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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1937603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Dizziness, Immunisation, Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670778

Write-up: swelling; light headed; feeling shivery; Swollen glands; Armpit pain; BOOSTER; This is a spontaneous report received from a contactable reporter(s) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111252018345140-MIU35. Other Case identifier(s): GB-MHRA-ADR 26253626. A 52 year-old female patient (not pregnant) received bnt162b2, administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS, start date: 17Sep2021, stop date: 17Sep2021. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 1, Single), administration date: 17Feb2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, Single), administration date: 06May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "BOOSTER"; SWELLING (medically significant) with onset 20Nov2021, outcome "recovering", described as "swelling"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "unknown", described as "light headed"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovering", described as "feeling shivery"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "recovering", described as "Swollen glands"; AXILLARY PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "Armpit pain". Clinical Course: There was no reaction until 4 days post vaccine then started feeling shivery and light headed. Within a few hours the armpit on the side of the vaccine became painful and suddenly swollen. Significant general swelling settled within an hour to swollen individual nodes (bean shaped) that were both palpable and visible. Considerable pain for 2 days settling to mild discomfort now. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis) and there were no details provided for any relevant investigations or tests conducted. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937670 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA MODENA / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Lower respiratory tract infection, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); chest infection; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26263245) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (chest infection), the first episode of CHEST PAIN (Chest pain), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Modena) for an unknown indication. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (chest infection) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (chest infection), the last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant information were provided. No treatment information were provided Heart flutters and palpitations. Chest infection with it being difficult to breathe. Patient had not tested positive for COVID-19 since having the vaccine. It was reported that Patient''s report was related to possible inflammation of the heart (myocarditis or pericarditis) Company Comment: This RA case concerns a 54 year old female with no relevant medical history , who experienced Serious ( Medically Significant ), unexpected events of chest pain which occurred 8 days after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , On an unknown date , the following Serious ( Medically Significant ) , unexpected events of Lower respiratory tract infection , Chest pain, Dyspnea , palpitations and tachycardia occurred with the vaccination with the 3rd dose . It was noted that this report of the patient was related to a possible inflammation of the heart but this event was not coded per RA report. The re-challenge for this case was captured as unknown per RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report; Sender''s Comments: This RA case concerns a 54 year old female with no relevant medical history , who experienced Serious ( Medically Significant ), unexpected events of chest pain which occurred 8 days after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , On an unknown date , the following Serious ( Medically Significant ) , unexpected events of Lower respiratory tract infection , Chest pain, Dyspnea , palpitations and tachycardia occurred with the vaccination with the 3rd dose . It was noted that this report of the patient was related to a possible inflammation of the heart but this event was not coded per RA report. The re-challenge for this case was captured as unknown per RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report


VAERS ID: 1937800 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
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.MOD20214

Write-up: Pain in arm; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26278332) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. COmpany comment: This is a regulatory authority case concerning a 55-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of pain in extremity. The event occurred approximately 1 days after the third dose of mRNA 1273 vaccine. Patient was also vaccinated with CHADOX1 NCOV-19. A SARS-CoV 2 virus test was performed and was negative. No treatment required was reported and the outcome of the event is not recovered. The rechallenge is reported as unknown. The vaccine CHADOX 1 NCOV-19 is a co suspect for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This is a regulatory authority case concerning a 55-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of pain in extremity. The event occurred approximately 1 days after the third dose of mRNA 1273 vaccine. Patient was also vaccinated with CHADOX1 NCOV-19. A SARS-CoV 2 virus test was performed and was negative. No treatment required was reported and the outcome of the event is not recovered. The rechallenge is reported as unknown. The vaccine CHADOX 1 NCOV-19 is a co suspect for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1937820 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH322U / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Immunisation, Interchange of vaccine products, Investigation, Malaise, Nausea, Off label use, SARS-CoV-2 test, Tachycardia, Vomiting
SMQs:, 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), Medication errors (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Graves'' disease; Penicillin allergy; Thyroid activity decreased
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Unknown results; Comments: Nasal Swab; Test Date: 202111; Test Name: Tests; Result Unstructured Data: Test Result:ruled out MI or clot or other causes
CDC Split Type: GBPFIZER INC202101695050

Write-up: tachycardia; Off-label use; Interchange of vaccine products; Booster; physically unwell; severe headache; nausea; fatigue; vomiting; dizziness; chest pain.; This is a spontaneous report received from contactable reporter (nurse). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 16Nov2021 12:00 (Lot number: FH322U) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The most recent COVID-19 vaccine was administered in workplace clinic. Relevant medical history included: "Graves disease treated to cause underactive thyroid" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included: LEVOTHYROXINE. No other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Covid-19 vaccine astrazaneca (first dose, no adverse event), for COVID-19 Immunization; Covid-19 vaccine astrazaneca (second dose, no adverse event), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (hospitalization) with onset 16Nov2021 12:00, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 16Nov2021 12:00, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 16Nov2021 12:00, outcome "unknown", described as "Booster"; TACHYCARDIA (hospitalization) with onset 24Nov2021, outcome "not recovered", described as "tachycardia"; MALAISE (non-serious) with onset 24Nov2021 05:30, outcome "not recovered", described as "physically unwell"; HEADACHE (non-serious) with onset 24Nov2021 05:30, outcome "not recovered", described as "severe headache"; NAUSEA (non-serious) with onset 24Nov2021 05:30, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 24Nov2021 05:30, outcome "not recovered", described as "fatigue"; VOMITING (non-serious) with onset 24Nov2021, outcome "not recovered", described as "vomiting"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "not recovered", described as "dizziness"; CHEST PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "chest pain.". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, tachycardia (start date: Nov2021).The events "tachycardia", "physically unwell", "severe headache", "nausea", "fatigue", "vomiting", "dizziness" and "chest pain." were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) unknown results, notes: Nasal Swab; tests: (Nov2021) ruled out mi or clot or other causes. Therapeutic measures were taken as a result of tachycardia, malaise, headache, nausea, fatigue, vomiting, dizziness, chest pain included Fluids, anti-Semitic, analgesics, monitoring. Clinical course: Became physically unwell the following morning (reported started at 24Nov2021 05:30) with severe headache, nausea, fatigue, this escalated through the night (24Nov2021) to vomiting dizziness and chest pain. Urgent care provider sent ambulance to evaluate. Tachycardia and transferred to hospital. Patient was fit and well prior no signs of infection. Tests (Nov2021) ruled out MI or clot or other causes but diagnosed as having a bad reaction to the vaccination.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1937907 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005884 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Aphasia, deviation of the rima oris following heterologous vaccination.; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-812478) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of APHASIA (Aphasia, deviation of the rima oris following heterologous vaccination.) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005884) for COVID-19 immunisation. Previously administered products included for COVID-19 vaccination: COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) on 25-Apr-2021 and COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) on 16-May-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03) and COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03). On 16-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 16-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced APHASIA (Aphasia, deviation of the rima oris following heterologous vaccination.) (seriousness criterion medically significant). On 16-Nov-2021, APHASIA (Aphasia, deviation of the rima oris following heterologous vaccination.) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant information was provided. No treatment information was given. The patient received the 1st dose of the Comirnaty vaccine, on 25-Apr-2021, at 9:42 a.m., batch EX3510, expiry date 31-Aug-2021, left arm; the 2nd dose of the Comirnaty vaccine, on 16-May-2021, at 1:47 p.m., batch FA4597,expiry date 31-Aug-2021, left arm. Company comment: This case concerns an 87-year-old female patient with no medical history provided who experienced serious unexpected event of Aphasia. The event occurred and resolved on the same day after the first dose of mRNA-1273. The rechallenge was unknown as the patient experienced adverse event after the first dose which resolved at the time of the report but no information about the second dose was available. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that the patient received two doses of Comirnaty together with one dose of Spikevax and, therefore, Interchange of vaccine products could have been considered in this particular case. Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Live Follow-up received on 30-Nov-2021: Past drug history is added. On 30-Nov-2021: Translation received on 2-Dec-21 includes event verbatim and senders comment; Sender''s Comments: This case concerns an 87-year-old female patient with no medical history provided who experienced serious unexpected event of Aphasia. The event occurred and resolved on the same day after the first dose of mRNA-1273. The rechallenge was unknown as the patient experienced adverse event after the first dose which resolved at the time of the report but no information about the second dose was available. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that the patient received two doses of Comirnaty together with one dose of Spikevax and, therefore, Interchange of vaccine products could have been considered in this particular case.


VAERS ID: 1938125 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:107/62 mmHg; Comments: pre vaccination; Test Date: 20211116; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:97/53 mmHg; Comments: post vaccination
CDC Split Type: PHPFIZER INC202101662949

Write-up: Fainting; COLD CLAMMY EXTREMETIES; blood pressure 97/53 mmHg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119552 (RA). A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 32025BD) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Fainting"; COLD SWEAT (non-serious) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "COLD CLAMMY EXTREMETIES"; HYPOTENSION (non-serious) with onset 16Nov2021, outcome "unknown", described as "blood pressure 97/53 mmHg". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 107/62 mmHg, notes: pre vaccination; (16Nov2021) 97/53 mmHg, notes: post vaccination. Therapeutic measures were taken as a result of syncope, cold sweat with unspecified immediate patient care done. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938129 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32155BA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:170/90 mmHg; Comments: 14:30
CDC Split Type: PHPFIZER INC202101663013

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119700 (PHFDA). A 62 year-old female patient (unknown if pregnant) received BNT162B2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 32155BA) at the age of 62 years as dose number unknown, single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 at 14:30, outcome "recovering", described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 170/90 mmHg, notes: 14:30. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1938130 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32155BA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate
SMQs:, Arrhythmia related investigations, signs and symptoms (broad)

Life Threatening? No
Birth Defect? No
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: 20211116; Test Name: heart rate; Result Unstructured Data: Test Result:53; Comments: bpm 16:03
CDC Split Type: PHPFIZER INC202101663014

Write-up: LOWER HEART RATE; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119704 (PHFDA). A 30 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 32155BA) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BRADYCARDIA (medically significant) with onset 16Nov2021 16:03, outcome "unknown", described as "LOWER HEART RATE". The patient underwent the following laboratory tests and procedures: heart rate: (16Nov2021) 53, notes: bpm, 16:03. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1938137 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663168

Write-up: Loss of consciousness; Dizziness; BLURRY VISION; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119889 (RA). A 17-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 16Nov2021, outcome "recovered" (2021), described as "Loss of consciousness"; DIZZINESS (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "Dizziness"; VISION BLURRED (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "BLURRY VISION". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32155BA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Blood pressure; Result Unstructured Data: Test Result:170/90
CDC Split Type: PHPFIZER INC202101663432

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120446 (PHFDA). A male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 32155BA) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 14:15, outcome "recovering", described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 170/90. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938165 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32155BA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Blood pressure; Result Unstructured Data: Test Result:175/90
CDC Split Type: PHPFIZER INC202101663459

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120444 (PHFDA). A 43-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 32155BA) at the age of 43 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 15:00, outcome "recovering", described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 175/90. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938259 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-11-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006273 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Glaucoma; Heart pounding; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: bleeding, (spontaneous psoas bleed); This case was received via regulatory authority on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of MUSCLE HAEMORRHAGE (bleeding, (spontaneous psoas bleed)) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3006273) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma, Heart pounding and Osteoporosis. On 22-Oct-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced MUSCLE HAEMORRHAGE (bleeding, (spontaneous psoas bleed)) (seriousness criterion life threatening). At the time of the report, MUSCLE HAEMORRHAGE (bleeding, (spontaneous psoas bleed)) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment medications reported. Company comment: This regulatory authority case concerns an 85-year-old, female patient with no relevant medical history, who experienced serious unexpected event of muscle hemorrhage, reported as spontaneous, psoas bleeding. The event occurred approximately 25 days after the third dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable as event occurred after the third dose so no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Translation received on 3-Dec-2021: Event verbatim updated; Sender''s Comments: This regulatory authority case concerns an 85-year-old, female patient with no relevant medical history, who experienced serious unexpected event of muscle hemorrhage, reported as spontaneous, psoas bleeding. The event occurred approximately 25 days after the third dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable as event occurred after the third dose so no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.


VAERS ID: 1940530 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9678 / UNK - / OT
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 304392C2A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Inflammation, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202107239

Write-up: Extensive arm inflammation; Erythema on the arm; Arm pain; This spontaneous case from PRIVACY was retrieved on 02-Dec-2021 from the regulatory authority (reference number: ES-AEMPS-1057214) reported by other healthcare professional and concerned a 77-year-old, female patient. The patient''s medical history and concomitant medication details were not reported. On 15-Nov-2021, the patient was vaccinated with Chiromas (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: one dosage form, route of administration, anatomical location: not reported) for flu vaccination. The batch number reported was 304392C2A and expiry date 30-Apr-2022. On the same date, the patient was vaccinated with non-company co-suspect Comirnaty vaccine (tozinameran; dose: one dosage form, route of administration, anatomical location: not reported) for SARS-CoV-2 vaccination. The batch number reported was FH9678 and expiry date 31-Mar-2022. On 16-Nov-2021, one day after receiving Chiromas (TIV) and Comirnaty vaccine, the patient experienced arm pain, erythema on the arm and extensive arm inflammation. At the time of initial reporting, the patient did not recover from the events of ''inflammation'', ''localised erythema'' and ''pain in arm''. The reporter did not provide causality assessment. All events were assessed as serious due to criterion of medical significance. Company Comment: A 77-year-old, female patient was vaccinated with Chiromas (TIV) and non-company co-suspect Comirnaty vaccine. One day following vaccination, the patient experienced arm pain, erythema and extensive arm inflammation. Information regarding medical history and concomitant medications was not provided. Causality is confounded by concurrently administered co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender''s Comments: A 77-year-old, female patient was vaccinated with Chiromas (TIV) and non-company co-suspect Comirnaty vaccine. One day following vaccination, the patient experienced arm pain, erythema and extensive arm inflammation. Information regarding medical history and concomitant medications was not provided. Causality is confounded by concurrently administered co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.


VAERS ID: 1940633 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Immunisation, Interchange of vaccine products, Investigation, Off label use, Supraventricular tachycardia
SMQs:, Supraventricular tachyarrhythmias (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure measurement; Result Unstructured Data: Test Result:130 per 70; Test Name: clinical examination; Result Unstructured Data: Test Result:Regular junctional tachycardia; Comments: Regular junctional tachycardia with fine QRS at 170 / min, well tolerated
CDC Split Type: FRPFIZER INC202101665191

Write-up: Tachycardia supraventricular; off-label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-MA20215237 (RA). A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Lot number: FG7911) at the age of 66 years old as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (1st dose, Lot: ABW0018, left arm, Astra Zeneca vaccine), administration date: 28Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (2nd dose, Lot: ABW7189, left arm, Astra Zeneca vaccine), administration date: 06Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; SUPRAVENTRICULAR TACHYCARDIA (hospitalization) with onset 16Nov2021, outcome "recovered", described as "Tachycardia supraventricular". The event "tachycardia supraventricular" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 130 per 70; clinical examination: regular junctional tachycardia, notes: Regular junctional tachycardia with fine QRS at 170 / min, well tolerated. Therapeutic measures were taken as a result of supraventricular tachycardia. The course of the event was as follows: no known heart disease. Tachycardia reduced by Krenosin.


VAERS ID: 1940816 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Malaise, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670483

Write-up: feverish; Felt ill; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111250804356150-QC7SR. Other Case identifier(s): GB-MHRA-ADR 26248111. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3, booster, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for COVID-19 Immunisation, reaction(s): "felt ill"; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for COVID-19 immunisation, reaction(s): "felt ill". The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; MALAISE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Felt ill"; PYREXIA (medically significant), outcome "not recovered", described as "feverish". Felt ill with previous vaccines too, the patient not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that report not related to possible inflammation of the heart myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940856 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dysgeusia, Dyspnoea, Headache, Liver function test, Lymphadenopathy, Nasal congestion, Oropharyngeal pain, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Myocardial disorder; Palpitations; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Name: LF Test; Result Unstructured Data: Test Result:Negative; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101670520

Write-up: Headache; Sore throat; Glands swollen; Taste metallic; Shortness of breath; cough; tight chest; Palpitations; Congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202111251045118370-PEBS3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26249003 (MHRA). A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH3220) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Palpitations" (unspecified if ongoing); "myocardia" (unspecified if ongoing); "covid-19", start date: Mar2020 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: COUGH (medically significant) with onset 2021, outcome "unknown", described as "cough"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "tight chest"; DYSGEUSIA (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Taste metallic"; DYSPNOEA (medically significant) with onset 16Nov2021, outcome "recovered with sequelae" (2021), described as "Shortness of breath"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; LYMPHADENOPATHY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Glands swollen"; OROPHARYNGEAL PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Sore throat"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Palpitations"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as " Congestion ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test; liver function test: negative. Clinical course: Have rheumatoid arthritis and previously had myocardia and palpitations. Believed to have had covid in March 2020. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. It was stated that feelings of a tight chest accompanied with some shortness of breath. Palpitations noticeable and more so at night. Congestion and sore throat accompanied by a cough. Recent LF test undertaken and results were negative. 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: 1940898 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670587

Write-up: Booster; Headache; This is a spontaneous report received from a contactable reporter (consumer) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111251755007960-ALZBG. Other Case identifier: GB-MHRA-ADR 26253283. A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache". Clinical course: Severe headaches. 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. Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1941036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Headache, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (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: GBPFIZER INC202101675053

Write-up: Stroke; Headache; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111261845110710-CNQTU (RA). Other Case identifier(s): GB-MHRA-ADR 26258480 (RA). A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer. Dose 1), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer. Dose 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 18Nov2021, outcome "recovered" (25Nov2021), described as "Stroke"; HEADACHE (disability, medically significant) with onset 18Nov2021, outcome "recovered" (25Nov2021), described as "Headache". Clinical information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The doctor suspected a stroke, due to the server headaches. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1941100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Immunisation, Interchange of vaccine products, Muscular weakness, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EZETIMIBE; LANSOPRAZOL; BISOPROLOL; PRALUENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Palpitations
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101675220

Write-up: Acute diarrhoea; Frontal headache; Muscular weakness; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111270733533490-ZURX7 (RA). Other Case identifier(s): GB-MHRA-ADR 26259984 (RA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FKO596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Palpitations" (unspecified if ongoing); "Heart bye pass", stop date: 2018. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: EZETIMIBE, start date: 05May2018; LANSOPRAZOL, start date: 05May2018; BISOPROLOL, start date: 07May2018; PRALUENT, start date: 09Oct2018. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE, Primary Immunization series complete), administration date: 21Feb2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (DOSE 2, SINGLE, Primary Immunization series complete), administration date: 15May2021, for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Acute diarrhoea"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Frontal headache"; MUSCULAR WEAKNESS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Muscular weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) no - negative covid-19 test. Patient was not enrolled in clinical trial. No follow up attempts are possible. No further information is expected.


VAERS ID: 1941116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Application site erythema, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101675148

Write-up: Painful itching in patches on back , scalp , face, no rash though; Hives giant; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111270948064760-6PGMD (MHRA). Other Case identifier(s): GB-MHRA-ADR 26260484 (MHRA). A 57-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH4751) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Urticaria" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Hives giant"; OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; APPLICATION SITE ERYTHEMA (medically significant), outcome "not recovered", described as "Painful itching in patches on back , scalp , face, no rash though". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative, notes: No - Negative COVID-19 test. Clinical Course: She had suffered urticaria before in the past, but She believes having either flu vaccine or booster COVID jab or the two together close together might have triggered immune response. Patient has not had symptoms associated with COVID-19. Painful itching in patches on back, scalp, face, no rash though. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). It was stated that patient was waiting for other blood tests at hospital for itching reason, this not told by physician it could be vaccine that caused it as only just realized it might be that.


VAERS ID: 1941144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK00112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675055

Write-up: Breathlessness; Acute chest pain; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111271313120750-WBQJF (MHRA). Other Case identifier(s): GB-MHRA-ADR 26261283 (MHRA). A male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Fk00112) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i... The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; DYSPNOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Breathlessness"; CHEST PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Acute chest pain". Clinical course: Text for relevant medical history and concurrent conditions: Stains. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1941150 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Immunisation, Interchange of vaccine products, Nasal congestion, Nasopharyngitis, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Epilepsy; HIV positive (HIV-positive with symptoms or reduction in immune response)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101675283

Write-up: Head cold; Off label use; Interchange of vaccine products; Booster; blocked nose; bloody snot/slight bleeding from nose at times; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority . Regulatory number: GB-MHRA-WEBCOVID-202111271448040240-Y19VQ (MHRA). Other Case identifier: GB-MHRA-ADR 26261671 (MHRA). A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Fh4751) as dose 3 (booster) single for COVID-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Dementia" (unspecified if ongoing); "HIV positive" (unspecified if ongoing), notes: HIV-positive with symptoms or reduction in immune response. Under investigation for epilepsy and dementia. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (medically significant) with onset 2021, outcome "recovering", described as "blocked nose"; NASOPHARYNGITIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Head cold"; EPISTAXIS (medically significant) with onset 2021, outcome "unknown", described as "bloody snot/slight bleeding from nose at times". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Therapeutic measures were taken as a result of nasal congestion, nasopharyngitis, epistaxis which include sprays to decongest but no effect. Patient was seeking medical advice via doctor next week. The patient report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1941211 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Sleep disorder
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Cancer; Chemotherapy (Had Cancer and Chemotherapy 17 years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675536

Write-up: pain in arm; Pain in arm, in my shoulders; pain keeping me awake is not getting any better; Arthritic pains; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111280729179810-APJUH. Other Case identifier(s): GB-MHRA-ADR 26262691. A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Chemotherapy" (unspecified if ongoing), notes: Had Cancer and Chemotherapy 17 years ago. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 21Feb2021, for Vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 16May2021, for Vaccination. The following information was reported: OFF LABEL USE (disability) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 16Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (disability), outcome "not recovered", described as "pain in arm"; ARTHRALGIA (disability) with onset 18Nov2021, outcome "not recovered", described as "Arthritic pains"; ARTHRALGIA (disability), outcome "not recovered", described as "Pain in arm, in my shoulders"; SLEEP DISORDER (disability), outcome "not recovered", described as "pain keeping me awake is not getting any better". Clinical course: Patient had cancer and chemotherapy 17 years ago. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient reported pain in arm, in shoulders, not able to lay down properly, pain keeping her awake and was not getting any better seems like arthritis has just set in. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow up attempts are possible. No further information is expected.


VAERS ID: 1941335 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: fever; Result Unstructured Data: Test Result:39.5
CDC Split Type: ITPFIZER INC202101665413

Write-up: other, at night fever 39.5 a day, then rising for two days, asthenia, intense shiver; other, at night fever 39.5 a day, then rising for two days, asthenia, intense shiver; other, at night fever 39.5 a day, then rising for two days, asthenia, intense shiver; This is a spontaneous report received from a contactable reporter (Other HCP) from the regulatory auhtority-WEB. Regulatory number: IT-MINISAL02-812703. A 65 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 16Nov2021 08:28 (Lot number: 1F1006A, Expiration Date: 31Dec2021) at the age of 65 years as dose 3, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (medically significant), PYREXIA (medically significant), CHILLS (medically significant) all with onset 16Nov2021, outcome "recovered" (22Nov2021) and all described as "other, at night fever 39.5 a day, then rising for two days, asthenia, intense shiver". Therapeutic measures were taken as a result of asthenia, pyrexia, chills. Actions Taken included acetaminophen. Reporter Comment: Inoculation site: left deltoid Sender Comment: 22Nov2021 agency: reaction changed to "serious" due to hyperpyrexia. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Inoculation site: left deltoid


VAERS ID: 1941360 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Laryngospasm, Vaccination site erythema, Vaccination site inflammation, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101688946

Write-up: Booster dose; Local reaction at the injection site (redness, swelling, inflammation). Nocturnal laryngospasm.; Local reaction at the injection site (redness, swelling, inflammation). Nocturnal laryngospasm.; Local reaction at the injection site (redness, swelling, inflammation). Nocturnal laryngospasm.; Local reaction at the injection site (redness, swelling, inflammation). Nocturnal laryngospasm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority WEB. Regulatory number: IT-MINISAL02-813343 (MINISAL02). A 53 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 13:00 (Lot number: 1F1005A, Expiration Date: 04Dec2021) at the age of 53 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CARDIOASPIRIN. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster dose"; VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE SWELLING (medically significant), VACCINATION SITE INFLAMMATION (medically significant), LARYNGOSPASM (medically significant) all with onset 16Nov2021, outcome "recovering" and all described as "Local reaction at the injection site (redness, swelling, inflammation). Nocturnal laryngospasm.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site inflammation, laryngospasm.clinical course Actions taken [For laryngospasm: taking antihistamine (Tinset 30 mg tablets) and For local reaction: ice] No follow-up attempts are needed. No further information is expected


VAERS ID: 1942925 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Redness; Swollen arm; Pain in arm; This case was received via RA (Reference number: GB-MHRA-ADR 26264664) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Pain in arm) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). On 22-Nov-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 24-Nov-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. At the time of the report, ERYTHEMA (Redness) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Additional event information included, patient experienced red hot swollen arm and itchy from vaccination site to forearm . pain got resolved after 6 days and swelling took over a week to resolve. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of erythema, peripheral swelling, and pain in extremity. The events occurred an unknown time after the booster dose of mRNA-1273. The rechallenge was not applicable since information about previous doses has not been disclosed. All events resolved spontaneously without medical intervention. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of erythema, peripheral swelling, and pain in extremity. The events occurred an unknown time after the booster dose of mRNA-1273. The rechallenge was not applicable since information about previous doses has not been disclosed. All events resolved spontaneously without medical intervention. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1943086 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-11-16
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD955 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test positive, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disorder gait; Memory disturbance (excl dementia)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20211224465

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority, FR-AFSSAPS-MA20215556] concerned a 78 year old male. The patient''s weight was 92.5 kilograms, and height was 173 centimeters. The patient''s concurrent conditions included: disorder gait, and memory disturbance (excl dementia). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: UNKNOWN) 1 dosage forms, dose number in series was 1, 1 total administered on 02-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced vaccination failure, and was hospitalized (date unspecified). Laboratory data included: COVID-19 PCR test positive (NR: not provided) Positive. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 02-JUN-2021. The outcome of vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint, and reference number requested.


VAERS ID: 1944842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-11-16
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY; SEROQUEL XR; DEPAKINE RETARD; SEROQUEL XR
Current Illness: Bipolar affective disorder; Bronchial carcinoma; Psychosis
Preexisting Conditions: Medical History/Concurrent Conditions: Lung lobectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: PCR test CT$g 30
CDC Split Type: ATPFIZER INC202101679761

Write-up: Asymptomatic COVID-19; Asymptomatic COVID-19; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority. Regulatory number: AT-BASGAGES-2021-062474 (BASGAGES). A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Jul2021 (Lot number: FD6840, Expiration Date: 31Oct2021) as dose 2, single and administration date 21May2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bronchial carcinoma" (ongoing); "Bipolar affective disorder" (ongoing); "Lung lobectomy" (not ongoing); "Psychosis" (ongoing). Concomitant medications included: aripiprazole (ABILIFY, 400 mg) taken for psychosis and ongoing; quetiapine fumarate (SEROQUEL XR, 200 mg) taken for psychosis and ongoing; valproate sodium, valproic acid (DEPAKINE RETARD, 333 mg/145 mg) and ongoing; quetiapine fumarate (SEROQUEL XR, 300 mg) taken for psychosis and ongoing. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 16Nov2021, outcome "recovered" and all described as "Asymptomatic COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2021) positive, notes: PCR test CT$g 30. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101710118 LOE/at risk scenario


VAERS ID: 1944844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Diarrhoea, Insomnia, Myalgia, Palpitations, Pyrexia, SARS-CoV-2 antibody test, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 respiratory infection
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:increased; Test Date: 20211001; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:1700 BAU/mL
CDC Split Type: ATPFIZER INC202101678782

Write-up: Sometimes strong palpitations with undefined malaise in the heart area; Watery diarrhoea; Blood pressure increased; Fever chills; Vaccination related malaise; Joint and muscle pain; Insomnia; Joint and muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: AT-BASGAGES-2021-062586 . A 74-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 21:00 (Lot number: FF2834) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19 respiratory infection", start date: 2020, stop date: 2020. The patient''s concomitant medications were not reported. The following information was reported: PALPITATIONS (medically significant) with onset 16Nov2021, outcome "recovering", described as "Sometimes strong palpitations with undefined malaise in the heart area"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Watery diarrhoea"; BLOOD PRESSURE INCREASED (non-serious) with onset 16Nov2021, outcome "recovering", described as "Blood pressure increased"; PYREXIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Fever chills"; VACCINATION COMPLICATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "Vaccination related malaise"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 16Nov2021, outcome "recovering" and all described as "Joint and muscle pain"; INSOMNIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Insomnia". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) increased; sars-cov-2 antibody test: (01Oct2021) 1700 bau/ml. Result of assessment (source of assessment: Reporter; all events) RELATED. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1944921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: BGPFIZER INC202101692726

Write-up: Hypertensive crisis; Blood pressure high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority -WEB. Regulatory number: BG-BDA-22375. A 61 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: FA4632) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSIVE CRISIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "Hypertensive crisis"; HYPERTENSION (non-serious) with onset 16Nov2021, outcome "recovering", described as "Blood pressure high". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) high. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1945748 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Disease recurrence, Heart rate, Hypertension, Immunisation, Investigation
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Parkinson''s disease (Advanced Parkinson''s disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (Old hypertension with recent stopping 6 months ago in front of hypotensive episodes)
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood pressure; Result Unstructured Data: Test Result:200/100 mmHg; Test Date: 20211116; Test Name: blood pressure; Result Unstructured Data: Test Result:210/110 mmHg; Test Date: 20211117; Test Name: blood pressure; Result Unstructured Data: Test Result:120/70 mmHg; Test Date: 20211116; Test Name: heart rate; Result Unstructured Data: Test Result:65; Comments: beats / min; Test Date: 20211117; Test Name: Bio; Result Unstructured Data: Test Result:normal with negative troponin.
CDC Split Type: FRPFIZER INC202101679098

Write-up: Booster; Arterial hypertension; Arterial hypertension; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-TS20215785 (RA). An 89-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Nov2021 (Lot number: Unknown) as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (not ongoing), notes: Old hypertension with recent stopping 6 months ago in front of hypotensive episodes; "Parkinson''s disease" (ongoing), notes: Advanced Parkinson''s disease. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HYPERTENSION (medically significant), DISEASE RECURRENCE (medically significant) all with onset 16Nov2021, outcome "recovered" (17Nov2021) and all described as "Arterial hypertension". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 200/100 mmHg; (16Nov2021) 210/110 mmHg; (17Nov2021) 120/70 mmHg; heart rate: (16Nov2021) 65, notes: beats / min; investigation: (17Nov2021) normal with negative troponin.. Therapeutic measures were taken as a result of hypertension, disease recurrence. Additional information: 11/16/2021 (D3 of the vaccine): discovery of a blood pressure of 200/100 mmHg during a rehabilitation consultation as part of the monitoring of his Parkinson''s disease. Emergency consultation with the general practitioner:No functional complaints, normal clinical examination apart from re-checked blood pressure at 210/110 at 200/100 mmHg. Heart rate at 65 beats / min. Prescription of Lercan� 20mg and a biological assessment.17/11/2021: The patient was doing very well with a blood pressure of 120/70 mmHg. Normal biological assessment with negative troponin. In total, an outbreak of asymptomatic grade III arterial hypertension 3 days after the booster injection of Comirnaty� and resolved within 24 hours with Lercan� in an 89-year-old patient with a history of hypertension (untreated for 6 months due to episodes of hypotension). Continuation of simple surveillance. No functional complaints. NB: A drug is coded in substance when the specialty name is not known. Information contained in the statement. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1946045 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Lower respiratory tract infection, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest infection; Fatigue; Nausea; Appetite lost; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26264878) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea), DECREASED APPETITE (Appetite lost) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) in a 78-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 01-Nov-2021 to an unknown date for Flu prevention. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest infection) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved with sequelae and DECREASED APPETITE (Appetite lost) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment: This regulatory case concerns a 78-year-old, female patient with medical history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious events of fatigue, nausea, decreased appetite and lower respiratory tract infection. The events fatigue, nausea and decreased appetite occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start date of the event lower respiratory tract infection was not provided. The report stated that the patient had spoken with her General physician. However, no further details were provided. Treatment information was also not provided. The events fatigue and nausea had resolved with sequelae at the time of the report. The events decreased appetite and lower respiratory tract infection had not resolved at the time of the report. The rechallenge was unknown as per Regulatory Authority report. The history of concoomitant administration of Influenza vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 78-year-old, female patient with medical history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious events of fatigue, nausea, decreased appetite and lower respiratory tract infection. The events fatigue, nausea and decreased appetite occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start date of the event lower respiratory tract infection was not provided. The report stated that the patient had spoken with her General physician. However, no further details were provided. Treatment information was also not provided. The events fatigue and nausea had resolved with sequelae at the time of the report. The events decreased appetite and lower respiratory tract infection had not resolved at the time of the report. The rechallenge was unknown as per Regulatory Authority report. The history of concoomitant administration of Influenza vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1946072 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Nasal congestion, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (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: SARS-COV-2 VACCINE
Current Illness: Allergic reaction; Penicillin allergy (life threatening allergic reaction when was a baby)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Cough; As the day went on; After an hour or so; Feverish; Dizzy; Cough resembling asthma; Nose congestion; Breathlessness; Fever chills; Tiredness; Light headedness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26265883) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), DIARRHOEA (As the day went on), FEELING ABNORMAL (After an hour or so), PYREXIA (Feverish), DIZZINESS (Dizzy), COUGH (Cough resembling asthma), NASAL CONGESTION (Nose congestion), DYSPNOEA (Breathlessness), PYREXIA (Fever chills), FATIGUE (Tiredness) and DIZZINESS (Light headedness) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 12-Oct-2021. Previously administered products included for Product used for unknown indication: Penicillin. Past adverse reactions to the above products included No adverse event with Penicillin. Concurrent medical conditions included Allergic reaction and Penicillin allergy (life threatening allergic reaction when was a baby). Concomitant products included SARS-COV-2 VACCINE for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced COUGH (Cough resembling asthma) (seriousness criterion medically significant), NASAL CONGESTION (Nose congestion) (seriousness criterion medically significant), DYSPNOEA (Breathlessness) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and DIZZINESS (Light headedness) (seriousness criterion medically significant). On an unknown date, the patient experienced COUGH (Cough) (seriousness criterion medically significant), DIARRHOEA (As the day went on) (seriousness criterion medically significant), FEELING ABNORMAL (After an hour or so) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and DIZZINESS (Dizzy) (seriousness criterion medically significant). On 16-Nov-2021, DIZZINESS (Light headedness) had resolved. On 18-Nov-2021, PYREXIA (Fever chills) had resolved. On 19-Nov-2021, FATIGUE (Tiredness) had resolved. On 23-Nov-2021, DYSPNOEA (Breathlessness) had resolved. At the time of the report, COUGH (Cough), DIARRHOEA (As the day went on), FEELING ABNORMAL (After an hour or so), PYREXIA (Feverish), DIZZINESS (Dizzy), COUGH (Cough resembling asthma) and NASAL CONGESTION (Nose congestion) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Company Comment - This case concerns a 69 year old male patient with no relevant medical history, who experienced the serious unexpected events of cough, nasal congestion, dyspnea, fatigue, pyrexia, dizziness and feeling abnormal. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.The patient was felt dizzy and lightheaded within 2 minutes from having vaccine. That passed after half an hour. After an hour or so, the patient felt tired, feverish but felt cold. Checked pulse rate and oxygen, heart beat up slightly but oxygen normal. As the day went on, felt breathless. Breathlessness, and nose congestion continued. The patient still had cough and started taking inhaler. After vaccine, that felt exactly the same as when had COVID 5 weeks previous to the vaccine. The patient felt worse after the vaccine than when he had COVID. Patient had not tested positive for COVID-19 since having the vaccine. The patient regularly checked his pulse rate /oxygen levels, Pulse rate were increased slightly for about a week and then reverted to normal. The patient had no illnesses and was not taking any medications.; Sender''s Comments: This case concerns a 69 year old male patient with no relevant medical history, who experienced the serious unexpected events of cough, nasal congestion, dyspnea, fatigue, pyrexia, dizziness and feeling abnormal. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1946151 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK LA / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Fatigue, Head discomfort, Influenza, Nasopharyngitis, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Experiencing it like a bad flu.); Flu; Comments: If relevant, I have tested positive for Covid before in january 2021, experiencing it like a ''bad flu''. 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: Test Date: 202101; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: GBSA2021SA406439

Write-up: This case involves a 24 years old female patient (height: 170 cm and weight: 74 kg) who had pain, head cold (nasopharyngitis), flu (influenza), the afternoon after vaccine (pyrexia), quite tired (fatigue), developed some pain in each arm after a few hours, more so on left (vaccination site pain), feeling some tightness in chest (chest discomfort), fatigue, chest pain and blocked feeling (head discomfort) after receiving INFLUENZA VACCINE, HEPATITIS A VACCINE and COVID-19 VACCINE MRNA BIONTECH. The patient''s medical history included Influenza and coronavirus disease-2019 (COVID-19) in JAN-2021 with Experiencing it like a bad flu. The patient''s past vaccination(s) included COVID-19 VACCINE MRNA BIONTECH on 23-JAN-2021 and on 09-APR-2021 (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient''s past medical treatment(s) and family history were not provided. Patient had not symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. On 16-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site and a dose of suspect COVID-19 VACCINE MRNA BIONTECH not produced by Sanofi (Dose 3a, lot number and expiration date not reported) via unknown route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect HEPATITIS A VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 16-Nov-2021, the patient developed a serious pain, head cold (nasopharyngitis), some pain in each arm after a few hours, more so on left (vaccination site pain) and blocked feeling (head discomfort), on the same day following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MRNA, (unknown latency) following the administration of HEPATITIS A VACCINE. On 17-Nov-2021, the patient developed a serious the afternoon after vaccine (pyrexia), quite tired (fatigue) and feeling some tightness in chest (chest discomfort) one day following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MRNA, (unknown latency) following the administration of HEPATITIS A VACCINE. On an unknown date, the patient developed a serious fatigue, chest pain and flu (influenza) (unknown latency) following the administration of vaccines. All events were assessed as medically significant. Relevant laboratory test results included: In January 2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test was Positive. It was not reported if the patient received a corrective treatment. It was reported that, at first patient did not have any problems, but developed some pain in each arm after a few hours, more so on left (where I had Pfizer vaccine). This pain stayed for a day or so. The following day patient was quite tired and felt like she had a head cold, blocked feeling. The afternoon after vaccine, maybe 21-22 hours later, started feeling some tightness in chest. Wasn''t too bad but she felt different to usual. she tried not to worry about it and thought it could be anxiety. It resolved within a couple of hours. It started whilst she was working but made sure to relax and rest and felt better after that. Patient is not enrolled in clinical trial. Patient was not admitted to hospital. The patient had not presence of pericardial rub, or changes in heart sounds. The patient was not asymptomatic. The patient had no signs of a systemic disease that may be responsible for the presentation. The possible blood clots or low platelet count and myocarditis or pericarditis was not related to patient''s report. The patient recovered for the event chest discomfort on 17-Nov-2021, for the event fatigue and vaccination site pain on 18-Nov-2021. The patient did not recover for the event pain, nasopharyngitis, influenza and fiver. At the time of reporting, the outcome was unknown for the event fatigue, chest pain and head discomfort. There would be no information on the batch number for this case.; Sender''s Comments: This case concerns a 24-year-old female patient who had pain, nasopharyngitis, influenza, pyrexia, fatigue, vaccination site pain, chest discomfort, fatigue, chest pain and head discomfort after vaccination with INFLUENZA VACCINE, HEPATITIS A VACCINE and COVID-19 VACCINE MRNA BIONTECH. The time to onset is compatible. The patient''s medical history included Influenza and COVID-19 in JAN-2021 with Experiencing it like a bad flu. The patient''s past vaccination(s) included COVID-19 VACCINE MRNA on 23-JAN-2021 and on 09-APR-2021. In January 2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test was Positive. However, patient''s medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 1946197 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Asthma; Fibromyalgia; Irritable bowel (Irritable bowel disease); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis); Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started, unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shortness of breath; Tachycardia; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26283426) on 03-Dec-2021 and was forwarded to Moderna on 03-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and TACHYCARDIA (Tachycardia) in a 44-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started, unsure when symptoms stopped). Concurrent medical conditions included Irritable bowel (Irritable bowel disease), Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis), Asthma, Fibromyalgia and Rheumatoid arthritis. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Feb-2021 to 13-Feb-2021 and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-May-2021 to an unknown date for COVID-19. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant) and TACHYCARDIA (Tachycardia) (seriousness criteria disability and medically significant). At the time of the report, CHEST PAIN (Chest pain) had not resolved and DYSPNOEA (Shortness of breath) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Date of last administration for concomitant COVID-19 VACCINE ASTRAZENECA was given as 2 May 2021. Treatment information was not provided by the reporter. It was reported that the patient had shortness of breath, low oxygen saturations, tachycardia and chest pain to A+E.. She had no any other heart related inflammation like pericarditis or myocarditis nor possible blood clots or low platelet counts. Patient was not enrolled in clinical trial also. This case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Chest Pain, Dyspnea, and Tachycardia. The events, which were disabling and medically significant for the patient, occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Chest Pain, Dyspnea, and Tachycardia. The events, which were disabling and medically significant for the patient, occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1946335 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Lymph node pain, Off label use, Salivary gland enlargement, Salivary gland pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101688999

Write-up: off label use; Interchange of vaccine products; Lymph node pain; Salivary gland pain; Salivary gland hypertrophy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IT-MINISAL02-812928 (RA). A 56 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid right, administration date 16Nov2021 19:16 (Lot number: FG6270) as dose 2 (initial pfizer dose), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (DOSE 1. , Batch : ABV2856), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (hospitalization), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization), outcome "unknown", described as "Interchange of vaccine products"; LYMPH NODE PAIN (hospitalization) with onset 16Nov2021, outcome "not recovered", described as "Lymph node pain"; SALIVARY GLAND PAIN (hospitalization) with onset 16Nov2021, outcome "not recovered", described as "Salivary gland pain"; SALIVARY GLAND ENLARGEMENT (hospitalization) with onset 16Nov2021, outcome "not recovered", described as "Salivary gland hypertrophy". Additional clinical courses: Takes Oki. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-11-16
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, 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:
CDC Split Type: ITPFIZER INC202101687355

Write-up: Bell''s hemifiaccial palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-813318 Regulatory Authority. A 49 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Jul2021 (Lot number: FF2752) as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), for COVID-19 immunization. The following information was reported: BELL''S PALSY (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Bell''s hemifiaccial palsy". Actions taken (corticosteroids vitamins group B gastric protector artificial tears). Therapeutic measures were taken as a result of bell''s palsy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946368 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymphadenopathy, Peripheral swelling, Pyrexia, Vaccination site erythema
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)

Life Threatening? No
Birth Defect? No
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 INC202101688950

Write-up: booster dose; swelling in the left shoulder; Hyperpyrexia (40 �C); Erythema throughout the Comirnaty vaccine administration area; swollen left axillary lymph node; swollen cervical latero lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Agency Agency-WEB. Regulatory number: IT-MINISAL02-813354. A 50 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 14:33 (Lot number: 1F1016A, Expiration Date: 16Nov2021) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: FLUARIX TETRA taken for immunisation, administration date 16Nov2021 14:33. Vaccination history included: Comirnaty vaccine (First dose, at 10:46, batch: EJ6797, batch expiry: 30Apr2021.), administration date: 17Jan2021, for covid-19 immunisation; Comirnaty vaccine (Second dose, at 11:08, batch: EL0725, batch expiry: 31Mar2021), administration date: 07Feb2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021 14:33, outcome "unknown", described as "booster dose"; PERIPHERAL SWELLING (medically significant) with onset 16Nov2021, outcome "recovering", described as "swelling in the left shoulder"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovered", described as "Hyperpyrexia (40 �C)"; VACCINATION SITE ERYTHEMA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Erythema throughout the Comirnaty vaccine administration area"; LYMPHADENOPATHY (medically significant) with onset 16Nov2021, outcome "recovering", described as "swollen left axillary lymph node"; LYMPHADENOPATHY (medically significant) with onset 16Nov2021, outcome "recovering", described as "swollen cervical latero lymph nodes". Therapeutic measures were taken as a result of vaccination site erythema. After administration of antihistamine cream based on promethazine slight improvement of erythema. On 22Nov2021, swollen lymph nodes remained. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1946442 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Nasal congestion, Pyrexia, Seizure, Somnolence, Tremor, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-THYROXIN [LEVOTHYROXINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:39.1 Centigrade
CDC Split Type: LTPFIZER INC202101689015

Write-up: Convulsions; Body temperature increased til 39.1 C; Fatigue; Drowsiness; Nasal congestion; Trembling; Severe injected hand pain; This is a spontaneous report received from a contactable reporter (mother of patient) (Consumer or other non-HCP) from the Agency Regulatory Authority-WEB. The reporter is the parent. Regulatory number: LT-SMCA-4378 Regulatory Authority. A 12-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration. administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXIN [LEVOTHYROXINE] taken for thyroid disorder. Vaccination history included: Covid-19 vaccine (1st dose, primary immunization series complete, but unknown manufacturer), for COVID-19 immunisation. The following information was reported: SEIZURE (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Convulsions"; VACCINATION SITE PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "Severe injected hand pain"; PYREXIA (non-serious) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Body temperature increased till 39.1 C"; TREMOR (non-serious) with onset 16Nov2021, outcome "recovered" (19Nov2021), described as "Trembling"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovering", described as "Fatigue"; SOMNOLENCE (non-serious) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Drowsiness"; NASAL CONGESTION (non-serious) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Nasal congestion". The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) 39.1 Centigrade. Therapeutic measures were taken as a result of vaccination site pain, pyrexia. Therapeutic measures were taken as a result of pyrexia: included paracetamol 500 mg tablets three times per day and Ibufen were used. The doctor was not informed about patient''s symptoms. It was mentioned adverse reactions lasted until 19-Nov-2021. The doctor was not informed about that. On the reporting date hand pain and fatigue still persist. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.


VAERS ID: 1946538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-11-16
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

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: 20211116; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: PositiveIu international unit(s)
CDC Split Type: PTPFIZER INC202101688356

Write-up: Vaccination failure; COVID-19/ Symptoms of infection included: fever, dry cough, headache, rhinorrea; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA and product quality group. Regulatory number: PT-RA-B202111-1858 (RA). A 41 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Aug2021 (Lot number: FG4442) as dose 2, 0.3 ml single and intramuscular, administration date 10Jul2021 (Lot number: FF0680, Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 16Nov2021, outcome "unknown", described as "COVID-19/ Symptoms of infection included: fever, dry cough, headache, rhinorrea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive, notes: PositiveIu international unit(s). The product quality complaint group reported Investigational Report received on 02Dec2021 included: Bnt162b2 (COMIRNATY, Batch/Lot Number: FF0680, expiration date:31Oct2021. Conclusion from the testing division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-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 6257892 (see File attachment in this investigation record) The complaint for 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(s) of the reported lot FF0680. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Testing concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. According to complaint investigation from testing results regarding bnt162b2 (COMIRNATY, Batch/Lot #: FG4442, expiration date: Unknown. Conclusion from the testing division was: The complaint for PFIZERBIONTECH 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(s) of the reported lot FG4442. A Complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Testing concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: Other information-First dose: Comirnaty, 10Jul2021, Lot FF0680. Second dose: Comirnaty, 10-08-2021, Lot FG4442. Onset of symptoms on 14Nov2021: fever, dry cough, headache and rhinorrhea. Positive PCR test on 16Nov2021. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-First dose: Comirnaty, 10Jul2021, Lot FF0680. Second dose: Comirnaty, 10-08-2021, Lot FG4442. Onset of symptoms on 14Nov2021: fever, dry cough, headache and rhinorrhea. Positive PCR test on 16Nov2021.


VAERS ID: 1949056 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Chills, Dyspnoea, Erythema, Eye discharge, Face oedema, Fatigue, Gingival bleeding, Gingival oedema, Headache, Heart rate, Heart rate increased, Impaired work ability, Increased upper airway secretion, Localised oedema, Movement disorder, Muscular weakness, Myalgia, Oedema peripheral, Pain, Pain in extremity, Pyrexia, Sputum increased, Vaccination site movement impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Gingival disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXIN ORION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to arthropod sting; Depression; Infection; Penicillin allergy; Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Test Name: pulse; Result Unstructured Data: Test Result:100 and above and sometimes hard-beating; Test Name: pulse; Result Unstructured Data: Test Result:continued high and at times beating for two days
CDC Split Type: FIPFIZER INC202101696309

Write-up: hand went inert; muscles are weak; heart problems; Neck oedema; Gingival oedema/gums were swollen; Gingival bleeding/gums bled upon tooth brushing; Difficulty breathing; Headache; Pyrexia/fever; Fatigue; Chills; Increased upper airway secretion/persistent mucus began to rise in the throat and mouth,which had to be constantly spit out; persistent mucus began to rise in mouth,which had to be constantly spit out/mucus secretion; Pain in extremity/pain began in the arm, all the way to the thumb; Shooting pain/pain to behind the left ear; Oedema peripheral/fingers swollen; Inability to work/stay out of work; Myalgia/muscular tenderness; Vaccination site movement impairment; Eye discharge/Eyes began to leak thick fluid; Heart rate increased; Red face; Face oedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory agency-WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217156 (RA). A 40 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 14:50 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "penicilin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "allergy to mosqutio and wasp stings" (unspecified if ongoing); "infection" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXIN ORION taken for depression. Past drug history included: Flixotide for flu; Bricanyl for flu. The following information was reported: PAIN IN EXTREMITY (life threatening) with onset 16Nov2021 14:50, outcome "recovered", described as "Pain in extremity/pain began in the arm, all the way to the thumb"; PAIN (life threatening) with onset 16Nov2021, outcome "recovering", described as "Shooting pain/pain to behind the left ear"; MOVEMENT DISORDER (life threatening), outcome "unknown", described as "hand went inert"; INCREASED UPPER AIRWAY SECRETION (life threatening) with onset 16Nov2021 15:10, outcome "recovering", described as "Increased upper airway secretion/persistent mucus began to rise in the throat and mouth,which had to be constantly spit out"; SPUTUM INCREASED (life threatening) with onset 16Nov2021 15:10, outcome "recovering", described as "persistent mucus began to rise in mouth,which had to be constantly spit out/mucus secretion"; EYE DISCHARGE (life threatening) with onset 16Nov2021, outcome "recovering", described as "Eye discharge/Eyes began to leak thick fluid"; HEADACHE (life threatening) with onset 16Nov2021 16:00, outcome "recovering", described as "Headache"; PYREXIA (life threatening) with onset 16Nov2021 16:00, outcome "recovered", described as "Pyrexia/fever"; FATIGUE (life threatening) with onset 16Nov2021 16:00, outcome "recovered", described as "Fatigue"; CHILLS (life threatening) with onset 16Nov2021 16:00, outcome "recovered", described as "Chills"; HEART RATE INCREASED (life threatening) with onset 16Nov2021, outcome "recovering", described as "Heart rate increased"; ERYTHEMA (life threatening) with onset 16Nov2021, outcome "recovering", described as "Red face"; FACE OEDEMA (life threatening) with onset 16Nov2021, outcome "recovering", described as "Face oedema"; LOCALISED OEDEMA (life threatening) with onset 17Nov2021, outcome "recovering", described as "Neck oedema"; OEDEMA PERIPHERAL (life threatening) with onset 16Nov2021, outcome "recovering", described as "Oedema peripheral/fingers swollen"; GINGIVAL OEDEMA (life threatening) with onset 17Nov2021, outcome "recovering", described as "Gingival oedema/gums were swollen"; GINGIVAL BLEEDING (life threatening) with onset 17Nov2021, outcome "recovering", described as "Gingival bleeding/gums bled upon tooth brushing"; DYSPNOEA (life threatening) with onset 17Nov2021, outcome "recovering", described as "Difficulty breathing"; IMPAIRED WORK ABILITY (life threatening) with onset 16Nov2021, outcome "recovering", described as "Inability to work/stay out of work"; MYALGIA (life threatening) with onset 16Nov2021, outcome "recovered", described as "Myalgia/muscular tenderness"; VACCINATION SITE MOVEMENT IMPAIRMENT (life threatening) with onset 16Nov2021, outcome "recovering", described as "Vaccination site movement impairment"; MUSCULAR WEAKNESS (life threatening), outcome "unknown", described as "muscles are weak"; CARDIAC DISORDER (life threatening), outcome "unknown", described as "heart problems". The patient underwent the following laboratory tests and procedures: heart rate: 100 and above and sometimes hard-beating; continued high and at times beating for two days. Therapeutic measures were taken as a result of pain in extremity, pain, movement disorder, increased upper airway secretion, sputum increased, eye discharge, headache, pyrexia, fatigue, chills, heart rate increased, erythema, face oedema, localised oedema, oedema peripheral, gingival oedema, gingival bleeding, dyspnoea, impaired work ability, myalgia, vaccination site movement impairment, muscular weakness, cardiac disorder. The clinical course was reported as follows: About 10 to 20 seconds after the vaccination, severe shooting pain began in the arm, all the way to the thumb and behind the left ear. The hand went inert. Patient took Ibuxin as advised by the vaccinating person. 20min after the vaccination, persistent mucus began to rise in the throat and mouth, which had to be constantly spit out. Eyes began to leak thick fluid. At about 4pm, a headache, fever, and severe fatigue and chills began. Pulse was 100 and above and sometimes hard-beating. The face was red. The next morning 17Nov upon waking up the face was severely swollen, as were the neck and fingers, the hand was more sore and inoperable. Her gums were swollen and bled upon tooth brushing. At times, it was difficult to breathe due to the mucus and swelling. She took Ibuxin and cortisone. She had to stay out of work (Wed-Fri). The fever was intermittent and lasted for four days, with mucus secretion controlled by the drug. The eyes continued to leak, the hand gradually improved. The fatigue was severe for 3 days, the muscular tenderness and chills of the body lasted also 3 days. The pulse continued high and at times beating for two days. Today 22Nov she was at work and the hand was normal. There was no fever. There was still a clear swelling in the face in some places. Eyes leak less but still interfere with work. There was little mucus secretion. Fatigue was relieved, although the muscles were weak. She was used to heart problems. Without the medicines at home, she would have had to seek hospital treatment, and it was very close even now. At the end of the last spring illness, the doctor found that she had an outbreak of infection based on tests and symptoms. Since then, she has been taking Flixotide and Bricanyl during the flu on the prescription of doctors. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1949064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-11-16
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Hypoxia, Oxygen saturation, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: oxygen saturation; Test Result: 81 %; Comments: Hypoxemia
CDC Split Type: FRPFIZER INC202101719969

Write-up: Vaccination failure; covid-19; Hypoxemia oxygen saturation 81%; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: FR-AFSSAPS-AN20214552. A 47 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Jun2021 (Lot number: FC5435) as dose 2,single and intramuscular, administration date 11May2021 (Lot number: EX6537) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (hospitalization) with onset 16Nov2021, outcome "unknown", described as "covid-19"; HYPOXIA (hospitalization) with onset 16Nov2021, outcome "not recovered", described as "Hypoxemia oxygen saturation 81%". The patient underwent the following laboratory tests and procedures: oxygen saturation: (21Nov2021) 81 %, notes: Hypoxemia. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-11-16
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101709987

Write-up: SARS-CoV-2 test positive; Drug ineffective; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-LL20217818 (AFSSAPS). Other Case identifier(s): FR-AFSSAPS-2021159169 (AFSSAPS). A 58-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20May2021 (Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Nov2021 (as reported), outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive. The time interval between beginning of drug administration and start of reaction/event was 6 months (as reported). The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1949150 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1003A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Malaise, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; NEBILOX; ZOCOR
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101696448

Write-up: Consciousness loss; Feeling sick; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NY20215204 Regulatory Authority. A 72 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 1F1003A) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension arterial" (ongoing). Concomitant medication(s) included: KARDEGIC taken for cardiovascular disorder (ongoing); NEBILOX taken for hypertension (ongoing); ZOCOR taken for thrombosis prophylaxis (ongoing). Vaccination history included: Covid-19 vaccine (1st dose, Unknown manufacturer), for COVID-19 immunisation, reaction(s): "no adverse reaction". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Consciousness loss"; MALAISE (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Feeling sick"; HEADACHE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Nausea". During the night of the vaccine, the patient reported the onset of headaches, nausea and malaise in the lavatory, with loss of consciousness. On 17Nov2021 at 9:20, he was found by his wife, unconscious in the toilet. On 18Nov2021: persistence of the headaches and nausea. Advice given by the Agency : consultation with his general practitioner. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949165 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Immunisation, Myopathy, Rhabdomyolysis, Visual analogue scale
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carnitine palmitoyltransferase deficiency; Myopathy
Allergies:
Diagnostic Lab Data: Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:more than 24000; Comments: very elevated; Test Name: VAS; Result Unstructured Data: Test Result:9/10
CDC Split Type: FRPFIZER INC202101696403

Write-up: Rhabdomyolysis; Myopathy aggravated; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the WEB. Regulatory number: FR-AFSSAPS-PB20217057. A 69 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: Unknown) as dose 3,single for covid-19 immunisation. Relevant medical history included: "Carnitine palmitoyltransferase deficiency" (unspecified if ongoing); "Myopathy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), administration date: 22Apr2021, for covid-19 immunization; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 16Nov2021, outcome "unknown", described as "booster"; RHABDOMYOLYSIS (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Rhabdomyolysis"; MYOPATHY (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Myopathy aggravated". The patient was hospitalized for immunisation, rhabdomyolysis, myopathy (start date: 20Nov2021). The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase: more than 24000, notes: very elevated; visual analogue scale: 9/10. Clinical course reported as: 24 hours after the injection, onset of fever, body aches, myalgia in the calves of the thighs, biceps and arms. Very dark urine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1949197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Body mass index, Fall, Immunisation, Portogram, Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blindness, one eye; Depressive state; Hypertension arterial; Hypothyroidism; Ischaemic heart disease (Left anterior descending artery, common trunk.); Morbid obesity; Obstructive sleep apnea syndrome (Treated with a device); Osteoarthritis; Venous thrombosis (Recurrent thromboembolic venous disease (long-term anticoagulation))
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Gasometry; Result Unstructured Data: Test Result:Hypoxemia; Comments: increased oxygen requirements to 10 L/minute; Test Name: Body mass index; Result Unstructured Data: Test Result:51; Test Date: 20211117; Test Name: Computed tomography chest angiography; Result Unstructured Data: Test Result:extensive involvement of the pulmonary parenchyma; Comments: (25-50%). No evidence to suggest a pulmonary embolism.; Test Date: 20211121; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Eupnoeic on oxygen flow 75% of fraction of inspired oxygen Flow rate 50 l/minute; Test Date: 20211117; Test Name: Severe Acute Respiratory Syndrome Coronavirus 2 serology; Test Result: Negative ; Test Date: 20211117; Test Name: SARS-COV-2 antigenic test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101748781

Write-up: Fall at home; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. A 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Morbid obesity" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Depressive state" (unspecified if ongoing); "Ischaemic heart disease" (unspecified if ongoing), notes: Left anterior descending artery, common trunk.; "Hypothyroidism" (unspecified if ongoing); "Obstructive sleep apnea syndrome" (unspecified if ongoing), notes: Treated with a device; "thromboembolic venous disease" (unspecified if ongoing), notes: Recurrent thromboembolic venous disease (long-term anticoagulation); "Osteoarthritis" (unspecified if ongoing); "Left eye blindness" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, Lot # not provided, Route of administration not provided, Anatomical location not provided), for COVID-19 IMMUNISATION; Comirnaty (DOSE 2, Lot # not provided, Route of administration not provided, Anatomical location not provided), administration date: May2021, for COVID-19 IMMUNISATION. The following information was reported: IMMUNISATION (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Booster"; FALL (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Fall at home". The patient underwent the following laboratory tests and procedures: blood gases: (19Nov2021) hypoxemia, notes: increased oxygen requirements to 10 L/minute; body mass index: (unspecified date) 51; portogram: (17Nov2021) extensive involvement of the pulmonary parenchyma, notes: (25-50%). No evidence to suggest a pulmonary embolism; respiratory rate: (21Nov2021) 18, notes: Eupnoeic on oxygen flow 75% of fraction of inspired oxygen Flow rate 50 l/minute; sars-cov-2 antibody test: (17Nov2021) negative; sars-cov-2 test: (17Nov2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1949495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Had blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211129; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101712242

Write-up: Chest pain; Shortness of breath; Myocarditis; Off label use; BOOSTER; Interchange of vaccine product; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 07Dec2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-RA-WEBCOVID-202111301944292140-RA (RA). Other Case identifier(s): RA-ADR 26273503 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 vaccination; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine product"; MYOCARDITIS (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Myocarditis"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath". The events "myocarditis", "chest pain" and "shortness of breath" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (29Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: the patient has not had symptoms associated with COVID-19. Myocarditis, chest pain, shortness of breath. Attended accident and emergency (A&E) on 19Nov2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report related to possible inflammation of the heart. The patient had blood tests and electrocardiogram (ECG). Symptoms did not lead to a hospital stay. A diagnosis was made by a medical professional (A&E general practitioner GP). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1949503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Chest pain, Dizziness, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Limb discomfort, Nausea, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmogenic right ventricular dysplasia (Pacemaker and ICD fitted); Atrial fibrillation;
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101711898

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Heart extremely fragile and painful; lightheaded; limb discomfort; nauseous; Atrial fibrillation; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202111302127218880-HXRUV (MHRA). Other Case identifier(s): GB-MHRA-ADR 26274331 (MHRA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ARVC" (unspecified if ongoing), notes: Pacemaker and ICD fitted; "AF", start date: 2007, stop date: 2007; "AF", start date: 2016, stop date: 2016. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; NAUSEA (disability, medically significant), outcome "recovered", described as "nauseous"; ATRIAL FIBRILLATION (disability, medically significant) with onset 17Nov2021, outcome "recovering", described as "Atrial fibrillation"; FATIGUE (disability, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (disability, medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (disability, medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (disability, medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (disability, medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (disability, medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; CARDIAC DISORDER (disability, medically significant), outcome "unknown", described as "Heart extremely fragile and painful"; DIZZINESS (disability, medically significant), outcome "unknown", described as "lightheaded"; LIMB DISCOMFORT (disability, medically significant), outcome "unknown", described as "limb discomfort". The events "nauseous", "atrial fibrillation", "fatigue/unusual tiredness", "chest pain", "fever", "shortness of breath", "heart palpitations", "racing heart (tachycardia)", "heart extremely fragile and painful", "lightheaded" and "limb discomfort" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient last menstrual period date : 01May2021. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Went in to AF, also fast heart rhythm and short episodes of VT. Heart extremely fragile and painful, lightheaded, nauseous, limb discomfort. Lasted on and off for a week. Heightened chances of VT and ICD administering in appropriate shock therapy. No treatment offered, just told to sit it out and suffer. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "Yes". Additional questions: Did the symptoms lead to a hospital stay?: "No". Was a diagnosis made by a medical professional?: "Yes". If yes, please confirm the type of healthcare professional (cardiologist, GP etc) that provided this diagnosis and any specific details of the diagnosis given: "Cardiologist". Are you happy for us to contact your GP or treating physician?: "No". Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken?: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1949529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Fatigue, Immunisation, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (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: COATED ASPIRIN; CETIRIZINE; LANSOPRAZOLE; SIRDUPLA; TILDIEM LA; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma (Sirdupla inhaler was a steroid, taken 2 puffs twice daily for asthma); Gastroesophageal reflux; Paroxysmal atrial fibrillation; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101712549

Write-up: Paroxysmal atrial fibrillation; Palpitations/ Heart palpitations; Patient received booster dose of COMIRNATY; Fatigue/unusual tiredness; Racing heart (tachycardia); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112010859556540-CG1D4 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26274489 (MHRA). A 57 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gastroesophageal reflux" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Paroxysmal atrial fibrillation" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Suspected COVID-19", start date: 31Mar2020, stop date: 05Apr2020; "Asthma" (unspecified if ongoing), notes: Sirdupla inhaler was a steroid, taken 2 puffs twice daily for asthma. Concomitant medication(s) included: COATED ASPIRIN taken for atrial fibrillation, start date: 01Nov2009; CETIRIZINE taken for hypersensitivity; FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V] taken for immunisation, administration date 12Oct2021; LANSOPRAZOLE taken for gastrooesophageal reflux disease; SIRDUPLA taken for asthma; TILDIEM LA taken for atrial fibrillation, start date: 01Nov2009; VENTOLIN [SALBUTAMOL SULFATE] taken for asthma. Past drug history included: Depo-medrone. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE,Lot Number: UNKNOWN, Route of Administration: Unspecified.), administration date: 12May2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLE,Lot Number: UNKNOWN, Route of Administration: Unspecified.), administration date: 21Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; ATRIAL FIBRILLATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Paroxysmal atrial fibrillation"; PALPITATIONS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Palpitations/ Heart palpitations"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Feb2021) no - negative covid-19 test. Clinical course: The patient was not enrolled in clinical trial. the patient had increased frequency of PAF (paroxysmal atrial fibrillation) events, especially at night and also increased frequency of daytime palpitations. The patient had not tested positive for COVID-19, since having the vaccine. It was reported that the symptoms did not lead to hospital stay. The diagnosis was not made by medical profession. There was no imaging such as but not limited to, chest X-ray, echocardiogram, cardiac MRI (magnetic resonance imaging), chest computerised tomography (CT) carried out. There was no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. 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-202101766588 same patient, differtn event, different dose (dose 2)


VAERS ID: 1949844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C18-05 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Dyspnoea, Paraesthesia, Pyrexia, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID-19 respiratory infection (I had the disease in Oct-2020. No)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211223849

Write-up: Vaccination site pain; Chest pain; Pyrexia; Rigors; Breathing difficult; Localised tingling; Paraesthesia hand; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, HR-HALMED-300052415] concerned a 35 year old male. The patient''s weight was 105 kilograms, and height was not reported. The patient''s past medical history included: covid-19 respiratory infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21c18-05 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 15-NOV-2021 for covid-19 vaccination in Arm (unspecified) (Dose number in series 1). No concomitant medications were reported. On 16-NOV-2021, the patient experienced vaccination site pain, chest pain, pyrexia, rigors, breathing difficult, localised tingling, paraesthesia hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination site pain, chest pain, pyrexia, rigors, breathing difficult, localised tingling, and paraesthesia hand on 20-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1949938 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ear pain, 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: DEMODERNATX, INC.MOD20214

Write-up: This case was received via Agency (Reference number: DE-PEI-202100231009) on 05-Dec-2021 and was forwarded to Moderna on 05-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS in a 25-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced FACIAL PARALYSIS (seriousness criterion hospitalization) and EAR PAIN . At the time of the report, FACIAL PARALYSIS and EAR PAIN had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient initials were reported. It was reported that previous vaccinations with Moderna was done and no information was reported about it. Company comment This is a Regulatory Authority case that concerns a 25-year-old male patient with no medical history reported, who experienced the serious expected event of facial palsy which required hospitalization and a non-serious event. The event occurred approximately 5 days after a dose of mRNA-1273. The rechallenge is not applicable, since dose number is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reporter''s Comments: Previous vaccination (s) with Moderna is done, none details on this; Sender''s Comments: This is a Regulatory Authority case that concerns a 25-year-old male patient with no medical history reported, who experienced the serious expected event of facial palsy which required hospitalization and a non-serious event. The event occurred approximately 5 days after a dose of mRNA-1273. The rechallenge is not applicable, since dose number is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1949939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4592 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation, Mydriasis, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORAZEPAM NORMON; TWICOR; BISOPROLOL NORMON; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101694899

Write-up: Syncope vasovagal; Dilated pupils; Pallor; Churning of stomach; Dizziness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: ES-AEMPS-1056423 (RA). An 81 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Nov2021 (Lot number: FG4592) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Infarct myocardial" (unspecified if ongoing); "Fibrillation atrial" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM NORMON taken for insomnia, start date: 23Nov2011; TWICOR taken for hypercholesterolaemia, start date: 24Jan2020; BISOPROLOL NORMON taken for hypertension, start date: 23Feb2017; ELIQUIS taken for atrial fibrillation, start date: 12Jul2019. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunisation, reaction(s): "No adverse effect"; Comirnaty (DOSE 2, SINGLE), administration date: 2021, for COVID-19 Immunisation, reaction(s): "Dizziness", "Dilated pupils", "Churning of stomach", "Pallor", "Syncope vasovagal". The following information was reported: SYNCOPE (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Syncope vasovagal"; MYDRIASIS (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Dilated pupils"; PALLOR (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Pallor"; NAUSEA (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Churning of stomach"; DIZZINESS (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Dizziness"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster". After 18 hours of inoculation, dizziness and increasing nausea for half an hour until reaching a moment in which she thinks she lost consciousness for a few seconds gradually recovering in half an hour. She also had a basically the same reaction in the 2nd dose of the same vaccine, although on the contrary, in the 1st dose he did not manifest this extreme symptom. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1950192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, C-reactive protein, Chest discomfort, Echocardiogram, Electrocardiogram, Immunisation, Influenza like illness, Musculoskeletal stiffness, Myocarditis, Troponin I
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Coronary angiogram; Result Unstructured Data: Test Result:Normal coronary vessels seen; Test Date: 20211123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:168 (maximal value); Test Date: 20211125; Test Name: C-reactive protein; Result Unstructured Data: Test Result:56; Test Date: 20211125; Test Name: Echocardiography; Result Unstructured Data: Test Result:Unchanged from previous investigations; Comments: (known smaller valve leaks), no findings of focal/global deterioration of function of the left ventricle or pericardial fluid. Short period of non-sustained ventricle tachycardia of about 25 complexes, probably related to the myocarditis. No suspicion of acute coronary syndrome.; Test Date: 20211123; Test Name: ECG; Result Unstructured Data: Test Result:Unchanged from previous investigations; Comments: (sinus rhythm and known right bundle-branch block); Test Date: 20211123; Test Name: Troponin I; Result Unstructured Data: Test Result:9051 (maximal value); Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: Test Result:840
CDC Split Type: NOPFIZER INC202101696648

Write-up: Booster; Probable myocarditis; stiffness in shoulder; influenza-like symptoms; stiffness/tenderness/"soreness" of upper part of chest (not direct pain); This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: NO-NOMAADVRE-FHI-2021-Ud9j81. Other Case identifier(s): NO-NOMAADVRE-E2B_00062961. A 78 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 15Nov2021 (Lot number: FJ5782) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunisation; Comirnaty (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (hospitalization) with onset 16Nov2021, outcome "recovering", described as "Probable myocarditis"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness in shoulder"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "influenza-like symptoms"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "stiffness/tenderness/"soreness" of upper part of chest (not direct pain)". The patient was hospitalized for myocarditis (start date: 23Nov2021). The events "probable myocarditis", "stiffness in shoulder", "influenza-like symptoms" and "stiffness/tenderness/"soreness" of upper part of chest (not direct pain)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: angiocardiogram: (Feb2021) normal coronary vessels seen; c-reactive protein: (23Nov2021) 168 (maximal value); (25Nov2021) 56; echocardiogram: (25Nov2021) unchanged from previous investigations, notes: (known smaller valve leaks), no findings of focal/global deterioration of function of the left ventricle or pericardial fluid. Short period of non-sustained ventricle tachycardia of about 25 complexes, probably related to the myocarditis. No suspicion of acute coronary syndrome; electrocardiogram: (23Nov2021) unchanged from previous investigations, notes: (sinus rhythm and known right bundle-branch block); troponin i: (23Nov2021) 9051 (maximal value); (25Nov2021) 840. Additional information: The patient experienced probable myocarditis. 1-2 days after dose 3 of Comirnaty the patient developed influenza-like symptoms and stiffness/tenderness/"soreness" in her shoulders and upper part of chest (not direct pain). She awaited for some days before she contacted her physician and was hospitalized on 23Nov2021. The regulatory authority assessed the casual relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1950233 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Dizziness, Headache, Influenza like illness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20214

Write-up: 160/100 blood pressure; Headache; Dizziness; Flu-like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Dec-2021 and was forwarded to Moderna on 03-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 56-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced BLOOD PRESSURE INCREASED (160/100 blood pressure), HEADACHE (Headache) and DIZZINESS (Dizziness). On 17-Nov-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved with sequelae. On 22-Nov-2021, BLOOD PRESSURE INCREASED (160/100 blood pressure), HEADACHE (Headache) and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. The Concomitant medication was not reported. Patient 1st dose of Moderna Vax in November 15, 2021 and experienced the following flu-like symptoms on day 1 & 2 followed by headache and dizziness on day 3. The following days up to reporting was the elevated high blood pressure of 160/100 which was usually 130/90. Patient have a maintenance medicine (hypertension) Micardis 80mg/day which the patient have been using to manage bp. Company comment: This case concerns a 56-year-old male patient with no relevant medical history who experienced serious unexpected event of influenza like illness. The event occurred approximately 1 day after the 1st dose of the mRNA-1273 . Rechallenge was not applicable since due to lack of information on the second dose, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 56-year-old male patient with no relevant medical history who experienced serious unexpected event of influenza like illness. The event occurred approximately 1 day after the 1st dose of the mRNA-1273 . Rechallenge was not applicable since due to lack of information on the second dose, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1950375 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-18
Onset:2021-11-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Thrombocytopenia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Patient had underlying disease of type 2 DM, HTN, CAD, HF and liver cirrhosis with ascites and EV (baseline platelet 80-90K). He was admitted to ACU for consciousness disturbance. After admission, severe thrombocytopenia, and high D-dimer titer ($g10,000) was noted, due to the fact that the patient just had the 2nd dose Moderna vaccination on October 18, pasty was consulted on 16 NOV 2021, for VITT but it couldn''t be ruled out. And the final anti-PF4 antibody was negative (O.D:0.39). Patient experienced, acute seizure episode on the evening of 17 Nov 2021, with bil, rapid blinking, tongue biting with bloody vomitus, accompanied with consciousness changes. The symptoms subsided after Ativan given once. Emergent brain CT showed bilateral cerebellar, occipital, parietal, and frontal infarction with right caudate nucleus hemorrhage. On 18 NOV 2021, peripheral duplex showed no evidence of DVT. On On 18 NOV 2021, for anemia and thrombocytopenia stills with hemolysis and trivial fragmented RBC, a nephrologist was consulted in suspect of thrombotic microangiopathy, and plasma exchange was performed since November 19, ADAMTS-13 result was still pending, brain MRV (November 27) also pending. 15 Nov 2021, 16 Nov 2021, 17 Nov 2021, 19 Nov 2021; PLT was done, and results are as; 10, 23, 23, 71,000/uL respectively. On 29 Nov 2021, the son of the patient reported that the patient was in a coma at home. This case concerns an 81-year-old male patient with no medical history, who experienced the unexpected serious adverse event of special interest Thrombocytopenia. The event occurred approximately 30 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns an 81-year-old male patient with no medical history, who experienced the unexpected serious adverse event of special interest Thrombocytopenia. The event occurred approximately 30 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1951122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-24
Onset:2021-11-16
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, 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:
CDC Split Type: AUPFIZER INC202101698576

Write-up: Bell''s palsy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 669661. A 36-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 24Oct2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BELL''S PALSY (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Bell''s palsy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951123 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Chest discomfort, Chills, Diarrhoea, Dysgeusia, Head discomfort, Mental impairment, Muscle spasms, Muscle twitching, Nausea, Paraesthesia, Rhinorrhoea, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101698578

Write-up: Mental impairment; Burning sensation; Chest discomfort; Chills; Diarrhoea; Dysgeusia; Head discomfort; Injection site pain; Muscle spasms; Muscle twitching; Nausea; Paraesthesia; Rhinorrhoea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 669670 (TGA ADR#). A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 16Nov2021, outcome "recovering", described as "Mental impairment"; BURNING SENSATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "Burning sensation"; CHEST DISCOMFORT (non-serious) with onset 16Nov2021, outcome "recovering", described as "Chest discomfort"; CHILLS (non-serious) with onset 16Nov2021, outcome "recovering", described as "Chills"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Diarrhoea"; DYSGEUSIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Dysgeusia"; HEAD DISCOMFORT (non-serious) with onset 16Nov2021, outcome "recovering", described as "Head discomfort"; VACCINATION SITE PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "Injection site pain"; MUSCLE SPASMS (non-serious) with onset 16Nov2021, outcome "recovering", described as "Muscle spasms"; MUSCLE TWITCHING (non-serious) with onset 16Nov2021, outcome "recovering", described as "Muscle twitching"; NAUSEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Nausea"; PARAESTHESIA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Paraesthesia"; RHINORRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Rhinorrhoea". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1951532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101699293

Write-up: Syncope; Hypotension; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 671229. A 18 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Syncope"; HYPOTENSION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Hypotension". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-11-16
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Basedow's disease
SMQs:, Optic nerve disorders (broad), Hyperthyroidism (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101699510

Write-up: basedow''s disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 671948 Regulatory Authority. A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW''S DISEASE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "basedow''s disease". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1952615 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Gastrointestinal pain, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101702535

Write-up: Dyspnoea; Gut pain; Pyrexia; Headache; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority WEB. Regulatory number: DE-PEI-CADR2021201238 (PEI). Other Case identifier(s): DE-CADRPEI-2021201238 (PEI Webportal), DE-PEI-202100225745 (PEI). A 16 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: 1F1010A) at the age of 16 years as dose unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Dyspnoea"; GASTROINTESTINAL PAIN (hospitalization) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Gut pain"; PYREXIA (non-serious) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Pyrexia"; HEADACHE (non-serious) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Headache"; CHILLS (non-serious) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Chills". Additional information: Admission and overnight hospitalization due to the symptoms mentioned. Spontaneous improvement, only pain in the upper abdomen persisting. "Labor blande". No diarrhea, no constipation. Stop date of event headache was 17Nov2021 and stop date of event gut pain 17Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1952756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101718763

Write-up: Tachycardia; This is a spontaneous report received from a contactable Pharmacist from the Agency Agency-WEB. Regulatory number: ES-AEMPS-1053678. An adult female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Tachycardia". The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1953013 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest pain, Dyspnoea, Electrocardiogram, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Oxygen saturation, Pain, Palpitations, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; FOSTAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Flu (temperature, blocked nose, chesty productive cough); Panic attack; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20211121; Test Name: Blood test; Result Unstructured Data: Test Result:nfection/inflammation marker was up; Test Date: 20211121; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:abnormal t-wave; Test Date: 20211121; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal; Test Date: 20211121; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202101712078

Write-up: myocarditis; pericarditis; pain; Heart palpitations; Chest pain; Shortness of breath; booster; Interchange of vaccine products; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111291932562050-URTJI (RA). Other Case identifier(s): GB-MHRA-ADR 26266865 (RA). A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Influenza", start date: 20Oct2021, stop date: 27Oct2021, notes: temperature, blocked nose, chesty productive cough; "panic attack" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for panic attack, start date: 03Nov2021; FOSTAIR taken for asthma, start date: 20Jan2020. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE-1), administration date: 20Feb2021, for COVID-19 immunisation, reaction(s): "Fever chills", "Vomiting", "Fatigue", "Headache"; Covid-19 vaccine (DOSE-2, Manufacturer unknown.), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; PAIN (medically significant), outcome "recovered" (2021), described as "pain"; CHEST PAIN (medically significant) with onset 21Nov2021 05:00, outcome "recovered" (22Nov2021), described as "Chest pain"; DYSPNOEA (medically significant) with onset 21Nov2021 05:00, outcome "recovered" (23Nov2021), described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations". The events "myocarditis" and "pericarditis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (21Nov2021) normal; blood test: (21Nov2021) nfection/inflammation marker was up; electrocardiogram: (21Nov2021) abnormal t-wave; (21Nov2021) normal; oxygen saturation: (21Nov2021) normal. Therapeutic measures were taken as a result of myocarditis, pericarditis, chest pain, dyspnoea. Clinical information: Woke up on 21 November 2021 at 5am with chest pains and shortness of breath. At 8am partner drove me to accident and emergency (a&e) after paracetamol didn''t reduce the pain. Was seen by the triage nurse, blood pressure and oxygen were fine, but electrocardiogram (ecg) came back as abnormal t-wave. Saw a general practioner (GP) in the urgent care unit who transferred me back to a&e for further investigation. Had another ecg with the same result and then had bloods taken. She understands from the doctor these came back fine except for infection/inflammation marker was up. Suggested to take naproxen and rest at home to see if I improved. Also, a course of antibiotics in case I actually had an infection but doctor at a&e thought it might be a reaction to the booster jab as they had seen two other people that day with similar symptoms. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report relates to possible inflammation of the heart (myocarditis or pericarditis. The symptoms lead to a hospital stay. Diagnosis not made by a medical professional. Patient was hospitalized for 9 hours, due to symptoms myocarditis or pericarditis. If yes, please confirm the type of healthcare professional (cardiologist, GP etc) that provided this diagnosis and any specific details of the diagnosis given.: "A&e doctor thought it might be a reaction to the vaccine. Patient received antibiotics as a treating medication. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not currently breastfeeding. Events fever chills onset date 20Feb2021 and recovered on 22Feb2021, vomiting onset date 21Feb2021 and recovered on 21Feb2021, fatigue onset date 20Feb2021 and recovered on 27Feb2021 headache onset date 20Feb2021 and recovered on 22Feb2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953118 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Rash papular, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101711912

Write-up: Booster; Raised, lumpy rash; Itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111301638196490-Z1UYF (RA). Other Case identifier(s): GB-MHRA-ADR 26273118 (RA). A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH4751) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; RASH PAPULAR (medically significant) with onset 16Nov2021, outcome "recovering", described as "Raised, lumpy rash"; RASH PRURITIC (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Itchy rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Raised, lumpy extremely itchy rash started on the day of the booster. Firstly on back of neck, down back then armpits and arms. It has now reached the back of knees. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1953210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymph node pain, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (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 Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101712409

Write-up: Lymph node pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112011010294800-WS7IT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26274685 (MHRA). A 48-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: fh4751) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Additional information: Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose-1, Primary Immunization Series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose-2, Primary Immunization Series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; LYMPH NODE PAIN (medically significant) with onset 17Nov2021, outcome "recovering", described as "Lymph node pain". Case reported as medically significant by health authority. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953215 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Immunisation, Muscle spasms, Nightmare, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (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: DIAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101712465

Write-up: back in spasm; Nightmare; Pain in l arm; Pain back; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112011102521190-SRSLS (RA). Other Case identifier(s): GB-MHRA-ADR 26275047 (RA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM. Past drug history included: Atomoxetine for ADHD. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation; Bnt162b2 (DOSE 2), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pain in l arm"; MUSCLE SPASMS (medically significant), outcome "unknown", described as "back in spasm"; BACK PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pain back"; NIGHTMARE (medically significant), outcome "unknown", described as "Nightmare". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of pain in extremity, back pain. Clinical course: severe pain in arm and back in spasm since injection, the patient was on diazepam it is so bad. Nightmares as well. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1953887 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/90 mmHg; Comments: 09:58
CDC Split Type: PHPFIZER INC202101713117

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121493. A 47 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 47 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 09:58, outcome "recovered" (16Nov2021 10:20), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 160/90 mmHg, notes: 09:58. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953896 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:170/80 mmHg; Comments: 09:28
CDC Split Type: PHPFIZER INC202101713150

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121484. A 49 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 49 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 09:28, outcome "recovered" (16Nov2021 09:43), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 170/80 mmHg, notes: 09:28. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953897 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:180/100 mmHg; Comments: 09:40
CDC Split Type: PHPFIZER INC202101713151

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121491 (RA). A 44 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 44 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 09:40, outcome "recovered" (16Nov2021 10:30), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 180/100 mmHg, notes: 09:40. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953898 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:180/100 mmHg; Comments: 09:40
CDC Split Type: PHPFIZER INC202101713152

Write-up: Elevated BP (180/100); Injection site numbness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121492 (RA). A 25 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: PCB0002) at the age of 25 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 16Nov2021 09:40, outcome "recovered" (16Nov2021 10:00), described as "Elevated BP (180/100)"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 16Nov2021 02:30, outcome "recovered" (17Nov2021 07:00), described as "Injection site numbness". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 180/100 mmHg, notes: 09:40. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1953936 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 4 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood pressure systolic increased, Heart rate, Heart sounds, Incorrect dose administered, Oxygen saturation
SMQs:, Hypertension (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Glycemia; Test Result: 103 mg; Test Date: 20211116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:139/75 mmHg; Test Date: 20211116; Test Name: Heart rate; Result Unstructured Data: Test Result:78 beats per minute; Test Date: 20211116; Test Name: AC; Result Unstructured Data: Test Result:S1 and S2 rhythmic; Test Date: 20211116; Test Name: SPO2; Test Result: 98 %
CDC Split Type: PTPFIZER INC202101702903

Write-up: Administration error; Blood pressure: 139/75 mmHg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB. Regulatory number: PT-INFARMED-E202111-1890. A 93 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 1F1014A) at the age of 93 years as dose 4, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1- Lot EL1491), administration date: 06Jan2021, for COVID-19 immunization, reaction(s): "No adverse event"; Comirnaty (Dose 2- Lot EJ6134), administration date: 27Jan2021, for COVID-19 immunization, reaction(s): "No adverse event"; Comirnaty (Dose 3- Lot PCB0003), administration date: 11Nov2021, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: INCORRECT DOSE ADMINISTERED (medically significant) with onset 16Nov2021, outcome "unknown", described as "Administration error"; BLOOD PRESSURE SYSTOLIC INCREASED (medically significant) with onset 16Nov2021, outcome "unknown", described as "Blood pressure: 139/75 mmHg". The patient underwent the following laboratory tests and procedures: blood glucose: (16Nov2021) 103 mg; blood pressure measurement: (16Nov2021) 139/75 mmHg; heart rate: (16Nov2021) 78 beats per minute; heart sounds: (16Nov2021) s1 and s2 rhythmic; oxygen saturation: (16Nov2021) 98 %. Reporter Comment: Medication error occurred? Yes Other information First dose: 06Jan2021 Lot EL1491 Second dose: 27Jan2021 EJ6134 Third dose: 11Nov2021 Lot PCB0003 Observation after inappropriate administration of the 4th dose. SPO2(oxygen saturation): 98 percent; BP (Blood pressure): 139/75 mmHg; Glycemia 103 mg; HR (Heart rate): 78 beats per minute and A.C (Cardiac Auscultation/ Heart Sounds): S1 and S2 Rhythmic. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Medication error occurred? Yes Other information First dose: 06Jan2021 Lot EL1491 Second dose: 27Jan2021 EJ6134 Third dose: 11Nov2021 Lot PCB0003 Observation after inappropriate administration of the 4th dose. SPO2(oxygen saturation): 98 percent; BP (Blood pressure): 139/75 mmHg; Glycemia 103 mg; HR (Heart rate): 78 beats per minute and A.C (Cardiac Auscultation/ Heart Sounds): S1 and S2 Rhythmic.


VAERS ID: 1954469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5775 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211233183

Write-up: JOINT INFLAMMATION; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, RO-NMA-2021-SPCOV15388] concerned a 42 year old adult female of unspecified race and ethnic origin. The patient''s weight was 53 kilograms, and height was 160 centimeters. The patient''s past medical history included: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported, batch number: ACA5775 expiry: Unknown) 1 dosage forms, 01 total administered on 13-NOV-2021 for active immunisation. No concomitant medications were reported. On 16-NOV-2021, the patient experienced joint inflammation on the right knee, right hip and right elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint inflammation. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1955885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101735488

Write-up: appendectomy; took her to the hospital in emergency due to a lot of vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (hospitalization) with onset 16Nov2021, outcome "unknown", described as "took her to the hospital in emergency due to a lot of vomiting"; APPENDICECTOMY (hospitalization) with onset 16Nov2021, outcome "unknown", described as "appendectomy". The events "took her to the hospital in emergency due to a lot of vomiting" and "appendectomy" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of vomiting, appendicectomy. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1955917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Iritis
SMQs:, Ocular infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20211234908

Write-up: IRITIS; This spontaneous report received from a physician via a Regulatory Authority [RA-21012783] concerned a 57 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) 1 dosage forms, 1 total, administered on 01-NOV-2021 for covid-19 immunisation (Dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 16-NOV-2021, the patient experienced iritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from iritis. This report was serious (Other Medically Important Condition).


VAERS ID: 1956296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-11-16
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BUPRENORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addiction to drugs; COPD; Emphysema; Obesity; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Bio: L452R mutation; CT value: 20.9
CDC Split Type: FRPFIZER INC202101718857

Write-up: Vaccination failure/ COVID-19 with symptoms/ tested positive for SARS-CoV-2 test; Vaccination failure/ COVID-19 with symptoms/ tested positive for SARS-CoV-2 test; respiratory distress; This is a spontaneous report received from a contactable reporter (pharmacist) from the regulatory authority-WEB; the Regulatory report number is FR-AFSSAPS-LY202112752. A 64-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscularly on 16Aug2021 (batch/lot number: FE8244) as DOSE 2, SINGLE and received the first dose of bnt162b2 (COMIRNATY), intramuscularly on 26Jul2021 (batch/lot number: FF3318) as DOSE 1, SINGLE for COVID-19 immunization. Relevant medical history included: "COPD" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "Sleep apnoea syndrome" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Addiction to drugs" (unspecified if ongoing). Concomitant medication included: BUPRENORPHINE. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Nov2021, outcome "recovering," and all described as "Vaccination failure/ COVID-19 with symptoms/ tested positive for SARS-CoV-2 test"; RESPIRATORY DISTRESS (hospitalization, medically significant) with onset 16Nov2021, outcome "unknown," described as "respiratory distress." The patient was hospitalized for vaccination failure, COVID-19, respiratory distress (start date: 16Nov2021, discharge date: 19Nov2021, hospitalization duration: 3 days). The patient underwent laboratory tests and procedures: SARS-CoV-2 test: (17Nov2021) positive, notes: Bio: L452R mutation; CT value: 20.9. Additional information: On 12Nov2021: appearance of 1st symptoms: headache, loss of smell and taste. On 16Nov2021: respiratory distress - hospitalization. On 19Nov2021: Returned home. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956318 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:greater than 220 mmHg; Comments: hypertension
CDC Split Type: FRPFIZER INC202101719146

Write-up: Hypertension; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-MP20218752 (AFSSAPS). A 92 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FG7911) at the age of 92 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 16Nov2021, outcome "unknown", described as "booster"; HYPERTENSION (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Hypertension". The patient underwent the following laboratory tests and procedures: blood pressure systolic: (20Nov2021) greater than 220, notes: hypertension. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1956381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-11-16
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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: Facioplegia (Peripheral facial palsy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101715716

Write-up: Facioplegia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the -WEB. The reporter is the patient. Regulatory number: FR-AFSSAPS-TS20215843. A 60 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 03Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Facioplegia", start date: 2009, stop date: 2009, notes: Peripheral facial palsy. The patient''s concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "Facioplegia". At present, the patient still has great weakness of the muscles of the face on the right side. Peripheral facial paralysis. In total, occurrence of facial paralysis approximately 2.5 months after an injection (rank unspecified) of Comirnaty in a patient with a history of facial paralysis. Role of the vaccine excluded. The case was considered non-serious by the patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1956419 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-16
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: ultrasound; Result Unstructured Data: Test Result:acrania; Test Date: 20211116; Test Name: ultrasound; Result Unstructured Data: Test Result:acrania
CDC Split Type: FRPFIZER INC202101724583

Write-up: spontaneous abortion; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. A female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Oct2021 (Lot number: FH0161) as dose 2, single for covid-19 immunisation. The patient is expected to deliver one baby(s). The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 16Nov2021, outcome "unknown", described as "spontaneous abortion". The pregnancy resulted in spontaneous abortion. The fetal outcome is congenital anomaly. The patient underwent the following laboratory tests and procedures: ultrasound foetal: (11Sep2021) acrania; (16Nov2021) acrania. Clinical course: Background / History of the disease:Vaccination against COVID-19 with the Comirnaty vaccine: dose 2 on 29Oct2021 of batch FH0161 in the left arm. Clinical signs and chronology of facts:On 16Sep, the dating ultrasound makes it possible to estimate the onset of pregnancy on 01Sep2021.Biology / additional examinations / etiological research: 1st trimester ultrasound on 11Sep: acrania.Confirmation of the diagnosis of acrania by follow-up ultrasound re-reading on 16Nov.Summary of the care: Psychological follow-up of the mother in progress Evolution :Curettage with trophoblastic biopsy scheduled for 23Nov2021.Baby died on 16Nov2021.Conclusion: Baby case of congenital anomaly of acrania type, identified at three weeks after the injection of a second dose of anti-Covid Comirnaty vaccination in the mother.The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures.Official Bulletin of the Minister in charge of Health number 84/50, January 24, 1985. Published in Therapy 2011; 66 (6): 517-525) No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101719108 baby/mother cases


VAERS ID: 1956573 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coeliac disease, Condition aggravated, Decreased appetite, Diarrhoea, Diverticulum, Headache, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZAPAIN
Current Illness: Coeliac disease; Diverticular disease
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Immunodeficiency (Has an illness which reduces the immune response (e.g. immunodeficiency)); Myalgic encephalomyelitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101712750

Write-up: Vomiting; Loose bowel; Primary Immunisation: Unknown Manufacturer; Booster: Comirnaty; Primary Immunisation: Unknown Manufacturer; Booster: Comirnaty; The patient received third (booster) dose of COMIRNATY; Decreased appetite; Fever; Muscle ache; Headache; Coeliac disease; Coeliac Disease: condition aggravated; Diverticular disease; Diverticular Disease: condition aggravated; Felt very unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112011732264790-CZS66 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26277102 (MHRA). A 75-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); " M.E. Myalgic encephalomyelitis" (unspecified if ongoing); "Coeliac disease" (ongoing); "Diverticular disease" (ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency). Concomitant medications included: codeine phosphate, paracetamol (ZAPAIN) taken for arthritis. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Unknown, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Unknown, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Primary Immunisation: Unknown Manufacturer; Booster: Comirnaty"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "The patient received third (booster) dose of COMIRNATY"; COELIAC DISEASE (medically significant) with onset 2021, outcome "not recovered", described as "Coeliac disease"; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome "not recovered", described as "Coeliac Disease: condition aggravated"; DIVERTICULUM (medically significant) with onset 2021, outcome "not recovered", described as "Diverticular disease"; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome "not recovered", described as "Diverticular Disease: condition aggravated"; DECREASED APPETITE (medically significant) with onset 16Nov2021, outcome "recovering", described as "Decreased appetite"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovered" (20Nov2021), described as "Fever"; MYALGIA (medically significant) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Muscle ache"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (21Nov2021), described as "Headache"; VOMITING (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Vomiting"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovered" (01Dec2021), described as "Loose bowel"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "Felt very unwell". Felt very unwell. She had diverticular Disease and Coeliac Disease and all the symptoms aggravated this. Also had M.E. and so muscle ache was severe. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1956676 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Insomnia, Interchange of vaccine products, Off label use
SMQs:, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101721422

Write-up: Primary immunisation series: AstraZeneca; Booster: COMIRNATY; Primary immunisation series: AstraZeneca; Booster: COMIRNATY; The patient received third (booster) dose of COMIRNATY; Headache/head pain; Chronic insomnia/did not sleep at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112021546425620-OX7FH (RA). Other Case identifier(s): GB-MHRA-ADR 26281839 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH3220) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient did not have symptoms associated with COVID-19, not had a COVID-19 test. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date Oct2021. It was reported that the patient does not take any other medications. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLELot Number: UNKNOWN), administration date: 20May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLELot Number: UNKNOWN), administration date: 07Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Primary immunisation series: AstraZeneca; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "The patient received third (booster) dose of COMIRNATY"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as " Headache/head pain"; INSOMNIA (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Chronic insomnia/did not sleep at all". Since having the booster and the patient had severe headache around 12 hours after dose given. It lasted all night and she did not sleep at all. The patient managed to resolve it the next day with many painkillers. The patient had not tested positive for COVID-19, since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1956883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Fatigue, Myocarditis, Palpitations, Pyrexia, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 INC202101722383

Write-up: Fatigue/unusual tiredness; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Fainting; possible inflammation of the heart (myocarditis or pericarditis); Exhaustion; Coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112031548299300-SANTT (RA). Other Case identifier(s): GB-MHRA-ADR 26287391 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation. The following information was reported: FATIGUE (disability) with onset 16Nov2021, outcome "not recovered", described as "Exhaustion"; COUGH (disability) with onset 16Nov2021, outcome "not recovered", described as "Coughing"; FATIGUE (disability), outcome "unknown", described as "Fatigue/unusual tiredness"; PYREXIA (disability), outcome "unknown", described as "Fever"; DYSPNOEA (disability), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (disability), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (disability), outcome "unknown", described as "Racing heart (tachycardia)"; SYNCOPE (disability), outcome "unknown", described as "Fainting"; MYOCARDITIS (disability), outcome "unknown", described as "possible inflammation of the heart (myocarditis or pericarditis)". The symptoms did not lead to a hospital stay and there were no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957021 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial flutter, Cardiac flutter, Chest pain, Dyspnoea, Fatigue, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), 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:
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.; Comments: No. Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Racing heart (tachycardia); Heart palpitations; Chest pain; Shortness of breath; Fatigue/unusual tiredness; heart flutters; Heart fluttering; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26294307) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (heart flutters), the first episode of CHEST PAIN (Chest pain), CARDIAC FLUTTER (Heart fluttering), TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart palpitations), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue/unusual tiredness) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On an unknown date, the patient experienced ATRIAL FLUTTER (heart flutters) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, ATRIAL FLUTTER (heart flutters) and CARDIAC FLUTTER (Heart fluttering) had not resolved and TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart palpitations), the last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No.Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Within half an hour of having the vaccination the patient experienced severe crushing pain to left side of chest. ECG, blood test and X ray the same day but didn''t show anything. Since then, the patient had experienced heart flutters but haven''t had this checked out as don''t want to take anymore Regulatory Authority time. It was reported that the patient has not had symptoms associated with COVID-19 and had not tested positive for COVID-19 since having the vaccine. Reportedly, the patient was not enrolled in clinical trial The patient stated that their report related to possible inflammation of the heart (myocarditis or pericarditis) and answered to the following questions: Please provide details of any relevant investigations or tests conducted: "As above - Hospital � 16-Nov-2021. Additional questions Did the symptoms lead to a hospital stay? Yes Was a diagnosis made by a medical professional? No Are you happy for us to contact your GP or treating physician? No Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken? Yes Was the troponin normal or raised? Bloods were taken on 16/11/2021 a few hours after vaccine and everything was normal at that point Company Comment - This case concerns a 53 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected events of atrial flutter, chest pain, cardiac flutter, tachycardia, palpitations,dyspnoea and fatigue . The event chest pain occurred on the same day after the third dose of mRNA-1273 vaccine. The event cardiac flutter occurred 1 day after the third dose of mRNA-1273 vaccine. The other events occurred on an unknown date after the third dose of mRNA-1273 vaccine.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 53 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected events of atrial flutter, chest pain, cardiac flutter, tachycardia, palpitations,dyspnoea and fatigue . The event chest pain occurred on the same day after the third dose of mRNA-1273 vaccine. The event cardiac flutter occurred 1 day after the third dose of mRNA-1273 vaccine. The other events occurred on an unknown date after the third dose of mRNA-1273 vaccine.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1957180 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling hot, Heart rate, Hypertension, Immunisation, Interchange of vaccine products, Off label use, Oxygen saturation, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vertigo (was investigated for vertigo 6 years ago which was reported as ruled out.); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: The patient did not have any relevant medical history or concurrent conditions.
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:194/117; Test Date: 20211116; Test Name: Blood pressure; Result Unstructured Data: Test Result:BP is continuously high; Test Date: 20211116; Test Name: Heart rate; Result Unstructured Data: Test Result:HR 98; Test Date: 20211116; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:o2 says 100% %; Test Date: 20211116; Test Name: Respiratory rate; Result Unstructured Data: Test Result:Rr 20
CDC Split Type: IEPFIZER INC202101719424

Write-up: Off label use; Interchange of vaccine products; Booster; BP 194/117 / BP is continuously high; 15 minutes post booster, had hot sensation in the nape to head; This is a spontaneous report received from a contactable reporter(s) (Other HCP) Regulatory number: IE-HPRA-2021-086870. Other Case identifier(s): IE-HPRA-HMARR-2021111611196. A 46 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FH0114) at the age of 46 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; HYPERTENSION (medically significant) with onset 16Nov2021, outcome "unknown", described as "BP 194/117 / BP is continuously high"; FEELING HOT (medically significant) with onset 16Nov2021, outcome "unknown", described as "15 minutes post booster, had hot sensation in the nape to head". The events "bp 194/117 / bp is continuously high" and "15 minutes post booster, had hot sensation in the nape to head" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 194/117; (16Nov2021) bp is continuously high; heart rate: (16Nov2021) hr 98; oxygen saturation: (16Nov2021) o2 says 100%; respiratory rate: (16Nov2021) rr 20. Clinical course: The patient was not taking any concomitant medication. The patient did not have any relevant medical history or concurrent conditions. It was reported that 15 minutes later on 16Nov2021, the patient experienced a hot sensation in the nape of head. The patient was also brought to the Emergency Department for further assessment as blood pressure was reported as continuously high, 194/117. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1957415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Loss of consciousness, Malaise, Nausea, Pyrexia, Syncope
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), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: Fever: 38 to 40.5 degrees Celcius; Test Date: 20211124; Test Name: Body temperature; Result Unstructured Data: Test Result:40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celcius
CDC Split Type: NLPFIZER INC202101716886

Write-up: lost consciousness; Syncope; Headache; Nausea; Fever: 38 to 40.5 degrees Celcius; Cold chills; Not feeling well; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: NL-LRB-00720782 (LRB). Other Case identifier(s): NL-LRB-00724641 (RA). A 29 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Lot number: FG6273) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Disease risk factor" (unspecified if ongoing). No previous COVID-19 infection. The patient''s concomitant medications were not reported. There was no past drug therapy BioNTech/Pfizer vaccine (Comirnaty). The following information was reported: SYNCOPE (medically significant) with onset 26Nov2021, outcome "unknown", described as "Syncope"; LOSS OF CONSCIOUSNESS (medically significant) with onset 26Nov2021 22:00, outcome "unknown", described as "lost consciousness"; CHILLS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Cold chills"; PYREXIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Fever: 38 to 40.5 degrees Celcius"; HEADACHE (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 16Nov2021, outcome "not recovered", described as "Not feeling well". The patient underwent the following laboratory tests and procedures: body temperature: (24Nov2021) Fever: 38 to 40.5 degrees Celcius. During patient''s evening shift with colleague she was not fit, but in her opinion fit enough to come to work. About 10 minutes (26Nov2021) before the end of her shift at 22:00 she lost consciousness. Her colleague found her around 22:10. She couldn''t wake me up at first either and called in a colleague from the other department (nursing home). Patient had never experienced this before. She stated that on Monday she will go to the doctor for this. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Unconscious: Additional information ADR: During my evening shift with my colleague I was not fit, but in my opinion fit enough to come to work. About 10 minutes before the end of my shift at 22:00 I lost consciousness. My colleague found me around 22:10. She couldn''t wake me up at first either and called in a colleague from the other department (nursing home). I have NEVER experienced this before. Monday I will go to the doctor for this. Service number available: yes. Previous COVID-19 infection: No. Sender''s comment: Since the nature of the reported reaction does not imply seriousness according to one of the RA critera, the report was considered as non-serious by a regulatory authority. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Unconscious : Additional information ADR: During my evening shift with my colleague I was not fit, but in my opinion fit enough to come to work. About 10 minutes before the end of my shift at 22:00 I lost consciousness. My colleague found me around 22:10. She couldn''t wake me up at first either and called in a colleague from the other department (nursing home).


VAERS ID: 1957491 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Headache, Immunisation, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dental implantation (taking unspecified steroids and antibiotics.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101719500

Write-up: Tight chest; Tonturas; Headache; Myalgia; General malaise; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: PT-INFARMED-B202111-1996. A 33 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: Unknown) at the age of 33 years as dose 3 (booster), 0.3ml single for covid-19 immunisation. Relevant medical history included: "Dental implantation" (unspecified if ongoing), notes: taking unspecified steroids and antibiotics. The patient''s concomitant medications were not reported. Past drug history included: Steroids; Antibiotics. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE), for Covid-19 immunisation, reaction(s): "No adverse event"; Bnt162b2 (DOSE 2, 0.3 ML SINGLE), for Covid-19 immunisation, reaction(s): "no adverse event". The following information was reported: CHEST DISCOMFORT (medically significant) with onset 16Nov2021, outcome "unknown", described as "Tight chest"; DIZZINESS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Tonturas"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovering", described as "Headache"; MYALGIA (medically significant) with onset 16Nov2021, outcome "recovering", described as "Myalgia"; MALAISE (medically significant) with onset 16Nov2021, outcome "unknown", described as "General malaise"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of chest discomfort, dizziness, headache, myalgia, malaise. Additional information: Treatment of ADR headache was performed with paracetamol, 1000 mg, every 8 hours, alternating with ibuprofen, 600 mg. At the date of the most recent contact with the notifier (13 days after the start of the ADRs), the patient reported that she was "in recovery", referring that the headache and myalgia (muscle discomfort at the level of the neck and left shoulder) occurred episodically, no longer needing treatment. The respective evolutions are unknown afterwards. The patient has no relevant clinical history and is not aware of allergies. Two weeks before the administration of the vaccine, she underwent an oral intervention for placement of two dental implants, with unspecified steroids and antibiotics. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1957539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-11-16
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

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: 20211116; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: positive
CDC Split Type: PTPFIZER INC202101735091

Write-up: COVID-19; positive result for SARS-2 virus on 16Nov2021. Covid +.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-1653. A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 11May2021 (Lot number: EX6537) as dose 2, 0.3 ml single and intramuscular, administration date 13Apr2021 (Lot number: EW2243) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Nov2021, outcome "unknown", described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 16Nov2021, outcome "unknown", described as "positive result for SARS-2 virus on 16Nov2021. Covid +.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive, notes: positive. Clinical comment:The reporters assessment of the casual relationship of the (All events) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Probable Reporter Comment: Other information-First dose: 13Apr2021~Pfizer~EW2243 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-First dose: 13Apr2021~Pfizer~EW2243


VAERS ID: 1957554 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Dizziness, Headache, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101730766

Write-up: back pain in the kidney areas; Stomach ache; Leg pain; Dizziness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: RO-NMA-2021-SPCOV15022 (RA). A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) at the age of 26-years-old as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient took concomitant medications. The following information was reported: BACK PAIN (life threatening) with onset 16Nov2021, outcome "recovering", described as "back pain in the kidney areas"; ABDOMINAL PAIN UPPER (life threatening) with onset 16Nov2021, outcome "recovering", described as "Stomach ache"; PAIN IN EXTREMITY (life threatening) with onset 16Nov2021, outcome "recovering", described as "Leg pain"; DIZZINESS (life threatening) with onset 16Nov2021, outcome "recovering", described as "Dizziness"; HEADACHE (life threatening) with onset 16Nov2021, outcome "recovering", described as "Headache". Therapeutic measures were taken as a result of back pain, abdominal pain upper, pain in extremity, dizziness, headache and included treatment with Dafalgan, kidney-related treatment (as per patient'' statement). Sender Comment: The Sender (i.e. the medical assessor from the Regulatory Authority) considers this case to be non-serious, but the case seriousness is maintained in RA as provided by the Reporter, as per the current RA legislation requirements. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1957637 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. On 16-NOV-2021 the patient sought medical advice for shortness of breath, and due to sepsis, heart failure, acute kidney injury and liver function impairment, the patient was transferred to the ICU. The physician was explained that patient disease was heart failure with other complications. On 29-NOV-2021 patient was transferred to general ward and patient felt it hard to control his body Company comment: This regulatory case concerns a 57-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of DYSPNOEA. The event occurred the day after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is not resolved. According to source document narrative, patient was admitted to the ICU due to sepsis, heart failure, liver function impaired and acute kidney injury. No treatment details were provided; however, it is stated that the patient was transferred to the general ward about 13 days after admission. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 57-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of DYSPNOEA. The event occurred the day after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is not resolved. According to source document narrative, patient was admitted to the ICU due to sepsis, heart failure, liver function impaired and acute kidney injury. No treatment details were provided; however, it is stated that the patient was transferred to the general ward about 13 days after admission. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957678 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: TWMODERNATX, INC.MOD20214

Write-up: Skin rashes (non-injection site); Pruritus; Alopecia; This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)), PRURITUS (Pruritus) and ALOPECIA (Alopecia) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 01-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion medically significant), PRURITUS (Pruritus) (seriousness criterion medically significant) and ALOPECIA (Alopecia) (seriousness criterion medically significant). At the time of the report, RASH (Skin rashes (non-injection site)), PRURITUS (Pruritus) and ALOPECIA (Alopecia) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. The patient received the second dose of COVID-19 (Moderna) vaccine on 1-Nov-2021. The patient visited the Emergency Department of the hospital on 16-Nov-2021 due to fever. The patient was hospitalized on 17-Nov-2021. Patient experienced rash over bilateral forearms which was then improved. On 14-Nov-2021 she became generally weak and sleepy and 3 days ago, fever up to 39'' [sic: �]C (forehead) occured [sic: occurred] without chillness. Antipyretics provided relief but it recurred. Accompanied symptoms include SOB, chest tightness, decreased appetite and constipation. Chronic sputum production with increased amount (white to yellow) these days is mentioned. Lab data included WBC 20K, CRP 12 mg/dl, procalcitonin 0.54. U/A: no pyuria; CXR: no obvious pneumonia patch. Under the impression of fever, cause to be determined, r/o pneumonia & influenza, UTI unlikely, patient was admitted for further management and was discharged on 22-Nov-2021. After admission, we kept empiric flumarin used. Fever subsided after 18-Nov-2021. Macular rash developed post COVID-19 vaccine, over forearms and subsided. Similar ones over thighs were noted during this admission course. Mycomb and allegra provided relief. Dyspnea improved greatly and BCx came back negative Latest lab data showed decreased CRP (12 -$g 7mg/dl). Flumarin has been administered for 6 days. With relatively stable condition, the patient was discharged on 22-Nov-2021 with OPD follow and blood test was arranged. The patient returned to the outpatient clinic of the [Department of] Thoracic Medicine for visit on 29-Nov-2021. Company comment: This case concerns a 47-year-old female patient with no relevant medical history who experienced serious unexpected events of rash, pruritus, alopecia. The events occurred approximately 15 days after the 2nd dose of the mRNA-1273 Reportedly, the patient visited ED due to fever and was hospitalized on the following day. There was bilateral rash on forearms. Two days prior to ED visit, the patient was weak and sleepy with fever of 39 degrees Celsius. Additional symptoms were shortness of breath, chest tightness, decreased appetite and constipation, as well as increased discolored sputum production. .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old female patient with no relevant medical history who experienced serious unexpected events of rash, pruritus, alopecia. The events occurred approximately 15 days after the 2nd dose of the mRNA-1273 Reportedly, the patient visited ED due to fever and was hospitalized on the following day. There was bilateral rash on forearms. Two days prior to ED visit, the patient was weak and sleepy with fever of 39 degrees Celsius. Additional symptoms were shortness of breath, chest tightness, decreased appetite and constipation, as well as increased discolored sputum production. .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957690 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Drug allergy (Uncertain drug).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Erythematous maculopapular; Erythematous maculopapular; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH ERYTHEMATOUS (Erythematous maculopapular) and RASH MACULO-PAPULAR (Erythematous maculopapular) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Drug allergy (Uncertain drug). On 14-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Erythematous maculopapular) (seriousness criterion hospitalization) and RASH MACULO-PAPULAR (Erythematous maculopapular) (seriousness criterion hospitalization). At the time of the report, RASH ERYTHEMATOUS (Erythematous maculopapular) and RASH MACULO-PAPULAR (Erythematous maculopapular) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 2021/11/16 Patient went to ER/admission and reported Multiple erythematous maculopapular skin rashes over the trunk and Extremities since 11/15. Patient also reported Vital Signs: TPR 37.3/107/18, BP 135/95, and Lab. data showed WBC 16.35 * 10 ^3/�L, Neut 83.0, Lym:10.9 %, D-dimer :1030 ng/ml Diphenhydramine 30mg q8h IVD, Acetaminophen 500 mg 1# QID, hydrocortisone 100 mg q8h IVP On 2021/11/17 Patient Consulted Dermatologist- drug eruption is most likely. On 2021/11/18 Patient was clinical improving and discharged. The follow-up care is as follow 2021/12/04 the patient''s phone was shut down. This case concerns a 28-year-old female patient with relevant medical history of Drug allergy, who experienced the unexpected serious events of Rash Erythematous and Rash Maculo-Papular. The events, which caused hospitalization for the patient occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Drug Allergy remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 28-year-old female patient with relevant medical history of Drug allergy, who experienced the unexpected serious events of Rash Erythematous and Rash Maculo-Papular. The events, which caused hospitalization for the patient occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Drug Allergy remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1958711 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradyarrhythmia, Dyspnoea, Immunisation, Pyrexia, Shock symptom, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Bradyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Pulmonary vein isolation; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101728308

Write-up: Shock symptom; Dyspnoea; bradycardic atrial fibrillation; Pyrexia; Somnolence; Vomiting; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-062435. A 39 year-old male patient received BNT162B2 (COMIRNATY), solution for injection, intramuscular, administration date 16Nov2021 (Lot number: Ff2834) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "atrial fibrillation", start date: 2012 (unspecified if ongoing); "pulmonary vein isolation", start date: 2012 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, UNKNOWN MANUFACTURER), for covid-19 immunisation; Covid-19 vaccine (dose 2, UNKNOWN MANUFACTURER), for covid-19 immunisation. The patient experienced IMMUNISATION (hospitalization, Medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; SHOCK SYMPTOM (hospitalization, Medically significant) with onset 17Nov2021, outcome "not recovered", described as "Shock symptom"; DYSPNOEA (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Dyspnoea"; BRADYARRHYTHMIA (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "bradycardic atrial fibrillation"; PYREXIA (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Pyrexia"; SOMNOLENCE (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Somnolence"; VOMITING (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "Vomiting". Additional information included: Sender Comment: The report is for one patient. The causal relationship of Comirnaty and Vomiting assessed as Probable/Likely by the HCP. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1958793 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haematuria, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101728322

Write-up: Nausea; Vomiting; Macroscopic haematuria; This is a spontaneous report received from a contactable reporter(s) (Physician) from a regulatory authority-WEB. Regulatory number: AT-BASGAGES-2021-062444 (BASGAGES). A 68 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Lot number: FH0161) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (hospitalization) with onset 16Nov2021, outcome "unknown", described as "Nausea"; VOMITING (medically significant) with onset 16Nov2021, outcome "unknown", described as "Vomiting"; HAEMATURIA (medically significant) with onset 16Nov2021, outcome "unknown", described as "Macroscopic haematuria". The events "nausea", "vomiting" and "macroscopic haematuria" were evaluated at the emergency room visit. Result of assessment for all events (source: HCP; a regulatory authority assessment) CERTAIN. Reporter Comment: Treatment of side effect 1: no progress as the patient went to the emergency room Treatment of side effect 3: see above No follow-up attempts are possible. No further information is expected.


VAERS ID: 1959789 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31191TB / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Monoparesis, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101728696

Write-up: Transient ischaemic attack; Right arm paresis; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100261140. A 60 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Oct2021 (Lot number: 31191TB) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 16Nov2021, outcome "recovered" (2021), described as "Transient ischaemic attack"; MONOPARESIS (hospitalization) with onset 16Nov2021, outcome "recovered" (2021), described as "Right arm paresis". Result of Assessment: Comirnaty/ event(s): Transient ischaemic attack, Right arm paresis/ Regulatory Authority: D. Unclassifiable.


VAERS ID: 1959801 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-11-16
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVY8 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Cerebral artery perforation, Cerebral infarction, Cerebral ischaemia, Embolic cerebral infarction, Full blood count, Hemiparesis, Magnetic resonance imaging, Microangiopathy, Troponin T
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Cholesterol; Result Unstructured Data: Test Result:slightly elevated; Test Date: 2021; Test Name: CK; Result Unstructured Data: Test Result:4.47; Comments: slightly elevated; Test Date: 2021; Test Name: blood count; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:small embolic infarcts; Comments: in the left anterior mediastinal stroma area; Test Date: 2021; Test Name: Trop T; Result Unstructured Data: Test Result:13 ng/L; Comments: limit value up to 5
CDC Split Type: DEPFIZER INC202101730141

Write-up: Hemiparesis (right); Middle cerebral artery perforation; cerebral medial infarct li; Cerebral ischemia in the mediastromal area on the left side; small embolic infarcts in the left anterior mediastinal stroma area; formal microangiopathlsch; This is a spontaneous report received from a non-contactable consumer from the Regulatory number: DE-PEI-202100262404. An 82-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), administration date 30Sep2021 (Lot number: SCVY8) at the age of 82 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "arterial hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: COVID-19 vaccine (dose 1 [manufacturer unknown], Batch/Lot number : unknown), for COVID-19 immunisation. The following information was reported: CEREBRAL ARTERY PERFORATION (hospitalization, medically significant, life threatening) with onset 16Nov2021, outcome "not recovered", described as "Middle cerebral artery perforation"; CEREBRAL INFARCTION (hospitalization, medically significant, life threatening) with onset 16Nov2021, outcome "not recovered", described as "cerebral medial infarct li"; HEMIPARESIS (hospitalization, medically significant, life threatening) with onset 16Nov2021 02:00, outcome "not recovered", described as "Hemiparesis (right)"; CEREBRAL ISCHAEMIA (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "Cerebral ischemia in the mediastromal area on the left side"; EMBOLIC CEREBRAL INFARCTION (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "small embolic infarcts in the left anterior mediastinal stroma area"; MICROANGIOPATHY (hospitalization, life threatening) with onset 2021, outcome "unknown", described as "formal microangiopathlsch". It was reported that the patient was presented to the emergency department. The patient had woken up with a right hemiparesis at about 2 o''clock in the morning. She had gone to bed at 9:45 p.m. the previous day (15Nov2021), where everything was still "normal." An art. She could not say why the patient was taking aspirin. The patient was hospitalized for cerebral artery perforation, cerebral infarction, hemiparesis, cerebral ischaemia, embolic cerebral infarction, microangiopathy (start date: 06Nov2021, discharge date: 19Nov2021, hospitalization duration: 13 days). The event "hemiparesis (right)" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood cholesterol: (2021) slightly elevated; blood creatine phosphokinase: (2021) 4.47, notes: slightly elevated; full blood count: (2021) unknown results; magnetic resonance imaging: (2021) small embolic infarcts, notes: in the left anterior mediastinal stroma area; troponin T (normal high range 5): (2021) 13 ng/L, notes: limit value up to 5. The relatedness of BNT162B2 to the events were assessed via PEI. The result of assessment was as follows: middle cerebral artery perforation: indeterminate; cerebral infarction: unclassifiable; hemiparesis (right): indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1959970 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling abnormal, Heart rate, Insomnia, Malaise, Palpitations, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Dementia (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood pressure; Result Unstructured Data: Test Result:230/130; Test Date: 2021; Test Name: heart beat; Result Unstructured Data: Test Result:occasionally heart calmed down; Test Date: 20211116; Test Name: heart beat; Result Unstructured Data: Test Result:beating like crazy all the time feeling really bad; Comments: beating abnormally all the time
CDC Split Type: FIPFIZER INC202101729151

Write-up: Malaise; Felt faint/feeling of fainting; Blood pressure increased; Palpitations; Difficulty sleeping/could not sleep at all; feeling really bad; like a state of shock; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217280. A 47 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: Malaise (life threatening) with onset 16Nov2021, outcome "recovering", described as "Malaise"; Dizziness (life threatening) with onset 16Nov2021, outcome "recovering", described as "Felt faint/feeling of fainting"; Blood Pressure Increased (life threatening) with onset 16Nov2021, outcome "recovering", described as "Blood pressure increased"; Palpitations (life threatening) with onset 16Nov2021, outcome "recovering", described as "Palpitations"; Insomnia (life threatening) with onset 16Nov2021, outcome "recovering", described as "Difficulty sleeping/could not sleep at all"; Feeling Abnormal (life threatening) with onset 16Nov2021, outcome "unknown", described as "feeling really bad"; Shock (life threatening) with onset 2021, outcome "unknown", described as "like a state of shock". Course of events: It was reported that her heart started beating like crazy all the time feeling really bad occasionally heart calmed down but soon started again 24 hours awake, initially no difference between day and night the patient did not feel tired at all, all the time besides very bad malaise. Eventually feeling of fainting when falling asleep and immediately upon waking up. She could not sleep at all. However, this alone did not cause those symptoms because the heart was beating abnormally all the time. It felt like a state of shock in the body. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (16Nov2021) 230/130; heart rate: (2021) occasionally heart calmed down; (16Nov2021) beating like crazy all the time feeling really bad, notes: beating abnormally all the time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Meniere''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101772288

Write-up: severe vomiting; booster; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 15:00 (Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Meniere''s disease" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single, Left arm, Intramuscular injection, Lot number: EP9598), administration date: 11Mar2021, for COVID-19 immunisation; Comirnaty (Dose 2, 0.3 mL, Left arm, Intramuscular injection, Lot number: ER9470), administration date: 01Apr2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "Meniere''s disease aggravated". The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021 15:00, outcome "unknown", described as "booster"; VOMITING (medically significant) with onset 16Nov2021 22:00, outcome "unknown", described as "severe vomiting". 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) : FR-PFIZER INC-202101728630 same reporter, suspect, different events, suspect dose


VAERS ID: 1960363 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Malaise, Off label use, Product use issue
SMQs:, Medication errors (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101732002

Write-up: feeling unwell; Shingles; Patient received third dose on 16Nov2021; Patient received third dose on 16Nov2021; Patient received third dose on 16Nov2021; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112051336371820-RTHXH (MHRA). Other Case identifier(s): GB-MHRA-ADR 26291203. A female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 16Nov2021. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test, not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1, SINGLE, Batch/Lot number : Unknown), administration date: 19Mar2021, for Vaccination; COVID-19 vaccine astrazeneca (DOSE 2, SINGLE, Batch/Lot number : Unknown), administration date: 01Jun2021, for Vaccination. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Patient received third dose on 16Nov2021"; PRODUCT USE ISSUE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Product use for unapproved combination"; MALAISE (medically significant) with onset 27Nov2021, outcome "recovering", described as "feeling unwell"; HERPES ZOSTER (medically significant) with onset 27Nov2021, outcome "recovering", described as "Shingles". The events "feeling unwell" and "shingles" were evaluated at the physician office visit. Clinical course: Normally a very fit and well person and had not been ill for years. 11 days after having COVID booster she started feeling unwell and this developed into Shingles. Doctor confirmed Shingles and prescribed medication. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960414 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101731765

Write-up: Heart racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112052352542230-HUGUG. Other Case identifier(s): GB-MHRA-ADR 26293394. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Heart racing". The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960628 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye disorder, Hypoaesthesia, Muscle spasms
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad), Retinal disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: right eye problems also; muscle spasm; Numbness of limbs; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26299150) on 08-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of limbs), EYE DISORDER (right eye problems also) and MUSCLE SPASMS (muscle spasm) in a 69-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No relevant medical history was provided by the reporter. Concomitant products included PARACETAMOL from 01-Jan-2020 to an unknown date for Arthritis. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HYPOAESTHESIA (Numbness of limbs) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE DISORDER (right eye problems also) (seriousness criterion medically significant) and MUSCLE SPASMS (muscle spasm) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness of limbs) had not resolved and EYE DISORDER (right eye problems also) and MUSCLE SPASMS (muscle spasm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. CC: This is a regulatory case concerning a 69-year-old male patient with no reported medical history, who experienced the serious (medically significant) unexpected events hypoasthesia of limbs, eye disorder and muscle spams . The events occurred approximately one days after the third dose of mRNA-1273. Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. Patient woke-up with sharp pain from mid left back/ felt like muscle spasm, burning pain in underside of right arm. Underside of arm has been numb ever since. Right eye problems also, unable to read without glasses also. No Treatment medication was provided.; Sender''s Comments: This is a regulatory case concerning a 69-year-old male patient with no reported medical history, who experienced the serious (medically significant) unexpected events hypoasthesia of limbs, eye disorder and muscle spams . The events occurred approximately one days after the third dose of mRNA-1273. Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1960722 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Immunisation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101730639

Write-up: Chest tightness; Coughing; Wheezes; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-086850. A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Type II diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1, Batch number: Unknown, It was noted in the report that in Jan2021, the patient experienced a suspected adverse reaction following the first dose of the vaccine (See linked case IE-HPRA-2021-087602).), administration date: Jan2021, for COVID-19 immunisation, reaction(s): "Adverse reaction"; Comirnaty (Dose 2, Batch number: Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHEST DISCOMFORT (medically significant) with onset 16Nov2021 08:35, outcome "unknown", described as "Chest tightness"; COUGH (medically significant) with onset 16Nov2021 08:35, outcome "unknown", described as "Coughing"; WHEEZING (medically significant) with onset 16Nov2021 08:35, outcome "unknown", described as "Wheezes". The events "chest tightness", "coughing" and "wheezes" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of chest discomfort, cough, wheezing. Clinical course: It was reported that the patient was not taking any concomitant medication. On 16Nov2021, at 08:35 immediately (less than a minute) post the booster dose, the patient experienced wheezes, chest tightness and coughing. The patient was administered salbutamol immediately and sent to the emergency department. The patient was treated with salbutamol (nebulization), SoluCortef and chlorpheniramine maleate (intravenously). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-087602


VAERS ID: 1960724 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Burning sensation, Butterfly rash, Cellulitis, Erythema, Eye swelling, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Rash, Skin swelling, Superinfection bacterial
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101728985

Write-up: Swollen eyes; puffy face rash all over the face; puffy face rash all over the face; Off label use; Interchange of vaccine products; Booster; Followed by blistering; Burning sensation; facial erythema, butterfly distribution and forehead; secondary bacterial superinfection (re facial cellulitis); Facial erythema; Feeling generally tired; secondary bacterial superinfection (re facial cellulitis); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-086908. Other Case identifier(s): IE-HPRA-CVARR2021111722688. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Past drug history included: Vaxzevria, start date: May2021, stop date: May2021, for COVID-19 immunisation, notes: Dose 1; Vaxzevria, start date: Jul2021, stop date: Jul2021, for COVID-19 immunisation, notes: Dose 2. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; BLISTER (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Followed by blistering"; BURNING SENSATION (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Burning sensation"; BUTTERFLY RASH (medically significant) with onset 16Nov2021, outcome "not recovered", described as "facial erythema, butterfly distribution and forehead"; CELLULITIS (medically significant), SUPERINFECTION BACTERIAL (medically significant) all with onset 16Nov2021, outcome "not recovered" and all described as "secondary bacterial superinfection (re facial cellulitis)"; ERYTHEMA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Facial erythema"; FATIGUE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Feeling generally tired"; EYE SWELLING (non-serious) with onset 17Nov2021 02:00, outcome "not recovered", described as "Swollen eyes"; RASH (non-serious) with onset 17Nov2021 02:00, outcome "not recovered", SKIN SWELLING (non-serious) with onset 17Nov2021, outcome "not recovered" and all described as "puffy face rash all over the face". Therapeutic measures were taken as a result of burning sensation, butterfly rash, cellulitis, erythema, fatigue, superinfection bacterial, eye swelling, rash, skin swelling. Clinical course: The patient was treated with antihistamine medication (not further specified). Two hours after vaccination, the patient had events. The patient was reviewed by her General Practitioner on 18Nov2021 and was treated with prednisolone (30 milligrams) for five days and antibiotic cover for possible secondary bacterial superinfection with Co-amoxiclav, in relation to facial cellulitis. The reporter stated that they plan to check the patient''s FBC, ESR, CRP, renal and liver function and will review the patient next week. The duration of reaction was reported as ongoing. The reporter stated that the symptoms were presented until the time of reporting. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-086973


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