female/ breast pain; Headache; Nausea; Sleep loss; Itchy legs/ Itchy upper limbs; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108030124571190-AUTVL, Safety Report Unique Identifier GB-MHRA-ADR 25744141. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on 31Jul2021 (at the age of 29-year-old) as dose 2, 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 at time of vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced poor sleep on an unspecified date, headache, nausea, sleep loss, itchy legs, and itchy upper limbs on 31Jul2021, breast pain female/ breast pain on 01Aug2021. Vaccination was early afternoon and nausea began within 6hrs along with a headache. Paracetamol resolves the headache but it does return twice a day on the third day only one instance of headache. Nausea frequent since day one (day one being vaccination day) on day three it began to lessen. Issues falling asleep and then staying asleep throughout the night each night since the vaccination. Itchiness was specifically arms, legs and face however this was during the night when sleep was difficult and possibly contributed to poor sleep. Breast pain began on day two, initially a slight ache on the right breast, at the right hand side of the breast. Not consistently aching, just minor ache lasting a few moments then disappearing. This occurred approximately 3-4 times on day two. On day three there were approximately 2-3 occasions of an ache on the same breast, towards the underside. The events were reported as medically significant. Therapeutic measures were taken as a result of headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of poor sleep was unknown, sleep loss was not recovered, itchy legs and itchy upper limbs recovered on 02aug2021, while the rest of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585478 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Menstrual disorder, SARS-CoV-2 test, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: CODEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Backache; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Menstruation abnormal; Raw throat; Headache; This case was received via RA (Reference number: 202108040905026110) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation abnormal), THROAT IRRITATION (Raw throat) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Backache and Lactation decreased. Concomitant products included CODEINE for Leg injury. On 30-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 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant) and THROAT IRRITATION (Raw throat) (seriousness criterion medically significant). At the time of the report, MENSTRUAL DISORDER (Menstruation abnormal) was resolving and THROAT IRRITATION (Raw throat) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 4-AUG-2021 for COVID-19 virus test result was No - Negative COVID-19 test patient informed that IUD replacement Jan 21 and no periods since (was in 6th year or prior IUD due to covid but still had very few occasions of spotting). Very unusual to get a period and/or any cramps & backache. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1585529 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: 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 INC202101014798

Write-up: Vaccination failure; Inappropriate schedule of vaccine administered; SARS-CoV-2 infection; Nausea; Pain in arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number GB-MHRA-WEBCOVID-202108070353058160-WAGLZ, Safety Report Unique Identifier GB-MHRA-ADR 25768923. A 40-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: unknown) via an unspecified route of administration on 31Jul2021 (age at vaccination 40-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via unspecified route of administration on 02Jun2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing. Patient had no symptoms associated with COVID-19. Patient was not on breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced vaccination failure, Inappropriate schedule of vaccine administered on an unspecified date, pain in arm on 31Jul2021, nausea on 01Aug2021 and sars-cov-2 infection on 06Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test was negative on an unspecified date No - Negative COVID-19 test. The outcome of the events sars-cov-2 infection was not recovered, nausea was recovered on 02Aug2021 and pain in arm was recovered on 03Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991984

Write-up: Headache; Fatigue; This is a solicited report from the RA from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108021251533400-DAJ6M, Safety Report Unique Identifier GB-MHRA-ADR 25740809. An 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 vaccination. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s last menstrual period date is 10Jul2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fatigue on 31Jul2021, headache on 01Aug2021. Events were reported as medical significant. Patient was not enrolled in clinical trial. The outcome of events was recovered on 02Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1586096 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: In data 30/07/21 mi ? stato somministrato il vaccino Moderna. In data odierna si ? manifestato un angiodema all''occhio destro palpebrale. ? seguito accesso al ps.; The dose of Moderna vaccine was 0.3 ml; This case was received via regulatory authority (Reference number: 765719) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGIOEDEMA (In data 30/07/21 mi ? stato somministrato il vaccino Moderna. In data odierna si ? manifestato un angiodema all''occhio destro palpebrale. ? seguito accesso al ps.) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 31-Jul-2021, the patient experienced ANGIOEDEMA (In data 30/07/21 mi ? stato somministrato il vaccino Moderna. In data odierna si ? manifestato un angiodema all''occhio destro palpebrale. ? seguito accesso al ps.) (seriousness criterion medically significant) and ACCIDENTAL UNDERDOSE (The dose of Moderna vaccine was 0.3 ml). At the time of the report, ANGIOEDEMA (In data 30/07/21 mi ? stato somministrato il vaccino Moderna. In data odierna si ? manifestato un angiodema all''occhio destro palpebrale. ? seguito accesso al ps.) was resolving and ACCIDENTAL UNDERDOSE (The dose of Moderna vaccine was 0.3 ml) had resolved. No concomitant medications provided. No treatment medications provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality of Accidental underdose is not applicable. Translation is pending.; 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. Causality of Accidental underdose is not applicable. Translation is pending.


VAERS ID: 1586098 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

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

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

Write-up: This case was received via E Agency (Reference number: 765819) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 24-year-old female patient who received mRNA-1273 (batch no. 3004669) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 31-Jul-2021, after starting mRNA-1273 (, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS had resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding the event have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the event have been provided at this time. No further information is expected.


VAERS ID: 1586155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Feeling abnormal, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope, 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Dizziness on standing up
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result:106/60 mmHg; Comments: 14:28; Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result:102/60 mmHg; Comments: 14:50; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210731; Test Name: pulse; Result Unstructured Data: Test Result:60; Comments: 14:28 /min; Test Date: 20210731; Test Name: pulse; Result Unstructured Data: Test Result:66; Comments: 14:50 /min; Test Date: 20210731; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202100987979

Write-up: Cold sweat; Feels poorly; Light-headed feeling; Loss of consciousness; Aphose; vasovagal reflexes; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122086. The patient was a 19 years old female. Body temperature before vaccination was 36.0 degrees centigrade. The patient''s history was no special need to record (dizziness on standing up has been a frequent occurrence since the past. There was no symptom at Influenza immunization vaccination or other vaccination). There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication was not reported. On 31Jul2021 at 14:22(the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. The onset date/time was reported as on 31Jul2021 at 14:25 (3 minutes after the vaccination). On 31Jul2021 at 14:50 (28 minutes after the vaccination), the outcome of the events was recovered. The course of the event was as follows: On 31Jul2021 at 14:22 (the day of vaccination), the patient received the vaccine. On 31Jul2021 at 14:25 (3 minutes after the vaccination), the patient was waiting in the seat and the patient appeared feels poorly and light-headed feeling. The nurse was called. The nurse took the patient to another room on foot and the patient felt Aphose, loss of consciousness. The patient was in the supine position and the lower limbs should be clenched in a fist. After about 30 seconds, consciousness was recovered. On 31Jul2021 at 14:28 (6 minutes after the vaccination), after the doctor''s observation, the patient was Consciousness clearly and had cold sweat (++). Blood pressure 106/60mmHg, pulse 60/min, SpO2 97%. No rash, no enanthema, no itching. No wheezing.No other respiratory symptoms, gastrointestinal symptoms.Diagnosis of vasovagal reflexes was made, and observation was carried out (no treatment such as intravenous drip). On 31Jul2021 at 14:50 (28 minutes after the vaccination), the patient was consciousness clearly, no cold sweat. No symptoms in standing position. Blood pressure 102/60mmHg, pulse66/min. On 31Jul2021 at 15:40 (1 hour and 18 minutes after the vaccination), the patient showed no particular change and then went home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: After vaccination, when the patient feels poorly, the patient should be moved to the place indicated by the doctor by wheelchair and stretcher.


VAERS ID: 1586159 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Nausea, Ophthalmological examination, Tremor, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Cholecystolithiasis (scheduled for surgery); Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210731; Test Name: eye examination; Result Unstructured Data: Test Result:the patient had normal light reflexes
CDC Split Type: JPPFIZER INC202100988695

Write-up: giddiness; feeling queasy; Vertigo; tremulousness of the hand appeared during the course of the observation in the seat; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21122157. The patient was a 46-year-old female. Body temperature before vaccination was 36.2 degrees Centigrade on 31Jul2021 (the day of vaccination). The patient''s family history was unknown. The patient experienced primary illness of depression, cholecystolithiasis (scheduled for surgery), and asthma. Previously, the patient experienced feeling hot and feeling queasy after receiving the influenza vaccine for immunisation. On 31Jul2021 at about 15:35 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 31Jul2021 at 15:45 (10 minutes after the vaccination), the patient experienced giddiness and feeling queasy. The course of the event was as follows: After receiving the vaccination with the COVID-19 vaccine, tremulousness of the hand appeared during the course of the observation in the seat. The nurse contacted the doctor and asked the patient to bed rest. The patient complained of vertigo, feeling queasy and tremulousness of limbs. On eye examination, the patient had normal light reflexes and no obvious paralysis of the extremities. Giddiness, feeling queasy, tremulousness did not improve, and patient was emergently transferred to the hospital. The outcome of the event was not recovered. The reporting physician classified the event as serious (Medically Significant) and the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases were unassessable. The reporting physician commented as follows: immediately after vaccination, the patient experienced vertigo, feeling queasy and tremulousness. The patient''s symptoms did not improve, so the emergency transferred action was taken. Information on the lot/batch number has been requested.


VAERS ID: 1586172 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Feeling abnormal, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: Test Result:86/58; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: SaO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100993754

Write-up: Vasovagal reflex; Feels poorly; Blood pressure decreased(86/58); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122158. A 41-year-old male (age at vaccination) patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021), via an unspecified route of administration on 31Jul2021 at 14:49 (the day of vaccination) (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination (31Jul2021) 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). The patient''s medical history was reported as none. The patient''s concomitant medications were not reported. On 31Jul2021 at 15:00 (11 minutes after the vaccination), the patient experienced vasovagal reflex. On 31Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: immediately after the vaccination, feels poorly and blood pressure decreased (86/58) occurred. On body no urticaria was reported, SaO2 98%, no dyspnoea. The symptoms improved by rapid infusion of saline solution. The reporting physician classified the events as non-serious and assessed that the events were unrelated to bnt162b2. The outcome of the events was resolved on 31Jul2021. The reporting physician commented as follows (reporter''s comment): It was considered blood pressure decreased due to vasovagal reflex.; Reporter''s Comments: It was considered blood pressure decreased due to vasovagal reflex.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Presyncope, Feeling abnormal, Blood pressure decreased and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1586242 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; 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: Sickness; Headache; Fever chills; Painful arm; This case was received via a regulatory authority (Reference number: ADR 25755394) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever chills) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-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 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 02-Aug-2021, PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever chills) had resolved. On 03-Aug-2021, ILLNESS (Sickness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1586276 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abnormal sensation in eye, Retinal artery occlusion, Retinal oedema
SMQs:, Embolic and thrombotic events, arterial (narrow), Corneal disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995718

Write-up: Left retinal arterial branch occlusion; The lower part of the posterior pole of the left eye; Something like a gray cloud appeared in the left eye; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. . This report received from the Agency . Regulatory authority report number is v21123142. This non-pregnant 62-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) intramuscular in the left arm on 30Jul2021 at 11:00 AM (at the age of 62-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included dyslipidaemia and hypertension (as reported, in the examination after onset, the patient had dyslipidaemia and hypertension was detected). 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. Concomitant medications were not reported. On 31Jul2021 at 21:30 (1 day 10 hrs 30 min after the vaccination), the patient experienced adverse events. The details of the clinical course as following: On 31Jul2021 around 21:30 (1 day 10 hrs 30 min after the vaccination), something like a gray cloud appeared in the left eye. On 02Aug2021 (2 days 13 hrs after vaccination), the patient went to the ophthalmology, there was the lower part of the posterior pole of the left eye. Suspected of left retinal arterial branch occlusion and with treatment with Xalatan for left eye 1 time, DIAMOX 250mg 2tablets 2times, ASPARA K 300mg 4tablets 2times. On 03Aug2021, went to the hospital for treatment. And planning to do head MRI and carotid artery ultrasound examination. The reaction already been reported to the manufacturer. The reporter stated the event results in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The event left retinal arterial branch occlusion reported as disability or permanent damage. All events resulted in physician office visit and with treatment received. On 03Aug2021, the outcome of events was not recovered. The reporting pharmacist classified the event as serious (can lead to disability) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases were hypertension and dyslipidaemia. But no medication or regular treatment.; Sender''s Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Retinal artery occlusion and Retinal edema. 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: 1586283 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Cognitive disorder, Coma scale, Fall, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock; Food allergy; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before the vaccinations; Test Date: 20210731; Test Name: Coma Scale; Result Unstructured Data: Test Result:I-2; Test Date: 20210731; Test Name: spo2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202100995791

Write-up: Anaphylactic shock; anaphylaxis; the patient collapsed on the chair; Coma Scale score of I-2; immeasurable blood pressure; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21122304. A 43-year and 9-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FF4204, expiration date: 31Oct2021) via an unspecified route of administration on 31Jul2021 at 16:14 (the day of vaccinations) (at age of 43-years-old) as dose 1, single for COVID-19 immunisation. Body temperature before the vaccinations was 36.1 degrees centigrade on 31Jul2021.Patients history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included the patient had a past medical history of anaphylactic shock to seafood. Food allergies: Seafood, banana, kiwi, mango, okra, yam. The patient had no family medical history. Patient concomitant medications were not reported. On 31Jul2021 at 16:18 (4 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: On 31Jul2021 at 16:14(the day of vaccinations), the patient received the coronavirus vaccine. On 31Jul2021 at 16:18 (the day of vaccinations), while the patient was placed under observation, the patient collapsed on the chair. The patient had a Coma Scale score of I-2, immeasurable blood pressure (BP), and oxygen saturation (SpO2) of 97%. Anaphylactic shock was considered. Adrenaline was administered, and a steroid was also used. Then, the symptoms improved gradually. On 01Aug2021 (1 day after vaccination), the outcome of the event was recovered. The reporter classified the event as serious (hospitalization, from 31Jul2021 to 01Aug2021) 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: 1586316 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Heart rate, Leukoderma, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (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: Medical History/Concurrent Conditions: Allergic reaction to bee sting (25 years ago, leukoderma appeared all over the body because of bee sting)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood Pressure; Result Unstructured Data: Test Result:149/75; Test Date: 20210731; Test Name: pulse rate; Result Unstructured Data: Test Result:no abnormal; Test Date: 20210731; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210731; Test Name: Respiratory rate; Result Unstructured Data: Test Result:no abnormal
CDC Split Type: JPPFIZER INC202100999555

Write-up: Anaphylaxis; Leukoderma; blood pressure was 149/75; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21122377. A 65-year and 8-mouth-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 31Jul2021 13:30 (the day of vaccination) (at the age of 65 years old) (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for COVID-19 immunization. There were points to be considered on the vaccine screening questionnaire: medical history included Allergic reaction to bee sting. The patient concomitant medications were not reported. On 31Jul2021 at 13:31 (1 minutes after the vaccination), the patient experienced Anaphylaxis and Leukoderma. The course of the event was as follows: After 0.3 ml intramuscular injection of COMIRNATY, a diameter of 0.5cm leukoderma appeared on both hands 20 seconds later. 25 years ago, leukoderma appeared all over the body because of bee sting, which was similar with the symptom after injected COMIRNATY. Consciousness normal, complexion normal, no wheezing, respiratory rate and pulse rate were no abnormal. SpO2 was 98%, blood pressure was 149/75, and there were no digestive symptoms. Leukoderma with a diameter of 3-5 cm was scattered on the back. Although it does not meet the definition of anaphylaxis, the initial response to rapid allergic reaction was taken. The symptoms did not worsen after returning home on Saturday afternoon. The patient underwent lab tests and procedures which included on 31Jul2021 blood pressure 149/75, heart rate: no abnormal, oxygen saturation: 98 %, respiratory rate: no abnormal. Therapeutic measures were taken as a result of events Anaphylaxis and Leukoderma. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no possible cause of the event such as any other diseases. The outcome of the event blood pressure was 149/75 was unknown, for other events outcome was resolving as on 31Jul2021. The reporter commented as follows: Stop the second vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1586317 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Chest pain, Dyspnoea, Headache, Malaise, Myocarditis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result: 36.7 Centigrade; Comments: before the vaccination.
CDC Split Type: JPPFIZER INC202100999559

Write-up: Myocarditis suspected; Chest pain; Shortness of breath; left chest strange feeling of /Left chest discomfort; headache; General malaise; This is a spontaneous report from a contactable Physician received from the Regulatory Authority. The Regulatory authority report number is v21122352. The patient was a 50-year and 8-month-old male. On 30Jul2021 at 17:30 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0348, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Relevant medical history and concomitant medications were not reported. On 09Jul2021, the patient received the vaccination of COMIRNATY intramuscular injection in the reporter''s clinic. On 31Jul2021 (1 day after the vaccination), headache, and general malaise began to develop. On 02Aug2021 in the morning (3 days after the vaccination), chest pain, shortness of breath, and left chest strange feeling of appeared and myocarditis was suspected. On 05Aug2021, as left chest discomfort, chest pain, and shortness of breath persisted, the patient visited the reporter''s clinic. For there was a possibility of myocarditis, the patient was introduced to the emergency outpatient. At the time of the reporting events outcome was unknown. The reporting Physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented: As chest discomfort appeared after the second dose vaccination of COMIRNATY intramuscular injection, it was considered that the patient might have myocarditis. The patient was introduced to the center on 05Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1587518 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-31
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Sars Cov 2 by PCR; Test Result: Positive
CDC Split Type: CRPFIZER INC202101008323

Write-up: fatigue, flu symptoms/ lost his sense of smell and taste; fatigue, flu symptoms/ lost his sense of smell and taste; This is a spontaneous report from a non-contactable consumer (patient) by a Pfizer colleague through COVAES. A 36-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Jul2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient presented fatigue, flu symptoms that began on Saturday 31Jul2021, on Monday 02Aug2021 he lost his sense of smell and taste. A swab was performed to determine the presence of Sars Cov 2 by PCR on 01Aug2021, presenting a positive result for Sars Cov 2 on 01Aug2021. The outcome of the events as not recovered. No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.


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