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

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



Case Details (Reverse Sorted by Onset Date)

This is page 355 out of 6,867

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VAERS ID: 1523856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Asthenia, Chills, Disturbance in attention, Dizziness, Eating disorder, Fatigue, Feeling of body temperature change, Malaise, Mobility decreased, Nausea, Pyrexia, SARS-CoV-2 test, Thirst
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopausal symptoms; Neck pain; Comments: I am post menopausal and have a merina coil fitted and also have hrt estradiol 25micr patches. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100922950

Write-up: painful joints; Fever; Weakness; Thirst excessive; Nausea; Felt giddy; Swollen abdomen/felt swollen in my upper right side; Exhaustion; cold shivers; Concentration impaired/poor concentration; Felt cold shivers , then hot; felt really sick; really bad aching & felt swollen in my upper right side; could not lift my arms or legs; could not eat anything; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107191257153720-N4QMR, Safety Report Unique Identifie GB-MHRA-ADR 25673566. A 60-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), (Lot Number: FE1510), via an unspecified route of administration on 15Jul2021 as DOSE 1, SINGLE DOSE for COVID-19 immunisation. Medical history included menopausal symptoms and neck pain. Patient was post-menopausal and have a merina coil fitted and also have hrt estradiol 25micr patches. Patient had not had symptoms associated with COVID-19. Concomitant medications included estradiol taken for menopausal symptoms from 15Jun2021 to an unspecified stop date; ibuprofen taken for neck pain from 14Jul2021 to 15Jul2021. The patient previously took mirena. The patient experienced fever, weakness, nausea, felt giddy, swollen abdomen, exhaustion, shivers, and concentration impaired all on 16Jul2021. Her symptoms came on very quickly the next day in the morning on 16Jul2021, after having her 2nd Pfizer vaccine. Patient had a temperature, felt really sick, very weak, painful joints, excessive thirst, could not eat anything, really bad aching and felt swollen in her upper right side. Felt cold shivers , then hot patient had poor concentration, could not lift her arms or legs. She drank a lot of water, at least 6 pints the following day. After 36hrs started to feel slightly better. Patient did not have any treatment. She stayed in bed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on 10Apr2021 (No - Negative COVID-19 test). The outcome of shivers and concentration impaired was recovered on 17Jul2021, events fever, thirst excessive and felt giddy was recovered on 18Jul2021, events weakness and swollen abdomen was recovered with sequelae on 19Jul2021, events nausea and exhaustion recovered on 19Jul2021, outcome of other events was recovering. This is a serious report received with serious criteria other medically important condition form RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523959 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Amylase, Amylase increased, Computerised tomogram abdomen, Pancreatitis acute, SARS-CoV-2 test
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACCRETE D3; AMYLASE; AZATHIOPRINE; BISACODYL; DULOXETINE; FOLIC ACID; FOSTAIR; HYOSCINE BUTYLBROMIDE; LANSOPRAZOLE; MONTELUKAST; SALBUTAMOL
Current Illness: Crohn''s disease (Currently on azathioprine for Crohn''s disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain
Allergies:
Diagnostic Lab Data: Test Name: amylase; Result Unstructured Data: Test Result: raised; Test Date: 20210718; Test Name: CT abdomen; Result Unstructured Data: Test Result: showed a normal pancreas; Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928700

Write-up: abdominal pain; raised amylase; Acute pancreatitis; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107201102146750-V9PSN, and Safety Report Unique Identifier is -MHRA-ADR 25679586. A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (lot/batch number not reported) as dose 2, single for COVID-19 immunisation. Medical history included abdominal pain, and ongoing Crohn''s disease. Currently on azathioprine for Crohn''s disease. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included calcium carbonate, colecalciferol (ACCRETE D3); amylase; azathioprine taken for Crohn''s disease; bisacodyl; duloxetine; folic acid; beclometasone dipropionate, formoterol fumarate (FOSTAIR); hyoscine butylbromide; lansoprazole; montelukast; and salbutamol. The patient experienced abdominal pain on an unspecified date with outcome of recovered, raised amylase on an unspecified date with outcome of recovered, and acute pancreatitis on 16Jul2021 with outcome of recovered on 20Jul2021. The events were assessed as serious (medically significant) by the regulatory authority. The clinical course was reported as follows: Admitted to hospital on 18Jul2021 with abdominal pain. Found to have a raised amylase. CT abdomen showed a normal pancreas. However, the likely diagnosis is acute pancreatitis following Pfizer vaccine 2nd dose. Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included CT abdomen: showed a normal pancreas on 18Jul2021, COVID-19 virus test: No - Negative COVID-19 test on 18Jul2021, amylase: raised on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524000 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1927 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Lymphadenopathy, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929172

Write-up: dazed/light headed; Breathlessness; Feverish; Headache; Neck swelling; Swollen lymph nodes; Swollen arm; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201428035060-TJRCV. Safety Report Unique Identifier GB-MHRA-ADR 25681180. A 45-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 16Jul2021 (Lot Number: FA1927), at the age of 45-years-old, 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. Patient is not pregnant. The patient experienced swollen arm on 16Jul2021 with outcome of recovering, feverish, headache, neck swelling and swollen lymph nodes on 18Jul2021 with outcome of not recovered, breathlessness on 19Jul2021 with outcome of recovering and dazed/light headed on an unknown date with unknown outcome. The clinical course included Felling feverish and dazed/light headed. Sudden sharp/intense headaches. Swollen neck, collarbone and shoulder area. Breathless after walking up stairs. Swollen arm. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test. 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: 1524021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac monitoring, Chest discomfort, Dysaesthesia, Myocarditis, Platelet count, SARS-CoV-2 test, Troponin T, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: cardiac monitoring; Result Unstructured Data: Test Result:normal; Test Name: platelet counts; Result Unstructured Data: Test Result:low; Test Date: 20210716; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: HS Troponin T; Result Unstructured Data: Test Result:elevated at 45 ng/L; Test Name: HS Troponin T; Result Unstructured Data: Test Result:falling to 28 ng/L; Test Name: HS Troponin T; Result Unstructured Data: Test Result:normal ng/L; Test Name: echo; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202100929022

Write-up: chest discomfort; right arm dysaesthesia; Myocarditis NOS; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201620479330-LYL6D. Safety Report Unique Identifier: GB-MHRA-ADR 25681583 A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history and concurrent conditions: None. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced chest discomfort on an unspecified date, myocarditis nos on 16Jul2021, right arm dysaesthesia on an unspecified date. Clinical course reported as: The patient reports a Pfizer Biontech vaccination approximately 5 weeks earlier. He has been well since. On day in question he experienced central chest discomfort, 8/10, with right arm dysesthesia. The patient was short-lived but he sought A+E where HS Troponin T was elevated at 45ng/L some hours after event, falling to 28 that night, and normal next day. He presented on a Friday was seen by a Cardiologist Saturday and was discharged on the Monday after asymptomatic entire week-end, nil on cardiac monitoring, echo on Monday normal. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included cardiac monitoring: normal, echo: normal, platelet count: low, sars-cov-2 test: no-negative covid-19 test on 16Jul2021. Outcome of chest discomfort was recovered, myocarditis nos was recovered on 16Jul2021, other was unknown. Case was reported as serious hospitalization. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1524026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928768

Write-up: Menstrual cramp; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202107201658244460-2YSDQ, Safety Report Unique Identifier GB-MHRA-ADR 25681785. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jul2021as dose 2, single for COVID-19 immunization. The patient''s medical history included endometriosis. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced menstrual cramps described as severe menstrual cramps, debilitating (assessed as medically significant) on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on Unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Headache, Malaise, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928953

Write-up: Back pain; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107201846416070-BJAJI and Safety Report Unique Identifier is GB-RA-ADR 25682603. A male patient of an unspecified age received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration on 16Jul2021 for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 16Jul2021, the patient experienced headache and feeling unwell. On 17Jul2021, patient experienced back pain. The case is serious (medically significant). The patient had COVID-19 Virus Test (Unknown date): No - Negative COVID-19 test. The outcome for headache, feeling unwell and backpain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524053 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Fatigue, Gastroenteritis viral, Joint noise, Joint swelling, Pain in extremity
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease; Lactation decreased; Rheumatoid arthritis (Awaiting hospital appointment for rheumatoid arthritis symptoms)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928680

Write-up: Pain in arm; Swelling at the back of my knees; Joint noise; Joint pain/very painful knees/very painful tender to touch knee and elbow joints, burning sensation in my joints; Diarrhea; Stomach flu; Fatigue; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201951150910-INWOK, Safety Report Unique Identifier: GB-MHRA-ADR 25682966. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Jul2021 (Lot Number: FD5613) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis (awaiting hospital appointment for rheumatoid arthritis symptoms), lactation decreased, and Hashimoto. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain in arm on an unspecified date; fatigue on 16Jul2021; diarrhea and stomach flu on 17Jul2021; and joint noise and joint pain on 18Jul2021. Clinical course reported: very painful knees and swelling at the back of her knees, very painful tender to touch knee and elbow joints, burning sensation in her joints. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events stomach flu was recovered on an unspecified date; "pain in arm" and "swelling at the back of her knees" was unknown; and for the rest of events was not recovered. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524114 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain, Pain in extremity, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934046

Write-up: Pain localised; Chills; Tinnitus; Headache; Tiredness/I felt very tired; My arm started hurting a few hours after the vaccine; Felt cold; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107211219590020-CAFTJ, Safety Report Unique Identifier GB-MHRA-ADR 25686429. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: FD8813), via an unspecified route of administration on 16Jul2021 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included lactation decreased from unspecified date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, and she was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain localised, chills, tiredness/ she felt very tired, tinnitus, headache, her arm started hurting a few hours after the vaccine, and she felt cold, all on 16Jul2021. The case was reported as serious with medically significant criterion. It was reported that her arm started hurting a few hours after the vaccine on Friday (16Jul2021). She could not use her arm as normal and she could not lie on that side, but it was not unbearable. By Sunday night (18Jul2021) it was better. The evening of her vaccination (16Jul2021) she felt very tired and she felt cold with chills. The chills had gone by the next day (17Jul2021) but she felt tired until late on Sunday (18Jul2021). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test (negative, no - negative COVID-19 test) on unspecified date. The outcome of the events was resolved on 17Jul2021 for "chills" and "headache", resolved on 18Jul2021 for "pain localized" and "tiredness/I felt very tired", resolved with sequel on unspecified date for "tinnitus", resolving for "my arm started hurting a few hours after the vaccine" and unknown for "felt cold". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524159 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-16
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nose bleed
Preexisting Conditions: Medical History/Concurrent Conditions: Nasal operation
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934073

Write-up: Bleeding nose; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107211700408360-ZMQ1R, Safety Report Unique Identifier -MHRA-ADR 25688119. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included nose bleed and nasal operation in 2016. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced bleeding nose on 16Jul2021. The event was reported as serious (medically significant). The patient was admitted to Urgent Care, occurrence repeated with further bleeding on the 18th-subsequently stopped. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Sent for blood tests by GP. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID-19 virus test: negative (No - Negative COVID-19 test) on 04Jun2021. The event was resolved on 18Jul2021 No follow-up attempts are possible. Information about batch no cannot be obtained. No further information is expected.


VAERS ID: 1524230 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, COVID-19, Computerised tomogram, Electrocardiogram, Haemoptysis, Headache, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: CO-CODAMOL
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Backache
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100949757

Write-up: Coughing blood; SARS-CoV-2 infection; Stomachache; Headache; 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 -MHRA-WEBCOVID-202107260638075530-WNXAM. A 34-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 17Jul2021 and ongoing, backache. The patient was not enrolled in clinical trial. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) taken for backache from 20Jul2021 to an unspecified stop date. On 16Jul2021 (same day of vaccination), patient experienced headache, on 19Jul2021, stomachache, on 21Jul2021, patient had a SARS-CoV-2 infection and on 22Jul2021, patient had coughing blood. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: unknown results, CT scan: unknown results, ECG: unknown results; all on an unspecified date, and SARS-CoV-2 test: Positive (Yes - Positive COVID-19 test) on 18Jul2021. The outcome of events was not recovered.


VAERS ID: 1524248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-07-16
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7934 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMOXIFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100961860

Write-up: Clot blood; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID-202107271059270740-BMNPI} Safety Report Unique Identifier {GB-MHRA-ADR 25713188}. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER7934; Expiration Date: unknown) via an unspecified route of administration on 21May2021 as dose 2, single for COVID-19 immunisation. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included clinical trial participant. Concomitant medications included tamoxifen taken for breast cancer from 16Feb2017 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. On 16Jul2021, the patient experienced clot blood. Patient was sent to hospital, where he was diagnosed with clot blood and prescribed with Xarelto. The event was considered serious as other medically important condition and life-threatening. Therapeutic measures were taken as a result of clot blood. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test. The clinical outcome of the event was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1524270 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eczema infantile, Exposure via breast milk, Infant sedation
SMQs:, Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916617

Write-up: Maternal exposure during breast feeding; Infant sedation; Eczema infantile; This spontaneous report received from a consumer (parent). This is the second of two reports. The first report is a report downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107182139516910-H7CB2, Safety Report Unique Identifier is GB-MHRA-ADR 25670048. A 4 months old infant patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transmammary route of administration (unspecified parent route of administration) on 15Jul2021 (Batch/Lot number unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient experienced maternal exposure during breast feeding on an unspecified date; eczema infantile and infant sedation both on 16Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Symptoms reported affected my breastfed 4 month old baby. Patient has not tested positive for COVID-19 since having the vaccine. The patient recovered from infant sedation on an 16Jul2021 while patient had not recovered from eczema infantile. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100927765 Mother


VAERS ID: 1524273 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Disease recurrence, Inappropriate schedule of product administration, Inflammation
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Medication errors (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100924825

Write-up: inflammation; arthritis; inflammation/pain has occured both times; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107181337148530-F4HDI, Safety Report Unique Identifier GB-RA-ADR 25669750. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 at the age of 54 years old (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arthritis from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21May2021 (Lot number was not reported) for COVID-19 immunisation and experienced inflammation, arthritis, swelling, suspicion (also reported as Endometrial polyp), pain and toe cramps. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced inflammation and arthritis both on an unspecified date. The events were reported as serious (medically significant). The clinical course was reported as follows: This inflammation/pain has occurred both times I have taken the vaccine. I had a suspicion the first time and then the second time I ensured I did not carry out any activity which may cause the toe''s inflammation. And right on cue approx. 40 hrs. later the same inflammation has occurred. This time, I am prepared and hopefully naproxen will reduce the pain. The first period took approx. 10 days to resolve, my inflammations have never lasted this long, normally they get better after 3 days. The patient also received the second dose on 16Jul2021 which is an inappropriate schedule of vaccine administered. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100916397 same patient and drug; similar events; different dose


VAERS ID: 1524380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Physical examination, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 07/16/2021; Test Name: Temperature; Result Unstructured Data: Test Result: Unknown; Test Date: 07/16/2021; Test Name: vital parameters; Result Unstructured Data: Test Result: Normal vital parameters.
CDC Split Type: ITPFIZER INC202100925096

Write-up: This is a spontaneous report from a contactable consumer (patient), downloaded via the regulatory authority (IT-MINISAL02-758132). A 24-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# FF0688; expiration date: Oct 31, 2021), intramuscularly, in left arm (reported as left shoulder), on Jul 15, 2021, at 09:00, 30ug, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Comirnaty), on Jun 10, 2021, at 09:22, for COVID-19 immunisation. The patient reported "having vomited and passed out approximately 14 hours after the administration of the Comirnaty vaccine," on Jul 16, 2021. Impact on quality of life was 5/10. The patient underwent lab tests and procedures, which included body temperature: unknown on Jul 16, 2021 and vital parameters: normal vital parameters on Jul 16, 2021. The patient recovering from all events. Reporter''s comment: Vomiting and fainting 14 hours after administration of the drug Comirnaty. Regulatory authority''s comment: Second dose administered at 09:00 on Jul 15, 2021. First dose administered at 09:22, on Jun 10, 2021. No follow-up attempts possible. No further information is expected.


VAERS ID: 1524405 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea exertional, Hyperpyrexia, Myalgia, Sense of oppression
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern; vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern; vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern; vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern; vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern; This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern) in a 42-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003605) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced HYPERPYREXIA (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern), CHEST PAIN (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern), SENSE OF OPPRESSION (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern) and MYALGIA (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern). At the time of the report, HYPERPYREXIA (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern), DYSPNOEA EXERTIONAL (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern), CHEST PAIN (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern), SENSE OF OPPRESSION (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern) and MYALGIA (vaccinazione covid con MODERNA 2 dose il 16/7/21:,iperpiressia, dolori muscolari, dolore retrosternale della durata di alcune ore. Tre giorni dopo, comparsa dispnea da sforzo e oppressione retrostern) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Lab data was not provided. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the 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: 1524589 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Decreased appetite, Discomfort, Dizziness, Fatigue, Hyperhidrosis, Hyperpyrexia, Insomnia, Malaise, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: MXPFIZER INC202100956299

Write-up: extreme sweating; fever reached 42 degrees; a strong cough; I took my temperature and it had reached 37.5, once reached centigrades; it was almost impossible to sleep; nausea; body pain; dizziness; a little discomfort; fatigue; poor appetite; This is a spontaneous report from a contactable consumer (patient) received via email. A 46-year-old male patient received bnt162b2 (Batch/Lot Number: unknown), second dose via an unspecified route of administration on 16Jul2021 at the age of 46-year-old as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 on an unspecified date for covid-19 immunization and developed pain in the arm. The patient experienced dizziness, a little discomfort, fatigue, poor appetite all on 16Jul2021; i took my temperature and it had reached 37.5, it was almost impossible to sleep, nausea, body pain all on 17Jul2021, a strong cough on 20Jul2021, extreme sweating, fever reached 42 degrees on 21Jul2021. The events were serious per medically significant. The patient stated that "Last Friday, 16Jul2021, I received the second dose of vaccine for COVID in PRIVACY. The first dose did not go beyond a small pain in the arm, however the second dose was something that I never imagined would happen to me. That same day of the application I started with a little discomfort and dizziness, fatigue all day and poor appetite. The next day I took my temperature and it had reached 37.5 c at 5 in the afternoon. I started taking 500mg of paracetamol every 8 hours. My temperature would drop but only for 6 hours and the other two would raise it again. The nausea increased and at night it was almost impossible to sleep due to the temperature and discomforts such as loss of appetite, nausea and body pain. By the 3rd day the effect of Paracetamol was 4 1/2 hrs and it took more than 30 min to begin to take effect once I took it. I discussed it with my doctor, and he told me to do the test with neomelubrin 500 mg instead of paracetamol. The results were satisfactory the first 2 times but it began to lose efficacy, just like paracetamol. The temperature did not drop below 37.5 degrees at any time. I had seen that in these cases the side effects disappeared after the 3rd day. So, I was not worried. On the 4th day I woke up with 38.5 and a strong cough, periods of 1-hour sleep and extreme fatigue. I started combining neomelubrin and paracetamol, alternating 1 tablet every 4 hours instead of 1g of paracetamol every 8 hours. It made me better to dose than to take a heavy dose every time. Well now the effect lasted less and less, and the temperature rose to 39 degrees. My doctor recommended that I do the COVID test since I could have been infected without realizing it a day before or when taking the vaccine On the 5th day I took the test and had a negative result for COVID With a fever I reached 42 degrees on one occasion and had to lower the temperature with cold water. They changed my medicine now to naproxen sodium;paracetamol (FEBRAX), taken every 8 hours along with 1 paracetamol (TYLENOL) 500mg. So I was losing effect all day at 7 am and taking effect from 40 min to 1 hr after taking them. My temperature did not drop below 38.5 by natural means and I had extreme sweating, especially 2 hours after taking the dose. With this medicine, however, I was able to sleep much better, I could already sleep up to 3 hours in a row. On the 6th day I woke up with a temperature of 39 and it naturally dropped to 36 with sweating at 3 hours, and I had the advantage of already achieving almost 8 hours without much increase in temperature (37.5) between doses. Finally, this morning I woke up more stable, with small elevations of 0.5 to 1 degree, but I can now walk and eat calmly. I continued taking naproxen sodium;paracetamol only as an anti-inflammatory on the recommendation of my doctor. For this day (24Jul2021) I no longer have any discomfort, I am just getting stronger. I write all this because Pfizer never puts more than 48hrs of side effects and severe cases within its side effects in less than 10% of the cases. There is no support line and doctors can only prescribe acetaminophen. I think that if extreme side effects were explained somewhere, they would help us a lot, as I did not find a single doctor who knew of a case with effects as severe and long-lasting as mine. As a person outside of medicine, seeing that my temperature increases more and more, it costs more to lower it and the effect of the medicine lasts less, I sensed the worst. something that you have found with cases similar to mine where the vaccine affected us so strongly." Therapeutic measures were taken as a result of events. The patient underwent lab test which included: COVID-19 test on 21Jul2021: Negative. The outcome of events was resolving. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-202100956319 same reporter/ patient/drug, different vaccine dose and event.


VAERS ID: 1524669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Headache, Hypoaesthesia, Nausea, Paraesthesia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Sexual dysfunction (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: PLPFIZER INC202100921420

Write-up: tingling; numbness in the neck/ numbness in the cheeks/ numbness in the mouth/ numbness in the legs/ numbness in the hands; headache; vaccination site pain; nausea; weakness; diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FD8274), via an unspecified route of administration on 16Jul2021 09:40 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Jul2021, about 3 hours after vaccination the patient started to experienced tingling,nausea, weakness and diarrhea, numbness in the neck/ numbness in the cheeks/ numbness in the mouth/ numbness in the legs/ numbness in the hands, about an hour after vaccination experienced headache, vaccination site pain, so she used APAP. The symptoms did not go away so the reporter called the ambulance around 18:00. The treatment was received for all the adverse events. Paramedics gave the woman intravenous drugs (no specific names were given), the woman was not taken to the hospital. The reporter went to sleep, and on 17Jul2021 the symptoms resolved, only the headache and vaccination site pain remained. The symptoms did not reoccur. The reporter agreed to further contact. The clinical outcome for the events tingling, nausea, weakness, diarrhea, numbness in her neck, numbness in the cheeks, numbness in the mouth, numbness in the legs, numbness in the hands was reported as recovered on 17Jul2021 while for events headache and vaccination site pain was reported as unknown.


VAERS ID: 1524692 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sinus tachycardia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE ) and SINUS TACHYCARDIA ) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004498) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Jul-2021, the patient experienced SYNCOPE (seriousness criterion medically significant) and SINUS TACHYCARDIA (seriousness criterion medically significant). On 16-Jul-2021, SYNCOPE and SINUS TACHYCARDIA had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were 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: 1524696 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214006 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: This regulatory authority case reported by a consumer, describes the occurrence of asthenia, nausea, headache and myalgia in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 214006) for COVID-19 immunisation. No medical history reported. On Jul 15, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscularly; .5 milliliter. On Jul 16, 2021, patient experienced asthenia (disability), nausea(disability), headache (disability) and myalgia (disability). On Jul 16, 2021, nausea resolved. On Jul 17, 2021, asthenia, headache and myalgia resolved. No concomitant medications or treatment information provided by the reporter. 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: 1525243 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (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), 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: BOOTS ALLERGY RELIEF; MIRENA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
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: Swelling arm; Ache; Fever chills; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), PAIN (Ache), PYREXIA (Fever chills) and HEADACHE (Headache) in a 39-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 and Suspected COVID-19 from 24-Nov-2020 to 04-Dec-2020. Concomitant products included LEVONORGESTREL (MIRENA) for Birth control, CHLORPHENAMINE MALEATE (BOOTS ALLERGY RELIEF) for Eczema, PARACETAMOL for Pain relief. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On 18-Jul-2021, PYREXIA (Fever chills) had resolved. On 19-Jul-2021, PERIPHERAL SWELLING (Swelling arm) had resolved. At the time of the report, PAIN (Ache) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative (Negative) No - Negative COVID-19 test. Treatment was not reported. Patient has 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. Event seriousness assessed as per Regulatory Authority reporting.; 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. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1525496 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Injection site reaction, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Zich onwel voelen; Reactie op de injectieplaats; Misselijkheid; Rillingen; Vermoeidheid; Hoofdpijn; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Zich onwel voelen), INJECTION SITE REACTION (Reactie op de injectieplaats), NAUSEA (Misselijkheid), CHILLS (Rillingen), FATIGUE (Vermoeidheid) and HEADACHE (Hoofdpijn) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced MALAISE (Zich onwel voelen) (seriousness criterion disability), INJECTION SITE REACTION (Reactie op de injectieplaats) (seriousness criterion disability), NAUSEA (Misselijkheid) (seriousness criterion disability), CHILLS (Rillingen) (seriousness criterion disability), FATIGUE (Vermoeidheid) (seriousness criterion disability) and HEADACHE (Hoofdpijn) (seriousness criterion disability). On 16-Jul-2021, MALAISE (Zich onwel voelen), INJECTION SITE REACTION (Reactie op de injectieplaats), NAUSEA (Misselijkheid), CHILLS (Rillingen), FATIGUE (Vermoeidheid) and HEADACHE (Hoofdpijn) was resolving. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter Company''s comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1526464 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100939743

Write-up: This is a spontaneous report from a contactable consumer (patient), downloaded via the regulatory authority (ES-AEMPS-948174). A 32-year-old female patient received a dose of BNT162B2 (Comirnaty, lot# FE6208), at the age of 32, intramuscularly, in left arm, on Jul 16, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On Jul 16, 2021, patient experienced dizziness and syncope. Serious events (medically significant); with outcome of recovered on Jul 16, 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1526470 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Condition aggravated, Electrocardiogram, Electrocardiogram ambulatory, Extrasystoles, Heart rate, Heart rate irregular, Physical examination
SMQs:, Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Extrasystoles supraventricular
Allergies:
Diagnostic Lab Data: Test Date: 20201005; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:rhythmic heart tones no murmur; Test Date: 20201006; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:rhythmic, no murmur; Test Date: 20201106; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:arrhythmic; Test Date: 20201005; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:preserved vesicular murmur without overadded noise; Test Date: 20201106; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:normal; Test Date: 20201006; Test Name: BP; Result Unstructured Data: Test Result:120/60; Test Date: 20201005; Test Name: ECG; Result Unstructured Data: Test Result:sinus arrhythmia at 86 bpm; Test Date: 20201106; Test Name: ECG; Result Unstructured Data: Test Result:arrhythmic atrial; Test Date: 2016; Test Name: HOLTER; Result Unstructured Data: Test Result:Unknown; Comments: Not provided; Test Date: 20201110; Test Name: HOLTER; Result Unstructured Data: Test Result:Report: "Sinusal rhythm. Sinus arrhythmia.; Comments: Report: "Sinusal rhythm. Sinus arrhythmia. The average Heart Rate was 84. Minimum Heart Rate was 47 at 06:42. Maximum Heart Rate was 171 at 5:25 PM. 143 ventricular ectopics were registered. 4 supraventricular ectopics were registered. No significant pauses.; Test Date: 20201005; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Comments: 86 bpm; Test Date: 20201006; Test Name: Heart rate; Result Unstructured Data: Test Result:70; Comments: bpm; Test Date: 20201110; Test Name: HOLTER; Result Unstructured Data: Test Result:84; Comments: The average Heart Rate; Test Date: 20201110; Test Name: HOLTER; Result Unstructured Data: Test Result:47; Comments: Minimum Heart Rate at 06:42; Test Date: 20201110; Test Name: HOLTER; Result Unstructured Data: Test Result:171; Comments: Maximum Heart Rate 5:25 PM; Test Date: 20201005; Test Name: Functional Exploration; Result Unstructured Data: Test Result:Normal appearance and morphology thorax, not painf; Comments: Normal appearance and morphology thorax, not painful to the digital pressure.; Test Date: 20201106; Test Name: Functional Exploration; Result Unstructured Data: Test Result:Exploration cardiac auscultation arrhythmic; Comments: Exploration cardiac auscultation arrhythmic No murmur. Pulmonary Auscultation: normal. Upper Limbs: radial pulses preserved. Lower Limbs: pedis pulses preserved and symmetrical.
CDC Split Type: ESPFIZER INC202100955055

Write-up: Extrasystoles; Condition aggravated; irregular heartbeat; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency regulatory authority number ES-AEMPS-952695. A 34-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FC1435), first dose via intramuscular route of administration on 13Jul2021 (at the age of 34-year-old) as a single for COVID-19 immunisation. Medical history included supraventricular extrasystoles from 05Oct2020 to an unknown date. The patient''s concomitant medications were not reported. The patient did not know if had COVID-19 or not. On 16Jul2021, the patient experienced extrasystoles, condition aggravated, irregular heartbeat. The patient underwent lab tests and procedures which included auscultation: rhythmic heart tones no murmur on 05Oct2020, auscultation: rhythmic, no murmur on 06Oct2020, auscultation: arrhythmic on 06Nov2020, auscultation: preserved vesicular murmur without over added noise on 05Oct2020 , auscultation: normal on 06Nov2020, blood pressure measurement: 120/60 on 06Oct2020 , electrocardiogram: sinus arrhythmia at 86 bpm on 05Oct2020, electrocardiogram: arrhythmic atrial on 06Nov2020, electrocardiogram ambulatory: unknown on 2016 Not provided, electrocardiogram ambulatory: report: "sinusal rhythm. sinus arrhythmia. On 10Nov2020 Report: "Sinusal rhythm. Sinus arrhythmia. The average Heart Rate was 84. Minimum Heart Rate was 47 at 06:42. Maximum Heart Rate was 171 at 17:25. 143 ventricular ectopics were registered. 4 supraventricular ectopics were registered. No significant pauses, heart rate: 86 on 05Oct2020, 86 bpm, heart rate: 70 on 06Oct2020 bpm, heart rate: 84 on 10Nov2020 the average Heart Rate, heart rate: 47 on 10Nov2020 Minimum Heart Rate at 06:42, heart rate: 171 on 10Nov2020 Maximum Heart Rate 5:25 PM. Therapeutic measures were taken as a result of extrasystoles (extrasystoles), condition aggravated (condition aggravated), irregular heartbeat (heart rate irregular). It was reported this year he has suffered several episodes of generally non-serious sinus arrhythmia treated at the health center. Since the vaccine I notice the irregular heartbeat constantly and together with the aforementioned extrasystoles, it becomes uncomfortable and worrying because they are stronger than normal. The average Heart Rate was 84. Minimum Heart Rate was 47 at 06:42. Maximum Heart Rate was 171 at 5:25 PM. 143 ventricular ectopics were registered. 4 supraventricular ectopics were registered. No significant pauses. On 06Nov2020, the patient presented since mid-September palpitations and extra feeling of beats without chest pain. they begin to bother him in daily activities. In ECG arrhythmic atrial. Functional Exploration cardiac auscultation arrhythmic. No murmur. Pulmonary Auscultation: normal. Upper Limbs: radial pulses preserved. Lower Limbs: pedis pulses preserved and symmetrical. On 04Nov2020, he has back to have episodes of self-limiting tachycardia. He refers that they are something more frequent and that already condition his normal life. Plan was presential appointment. 06Oct2020 he has presented 3 episodes of palpitations without tachycardia, between 30 and 60 minutes, with spontaneous recovery. He related it to anxiety. Physical examination was BP 120/60, Hear rate 70 bpm. Cardiac auscultation rhythmic, no murmur. Self-control of heart rate and anxiety symptoms. On 05Oct2020 he refers that this morning has started with a feeling of tachycardia and extrasystoles. Normal appearance and morphology thorax, not painful to the digital pressure. CA (cardiac auscultation) rhythmic heart tones no murmur. Pulmonary auscultation. preserved vesicular murmur without over added noises. ECG: sinus arrhythmia at 86 bpm. He has no treatment for extrasystoles. The outcome of the events was reported as not resolved. No follow-up attempts are possible. Information about batch number cannot be obtained.


VAERS ID: 1526832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Joint pain; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929089

Write-up: headache; joint pain; Headache occurring; Generalized joint pain; Generalised muscle aches; Swollen lymph nodes; 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-202107202347335910-HEDQU. Safety Report Unique Identifier GB-MHRA-ADR 25683740. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: FD8813) dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included joint pain and lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced headache on an unspecified date with outcome of recovered, joint pain on an unspecified date with outcome of recovered, headache occurring on 16Jul2021 with outcome of not recovered, generalized joint pain on 16Jul2021 with outcome of not recovered, generalised muscle aches on 16Jul2021 with outcome of recovered on 18Jul2021, swollen lymph nodes on 16Jul2021 with outcome of not recovered. Seriousness criteria was provided as disabling or Incapacitating by regulatory authority. Narrative case summary and further information: All reactions, side effects came on very strongly the day after the vaccination and lasted strongly for three days. But five days later patient still has a severe headache and a swollen lymph node and joint pain. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain of skin
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 INC202100934359

Write-up: Skin pain; This is a spontaneous report from a contactable consumer. This is the second reports. The first report is a report downloaded from the Regulatory Agency (MHRA) is GB-MHRA- WEBCOVID- 202107211957434800-8UMEM. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient previously took first dose of BNT162B2 on 05May2021 and experienced late period. The patient experienced skin pain on 16Jul2021. It was reported that after the second dose on 14Jul2021, patient developed intense skin pain on the scalp to the point the patient could not touch the skin or move hair in that area. The event was reported as serious (medically significant). The patient recovered from the event 19Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1526985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neuralgia, Pyrexia, SARS-CoV-2 test, Tenderness
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934354

Write-up: Nerve pain; Neck stiff; Mobility decreased; Fever; Tenderness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107212236348430-FDGVZ], Safety Report Unique Identifier [GB-MHRA-ADR 25689688]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Batch/Lot Number: FD5613) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced tenderness on 16Jul2021; nerve pain, neck stiff, mobility decreased and fever. The events were assessed as serious (hospitalization, medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on unknown date. The outcome of the events was not recovered. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527003 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934198

Write-up: Vomiting; Light-headed/ dizzy; weak; Headache; 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-202107220310599130-UCEID, Safety Report Unique Identifier GB-MHRA-ADR 25690017. A 28-year-old female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot number: Unknown was not reported), via an unspecified route of administration on 16Jul2021, at the age of 28 years, as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 16Jul2021, the patient experienced headache. On 17Jul2021, the patient experienced vomiting, lightheaded/ dizzy and weak. The clinical course was reported as follows: Friday afternoon- jab was done, Friday night - started feeling headache, Saturday night - felt dizzy & weak started vomiting; headache was intense took paracetamol. Continued till Sunday. Monday - stopped vomiting felt a bit better but headache felt noon till night. Tuesday - headache felt again took paracetamol. Wednesday- went back to work but on Wednesday night has headache again. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the events headache was not recovered; outcome for vomiting was recovered on 18Jul2021; outcome for lightheaded/ dizzy was recovered with sequel; outcome for weak was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1527015 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis infected, Eczema, Inappropriate schedule of product administration, Rash
SMQs:, Anaphylactic reaction (broad), 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: MOMETASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema; Eczematous rash; Rash
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941417

Write-up: after second dose my eczema became severe; Rash on leg become infected; inappropriate schedule of vaccination administered; Rash on leg; This is a spontaneous report from a contactable consumer or other non hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107220916194670-2CCQB. Safety Report Unique Identifier (GB-MHRA-ADR 25691422). A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FD5613), via an unspecified route of administration on 09Jul2021 at a single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW4109), via an unspecified route of administration on 21May2021 at a single dose for COVID-19 immunization. Eczema occurred after the first dose. Relevant medical history included eczema, rash and eczematous rash. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included mometasone taken for eczematous rash from 14Jul2021 to 20Jul2021. The patient experienced rash on leg on 16Jul2021. Clinical course was provided as follows. The patient had mild eczema before vaccination. After first vaccine it became worst and after second dose the eczema became severe, spreaded into his face. Week after the second dose, the rash on his leg has become infected. The patient has been taking antibiotic (flucloxacillin) for 2 days. There was no improvement on the leg yet. The events were serious as medically significant, apart from inappropriate schedule of product administration (non-serious). Outcome for inappropriate schedule of product administration was unknow, while other events were not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527118 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Erythema, Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
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: faint; soreness; Redness; Ache; Dizz/felt faint; Queasy; Shivers; Feverish/temperature increased; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (faint) in a 50-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 PARACETAMOL from 17-Jul-2021 to 17-Jul-2021 for Headache. In 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 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 16-Jul-2021, the patient experienced PAIN (Ache), DIZZINESS (Dizz/felt faint), NAUSEA (Queasy), CHILLS (Shivers), PYREXIA (Feverish/temperature increased) and HEADACHE (Headache). On 17-Jul-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant) and PAIN (soreness). On 17-Jul-2021, DIZZINESS (Dizz/felt faint), NAUSEA (Queasy), CHILLS (Shivers), PYREXIA (Feverish/temperature increased) and HEADACHE (Headache) had resolved. On 19-Jul-2021, PAIN (Ache) had resolved. On 24-Jul-2021, ERYTHEMA (Redness) had resolved. At the time of the report, SYNCOPE (faint) and PAIN (soreness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the 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: 1527227 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Rectal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: Rectal bleeding; Diarrhea; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 21-Jul-2021, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant). On 21-Jul-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) had not resolved. 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. No concomitant medications were reported. No treatment information was reported. Company Comment : Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1527628 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Headache, Heart rate, Heart rate irregular, Hypothermia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:35 Centigrade; Comments: Hypothermia; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:fever had risen Centigrade; Test Date: 20210716; Test Name: HR; Result Unstructured Data: Test Result:80-140; Comments: oscillating between 80-140
CDC Split Type: ITPFIZER INC202100937389

Write-up: fever had risen; Hypothermia, 35 C, ref who could not keep warm even with three blankets, HR oscillating between 80-140. Hypostenia, headache; Hypothermia, 35 C, ref who could not keep warm even with three blankets, HR oscillating between 80-140. Hypostenia, headache; Hypothermia, 35 C, ref who could not keep warm even with three blankets, HR oscillating between 80-140. Hypostenia, headache; Hypothermia, 35 C, ref who could not keep warm even with three blankets, HR oscillating between 80-140. Hypostenia, headache; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-759163. A 29-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular on 16Jul2021 at age of 29-year-old (Lot Number: FF4213) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hypothermia, 35 centigrade, referred who could not keep warm even with three blankets, heart rate oscillating between 80-140, hyposthenia, headache on 16Jul2021. The patient called 118 which then took him to the emergency room at 03:23 of 17Jul2021 where the fever had risen. The outcome of the event fever was unknown, the outcome of other events was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1527656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Bone pain, Chills, Decreased appetite, Dysentery, Fatigue, Headache, Pyrexia, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ITPFIZER INC202100954797

Write-up: 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue.; 24 hours later: fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain. 48 hours later: stomach pain, dysentery and fatigue/vaccination site pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency WEB IT-MINISAL02-760687. A 37-years-old female patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FF0688) via intramuscular, administered in arm left (left shoulder) on 15Jul2021 as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FC5435) via an unspecified route of administration on 10Jun2021 as dose 1, single dose for covid-19 immunisation. On 16Jul2021 (24 hours later) fever 38 Degrees C, chills, bone pain, vomiting, loss of appetite, severe headache, arm pain and vaccination site pain. On 17Jul2021 (48 hours later) stomach pain, dysentery, and fatigue. The patient was hospitalized for all the events. Therapeutic measures were taken as a result of events included treatment with intake of TACHIPIRINA, PERIDON and lactic ferments. Impact on quality of life (10/10). The patient underwent lab tests and procedures which included Body temperature: 38 centigrade on 16Jul2021. The outcome of all the events was recovered with sequel on an unspecified date. No follow-up attempts possible. No further information expected ; Reporter''s Comments: none


VAERS ID: 1527706 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Henoch-Schonlein purpura, Vasculitis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100935611

Write-up: Vasculitis; suspected IgA vasculitis; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority. A 30-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vasculitis and suspected IgA vasculitis on 16Jul2021 with outcome of unknown. The patient was hospitalized for the events from 20Jul2021 to an unknown date. On 16Jul2021 at unknown time (4 days after the vaccination), the patient experienced suspected IgA vasculitis and vasculitis. On 20Jul2021 (8 days after the vaccination), the patient was admitted to hospital. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1527721 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result: 35.9 Centigrade; Comments: before the vaccination.
CDC Split Type: JPPFIZER INC202100935909

Write-up: anaphylaxis; Itching; wheals at about 1 cm on the neck and abdomen; type I allergy reaction; This is a spontaneous report from a contactable physician (vaccinator). This is a report received from the Regulatory Authority. The regulatory authority report number is v21120813. A 68-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 16Jul2021 14:37 (Batch/lot number: FC3661; Expiration date: 30Sep2021), at age 68 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history included allergy to penicillin from an unknown date, not reported if ongoing or not. Patient''s history according to the vaccine screening questionnaire included allergy to penicillin. Concomitant medications were not reported. Body temperature before vaccination was on 16Jul2021 35.9 degrees Centigrade. On 16Jul2021 at 14:42 (5 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: During the follow-up after the vaccination (about 5 minutes after the vaccination), the patient experienced itching and wheals at about 1 cm on the neck and abdomen. Intravenous drip and stronger MINOPHAGEN were given (as reported). On 16Jul2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: type I allergy reaction.


VAERS ID: 1527754 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Body temperature, Shock
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis (Steroid and biological drug were being administered for rheumatoid arthritis)
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm embolization; Aneurysm of abdominal aorta; Aortic aneurysm repair; Arterial aneurysm repair; Arteriosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100957969

Write-up: left common iliac aneurysm rupture; shock vital; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121811. A 73-year-old (reported as 73-year and 2-month-old) female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Jul2021 14:33 (Batch/Lot Number: FC8736; Expiration Date: 30Sep2021) as dose 1, single at the age of 73-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis (Steroid and biological drug were being administered for rheumatoid arthritis), stent graft and left internal iliac artery coil embolization for the left common iliac aneurysm three years ago (2018), and after performing arch aortic aneurysm stent graft on Jun2021 recently, and arteriosclerotic disease. Concomitant drugs included steroid and biological drug were being administered for rheumatoid arthritis. Body temperature before vaccination was 36.4 degrees centigrade. On 16Jul2021 at 14:33 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (The day of the vaccination), the patient experienced left common iliac aneurysm rupture. On 16Jul2021 (The day after the vaccination), the patient was admitted to the hospital. On 21Jul2021 (5 days after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 16Jul2021, the first COVID-19 vaccination was performed, and after observation for 15 minutes, the patient returned home without any problems. However, on the same day, the patient was emergency transported to hospital by ambulance due to shock vital, and was diagnosed with left common iliac aneurysm rupture, and stent implantation was performed, and the patient was admitted to the ICU. On 21Jul2021, the patient had no problem in consciousness level and limb movement, and was scheduled to move to the general ward. The reporting physician classified the event as serious (caused hospitalization from 16Jul2021 and life-threatening) and the causality between the event and bnt162b2 as unassessable. Other possible causes of the event are as following: Steroid and biological drug were being administered for rheumatoid arthritis. It was after performing stent graft and left internal iliac artery coil embolization for the left common iliac aneurysm three years ago (2018), and after performing arch aortic aneurysm stent graft on Jun2021 recently. The reporting physician commented as follows: Originally, the patient had underlying disease of arteriosclerotic disease, and the relationship was unknown, but it could not be denied that the vaccine might have caused the rupture of the original arterial lesion by any mechanism. Therefore, the event was reported.


VAERS ID: 1527782 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

Administered by: Other       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, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Dermatitis atopic; Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100964276

Write-up: chest pain/myocarditis; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC5947, Expiration date: 30Sep2021), via intramuscular route, administered in left arm on 10Jul2021 10:45 (the day of vaccination) (at the age of 22-year-old), as Dose 1 single, for COVID-19 immunization. Medical history included epilepsy, dermatitis atopic, and asthma bronchial, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received prescription drugs within 2 weeks of vaccination. On 16Jul2021 (the 7th day of vaccination), the patient experienced chest pain. On 17Jul2021 (the 8th day of vaccination), the patient was diagnosed with myocarditis which caused hospitalization in hospital. On 28Jul2021 (the 19th day of vaccination), the patient was be discharged from the hospital. Since the vaccination, the patient had been tested for COVID-19 was unknown. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis.


VAERS ID: 1527785 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: SpO2; Test Result: 99%; Test Date: 20210716; Test Name: physical examination; Result Unstructured Data: Test Result: chest sound was clear, and consciousness was clear; Test Date: 20210716; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: 130/80; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100967233

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21120496. A 56-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD0889; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration on 16Jul2021 18:30 (at the age of 56years) as dose1, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire. On 16Jul2021 at 18:45 (15 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event anaphylaxis was as follows: Approximately 15 minutes after the vaccination, redness of face, and neck itching appeared. SpO2 was 99%, blood pressure was 130/80, chest sound was clear, and consciousness was clear; thus, it was not considered serious and intravenous infusion of replenisher solution and prednisolone was initiated. At the time when infusion was completed, the symptoms improved, and the patient returned home. On 16Jul2021 (on the same day of the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: It was considered anaphylaxis (mild). Follow-up attempts are completed. No further information is expected.


VAERS ID: 1527824 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Shock
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: body temperature; Result Unstructured Data: normal
CDC Split Type: JPTAKEDA2021TJP068325

Write-up: Psychogenic shock (feeling of warmth); Bradycardia; This case was received via Regulatory Authority(Reference number: 2021TJP068325) on 24-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Psychogenic shock (feeling of warmth)) and BRADYCARDIA (Bradycardia) in a 31-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003657) for COVID-19 vaccination. The patient''s past medical history included Hyperthyroidism since an unknown date. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced SHOCK (Psychogenic shock (feeling of warmth)) (seriousness criterion medically significant) and BRADYCARDIA (Bradycardia) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE BITARTRATE (ADRENALINE (EPINEPHRINE) INJECTION BP 1:1000) on 16-Jul-2021 at a dose of 0.4 mg. On 16-Jul-2021, SHOCK (Psychogenic shock (feeling of warmth)) and BRADYCARDIA (Bradycardia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 36.1 degree celsius (normal) normal. No treatment medication information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: 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: 1528439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100949376

Write-up: central pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number. A 25-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: FD4555) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing depression. Concomitant medications were not reported. The patient had central pulmonary embolism on 16Jul2021 and was hospitalized in 2021. Event was considered as life threatening. Outcome of the event was unknown. Relatedness of drug to reaction pulmonary embolism with the suspect drug per physician was likely. Health authority comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected


VAERS ID: 1528445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (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: VALACICLOVIR [VALACICLOVIR HYDROCHLORIDE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963449

Write-up: Pulmonary embolism; Pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 588368. A 38-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included valaciclovir hydrochloride (VALACICLOVIR) taken for an unspecified indication from an unspecified date. The patient experienced pulmonary embolism and pyrexia on 16Jul2021. Onset Time in Days: 9 days. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1528680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram head, Lumbar puncture, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy (Well treated); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-alcohol user (Previous excessive alcohol consumption)
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Blood test; Result Unstructured Data: Test Result:No result; Test Date: 202107; Test Name: Brain CT; Result Unstructured Data: Test Result:No result; Test Date: 202107; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:No infection; Comments: No infection, examining for autoimm. encephalitis
CDC Split Type: DKPFIZER INC202100948632

Write-up: Status epilepticus (relatively refractory for now); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 63-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 (Lot Number: FD0932) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ex-alcohol user (previous excessive alcohol consumption), ongoing epilepsy (well treated), and ongoing hypertension. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: FC2336, Expiry Date: 30Sep2021) on 09Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced status epilepticus (relatively refractory for now) on 16Jul2021. On 16Jul2021, 48 hours after the second vaccination, the patient developed status epilepticus. The ADRs (adverse drug reactions) were reported by the reporter as being life threatening and resulting in hospitalization (intensive care unit) on 16Jul2021. Test results from Jul2021: Lumbar puncture: No infection, examining for autoimmune encephalitis; Brain CT (computed tomography): No result; Blood test: No result. No treatment or medical procedure due to the ADRs were reported. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1529469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-07-16
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

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: 20210716; Test Name: COVID-19 antigen test; Test Result: Positive ; Comments: Rapid antigen test SARS-COV2
CDC Split Type: ESPFIZER INC202100949032

Write-up: patient tested positive for rapid antigen test SARS-COV2 on 16Jul2021; patient tested positive for rapid antigen test SARS-COV2 on 16Jul2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number ES-AEMPS-948277. A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EM0477), via an unspecified route of administration, on 13Jan2021, as dose 1, single and second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL8723) via an unspecified route of administration, on 06Feb2021, as dose 2, single both doses for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient tested positive for rapid antigen test SARS-COV2 on 16Jul2021 and experienced diarrhea on 10Jul2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test (rapid antigen test SARS-COV2): positive on 16Jul2021. The outcome of event COVID-19 was unknown. Conclusion: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5693567. The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EL8723. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed. For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5595397. The complaint for a cardiac arrest after vaccination of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1529481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Ear pain, Facial asymmetry, Headache, Oculofacial paralysis, Physical examination
SMQs:, Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Ocular motility disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bell''s palsy (Hereditary family factor)
Allergies:
Diagnostic Lab Data: Test Name: physical exam and history; Result Unstructured Data: Test Result:Level 3
CDC Split Type: ESPFIZER INC202100948974

Write-up: Left eye orbicular paralysis; Pain in left retroauricular region; Pain in left retroauricular region; Deviation of left oral comisura; Bell''s palsy; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB with regulatory authority number ES-AEMPS-949691. A 46-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE6208), via an unspecified route of administration on 07Jul2021 as dose 2, single for COVID-19 immunization. Medical history included Family history of Siblings also affected by family paralysis, Hereditary family factor. Concomitant medications were not reported. On 16Jul2021, patient experienced bell''s palsy (Bell''s sign). And on an unspecified date patient experienced left eye orbicular paralysis, pain in left retroauricular region, deviation of left oral comisura. The patient underwent lab tests and procedures which included physical examination (physical exam and history): Level 3 on unspecified date. The outcome for the event bell''s palsy was resolving and for remaining events outcome was reported as unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1529485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 LA / OT

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MG [MAGNESIUM]; VIT C
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia inguinal; Hydrosalpinx; Myomectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/80 mmHg
CDC Split Type: ESPFIZER INC202100954954

Write-up: Facial droop; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-952046. A 46-years-old nonpregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- FD8274), intramuscularly, administered in Arm Left on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- FA4632), intramuscularly, administered in Arm Left on 16Jun2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included hydrosalpinx from an unknown date, inguinal hernia from an unknown date and had myomectomy on an unknown date. Concomitant medication(s) included magnesium (MG [MAGNESIUM]) taken for an unspecified indication, from an unknown start date, ascorbic acid (VIT C) taken for an unspecified indication, from an unknown start date. On 16Jul2021, the patient went to the Emergency Department, for clinical compatible right facial paralysis since yesterday presents difficulty in eye closure, deviation of the corner and fluids are escaped to the contralateral side. On 18Jul2021, the patient underwent lab tests which included blood pressure measurement and results were 135/80 mmhg. The patient went to emergency room for the treatment. The patient was treated with symptomatic treatment with corticoid cycle is prescribed and recommendations in the absence of hospital loud alarm data with symptomatic treatment. The patient was treated with OMEPRAZOLE 20 mg: 1 capsule, every 24 hours, fasting in the morning. Oral route and PREDNISONE 30 mg: 2 tablets for 5 days, 1 tablet and a half 3 days, 1 tablet 3 days, ? as a discharged treatment. Currently the patient is taking URBASON SOLUBLE (40 MG AMPOULES) 1.5 AMPOULES c/1 Hours as treatment for the event. The outcome of the event was reported as recovering at the time of report. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1529500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood creatine phosphokinase, Blood glucose, Blood pressure measurement, Blood test, Body temperature, Coma scale, Computerised tomogram head, Contusion, Electrocardiogram ambulatory, Fatigue, Haemorrhage, Heart rate, Hyperhidrosis, Oxygen saturation, Seizure, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN; ORLOC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: creatine kinase; Result Unstructured Data: Test Result:86; Test Date: 20210716; Test Name: blood glucose; Result Unstructured Data: Test Result:6.7; Test Date: 20210717; Test Name: blood glucose; Result Unstructured Data: Test Result:8.5; Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:139/82; Test Date: 20210630; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210717; Test Name: temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20210717; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:15; Test Date: 20210716; Test Name: head CT; Result Unstructured Data: Test Result:a small striated cerebral infarction; Comments: on the left in the cerebellum response to referral data, no new changes.; Test Date: 20210630; Test Name: Holter; Result Unstructured Data: Test Result:unknown results; Test Date: 20210717; Test Name: pulse rate; Result Unstructured Data: Test Result:87/min; Test Date: 20210717; Test Name: saturation; Test Result: 96 %; Test Date: 20210716; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.9
CDC Split Type: FIPFIZER INC202100974105

Write-up: Fatigue; Hyperhidrosis; Low back pain; hemorrhages in both front and back of both thighs/ painless bleeding; both hands on the back of the palms and wrists rather large (4x 4 -5 cm) painless bleeding (extensive bruising); Seizure; The first report is a report from a contactable consumer (patient) and downloaded from the Regulatory Authority This consumer reported information for both first and second vaccine dose. This is the second of two reports, for the second vaccine dose. An unspecified male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Jun2021 as single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications included valsartan (DIOVAN) and bisoprolol fumarate (ORLOC), both taken for hypertension and from 2015. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 03Apr2021 as single dose for COVID-19 immunization and experienced urine ketone body present, extrasystoles atrial, feeling cold, extrasystoles ventricular, arthralgia, white blood cell count increased, seizure, neuralgia, headache, chills, LBBB, fatigue, feeling hot, hyperhidrosis, low back pain, neck pain, walking difficulty, malaise, blood pressure increased, dyspnoea exertional, tendon pain, myalgia, toe injury, haematoma, pain in extremity and abdominal pain lower. On 16Jul2021, the patient experienced seizure. On an unspecified date, the patient experienced fatigue, hyperhidrosis, low back pain, hemorrhages in both front and back of both thighs, both hands on the back of the palms and wrists rather large (4x 4 -5 cm) painless bleeding. The patient underwent lab tests and procedures which included creatine kinase: 86 on 16Jul2021, blood glucose: 6.7. On 16Jul2021, blood glucose: 8.5. On 17Jul2021, blood pressure measurement: 139/82. On 17Jul2021, blood test: normal. On 30Jun2021, body temperature: 35.9 centigrade on 17Jul2021, glasgow coma scale: 15. On 17Jul2021, head CT: a small striated cerebral infarction. On 16Jul2021 on the left in the cerebellum response to referral data, no new changes, holter: unknown results. On 30Jun2021, pulse rate: 87/min. On 17Jul2021, oxygen saturation: 96 % on 17Jul2021, leukocytes: 9.9. On 16Jul2021. The event of seizure resulted in emergency room visit. The outcome of events was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1529566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sleep apnea
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202100966930

Write-up: Bilateral deep vein thrombosis; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-RE20212027. A 45-years-old male patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 2 intramuscular, administered in Arm Left on 05Jul2021 (Batch/Lot Number: FD7959, expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sleep apnoea from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was not considered at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19, having performed a COVID-19 test. On 16Jul2021, the patient experienced bilateral deep vein thrombosis. The patient has an emergency consultation with an angiologist and then undergoes a medical intervention. Laboratory tests included sars-cov-2 test: negative on 01Mar2021. The clinical outcome of the event was not recovered. Note: Subject to further investigations that could be carried out as part of legal or amicable compensation procedures. Official bulletin of the Ministry of Health Number 84/50, 24Jan1985. Therapie 1985; 40:111-8. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1530024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder, SARS-CoV-2 test, Stress, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941709

Write-up: stress; brown spotting/started bleeding (bright red blood) which is still continuing today (6 days later); Menstruation abnormal; This is a spontaneous report from a contactable consumer (patient). The consumer reported for 2 patients. This is the first of two reports. The first report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221844508410-CIP0S and Safety Report Unique Identifier GB-MHRA-ADR 25694807. A female of an unspecified age received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021, (Batch/Lot Number: FE1510) as dose 1, single for COVID-19 immunization. The patient medical history included: patient is healthy, do not smoke and do not drink. Patient has not had symptoms associated with COVID-19. There were no concomitant medications. On 16Jul2021, the patient experienced brown spotting/ started bleeding (bright red blood) which is still continuing today (6 days later) and menstruation abnormal. On an unspecified date, the patient experienced stress. The clinical course was reported as follows: The patient had menstruation bleeding had just stopped prior to getting the Pfizer/BioNTech vaccine. On the day of getting the jab, patient had very mild dark brown spotting (as is common for the end of a menstruation cycle). A few hours after receiving the vaccine, patient started bleeding (bright red blood) which is still continuing today (6 days later). The patient periods are always regular. Therefore, such a bleeding is uncommon for the patient. On the day of receiving the vaccine, according to the patient she was very happy. Both she and her husband had both been waiting for a long time for an appointment for the Pfizer/BioNTech shot, which they considered the most effective vaccine on the market. She can therefore confirm that stress or similar is not connected with the above described phenomenon. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The patient had COVID-19 Virus test (Unknown date): No - Negative COVID-19 test. The outcome for the event brown spotting/started bleeding (bright red blood) which is still continuing today (6 days later) and stress was recovering; outcome for menstruation abnormal was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1530169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Contusion, Electromyogram, Feeling hot, Gait disturbance, Limb discomfort, Paraesthesia, Peripheral swelling, Ultrasound Doppler, Ultrasound abdomen
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to insect sting; Epidural anaesthesia; Fibromyalgia; Food allergy; Herbal allergy; Oligoarthritis
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown result; Test Name: Electromyography; Result Unstructured Data: Test Result:unknown result; Test Name: Echo abdomen; Result Unstructured Data: Test Result:unknown result; Test Name: Echocolordoppler lower limbs; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC202100939500

Write-up: Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; Difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs. After 2 days, bruising of the limbs and continuous tingling appear; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IT-MINISAL02-758970. A 27-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single (Deltoid Right/right shoulder) for covid-19 immunisation. Medical history included Fibromyalgia, Chronic Oligoarthritis, Wasp allergy, Thyme allergy, Truffle allergy, Epidural anaesthesia. The patient''s concomitant medications were not reported. The patient previously took sulfasalazine. The patient experienced difficulty walking with swelling, heaviness, tingling and excessive heat in the lower limbs on 16Jul2021. After 2 days (18Jul2021), bruising of the limbs and continuous tingling appear. Impact on quality of life (10/10). The patient had Echocolordoppler lower limbs, arterial venous, and femoral. Performed Blood tests, Echo abdomen and electromyography recommended lower limbs. The outcome of the events was not recovered. Events reported as serious due to disability. Reporter comment: Chronic oligoarthritis Fibriomyalgia Sulfasalazine Epidural anesthesia reaction Wasp, thymus, truffle No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reporter''s Comments: Chronic oligoarthritis Fibriomyalgia Sulfasalazine Epidural anesthesia reaction Wasp, thymus, truffle


VAERS ID: 1530220 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: Bladder cancer; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100943951

Write-up: Loss of consciousness; nausea; cold sweat; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21121377. A 57-year and 1-month-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 16Jul2021 at 13:00 (Lot Number: EY0572; Expiration Date: 31Oct2021) (at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included bladder cancer and hypertension, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took amlodipine (2.5 mg) for hypertension. Body temperature before vaccination was 36.4 degrees Centigrade. On 16Jul2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 16Jul2021 at 13:25 (25 minutes after the vaccination), the patient experienced loss of consciousness, nausea and cold sweat. On 16Jul2021 (the day of vaccination), the outcome of the events was recovered. The course of the event was as follows: after vaccination, in waiting time, the patient experienced nausea, cold sweat, and loss of consciousness. Consciousness was back shortly after. Administered IV drips of steroid, H1, H2 blocker, HISHIPHAGEN. The symptoms gradually improved, prescribed antihistamine agent (LEVOCETIRIZINE) for two days, and the patient returned home. The reporting pharmacist classified the event as serious (Medically significant) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: considered there was a causality with vaccine, told the patient to postpone the 2nd dose of vaccination.


VAERS ID: 1530341 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chills, Dizziness, Dyspnoea, Fatigue, Heart rate, Heart rate increased, Hyperventilation, Hypoaesthesia, Hypoaesthesia oral, Illness, Oxygen saturation, Oxygen saturation decreased, Palpitations
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Pulse rate; Result Unstructured Data: Test Result:125; Comments: breaths/min 11:40 high; Test Date: 20210716; Test Name: Oxygen saturation; Test Result: 90 %; Comments: 11:40; Test Date: 20210716; Test Name: Oxygen saturation; Test Result: 70 %; Comments: 11:59; Test Date: 20210716; Test Name: Oxygen saturation; Test Result: 99 %; Comments: 12:00 (after receiving epinephrine)
CDC Split Type: NOPFIZER INC202100948967

Write-up: very tired; heavy breath; got very sick; SHIVERING; BREATHING DIFFICULT; PALPITATION; ANAPHYLAXIS; NUMBNESS MOUTH; DIZZINESS/dizzy; NUMBNESS IN FACE; OXYGEN SATURATION LOW (70 %)/oxygen saturation was 90 %; HIGH PULSE RATE/pulse was high/125; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uymwdx. A 39-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 16Jul2021 11:38 (Lot Number: FF0900) as dose 1, single (at the age of 39 years old) for COVID-19 immunisation. Medical history included allergy to nuts from an unknown date. The patient''s concomitant medications were not reported. On 16Jul2021 at 11:40 her pulse was high (125, regular) which was also reported as high pulse rate and her oxygen saturation was 90 %. On 16Jul2021 at 11:43, the patient experienced anaphylaxis; reported that five minutes after the vaccination, she got dizzy (also reported as dizziness) and experienced palpitation and numbness in face and numbness mouth. At 11:59, she got very sick with heavy breath also reported as breathing difficult and oxygen saturation low (70 %), and shivering. Epinephrine was administered at 12:00, followed by improvement and an oxygen saturation of 99 %, but she still had shivering and was very tired. The ambulance arrived and she received hydrocortisone IV, before she was transported to the emergency ward at the hospital. The reporter was a physician (possibly working at the vaccination center). The reactions were reported as serious (life threatening and hospitalization). The patient underwent lab tests and procedures on 16Jul2021 which included pulse rate: 125 breaths/min (high) at 11:40, oxygen saturation: 90 % at 11:40 , 70 % at 11:59, 99 % at 12:00 (after receiving epinephrine). Therapeutic measures were taken as result of the events. The outcome of the events was recovered/resolved on unspecified time in 16Jul2021. The causality assessment is Probable. Reporter Comment: Regulatory Authority: More information regarding this case will be requested from the hospital. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Probable. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Regulatory Authority: More information regarding this case will be requested from the hospital.


VAERS ID: 1531373 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Ear pain, Extensive swelling of vaccinated limb, Fatigue, Headache, Hot flush, Injection site reaction, Malaise, Myalgia, Nausea, Peripheral coldness, Pyrexia, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DAFALGAN; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: Bisoprolol EG 5 mg, Spironolactone EG 25 mg, Olmesartan Plus HTC EG 40 mg/25 mg, Lercanidipine EG 20 mg, Desloratadine EG 5mg (insect stings).
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210807470

Write-up: CONVULSIONS; EAR PAIN; COLD FEET SENSATION; HOT FLASHES; DIZZINESS; EXTENDED ARM SWELLING; INJECTION SITE REACTION; CHILLS; MALAISE; JOINT PAIN; MUSCLE PAIN; FATIGUE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-101889] concerned a 51 year old male of unknown race, and ethnic origin. The patient''s weight was 120 kilograms, and height was 183 centimeters. The patient''s past medications included bisoprolol EG 5 mg, spironolactone EG 25 mg, olmesartan plus hydrochlorothiazide (htc) EG 40 mg/25 mg, lercanidipine EG 20 mg, desloratadine EG 5mg (insect stings). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1605 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-JUL-2021 for covid-19 immunisation. Concomitant medications included paracetamol, and Dafalgan. On 16-JUL-2021, the patient experienced ear pain, cold feet sensation, hot flashes, dizziness, extended arm swelling, convulsions, injection site reaction, chills, malaise, joint pain, muscle pain, fatigue, nausea, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, fatigue, ear pain, nausea, fever, cold feet sensation, hot flashes, chills, joint pain, dizziness, extended arm swelling, convulsions, malaise, injection site reaction, and headache. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment:- Parac?tamol 1 gr- Dafalgan 1grEvolution of the ADR: No improvement Situations:Other: very good question, I had no choice for the vaccine.; Sender''s Comments: V0: 20210807470-COVID-19 VACCINE AD26.COV2.S- Convulsions, ear pain, cold feet sensation, hot flashes, dizziness, extended arm swelling, injection site reaction. This events is considered unassessable. The events 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 events. 20210807470-COVID-19 VACCINE AD26.COV2.S- Chills, malaise, joint pain, muscle pain, fatigue, nausea, fever, headache. This events is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1531396 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-16
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1742 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Blood pressure measurement, Extraocular muscle paresis, Headache, Inappropriate schedule of product administration, Muscular weakness, Pain in jaw
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hearing impairment (broad), Osteonecrosis (broad), Ocular motility disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (family history of MS and diabetes but neither has presented in me); Inflammation (doc couldn''t be sure, saw inflammation in tests); Lactose intolerance (lactose intolerance or milk protein allergy (doc couldn''t be sure, saw inflammation in tests),); Low blood pressure (Low blood pressure (not dangerously low); Milk protein allergy (lactose intolerance or milk protein allergy (doc couldn''t be sure, saw inflammation in tests),); MS (family history of MS and diabetes but neither has presented in me)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Low; Comments: not dangerously low
CDC Split Type: CAPFIZER INC202100942270

Write-up: right eye muscles felt weak, and then right lower jaw and upper front; right eye muscles felt weak, and then right lower jaw and upper front; Headache; Occasional ache in jaw; Bell''s Palsy; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER1742), via an unspecified route of administration in arm left on 16Jun2021 at 11:00 AM (at the age of 41-year-old) as a dose 2, single for COVID-19 immunisation. The family medical history included MS and diabetes, but neither has presented in patient. The patient''s medical history included low blood pressure, (not dangerously low), lactose intolerance, milk protein allergy, lactose intolerance or milk protein allergy (doc couldn''t be sure, saw inflammation in tests), Inflammation, (doc couldn''t be sure, saw inflammation in tests). The patient''s concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride, (sporadically). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA9093), via an unspecified route of administration in arm left on 20Mar2021 at 02:00 PM as a dose 1, single for COVID-19 immunization. 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, has the patient been tested for COVID-19 was reported as no. On 18Jul2021 at 05:00 PM, the patient experienced headache (right back of head), migrating to inner right ear. Occasional ache in jaw. After about four days from onset of headache. On 22Jul2021, the patient experienced right eye muscles felt weak and then right lower jaw and upper front muscles below nose. Went to emergency and by the time the patient saw a physician the right side of his face had visible drop. The patient was diagnosed with Bell''s Palsy on 18Jul2021 at 05:00 PM. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Hospitalization prolonged was reported as no. Treatment received for the adverse events included prednisone (7 days), monitoring for 4 weeks. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure, resulted as low, not dangerously low. The device date was on 23Jul2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Migraine, Nausea, Paraesthesia, Photophobia, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Cranial Computerised tomogram; Result Unstructured Data: Test Result:without significant findings; Test Date: 202107; Test Name: MRI; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: ESPFIZER INC202100953448

Write-up: paresthesias in the left hemibody with blurred vision of the right eye; paresthesias in the left hemibody with blurred vision of the right eye; very strong migraine, with photophobia, nausea and long duration; very strong migraine, with photophobia, nausea and long duration; very strong migraine, with photophobia, nausea and long duration; Vision problems; Some headache; This is a spontaneous report from a contactable consumer (parent). A 25-year-old female patient received BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on 14Jul2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On Friday 16Jul2021, the patient began to notice vision problems and some headaches. On Monday 19Jul2021, she started with a very strong migraine, with photophobia, nausea and prolonged duration that she did not remit with analgesics; it required emergency care and intravenous medication (Tramadol). On Tuesday 20Jul2021, she had to go to the emergency room again because the headache did not subside and she also presented paresthesias in the left hemibody with blurred vision in the right eye. She had a Cranial Computerized tomogram (TAC) without significant findings. Her paresthesia''s subsided the next day but the blurred vision continued to until time of report, without the ophthalmological examination being detected no findings to explain it. The reporter stated that it was clearly related to the vaccine as she has not suffered from migraines. At the time of report she was without a diagnosis or treatment and was awaiting the results of an MRI. Outcome of the event vision blurred was not recovered, vision problems and some headaches was unknown, and the remaining events was recovered on an unspecified date. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1532605 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (patient with multiple allergies to dust, argan oil, peanuts); Cyst rupture (cyst rupture with hemorrhagic shock 2018); Dust allergy; Haemorrhagic shock (cyst rupture with hemorrhagic shock 2018); Peanut allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100948921

Write-up: Oedema Quincke''s (edema of the face with hot flashes); This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-TS20213123. A 22-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FE3065),intramuscular on 16Jul2021 as dose 1, single for covid-19 immunization. Medical history included cyst rupture with hemorrhagic shock from 2018, dust allergy, allergy to argan oil, and allergy to peanuts from an unknown date. The patient''s concomitant medications were not reported. On 16Jul2021, 30 minutes after injection, patient had edema of the face with hot flashes determined to be oedema Quincke''s. In total, the physician reported that patient had oedema Quincke''s 30 minutes after dose 1 of bnt162b2 and received adrenaline. The patient was hospitalized for surveillance. The outcome of the event was recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1532779 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941826

Write-up: Paresthesia; Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221950054310-TZFFS. Safety Report Unique Identifier (GB-MHRA-ADR 25695169). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 16Jul2021, the patient experienced paresthesia and chest pain. Outcome of the events was not recovered. The patient underwent lab test which included Covid-19 virus test: no - negative Covid-19 test on 18Jul2021. The events were assessed as serious and medically significant by regulatory authority. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1532912 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Musculoskeletal stiffness, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943058

Write-up: Dizziness; Stiff fingers; Numbness in leg; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107231239268570-OJOFJ, Safety Report Unique Identifier GB-MHRA-ADR 25698750. A 39-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (lot number: FC9001) as dose 2, single for COVID-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced dizziness/ feeling dizzy more often, stiff fingers, numbness in leg on 16Jul2021. The events were considered a disability. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative COVID-19 test on 19Jul2021. The patient was recovering from the event, stiff fingers and not recovered from the remaining events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-16
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Embolism venous, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain; Vomiting
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943241

Write-up: Venous thromboembolism; vomiting; abdominal pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107232200331510-XXNUW, Safety Report Unique Identifier GB-MHRA-ADR 25702144 . A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA1027), via an unspecified route of administration on 15Jun2021 as single dose for COVID-19 immunization. Medical history included abdominal pain and vomiting. Patient is not pregnant .Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. COVID-19 virus test on an unknown date was negative. The patient''s concomitant medications were not reported.The patient experienced venous thromboembolism on 16Jul2021 (as reported) and on an unknown date in 2021 vomiting and abdominal pain, all serious due to hospitalization from 18Jul2021 to 18Jul2021. Events required emergency room and physician office visit and patient received antibiotics as treatment.Clinical course was reported as follows: on 18Jul2021 presented with 2/7 lower abdominal pain and vomiting reported A&E diverted to GP where advised needs ambulance to return to A&E, needs urgent assessment in A&E, admission to Hospital, diagnosis: at risk of venous thromboembolus, discharged. On 19Jul2021 treated with antibiotics and CT scan requested. Outcome of venous thromboembolism was unknown, outcome of the other events was recovered in Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Fatigue, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100943206

Write-up: pain; As the day went on I felt really exhaust; didn''t have energy to do things; 3rd day after having the vaccine, it started around 2pm I had pain at the back right side; Muscle pain; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107232222562130-WILL2, Safety Report Unique Identifier GB-MHRA-ADR 25702156 A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), 13Jul2021 at single dose for COVID-19 immunisation. Relevant medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain, muscle pain on 16Jul2021, 3rd day after having the vaccine, it started around 2pm pain at the back right side on 17Jul2021 with outcome of unknown, as the day went on felt really exhaust on an unspecified date and didn''t have energy to do things on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 21May2021. Clinical course was provided as follows. On the 3rd day after having the vaccine, it started around 2pm the patient had pain at the back right side. Like a tight squeeze or cramp that wouldn''t go. As the day went on the patient felt really exhaust and didn''t have energy to do things. Picking things up was difficult, her body was in pain. At night she couldn''t even do anything, the pain was all over her muscle. She couldn''t get out of the bed, she had someone bring me 2 paracetamol with water and went back to bed. Next day she felt so much better like it never existed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Pain was resolving, muscle pain resolved, outcome for pain at the back right side, really exhaust and no energy to do things was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532997 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Feeling abnormal, Influenza, Nasopharyngitis, SARS-CoV-2 test, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (broad), Dementia (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: ZAPAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cyst
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100943441

Write-up: fuzzy head; cold; dry cough; tiredness; hot and cold post-nasal drip; Flu; This is a spontaneous report from a contactable CONSUMER OR OTHER NON PROFESSIONAL. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107232325029090-JGVM2], Safety Report Unique Identifier [GB-MHRA-ADR 25702232]. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunization (35-year-old at vaccination). Medical history included cyst from an unknown date and unknown if ongoing. Concomitant medication(s) included codeine phosphate, paracetamol (ZAPAIN) taken for cyst from 04Dec2016 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced fuzzy head (feeling abnormal) (medically significant) on an unspecified date with outcome of unknown, cold (nasopharyngitis) (medically significant) on an unspecified date with outcome of unknown, dry cough (cough) (medically significant) on an unspecified date with outcome of unknown, tiredness (fatigue) (medically significant) on an unspecified date with outcome of unknown, flu (influenza) (medically significant) on 16Jul2021 with outcome of not recovered. The patient had bad dry cough, tiredness and fuzzy head. She also had hot and cold post-nasal drip. The patient underwent covid-19 virus test with negative result on 17Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1533048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest discomfort, Mood altered, Mouth ulceration, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; FLUTICASONE PROPIONATE; GLUCOSAMINE AND CHONDROITIN; HYDROXOCOBALAMIN; IBUPROFEN; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis (medication for managing); Back pain; Diarrhoea; Joint pain (general joint pain); Seasonal allergy (medication for managing); Sinus disorder (medication for managing)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943317

Write-up: ok; normally; Joint ache; Backache; Mood change; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107241116001390-ZT71R. Safety Report Unique Identifier GB-MHRA-ADR 25702895. A 35-year-old male patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FE1510) as dose 2, single for covid-19 immunisation. Medical history included Allergic rhinitis, Joint pain, diarrhoea. Sinus issues and allergic rhinitis - medication for managing those and also seasonal allergies. Joint care supplements for backpain and general joint pain. B12 injections every 12 weeks. Patient has not had symptoms associated with COVID-19. Concomitant medications included fexofenadine taken for allergy, start and stop date were not reported; fluticasone propionate taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine (GLUCOSAMINE AND CHONDROITIN) taken for joint ache, start and stop date were not reported; hydroxocobalamin taken for pernicious anaemia, start and stop date were not reported; ibuprofen taken for backache, start and stop date were not reported; colecalciferol (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient experienced chest discomfort (ok) on an unspecified date with outcome of unknown, mouth ulceration (normally) on an unspecified date with outcome of unknown, joint ache on 16Jul2021 with outcome of not recovered, backache on 16Jul2021 with outcome of not recovered, mood change on 16Jul2021 with outcome of recovering. Events seriousness criteria was medically significant. It seems to have impacted previous conditions more than specifically causing them. Joint ache and backache which are normally ok, and have been for months, suddenly worsened. Mood changed to being more anxious, stressed, generally worsened. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date.


VAERS ID: 1533102 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Fatigue
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: CODEINE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Neuralgia; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100942971

Write-up: Fatigue extreme/fatigue; Bleeding nose; 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-202107241703535030-CMQKK. Safety Report Unique Identifier GB-MHRA-ADR 25703246. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased and neuralgia. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included codeine taken for neuralgia from 01Jan2020 to an unspecified stop date; tramadol taken for neuralgia from 01Jun2021 to an unspecified stop date. The patient experienced fatigue extreme/fatigue and epistaxis on 16Jul2021 affecting daily life. The events were assessed as serious (medically significant). The outcome of the event fatigue was not recovered and bleeding nose was recovered on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533167 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dysphagia, Ear pain, Fatigue, Lymphadenopathy, Myalgia, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Tonsillitis bacterial
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Tonsillitis
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100943366

Write-up: throat pain/sore throat; swollen lymph nodes; difficulty swallowing; ear ache; chills; nausea; muscle aches; fatigue; Tonsillitis/pus all over tonsils/tonsillitis probably caused by bacterial infection; fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107242153459660-Q9Q85. Safety Report Unique Identifier GB-MHRA-ADR 25703495. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Jul2021 (Lot Number: FF3319) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included tonsillitis, pyrexia. The patient''s concomitant medications were not reported. The patient experienced throat pain/ sore throat on an unspecified date with outcome of unknown, swollen lymph nodes on an unspecified date with outcome of unknown, difficulty swallowing on an unspecified date with outcome of unknown, ear ache on an unspecified date with outcome of unknown, chills on an unspecified date with outcome of unknown, nausea on an unspecified date with outcome of unknown, fever on 16Jul2021 with outcome of unknown, muscle aches on an unspecified date with outcome of unknown, fatigue on an unspecified date with outcome of unknown, tonsillitis on 21Jul2021 with outcome of not recovered. Events were serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 23Jul2021. The clinical course was reported as follows: Patient got a fever in the middle of the night the night of vaccine. She felt so awful chills, nausea, fever, muscle aches etc, then it went away she felt fine for a few days. But she did not feel uncontrollably hot for days after (later realised I had a fever after testing temp regularly) on the 22nd she woke up with a sore throat lasted all day. The 23rd was the worst she had ever felt severe muscle aches, swollen lymph nodes, ear ache, pus all over tonsils, throat pain, difficulty swallowing fatigue, fever. (Tested negative for COVID) Phoned 111 in middle of night after waking up in excruciating pain and fever doctor said she would have to go into hospital said she had severe tonsillitis probably caused by bacterial infection and gave penicillin antibiotics course. She never get ill she had not had a virus/ been ill since late 2019 then 2 years before that. She never get ill but after having the COVID vaccine. This was the worst and illest she had ever felt in her life. 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: 1533568 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Mouth swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100959047

Write-up: Angioedema of the lips, tongue, palatine arches and uvula; Angioedema of the lips, tongue, palatine arches and uvula; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. A male patient of an unspecified age received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Jul2021, patient experienced angioedema of the lips, tongue, palatine arches and uvula. Patient treated with steroid and injectable antihistamine. Patient recommended access to the DEA (Emergency and admission department). Outcome of the events was unknown. Reporter Comment: Angioedema of the lips, tongue, palatine arches, treated with steroid and injectable antihistamine. Patient recommended access to the DEA (Emergency and admission department). The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1533629 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood gases, Blood pressure increased, Blood pressure measurement, Blood test, Chest X-ray, Cough, Electrocardiogram, Erythema, Malaise, Oxygen saturation, Oxygen saturation decreased, Pruritus, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy (Facial rash/ dyspnoea developed after eating mackerel fish. Urgent visit to H needed.)
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:180/100 mmHg; Comments: At 15:45; Test Date: 20210716; Test Name: Hematology; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210716; Test Name: Chest X-P; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210716; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210716; Test Name: SPO2; Result Unstructured Data: Test Result:93-94 %; Comments: At 15:45; Test Date: 20210718; Test Name: Vital signs; Result Unstructured Data: Test Result:Stable; Test Date: 20210716; Test Name: Blood gas; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: JPPFIZER INC202100951724

Write-up: Pruritus; Blood pressure (BP) was 180/100 mmHg; Oxygen saturation was decreased with SPO2 at 93-94%; Anaphylaxis; Generalized malaise; Redness of back; Cough aggravated; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number . A 66-year-old female received BNT162b2 (COMIRNATY, Intramuscular injection, Lot number: FD0889, expiration date: 30Sep2021) via an unspecified route of administration, on 16Jul2021 at 15:05, at the age of 66 years old, as single dose for COVID-19 immunisation. Past medical history of facial rash and dyspnoea which developed after eating mackerel fish. Concomitant drugs were not provided. On 16Jul2021 at 15:30 (25 minutes after the vaccination), generalized malaise, redness of back, and cough aggravated. At 15:45 the same symptoms were persisting and blood pressure (BP) was 180/100 mmHg, oxygen saturation was decreased with SPO2 at 93-94%. At 15:53 epinephrine (EPIPEN) was injected at treatment due to the events, it the outside part of the right thigh. At 15:54, a route was secured from the right forearm. At 16:02, desclofeniramine maleate (POLARAMIN) 1A was injected from the side. At 17:06, the patient was taken to the hospital by ambulance. The patient underwent blood gas, ECG, Chest X-P and hematology tests. The patient was hospitalized for observation of the course of the events. At 18:30, after using Epipen and Polaramin, the patient experienced a relapse of erythema/pruritus. On 17Jul2021 (1 day after vaccination), levocetirizine (XYZAL) tablet 5 mg for internal use was initiated and taken orally for 3 days. On 18Jul2021 (2 days after vaccination), whole physical condition and vital signs were stable. On 19Jul2021 (3 days after vaccination), the symptoms improved, and the patient was discharged from hospital. The events experienced on 16Jul2021 were judged as an anaphylactic reaction from which the patient was considered recovered on 19Jul2021 (3 days after vaccination). The reporter classified the events as serious due to hospitalization, from 16Jul2021 to 19Jul2021. Reporter''s comments: The patient family stated that the patient had a past medical history of facial rash and dyspnoea which developed after eating mackerel fish. The patient visited a hospital urgently. The course of the event was observed.


VAERS ID: 1533635 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cold sweat, Nausea, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202100951845

Write-up: Blood pressure decreased; 5 minutes after the vaccination, the patient experienced Wheezing; Cold sweat; Vomiting; queasy continued; This is a spontaneous report from a contactable physician. A 65-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 16Jul2021 09:45 (Lot Number: EY5422; Expiration Date: 31Aug2021) as single dose (at age of 65-years-old) for covid-19 immunisation. Medical history included asthma bronchial. Concomitant medications were not reported. On 25Jun2021 at 09:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization (at age of 65-years-old). On 16Jul2021 09:50 patient experienced blood pressure decreased, 5 minutes after the vaccination, the patient experienced wheezing, cold sweat, vomiting, queasy continued. The clinical course was as follows: The patient was a non-pregnant 65-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included Bronchial asthma. On 25Jun2021 at 09:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 16Jul2021 at 09:45 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 16Jul2021 at 09:45 (as reported) (after the vaccination), the patient experienced adverse events. The adverse events were following: 5 minutes after the vaccination, the patient experienced Wheezing, Cold sweat and Vomiting. Blood pressure decreased and EPIPEN intramuscular injection was performed. The symptom tended to improve, but queasy continued, and the patient was carried to emergency. The outcome of the events was recovered on unknown date with treatment including EPIPEN. The reporter stated the events results in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: As per available information, the causal association between the events blood pressure decreased, wheezing, cold sweats, vomiting and nausea and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1533861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: ADHD; Asthma bronchial; Bipolar II disorder; Endometriosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100949399

Write-up: Atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the regulatory agency-WEB. The regulatory authority report number is SE-MPA-2021-064074 with safety report unique identifier SE-VISMA-1626790036248. A 27-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 14Jul2021 as dose 1, single for covid-19 immunisation. Ongoing medical histories included attention deficit hyperactivity disorder (ADHD), asthma bronchial, bipolar II disorder, and endometriosis. The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation (hospitalization) on 16Jul2021. Reported suspected side effect was atrial fibrillation which occurred one and a half days (as reported) after the first dose. The patient was admitted to the hospital and that she changed to sinus rhythm after treatment with Flecainide. It was also described that the patient has no previously known atrial fibrillation. Course: Recovered without damage. The case was assessed as serious, hospital care. The patient recovered from the adverse event on 17Jul2021. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1534601 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100964256

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer via the Regulatory Authority. The regulatory authority report number is ZA-SAHPRA-202107180959160910-1C7MT. A 70-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: FC1436), via an unspecified route of administration, on 14Jul2021 (at the age of 70 years), as dose 2, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Jul2021, the patient experienced local reaction. The event was considered serious as disabling or incapacitating. The patient had not recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1535747 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19 (Covid-19)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210808836

Write-up: HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-948449] concerned a 30 year old male of unknown race and ethnicity. The patient''s weight was 103 kilograms, and height was 191 centimeters. The patient''s past medical history included asymptomatic covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-04 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 30-JUN-2021 to left arm for covid-19 vaccination. Drug start period 17 days. No concomitant medications were reported. On 16-JUL-2021, the patient experienced headache. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 30-JUN-2021. The patient had not recovered from headache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210808836-covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1535769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Administration site oedema, Arthralgia, Headache, Nausea, Paraesthesia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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: ITJNJFOC20210809075

Write-up: PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; PRESENTS NAUSEA, VOMITING, HEADACHE CRISIS, DIFFUSE JOINT PAINS, EDEMA OF THE RIGHT ARM AT THE SITE OF INOCULATION, BILATERAL PARALYSIS OF THE UPPER LIMB, FEVER; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-763249] concerned a female of unspecified age, race and ethnicity. The patient''s weight was 76 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 and expiry: 28-FEB-2023) 1 dosage forms, 1 total administered on 09-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced nausea, vomiting, headache/headache crisis, diffuse joint pains (generalized joint pains), edema of the right arm at the site of inoculation (administration site edema), bilateral paralysis of the upper limb (paraesthesia of limb) and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from presents nausea, vomiting, headache crisis, diffuse joint pains, edema of the right arm at the site of inoculation, bilateral paralysis of the upper limb, fever. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0.20210809075-covid-19 vaccine ad26.cov2.s -edema of the right arm at the site of inoculation . 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). 20210809075-covid-19 vaccine ad26.cov2.s -nausea, vomiting, headache, diffuse joint pains, bilateral paralysis of the upper limb and fever.. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1537687 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Pain in extremity, Peripheral artery thrombosis, Peripheral ischaemia
SMQs:, Embolic and thrombotic events, arterial (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100985067

Write-up: partial thrombosis of the a. radialis left side was diagnosed on 16Jul2021 with ischemia of the fingers I,II and V; partial thrombosis of the a. radialis left side was diagnosed on 16Jul2021 with ischemia of the fingers I,II and V; pain and feeling of cold in the left thumb 7 days after the vaccination; pain and feeling of cold in the left thumb 7 days after the vaccination; This is a spontaneous report from a contactable physician received from medical information team. A 15-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 25Jun2021 (age at vaccination 15-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. In 2021, 7 days after receiving first dose, the patient developed pain and a feeling of coldness in her left thumb, after a further 5 days a heat difference right/left could also be objectively determined. A partial thrombosis of the left radial artery with ischemia of fingers I, II and V was diagnosed at the Hospital on 16Jul2021. The clinic has improved under therapy with prostaglandin and Arixta. The investigation of thrombosis (coagulation disorder, vasculitis) was negative. A vaccination side effect was suspected. The patient was discharged on 24Jul2021 and receives thrombosis prophylaxis with Inhixa 60mg s.c. daily for another 14 days. It was reported that the patient mother is a high-risk patient with regards to COVID, the daughter should definitely be fully immunized. The reporter asked how likely thrombosis was to be seen as a side effect of the vaccination and how should one proceed with the second vaccination. The originally planned date was 06Aug21, wanted to know about postponing the date by how much, should stay with Comirnaty or should you change the preparation. Therapeutic measures were taken as a result of events. The outcome for the events was reported as resolving at the time of this report. Follow up information has been requested.; Sender''s Comments: Based on limited available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Peripheral arterial thrombosis" "Peripheral ischemia" due to temporal relationship and current known drug 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: 1537690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963712

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 589493. A 46-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pericarditis on 16Jul2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1537695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963991

Write-up: Syncope; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 590220. A 26-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced syncope on 16Jul2021. The outcome of the event recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1537885 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Lyme-Borreliose; Result Unstructured Data: Test Result:unknown result; Comments: Hypoesthesia on the left side of the face. Left lid closure incomplete. Exclusion Apoplexy.; Test Name: cranial CT; Result Unstructured Data: Test Result:unknown result; Comments: Hypoesthesia on the left side of the face. Left lid closure incomplete. Exclusion Apoplexy.; Test Name: Laboratory test; Result Unstructured Data: Test Result:unknown result; Comments: Hypoesthesia on the left side of the face. Left lid closure incomplete. Exclusion Apoplexy.
CDC Split Type: DEPFIZER INC202100979155

Write-up: Left facial palsy; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-202100145047. A 32-year-old female patient received BNT162B2 (Comirnaty, Formulation: Solution for Injection, Lot Number: Unknown), via intramuscular route of administration, on 17Jun2021 (at the age of 32-year-old), as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Jul2021, 29 days after the administration of vaccine, the patient experienced left facial paralysis. The patient underwent lab tests and procedures which included Borrelia test: unknown result, hypoesthesia on the left side of the face, left lid closure incomplete and exclusion apoplexy; Computerised tomogram head: unknown result, hypoesthesia on the left side of the face, left lid closure incomplete and exclusion apoplexy; laboratory test: unknown result, hypoesthesia on the left side of the face, left lid closure incomplete and exclusion apoplexy; on unspecified dates. Causality assessment result was reported as unclassifiable. The outcome of the event was reported as not resolved. Health Authority''s Comment: Hypoesthesia on the left side of the face, INA LB Cranial Computed Tomography, laboratory. Left lid closure incomplete. Exclusion Apoplexy. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1537902 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3234 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100979996

Write-up: Facial palsy; This is a spontaneous report from a non-contactable Consumer or other non-healthcare professional downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number DE-PEI-202100149656. A 58-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FC3234), second dose via intramuscular route of administration on 12Jul2021 (at the age of 58-year-old), as a single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine given to patient was bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FC3095), first dose via an unspecified route of administration on 14Jun2021 (at the age of 58-year-old), as a single for COVID-19 immunisation and experienced no adverse effects. On 16Jul2021, the patient experienced facial palsy. The outcome of the event was reported as not resolved. Sender''s comments: First vaccination with Comirnaty FC3095 on 14Jun21, well tolerated. Underlying disease hypertension. CADR2021149000 No follow-up attempts possible. No further information expected.


VAERS ID: 1537973 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, C-reactive protein, Chest discomfort, Dyspnoea, Electrocardiogram, Myocarditis, Physical examination
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Auscultation; Result Unstructured Data: Test Result:Regular heart beat equal to periphere pulse rate; Test Date: 202107; Test Name: Auscultation; Result Unstructured Data: Test Result:Normal and no murmur; Test Date: 202107; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:115/70 mmHg; Test Date: 202107; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Below 3; Test Date: 202107; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:SR frequency 68, no block and no sign of ischaemia; Test Date: 202107; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:No pericarditis-configuration; Test Date: 202107; Test Name: Physical examination; Result Unstructured Data: Test Result:Natural colors, no declive oedemas in extremities; Test Date: 202107; Test Name: Physical examination; Result Unstructured Data: Test Result:Thorax: No palpation soreness of tissue or muscles; Test Date: 202107; Test Name: Physical examination; Result Unstructured Data: Test Result:Not acute careworn, normal respiration
CDC Split Type: DKPFIZER INC202100954654

Write-up: Briefly dyspnoea; Chest pressure; NB myocarditis; Chest discomfort; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number DK-DKMA-WBS-0079270. An 18-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 15Jul2021 (Batch/Lot Number: FD0932) as second dose, single for COVD-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, Batch/Lot Number: FC2336, Expiration Date: 30Sep2021) for COVID-19 immunization on 08Jun2021. On 16Jul2021, the patient experienced chest discomfort, chest pressure, nb myocarditis On an unspecified date, the patient experienced briefly dyspnoea. It was reported that the adverse drug reaction''s were by the reporter reported as resulting in hospitalisation. No treatment due to the adverse drug reaction''s was reported or medical procedure was performed. The patient underwent lab tests and procedures which included auscultation: regular heart beat equal to periphere pulse rate on Jul2021, auscultation: normal and no murmur on Jul2021, blood pressure measurement: 115/70 mmhg on Jul2021, c-reactive protein: below 3 on Jul2021, electrocardiogram: sr frequency 68, no block and no sign of ischaemia on Jul2021, electrocardiogram: no pericarditis-configuration on Jul2021, physical examination: natural colors, no declive oedemas in extremities on Jul2021, physical examination: thorax: no palpation soreness of tissue or muscles on Jul2021, physical examination: not acute careworn, normal respiration on Jul2021. The outcome of the event briefly dyspnoea was recovered on an unspecified date while for the other events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1537993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-16
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN STADA; FAVE DE FUCA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Pain menstrual
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100982521

Write-up: Abnormal bleeding outside of menstruation; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-948241. A 36-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Arm Left on 28Jun2021 (Batch/Lot number was not reported) as dose 1, 0.3ml single for covid-19 immunization. The patient medical history included menstruation pain, and constipation. Concomitant medications included ibuprofen (IBUPROFEN STADA) taken for dysmenorrhoea from 04Jul2021 to 06Jul2021; fucus vesiculosus, rhamnus frangula bark, rhamnus purshiana bark (FAVE DE FUCA) taken for constipation from 06Jun2021 to 06Jun2021. The patient experienced abnormal bleeding outside of menstruation on 16Jul2021. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1538000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 LA / -

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: ESPFIZER INC202100960269

Write-up: Lymphadenopathy axillary; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number ES-AEMPS-949658. A 32-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in left arm on 14Jul2021 (Lot Number: FF3318, unknown expiration) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No history of COVID-19. The patient previously received first dose of COMIRNATY for COVID-19 immunisation on unspecified date. The patient experienced lymphadenopathy axillary on 16Jul2021. The patient had not yet recovered from the event. The event was assessed as serious (medically significant). No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1538002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ESPFIZER INC202100954995

Write-up: Pulmonary thromboembolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-950100. A 43-year-old male patient received BNT162B2 (COMIRNATY), via an unknown route of administration, on 05Jul2021 (Batch/Lot Number: FC5089) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 16Jul2021, the patient experienced pulmonary thromboembolism which caused the patient''s hospitalization. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Coagulation test, Fibrin D dimer, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Coagulation test; Result Unstructured Data: Test Result: Normal; Test Date: 20210716; Test Name: D- dimer; Result Unstructured Data: Test Result: Normal.
CDC Split Type: ESPFIZER INC202100960271

Write-up: Paresthesia of limbs; loss of strength in the left hemi-body; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-955492. A 38-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FF0900, expiry date not reported), intramuscular on 15Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of Comirnaty for covid-19 immunisation (Batch/lot number: FC1440) on 24Jun2021. Patient reported paresthesia of limbs also described as loss of strength in the left hemibody the day after administration of the second dose of Comirnaty (on 16Jul2021). Patient visited the Emergency Department that same day, after exploration did not show loss of strength or sensitivity. The events were reported as medically significant There were no complementary tests except coagulation test + D-dimer, which resulted normal on 16Jul2021. The patient was recovering from the conditions paresthesia of limbs and loss of strength in the left hemi-body; which was now described as "paresthesias". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatine phosphokinase MB, Body temperature, Echocardiogram, Electrocardiogram, Myocarditis, Oropharyngeal pain, Pyrexia, Troponin T
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Test Name: creatine kinase-myocardial band mass; Result Unstructured Data: Test Result:162 ug/L; Test Date: 20210719; Test Name: creatine kinase-myocardial band mass; Result Unstructured Data: Test Result:stabilized ug/L; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:increased; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:good pumping function; Comments: no pericardial fluid, no cardiac arrhythmia during monitoring; Test Date: 20210719; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:normal; Test Name: electrocardiogram; Result Unstructured Data: Test Result:clear ST segment elevations consistent; Comments: clear ST segment elevations consistent with myocarditis in leads V3-V6, aVL, I, aVR, II and aVF, which were then converted to inverted T waves.; Test Name: troponin T; Result Unstructured Data: Test Result:2106 ug/L
CDC Split Type: FIPFIZER INC202100954778

Write-up: Myocarditis; Oropharyngeal pain/throat became sore; Pyrexia/fever; non-ST-elevation myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FI-FIMEA-20213685. A 22-year-old male patient received bnt162b2 (COMIRNATY Solution for injection, Lot Number: FD4555) via intramuscularly on 13Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Jul2021, the patient experienced pyrexia/fever developed, oropharyngeal pain/throat became sore, chest pain in the morning which recurred in the evening and myocarditis. They were then admitted to hospital in Jul2021. On unspecified date, electrocardiogram showed clear ST segment elevations consistent with myocarditis in leads V3-V6, aVL, I, aVR, II and aVF, which were then converted to inverted T waves. On unspecified date, there was also a clear non-ST-elevation myocardial infarction as Creatine kinase-myocardial band mass (CKMBm) was at 162 ug/l, troponin T (TnT) was at 2106 ng/l indicating myocarditis. However, cardiac ultrasound showed good pumping function, no pericardial fluid, no cardiac arrhythmia during monitoring on unspecified date. On 19Jul2021, creatine kinase-myocardial band mass stabilized, cardiac ultrasound was normal, and the patient was feeling well. On 19Jul2021 the patient was discharged. The patient underwent lab test which included Body temperature as increased on 16Jul2021. The clinical outcome of all events was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1538090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood creatine phosphokinase, Blood immunoglobulin G, Blood pressure measurement, Chest X-ray, Coma scale, Echocardiogram, Electrocardiogram, Epstein-Barr virus test, Gamma-glutamyltransferase, HIV test, Heart rate, Heart sounds, Hepatic cytolysis, Hepatitis A virus test, Hepatitis B virus test, Herpes simplex test, Lipase, Parvovirus B19 test, Prothrombin time, Ultrasound abdomen, Varicella virus test
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MELATONINE; NOVORAPID; TRESIBA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asperger''s disorder; Migraine; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:433 IU/l; Test Date: 20210717; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:422 IU/l; Test Date: 20210718; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:239 IU/l; Test Date: 20210719; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:161 IU/l; Test Date: 20210716; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:788 IU/l; Test Date: 20210717; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:344 IU/l; Test Date: 20210718; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:89 IU/l; Test Date: 20210719; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:43 IU/l; Test Date: 20210716; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:270 IU/l; Test Date: 20210717; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:295 IU/l; Test Date: 20210718; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:262 IU/l; Test Date: 20210719; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:228 IU/l; Test Date: 20210716; Test Name: total bilirubin; Result Unstructured Data: Test Result:20 umol/l; Test Date: 20210718; Test Name: total bilirubin; Result Unstructured Data: Test Result:7 umol/l; Test Date: 20210719; Test Name: total bilirubin; Result Unstructured Data: Test Result:6 umol/l; Test Date: 20210718; Test Name: Creatine kinase; Result Unstructured Data: Test Result:66 IU/l; Test Date: 20210719; Test Name: Creatine kinase; Result Unstructured Data: Test Result:59 IU/l; Test Name: IgG; Result Unstructured Data: Test Result:positive for anti-SARS CoV2 antibodies; Test Name: blood pressure; Result Unstructured Data: Test Result:124/97 mmHg; Test Name: Lung x-rays; Result Unstructured Data: Test Result:No pneumothorax, no cardiomegaly; Comments: computed tomography index = 0.44, no infectious outbreaks; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:15; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Preserved left ventricular ejection fraction,; Comments: no pericardial effusion; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:RSR, no conduction or repolarization abnormalities; Comments: PR ok, QT ok, normal axis, no signs of pericarditis.; Test Name: Epstein-Barr virus; Test Result: Negative ; Test Date: 20210716; Test Name: Gamma GT; Result Unstructured Data: Test Result:123 IU/l; Test Date: 20210717; Test Name: Gamma GT; Result Unstructured Data: Test Result:137 IU/l; Test Date: 20210718; Test Name: Gamma GT; Result Unstructured Data: Test Result:102 IU/l; Test Date: 20210719; Test Name: Gamma GT; Result Unstructured Data: Test Result:90 IU/l; Test Name: heart rate; Result Unstructured Data: Test Result:104 bpm; Test Name: Heart sounds; Result Unstructured Data: Test Result:Regular heart sounds with systolic murmur (already; Comments: known). Pulmonary auscultation clear; Test Name: HVA; Test Result: Negative ; Test Name: HVB; Test Result: Negative ; Test Name: Herpes simplex; Test Result: Negative ; Test Name: HIV test; Test Result: Negative ; Test Date: 20210716; Test Name: lipase; Result Unstructured Data: Test Result:normal; Test Name: parvovirus B19; Test Result: Negative ; Test Date: 20210716; Test Name: Prothrombin time; Test Result: 86 %; Test Date: 20210717; Test Name: Prothrombin time; Test Result: 79 %; Test Date: 20210718; Test Name: Prothrombin time; Test Result: 84 %; Test Date: 20210719; Test Name: Prothrombin time; Test Result: 91 %; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:Hepatomegaly, with a right hepatic arrow; Comments: measured at 11.5 cm. Homogeneous echostructure, normally echogenic No other anomalies.; Test Name: varicella zoster virus; Result Unstructured Data: Test Result:suggests an old infection
CDC Split Type: FRPFIZER INC202100949083

Write-up: Hepatic cytolysis; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-AN20212925. A 12-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route on 17Jun2021 (Batch/Lot Number: FC5435) as dose 1, single for COVID-19 immunisation; insulin aspart (NOVORAPID) via subcutaneous route from 08Jul2021 (Batch/Lot Number: Unknown) to 16Jul2021, at an unknown dose and frequency for type 1 diabetes mellitus; and insulin degludec (TRESIBA) via subcutaneous route from 08Jul2021 (Batch/Lot Number: Unknown) to 16Jul2021 at an unknown dose, as needed for type 1 diabetes mellitus. Medical history included migraine from, Asperger''s disorder, and type 1 diabetes mellitus, all from unknown dated and unknown if ongoing. Maternal history of Hashimoto''s thyroiditis. Concomitant medication included melatonine taken for an unspecified indication from 2020 to. The patient experienced hepatic cytolysis providing the indication for hospitalization on 16Jul2021. Course of events are as follows: the patent treated with insulin therapy (Lantus and Apidra) was replaced on 07Jul2021 with Apidra and Novorapid. Consultation at the emergency room on 16Jul2021 for epigastric and bilateral thoracic base pain that started the same morning. The patient had been seen the day before by a physician and did not have any pain at that time. Etiological workup was negative. Possibility of treatment with melatonin introduced in 2020; no information about whether treatment was pursued; melatonin was not given during the period of hospitalization and not prescribed at discharge. Three (3) tablets of paracetamol was given in 24 hours. The patient had no toxic substances, no suggestion of drug toxicity, no recent viral infection, no suggestion of contagion; no travel. Clinical examination at the emergency room revealed heart rate = 104 bpm; blood pressure = 124/97mmHg, and was apyretic. The patient had localized pain at the epigastric cavity plus basal thoracic pain bilaterally, reproduced upon palpation. Pain upon palpation of both hypochondriac regions. Diffuse abdominal pain without guarding or contracture. Bowel sounds heard. No jaundice, no hepatomegaly; Glasgow Coma Scale 15, no flapping tremor, no hemorrhagic syndrome. Intense pain rated at 10/10 in the morning Paracetamol taken 8 hours partially relieved the pain. Onset of nausea without vomiting Apyretic. Epigastric pain radiating to the basal thoracic and hypochondriac regions bilaterally. Pain not modified by food. No other symptoms except a bent-over position while walking to relieve pain. No urinary symptoms, lumbar percussion not painful. Regular heart sounds with systolic murmur (already known). Pulmonary auscultation clear. Pain on deep inhalation. Trunk bent forward over legs to relieve pain. No discoloration of the stools or dark urine. Additional tests included: Abdominal ultrasound: Hepatomegaly, with a right hepatic arrow measured at 11.5 cm. Homogeneous echostructure, normally echogenic No other anomalies. Electrocardiogram: RSR, no conduction or repolarization abnormalities, PR ok, QT ok, normal axis, no signs of pericarditis. Lung x-rays: No pneumothorax, no cardiomegaly; computed tomography index = 0.44, no infectious outbreaks. Echocardiogram: Preserved left ventricular ejection fraction, no pericardial effusion. Aspartate aminotransferase (10-34 UI/L): 788 (16Jul2021); 344 (17Jul2021); 89 (18Jul2021); 43 (19Jul2021). Alanine aminotransferase (10-59 UI/L): 433(16Jul2021); 422 (17Jul2021); 239 (18Jul2021); 161 (19Jul2021). Alkaline phosphatase (128-420 UI/L): 270 (16Jul2021); 295 (17Jul2021); 262 (18Jul2021); 228 (19Jul2021). Gamma GT (6-38 UI/L): 123 (16Jul2021); 137 (17Jul2021); 102 (18Jul2021); 90 (19Jul2021). Total bilirubin (5-21 umol/L): 20 (16Jul2021); 7 (18Jul2021); 6 (19Jul2021). Creatine kinase (35-145 UI/L): 66 (18Jul2021), 59 (19Jul2021). Lipase was normal on 16Jul2021. Prothrombin time 86% (16Jul2021); 79 % (17Jul2021); 84% (18Jul2021); 91% (19Jul2021). Serologies for HVA, HVB, HIV, HSV, EBV and parvovirus B19 were negative. Serology for varicella-zoster virus suggests an old infection. IgG positive for anti-SARS CoV2 antibodies. Serologies for cytomegalovirus and adenovirus, Polymerase chain reaction tests for HHV6 and hepatitis C, and Immunological workup were all pending. Conclusion was Hepatic cytolysis one month after vaccination with Comirnaty in a diabetic patient with recently modified insulin treatment. The patuent had favorable outcome from the hepatic workup; modification of insulin therapy with resumption of Lantus and introduction of Humalog. Action taken in response to the event for insulin aspart and insulin degludec was permanently withdrawn. Outcome of the event was recovering. NB: Accountability made without prejudice to investigations elements that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538148 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, C-reactive protein, Chest X-ray, Coma scale, Echocardiogram, Electrocardiogram, Hypoaesthesia, Liver function test, Magnetic resonance imaging, Myocarditis, N-terminal prohormone brain natriuretic peptide, Neurological examination, Physical examination, Pyrexia, Renal function test, SARS-CoV-2 test, Troponin, Ultrasound Doppler
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (serology in July2020 positive (index 155.3))
Allergies:
Diagnostic Lab Data: Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Name: Chest radiography; Result Unstructured Data: Test Result:no cardiomegaly; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Name: C-reactive protein; Result Unstructured Data: Test Result:23 mg/l; Test Date: 20210718; Test Name: echocardiography; Result Unstructured Data: Test Result:Normal intracardiac structure, no morphological ab; Comments: Normal intracardiac structure, no morphological abnormalities. No intracardiac thrombus. Normal aortic and pulmonary valve Doppler ultrasounds. No mitral or aortic valvular heart disease. Coronary arteries in place. Left ventricle function: left ventricular ejection fraction = 63 %, interventricular septum diameter 7mm, end-diastolic left ventricular diameter 41mm, E/Ea 7.7. Right ventricle function: Tricuspid annular plane systolic excursion 25mm, S waves in DTI (diffusion tensor imaging) 12cm/s, rounded septal curvature. Dry pericardium.; Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal; Test Date: 20210718; Test Name: electrocardiogram; Result Unstructured Data: Test Result:a regular sinus rhythm at 80bpm; Comments: a regular sinus rhythm at 80bpm, normal axis, isoelectric T wave in DII and negative in DIII and aVF (augmented vector foot). QTc = 370ms; Test Name: liver function tests; Result Unstructured Data: Test Result:normal; Test Date: 20210722; Test Name: Magnetic Resonance Imaging; Result Unstructured Data: Test Result:Appearance of focal myocarditis; Comments: Appearance of focal myocarditis of the mid-ventricular lateral wall of the left ventricle showing no abnormalities of left ventricular function or ventricular volumes.; Test Name: Neurological examination; Result Unstructured Data: Test Result:No neurological focal signs, no meningeal stiffnes; Comments: No neurological focal signs, no meningeal stiffness, no photo-phonophobia, no purpura. No pain since admission.; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:531 ng/L; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:752 ng/L; Test Name: Cardiology examination; Result Unstructured Data: Test Result:Regular heart sounds; Comments: Regular heart sounds, no murmur. cardiac resynchronization therapy < 3 seconds, symmetrical femoral pulses. No sign of cardiac insufficiency. Neuro: Glasgow 15. Pupils reactive and symmetrical. Normal cranial pairs, normal deep tendon reflexes. No cerebellar syndrome, normal walk.; Test Name: kidney function test; Result Unstructured Data: Test Result:normal; Test Date: 202007; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: Troponin; Result Unstructured Data: Test Result:232 ng/L; Test Name: Troponin; Result Unstructured Data: Test Result:483 ng/L; Test Name: aortic and pulmonary valve Doppler ultrasounds; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202100954930

Write-up: Myocarditis; sensation of numbness of the left arm; fever; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-MP20215476. A 12-year-old male patient received BNT162B2 (COMIRNATY; lot number: FF0688) intramuscular, administered the right arm on 14Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (serology in July2020 positive (index 155.3). The patient''s concomitant medications were not reported. The patient experienced myocarditis, sensation of numbness of the left arm and fever on 16Jul2021. Since 16Jul2021, intermittent thoracic pain, relieved by doliprane, but recurrent with night wakings, and sensation of numbness of the left arm (right arm vaccine). Associated fever on 16Jul2021. Visit to the emergency room on 17Jul2021 and 18Jul2021. Good test results, clinical examination with no abnormal findings. C-reactive protein 23 mg/L, electrolytes and kidney and liver function tests are normal. Troponin 232 ng/L then 483 ng/L. N-terminal pro-brain natriuretic peptide 531 ng/L then 752 ng/L. Normal electrocardiogram. Chest radiography shows no cardiomegaly. Good general condition. No pain. Cardiology: Regular heart sounds, no murmur. cardiac resynchronization therapy < 3 seconds, symmetrical femoral pulses. No sign of cardiac insufficiency. Neuro: Glasgow 15. Pupils reactive and symmetrical. Normal cranial pairs, normal deep tendon reflexes. No cerebellar syndrome, normal walk. No neurological focal signs, no meningeal stiffness, no photo-phonophobia, no purpura. No pain since admission. Ongoing etiological assessment with search for other causes of myocarditis (viral Polymerase Chain Reaction, thyroid stimulating hormone...) Electrocardiography on 18Jul2021, finding: a regular sinus rhythm at 80bpm, normal axis, isoelectric T wave in DII and negative in DIII and aVF (augmented vector foot). QTc = 370ms Trans-thoracic echocardiography on 18Jul2021: Normal intracardiac structure, no morphological abnormalities. No intracardiac thrombus. Normal aortic and pulmonary valve Doppler ultrasounds. No mitral or aortic valvular heart disease. Coronary arteries in place. Left ventricle function: left ventricular ejection fraction = 63 %, interventricular septum diameter 7mm, end-diastolic left ventricular diameter 41mm, E/Ea 7.7. Right ventricle function: Tricuspid annular plane systolic excursion 25mm, S waves in DTI (diffusion tensor imaging) 12cm/s, rounded septal curvature. Dry pericardium. Magnetic Resonance Imaging on 22Jul2021. Appearance of focal myocarditis of the mid-ventricular lateral wall of the left ventricle showing no abnormalities of left ventricular function or ventricular volumes. The patient was hospitalized due to the events. Outcome: healing in process/ recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1538177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Computerised tomogram, Interchange of vaccine products, N-terminal prohormone brain natriuretic peptide, Pain, Platelet count, Pulmonary embolism, Troponin, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
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: Benign prostatic hyperplasia; Hypercholesteremia; Hypertension arterial; Obesity; Prosthesis implantation (recent surgery); Sedentary; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: computerised tomography scan; Result Unstructured Data: Test Result:a bilateral pulmonary embolism.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.3; Comments: previosuly; Test Date: 20210718; Test Name: C-reactive protein; Result Unstructured Data: Test Result:50.3; Test Date: 20210718; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:normal; Test Date: 20210718; Test Name: Platelet; Result Unstructured Data: Test Result:471 x10 9/l; Test Date: 20210718; Test Name: Troponin; Result Unstructured Data: Test Result:normal; Test Date: 20210719; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:no venous thrombosis of the lower limbs was found
CDC Split Type: FRPFIZER INC202100954846

Write-up: bilateral pulmonary embolism; C-reactive protein 50.3 (4.3 previously); pain; interchange of vaccine products; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-PO20213726. A 55-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via intramuscular, administered in the arm, on 16Jul2021, as dose 2, 0.3 mL single for covid-19 immunisation; COVID-19 vaccine nrvv ad (chadox1 ncov-19; VAXZEVRIA), via intramuscular, administered in the arm, on 24Apr2021 (Batch/Lot Number: Unknown), as dose 1, 0.5 mL single, for COVID-19 vaccination. The patient''s medical history (risk factors for pulmonary embolism) included hypertension arterial, benign prostatic hyperplasia, Type 2 diabetes mellitus, hypercholesteremia, obesity, sedentary lifestyle, a recent surgery for placement of elbow prosthesis on 25Jun2021. The patient''s concomitant medications were not reported. On 19Jul2021, it was reported that the patient experienced bilateral pulmonary embolism in a patient with heterologous astrazeneca/COMIRNATY vaccination. An onset of pain 48 hours later was also reported. The patient underwent laboratory test and procedures on 19Jul2021 which included computerised tomography scan and revealed a bilateral pulmonary embolism, doppler ultrasound was performed and no venous thrombosis of the lower limbs was found. Biological check-up on 18Jul2021 showed platelets of 471 g/l, C-reactive protein of 50.3 (4.3 previously), Troponin and normal N-terminal pro-brain natriuretic peptide. The outcome of the event CRP increased was unknown, while for the remaining events was recovering. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1538446 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Blood test, Chills, Cluster headache, Confusional state, Dizziness, Fatigue, Headache, Heart rate, Liver function test increased, Malaise, Memory impairment, Migraine, Myalgia, Nausea, Pain, Paraesthesia, Pruritus, Rash, Retching, SARS-CoV-2 test, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hypothyroidism; Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:slightly elevated; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50; Test Name: Blood; Result Unstructured Data: Test Result:fine; Test Name: heart rate; Result Unstructured Data: Test Result:slightly elevated; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100949999

Write-up: felt sick; nausea/Nauseous; wiped out/tired; confusion; forgetfulness; all came back; cluster migraines; mins; Hives; Shivering; joints ache; Muscles and joints ached; Rash developed on wrist/Rash on arm; itchy/Itching; tingling face, neck and head; Dizziness; headache; pain; Cluster headaches; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority Regulatory Agency (MHRA). Regulatory authority report number (GB-MHRA-WEBCOVID-202107251950422180-GWCKF), Safety Report Unique Identifier (GB-MHRA-ADR 25704264). A 45-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at dose 2, single on 16Jul2021 (at the age of 45-year-old) for COVID-19 immunization. Medical history included suppressed lactation, migraine, hypothyroidism, endometriosis. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included desogestrel (CERAZETTE) taken for endometriosis; levothyroxine sodium (THYROXINE) taken for hypothyroidism. The patient experienced cluster headaches on 16Jul2021, hives, shivering, tiredness on 17Jul2021. Reaction within 20 mins of vaccine (16Jul2021), tingling face, neck and head with dizziness. Returned to vaccine centre and blood pressure 90/50 - kept on for 45 mins. Headache within 20 mins and has continued with a combination of sharp pains and immense pressure. Pain killers not working. Rash developed on wrist within 36 hours (on 17Jul2021) and skin felt itchy, like she was being bitten by mosquitoes. Rash on arm very itchy and got bigger over 7 days. Felt sick immediately and varying levels of nausea/Nauseous since the vaccine 9 days ago. Day after jab felt like she had been drinking and had a massive gym work out. Muscles and joints ached immensely (on 17Jul2021). Muscles ached for 4 days, still feel very tired and wiped out. Confusion and forgetfulness- probably from such bad headaches. Sleeping longer but not feeling rested at all. Visited A&E on day 9 (today) full bloods done and all came back ok. They wanted to do a large dose of aspirin to try and get the pain under control, but declined due to risk of bleeding. Doctor advised likely triggered cluster migraines that she has nott has for 20 years, and no form of migraine in 10 years. Advised to see GP for migraine meds and long term management. 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: "Full bloods done and observations. Bloods fine and blood pressure and heart rate slightly elevated from my normal." The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No-Negative COVID-19 test). The outcome of the event Tingling skin, Itching, hives was resolved with Sequel, the outcome of the event Shivering was resolved on 21Jul2021, the outcome of the event nausea/Nauseous, cluster headaches was not resolved, the outcome of the other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1538447 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; YASMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; Endometritis; 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 INC202100949996

Write-up: Appetite lost; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom''s Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202107252003300480-ZNOCJ, Safety Report Unique Identifier GB-MHRA-ADR 25704266. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: FD8813), via an unspecified route of administration at single dose on 16Jul2021 for COVID-19 immunisation at the age of 29-year-old. Medical history included Lactation decreased, anxiety disorder, endometritis. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and not currently breastfeeding. Concomitant medications included amitriptyline hydrochloride (AMITRIPTYLIN) taken for anxiety disorder; drospirenone, ethinylestradiol (YASMIN) taken for endometritis. The patient experienced : Severe Nausea and total lack of appetite on 16Jul2021 with outcome of recovered on 20Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538477 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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 INC202100949691

Write-up: awake; Insomnia; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107252256444060-7TORD], Safety Report Unique Identifier [GB-MHRA-ADR 25704407]. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Jul2021 (at the age of 37-year-old) (Batch/lot number: Not Known, Expiration Date: not reported), as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased on an unknown date. The patient''s concomitant medications were not reported. Patient experienced awake on an unspecified date and insomnia on 16Jul2021. The events were considered serious as other medically important condition. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unknown date. The outcome of the event awake was recovering and insomnia was not recovered. The clinical course was reported as follows: Insomnia - even if the patient start to fall asleep her body forces itself back awake. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional Information: Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No


VAERS ID: 1539174 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dizziness, Headache, Increased viscosity of upper respiratory secretion, Nausea, Restlessness, Retching, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100949164

Write-up: Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; Gets dizzy and gets a headache a few minutes after the vaccine is given. nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless; compatible with a severe immediate allergic / anaphylactic reaction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uz9nyx. A 43-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 16Jul2021 12:50 (Batch/Lot Number: FF0900), at the age of 43 years old, as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Jul2021, the patient gets dizzy and gets a headache a few minutes after the vaccine is given. Gets nausea and vomiting after about 10 minutes, subsequent experience of mucus and tightness in the throat and becomes restless. Clinical course was reported as follows. On 16Jul2021, few minutes after the vaccination, the patient developed dizziness and headache. After about 10 minutes the patient developed nausea, and retching, followed by an experience of increased viscosity of upper respiratory secretion, throat tightness, and restlessness. The patient received 0.5 mg epinephrine I.M. and was hospitalised for further observation. The patient''s outcome was unknown, at the time of the report. The case was considered to be serious. Outcome of the events was unknown. Sender''s comment: The event described may be compatible with a severe immediate allergic / anaphylactic reaction. Anaphylaxis is defined as a severe, life-threatening systemic hypersensitivity reaction characterized by rapidly onset and potentially life-threatening symptoms from two or more organ systems such as skin, respiratory tract, circulation, gastrointestinal tract or otherwise. Anaphylaxis requires immediate treatment (1). Severe immediate allergic reaction is a broader term that includes anaphylaxis, but also a reaction with symptoms such as urticaria, angioedema, respiratory distress (eg wheezing, stridor). Reports of possible anaphylaxis are assessed according to the criteria for anaphylaxis (1). The criteria are used to grade with how much diagnostic certainty one can grade the reported symptoms as an anaphylaxis. According to the criteria, the event can be classified as an anaphylactic reaction at level 3 of diagnostic certainty based on the minor symptoms nausea and experience of tightness in the throat. No symptoms relevant to anaphylaxis from other organ systems have been reported. The relatedness of drug to all events was possible as per Regulatory Authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1539995 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210810236

Write-up: FAINT; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-3240] concerned a 35 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-05 expiry: UNKNOWN) 0.5 ml, 1 total was administered on 16-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-JUL-2021, the patient experienced faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint on 16-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210810236-COVID-19 VACCINE AD26.COV2.S-faint. 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: 1539997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210808802

Write-up: SYNCOPE AFTER TAKING THE JANSSEN VACCINE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3397] concerned a 25 year old male of unspecified race and ethnicity. The patient''s weight was 71 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) start therapy date was not reported, 0.5 ml, 1 total administered on for covid-19 immunisation. Concomitant medications included folic acid. On 16-JUL-2021, the patient experienced syncope after taking the Janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope after taking the Janssen vaccine on 16-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210808802- Covid-19 vaccine ad26.cov2.s- Syncope after taking the Janssen vaccine. 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: 1540167 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Insulin-dependent diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100966991

Write-up: 1/2 day after 2nd vaccination generalised Urticaria; Lightheadedness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-BASGAGES-2021-35799. A 30-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jul2021(at the age of 30-year-old) (Batch/Lot Number: FE6208) as single dose for COVID-19 immunisation. Medical history included ongoing type 1 diabetes mellitus. The patient''s concomitant medications were not reported. The patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 11Jun2021 (at the age of 30-year-old) (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The patient experienced 1/2 day after 2nd vaccination generalised urticaria (hospitalization) on 16Jul2021 with outcome of recovered in Jul2021, lightheadedness (hospitalization) on 16Jul2021 with outcome of recovered in Jul2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1541239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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: BUSPIRONE HYDROCHLORIDE; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Feeling anxious; Gastrooesophageal reflux disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100960238

Write-up: Tingling lips, Tingling tongue; Tingling sensation, Tingling feet/hands; This is a spontaneous report from a contactable consumer (patient). This is a report downloaded from the Regulatory Authority. -WEB, regulatory authority number GB-MHRA-WEBCOVID-202107220949027250-IOVMN, Safety Report Unique Identifier GB-MHRA-ADR 25691443. A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 as single dose for COVID-19 immunisation. Medical history included feeling anxious and acid reflux (esophageal). She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medications included buspirone hydrochloride taken for feeling anxious from 04Jun2021 and omeprazole taken for acid reflux (esophageal). The patient experienced tingling sensation on 16Jul2021, tingling lips on 18Jul2021, tingling feet/hands on 19Jul2021, and tingling tongue on 20Jul2021. Case narrative: Doctor has just dismissed her concerns and told her to wait a few days in which nothing has changed. 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. No further information expected.


VAERS ID: 1541245 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne, Diarrhoea, Dysmenorrhoea, Heavy menstrual bleeding, Nipple pain, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100967122

Write-up: Heavy periods; Pain; Menstrual cramps; Diarrhea; Acne; Nipple tenderness; This is a spontaneous report from two contactable consumers downloaded from a regulatory authority, regulatory authority number GB-MHRA-WEBCOVID-202107232232557530-7UJPL, Safety Report Unique Identifier GB-MHRA-ADR 25702147. A 27-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 06Jul2021, as a dose 1, single dose for COVID-19 immunisation. Medical history included lactation decreased, and acne. The patient concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 30May2021, as a single dose for COVID-19 immunisation. On 16Jul2021, the patient had heavy periods. She had the bar implant, so she does not get periods. Before flow she had severe acne (on an unknown date in 2021) and nipple tenderness (on an unknown date in 2021), these symptoms would be typical of her periods (without implant). As flow began, her menstrual cramps (on an unknown date in 2021) were horrendous and much more painful (on an unknown date in 2021) than she ever experienced before, and they led to diarrhoea (on an unknown date in 2021) and she therefore had to take time off work. Again, this wouldn''t be the norm as ibuprofen would reduce the pain. Patient has not tested positive for COVID-19 since having the vaccine. Seriousness for the events was reported as medically significant. The outcome of the event heavy periods was not resolved, and the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1541257 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Headache, Hypoacusis, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100957095

Write-up: Hearing reduced; Runny nose; Loss of smell; Loss of taste; Fever; Headache; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107260821186470-L9BWQ, Safety Report Unique Identifier GB-MHRA-ADR 25705173. A 38-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever and headache on 16Jul2021; loss of smell, loss of taste, and runny nose on 17Jul2021; then hearing reduced on 21Jul2021. 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 18Jul2021. 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. Outcome of the loss of smell and loss of taste was not recovered, of the fever was recovered on 19Jul2021, of the headache was recovered on 18Jul2021, of the hearing reduced was recovering, and of the runny nose was recovered with sequel on 25Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Small intestinal obstruction, X-ray with contrast upper gastrointestinal tract
SMQs:, Gastrointestinal obstruction (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Citrate reaction; Intestinal obstruction; Sigmoid polyp; Sigmoidectomy; Subileus (admitted to the reporter''s hospital in Nov2020); Takayasu''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: CT; Result Unstructured Data: Test Result:small intestinal edema and dilatation; Test Date: 20210716; Test Name: small bowel; Result Unstructured Data: Test Result:Suspected to be intestinal obstruction
CDC Split Type: JPPFIZER INC202100958690

Write-up: Small intestinal obstruction; This is a spontaneous report from a contactable pharmacist received from the RA. Regulatory authority report number is v21121815. A 76-year-old female patient received COVID-19 VACCINE - MANUFACTURER UNKNOWN, via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was unknown. Medical history included primary diseases as Takayasu''s disease, Sigmoid polyp (Had surgery history, non-malignant) alcohol allergy, citrate allergy, recurrent episodes of intestinal occlusion, and subileus. The patient''s concomitant medications were not reported. On 16Jul2021 (1 day after the vaccination), the patient experienced small intestinal obstruction. On 16Jul2021 (1 day after the vaccination), the patient was admitted to the hospital. On 24Jul2021 (9 days after the vaccination), the outcome of the event was recovering. The course of the event was as follows. The first dose was administered on 15Jul2021. On the morning of 16Jul2021, the patient began to have flatulence, but ingested breakfast and lunch. Afterwards, he began to experience abdominal pain and vomited by the afternoon. The patient visited the reporter''s hospital nearby for X-ray examination and small intestine niveau, which was suspected to be intestinal obstruction, and visited the reporter''s hospital. CT showed small intestinal edema and dilatation, which was diagnosed as small intestinal obstruction, and the patient was admitted for treatment. After admission, he was treated with starvation and fluid replacement. On the fourth day of admission, radiography showed improvement and liquid intake was started. Food intake gradually increased, and bowel movements were well controlled. On 24Jul2021, the symptoms were relieved, and the patient was discharged. The reporting pharmacist classified the event as serious (hospitalized) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases was around the age of 60, a partial resection of the sigmoid colon was performed for a sigmoid polyp, and there was an experience of reoperation for adhesive ileus. Regular reexaminations were performed about 8 years after surgery, after which no further examinations were performed. Afterwards, he had recurrent episodes of intestinal occlusion and was also admitted to the reporter''s hospital in Nov2020 due to subileus. Information on the lot/batch number has been requested.


VAERS ID: 1541761 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Coma scale, Epilepsy, Heart rate, Loss of consciousness, Oxygen saturation decreased, PO2, Photopsia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? 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: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:88/52 mmHg; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:89/59 mmHg; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:110 mmHg; Comments: recovered; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:115/65 mmHg; Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:88 mmHg; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210716; Test Name: JCS; Result Unstructured Data: Test Result:0; Test Date: 20210716; Test Name: heart rate; Result Unstructured Data: Test Result:57; Test Date: 20210716; Test Name: heart rate; Result Unstructured Data: Test Result:68; Test Date: 20210716; Test Name: SpO2; Test Result: 57 %; Test Date: 20210716; Test Name: SpO2; Test Result: 68 %; Test Date: 20210716; Test Name: SpO2; Test Result: 98 %; Test Date: 20210716; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202100965395

Write-up: Transient loss of consciousness/no response to calling; Suspected Epilepsy; convulsion (bilateral upper and lower limbs); SpO2 57; eye flickering; BP 88/52mmHg; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21121523. A 50-year-old female patient received BNT162b2 (COMIRNATY), first dose, via an unspecified route of administration on 16Jul2021 12:16 (Lot Number: FD0348; Expiration Date: 31Oct2021) at the age of 50 years old, at 0.3ml single dose for covid-19 immunisation. The patient was a non-pregnant 50-year old female (age at vaccination). Body temperature before vaccination on 16Jul2021 was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient was not using other medications for other disease. The patient was not pregnant at the time of vaccination. On 16Jul2021 at 12:16 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0348, Expiration date: 31Oct2021) via an unspecified route of administration at 0.3ml, single dose for COVID-19 immunization. The patient experienced transient loss of consciousness/no response to calling on 16Jul2021 12:33, suspected epilepsy on 16Jul2021 12:33, convulsion (bilateral upper and lower limbs) on 16Jul2021 12:33, spo2 57 on 16Jul2021 12:33, eye flickering on 16Jul2021 12:33, BP 88/52mmhg on 16Jul2021 12:33. Event onset date reported as 16Jul2021 at 12:33 (the day of vaccination). The course of the event was as follows: 15 minutes after receiving the first inoculation of COMIRNATY, the patient showed symptoms of eye flickering with subsequent convulsion (bilateral upper and lower limbs). There was no response to calling. After 30 seconds, the patient recovered consciousness. The patient moved from a seated position to the bed in a wheelchair. BP decreased to 88/52 mmHg. (Normally BP 100 mmHg) With legs elevated, BP recovered to 110 mmHg. No wheeze. No skin eruption. No obvious neurological abnormality findings. Since the patient had transient loss of consciousness and experienced convulsion for the first time, an emergency call was made. Records was as below: On 16Jul2021 at 12:33, the patient experienced consciousness JCS 0, Blood Pressure 88/52, blood pressure 89/59, SpO2 98, SpO2 68, Pulse 57. Clinical Course (convulsion for about 30 seconds) were as below: At 12:33, convulsion occurred developed (to bed) BP 88/52, HR 57, SpO2 57, alert. At 12:37, BP 89/59, HR 68, SpO2 98, alert. At 12:40, no neurological findings. No Convulsion. At 12:43, emergency call was made. BP 115/65, SpO2 97%. The physician''s note was as below: 15 minutes after vaccination, the patient showed eye flickering and subsequently experienced transient loss of consciousness. Convulsion of bilateral upper and lower limbs lasted for 30 seconds (in seated position). Consciousness subsequently recovered. (Normally BP 100 mmHg). BP 88mmHg. JCS 0. No skin eruption. No obvious neurological abnormality findings. No Wheeze. With legs elevated, BP subsequently recovered to BP 110 mmHg. Since the patient experienced transient loss of consciousness and convulsion (first time), emergency call was made. No medical history. On 16Jul2021(the day of vaccination), the outcome of the events was recovered, the outcome of the events SpO2 57, BP 88/52mmHg was recovered on 16Jul2021 12:43. The reporting physician did not provide seriousness and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Suspected epilepsy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541771 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Discomfort, Dizziness, Dysphoria, Heart rate, Hypertension, Limb discomfort, Oxygen saturation, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIVALO; XYZAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: BP; Result Unstructured Data: Test Result:170/96; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Test Date: 20210716; Test Name: HR; Result Unstructured Data: Test Result:90s; Test Date: 20210716; Test Name: Pulse; Result Unstructured Data: Test Result:93; Test Date: 20210716; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100966056

Write-up: Blood pressure 170/96; Palpitations; Swaying feeling/giddiness; something wrong with my legs; dysphoria; The state of discomfort; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121521. A 64-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD0348; Expiration Date: 31Oct2021), via an unspecified route of administration on 16Jul2021 19:13 (at age of 64 years old) as single dose for COVID-19 immunisation. Medical history included Hypercholesterolaemia, Pollinosis. Concomitant medication included pitavastatin calcium (LIVALO) for hypercholesterolaemia; levocetirizine dihydrochloride (XYZAL) for Pollinosis. The patient was a 64-year and 2-month-old female. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had medical history of Hypercholesterolaemia, pollinosis. On 16Jul2021 at 19:13 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0348, Expiration date was 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The onset date/time was reported as on 16Jul2021 at 19:40(27 minutes after the vaccination). The course of the event was as follows: On 16Jul2021 at 19:13 (the day of vaccination), the patient received the first dose of the vaccine. On 16Jul2021 at 19:28 (15 minutes after the vaccination), observation was over. On 16Jul2021 at 19:40 (27 minutes after the vaccination), the patient complained of palpitations and swaying feeling before going home. Vital signs were good with BP 170/96, HR 90s, SpO2 98% (RA), and no specifically marked in the inspection of the matter. No neurological findings. The patient said that "I heard the lines of Korean dramas'', and the patient with state of discomfort. As the patient wished to have her further examined, she was raced to a hospital. Seriousness did not provided, The causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown on 16Jul2021 at 20:08(55 minutes after the vaccination). Response and Observation Records at First-aid Room: Status upon onset: On 16Jul2021 at 19:40 (27 minutes after the vaccination), consciousness: II-10. Vital signs: Blood pressure 170/96, SpO2: 98%, Pulse: 93, Body temperature: 35.8 degrees Centigrade. Course: On 16Jul2021 at 19:13 (the day of vaccination), the patient received the vaccine. On 16Jul2021 at 19:28 (15 minutes after the vaccination), observation was over, and the patient tried to walk home, but appeared dysphoria. On 16Jul2021 at 19:40 (27 minutes after the vaccination), the patient complainted: ''there was something wrong with my legs, and I had swaying feeling.'' On 16Jul2021 at 19:55 (42 minutes after the vaccination), the patient was referred to the emergency room because of her wish. Remarks by physician: After the vaccination, the patient complained of giddiness and palpitations. Anaphylaxis was not applicable. The patient strongly wished to have her further examined, It was decided that she should be transferred to a hospital. Other notes: On 17Jul2021(1 day after the vaccination), the nurse in charge was able to talk to the patient, The patient received iv drip at the hospital that she was transferred to. About two hours later, the patient''s condition was recovering, and she walked home. The patient was instructed to take in sufficient fluids, as she was considered to have a possible heat illness. The patient was also told that the symptoms appeared this time were caused by temporary physical deconditioning, and that there would be no problem with her receiving the 2nd vaccination. Pre-vaccination Screening Questionnaire for COVID-19 vaccine: The patient was received the COVID-19 vaccine for the first time. The patient currently live in the same city, town or village as the city, town or village on the coupon. The patient had read the (Description of the COVID-19 vaccine) to understand its effects and adverse side effects. The patient suffered from pollinosis and hypercholesterolaemia, received XYZAL, LIVALO 1 mg. The patient did not have a fever or been sick in the last month. There was no part of body felt uncomfortable today. The patient did not have convulsions (seizures). The patient did not experience severe allergic symptoms (eg, anaphylaxis) to medications or foods. The patient did not been sick after vaccination. The patient was not pregnant currently (eg, your period is later than expected) Not breastfeeding. The patient did not receive any vaccinations in the past two weeks. On 16Jul2021 (the day of vaccination), the outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541801 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Coronary artery stenosis, Dyspnoea, Electrocardiogram, Hyperthermia, Myocarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:41s Centigrade; Test Date: 20210717; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:No significant change in ST-T, troponin increased; Comments: No significant change in ST-T, troponin increased; Test Date: 20210717; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST increased, myocardial deviation enzyme increase; Comments: ST increased, myocardial deviation enzyme increased
CDC Split Type: JPPFIZER INC202100977866

Write-up: Arthralgia of extremities; Fever at 38sCentigrade; Dyspnoea; Acute myocarditis; Significant coronary artery lesions; Fever at 41s centigrade; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121631. A 43-year and 10-month-old male patient received the unknown dose of COVID-19 Vaccine - Manufacturer Unknown (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 16Jul2021 at 11:00 (the day of vaccination) (age at vaccination: 43-year and 10-month-old) as a dose number unknown, single for COVID-19 immunization. Relevant medical history was not reported. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. On 16Jul2021 at 18:00 (7 hours after the vaccination), the patient experienced pyrexia, dyspnoea and arthralgia of extremities. On 17Jul2021 (1 days after the vaccination), the patient was admitted to the hospital. On 22Jul2021 (6 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: 7 hours after vaccination, the patient developed arthralgia of extremities, fever at 38s centigrade and dyspnoea. After taking oral antipyretics for observation of symptoms, the patient developed fever at 41s centigrade symptoms the next morning and an ambulance was urgently called to move to the hospital. At the time of the patient''s visit to the hospital, electrocardiogram showed no significant change in ST-T, but due to troponin increased, emergency arterial catheterization was performed. The patient was considered to have significant coronary artery lesions. After that, the electrocardiogram showed ST elevation, and acute myocarditis was judged due to myocardial enzyme deviation elevation, and the patient was admitted to the hospital. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of events was recovered on 22Jul2021. Information on lot/batch number has been requested


VAERS ID: 1541964 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient with a history of vasovagal episodes with Valsalva maneuver
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210811758

Write-up: SYNCOPE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-R202107-3273] concerned a 27 year old of unspecified sex , unknown race and ethnicity. The patient''s weight was 67 kilograms, and height was 182 centimeters. The patient''s pre-existing medical conditions included: Patient with a history of vasovagal episodes with Valsalva maneuver. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) .5 ml,1 total, administered on 16-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-JUL-2021, the patient experienced syncope, the duration of the event was 30 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 16-JUL-2021. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Concomitant Medication-N0 Medication Error Occurred-No Other information-Patient with history of vasovagal episodes with Valsalva maneuver; Sender''s Comments: V0:20210811758- covid-19 vaccine ad26.cov2.s -SYNCOPE. 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: MEDICAL HISTORY


VAERS ID: 1545796 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100989918

Write-up: Thrombosis; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority report number is DE-PEI-202100140709. A 58-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 07Jul2021 (at the age of 58 year) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. The patient previously received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 16Jul2021, the patient experienced Thrombosis. Therapeutic measures were taken as a result of thrombosis. This report is serious - other. The outcome of event was not recovered. Sender Comment: Was outpatient treatment required ?: Yes Relatedness of drug to reactions/events Source of assessment: PEI Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1545829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210815804

Write-up: PERIPHERAL FACIAL PALSY, RIGHT; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP] concerned a 53 year old male with unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 21C11-01 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced peripheral facial palsy, right, and on unspecified date patient was hospitalized. The action taken with covid-19 vaccine was not applicable. The outcome of peripheral facial palsy, right was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210815804-Covid-19 vaccine -Peripheral Facial Palsy, Right. 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).


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